Q4 2024 HUTCHMED (China) Ltd Earnings Call
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David Ng, Alec Stranahan,
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David Ng, Alec Stranahan,
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Speaker Change: Welcome, everyone. Thank you for joining Hutch Mat 2020 for full-year results call.
Speaker Change: Should you experience any technical difficulties. Please senate chat message in the chat box.
Speaker Change: This session will also be recorded N D recorded webcast will be posted on the platform.
Speaker Change: Our DSO.
Speaker Change: And just to go over some of the say Hubbard Safe Harbor statement.
Speaker Change: The performance and results of operation of <unk> within this presentation I'll all historical in nature and past performance is no guarantee of future results.
Speaker Change: <unk> looking statements are based on current beliefs and expectations of management regarding future events and are subject to significant no better no worse and uncertainty. So one of these reasons that materialize steady assumption may be proved to be incorrect and actual results may vary from what was mentioned in the forward looking statement.
Speaker Change: Today, we will have a very good lineup of presentation.
Speaker Change: Our Chief Executive Officer, Chief Scientific Officer of DOCSIS, you will have the opening and then our Chief Financial Officer, Johnny Chen will go over the 2020 for financial review and outlook and then our head of commercial Josh Riyadh will go over the hour commercial aspects and that will be followed by.
Speaker Change: Our head of R&D, and Chief Medical Officer, Michael Shea to talk about our pipeline updates and also argue a T. T C platform and that will be followed by closing remarks Biotoxins. Soon that we will have to Q&A. So why with Delphi that delay I will pass over the presentation to adopt tissue.
Speaker Change: Okay. Thank you David.
Speaker Change: Good morning, Good evening, everyone welcome to Huntsman results Conference call.
Speaker Change: Today, we announced a 2024 full year result was.
Speaker Change: We are pleased and proud.
Speaker Change: To report a net profit for 2024.
Speaker Change: Behind the global commercial successful through exactly.
Speaker Change: The management will share more details on this one until April results and provide an update.
Speaker Change: For 2025.
Speaker Change: Overall financially for zircon did exceptionally well with.
Speaker Change: With total sales of $296 million.
Speaker Change: On the pipeline, we saw several little nib full approval in China with expansion into the first line <unk> exon 14, skipping non small cell lung cancer.
Speaker Change: Globally sublet to NIM.
Speaker Change: Savanna Assaf wrong studies progressed well.
Speaker Change: Physician that positioning has swell for potential global registration.
Speaker Change: Towards the end of 'twenty 'twenty four we reported positive sachi interim analysis in China in second line Egfr mutation positive net amplified non small cell lung cancer patients leading to NDA submission.
Speaker Change: And of the 20th only pool.
Speaker Change: So frequently.
Speaker Change: Towards the end of the year, we received.
Speaker Change: Approval.
Speaker Change: For second line endometrial cancer.
Speaker Change: In combination with Singtel and map, we believe these new indications and new to the approval of new products will help drive China commercial.
Speaker Change: 2025 is shaping up a big year for the pipeline.
Michael Shea: Michael will go through the.
Speaker Change: The details with you.
Speaker Change: And looking forward, we are starting to get excited about our next generation innovations and they saw a T T C.
Speaker Change: Now starting to move towards cleaning.
Speaker Change: The success of these programs will ensure our long term growth beyond 2020 or 30.
Speaker Change: With that let me invite my colleagues Jolly our.
Speaker Change: Our CFO to go through the results Johnny please thank.
Johnny Chen: Thank you Doctor show and.
Speaker Change: Yes.
Speaker Change: We end the year with cash resources of over $830 million, which reflects a small reduction of around 50 million from 2023.
Speaker Change: A portion of the use of the cash resources will utilize for our long term incentive plan to retain tenants.
Speaker Change: Another portion was attributable for working capital to support our ex China collaboration with Takeda.
Speaker Change: Moving on to the next page.
Speaker Change: On the financial results.
Speaker Change: <unk> recognized consolidated revenue of $630 million and reported a net income of 37 million.
Speaker Change: Our oncology business revenue met our guidance last year to achieve over 260 million revenue.
Speaker Change: Overall profitability was the result of strong commercial performance ongoing recognition of deferred revenue tight control over selling and admin expenses as well as scaling down our ex China R&D operations from the restructuring initiatives, we started in 2023.
Speaker Change: On the right hand side of the page as you can see the 2025 revenue guidance for our oncology business is $350 million to $450 million.
Speaker Change: As compared to last year. This guidance has taken into account.
Speaker Change: Non recurring service and manufacturing income from Takeda to support regulatory approval and also commercial launch in various jurisdictions in 2024.
Speaker Change: I will now pass on stool, our head of commercial judge yet.
Speaker Change: Thank you Jeremy.
Speaker Change: If we look at the <unk>.
Speaker Change: Commercial side, the overall pension man oncology put a photo deliver a very solid performance with a half billion USD sales, which is E <unk> sales and a more than double the sales of 2023.
Speaker Change: The growth, mainly driven by <unk> as our CEO mentioned and also.
Speaker Change: Illuminate and the surrender continued to deliver a girl's seeing a very complicated market environment.
Speaker Change: Focus is a little bit effect with more competition to the market as everyone knows status.
Speaker Change: Nowadays our five Mega entry met inhibitor in the market. Nowadays in 2025 would continue to look for ambitious target with more than 30% growth for our combined portfolio.
Speaker Change: Next slide.
Speaker Change: If you look at that.
Speaker Change: The 2020 employees that boosts, our full year performance.
Speaker Change: What's your life, but the key to outside of China of course U S play a dominant low water success, but within a 12 months period, we risk.
Speaker Change: For <unk> could get to approval in 12 countries and we also believe that the market being European once weighed the major market European once they get to <unk>.
Speaker Change: But.
Speaker Change: The gross walk further being drive them and also the guideline international guidelines being supported at a brand for the growth for Japan with Tequila is experiencing a gi, especially some previous experience with Vectibix, we have a high expectation as well.
Speaker Change: Next slide.
Speaker Change: Given that in China, we know that today is the aging population and with the lifestyle change. The CSC is now a leading cancer type.
Speaker Change: China anti VEGF humongous, a well adopted in the later line treatment of the Mcse.
Speaker Change: <unk> achieved a 115 million U S dollar fee in 2025, and still keep the sudden Madden NCIC market leader position with a very strong data and the violence support of course, the market, becoming more and more complicated and also the competition become severe with more rig affiliate budget area.
Speaker Change: Going to the market and also the tesoro to get the reimbursement.
Speaker Change: And in December 2020, full internet to receive its EMC second line approval and this is a breed of Egypt T. Chek combo with PD, one into that gynecology market and it will further drive our growth in the future.
Speaker Change: Next slide.
Speaker Change: Dan we shifted gears to talk to you about neuro endocrinology to Louis which is a relatively neglected area in the oncology community due to the low incidence and the wide debate distributing embarrass, Oregon across the body recent year with.
Speaker Change: More medical education English touch mandatory of quick critical low natural received a lot of attention by the oncologist and a surrender with it for differentiation differentiated profile become the lead up to Teekay parent and continue to gain market share.
Speaker Change: Putting put I'd give you a survey.
Speaker Change: In 2020 full surrender continuing to deliver double digit growth.
Speaker Change: Of course on the fixed side, we see a lot of players coming to the market, especially you'll see that in U S. S E coming to the market is whereas a lot of our new <unk> under development.
Speaker Change: Let's talk about oil process.
Speaker Change: <unk> is the first bank inhibit being approved in China, and the web powder set up a process to really change at a meta operation in cancer patients life in China.
Speaker Change: In 2020 for gasoline board, new player boats from our local and multinational into the market, especially when we see it as an ideal coverage for the first line.
Speaker Change: While all processes do the second line coverage, but with the atheist commercial capability.
Speaker Change: Gland cancer area and also wide coverage will package was hold a sales number and the continued to penetrate and vast the China market. We believe the full approval of <unk> in the Reimbursable lifting afterwards, plus the potential business opportunity to combine with a grateful for mantech verification patients well.
Speaker Change: Regain the momentum of the brand.
Alton: Thank you Alton.
Alton: Now let's shift.
Speaker Change: Two the Michael Yeah. Thank you George Good morning, Good evening, everyone and get you a pipeline update.
Speaker Change: So we have made a tremendous progress are hardly state product. So in addition to a global approval you'd CRC.
Speaker Change: <unk> is also expanding into new indications beyond <unk>.
Speaker Change: Mutual cancer in the RCC.
Speaker Change: So two other compounds.
Speaker Change: <unk> also in late stage Dybala me in multiple indications.
Speaker Change: Our second wave of hematology product subtle planet and Tazemetostat are all NDA stage and the registration trials for new indications involvement.
Speaker Change: And also I want to bring attention our third wave of products.
Speaker Change: <unk>, our FGF Rd bidder and the Reno Sunitinib ideas one on to Joey editor I'll also add that paper Charles trial stage to propel future growth next slide.
Speaker Change: On the lifecycle indication dybala been we received a conditional approval in China, one for Quentin a question Antonella map in the dream of a second line of mutual cancer.
Speaker Change: <unk> indicated that incidence and mortality are projected to grow in China, and the patients who progressed on the first light their favorite named with high unmet need.
Speaker Change: And the pivotal trial for <unk> one.
Speaker Change: We have presented data in <unk> 'twenty 'twenty four.
Speaker Change: Combination.
Speaker Change: Quintin Abbott's been telemacho meaningful advocacy, a manageable safety profile.
Speaker Change: The overall response rate 87 advocacy valid patients was 35, 6% <unk>.
Speaker Change: Including two complete responses and the TCR was 88% absorption of response was not reached.
Speaker Change: And also the medium PFS was nine five months and the median survival was 21 months.
Speaker Change: So up to now the most commented therapy option for a second line of my choice that cancer is that chemotherapy.
Speaker Change: For granola bites and Telemark Commvault and the new chemo free regimens. This group of patients with very high unmet need.
Speaker Change: Okay next slide.
Speaker Change: Increase the mortality rate and rental renal chancery in China also outpaced other developed nations and a second line treatment option I believe named are limited in China.
Speaker Change: So we're seeing that too.
Speaker Change: The phase III results in the second line RCC, Batesville, Quintin at plus intangible amount versus accident or <unk> as the comparator.
Speaker Change: So I'm very pleased to report that today earlier, we announced positive topline results.
Speaker Change: For CCAR two trial.
And in the NDA preparation is planned.
Speaker Change: If approved this will be the first immune checkpoint inhibitor and the <unk> combo in China for the second line RCC, It's all very excited.
Speaker Change: Two reported in the upcoming scientific conference.
Speaker Change: Next slide.
Speaker Change: In partnership with Astrazeneca, we are making great progress on Saba led in that global and the China development.
Speaker Change: These are the late stage trial has.
Speaker Change: Three led by Astrazeneca and for lagged behind Med in multiple cancer type with Matt operations, including non small cell lung cancer papillary renal cell carcinoma in the gastric cancer.
Speaker Change: We are excited to see the global phase two trial Silvana, while reported topline results next week at the European lung cancer <unk>.
Speaker Change: Congress in Paris.
Speaker Change: The minutes on 14 nano.
Speaker Change: Non small cell lung cancer, a confirmatory phase III beat trial also reached a positive readout and we received the full approval in the second line.
Speaker Change: And also expand the label to first line indication.
Speaker Change: So the update the result Oss results were also presented at <unk> next week.
Speaker Change: China Phase III randomized trial outside of the Saba led in the plasma IC burden that versus chemo after progression on Egfr Teekay I also reached positive top line results.
Speaker Change: The Preplanned interim analysis.
Speaker Change: So we have submitted NDA I received the breakthrough therapy designation.
Speaker Change: The NDA is currently under priority review.
Speaker Change: The global some EDA trial in PRC also completed enrollment and other trials led by AZ and the China also currently enrolling patients in lung cancer and gastric cancer next slide.
Speaker Change: The Saatchi, China Phase III trial met the primary endpoint of PFS at the interim analysis of wheat.
Speaker Change: At the briefs with destination and then these NDA under priority review.
Speaker Change: So saatchi evaluate a combination of Saba led an <unk> result for the treatment of patients with <unk> mutant non small cell lung cancer with met amplification off the progression of <unk>.
Speaker Change: First second third generation, TPI and compare rates to chemotherapy.
Speaker Change: Im a stretch with Pemetrexed plus platinum doublet.
Speaker Change: And the results will be submitted for presentation at upcoming scientific conference.
Speaker Change: Next slide.
Speaker Change: In October 24.
Speaker Change: <unk> announced positive results, while Savana global Phase II study demonstrate the high.
Speaker Change: Clinically meaningful and durable response rate.
Speaker Change: So Matt amplification of our already expression represent about 34% of taxes Congress or refractory patients.
Speaker Change: In the world lung cancer twenty-five two AZ reported 52% of overall response rate seven.
Speaker Change: 7.2 months.
Speaker Change: As a nine six month duration of response.
Speaker Change: Chemo naive patients.
Speaker Change: So.
Speaker Change: Despite the narrow posted to and the Orange is 31.
Speaker Change: The second line treatment remain very limited because saatchi and Savana data support.
Speaker Change: Chemo free option, while Biomarkers selected met positive Egfr mutant patients progress on the <unk>.
Speaker Change: So the combo have a very balanced safety efficacy and quality of life profile.
Speaker Change: And also the global sovereign phase three trial also will evaluate the efficacy and safety of these carnival in matter over express <unk> amplified patient versus chemotherapy.
Speaker Change: The recruitment has expanded to complete this year next slide.
Speaker Change: Our next wave product hazmat as that is a global first in class easy H two inhibitor and all first in licensed product eidson.
Speaker Change: Tazemetostat has a proven and U S board certain epithelioid sarcoma anabolic glut in Beaumont and also in Japan for easy edge to Jim Mutate, a positive volatility lymphoma.
Speaker Change: We have completed China bridging study and the results are consistent with a global study.
We are planning to report the top line result later this year.
Speaker Change: The NDA is currently under review Westar line Folliculin BOMA.
Speaker Change: The urge to mutation and we expand the approval made this year.
Speaker Change: And also China is up participating the global Phase III Symphony trial, evaluating Tazemetostat plus square in the second line Follicular lymphoma with a potential indication expansion.
Speaker Change: Next slide.
Speaker Change: We reported.
Speaker Change: The first immune.
Speaker Change: Autoimmune agents, although planet is a high <unk> differentiate on Aro as white tea <unk>.
Speaker Change: It offered a dual mechanism targeting both b cell to prevent auto antibody production and also prevent macrophage destroying the platelet.
Speaker Change: So this is IQ a report on the China ETP treatment landscape.
Speaker Change: We believe several planet not only can compete in the this quarter million ITT patients. While currently on alternative treatment, but also potentially help patients will last follow up primarily due to no other alternative effective treatment.
Speaker Change: Next slide.
Speaker Change: The phase III is one one resolved we reported the results last year at the European Hematology Association meeting.
Speaker Change: Demonstrate robust overall response rate of 71% and the durable response rate of 48% in relapsed refractory primary IDP patients.
These high response rate are on par with almost all the other alternatives treatment, particularly in this patient is a highly pretreated patient.
Speaker Change: Over 75% of the patients had primarily treated with the <unk>.
Speaker Change: So update the results were also presented at the Ash meeting last year.
Speaker Change: Showing a long term treated treatment leads with durable response rates 41, 51%.
Speaker Change: And also.
Speaker Change: The overall response rate, 81%, so significant battered and many other treatment options.
Speaker Change: Next slide.
Speaker Change: So the sabo planet.
Speaker Change: The NDA is currently under review and we're very working closely with an M. P. Eight and look forward to bring this innovative medicine to the patients.
Speaker Change: And also we have another.
Speaker Change: Indication autoimmune disease.
Speaker Change: In development.
Speaker Change: Sure.
Speaker Change: Antibody autoimmune hemolytic anemia.
Speaker Change: The phase II results were also presented at <unk> last year and the subsequent publishing Lanza hematology.
Speaker Change: The Saville planet demonstrate encouraging hemoglobin benefits compared with placebo with a overall response rate of 43% versus zero percent in the placebo group for the first eight weeks and the also the overall response rate of 67, 7%.
Speaker Change: And the durable response rate of 47, 6% during the 24 week of a subtle planet treatment.
Speaker Change: It also demonstrated favorable safety profile. So we initiate the phase III portion of the eastern two study.
Speaker Change: In the White Hot and we currently enrolling patients and on track to finish enrollment this year.
Speaker Change: Next slide.
Speaker Change: And pancreatic cancers that deadly disease with SKU, John that need with the five year survival rate of is less than 13%.
Speaker Change: It is the immune cold tumor and euro now respond to immunotherapy.
Speaker Change: And sore of fat in the R&D and marketing neuroendocrine tumors is a bad job FGF, our SaaS, one our <unk> inhibitor and also show immune modulating function.
Speaker Change: So we're currently conducting a phase two three trial of <unk> <unk> combination are accounted as a map and a chemotherapy of a treatment naive of pancreatic cancer and the study was informed by our investigator initiative trial presented at <unk> Gi last year.
Speaker Change: Using sort of found that combined as Carol Lizak map.
Speaker Change: <unk> PD, one inhibitor plus chemotherapy in the frontline setting.
Speaker Change: And the overall response rate was 50% versus 27% in the chemo arm.
Speaker Change: And the median PFS OS reached the nine months and 13 months, respectively, compared with only 5.8 months and the $8 six months in the control group.
So the phase two stage, where are they fully enrolled and we are expanding the had the phase two readout later this year.
Speaker Change: Next slide.
Speaker Change: Sure I'm going to update you about our antibody target therapy conjugate that ATC platform.
Speaker Change: So for the past three years.
Speaker Change: Really in nature.
Speaker Change: Invested significant resources into this new platform, which should provide multiple drug candidates in the future.
And compare with the traditional ADC.
Speaker Change: That the Thomson payload is replaced with the target small molecule.
Speaker Change: And as <unk> has several key differentiation compared with the traditional ADC platform.
Speaker Change: It could have better advocacy through antibody small molecule combination that will target specific mutations.
Speaker Change: Cal Ripken drug resistant and potentially support combination.
Speaker Change: With target therapy, with chemo and Immunotherapies, so pretty collect in the early stage are they lineup setting with sustained up here.
Speaker Change: On the safety side it has to improve the safety given with a lower <unk> target and the off tumor toxicity of small molecule.
Speaker Change: The lesser less less Milo suppression compared with chemo based ADC and you really have or we can think have a better quality of life and cytotoxin base the conjugate.
Speaker Change: He also has the attracted PK profile, resulting from antibody guided deliberates of target sites.
Speaker Change: We'll improve the viability of bioavailability and reduced drug drug interaction.
Speaker Change: Okay. So and are now sold the ADC platform has the potential to incorporate high molecule away drops payloads, such as prototypes or a protein protein inhibitors.
Speaker Change: Okay next slide.
Speaker Change: Yes, this slides I'm going to show you a preclinical proof of concept of our target.
Speaker Change: <unk> and.
Speaker Change: And so in this case.
Speaker Change: And our.
Speaker Change: Target antibody is linked to a target therapy payload that TD, one with a special linker.
Speaker Change: So on the last figure here it you guys see that target.
Speaker Change: Antibody, which is shown in green here and a small molecule payload GT one.
Speaker Change: Showing red.
Speaker Change: Have a gross tumor growth inhibition and the combination of both actually have a more synergistic fad.
Speaker Change: But it's very importantly, a single dose of the target therapy that ADT see show a robust anti tumor activity.
Speaker Change: When it comes.
Speaker Change: They compare with the either the antibody alone Halo alone or a combination of the antibody and payload up together.
Speaker Change: More importantly on the right hand side, we also show.
Speaker Change: Yes.
Speaker Change: Small molecule PD, one payload alone or in combination with antibody actually will not tolerate very well at Sherwood body weight reduction.
Speaker Change: The ATC dosing does not influence the body weight. So it is a very important preclinical proof of concept of 80 D C.
So a single those eight DTC deliver 14 days of tumor progression rig.
Speaker Change: Regression then good and also the good tolerability. So this is really demonstrate the unique feature are flooded.
Speaker Change: A T T C platform next slide.
Speaker Change: So our next.
Speaker Change: These generation technology leverage.
Speaker Change: Our expertise in target therapy, and also small molecule inhibitor and also the payload.
Speaker Change: Chemistry, and the counter date potentially have a key advantage over traditional adcs.
Speaker Change: On the right hand side targets protein required for cancer growth.
Speaker Change: Has the synergies as a combination in fact with functional antibody and also the ability of the combined with I O chemo.
Speaker Change: Or targets they are a standard of care, particularly in the frontline setting.
Speaker Change: And they can't overcome chemo resistant, which it still arent delivered about that driver mutations so.
Speaker Change: Benefit for further optimize this can also.
Speaker Change: Overcome.
Speaker Change: Small molecule with a narrow therapeutic window.
Speaker Change: Saw a reduction of on target off tumor toxicity. All platform is fascinated to deliver high potent concentration of small molecule.
Speaker Change: So it can be those long term, where they improve the safety window and we also reduced systemic toxicity off small molecule.
Speaker Change: Okay. So.
Speaker Change: The our first a T T C.
Speaker Change: As tough as Sue mentioned, we are conducting.
Speaker Change: Indeed, nibbling study and they could potentially our first global clinical study could be initiated later this year.
Speaker Change: So to recap of R&D progress Hutch, Matt has a deep and broad portfolio in oncology hematology and recently in autoimmune disease.
Speaker Change: Our R&D team and the global partners remained focused and executed well for the past year.
Speaker Change: And we have multiple near term NDA approvals and also late stage debottleneck catalysts in that.
Speaker Change: In the next year.
Speaker Change: In addition, our Nomura T D C platform, but also lidl multiple potentially first in class globally competitive assets into the clinical development in next few years.
Dr. Xu: So next I'll turn to Dr. Xu.
Speaker Change: Okay. Thank you Mike just twos.
Dr. Xu: Some of it up.
Dr. Xu: We think the most important milestone for us in 'twenty 'twenty four is that we achieved profitability ahead of our schedule.
Dr. Xu: And look for looking forward, we're quite excited about the growth.
Dr. Xu: Prospects and you can see here in the near term we.
Dr. Xu: We expect a topline and bottomline growth to accelerate behind.
Dr. Xu: For zircon launches around the world.
Dr. Xu: And the new indications in China, such as E. M. C. This year.
Dr. Xu: Potentially RCC next year some time.
Dr. Xu: And for several internet.
Dr. Xu: We believe the.
Dr. Xu: The new indication behind the Sochi started in China.
Dr. Xu: In second line Egfr mutation positive net amplified patients.
Dr. Xu: Once approved should give a big boost.
Dr. Xu: It's targeting.
Dr. Xu: A much bigger patient population.
Dr. Xu: Okay.
Certainly more importantly for civil isn't it we are hopeful that savanna and several studies if successful.
Dr. Xu: We'll support.
Dr. Xu: Registration globally and allow us to bring this important medicine to patients globally.
Dr. Xu: In addition.
Dr. Xu: New products launches.
Dr. Xu: Tazemetostat solve the planet and all in now.
Dr. Xu: Pan <unk> inhibitor <unk> five three.
Dr. Xu: We will add further to the growth.
Dr. Xu: And looking ahead midterm.
Dr. Xu: We plan to leverage our strong cash.
Dr. Xu: To explore acquisition of products will M&A.
Dr. Xu: Opportunities in China.
Dr. Xu: To add further to our commercial portfolio.
Dr. Xu: And longer term of course.
Dr. Xu: We believe the ATT sees.
Dr. Xu: We will deliver and will ensure our long term growth.
Dr. Xu: Thank you very much.
David: David back to you.
David: Thank you Dr. Sue.
Speaker Change: And we will now proceed to the Q&A session everyone on the line. Please.
Speaker Change: Make sure you put down your name and maybe Youre Institute in your name.
Speaker Change: There are two methods to ask a question you can.
Speaker Change: Christy raised had button at the bottom of the screen there that we would call. Your name and then you can ask the question directly or you can type a question in the Q&A box also at the bottom of your screen.
Speaker Change: So the first question will be Goldman Sachs.
Speaker Change: Paul Choi.
Speaker Change: Or I can bring your line will be at <unk> now you can go ahead and ask question.
Speaker Change: Hi, This is <unk>, calling in for Paul. Thank you. So much for taking our question I guess, a couple of quick ones from us.
Speaker Change: Apologies if you already mentioned this but just curious about your phase III plans for <unk> in combination with Progresso ex China, and then secondly, I know you mentioned M&A briefly there how should we think about.
Speaker Change: Types of assets Youre looking at and the implications for your cash balance from 2025. Thanks, so much.
Speaker Change: Okay. Thank you for the question with regard to the phase III subtle internet.
Speaker Change: Great.
Speaker Change: I'll just.
Speaker Change: Ask Mike to to provide.
Speaker Change: Any details Mike, yes, so globally.
Speaker Change: Saba led in that right we have this.
Speaker Change: Sovereign trial Phase III program.
Speaker Change: Is the Tigris old Plaza Saba led in that.
Speaker Change: In Egfr resistant patient population and the actually took reso resistant patient population with a man met amplification or overexpression. So that the phase II trial is ongoing very well.
Speaker Change: <unk> is a has the 20 country participating over 200 sites opened for enrollment so we anticipate.
Speaker Change: AZ will finish recruitment this year. So we're also.
Speaker Change: Based on the Sochi and.
Speaker Change: Savanna data, we actually will be very interesting to see that will lead to the global potential registration yeah. So.
Speaker Change: Since it's randomized trial it has the potential to if it is positive.
Speaker Change: It will support our global registration, including U S EU and Japan in Warsaw.
Speaker Change: Okay. Thanks, Mike, Yes, with regard to your second question M&A or product acquisition or in licensing with product I mean, it's really too.
Speaker Change: Leverage our strong cash position, we have over $800 million in cash now and as you know we announced.
Speaker Change: We are in the process of divesting our non core business.
Speaker Change: That will add further to our cash balance.
Speaker Change: And.
Speaker Change: In terms of the type of products all acquisitions, we will M&A.
Speaker Change: It's all about.
Speaker Change: Adding products to our portfolio, but possibly products.
Speaker Change: In oncology immunology area well.
Speaker Change: Potentially with the synergy with our pipeline.
Speaker Change: So we will explore.
Speaker Change: Exploring potential opportunities. Thank you.
Speaker Change: Got it. Thank you so much congrats on the progress.
Speaker Change: Thank you.
Speaker Change: Thank you.
Speaker Change: And our next question will be from Jefferies.
Cara Dol: <unk> Jefferies Cara Dol.
Speaker Change: Kerry Your line is now open.
Speaker Change: Hi, Good morning. This is clearer for Kelly Thanks for taking my question and congrats on the progress.
Speaker Change: No.
Speaker Change: So maybe can you broadly talk about your strategy to integrate your.
Speaker Change: Tc programs into our portfolio.
Speaker Change: What kind of development Padua indication choice you Mike.
Speaker Change: Initially pursue <unk> will be your first candidate into clinics.
Speaker Change: And also thank you mentioned of platform.
Speaker Change: Potentially the chairman multiple progress.
Speaker Change: Could you talk about what are your key criterias to nominate those programs in.
Speaker Change: You mentioned the first global trial could be initiated this year are you looking to rod.
Speaker Change: Charles Mr partner or independently. Thank you.
Speaker Change: Okay.
Speaker Change: You are very much clearer.
Speaker Change: Obviously.
Speaker Change: Rethink this a T T C L.
Speaker Change: Really big potential.
Speaker Change: Obviously, a targeted therapies with.
Speaker Change: The first a few targets we are working on are targeting major signaling pathways in and he saw.
Speaker Change: Genetic alterations that known to be.
Speaker Change: Driver alterations.
Speaker Change: And with incidence rates.
Speaker Change: 30, or 40% of Ohio.
Speaker Change: In all tumors.
Speaker Change: And.
Speaker Change: Also there is a lot of evidence set of patients or tumors with these kind of.
Genetic auditory alterations tend to benefit less to two chemotherapies or two.
Speaker Change: <unk> two.
Speaker Change: Traditional toxin base Adcs so they saw.
Speaker Change: With this.
Speaker Change: Inhibition of this.
Speaker Change: <unk>.
Speaker Change: <unk>.
Speaker Change: Genetic alteration as hopefully you will.
Speaker Change: Or allow these patients to benefit better to two onto the treatments in terms of initial development plan and then you can think of.
Speaker Change: Initially lay lying as a as a single agent.
Speaker Change: Potentially.
Speaker Change: Single arm pivotal studies, but in parallel.
Speaker Change: The go ultimate goal is to move move these products into Frontline's I think are the major.
Speaker Change: Vantage of this agent to see that we have.
Speaker Change: Don't expect.
Speaker Change: Overlapping toxicities with <unk>.
Speaker Change: With frontline chemo base of frontline therapies, including.
Speaker Change: Chemo based.
Speaker Change: A D C. So hopefully.
Speaker Change: They can be combined with our whatever frontline <unk>. So we can move these two frontline is to target a much bigger patient population. So that's obviously ultimately it will all it will be the clinical data that will guide us where to go in.
Speaker Change: Hopefully Uh huh.
Speaker Change: No.
Speaker Change: If.
Speaker Change: Proven in clinics I think we believe they have they have a huge potentials. Thank you.
Speaker Change: Thank you.
Speaker Change: Thank you very much. Our next question is from Bank of America.
Stranahan Alec: Stranahan Alec.
Speaker Change: Alex Your line is now open go ahead.
Speaker Change: Okay great.
Speaker Change: Thanks, guys for taking our questions and congrats.
Speaker Change: That's on the progress last year I guess.
Speaker Change: Two questions from US first when you look at the EU opportunity for <unk>.
Speaker Change: I guess, how do you see this adding to the top line over the course of 2025 could this support or maybe even accelerate the already strong growth ex China are or is it maybe more of an incremental opportunity and then secondly on salvo.
Speaker Change: What sort of incremental info from from Savannah should we expect next week at <unk>.
Speaker Change: As a follow up to that.
Speaker Change: What would you want to see it in Safran for you and ask you to feel confident to proceed the global submissions is it essentially just confirming what we've seen in Savannah or are you maybe hoping for something more there. Thank you.
Alec: Yes, Alex.
Stranahan Alec: Thanks for the questions. So frequently live is obviously very early in global launches.
Alec: Last year is mainly U S.
Alec: While approved by EU by EMEA, but it takes time to to gain access so.
Alec: Really towards.
Alec: Very end of the year.
Alec: It was launching in Spain. So there are many more Congress to go and I'm sure. Our partner Takeda is highly focused on EU.
Alec: And also Japan.
Alec: Finally gain access.
Alec: In Japan and launched in Japan.
Alec: Around Thanksgiving time so.
Alec: A lot to go in Japan, as well I think that all of these markets will.
Alec: Certainly accelerated the growth.
Alec: Same in the U S as well I think it's.
Alec: We think we think.
Takeda will will do a great job.
Alec: As they have been very strong.
Alec: And the <unk>.
Alec: The launches.
Alec: <unk> in terms of Savannah, and the self from.
Alec: Savannah is a single arm study.
Alec: Only support.
Alec: Conditional approvals in U S and maybe a few other.
Alec: Small countries that.
Alec: Their support this kind of system. It is self wrong ultimate it will support full approval.
Alec: Around the world. So so separately obviously is the most important study.
Alec: And yeah. It's.
Michael Shea: It's enrolling very well as Mike pointed out in <unk>.
Alec: Indicating strong on them adequate lead with.
Alec: The targeted therapies in this patient population so.
Alec: No. We are we are quite hopeful of that.
Alec: Several studies will complete enrollment.
Alec: Very soon and we can oh.
Alec: Ultimately.
Alec: Support.
Alec: The global registration thank you.
Alec: Thank you.
Thank you very much next question goes to.
Speaker Change: A mirror garden.
Julie Simmonds: Julie Simmonds.
Speaker Change: Julie I think your line is now open go ahead with your question.
Speaker Change: Thank you very much yeah, just following on on a frequent snip.
Speaker Change: Just wondering Saar as sort of you know looking at additional indications in China and getting some data on <unk> wondering how branches potentially could get into global.
Speaker Change: Markets and what's required there.
Speaker Change: Yes, I mean, obviously.
Speaker Change: I'll end, there, Jeff VEGF or TK I combo.
Speaker Change: It has proven synergistic.
Speaker Change: The successful trial.
Speaker Change: With the Farooq Winton him in Scintillon novel combination.
Speaker Change: In second line endometrial cancer and now.
Speaker Change: Randomized.
Speaker Change: Study in renal cell carcinoma, clearly confirms the synergy.
Speaker Change: In terms of.
Speaker Change: Outside of China. So obviously, we share all the data with Takeda and this is clearly a.
Speaker Change: Low risk and proven.
Speaker Change: Ah clinical act activity.
Speaker Change: I think the only challenge is that seem to the math is not approved outside China. So.
Speaker Change: If whether we can or replacing <unk> with a different PD, one or will other IL.
Speaker Change: It just it just makes it a bit more challenging but clearly.
Speaker Change: PD one in Belgium for combo is.
Speaker Change: Hum proven.
Speaker Change: Mechanism that will.
Speaker Change: That will result in synergy.
Speaker Change: Excellent. Thank you and then just wondering back on the M&A side of things what sort of stage programs would you be looking at is this one thing to add to the later stage pipeline all bucket. They they sort of early early part of what you're doing.
Speaker Change: So I think it will be open minded about suddenly preferably a late stage.
Speaker Change: Something that could really are immediately accretive.
Speaker Change: Adding to our commercial portfolio.
Speaker Change: Lovely thank you.
Speaker Change: Kim.
Speaker Change: Thank you next.
Speaker Change: Next question goes to Kevin There's Adam Carter Adam Your line is now open go ahead.
Adam Carter: Thanks, very much thanks for taking my questions and congratulations on the results. My first question really is just on <unk> again, so last month during the earnings call. We had to eat that executive see what their heating base no matter poorly studied dataset utilization of J&J drug just likely to be most impactful in the second line non small cell lung cancer.
Adam Carter: So basically I'm just interested to hear about management views on how they see the <unk> trial potentially affecting a tablet an obsession because it does feel there's going to be an impact there.
Adam Carter: Second question is on <unk> and I see from the announcement that pose that question was primarily for flame and with growth potential and can start Blaine.
Adam Carter: Do you have a feel and the levels of market penetration that can be achieved from <unk> in the U S. Based on the sales it seems that you've taken quite a big significant contribution of the Mako already so just centrally.
Adam Carter: And how much more headroom is there in there for you to go out and then the final question is just an R&D expenses, obviously those were down quite a bit over the PDA. Just wondering how we should think about yet Lincoln future R&D expenditure, particularly the still April investment youre going to be putting into the ADT fees and perhaps just overall some opex in general thanks very much.
Okay. Thanks for the questions.
Adam Carter: I'll give you a quick answer on <unk>, and then I will ask them like it too.
Adam Carter: To.
Adam Carter: So your question all solvable and.
Adam Carter: Also the on the <unk>.
Adam Carter: Expenses or budget, so for exactly yes.
Adam Carter: <unk>.
Adam Carter: In EU, Japan, It's all fourth line indication on label, So clearly will be a <unk>.
Adam Carter: It will be for fly.
Adam Carter: In the United States. The label is a third line and above obviously fourth line is the.
Adam Carter: <unk> is blank arrived before the approval so its the low hanging fruit there.
Adam Carter: I'm pretty sure the label.
Adam Carter: <unk> covers a third I am pretty confident.
Adam Carter: Oklahoma Takeda will work well.
Adam Carter: No.
Adam Carter: Okay.
Adam Carter: Try their best to penetrate the third line.
Adam Carter: Really it's a it's a very different therapy.
Adam Carter: With proven efficacy and safety.
Adam Carter:
Adam Carter: Without the chemo without miles suppression suddenly, particularly if a patient for elderly patients.
Adam Carter: Or the immune compromised patients myeloid suppression could be could be.
Adam Carter: Our problem.
Speaker Change: And also several in on the I'll leave it to two two Mike Yeah. Thank you Adam Yes, so for <unk>.
Adam Carter: In terms of competition right I mentioned the marrow posa.
Speaker Change: Is.
Speaker Change: It's really in the unselected patient population and also is a chemo combo rifle Youre up youre going to see it not only the.
Speaker Change: The traditional chemo based that toxicity Milo suppression.
Speaker Change: The hematology toxicity bottle. So there are some very challenging toxicity or.
Speaker Change: Skin toxicity, and then big disadvantage is really.
Speaker Change: The dosing right. So they have to do the split dosing them very frequent infusions. So it is really poor.
Speaker Change: Is that a.
Speaker Change: Certainly.
Speaker Change: It is approved but is a very not a very clear biomarker selected patient population.
Speaker Change: Four four save Linda degrees or combination is really a <unk>.
Speaker Change: Aric convenient all key all oral regimen and also have a very precision selected target patient population as they just from what for the Sochi for the savanna data you're going to hear next week.
Speaker Change: Saatchi you in the future is math amplified overspread patient is really representative Barry.
Speaker Change: Big group of patients 34, 34% of patients with met all of our <unk> session.
Speaker Change: Amplification habit.
Speaker Change: It's a larger patient population with the clear driver mutation and this target therapy is really being effective battery to be union. So we believe if it is I mean, if it is approved or has an alternative has certainly has us.
Speaker Change: Convenience.
Speaker Change: And the precision medicine based approach. So I think just by looking audits therapy. This is a really.
Speaker Change: Hi, unmet need and where the kennedys convenient dosing. So we we think even I think a Z is also thinking this is really the competitive advantage for the <unk>.
Speaker Change: Ora target therapy combination.
Speaker Change: And.
Speaker Change: R&D expense ratio.
Speaker Change: We are actually very excited of our ADC platform right is.
Speaker Change: This is truly the first in class we think all of these assets are very globally.
Speaker Change: <unk> assets and.
Dr. Xu: I think the spreads also for our platform is we are very carefully selected the antibody doctor Sue alluded to these potential late garden.
Speaker Change: Born to tumor type are higher.
Dr. Xu: Yeah.
Dr. Xu: The higher percent of the driver too.
Dr. Xu: Mutation with.
Dr. Xu: With a lot of.
Dr. Xu: Commercial opportunity down there also ultimately we do want to take a.
Dr. Xu: These assets as our priority to invest.
Dr. Xu: I envision is really initially we're going to do a rapid global dose escalation.
Dr. Xu: <unk> have.
Dr. Xu: As a late line expansion clinical proof of concept so.
Dr. Xu: Once we demonstrate clinical activity. So we can still leverage a lot of opportunity not necessarily everything.
Dr. Xu: I have to be done by ourselves right because certainly we have.
Dr. Xu: Multiple assets.
Dr. Xu: By this platform, we can pretty much.
Dr. Xu: Duplicated and repeat the process hopefully.
Clint: When Clint.
Clint: Clinical proof of concept is demonstrated we can bring potential pardon me.
Clint: Party, Ian now nestles really just really exponentially grow our R&D budget.
Clint: What potential BD opportunity, we can manage the expense.
Clint: Expense, but certainly these are potentially exciting competitive molecule assets, we certainly will be a priority for company to invest for the future growth.
Clint: Okay. Thanks Mohit.
Clint: Thanks, very much again and Dan Congrats congratulations.
Clint: Thank you.
Clint: The next question go to UBS Tianjin.
Speaker Change: Centennial question are your line is now open go ahead with your question. Thank you.
Speaker Change: So it's very quick to see the encouraging preliminary data OBL HTC.
Speaker Change: 1 billion, how many ADT the candidates can move to clinical stage this year so well.
Speaker Change: <unk>, Oh, Wow key candidates or it will focus on.
Speaker Change: Thank you Kent ADC candidate.
Speaker Change: Yes, the short answer is multiple.
Speaker Change: As you heard from my garage, so we have already multiple payloads targeting different genetic drivers.
Speaker Change: Free payload will have.
Speaker Change: Has the potential to to be linked to different antibodies based on the <unk>.
Speaker Change: Based on the tumor antigen expression levels in various different tumors. So it's all about.
Speaker Change: Deliver this.
Speaker Change: Kylie potent targeted targeted therapies to different tumors. So so yeah, there will be multiple but but this is a year.
Speaker Change: It will get started it may be.
Speaker Change: These filings may be one or two maybe two this year, depending on timing and how the preclinical IND, enabling tox progress certainly one could be too, but there'll be more to follow.
Speaker Change: Later.
Speaker Change: Next year or even beyond.
Speaker Change: I see that's quite clear.
Speaker Change: That quest.
Speaker Change: Questions planting. So previously you guided <unk> <unk> five and it's very exciting that you have already achieved.
Speaker Change: So I just want to double check.
Speaker Change: Break even targets internally slide.
Speaker Change: Is it the guidance now.
Johnny Chen: The short answer is yes, maybe Johnny can provide more color on this suddenly we think will be.
Speaker Change: Profitable from here on it will be but.
Johnny Chen: But we believe we reached our selves.
Johnny Chen: Yes.
Johnny Chen: Sustaining kind of mode of operation Yes.
Johnny Chen: Yes. Thank you Dr. Fischer so attention.
Speaker Change: We have only been giving out this revenue guidance for our oncology business.
Speaker Change: But I.
Johnny Chen: Thank you.
Speaker Change: In terms of our targets.
Speaker Change: We ask doctors you mentioned that we have in.
Speaker Change: In our bonds achieved at the hour south south reliance self sustaining.
Speaker Change: Yeah.
Speaker Change: Profitability model already in 2024 in fact, we made profit 2023.
Speaker Change: Thanks to the funding come that we recognized from Takeda and this year, we have from our ongoing business. We have been able to add may break even in a slight profit this year and going forward. As we said we will maintain this a go and that will continue.
Speaker Change: To have this pathway, but this is not our guidance strictly to the market.
Speaker Change: One can take because of the divestment of our non core business, we will be recognizing a substantial.
Speaker Change: Substantial high amount of.
Speaker Change: In 2025.
Speaker Change: Yeah.
Speaker Change: That's great. Thank you.
Speaker Change: Thank you we have one question on the line is from Morgan Stanley Jacket. Blaine. This is a question is regarding our a T. T. C platform question. One is is there any molecular difference a modification in the TK I being use in the payload of R. A T T C as compared to.
Who are the traditional teekay I being consumed all Rowley. So that's question. One question two is would it be possible to use more potent <unk>.
Speaker Change: Hello.
Speaker Change: Relative to how ADC technology has allowed to use more toxic payload that would normally not be able to use systematically desk question number two and the final question is what do we think about the future potential dosage dosing frequency of our a T V C.
Speaker Change: Candidate.
Speaker Change: Okay. Thanks.
Speaker Change: So.
Speaker Change: Lot of questions here.
Speaker Change: So suddenly structure of the Tequila is visa old novo's structures chemical structures will be protected by patents and so obviously different from whatever is available all day.
Speaker Change: I actually don't even think.
Speaker Change: Anything approved against these targets.
Speaker Change:
Speaker Change: In terms of toxicity.
Speaker Change: A very potent T. J is I mean, that's the whole idea right. This is the <unk>.
Speaker Change: <unk>, we hope to improve.
Speaker Change: Clinical activities through a combination with the between the antibody and the payload at the same time, reducing toxicity.
Speaker Change: Because the free <unk>.
Speaker Change: Free circulating.
Speaker Change: Small molecule payload will be extremely low so so.
Speaker Change: Yeah.
Speaker Change: Toxicity associated with a payload.
Speaker Change: It will be will hopefully be a much reduced.
Speaker Change: So yes, that's I think that's that's that's that's the key rationale behind behind ATT sees.
Speaker Change: Certainly.
Speaker Change: <unk>.
Speaker Change: Mike already.
Speaker Change: Explains in detail.
Speaker Change: A clear definition.
Speaker Change: From traditional toxic based adcs.
Speaker Change: That you know this.
Speaker Change: H T C.
Speaker Change: <unk> therapies they are much.
Speaker Change: Much less.
Speaker Change: No.
Speaker Change: Uh huh.
Speaker Change: We expect a much less maiolo suppressing or overlapping toxicities with a with a chemo.
Speaker Change: And hence can be combined hopefully.
Speaker Change: Much better with the frontline chemo based.
Speaker Change: The standard of care so.
Speaker Change: Really the.
Speaker Change: The big potential is in combination.
Dr. Sue: Thank you Dr. Sue maybe will have the very final question off Tonight.
Cindy Chai: HSBC Cindy Chai Cindy.
Speaker Change: Cindy Your line is now open please ask your question.
Speaker Change: Hey, Thanks for taking my questions.
Speaker Change: To that achievement I, just have I'll take questions. So I know, we know that they have Uh huh.
Speaker Change: Tablets.
Speaker Change: And just wonder as frequently need mass steel product used by Hodge, Matt what's the currency impact in the future and also what's the progress of our manufacturing transfer to Takeda and whether the well after the manual factory.
Speaker Change: <unk> transferred finished whether they will produce <unk> and U S. All in Japan. Thanks, so much.
Speaker Change: Okay.
Speaker Change: Thank you for the question obviously tariffs.
Speaker Change: Tariffs.
Speaker Change: On pharmaceutical products being proposed by by President Trump, but no details at the moment.
Speaker Change: In terms of the level and.
Speaker Change: As you know right the cost of goods or cost for manufacturing for all pharmaceutical products are always relatively low.
Speaker Change: So the impact to two hour products, let's say through exactly remains to be to be assess.
Speaker Change: At the moment, it's really not clear.
Speaker Change: In terms of.
Speaker Change: Tech transfer to Takeda is going very well.
Speaker Change: Well no.
Speaker Change: Both API and drug product ultimately can be <unk>.
Speaker Change: Sourced outside China so.
Speaker Change: China can remain as a supplier or a hutch medical remain as a supplier, but at least so there will be.
Speaker Change: Multiple multiple sources to support our global market.
Speaker Change: Thank you.
Speaker Change: Thank you everyone I think we'll wrap up here. Thank you for the questions. Dr. Sue would you have like one last remark.
Dr. Sue: Yes, absolutely I just want to thank everyone for.
Dr. Sue: Participating this call and as are we.
Dr. Sue: We presented here Huntsman is in a very good positioning we have very strong cash.
Dr. Sue: We have.
Dr. Sue: Multiple products.
Dr. Sue: This year going through a regulatory.
Dr. Sue: Reviews, and hopefully Uh huh.
Dr. Sue: Come out positive.
Dr. Sue: We have for zircon are going well and expected to continue the momentum and as Solvolytic behind Savannah, all stuff wrong. Ultimately hopefully, we'll we are hopeful that we can bring this.
Dr. Sue: Important medicine to patients globally.
Dr. Sue: All this will.
Dr. Sue: Ensure accelerated growth.
Dr. Sue: For us for years to come and of course, the longer term, it's all about.
Dr. Sue: The next wave of innovation, particularly a to disease.
Dr. Sue: Thank you all for <unk>.
Dr. Sue: Participating in the call and look forward to interacting with you.
Dr. Sue: Thank you everyone. We'll now end the call.
Dr. Sue: Yeah.