Half Year 2024 HUTCHMED (China) Ltd Earnings Call

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David Ng: Hello, everyone. Welcome to Hatchmat 2014 Interim Results Presentation. My name is David Ng, Head of Hatchmat IR. Our results announcement, as well as our presentation slides, have already been uploaded to our company homepage, as well as the Hong Kong Style Exchange website.

David Ng: You have joined the meeting as an attendee and will be muted throughout the meeting. Hello everyone, Welcome to the HMET 2014 Interim Results presentation. My name is David Ng, head of HMET IL. Our results announcement, as well as our presentation slides, have already been uploaded to our company homepage, as well as the Hong Kong Stock Exchange website. Before we start, just a few quick reminders. All audiences are currently being muted during the presentation by our management.

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David Ng: Hello everyone. Welcome to HMET 2014 Interim Results Presentation. My name is David Ng, Head of HMET-IR. Our results announcement as well as our presentation slides have already been uploaded to our company homepage, as well as the Hong Kong Stock Exchange website. Before we start, just a few quick reminders. All audiences are currently muted during the presentation by our management, and then we will be followed by a Q&A session.

David Ng: Before we start, just a few quick reminders. All audiences are currently muted during the presentation by our management. And then we will be followed by a Q&A session.

David Ng: And then we will be followed by a Q&A session. Second, please type your name as well as your company name to appear on your screen. And finally... Please read on page two of our presentation slides for the safe harbor statement and disclaimer. The performance and results of operation of the hatchback contained within this presentation are historical in nature, and past performance is no guarantee of future results.

David Ng: Second, please type your name as well as your company name to show up on your screen. And finally, please read on page two of our presentation slides for this safe harbor statement and disclaimer. The performance and results on of operation of the Hatchmat contain within this presentation, a historical in nature. And past performance is no guarantee of future results.

David Ng: [inaudible]

Speaker Change: Second, please type your name as well as your company name to show up on your screen.

David Ng: And finally, please read on page 2 of our presentation slides for the Safe Harbor Statement and Disclaimer. The performance and results of operation of the hatchback contained within this presentation are historical in nature, and past performance is no guarantee of future results.

David Ng: So, without further delay, let me introduce our chief executive officer and chief scientific officer, Dr. Sue, to begin our presentation.

David Ng: So without further delay, let me introduce our Chief Executive Officer and Chief Scientific Officer, Dr. Su, to begin our presentation for today.

David Ng: So without further delay, let me introduce our Chief Executive Officer and Chief Scientific Officer, Dr. Su, to begin our presentation for today. Dr. Su.

And, um, but they don't consume.

Dr. Sue: Thanks, David. Good evening. Good morning, everyone. Welcome to Hatchmat First Half, 2024 results conference call. Within today, our Johnny Chan, CFO. George Yuan, Head of Commercial.

Dr. Su: Thank you, David. Good evening. Good morning, everyone.

Dr. Su: Thanks, David. Good evening. Good morning, everyone. Welcome to Hachmat First Half 2024 Results Conference Call.

Dr. Su: Welcome to Hachmat's First Half 2024 Results Conference Call. With me today are Johnny Chan, CFO, and George Yuan, Head of Commercial. George joined us a month ago.

Speaker Change: With me today are Johnny Chan, CFO , George Yuan, Head of Commercial,

George, join us a month ago. George is a highly experienced veteran in oncology product sales and marketing. He joined us from Mark, where he headed its China commercial operations for the last seven years with great success.

Dr. Su: George is a highly experienced veteran in oncology product sales and marketing. He joined us from Merck where he headed its China commercial operations for the last seven years with great success, and George will be followed by Mike who will give a brief update on the pipeline. Next slide, please. Slide number four.

Speaker Change: George joined us a month ago. George is a highly experienced veteran in oncology product sales and marketing.

Speaker Change: He joined us from Merck where he headed its China commercial operations for the last seven years with great success.

And George will be followed by Mike, who will give a brief update on the pipeline.

Speaker Change: And George will be followed by Mike, who will give a brief update on the pipeline.

Next slide, please.

Dr. Sue: Slide number four. Just to give you a quick summary, first half, 2024. We continue to execute on our strategy towards self-sustaining. As a big part of this strategy is globalization. We are launching through Quintenet worldwide with our partner to cater. And we look forward to filing for approval for our second product, several Internet in the US later this year with our partner AstraZeneca. On the pipeline, we continue to file the lifecycle indications for the first wave of product. At the same time, the second-wave product, Solve the Planet, has matters that NDAs are on the review in China, and we expect to launch them in the next 6-12 months.

Speaker Change: Next slide, please.

Dr. Su: Just to give you a quick summary of first half 2024. We continue to execute on our strategy towards self-sustaining, and a big part of this strategy is globalization.

Mike: Slide number four.

Mike: Just to give you a quick summary, first half 2024.

Mike: We continue to execute on our strategy towards self-sustaining.

Mike: [inaudible]

Mike: And a big part of this strategy is globalization.

Dr. Su: We are launching Frequentiner worldwide with our partner Takeda, and we look forward to filing for approval for our second product, Salve Latinib, in the U.S. later this year with our partner AstraZeneca in the pipeline. We continue to file for lifecycle indications for the first wave of products. IDH1-2 inhibitor, HMPL306, in Recurrent and Refractory AML, in China. All products experienced double-digit growth.

Mike: We are launching Frequentiner worldwide with our partner Takeda.

Mike: And we look forward to filing for approval for our second product, Cervaletinib, in the US later this year with our partner AstraZeneca.

Mike: On the pipeline, we continue to file for lifecycle indications for the first wave of products.

Mike: At the same time, the second web product, Solve the Planet, Tasmatis.ndh,

Mike: are under review in China, and we expect to launch them.

Mike: in the next 6 to 12 months.

Our best-in-class IDH-1-2 inhibitor, HMP-306, entered into Phase 3 in recurrent and refractory AML.

Mike: Our best-in-class IDH1-2 inhibitor, HMPL306, entered into Phase III.

Mike: in Recurrent and Refractory AML.

Dr. Sue: On commercialization, first and update on fruzecly U.S. performance, first-half in-locked cells reach just over $130 million U.S. suggesting strong early-uptake, we expect EU and Japan launches later this year. In China, all products experience the double-digit growth, while fighting through the fierce competition. Taken together, they combine in-marked cells, grew 145%, primarily driven by fruzecly U.S. cells.

Speaker Change: On commercialization, first, an update on Fruits Accolade U.S. performance.

Speaker Change: First half, in-market sales.

Speaker Change: reached just over 130 million U.S. dollars, suggesting strong early uptake.

Speaker Change: We expect EU and Japan launches later this year.

Speaker Change: in China.

Speaker Change: All products experience a double-digit growth while fighting through fierce competition.

Speaker Change: Taken together, the combined in-market sales grew 145%.

Speaker Change: primarily driven by exactly U.S. sales.

Johnny Cheng: So with that, I'll turn it to Johnny Chen, CFO, to give you more details on the financials.

Speaker Change: So with that, I'll turn it to...

Speaker Change: Johnny Chen, CFO , to give you more details on the financials.

Johnny Cheng: Johnny. Okay, thank you, Dr. Xu. So on page 6, as you all can see, we have made a profit of 26 million in the first half, with revenue of a market of products up 64% at constant exchange rate to 128 million. So oncology consolidated the revenue achieved the 168 million, on track to meet our full-year revenue guidance of 300 to 400 million.

Speaker Change: Johnny.

Johnny Chen: Okay, thank you, Dr. Hsu. So, on page 6, as you all can see, we have made profits of $26 million in the first half, with revenue of marketed products up 64% at constant exchange rates to $128 million.

Dr. Su: So Oncology Consolidated Revenue achieved $168 million, and we are still the market leader in the SurLine MCRC. And we believe the SurLine MCRC still has room to grow in China. Additionally, we received Hong Kong approval for SurLine MCRC. Yeah, our product pipeline continues to grow and mature. As you can see, we're actually making a lot of progress.

Speaker Change: So Oncology Consolidated Revenue achieved $168 million, on track to meet our full year revenue guidance of $300 to $400 million.

Johnny Cheng: R&D expenditures have reduced to 95 million, mainly due to a strategic reorganization of the external team and prioritization of projects.

Speaker Change: R&D expenditures have reduced to $95 million, mainly due to strategic reorganization of the X-China team and prioritization of projects.

Johnny Cheng: Turning to the next page, page 7. On the guidance, as highlighted just now, we are on track to meet our full-year oncology and immunology revenue guidance of 300 to 400 million.

Speaker Change: Turning to the next page, page 7.

Speaker Change: On the guidance as highlighted just now, we are on track to meet our full year oncology and immunology revenue guidance of $300 to $400 million.

Johnny Cheng: So we are likely to achieve the high end of the guidance due to the potential additional commercial milestones from Takeda. In addition, we are also likely to receive EU and Japan-related milestones in the second half.

Speaker Change: So we are likely to achieve the high end of the guidance due to the potential additional commercial milestones from Takeda. In addition, we are also likely to receive EU and Japan related milestones in the second half.

Johnny Cheng: Moving on to the next page, page 8. On the balance sheet, as you can see, we continue to maintain a strong cash position of over 800 million. So, on the bank borings, we are drawn from a low interest-bearing facility for the construction of our new Shanghai factory.

Speaker Change: Moving on to the next page, page eight.

Speaker Change: On the balance sheet, as you can see, we continue to maintain a strong cash position of over $800 million.

Speaker Change: So on the bank borrowings, we are drawn from a low interest bearing facility for the construction of our new Shanghai factory. We are getting net positive income as our actual borrowing rate is lower than our interest rate earned on our short-term deposit.

Johnny Cheng: We are getting less positive income as our actual borin rate is lower than our interest rate earned on our short-term deposit.

George Yuan: Now, I will pass to our head of commercial, George.

Speaker Change: Now I will pass to our Head of Commercial, George Yeo.

Thanks, Johnny.

George Yuan: First, let's talk to some mentioned. We have a very strong start of a quick neighbor in the US. This issue, the slides tend to show you the US results. We see a very strong Q1 and even stronger Q2. And if you look to the future, we are expecting a Japan. Provo in a very quick fashion and also we are waiting for EU reimbursement decision. Next line. And look at the China market for continuing the very competitive market, we still deliver a double digit gross and we're still the market leader in the SLI MCRC and we believe the MCRC still has room to grow in China.

George Yeh: Thanks, Johnny. First, let's...

George Yeh: Dr. Su mentioned we have a very strong start of continuity in the U.S. This shows you the slide 10, shows you the U.S. results. We see a very strong Q1 and an even stronger Q2.

Speaker Change: And if you look at the future, we were expecting Japan.

Speaker Change: approval in a very quick session and also we are waiting for EU reimbursement decision. Next slide.

Speaker Change: And look at the China market, for continue being a very competitive market, we still deliver a double-digit growth.

Speaker Change: and we're still the market leader in the SurLine MCRC. And we believe the MCRC still has a room to grow in China. Additionally, we receive a Hong Kong approval for MCRC SurLine.

George Yuan: Additionally, we receive Hong Kong approval for MCRC SLI.

George Yuan: Next move to the next slides for Solanda. This is where we are delivered in the first half of this year. We deliver a very good gross and we are the number two grand in the name treatment market and also we are getting market share.

Speaker Change: Next, move to the next slides. For Solyndra, in the first half of this year, we delivered a very good growth, and we are the number two brand in the NAM treatment market, and also we are gaining market share.

George Yuan: If you look at the guideline, we get a multiple endorsement for the treatment in Cisco in Carthage Island, and also we believe there's a lot of room to grow because this area is still under diagnosed and some of the treatments still need to be more rational and affordable to form the guideline. If you look at the next slides, the Opus is our first in-class math inhibits. We see the market become more cowed, but the gross of the first half of this year is still strong, and the math 14 testing become a standard care in the market.

Speaker Change: If you look at the guidelines, we get multiple endorsements for the treatment.

Speaker Change: in Cisco in Qatar guideline and also we believe there's a lot of room to grow because this area is still under diagnose and some of the treatments still need to be more rational and to form the guideline.

Speaker Change: If you look at the next slide, the opacity,

Speaker Change: Our first in class metinhibit.

Speaker Change: We see the market become more cloud, but the growth of the first half of this year is still strong, and the MAT-14 testing become a standard of care in the market. We still believe with AstraZeneca's strong platform in lung cancer, we can deliver a much stronger growth in China.

George Yuan: We still believe with AstraZeneca's strong platform in Lancaster, we can deliver a much stronger growth in China.

George Yuan: Look forward; we are preparing our ATP market growth. If you look at this market, this is our first in-class launch in China and we are this product's main way for us to move into in-knowledge field and we will sequence our business priority to address the low hand force first then going to a major market after an idea application.

Speaker Change: Look forward, we are preparing our ATP.

Marquette Groves: Market Grows.

Speaker Change: If you look at this market, this is our first in-class launch in China, and these products pave the way for us to move into the knowledge field. And we will sequence our business priority to address the low-hand foods first.

George Yuan: Then, if you look at our company, we are preparing the market, we are preparing the products, and we are preparing the organization to prepare the launch. If you look at the overall China commercial environment, we believe with the current encouragement of China innovation, the market situation becomes more favorable for the innovative medicine.

Speaker Change: then going to a major market after an idea application. Then if you look at the company, we are preparing the market, we are preparing the products, and we are preparing the organization to prepare the launch.

Speaker Change: And if you look at the overall China commercial environment, we believe with the current increasement of China innovation, the market situation become more favorable for the innovative medicine.

Mike: Now let's introduce Mike, our CMO. Thank you, George. Next slide. Yeah, our product pipeline of Continue the Grow, as you can see, we're actually making a lot of progress. We have six NDA or supplementary NDA under review globally and not only for Fuku Nene. We have international approval based on the Fresco 2 results. We also have the Fritiga and also the Fusica one for additional invocation in gastric cancer and individual cancer. More importantly, we also have a new product under review. We have the Savo plan F for the second line ITP and also a new product, TASMETIS data we license from Yvesson, also under priority review in China, and additionally, we have the Savo litinette, also for the confirmatory trial for medicine 14 under review for first line non-sport cell lung cancer.

Speaker Change: Now let's introduce Mike, our CMO.

Mike: Thank you, George. Next slide.

Mike: Yeah, our product pipeline continues to grow and mature. As you can see, we're actually making a lot of progress. We have six NDA or supplementary NDA under review globally.

Dr. Su: We have six NDAs or supplementary NDAs under review globally. And not only for Fuclinaneb, we have, you know, international approval based on the FRESCO2 results; we also have Fruteca and also the Fruceca one for additional indications in gastric cancer and endometrial cancer. Next slide. Slide 19, please.

Mike: And not only for Fukuninib, we have, you know, international approval based on the Fresco 2 results. We also have the Futiga and also the Fusica one for additional indication in gastric cancer and individual cancer.

Mike: More importantly, we also have a new product under review. We have the suboplanet for the

Mike: Satellite ATP

Mike: and also a new product, Tas-Medistat, we licensed from Ibsen, also under priority review in China.

Mike: And additionally, we have the subalternate also for the confirmatory trial for medicine 14 under review for first line non-small cell lung cancer.

So additional pipeline of Continue the Grow, we are very excited later this year. Our partner AstraZeneca, based on the Savannah trial, will have the potential to bring the Savo litinette into the US NDA submission, and also in the next few years, we continue to advance our pipeline in the registration study.

Mike: So additional pipeline continues to grow. We are very excited later this year.

Speaker Change: Our partner AstraZeneca, based on the Savannah trial, will have the potential to bring the salmonella into the US NDA submission.

Speaker Change: And also in the next few years, we continue to advance our pipeline in the registration study.

Mike: Dr. Su mentioned about the Rafael study; our new class compound IDH1 and 2 inhibitor HMPL 306 also engages the Phase III trial. Next slide. Slide 18. We have presented our second-line gastric cancer for Proclina, being combination with papillary Tatsal at the Astral plenary early in February, and also had the updated results at the Astral plenary session. We are really pleased that the robust clinical data showing the double over objective response rate, and also the progression free survival. And also, we look at the longest overall survival in the second-line setting has been reported. And this end yet is currently under the CDU review.

Speaker Change: and Dr. Su mentioned about the Raphael study.

Dr. Su: Our new class of compound IDH1 and 2 inhibitor.

Dr. Su: HMPL 306, also initiated the Phase 3 trial. Next slide.

Dr. Su: Slide 18, we have presented our second line gastric cancer for Fukuninib in combination with Paclitaxel.

Speaker Change: at the ASCO plenary early February , and also had the update results at the ASCO plenary session.

Speaker Change: We are really pleased that the robust clinical data

Speaker Change: showing the double the objective response rate and also the progression-free survival. And also we look at the longest over survival in the second line setting has been reported. And this NDA is currently under the CDE review.

Slide 19, please.

Dr. Su: And also, we update our FUSICA trial and, For QNNF with PD-1 centilumab in entomedial cancer, we reported the results at ASCO. We have seen a very robust overall response rate of 35.6%. Next slide.

Mike: And also, we update our for CIGA trial. And for clinical with PD-1, Centilla-Map, in the inometrial cancer reported the results at ASCO that we have seen very robust over response rate, 35.6% over response rate, and the medium PFS 9.51.

Speaker Change: Slide 19, please.

Speaker Change: And also we update our FUSICA trial and

Speaker Change: For QNNF with PD-1 centilumab in the enomedial cancer, we reported the results at ASCO and we have seen very robust overall response rate, 35.6%.

So this NDA has been accepted under priority review at the CD.

Speaker Change: overall response rate and the median PFS 9.51. So this NDA has been accepted under priority review at the CDE. Next slide.

Next slide.

Mike: Also, our for Quintanae plus Centilla-map in the RCC also fully recruited. We are waiting for the events for later this year. If positive, we're going to follow additional NDA for Quintanae in the RCC.

Speaker Change: Also, our Fuqua Internet Plus Sentinel app in the RCC also fully recruited. We are waiting for the events for later this year. If positive, we're going to file additional NDA for Fuqua Internet in the RCC.

Mike: Slide 21. And also, we are very excited about our next new product, our first innovative molecule, the thick inhibitor. We reported, we saw our EASL and Phase-1, EASL-1 trial in the Phase-3 at IFA, and also with the single TASIS publication and LENSA hematology.

Dr. Su: And also, we are very excited about our next new product, our first innovative molecule, the SICK inhibitor. We reported with our ISLAM Phase 1, ISLAM 1 trial in phase 3 at the IHA and also with the simultaneous publication of Lansat hematology. I really show this compound has a very robust best-in-class molecule in heavily pre-treated patients; over 75% of the patients pre-treated with TIPO-TIPO-RA also show a very robust durable response rate of 48% and overall response rate of 71%. And also, the side effect profile is very favorable compared with the low off-target effect, and there's no thrombolytic event like TPRA has.

Speaker Change: Slide 21.

Speaker Change: And also, we are very excited about our next new product, our first innovative molecule, the SICK inhibitor.

Speaker Change: We reported with our ISLAM Phase 1, ISLAM 1 trial in the Phase 3 at the IHA, and also with the simultaneous publication and Lansat hematology.

I really show this compound as a very robust, biasing-class molecule in heavily procured patients. Over 75% of the patient, procured as T-bo-T-B-R-A, also show a very robust, durable response rate 48% and over-response rate 71%. And this play-lay increase is very rapid within after week. And also, the side effect profile is very favorable compared with the load of target effects, and there's no symbolic event like the T-bo-R-A has. And also, internationally, we started the Phase-1 trial in ITP, in the US, EU, and Australia.

Speaker Change: I really show this compound as a very robust best-in-class molecule in heavily pre-treated patients. Over 75% of the patients pre-treated with t-po-t-po-R-A

Speaker Change: also show a very robust durable response rate, 48%, and overall response rate, 71%. And this platelet increase is very rapid within half the week.

Speaker Change: And also the side effect profile is very favorable compared with the low off-target effect, and there's no thrombolytic event like TPRA has.

Speaker Change: And also, internationally, we started the Phase 1 trial in ITP in US, EU, and Australia.

Mike: And also, at the EASL, we present our clinical-proper concept trial for warm auto-immune hematology and pneumonia and also selected primary presentation, also show very robust, 48% durable response rate and over-response rate of 67%. So the Phase-3 trial is already started in rolling patients.

Speaker Change: And also at the eHouse, we present our clinical proof of concept trial for warm autoimmune hemolytic anemia, and also selected primary presentation, also show very robust 48% durable response rate and overall response rate of 67%.

Speaker Change: So the phase three trial is already started and enrolling patients.

And for international development, we really think this is a great molecule, has a biasing-class potential and multiple development opportunities. For example, in secondary ITP, in T-bo-T-B-R-A, pre-treated patients and also, you know, there are other opportunities in combination with standard care and also potentially secondary ITP or other auto Lee, Slide 22.

Speaker Change: And for international development, we really think this is a great molecule.

Speaker Change: best-in-class potential, multiple development opportunities, for example in second-line ITP, in TIPO-TIPO-RA, pre-treated patients.

Speaker Change: And also, you know, there are other opportunities in combination with standard of care and also potentially secondary ITP or other autoimmune disease. Slide 22.

Mike: We also excited to see the advancement was solvalidimate or mad inhibitor. We have approval in China and also our global partner, AstraZeneca, is completing the completed re-enrollment and with the read-out in the second third line, there's a combination trial you met out-averrated patients. So the results were reading eagerly, with the potential for our second international NDA later this year. And also in China, we are disseminated the medicine 14 in the first line and also as a confirmed trial for approval in medicine 14, skipping new data patients. And also the our second line, EJFR refracted patient with meta amplification, the such study we're aiming to complete the re-enrollment later this year.

Dr. Su: We're also excited to see the advancement for salvolidinib, our MED inhibitor; we have approval in China, and also, our global partner AstraZeneca is completing, has completed re-enrollment, and with the readout in the second, third line, there is a combination trial in MED aborted patients. So the results we're reading eagerly with the potential for our second international NDA later this year And also in China, we have already submitted MEDICINE-14 in the first line, and also as a confirmatory trial for full approval in MEDICINE-14 escaping mutated patients. And in addition, our partner and, Slide 24.

Speaker Change: We're also excited to see the advancement for cyber lit in there.

Speaker Change: Our med inhibitor, we have approval in China and also our global partner AstraZeneca.

Speaker Change: is completing the, has completed the re-enrollment and with the readout in the second, third line, there's a combination trial, you met out aberrated patients.

Speaker Change: So the results we're waiting eagerly with the potential for our second international NDA later this year.

Speaker Change: And also in China, we already submitted the MEDICINE-14 in the first line, and also as a confirmatory trial for full approval in MEDICINE-14, skipping mutated patients.

Speaker Change: And also our second line, EGFR refractory patient with metamplification, the SACHI study, we're aiming to complete the enrollment later this year.

Mike: And in addition, our partner and continue to enroll in the other four phase three trials ongoing, two led by AstraZeneca and two in China.

Speaker Change: and in addition our partner and continue to enroll in the other four phase 3 trial ongoing, two led by AstraZeneca and two in China.

Mike: Next slide. And also at the R&D day, we update the outside world about we are launching this phase two, three trial, the sulfatonevine combination, the schema in first line, pancreatic cancer. This is really based on the high MME and also the robust clinical data we have seen from IIT trial in a sulfatonevine plaza, a chirolyzumath, the PD-1 inhibitor, this S1 and Abraxin versus the stand-up here, AG. We can see the overall response rate of reaching 50% versus 27%, medium PFS 9 months versus 5.8 months, and also the lung over a survive of 13 months. So this is really exciting data.

Speaker Change: Next slide.

Speaker Change: and also at the R&D day we update the outside world about we are launching this phase 2.3

Speaker Change: trial of surfadineb in combination with chemo in first line.

Speaker Change: pancreatic cancer. This is really based on the high unmet need and also the robust clinical data we have seen from IIT trial.

Speaker Change: in

Speaker Change: I saw a bat in that plaza.

Speaker Change: Akaralizumab, the pd-1 inhibitor.

Speaker Change: S1, and Abraxan versus the standard of care, AG.

Speaker Change: We can see the overall response rate of reaching 50% versus 27%.

Speaker Change: Meet MPFS 9 Months vs. 5.8 Months

Speaker Change: and also the lung overall survival, 13 months. So this is really exciting data. We really continue to enroll in this phase two trial, two, three trial and further advancing our pipeline in this first line PDAC.

We really continue to enroll in this phase two trial, two three trial, and further advancing our pipeline in this first line PDAC. Slide 24.

Mike: And also I mentioned that Raphael trial has started enrolling patients. This is our first Dewey inhibitor IIT-1 and two muted double mutant inhibitor, and is dressing a high proportion of AML patient and with high MME and we have reported our data both the China AML trial and also the international trial. We have seen very robust dura CR response. Next slide. As you can see, we reported at the RP2D dose, which is the 200-fistum relevant loading dose, followed by 100 milligrams dose. We have observed very robust CR and the CRH rate in the IIT-1 mutated patient.

Speaker Change: Slide 24.

Speaker Change: And also, I mentioned that Raphael trial has started enrolling patients. This is our first dual inhibitor, IDH1 and IDH2 double mutant inhibitor, and it's addressing a high proportion of AML patients.

Speaker Change: and with Hai Ameini. And we have reported our data, both the China AML trial and also the international trial, we have seen very robust dual CR response. Next slide.

Dr. Su: As you can see, we reported at the RP2D dose, which is the 252 mg loading dose, followed by 100 mg dose, we have observed very robust CR and the CRH rate in the IDH1 mutated patient. And you can see we reached 50%, and in the IDH2 mutated patient, we saw 62.5%, which is a really robust result if you're excluding the co-driver mutation with And also, very importantly, we observed very long overall survival, and we have seen 13 months overall survival in this IDH1 and IDH2 mutated patient.

Speaker Change: As you can see, we reported at the RP2D dose, which is the

Speaker Change: 252mg loading dose followed by 100mg dose.

Speaker Change: We have observed very robust CR and the CRH rate in the IDH1 mutated patient. You can see we reached 50%.

You can see we reached 50%, and in the IIT-2 mutated patient C62.5%, which is really robust result if you're including the co-driver mutation with three K-RAS. And also very importantly, we observed very long overall survival, and we have seen the 13 month overall survival in this IIT-1, IIT-2 mutated patient. So really showing this compound at the best-in-class potential in inhibiting both the IIT-1 and IIT-2. So the Phase III Raphael trial is currently ongoing and enrolling patients.

Speaker Change: and in the IDH2 mutated patients, C62.5%, which is a really robust result if you're excluding the co-driver mutation with Blit3 KRAS.

Speaker Change: And also, very importantly, we observed very long over our survival.

Speaker Change: and we have seen the 13 months over our survival.

Dr. Su: So, really showing this compound has the best-in-class potential for inhibiting both IDH1 and IDH2. So the phase 3 Raphael trial is currently ongoing and enrolling patients. We are very, very excited about this compound.

Speaker Change: in this IDH1 and IDH2 mu data patient. So really showing this compound has a best-in-class potential in inhibiting both IDH1 and IDH2. So the phase 3 Raphael trial is currently ongoing and enrolling patients. We are very excited about this compound.

Dr. Sue: We are very, very excited about this compound. Next, I'll turn back to Dr. Su. Okay, thanks, Mike.

Speaker Change: Next, I'll turn back to Dr. Su.

Speaker Change: [inaudible]

Just sum it up. You know, we had a strong first half, and we are optimistic about the second half. Our previous target was to achieve profitability by the end of 2025. We believe we are well on our way and potentially ahead of the curve. Looking ahead, there are a lot of events on this map. All lined up for 2025, 2026, and beyond. These events, if achieved, will help feel the growth for years to come.

Speaker Change: Okay, thanks Mark. Mike, to sum it up, you know, we had a strong

Mike: and we are optimistic about the second half.

Unknown Questioner: Our previous target was to achieve profitability by the end of 2025. We believe we are. And can you please also give an update on the regulatory approval status in China for second line gastric cancer? Yeah, that's my first question. And my second question is about the planet.

Speaker Change: Our previous target was to achieve profitability by end of 2025. We believe we are

Speaker Change: well on our way and potentially ahead of the curve.

Speaker Change: Looking ahead, there are a lot of events on this map.

Speaker Change: All lined up for 2025, 2026, and beyond.

Speaker Change: These events

Speaker Change: If achieved, will help fuel the growth for years to come.

Dr. Sue: This concludes the presentation, and thank you again for attending the call.

Speaker Change: This concludes the presentation, and thank you again for attending the call. The next is going to be Q&A.

The next is going to be Q&A. Thank you, Dr. Su. Thank you, everyone, for presentation.

David Ng: Next, we will have the Q&A session. There are two ways that you can ask the question. You can type your question in the Q&A box by just pressing the Q&A button at the bottom of your screen, or you can raise your hand, and after we call your name, we will unmute your line and then you can ask your question directly.

Speaker Change: Thank you, Dr. Hsu. Thank you, everyone, for the presentation. Next, we will have the Q&A session.

Speaker Change: There are two ways that you can ask a question.

Speaker Change: You can type your question in the Q&A box by just pressing the Q&A button at the bottom of your screen, or you can raise your hand, and after we call your name, we will unmute your line, and then you can ask your question directly.

David Ng: So let's first start with the very first question. It will be Alex Tranahan from Bank of America. So, Alex, your line is now unmute. Please ask your question. Okay, great. Thanks, guys, for the questions and congrats on the progress in the first half. Great to see the Frisokva launch. I was hitting on all cylinders in the US.

Speaker Change: So let's first start with the very first question. It will be Alec Stranahan from Bank of America. So Alec, your line is now on mute. Please ask your question.

Alec Warren Stranahan: Okay, great. Thanks, guys, for the questions and congrats on the progress in the first half. Great to see the Frisac launch hitting on all cylinders in the US.

Alex Stranahan: Two questions on Savannah. First, how do you see the data earlier this year at ACR for Savo? It's potentially reading into what we could see in the full data readout from Savannah later this year. And then who would be leading the US submission for Savo? And it's the year-end timing sort of from you guys or from AstraZeneca or both. Thank you.

Speaker Change: Two questions on Savannah. First, you know, how do you see the data. Earlier this year ACR for Savo is potentially reading into what we could see in the full data readout from Savannah later this year and then.

Speaker Change: Who would be leading the U.S. submission for Savo, and is the year-end timing sort of from you guys or from AstraZeneca or both? Thank you.

Okay.

Dr. Sue: Thanks, Alex, for the question. So briefly, obviously AstraZeneca is leading the trial, and but for NDA submission, it will be a complete package including preclinical early development. So we will be contributing to the package, but operationally, AstraZeneca is leading the whole thing.

Speaker Change: Okay. Thanks, Alec, for the question.

Speaker Change: So briefly, obviously AstraZeneca is leading the trial.

Speaker Change: But for NDA submission, it will be a complete package, including pre-clinical, early development. So we will be contributing to the package.

Mike: In terms of data, I'll ask Mike to comment. Yeah, so we have report our data previously, right? The WCLC and you know, particularly a mat-driven population. We do see a good mat-amplified patient with 50% of growth over response rate and over seven months PFS. So certainly, we are quite excited about this molecule and the clinical data. And so we'll expect the read out, of course, from AstraZeneca, right? When's the data mature enough later this year? If this is positive or repeat for previous study, previous result is certainly, you know, per the agreement with FDA, this will be the NDA submission package as AstraZeneca is going to, you know, submit.

Speaker Change: Operationally, AstraZeneca is leading the whole thing. In terms of data, I'll ask Mike to comment.

Mike: Yeah, so we have report our data previously right that WCLC and

Mike: you know, particularly in that driven population, we do see a, you know, good

Mike: MedAmplify patient, you know, with a 50% overall response rate and over seven months PFS. So certainly.

Mike: We are quite excited about this molecule and the clinical data.

Mike: And so we'll expect readout, of course, from AstraZeneca, right, once the data has matured enough.

Mike: later this year. If this is positive or repeat for previous study, previous result, it's certainly, you know, per the agreement with FDA, this will be the NDA submission package as AstraZeneca is going to, you know, submit. Yeah.

Yeah.

Great, thanks.

Dr. Sue: And maybe one quick one, if I can, just on Fruzacua, given you guys are manufacturing for Takeda. What kind of inventory stockings dynamic do you expect is going on? And what kind of inventory levels are you guys shooting for?

Speaker Change: Thanks. And maybe one quick one, if I can, just on Fruzacua, given you guys are manufacturing for Takeda, what kind of inventory stocking dynamic

Speaker Change: do you expect is going on and what kind of inventory levels are you guys shooting for? Thank you.

Thank you. So, you know, we are obviously helping Takeda on the manufacturing. I think they are catching up on the inventory early going. It was a pretty thing. I think you know, pretty much caught up. At the same time now, we are preparing for the European launch and also Japan launch as well. So we're basically doing full-time manufacturing for Takeda to support the preparation for launches. Got it.

Speaker Change: So, you know, we are obviously helping Takeda on the manufacturing. I think they are

Speaker Change: catching up on the on the inventory in the early going it was pretty thing I think you know pretty much caught up

Speaker Change: At the same time now, we are preparing for the European launch and also Japan launch as well. So we're basically doing full-time manufacturing for Takeda to support the preparation for launches.

Thank you.

Let me congratulate you on the progress. Thank you.

Thank you, Alec.

Speaker Change: Got it. Thank you. And congrats again on the progress. Thank you.

Chen Chen: So our next question is from Chen Chen of UBS. Chen Chen, your line is now unmuted. Please ask your question. Thank you.

Speaker Change: Thank you, Alec. So our next question is from Chen Chen of UBS. Chen Chen, your line is now unmuted. Please ask your question.

Management for Takeda questions. So my first question is on Fruzacua Internet. Well, it has very strong sales momentum in the U.S. So any chance for us to raise the sales guidance and also can management please elaborate a bit more on its like EU self strategy. And can you please also like update on the regulatory approval status, like in China, in second line gastric cancer?

Chen Chen: Thank you management for taking my questions. So my first question is all for Quinton Lipp.

Chen Chen: Well, it has very strong sales momentum in the U.S., so any chance for us to raise the sales guidance? And also, can management please elaborate a bit more on its, like, EU sales strategy?

Chen Chen: And can you please also like update on the regulatory approval status like in China in second-line gastric cancer?

Chen Chen: Yeah, that's my first question.

And my second question is also of the planet. I want to know like its China commercial strategy and what is our self guidance for the first year of commercialization and also any like BD progress. And it would be good if we could also elaborate a bit more, like it's U.S. and EU clinical trial plan. Thank you very much.

Chen Chen: Yeah, that's my first question. And my second question is on the planet. I want to know like it's a China commercial strategy, and what is our sales guidance for the first year of commercialization?

Unknown Executive: I want to know, like, China's commercial strategy and what is our sales guidance for the first year of commercialization? And also, any progress on BD? and it would be good if we could also elaborate a bit more on, like the US and EU clinical trial plans. Thank you very much. Okay, thank you very much for the question. Um, you know, while we are happy with the early performance of Phil Quentin in the U.S., we'll let you know as soon as we hear from Takeda on that.

Chen Chen: and also any, like, BD progress, and it would be good if we could also elaborate a bit more on, like, if US and EU clinical trial plan.

Dr. Sue: Okay, thank you very much for the question. You know, why we are happy with the early performance of Fruzacua Internet in the U.S. I mean, Takeda doesn't have any at the moment, doesn't have any updated or any update on the forecast or guidance. So we'll let you know as soon as we hear from Takeda on that. But regarding Europe, obviously it was approved in late June, and we've been supporting Takeda in preparation for lunch there, and it's going to be country by country. Obviously, pricing negotiation, reimbursement, pay or it's obviously, it's very complicated. So, but we do expect in a potential launch before end of this year in Europe.

Speaker Change: Thank you very much.

Speaker Change: Okay, thank you very much for the question.

Speaker Change: You know, while we are happy with the early performance of Phil Quentin in the U.S.,

Speaker Change: We, I mean, Takeda doesn't have any, at the moment, doesn't have any updated, or any update on the forecast or guidance.

Speaker Change: So we'll let you know as soon as we hear from Takeda on that. Regarding Europe

Unknown Executive: Regarding Europe, obviously, it was approved in late June, and we've been supporting Takeda in preparation for launch there. And it's going to be country by country.

Speaker Change: Obviously it was approved in late June and we've been...

Speaker Change: supporting Takeda in preparation for launch there. And it's gonna be country by country. Obviously, pricing negotiation, reimbursement.

Unknown Executive: Obviously, pricing negotiation, reimbursement, uh payer is obviously very complicated, so um, but we do expect a potential launch before the end of this year in Europe. Obviously, BD discussions are ongoing. We continue to engage with potential partners. Yeah, thanks for the information provided. And can you also please let us know the regulatory approval status of frequently used in second line gastric cancer? Can we expect anything in August or September?

Speaker Change: Obviously, it's very complicated, but we do expect a potential launch before the end of this year in Europe .

and I think Japan will, at the moment, the end-year review is on track as well.

Speaker Change: And I think Japan will...

Speaker Change: At the moment, the India review is on track as well.

Dr. Sue: So, the planet, obviously, BD discussions are ongoing. We continue to engage with potential partners, and at the same time, we just focused on clinical development globally, or outside China. As Mike mentioned, those optimization studies kicked off early this year, and we have multiple centers in the US and Europe now open, and we are just screening patients and enrolling patients at the moment. And I would expect that the business development discussions will continue along with clinical development as we progress through those optimization and towards potential registration or kickoff over the registration study.

Speaker Change: Obviously, BD discussions are ongoing. We continue to engage with potential partners.

Speaker Change: And at the same time, we just focus on clinical development globally or outside China. As Mike mentioned, the dose optimization

Mike: study kicked off early this year and we have multiple centers in the U.S. and Europe now open and we are just screening patients and enrolling patients at the moment. And I

Speaker Change: I would expect that the business development discussions will continue along with clinical development as we progress through the dose optimization and towards potential registration or kickoff of the registration study.

I think that's about clinical development. In terms of, you know, China commercialization or China preparation for China launch, a lot of work is going on at the moment as George already pointed out that we are still working on the marketing strategy and also preparing the organization as well. So, working as I'm going, at the moment we don't have any forecast for next year. I think we'll have to work through the models, and I think a major piece of it will be pricing at the moment. We are not ready to make any decisions on that yet.

Speaker Change: I think that's, that's about clinical development in terms of

Speaker Change: You know, China commercialization or China preparation for China launch.

Speaker Change: A lot of work is going on at the moment. As George already pointed out, we are still working on the marketing strategy and

George: Also preparing the organization as well.

Speaker Change: So work is ongoing. At the moment, we don't have any forecast for next year. I think we'll have to work through the models. And I think a major piece of it will be pricing. At the moment, we are not ready.

So, you know, when we are ready to share, we'll share with everybody our forecast going forward.

Speaker Change: to make any decisions on that yet. So.

Speaker Change: You know, when we are ready to share, we'll share with everybody our forecast.

So, really nothing to share at the moment, other than to say we are working very hard to prepare for the launch.

Mike: Yeah, thanks for the information provided, and can you also please let us know, or the regulars, the approval status of flu clinical like in second line gastrocancer. Can we expect like anything in August or September? So, all we can say is the NDA review is still ongoing, and we, you know, we don't comment. We actually can comment on the regulatory processes, but maybe Mike, if you have anything to add, please chime in. Yeah, I think like Dr. Su-Seth, right? The regulatory is ongoing; we cannot comment on. And although we have prepared, I mean, you know, updates, right, for additional analysis to CDE, but, you know, we anticipate the decision will be Q3 this year.

Speaker Change: Yeah, thanks for the information provided. And can you also please let us know the regulatory approval status of frequently like in second line gastric cancer? Can we expect like anything in August or September ?

Speaker Change: So all we can say is the NDA review is still ongoing and we, you know, we don't comment, we actually can't comment on the regulatory processes, but maybe Mike, if you have anything to add, please chime in.

Unknown Executive: To add, please show me. Yeah, I think like Dr. Su said, right, the regulatory process is ongoing, and we cannot comment on it. And although we have prepared, I mean, you know, updates, right, for additional analysis to CDE, but, you know, we anticipate the decision will be Q3 this year. Okay, cool. I'm Zafar Khanir.

Mike: Yeah, I think like Dr. Hsu said, right, the regulatory is ongoing, we cannot comment on and although we have prepared, I mean, you know, updates, right, for additional analysis to CDE, but, you know, we anticipate the decision will be Q3 this year.

Okay, cool. I'm definitely coming here.

Thank you. Thank you, thank you, Dr. Su-Seth. Thank you, Mike.

Mike: [inaudible]

Speaker Change: Okay, cool. I'm just working here. Thank you.

Unknown Executive: Thank you. Thank you, Dr. Xu. Thank you, Mike.

Just a reminder for anyone who wants to type in the question: you can type in the Q&A box and put in your question there.

Speaker Change: Thank you, Dr. Hsu. Thank you, Mike. Just a reminder for anyone who may want to type in the question, you can type the Q&A box and put in your question there. Next question is from Jeffrey Cara Dong. Cara, your line is now unmuted. Please ask your question.

Kara: Nick's question is from Jeffrey Kara Don.

Operator: Just a reminder for anyone who may want to type in a question, you can cut the Q&A box and put in your question there. Next question is from Jeffrey Caradong. Cara, your line is now unmuted. Please ask your question. Hi, good morning. This is Clara for Kelly.

Kara, your line is now unmuted. Please ask your question. Hi, good morning.

Unknown Executive: Thanks for taking our question and congratulations on all the progress. So just one quick question now for Kutinib, after around 10 months of launch in the US, obviously, we've seen really good launch momentum. I'm wondering, have you seen any dynamics of Kutinib being used in earlier lines in colorectal cancer? And, have you and your partner, Takeda, discussed any opportunity for Kutinib beyond geographic expansion? And like, what's the appetite for potential further development? Thank you. Okay, yeah, thanks, Clara, for the question. Obviously, you know, the US launch is still young and very early, very early into the process. We don't have any information yet.

Clara Ohm: This is Clara Ohm for Kelly. Thanks for taking our question, and congratulations on all the progress. So, I just want to clear question now for couldn't it? After around 10 months of launching in the U.S., obviously we've seen really good launch momentum. Wondering, have you seen any dynamic of the couldn't have been used in earlier lines in chloractyl cancer and wondering, have you and your partner, Takita, discuss any opportunity for couldn't have been beyond geographic expansion and like what's the apt type like for potential for the development? Thank you. Okay, yeah, thanks Clara for the question.

Clara Ong: Hi, good morning. This is Clara Ong for Kelly. Thanks for taking our question, and congratulations on all the progress. So just one quick question now for Kutinib. After around 10 months of launching in the U.S., obviously we've seen really good launch momentum. I'm wondering, have you seen any dynamic of Kutinib being used in earlier lines in colorectal cancer? And have you and your partner, Takeda, discussed any opportunity for Kutinib beyond geographic expansion? And what's the appetite like for potential further development? Thank you.

Obviously, you know, U.S. launch is still young and very early into the launch. We don't have any information. Actually, Takita has not shared with us any information regarding usage in early lines. We'll regard to clinical development of, you know, maybe Mike, Michelle, more about data generated in China in early lines, second line, first line, as well as maintenance setting, and these are very, you know, I think there are a lot of strong data there and working we continue to discuss with Takita, how we position in this particular disease segment, Mike. Yes, so we have done, you know, quite some IIT study in early line studying.

Clara Ong: Okay.

Speaker Change: Yeah, thanks, Clara, for the question. Obviously, you know, the U.S. launch is still young and very early, very early into the launch. We don't have any information. Actually, Takeda has not shared with us any information regarding usage.

Unknown Executive: Actually, Takeda has not shared with us any information regarding usage in early lines, on clinical development of, you know, data generated in China in earlier lines, second line, first line, as well as maintenance settings. And these are very, you know, I think there are a lot of strong data there, and we continue to discuss with Takeda how we position ourselves in this particular disease segment. Mike.

Speaker Change: in early lines. With regard to

Speaker Change: clinical development, or, you know, maybe Mike can share more about, you know,

Mike: data generated in China in earlier lines, second line, first line, as well as maintenance setting. And these are very, you know, I think there are a lot of strong data there and we continue to

Mike: discuss with Takeda how we position in this particular disease.

Mike: Yes, so we have done, you know, quite some IAT studies in earlier line settings. First, I think they were reported both at the ASMO last year and also at ASCO-GI and at ASCO this year, right? In their first line maintenance setting combined with catechizabine, we actually see very good tolerability and the long PFS1 and PFS2 that were reported. And also, in the second line setting, there are also multiple IATs really working on the combination with standard of care, including for FARI. And also, that was reported to have a pretty good over response rate and the PFS. So it's certainly the safety for conval is really well.

Mike: Sagamon.

First, I think reported both at the S-MOL last year and also ASCO GI and the ASCO this year, right? Their first line, maintenance setting, combined with cytosidobene, we actually see very good tolerability and the long PFS-1 and PFS-2, it was reported. And also in the second line setting, there are also multiple IITs really working on the combination with standard care, including for Fari, and also that was reported, have a pretty good over response rate and the PFS. So it's certainly the safety for convo is really well, that's really a reflect the equipment and it is highly specific by Jaffe inhibitor and combined with a lot of other therapies right, PD-1 chemo or so.

Speaker Change: And also, in the second line setting, there are also multiple IITs really working on the combination with standard of care, including for FARI.

Speaker Change: and also that was reported.

Speaker Change: have a pretty good over response rate and the PFS. So it's certainly the safety.

Mike: That's really a reflection of buquinidine as a highly specific biogas inhibitor and combined with a lot of other therapies, right? PD-1 chemo or so. And also, we see the combination with PD-1 also has quite good survival data. So we're providing all this information to Takeda, and certainly, the Takeda team is well aware of that and positioning their development down the road. Thanks, Mike, for being so helpful. Thank you. And obviously, congratulations on the result. Great.

Speaker Change: for Convo is really well, that's really reflect the buquinone as a highly specific biogas inhibitor and combined with a lot of other therapies, right, PD-1.

And also we see the combination with PD-1 also see quite good the survival data. So we are providing all these information to Takita, and certainly the Takita team is well aware of, and you know, positioning their development down the road. Thanks, Mike.

Speaker Change: And also we see a combination with PD-1, also see quite good survival data. So we're providing all this information to Takeda.

Speaker Change: and certainly the Takeda team as well, and you know positioning their development down the road, yeah.

Mike: Thanks, Mike.

Thank you, Sarah. Thank you, Mike.

Thank you, Dr. Sue.

Speaker Change: Super helpful, thank you.

Adam Mccarter: Our next question on the line will be Cavendish, Mr. Adam McCarter. Adam, your line is now unmuted. Please ask your question. Thank you, David. Thanks, everyone. Great presentation and, uh, all the congratulations. And result, great, great to see the news on Frazaclan and the momentum is gaining in the US.

David Ng: Thanks David, thanks everyone, great presentation and congratulations on the result, great to see the news on Frazacla and the momentum it's gaining in the US. I guess my first question really is again just on Frequentinib and the story that's evolving there in gastric cancer, so obviously not asking the management team to predict the outcome but I don't know if you could give us an indication of how confident you are in the strength of the data package that's been submitted to the Chinese regulators.

Unknown Executive: Great to see the news about ZAQA and the momentum it's gaining in the US. I guess my first question really is, again, just about Quintanib and the story that's evolving there in gastric cancer. So obviously, you know, not asking the management team to predict the outcome, but I don't know if you could give us an indication of how confident you are in the strength of the data package that's been submitted to the Chinese regulators.

I guess it's my first question really is again just one for Quintanub and the story that's evolving there in gastric cancer. So obviously, not asking the management team to predict the outcome, but I don't know if you could sort of give it an indication of how confident sort of you are in the strength of the data package that's been submitted to the Chinese regulators.

Unknown Executive: And then just a sort of a second question, just on looking at the costs going forward into the second half of the year. Obviously, we saw in the first period, a quite a reduction in the R&D expenses, but just wanted to see how to think about that going forward, obviously, with the initiation of the eSlim O2 and the Raphael Phase 3 studies into the second half of the year. Thank you very much.

Adam Mccarter: And then just a sort of a second question just on looking at the costs going forward to the second half of the year. Obviously, we saw the first period, so quite a reduction in the R&D expenses, but just wanted to see understand sort of how to think about that going forward. Obviously, with the initiation of the eSprimo 2 and the Raphael Phase 3 studies into the second half of the year. Thank you very much.

Speaker Change: And then just a sort of a second question just on looking at the costs going forward to the second half of the year, obviously we saw the first period.

David Ng: So quite a reduction in the R&D expenses, but just wanted to see, understand how to think about that going forward, obviously, with the initiation of the E-Sperm O2 and the Raphael Phase 3 studies into the second half of the year. Thank you very much.

Unknown Executive: Okay, thanks, Adam, for the questions. Maybe I'll ask Mike to comment on frequent inefficiency and also the Raphael study. And Johnny can comment on cost, the expected cost in the second half. Mike, go for it.

Okay, thanks, Evan, for the questions. Maybe I'll ask Mike to comment on through Quintanub and also the Raphael study, and Johnny can comment on the cost expected of the cost in second half. Mike, go for it. I think we did mention the earlier, right? The clinical data was presented at ASCO, and ASCO, right? The data was quite strong. If you can see the response rate, the PFS is really double. And this study was designed with the PFS and OS, called dual primary endpoint. I just want to emphasize, right? If one of the endpoints is positive, if it's considered as a podage trial, and the OS, in particular, did not reach the disco-influent significance, but we did observe this as the reported OS, especially quite long and comparably in the second line setting.

Speaker Change: Maybe I'll ask Mike to comment on Frequentinib-Gc and also the Raphael study.

David Ng: and Johnny can comment on the expected cost in second half.

Mike: I think, you know, we did mention earlier that this, you know, the clinical data was presented at ASCO, primary and ASCO, right, that the data was quite strong. If you look at the, you know, response rate, the PFS really doubled. And, you know, this study was designed with PFS and OS, dual primary endpoints. I just want to emphasize, right, if one of the endpoints is positive, it's considered a potage trial.

David Ng: Mike.

Mike: Go for it. I think, you know, we did mention earlier, right, this, you know, the clinical data was presented at ASCO, binary and ASCO, right, that

Mike: The data was quite strong. If you can see the response rate, the PFS really doubled.

Mike: And, you know, the OS, in particular, it did not reach statistical significance, but we did observe this is the reported OS is actually quite long and, you know, compared with the, you know, in the second line setting, one of the reasons it did not reach statistical significance is really, we have reported during the ASCO plenary and also in the publication published in the Nature of Medicine, there's an imbalance of the post treatment, right? And there was a significantly higher percentage of patients in the placebo group; almost 20% higher received the post-treatment therapy. And so this is one, the region; it did not reach statistical significance, but highly, we believe this is clinically relevant. Numerical increase of OS and is some found confounded by the post-trial post-therapy treatment.

Johnny: and, you know, the OS.

Speaker Change: in particular, it did not reach the statistical influence significance, but we did observe this is the reported OS is actually quite long. And, you know, compared with, you know,

Mike: One of the reasons it did not reach, it was a good significance is really, we have reported during the ASCO plenary, and also the publication, publishing the Nature Medicine. There's an imbalance of the post-treatment, right? And there's a significantly higher percent of the patient in the placebo on, almost 20 percent higher received the post-treatment therapy. And so, this is one of the reasons it did not reach a statistical significance. Highly, we believe this is clinically relevant, numerical increase, OS. And it's sometimes confounded by the post-treatment. Okay, so, again, the data was submitted, and I also mentioned additional analysis. Whatever we reported the CDE, but I cannot comment, right, about the approval.

Speaker Change: in the second line setting. One of the reasons it did not reach statistical significance is really we have reported during the ASCO plenary and also the publication published in the Nature of Medicine.

Mike: there's an imbalance of the post-treatment, right? And there's a significant higher percentage of patients in the placebo arm.

Speaker Change: almost 20 percent.

Speaker Change: At the region, it did not reach statistical significance, highly. We believe this is clinically relevant.

Mike: Numerical Increase OS, and some funds

Mike: Okay, so, again, the data was submitted, and I also mentioned additional analysis, whatever. We reported the CD, but I cannot comment, right, about the approval. So I think the decision will come most likely by Q3. Okay, so on the R&D expenditure, first half, as you can see, we spent about $95 million. Excellent. Thank you, thank you everyone, and congratulations again on the results. Thank you, Adam. Our next question is from Paul Choi from Goldman Sachs. Paul, your line is now unmuted. Please ask your question. Hi, can you hear me?

Johnny Cheng: So, I think the decision will come most likely by Q3, yeah. Okay, so on the R&D expenditure, first of all, as you can see, we spend about 95 minutes. Certainly, I think we haven't given any guidance to the market in terms of the total full year on the expenditure, but you can expect, because of the facing, once we'll expect that we will continue to invest in our R&D program. So, second half, you can expect we will ramp up more R&D investment. Certainly, it will be more than our first half.

Speaker Change: Certainly, I think we haven't given any guidance to the market in terms of the total full year R&D expenditure.

Speaker Change: But you can expect, because of the phasing, one should expect that we will continue to invest.

Speaker Change: in our R&D program so second half you can expect we will ramp up more R&D investment certainly it will be more than our first half so full year

So, full year, I think, is still within the range that we have basically given some indication earlier that we will continue to invest in a similar level of last year, but certainly this year overall, I think it will be less than last year, slightly.

Speaker Change: I think it's still within the range that we have basically given some indication earlier that we will continue to invest in a similar level of last year, but certainly this year overall I think will be less than last year slightly.

Thank you, everyone, and congratulations again, the results.

Speaker Change: Excellent. Thank you. Thank you, everyone. And congratulations again, the results.

Paul Choi: Thank you, Adam. Our next question is Paul Choi from Goldman Sachs. Paul, your line is now unmuted. Please ask your question. Can you hear me? Yes. Okay, great. Thank you for taking the questions. Good evening. My first question is just with regard to Hemasevastat Zerak in China. Can you comment first on your appetite to explore it in additional indications beyond follicular lymphoma, particularly either post-BTK or post-BCL. It seems like there's a lot to target opportunities like double-hit lymphoma and other lymphomas. And then second, in terms of the cadence of development first, I know you've obviously targeted ITP first here in the different locations, but can you maybe also comment on what the cadence of what we should expect next in terms of development might be?

Adam: Thank you, Adam.

Speaker Change: Our next question is Paul Choi from Goldman Sachs. Paul, your line is now unmuted. Please ask your question.

Operator: Yes. Okay, great. Thank you for taking the questions. Good evening.

Paul Choi: Can you hear me? Yes.

Paul Choi: Okay, great. Thank you for taking the questions. Good evening. My first question is just with regard to Temasev Estat, Tezzerak in China.

Paul Choi: My first question is just with regard to Temozevistat, Tezozeric in China. Can you please comment first on your appetite to explore it in additional indications beyond follicular lymphoma, you know, particularly either post-BTK or post-BCL? It seems like there's logic to target opportunities like double-hit lymphoma and other lymphomas. And then second, in terms of the cadence of development for sublapinib, I know you've obviously targeted ITP first here and additional indications, but can you maybe also comment on what the cadence of what we should expect next in terms of development might be? Thank you. Yeah, yeah, thank you, Paul.

Paul Choi: Can you comment first on your appetite to explore it in additional indications beyond follicular lymphoma, particularly either post-BTK or post-BCL? It seems like there's logic to target opportunities like double-hit lymphoma and other

Speaker Change: other lymphomas. And then second, in terms of the cadence of development first, so Vladimir, I know you've obviously targeted ITP first here and additional indications, but just can you maybe also comment on what the cadence of what we should expect next in terms of development might be? Thank you.

Thank you.

Mike: Okay, Mike, why don't you take your first comment on this? Yeah, thank you, Paul. You know, I think the, you know, task matter stat, right, is certainly it's the first in class, easy H2 inhibitor. And to follow your question, not only in the, our filing is the third line follicular lymphoma; it was based on the bridging study for the global study. And we are also currently doing a second line follicular lymphoma, along with our partner, Ipsin. This is a global Phase 3 trial in the second line, FL. We are, we are working together with Ipsin on the enrolled in the Phase 3 trial is the task matter stat combined with R square versus R square.

Paul Choi: Okay, Mike, why don't you take a first comment on this?

Unknown Executive: You know, I think the, you know, Tas-Med is that, right? It certainly is the first thing called an EZH2 inhibitor. And to follow your question, not only in the, our filing is for the third line, follicular lymphoma. It was based on the bridging study for the global study. And we're also currently doing a second line follicular lymphoma trial along with our partner, Ibsen. This is a global phase three trial. In the second line, FL, we are working together with Ibsen on the enrolling phase three trial of Tas-Med is that combined with R-squared versus R-squared.

Paul Choi: Yeah.

Mike: Yeah, thank you, Paul. You know, I think...

Speaker Change: The, you know, Tazmatistat, right? It certainly is a first-in-class EZH2 inhibitor. And to follow your question, not only in the, our

Speaker Change: filing is the third line follicular lymphoma. It was based on the bridging study for the global study. And we're also currently doing a second line.

Speaker Change: folliculitis, FOMA, along with our partner Ibsen. This is a global phase three trial.

Speaker Change: In the second line, FL, we are working together with Ibsen on the enrolling by Phase 3 trial is the Tasmatostat combined with R-squared versus R-squared. So this is certainly a big indication.

So this is certainly the big indication to expand the indication, and also, apparently we are, you know, at least for mechanistically, we are evaluating other opportunity for this indication. We have some combination study, you know, exploring the, the PICK combination with task matter stat and certainly Ipsin has done quite some exploratory study before so we're working with Ipsin to address any of the new indication develop. and Solva Planet internationally, right? Because I certainly we see the ITP, you know, the durable response rate 48% is really robust compared with any of these, you know, ITP treatment because this mechanism, we believe it is actually quite unique if blocking the, you know, the final cytosis through the sick inhibition and also working on the B cell to produce the auto antibiotic production.

Unknown Executive: So this certainly is a big indication to expand the indication. And also, currently, we are, you know, at least for mechanistically, evaluating other opportunities for this indication. We have some combination studies, you know, exploring the PI3K combination with Tas-Med is that. And certainly Ibsen has done quite some exploratory studies before.

Speaker Change: to expand the indication. And also, currently, we are, you know, at least for mechanistically, we are evaluating other opportunity for this indication. We have some combination study.

Unknown Executive: So we're working with Ibsen to address any of the new indication developments and SolarPlanet internationally, right? Because certainly, we see the ITP, you know, the durable response rate of 48% is really robust compared with any of these ITP treatments because this mechanism, we believe it is actually quite unique, blocking the phagocytosis through sick inhibition and also working on the B cell to reduce autoantibody production. So certainly, this is a dual mechanism that really explains this superiority compared with other molecules.

Speaker Change: and Solve a Planet internationally, right, because I certainly we see the ITP, you know, the durable response rate, 48% is really robust compared with any of these

Speaker Change: This mechanism, we believe it is actually quite unique.

Speaker Change: it's blocking the, you know, the phagocytosis.

Speaker Change: through the sick inhibition and also working on the B cell to reduce the autoantibody production. So certainly this is a dual mechanism really.

So certainly this is a dual mechanism really explained this superiority compared with other molecule and also particularly we are excited about these the patients are over 75% actually treated as the type of T-BRA average prior line therapy is four line. So certainly ITP is a one first in occasion, but we believe this is go far beyond that. And YHA also currently we're doing this probably in China, and this is certainly the high amount need because there's just no standard therapy, second line therapy globally, nothing, yeah? And so this is certainly a great occasion to continue the development for the registration path, and also we're working; we think this sick pathway has a lot of opportunity autoimmune disease, rheumatoid arthritis, with all the other indications.

Unknown Executive: And also, particularly we are excited about these; the patients are over 75% actually treated with the TIPO-TIPO-RA, and the average prior line therapy is four lines. So certainly, ITP is the first indication, but we believe this goes far beyond that. And WIHA also, currently, we're doing this trial in China. And this is certainly a high unmet need because there's just no standard therapy, second line therapy globally, nothing. Yeah

Speaker Change: explain this superiority compared with other molecules.

Speaker Change: Let's go far beyond that. And Y-Ha, also,

Speaker Change: Currently, we're doing this trial in China. And this is certainly the high unmet need, because there's just no standard therapy, second line therapy globally, nothing. Yeah. And so this is certainly a

Unknown Executive: And so this is certainly a great indication to continue the development for the registration path. And also, we're working, we think the sick pathway is, has a lot of opportunity for autoimmune disease, rheumatoid arthritis, with all the other indications. So we think, certainly we are working on, you know, additional positive, possible POC trials to further explore the opportunity for several plans. Internally, we are looking at these various potential solid tumors, obviously biomarker driven, both in addition to CRPC, potentially ovarian, small cell lung cancer, and so forth.

Speaker Change: a great indication to continue the development for the registration path. And also we're working, we think this

Speaker Change: pathway has a lot of opportunity, autoimmune disease, rheumatoid arthritis, with all the other indications. So we think certainly we are working on

So we think certainly we are working on, you know, additional, positive, possible POP trial tool further explore the opportunity for solo planning.

Speaker Change: you know, additional positive or possible POC trial to further explore the opportunity for solar planet.

Dr. Sue: Thanks Mike, I just want to add the whole, regarding tathmetis that, you know, yes, we have at the moment, follicular and epitheliois acuma, but there have been quite some progress in clinics in solid tumors, including Pfizer's recent report on CRPC. So internally we are looking at these various potential solid tumors, obviously, biomarker driven, both in addition to CRPC, potentially ovarian, small cell lung cancer, and so forth. So this, you know, I think it would be even more exciting than the third line follicular where it's been obviously it's getting quite crowded there, but still tathmetis that has a great safety profile can be combined with many other therapies, you know, in the second line setting, in combination with R-square, for instance, well tolerated and in the dose optimization study and also the early proof of cancer, not a great data there as well.

Speaker Change: Thanks, Mike. I just want to add to our poll regarding TazMetastat.

Speaker Change: You know, yes, we have, at the moment, follicular and epithelial sarcoma, but

Speaker Change: There have been quite some progress in clinics in solid tumors, including Pfizer's recent report on CRPC.

Speaker Change #105: Internally, we are looking at these various potential solid tumors, obviously biomarker driven, both in addition to CRPC, potentially ovarian, small cell lung cancer, and so forth. So these, you know,

Speaker Change: I think it would be even more exciting than the third-line colloquial where, you know, it's been, obviously it's getting quite crowded there, but still.

Speaker Change: Tess Metastat has great safety profile, can be combined with many other therapies in the second-line setting in combination with R-squared, for instance.

Speaker Change: well-tolerated. And in the dose optimization study, and also the early proof-of-concept, great data there as well.

So, you know, we think it's got great potential.

Speaker Change: [inaudible]

Dr. Sue: Thank you, Dr. Su. Thank you, Mike. Paul, does that answer your questions? Okay.

Speaker Change: Thank you, Dr. Su. Thank you, Mike. Paul, does that answer your questions?

Operator: Okay, so just a reminder, for anyone with questions, please type in the Q&A box or raise your hand. The next question comes from Yang Jing from Shanghai Putong Development Bank. Yang Jing, your line is now unmuted.

So, just a reminder: for anyone with questions, please type in the Q&A box or raise your hand.

Speaker Change: [inaudible]

Speaker Change: So just a reminder, for anyone with questions, please type in the Q&A box or raise your hand. The next question comes from Yang Jing from Shanghai Putong Development Bank. Yang Jing, your line is now unmuted. You can go ahead and ask your question.

Yangtian: The next question comes from Yangtian from Shanghai Poutine Development Bank. Yangtian, your line is now muted. You can go ahead and ask your question. Thanks, Benjamin, for taking my questions. Congratulations on the strong results. I've got two quick questions.

Operator: You can go ahead and ask your question. Thanks, Benjamin, for taking my question. Congratulations on the strong results. I've got two quick questions.

Speaker Change: Thanks, management, for taking my questions. Congratulations on the strong results. I've got two quick questions. The first one is on for Quentin Epps.

Unknown Questioner: The first one is on fluquantinibs. We have seen strong U.S. sales, and I'm wondering if you can share with us your doctor's feedback on fluquantinibs. So in terms of the patient's constitution, have we seen more patients who are relapsed from long-serve or new third-line CRC patients who have never used long-serve before?

The first one is on through Quentin Nibb. We have seen the strong U.S. sales. And I'm wondering if to kind of have shared with us the Dr. Sb back on from Quentin Nibb. So, in terms of the patient's constitution, have we seen more patients, who are relaxed from the long-serve or the new deadlines, CRC patients who never use long-serve before. And regarding the quarterly sales trajectory of through Quentin Nibb, consider we have a Europe approval already. And also, Japan approval, how do we think about the quarterly sales trajectory? For the four-year overseas sales of for Quentin Nibb, what are our current sales guidance for the overseas of for Quentin Nibb?

Speaker Change: We have seen the strong U.S. sales.

Speaker Change: I'm wondering if you can share with us the doctor's feedback on 4-Quintanille. So in terms of the patient's constitution, have we seen more patients who are relaxed from the long-serve or the new third-line CRC patients who never use long-serve?

Unknown Questioner: And regarding the quarterly sales trajectory of fluquinib, considering we have Europe approval already and also Japan's immediate approval, how do we think about the quarterly sales trajectory? For the four-year overseas sales of fluquinib, what is our current sales guidance for fluquinib in the overseas market? And the second question is about our bottom line because we are surprised to see that the company achieved net income in the first half. And in the opening remark, I believe we mentioned that HMED might achieve break-even ahead of the prior guidance year 2025. So does that mean we will achieve break-even in 2024 and turn profitable afterwards? These are my two questions.

Speaker Change: before. And regarding for the quarterly sales trajectory of frequent considering we have Europe approval already and also Japan immediate approval, how do we think about a quarterly sales trajectory for the

Speaker Change: Four-Year Overseas Sales of ProQuismib. What are our current sales guidance for the overseas of ProQuismib? And the second question is about

Dr. Sue: And the second question is about our bottom line, because we are surprised to see that the company has achieved that net income in the first half. And in the opening remark, I believe we mentioned that how to make money to break even ahead of our guidance year 2025. So, that's mean we will achieve break even 24 and 10 profitable in afterwards. These are my two questions. Thanks, Markman. Okay. Thanks. Thanks for your question. So, in regard to, you know, patient mix in the U.S., we have no clarity at the moment. I will take it out and share it with us.

Speaker Change #101: Our bottom line, because we are surprised to see that company has achieved that net income in the first half. And in the opening remark, I believe we mentioned that.

Speaker Change: might achieve breakeven ahead of prior guidance year 2025. So does that mean we will achieve breakeven 2024 and turn profitable in afterwards?

Unknown Executive: Thanks, my friends. But, you know, in the FRESCO2 study, obviously, the study population was patients who had already failed lung stuff or stavaga. So, I mean, still clearly demonstrated clinical benefit for those patients. So obviously, you know, in the U.S., we worked with the U.S. FDA to use the China study FRESCO and also the global study of FRESCO2 to support third-line approval. Now, clearly, frequentinib has a very unique pharmacological profile. Even patients who failed on stavaga can still benefit from frequentinib treatment.

Speaker Change: These are my two questions. Thanks, my friends.

Speaker Change: Okay, okay, thanks. Thanks for your question. So, with regard to, you know, patient mix in the U.S., we have no clarity at this moment, at the moment. Take it out and share it with us.

But, you know, in the Prasco-2 study, obviously, the study population was patients already failed, loss of or Stavaga. So, I mean, still clearly demonstrate clinical benefit for those patients. So, obviously, you know, in the U.S., we worked with the U.S. FDA to use the China study, Prasco, and also the global study of Prasco-2 to support fill line approval. Now, clearly, Quentin Nibb has a very unique pharmacological profile. Even patients failed on stavaga can still benefit from the through plenty of treatment. So, although we don't have any clarity as to how many patients treated or, you know, so far in the U.S.

Speaker Change: But, you know, in the FRASCO2 study, obviously the study population was patients who already failed LUNSF or...

Speaker Change: So, I mean, still clearly demonstrated clinical benefit for those patients. So obviously,

Speaker Change: In the U.S., we worked with the U.S. FDA to use the China study, FRESCO, and also the global study, FRESCO2, to support through-line approval. Now, clearly, flu-quantinib has a very unique

Speaker Change: pharmacological profile, even patients failed on Stavaga can still benefit from the frequentive treatment. So, although we don't have any clarity as to how many patients

Are fourth line and how many are third line. So, at the moment, we don't have the information.

Speaker Change: treated so far in the U.S. are fourth line and how many are third line. So at the moment we don't have the information.

Unknown Executive: So, we don't have any clarity as to how many patients treated so far in the U.S. are fourth line and how many are third line. So, at the moment, we don't have that information. With regard to four-year guidance, as I mentioned and alluded to earlier, Takeda has not shared with us any, you know, their updated version of the guidance. So we, we, You know, we don't have anything to

With regard to four year guidance, as I mentioned alluded to earlier, Takeda has not shared with us any, you know, the updated version of the guidance. So, we know we don't have anything to share. I think if you looked at Takeda's report, their quality report just came out today. They say they expect their oncology cells as a whole. I guess the majority would have been the vast majority would be for Quentin Nibb. They expect, you know, more than a hundred percent growth this year.

Speaker Change #103: With regard to four-year guidance, as I mentioned, alluded to earlier, Takeda has not shared with us any, you know, their updated version of the guidance. So we

Unknown Executive: I think if you looked at Takeda's report, their quarterly report just came out today, they say they expect their oncology sales as a whole, I guess the majority would be the vast majority would be frequented, they expect, you know, more than 100% growth this year. So we don't have any more specific, You know, guidance to share at the moment. The bottom line 2020, $25 million profit, it was a lot of effort internally from, from cost savings to maximizing the commercial values for our compounds. So yeah, thank you. I have no more questions. Thank you. Hey, Yang Jing.

Speaker Change: We don't have anything to share. I think if you looked at Takeda's report, their quality report just came out today.

Speaker Change: They say they expect their oncology sales as a whole, I guess majority would be the vast majority would be for quantitative, they expect you know more than a hundred percent growth this year.

So, you know, we don't have any more specific, you know, guidance to share at the moment.

Speaker Change: We don't have any more specific guidance to share at the moment.

Dr. Sue: The bottom line 2020 funding profit; it was a lot of effort internally from cost savings to maximising the commercial values for our compounds. Again, as I pointed out earlier, our previous target was end of 2025 to break even or to reach profitability. I think we are well on our way. I think we probably will achieve that ahead of end of 2025. Super question.

Speaker Change #117: The bottom line, 2020, $25 million profit, it was a lot of effort internally from the

Speaker Change: from cost savings to maximizing the commercial values for our compounds.

Speaker Change: As again, as I.

Speaker Change: pointed out early on that our previous target was end of 2025 to break even or to reach profitability. I think we are well on our way. I think we probably will achieve that ahead of end of 2025, so for sure.

Speaker Change: Great, great. Thanks. Thanks. Thank you. I have no more questions. Thank you.

Unknown Executive: So our next question is from Julie Simmons of Pamir, Lebanon. Julie, your line is now unmuted. Please ask your question. Thank you very much.

So our next question is from Julie Simmons of Pamir Libanum.

Speaker Change #104: Hey Yang Jing, so our next question is from Julie Simmons of Pamir, Lebanon. Julie, your line is now unmuted. Please ask your question.

Julie Simmons: Julie, your line is now unmuted. Please ask your question. Thank you very much. I was just wondering with the reduction in R&D expenditure in the first half of the year and sort of maybe a slight reorganisation of the focus away from ex-China trials. Does that affect any of your earlier stage programmes? Because we've got quite good visibility into what in the latest stage one. But does it change the balance of where the spending is going?

Julie Simmons: I was just wondering, with the reduction in R&D expenditure in the first half of the year and sort of maybe a slight reorganization of the focus away from ex-China trials, does that affect any of your earlier stage programs? Because clearly, we've got quite good visibility into what is in the later stage ones, but does it change the balance of where the spending is going? Okay, thanks, Julie, for the question. I think the, you know, obviously, we do routine portfolio prioritization, but, you know, any program worth investing in, we, we, you know, we fully support. I don't think we are terminating all the early programs. You know, so, if anything, the portfolio prioritization is largely driven by data and by process. So it's really not so much about purely cost savings at all.

Julie Simmons: Thank you very much. I was just wondering with the reduction in R&D expenditure in the first half of the year and sort of maybe a slight reorganization of the focus away from ex-China trials, does that affect any of your earlier stage programs? Because clearly we've got quite good visibility into what in the later stage ones, but does it change the balance of where the spending is going?

Okay, thanks, Julie, for the question. I think of the you know obviously we do routine portfolio prioritisation, but you know any programme worth investing, you know we are fully support. I don't think we are terminating all the early programmes. If anything, the portfolio prioritisation is largely driven by data and by prospects. So really not so much about purely cost savings at all. If anything, as you know, we just initiated phase one study on all many, which we think is a great compound as best-in-class potential in the class, and we are building actually an AML strategy.

Julie Simmons: Okay, thanks Julie for the question. I think of the, you know, obviously we do routine portfolio prioritization, but

Speaker Change #109: you know, any program worth investing, you know, we fully support. I don't think we are terminating all the early programs. You know, so if anything, the

Speaker Change: The portfolio prioritization is largely driven by data and by prospects. So really not so much about purely cost savings at all. If anything, as you know, we just initiated the

Unknown Executive: If anything, as you know, we just initiated the phase one study on our manning inhibitor, which we think is a great compound, has best-in-class potential in the class. And we are building, actually, an AML strategy. So, you know, our decision on portfolio prioritization is largely data-driven and also driven by our portfolio. As we have always communicated, we are more of a pipeline company instead of just targets. We don't necessarily chase the hot targets.

Speaker Change: Phase 1 study on Olmany, which we think is a great compound, has

Speaker Change: best-in-class potential.

Speaker Change: in the class. And we are building, actually, an AML strategy.

Dr. Sue: So you know all with precision on the portfolio prioritisation is largely data-driven and also driven by all portfolio. You know, as we always communicate it, we are more of a pipeline company instead of just targets. We don't necessarily chase the hot targets instead. We look at our pipeline, look at what we have, what you know, what additional targets or compounds we need to better cover the tumor types and address clinical needs. So that say basically you know the answer to the short answer is that you know we may delay a few specific programmes that we think the data wouldn't support or that data is not clear, but by and large we continue to invest in China.

Speaker Change: So.

Speaker Change: You know, our decision on the portfolio prioritization is largely data-driven and also driven by our portfolio. You know, as we always communicated, we are more of a pipeline company instead of just targets. We don't necessarily chase...

Unknown Executive: Instead, we look at our pipeline, look at what we have, and see what additional targets or compounds we need to better cover the tumor types and address clinical needs. So, that said, basically, the short answer is that we may delay a few specific programs that we think the data won't support or the data is not clear, but by and large, we continue to invest in China. Great, thank you.

Speaker Change: the hot targets. Instead, we look at our pipeline, look at what we have, what, you know, what additional targets or compounds we need to, to better cover the tumor types and, and, and address clinical needs.

Speaker Change: So...

Speaker Change: That said, basically, you know, the answer, short answer is that, you know, we may delay a few specific programs that we think the data wouldn't support or the data is not clear, but

Speaker Change: By and large, we continue to invest in China.

Thank you, Julie.

Speaker Change #100: Great, thank you.

Operator: Julie, just a reminder, if anyone still wants to ask questions, please raise your hand. So Dr. Hsu, I have one quick question on the Q&A box; maybe I'll just read it out. So the question is, regarding our cash balance, that we have been quite well positioned and are going to be profitable, has the board considered how to use this surplus capital? Will it be, will it be deployed to further business development, or will it be returned to shareholders?

Just a reminder: if anyone wants to ask questions, please raise your hand. So Dr. Su, I have one quick question on the Q&A box. Maybe I'll just read it out. So the question is regarding our cash balance that we have been quite well positioned and going to be profitable. Has the board considered how to use this surplus cash capital? Would it be, and how will it be deployed to further business development, or will it be returned to shareholders, Dr. Su? You know, I mean, we do have a very strong cash position with over $800 million in cash at the moment.

Speaker Change #106: Thank you, Julie. Just a reminder, if anyone still wants to ask a question, please raise your hand.

Speaker Change #110: So, Dr. Hsu, I have one quick question on the Q&A box, maybe I'll just read it out.

Speaker Change: So the question is regarding our cash balance that, you know, we have been quite well positioned and, you know, going to be profitable. Has the board considered how to use this surplus capital?

Speaker Change #107: Would it be, how will it be deployed to further business development or will it be returned to shareholders?

Dr. Hsu: Um, you know, I mean, we do have a very strong cash position with over 800 million dollars in cash at the moment. However, we, you know, we anticipate that gradually increasing our investments in programs in R&D and also in our commercialization as well to better cover the immunology section, for instance. I think, you know, it's just more of a capital management, if you will.

Speaker Change: [inaudible]

Speaker Change: You know, I mean, we do have a very strong cash position with over $800 million in cash at the moment. However, we know we anticipate

However, we, you know, we anticipate. The gradually increase our investments in programs, in R&D, and also in our commercialization as well to better cover immunology section, for instance. I think, you know, it's just some more of a captive management, if you will. So we clearly will continue to invest heavily in R&D, preparing for, you know, the future. I talked about the path to profitability and beyond, all the way beyond, you know, 2027, 28, but we have a lot coming: very exciting programs from our discovery. I anticipate, you know, certainly the investment R&D will gradually increase over the next few years.

Speaker Change #113: gradually increase our investments in programs in R&D and also in our commercialization as well to better cover immunology section, for instance. So I think, you know, it's just a more of a

Dr. Hsu: So we clearly will continue to invest heavily in R&D, preparing for, you know, the future. I talked about the path to profitability and beyond all the way beyond, you know, 2027, 28. But we have a lot coming, very exciting programs from our discovery. I anticipate, you know, certainly the investment in R&D will gradually increase over the next few years. We do have a lot coming, very exciting stuff in the field of discovery. Thank you, Zafar Suh.

Speaker Change: capital management, if you will. So we clearly will continue to invest heavily in R&D, preparing for

Speaker Change: The future. I talked about the path to profitability and beyond, all the way beyond, you know, 2027-28, but we have a lot coming.

Speaker Change: very exciting programs from our discovery. I anticipate, you know, certainly the investment in R&D will gradually increase over the next few years. We do have a lot coming, very exciting stuff in discovery.

We do have a lot coming. Very exciting stuff in discovery.

Thank you, Dr. Su.

Dr. Hsu: And then another question on the line is regarding our European launch. Of course, this will be dependent on our partner. So the question is, while we await the individual country reimbursement decisions, will there be any possible sales before the reimbursement decisions have been made? Does that mean that we have to wait till much later this year or maybe next year before the sales can happen from Europe?

Dr. Sue: And then another question on the line is regarding our European launch. Of course, this will be depending on our partner. So the question is why we await the individual country reimbursement decision. Will there be any possible sales happening before the reimbursement decision has been made? Does it mean that we have to wait till much later this year or maybe next year before the sales can happen from Europe? I mean, it goes country by country, I guess. I think the data is working simultaneously with all these EU countries. Some in some countries, the process is shorter; in other countries, it can take longer, but you need to gain country-level approval before you can launch in these countries.

Speaker Change #118: Thank you, Dr. Hsu. And then another question on the line is regarding our European launch. Of course, this will be depending on our partner. So the question is why we await the

Speaker Change #108: individual country reimbursement decision. Will there be any possible sales happening before the reimbursement decision has been made? Does it mean that we have to wait till much later this year or maybe next year before the sales can happen from Europe ?

Speaker Change #111: I mean, it goes country by country, I guess. I think Takeda is working simultaneously with with all these EU countries.

Speaker Change #114: In some countries, the process is shorter. In other countries, it can take longer. But you need to gain country-level approval before you can launch in these countries. At the moment, EU recommended or approved it, but still need to work at a country level.

At the moment, EU recommended, but we're still approving it, but still need to work at a country level. They're working very hard, and these launches will come and will start later this year.

Speaker Change #114: They're working very hard. And, you know, these launches will come and will start later this year.

Thank you, Dr. Su.

Operator: Thank you, Dr. Hsu. We don't have any more questions on the line. Dr. Hsu, would you like to make some concluding remarks? Sure, just, you know, thank everyone again for attending the call. Clearly, as you can see, we are executing well on our strategy towards profitability; we have made huge progress, and we had a very strong first half of this year. And we expect the momentum to continue. And, again, thank you very much for attending the call.

We don't have any more questions on the line.

Dr. Sue: Dr. Su, would you like to make some concluding remarks? Sure, I just want to thank everyone again for attending the call. Clearly, as you can see, we are executing well on our strategy towards profitability. We made huge progress, and we had a very strong first half of this year, and we expect the momentum to continue. And again, thank you very much for attending the call. With that, it concludes our 24 interim result presentation, and if you have any further questions, please feel free to email us and talk to our IELT team.

Speaker Change #112: Thank you, Dr. Hsu. We don't have any more questions on the line. Dr. Hsu, would you like to make some concluding remarks?

Dr. Hsu: Sure, just, you know, I want to thank everyone again for attending the call.

Speaker Change #116: Clearly, as you can see, we are executing well on our strategy towards profitability. We made huge progress, and we had a very strong first half of this year, and we expect the momentum to continue. And again, thank you very much for attending the call.

Thank you very much, everyone.