HUTCHMED H1 2025 Earnings Report

HUTCHMED EPS Results

• Actual EPS: N/A
• Consensus EPS: $1.46
• Beat/Miss: N/A
• One Year Ago EPS: N/A

HUTCHMED Revenue Results

• Actual Revenue: N/A
• Expected Revenue: $330.40 million
• Beat/Miss: N/A
• YoY Revenue Growth: N/A

HUTCHMED Announcement Details

• Quarter: H1 2025
• Date: 8/7/2025
• Time: Before Market Opens
• Conference Call Date: Thursday, August 7, 2025
• Conference Call Time: 8:00AM ET

HUTCHMED (NASDAQ:HCM) (China) Ltd. is a holding company, which engages in the research and development, manufacture, and sale of pharmaceuticals and health-oriented consumer products. It operates through the Oncology/Immunology and Other Ventures segments. The Oncology/Immunology segment includes the discovery, development, and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. The Other Ventures segment involves the other commercial businesses which include the sales, marketing, manufacture, and distribution of prescription drugs and healthcare products. The company was founded on December 18, 2000 and is headquartered in Hong Kong.

HUTCHMED H1 2025 Earnings Call Transcript

Key Takeaways

• Positive Sentiment: The company reported a 25% increase in global Zecla sales in H1 2025, driven by strong uptake in key markets.
• Positive Sentiment: H1 ended with a $1.3 billion cash balance bolstered by a partial JV divestment, providing resources to advance ATTC development and pursue strategic investments.
• Negative Sentiment: Revenue for the period fell 10% to $278 million, leading management to lower full-year guidance to $270–350 million amid milestone phasing and a delayed Soflepanib launch.
• Positive Sentiment: A partial divestment of the Shanghai Pharma JV yielded over $600 million in proceeds, contributing to a record net income of $455 million in H1.
• Positive Sentiment: The first ATTC candidate (A251) is on track for an IND filing in September 2025, showcasing the company's novel antibody-targeted therapy conjugate platform.

Presentation

[David Ng, VP, Head - IR & Capital Strategies at HUTCHMED (China)]

Hello, everyone. This is David Ng, Head of Investor Relations of HutchMet. Thank you for joining HutchMet twenty '25 interim result presentation. Our results and presentation slides have already been posted on our home page as well as on the Hong Kong Stock Exchange website. Just a quick moment on the disclaimer.

[David Ng, VP, Head - IR & Capital Strategies at HUTCHMED (China)]

The performance and results of operation of Hutchinson Group contained within this presentation are historical in nature, and past performance is no guarantee of future results, and actual results may vary materially from those set forth in the forward looking statement. So today, we are very glad to have our CEO, doctor Su our CFO, mister Chen our c MO, doctor Xi, and our head of commercial, mister Yan, to go over the results and provide the latest update on our performance and the projects under development. As usual, we will have a q and a session at the very end when you can press the raise head button to ask questions and or type in the chat box, but please make sure you have your name and your company name on the screen. So now let us, welcome our, chief executive officer and chief scientific officer, doctor Weibo Xu, to break to begin our present presentation. Doctor Xu?

[Weiguo Su, CEO, Chief Scientific Officer & Executive Director at HUTCHMED (China)]

Thank you, David. If we go to the next slide. So, again, good evening, good morning, everyone. Welcome to the HutchMath mid year result conference call. The highlights for the, first half twenty twenty five, global commercial success, for Zecla continues to grow first half, up 25% comparing to 2024.

[Weiguo Su, CEO, Chief Scientific Officer & Executive Director at HUTCHMED (China)]

Orpassus or savolitinib, potentially our second global commercial product. There are filings ongoing based on Savannah in some countries. And, also, obviously, the global registration of study, SEFRAN study, is recruiting. We anticipate completion of recruitment later this year. And, of course, Elunate in China new indications, endometrial cancer approved early this year, and and and RCC already filed as well.

[Weiguo Su, CEO, Chief Scientific Officer & Executive Director at HUTCHMED (China)]

We do have a lot, going on. We expect in the next twelve months, our phase three first line non small cell lung cancer, osimertinib plus savolitinib study called Cenovo. Should should it we should it complete enrollment very, very soon. If anything, I think we already fully enrolled. Sephron, as I mentioned, should also complete recruitment shortly.

[Weiguo Su, CEO, Chief Scientific Officer & Executive Director at HUTCHMED (China)]

Surufatinib phase two three study in first line pancreatic cancer, phase two readout, and and a phase three transition, is progressing. OFGFR inhibitor NDA submission is in preparation, plan to file late this late later this year. And the savolitinib Samita study for PRCC globally and gastric cancer in China. NDA submissions are also planned. Fruquintinib RCC, as I mentioned, NDA filed early this year.

[Weiguo Su, CEO, Chief Scientific Officer & Executive Director at HUTCHMED (China)]

And and, within the next twelve months, we expect approval. The CEFRON study, of course, is phase three readout. Should be sometime first half next year. Our next generation innovation, very exciting, ATTC programs, the first candidate IND filing coming up very soon in a month or so, and we have more to come later this year. And we are also exploring BD activities for not only our ATTC programs, but other programs as well.

[Weiguo Su, CEO, Chief Scientific Officer & Executive Director at HUTCHMED (China)]

Without further ado, I'll just hand it over to, the next speaker, our CFO, Johnny Chan, to give you a financial overview and update. Johnny?

[Johnny Cheng, CFO & Executive Director at HUTCHMED (China)]

Thank you, doctor Su. On page six, we can see our balance sheet reflects a very strong cash position. Over 1,300,000,000.0 in cash resources, which includes proceeds from the partial divestments of our joint venture with Shanghai Farm. So these resources will allow us to accelerate global ATTC development and explore potential investment opportunities. Further down the balance sheet, under no other noncurrent liabilities, we have deferred approximately 18,000,000 of divestment gains as a provision for profit guarantee to the buyers.

[Johnny Cheng, CFO & Executive Director at HUTCHMED (China)]

This will be recognized over the guaranteed period subject to the joint venture's performance in the next few years. Turning over to page seven, our p and l. So overall, the revenue for the 2025 was 278,000,000, down 10% versus same time last year. Investments in r and d amounted to 72,000,000, reflecting multiple NDAs under review in China. On the bottom line, we have reported a record high net income of 455,000,000, mainly contributed by the partial divestments of our joint venture with Shanghai Farm.

[Johnny Cheng, CFO & Executive Director at HUTCHMED (China)]

Moving on to the next page. We have adjusted down our full year revenue guidance to between $270,000,000 to $350,000,000, mainly to reflect a revision for the phasing of certain clinical and commercial milestones and also the delay of soflepaneb commercial launch. I will now pass to our head of commercial, George Yuan, to share with us on the commercial performance.

[George Yuan, EVP & Head of Commercial at HUTCHMED (China)]

Thanks, Johnny. The first half year of our commercial results is relatively flat. For Zaclar, post a very strong growth, 25%, but offset by a weaker China performance in for three brands, Ilunette, Surrender, and Allpasses. Next slide. If we look at, Fruzacla, we know that CRC is the third most common cancer and also the second leading cancer for the fatality worldwide.

[George Yuan, EVP & Head of Commercial at HUTCHMED (China)]

And, with your country adding to the launch market and also include reimbursement, we see Fuzakula deliver a very strong solid growth in the first half year, especially Japan with Takeda's strength in and the know how in the CRC mark as well as the benefit and the value of Fusakra in CRC being highly recognized by NICE recommendation. So these products will continue to gain market share and through the expansion of the reimbursement and the new launch countries. Next slide. The China CRC market become very competitive in the later line. We see more rigafenib generics in the past one or two generics launched in the past twelve months.

[George Yuan, EVP & Head of Commercial at HUTCHMED (China)]

Also, there's a uptake of the combo regimen in the sirlime. Beva combo become cross line treatment become more popular than before. And, we we we face a final push by the rigafenib before the VBP. And so we adjust our market strategy, and we can back some of the share on the q two last this year. And we still believe we are the strong market leader in the third line CRC, and we will continue to be the market leader in the CRC.

[George Yuan, EVP & Head of Commercial at HUTCHMED (China)]

And the the EMC launch as well as the future RCC approval will further drive our growth. Next slides. The this year, the the MET, TKI, MET market went through a strong turbulence with additional four NADL listed products starting from the beginning with all of the four with the first line indication. Opas is actually lost market share in the beginning of the year, but through the middle of this year, we get a full approval first line as well as the such approval before the middle of this year. Our party has been well positioned for this year's renegotiation.

[George Yuan, EVP & Head of Commercial at HUTCHMED (China)]

Of course, Saatchi is certainly the key differentiator versus others TKIs. Also, we will strongly leverage the AstraZeneca's expertise in the lung cancer. The combo treatment will be the first and the best oral dual precision medicine to offer to the lung cancer patients. Next slide. If we look at the the net market, we also have some kind of headwinds.

[George Yuan, EVP & Head of Commercial at HUTCHMED (China)]

We see the octreotide generics launched in the market. Also, we saw this year lanotide gain to the NRDL and multiple nuclear medicine, the PRRT treatment is under clinical development, which is fighting for patient share in the top centers. We do see a short term hiccup for our business. But if we look at the future, we still believe we are the market leader in the T Care segment and we have an obligation to gain the market share for the whole segment as well as surrender in the net treatment. The diagnose and the know how of the treatment is for the NET is still growing and we believe there's a lot of education opportunity as a leader in the TKI segment, we will further drive the category. Next, I will hand over our Michael.

[Michael SHI, EVP - Head of R&D & Chief Medical Officer at HUTCHMED (China)]

Yeah. Thank you, George. I'm gonna give you update about our pipeline. So we have made tremendous progress in our late stage product development in addition to the global approval of the CRC, fuclinenib, also expanding into the new indication in China, such as endometrial cancer and RCC. And our, another brand, savolitinib, also achieved label expansion approval with multiple new indications in the late stage development, again with our partner AstraZeneca.

[Michael SHI, EVP - Head of R&D & Chief Medical Officer at HUTCHMED (China)]

Doctor. Su also mentioned Surufatinib is in the late Phase II development with a late Phase readout later this year. And our first HIM product, Tazemetostat, has been approved in China with additional new indication development in follicular lymphoma. Later on, I'll also give you update our SYK inhibitor in suboplanet for NDA and also the WiHA development. And our third wave product, ranasitamab and fenugatinib, also at a pivotal registration trial stage.

[Michael SHI, EVP - Head of R&D & Chief Medical Officer at HUTCHMED (China)]

All these products will profile our future growth. Next slide. And this slide also give you update about our early stage pipeline advancing or will be entered into the clinical development. First, seven sixty is our third generation BTK inhibitor, Currently, it's still in the phase two development in the refractory DLBCL. And our new MEN inhibitor, five zero six, also entered a clinical development, is in the dose escalation stage, in the AML.

[Michael SHI, EVP - Head of R&D & Chief Medical Officer at HUTCHMED (China)]

Also, today, I'm gonna give you updates on our new class of agent. Doctor Su mentioned the ATTC antibody target therapy conjugate product. Three early pipeline, A251, five eighty, and A30 will all enter clinical development later this year and also next year. Next slide. Here's our update about ATTC platform.

[Michael SHI, EVP - Head of R&D & Chief Medical Officer at HUTCHMED (China)]

During the last conference call, we disclose our new platform. And, so now we're actually making, pretty, advanced pro progress in our first three molecule and, all targeting enter clinic pretty soon. And so, I think the, ATTC have several key differentiation shown here, because we really leverage, and maximize the synergy between the target therapy antibody and also our small molecule know how as a as a as a payload and really through the linker optimization to really overcome some of these physical chemical properties of small molecules as a payload. So by doing that, it could have a better efficacy so antibody and small molecule combination while target specific mutations can overcome drug resistant and potently supported combination with other target therapy, particularly in the frontline setting. And also improve the safety given the low target, on target, and off tumor toxicity than the small molecule.

[Michael SHI, EVP - Head of R&D & Chief Medical Officer at HUTCHMED (China)]

And also unlike other toxin based ADC, it has less myelosuppression and also have a better quality of life. And also have a favorable pharmacokinetic profile resulting from antibody guided delivery to the targeted sites, improve the bioavailability, and reduce drug drug interaction, compared to the oral small molecule TKI. Next slide. So mechanistically, the ATTC can target protein required for cancer growth. It has a synergistic effect with a combination with functional antibody and also has the ability to combine with other chemo target therapy or standard of care chemotherapy and which is particularly important from the frontline side team.

[Michael SHI, EVP - Head of R&D & Chief Medical Officer at HUTCHMED (China)]

And the also, are numerous report the chemo based ADC is working less effectively with the tumors with mutation. So this will have the opportunity to really establish a better therapeutic window and through the reduction on target adult tumor toxicity. And and also it have other less other compound induced toxicities such as liver, QT, lung QT, etcetera. So it can be dosed long term with the improved safety window and, with a reduced systemic toxicity for small molecule. And more generally, the ATTC platform can also be expanded to incorporate high molecular weight drug payload, so this is actually a platform to have multiple opportunities.

[Michael SHI, EVP - Head of R&D & Chief Medical Officer at HUTCHMED (China)]

Next slide. So this is the design of our first ATTC candidate, A251. So on the antibody side, it uses a clinically proven, well established human ized IgG1 antibody and with a small molecule payload with a drug to antibody ratio of four. For the proof of concept of this platform, that the antigen we selected is expressed in multiple tumor type, and the antibody is internalized favorably. And on the payload side, it really leverage our small molecule expertise and with a highly potent, against kinase family with broader genetic alteration and has the potential to synergize with the antibody to overcome resistance and improve the efficacy.

[Michael SHI, EVP - Head of R&D & Chief Medical Officer at HUTCHMED (China)]

We also show you some of the bystander effect to kill the antigen negative cells. And also on the linker side, it it it has a pretty stable in the plasma, and it will you will be cleaved by the proteins highly expressed in the cancer cells. Have a very precise target delivery in the tumor cells. Next slide. And this slide shows some of the preclinical data for 08/1951.

[Michael SHI, EVP - Head of R&D & Chief Medical Officer at HUTCHMED (China)]

In a panel of tumor cells, we actually see a very potent activity with a subnomolar range of IC50 for first tumor cell lines with a high antigen expression. And in the middle figure, it shows the bystander effect. For antigen expressed tumor cells, it has the, you know, pretty good tumor killing, but low or no expressed antigen. Right? The the the the eight two five one has no antitumor activity.

[Michael SHI, EVP - Head of R&D & Chief Medical Officer at HUTCHMED (China)]

But if you co culture the antigen positive and negative cells, it actually have the the activity to kill the both negative and the positive cells. So it really demonstrate the bystander effect. And also it preserve the ADD ADCC activity as same as the naked antigen antibody showing on the right hand side figure here. Next slide. And this is a proof of concept, preclinical proof of concept for our eight two five one.

[Michael SHI, EVP - Head of R&D & Chief Medical Officer at HUTCHMED (China)]

The target antibody is linked to a target therapy payload, with a special linker. And the left figure show here is the target one antibody showing green and the small molecule payload with the showing red here with the biweekly dosing, and it shows tumor growth inhibition. And also the single dose of target one and ADTC shows a robust antitumor activity compared with the antibody alone or the small molecule payload alone or the combination both payload and antibody. So this is very important proof of concept showing a single dose ATTC deliver a sustained tumor inhibition over fourteen day period of time and show good tolerability. Because on the right hand side, we can see the payload itself or payload plus antibody, although have a under tumor effect, but they also reduce the body weight.

[Michael SHI, EVP - Head of R&D & Chief Medical Officer at HUTCHMED (China)]

But the eight thousand two hundred fifty one itself, those at the thirty milligram per kilogram, has no weight loss. So it's very important show not only induce that tumor regression, but also have a very good safety profile. Next slide. And also, the eight thousand two fifty one also show very good synergistic activity with the standard chemotherapy. The left panel here is the tumor xenograft model.

[Michael SHI, EVP - Head of R&D & Chief Medical Officer at HUTCHMED (China)]

The combo with chemo, show, you know, a synergistic effect. And also on the right hand side, we have seen the tumor cell line study also show that chemotherapy plus eight two five one have a a synergistic activity. So this is quite different from the other toxin based ADC because in the all all the clinical development setting, you can see most of the ADC, toxin based ADC cannot actually combine with the standard of care because the toxicity. Okay. Next slide.

[Michael SHI, EVP - Head of R&D & Chief Medical Officer at HUTCHMED (China)]

Also, I'm gonna highlight some of the progress on our, key assets, Savolitinib. And both in the global and the China development, really gonna drive the future growth. So at the ELCC twenty twenty five, we have reported the data for AC reported the data for Savanna study and showing the durable response overall response rate. And in the same conference, we also showed the our Savolitinib in medicine 14 speaking skipping non small cell lung cancer also show a very good response rate and also they sustain the overall survival. So this also lead to our approval, not only get a full approval for late line medicine 14 non small cell lung cancer indication, but also expanded the first line indication.

[Michael SHI, EVP - Head of R&D & Chief Medical Officer at HUTCHMED (China)]

Very importantly, George also mentioned about our second line EGFR TKI refractory patients, opacis plus osimertinib, EMET amplified patient. This one, we achieved the NMPA approval in the June and also has been selected in ASCO presentation at during the ask annual ASCO meeting. Doctor Su mentioned our PRCC, the CEMIDI trial, will also finish the also finish the recruitment, and the the readout for for this trial will be early next year. And for the China side, we also achieved the recruitment for the SINUVA first line trial. And also we are playing trying to finish this soft form trial recruitment this year.

[Michael SHI, EVP - Head of R&D & Chief Medical Officer at HUTCHMED (China)]

And the gastric cancer in meta amplified patients also are preparing NDA for later this year. Next slide. This is also showing the key results for SATCHI trial and in the overall intent to treat patient population the PFS OC plus Savolitinib which which is a half has a ratio of point three four, and the PFS improvement versus chemo from 4.5 to 8.2 a month. And, also, regardless, the first, second generation TKI treatment or prior third line TKI progress the patient, the hazard ratio is very consistent. And in particular, for third generation TKI refractory patient, as you can see, the control chemo arm have only have a PFS three months, and the plus OC reached the almost seven months.

[Michael SHI, EVP - Head of R&D & Chief Medical Officer at HUTCHMED (China)]

And also the response rate disease control rate and durability of response also has been extended by OC plus combination. Next slide. And interestingly, we also observed the publication for amiventanib in the MERIPOLSA two trial, as you recall, the ami plus chemo versus chemo trial. They also have a biomarker subgroup analysis. Men amplified patients only identify forty percent of the patients in the MERIPOLSA two trial.

[Michael SHI, EVP - Head of R&D & Chief Medical Officer at HUTCHMED (China)]

And unlike our our study for Versace, we observed about 50 30% of the meta amplification by FISH analysis. And so in the patient population, as you can see, the chemo arm actually both trials, the MERIPOSO-two and the SAGI trial, are very consistent. Remember, these patient have the amplification progressed on the prior third generation TKI and amibetinib trial, showing the PFS of 3.1 month, but their improvement is only to 4.4 months PFS with a hazard ratio of 0.51. So the patient population in this population, what we can conclude, just like the SAGI, meta amplified patients have very poor prognosis, their PFS only three months. But the Savolitinib plus OZ reached the PFS almost seven months with a hazard ratio of 0.32.

[Michael SHI, EVP - Head of R&D & Chief Medical Officer at HUTCHMED (China)]

So this is quite significant difference. Believe in the biomarker selected patient population, SARVO plus OC really demonstrates superior activity, really addressing these patients with a proper prognosis. And also both the SAVANNAH and the SAGI trial demonstrate the combo has a very effective effect in the patient with the baseline brain metastases. So these are the key difference between Aussie plus Savo compared with other study because this is the only biomarker selected patient population. And also, it's the only chemo free regimen.

[Michael SHI, EVP - Head of R&D & Chief Medical Officer at HUTCHMED (China)]

So we believe this will have a very substantial unit in the the clinical setting. Yeah. Next slide. And the Saatchi approval, I also want to mention, they enable us to go through the NRDL this year. And also, we present our savolitinib medicine 14 trial at the ELCC, and we have observed very substantial improvement of OS.

[Michael SHI, EVP - Head of R&D & Chief Medical Officer at HUTCHMED (China)]

So the patients with the prior treated with the patients with the OS of twenty five month, and the patient with the frontline setting, the treatment naive patient, the OS with the long follow-up have a OS with twenty eight months, and the upper level has still now been reached. So among all the MED TKI, the savolitinib actually demonstrate the longest over survival repeat repeated so far. So we are very excited about this, data. Next slide. And, also, Fukwinenib has been extending into the other indications.

[Michael SHI, EVP - Head of R&D & Chief Medical Officer at HUTCHMED (China)]

So, we already got early approval for the endometrial cry trial. We have the over response rate of, thirty five, percent, and also the median PFS reached 9.5 month. And we are also gonna present our phase three FRUCICA two trial at the upcoming ESMO later this year and showcase the activity has been chosen as a meaningful oral presentation. So we'll highlight the data and the NDA has already been excited and under review at the NMPA. Next slide.

[Michael SHI, EVP - Head of R&D & Chief Medical Officer at HUTCHMED (China)]

Our first hematological product Tasmatostats also got the third line follicular lymphoma approval. It showed a high consistency with the global trial and so at the EHA this year, we showed the patient in the third line follicular lymphoma with the RRC over response rate of sixty three point six and the percent. And the invect here are assessed the ORR with sixty eight percent. So, it's very consistent with the global trial leading to the approval in The US and Japan. Next slide.

[Michael SHI, EVP - Head of R&D & Chief Medical Officer at HUTCHMED (China)]

Surufatinib is our combination study in the pancreatic cancer. It's going very well. Pancreatic cancer is a highly deadly disease. It's have a five year survival rate at less than thirteen percent. In general, the PDIC is a cold tumor, immune cold tumor, and not responsive very well with the immunotherapy.

[Michael SHI, EVP - Head of R&D & Chief Medical Officer at HUTCHMED (China)]

From our preclinical work and the IT study, we actually demonstrate surfinanet as a VEGF inhibitor not only inhibited the VEGF FGFR pathway, but the c s one r inhibitor pathway also has a immunomodulating function. So this phase two three trial currently ongoing in combination of carolizumab PD-one and the chemotherapy for the treatment naive PDAC. So this will at the ASCO twenty twenty five, the investigator initiated trial also show this Surplus Carrelizumab with a chemotherapy in the first line demonstrate the over OR 51 versus twenty four percent of the chemo. And, also, there's a significant improvement of the PFS. So the phase two portion of this trial is gonna read out later this year what will trigger if the result's good, will trigger the decision making to the phase three portion of the trial.

[Michael SHI, EVP - Head of R&D & Chief Medical Officer at HUTCHMED (China)]

Next slide. Also, I'm gonna, give you an update about the, ESLON one, study. So we presented the data at last year that demonstrate a robot over a response rate of seventy one percent and the durable response, forty eight percent. So because the dual mechanism not only inhibited macrophage digestion, but also stimulating inhibited B cell production. So this dual mechanism of SYK inhibition really provides advantage, particularly in patients who are refractory to TPO TFR treatment.

[Michael SHI, EVP - Head of R&D & Chief Medical Officer at HUTCHMED (China)]

During the review course, as you recall, we submitted NDA and MMPA stipulate there's a lower impurity limit. So this require further CMC validation and stability test. So we target a resubmit with the additional data in the first half next 2026. And with additional rolling data will be next later part of the next year. So here's the update of our subplanet in the ITP NDA status.

[Michael SHI, EVP - Head of R&D & Chief Medical Officer at HUTCHMED (China)]

And next slide. And we also, have another, trial with warm autoimmune hemolytic anemia, the phase three trial. We have shown previously that suboplanet reached an overall response rate of sixty six percent and the durable response is forty seven percent because the the WiHA is a very deadly disease, and, no target therapy has been approved. So represent a high unmet need. So we are, very excited that phase three registration trial has already completed movement, recruitment with the data right readout next year.

[Michael SHI, EVP - Head of R&D & Chief Medical Officer at HUTCHMED (China)]

So, I think we make a very strong progress, in the r and d, and we're really hoping, our r and d team with our novel ATTC platform will develop new, treatment modality, for the for the new development, and our late stage pipeline will advance and propel for future growth. And so with that, I'll turn to doctor Hsu. Yeah.

[Weiguo Su, CEO, Chief Scientific Officer & Executive Director at HUTCHMED (China)]

Thank you, Mike, and also thank all speakers for the update. Before we get on to the, q and a, I just wanna highlight, give you a sum up. So, in the 2025, we completed SHPL partial divestment with the preceding of over 600,000,000 US dollars. We also, worked, on two major products, savolitinib and fruquintinib, in an effort to expand their indications. Savolitinib, we achieved we obtained the Saatchi approval in second line EGFR mutant non small cell lung cancer with, MET amplification.

[Weiguo Su, CEO, Chief Scientific Officer & Executive Director at HUTCHMED (China)]

We anticipate following the treatment with third generation EGFR TKI, about one third of patients will develop resistance due to MET amplification. So this combination the approval of this combination, savolitinib plus osimertinib, offers a treatment potential for these patients. And MET amplification, as we know, is a driver, and patients and these patients do very poorly on standard leukemia. And this this combination by precisely targeting the two drivers, EGFR mutation and MET and MET amplification, demonstrated very strong clinical benefits and also chemo free. And additional trials are ongoing, the first line EGFR mutant non small cell lung cancer with MET overexpression in China called the Sunnova study as well as the global phase three study in second line EGFR mutant mutant non small cell lung cancer called CEFRON study.

[Weiguo Su, CEO, Chief Scientific Officer & Executive Director at HUTCHMED (China)]

So we look forward to, data readout of these trials. We believe, MET activation play plays a major role in driving cancer growth In addition to lung cancer, as Mike pointed out, we also anticipate NDA submission for savolitinib in China in gastric cancer. And we also expect, data to read out in the global PRCC study, in in in combination with Imfinzi. Fruquintinib, we, obtained approval in second line endometrial cancer early this year, and we, filed for RCC.

[Weiguo Su, CEO, Chief Scientific Officer & Executive Director at HUTCHMED (China)]

So these, additional indications will continue to drive, the commercial performance of fruquintinib in China. Outside China, Fruzecla continues to grow, deliver 25% growth in the first half. And, know, we we expect, launches of this innovative product in other countries around the world, in in coming months. So what the there are launches you know, these launches will continue to drive the growth of Fruzecla outside China. So midterm, strategically, we we are exploring, how how we can leverage our cash to accelerate growth, both in commercialization and potentially r and d portfolio as well.

[Weiguo Su, CEO, Chief Scientific Officer & Executive Director at HUTCHMED (China)]

So looking for opportunities to acquire products or, commercial products or pipeline candidates. And, of course, we are highly focused on our ATTC platforms, very innovative, globally first in class molecules. Really, I look forward to the first molecule initiating clinical trial later this year and with more to follow. Longer term, we need to, if ATTCs reach clinical proof of concept as demonstrated in, preclinical setting, we expect these ATTCs to to position us for the long term future growth. These programs will, you know, as you know, right, will have potential to, to be positioned in in early alliance, particularly front lines in combination with chemos, in combination with IOs, and in combination with targeted therapies.

[Weiguo Su, CEO, Chief Scientific Officer & Executive Director at HUTCHMED (China)]

So, we expect that these platforms will deliver multiple, multiple products, in the future for us. Next slide. I think it this we you've seen this before. We we remain on course. We are committed to profitability, and we look to, you know, to the future, you know, with our next wave of innovation.

[Weiguo Su, CEO, Chief Scientific Officer & Executive Director at HUTCHMED (China)]

Thank you, and thank you very much. I think we are now open for questions. David, you want?

[David Ng, VP, Head - IR & Capital Strategies at HUTCHMED (China)]

Yep. Thank you, doctor Su. So we are now open for questions. So just in for the instructions, if you have a question, you can press the, raise hand button at the bottom of your screen, or you can type your question in the chat box, and I will ask the question on your behalf. So for the first question, can we have Matthew Yan from CiticlSA? Matthew, your line is now unmuted. Go ahead.

[Matthew Yan, Analyst at CITIC CLSA]

K. Thanks, David and brother Sue for taking my questions. Yeah. I've got three questions. First is regarding our very exciting ATTC platform.

[Matthew Yan, Analyst at CITIC CLSA]

I wonder, is it is it am I right that we'll be likely to see what drug targets it is in second half this year. Firstly, regarding a two five one and also the development strategy. It seems that MRI that you go directly to the frontline as combo chemo standard of care. Right? So this is first question regarding ATTC.

[Matthew Yan, Analyst at CITIC CLSA]

And second is about still about the the the the performance and the sales decline. Because I think you mentioned in your annual in your in your report that there's some reason related to the transitional effects of the change for sales team and marketing strategy. Can you get more elaboration on this? And this is my second question. Third question is regarding the sick inhibitor, sofloplanib.

[Matthew Yan, Analyst at CITIC CLSA]

Because of my original expectation is that to have finished the instability test by end of this year and received NDA approval. So what's the new message from CDE regarding this new new change of a a a new submission required next year? Yeah. That's all. Thank you.

[Weiguo Su, CEO, Chief Scientific Officer & Executive Director at HUTCHMED (China)]

Okay. Thank you very much, Matthew, for your questions. I briefly touch on your questions, and maybe Mike can chime in later. So regarding ATTC targets, the plan is to, for for a 20 for a two five one, which IND submission expected, in September, early September, just about a month from now. We expect to, our plan is to, to, disclose the structure, both the antibody and the payload, at the upcoming EORTC conference.

[Weiguo Su, CEO, Chief Scientific Officer & Executive Director at HUTCHMED (China)]

So you will you will you will see, you you will have all the information, all the preclinical, development or clinic preclinical data, at EORTC. Yeah. Development strategy, clearly, it it it I think they have these these molecules are very different from chemos. They'll have a very different from, chemo or toxin based ADCs. They will have very different safety profile, and we expect that these molecules can be will be able to to be combined with a variety of therapies, as I mentioned, including, you know, chemo, SOC, or IO, or even other targeted therapies.

[Weiguo Su, CEO, Chief Scientific Officer & Executive Director at HUTCHMED (China)]

So the development strategy for these molecules will obviously look for signals in the in in the early development. Certainly, have potential to target tumors with, with either the genetic ab aberration or genetic, alteration, which our payload targets, or, you know, high overexpression and so forth, so as a monotherapy. However, we all but that might be a strategy for rapid biomarker selected pathway for, for registration. But the much greater potential is in combination in first line, in combination with chemo, chemo IO, or even, other targeted therapies, targeting all comers, without even genetic alterations. And we will explain the rationale, at the UROTC conference.

[Weiguo Su, CEO, Chief Scientific Officer & Executive Director at HUTCHMED (China)]

So that's about, ATTC. Sales decline, team transitioning certainly had some impact, but a lot more than that. As you know, the anti corruption trial anti corrupting, anti corruption activity has been going on in China for some time. So compliance is now becoming more and more, important. Physicians are fully aware of compliance issues.

[Weiguo Su, CEO, Chief Scientific Officer & Executive Director at HUTCHMED (China)]

So they, so, you know, there is a a practice changing in in the field or in hospitals. So there's certainly much less or much care much more careful, off label, usage, you know, prescribed by the doctors. And and, so that, you know, certainly will, shrink the off label contribution to the total sales. So team is in transition. I think now we we are over with it.

[Weiguo Su, CEO, Chief Scientific Officer & Executive Director at HUTCHMED (China)]

The the off label usage dropped, but now stabilized. As a matter of fact, first quarter was will bottom now, and and the second quarter start to grow. We are pretty much back to where we we, we would expect, in in in June and July. So we we are very optimistic in the second half, the momentum will continue and and, will, perform to our expectations. So we believe the the sales decline in China is is is transitory, and and, we are already seeing a recovery, and and we are quite optimistic about about second half.

[Weiguo Su, CEO, Chief Scientific Officer & Executive Director at HUTCHMED (China)]

Your last question about SIC. So it it it's it it went through a lot of discuss we went through a lot of discussions with CDE on on this particular impurity and and how we address it both in in terms of, using tox studies to qualify the the the the level and, additional CMC studies to bring it all the way down to a minimum, or to blow the the the target or allow the target target level. So, you know, the activities went on in these two areas in parallel. And recent communication with CDE, they, guided us to focus on CMC. And and, now we are full speed ahead, in in in the CMC area where we have to where we have to, complete the PPQ batches, accumulate the stability data, but we expect to, have the data available for initial submission March or April next year, and with additional or longer term stability data to be rolled in since the program is under breakthrough therapy designation, in China.

[Weiguo Su, CEO, Chief Scientific Officer & Executive Director at HUTCHMED (China)]

So that's that's where things are. I know it's you know, we are all disappointed of of the delay, but at least now we have clarity. We we, we can drive with with, you know, our our activities. I also wanna mention, about potential outlicensing outside China. This program, as you know, because of these issues, we pretty much stopped the outside China clinical, development, even though US FDA was okay with, with the level of the of the impurity, allowed us to proceed, but but we felt, you know, we wanted to explore ways to sort this out.

[Weiguo Su, CEO, Chief Scientific Officer & Executive Director at HUTCHMED (China)]

And and I think this forced the issues in China forced us to look into, other ways. So I think we are we potentially have a strategy to go forward within The US with a new chemical entity with a with full, patent life. So, so I think it would make a lot of sense to, to switch the molecule outside China completely and and with a much longer, LOE for the product. But potentially, it could be a very short development timeline because of the Neng target, Neng and so I think outside China, it could actually present a very attractive, out licensing opportunity once we, finish some clinical early clinical, development. At least now, we we think it's a great target for for these indications.

[Weiguo Su, CEO, Chief Scientific Officer & Executive Director at HUTCHMED (China)]

It's probably the best in ITP and Waiha we have done so far, and it could be potentially useful for other indications as well. So I I think of this, with regard to ATTC and SIC, maybe Mike, if you have anything to chime in.

[Michael SHI, EVP - Head of R&D & Chief Medical Officer at HUTCHMED (China)]

Yeah.

[Michael SHI, EVP - Head of R&D & Chief Medical Officer at HUTCHMED (China)]

So thanks, doctor Su. I just wanna mention that for the clinical development side, I think we're very excited about this two five one development. And what we're trying to do is really the global development simultaneously with The US China development because, really, not only leverage, our synergy, but also take advantage of some of the regulatory, approach, particularly in The United States. The FDA is really, kind of encouraged for through this project front runner. Right?

[Michael SHI, EVP - Head of R&D & Chief Medical Officer at HUTCHMED (China)]

You can actually start a combination in earlier line setting much sooner compared with, actually, the CDE. So I think this is a part of the development strategy we're gonna undertake. You know? Even when we, you know, have the dose escalation, define the dose, we could actually move to the frontline combination earlier. So that will be the key for our development strategy.

[Michael SHI, EVP - Head of R&D & Chief Medical Officer at HUTCHMED (China)]

And and we think also, right, you talk about a target, and we we are planning to dip close at a future scientific conference later this year. But I think the most important, like I mentioned, our antibody selection is a well known target and have a well established drug in the clinic. But a payload is really the innovation part, and we think our target therapy payload with the linker will be developed. We really leverage our in house small molecule expertise can really deliver a lot of potential first in class molecule. You know, if this if it is a clinical proof of concept is reached, this will be a very robust platform for a lot of new generation molecule to come.

[Michael SHI, EVP - Head of R&D & Chief Medical Officer at HUTCHMED (China)]

Yeah. So I don't think I have too much to add on the sick part, the SYK inhibitor. Yeah. So thank you.

[David Ng, VP, Head - IR & Capital Strategies at HUTCHMED (China)]

Thank you, doctor Shi. Thank you, doctor Su. Next question is from Chen Chen of UBS. Chen Boshi, your line is now open. You can go ahead.

[David Ng, VP, Head - IR & Capital Strategies at HUTCHMED (China)]

Chen Chen, you can now go ahead. We can't hear. Maybe we'll I'll maybe we'll come back to Chen Chen. Let's take the next question first. Paul Choi of Goldman Sachs, Let us unmute your line now. And, Paul, please go ahead.

[Paul Choi, Biotechnology Analyst at Goldman Sachs]

Hi. Can you hear me now?

[David Ng, VP, Head - IR & Capital Strategies at HUTCHMED (China)]

Yes.

[Paul Choi, Biotechnology Analyst at Goldman Sachs]

Okay. Hi. Good evening, and thank you for taking our questions, and on the progress. I want to maybe just address the commercial side a bit first. And Doctor.

[Paul Choi, Biotechnology Analyst at Goldman Sachs]

Soo, you talked about your confidence in the second half recovery. But I want to maybe just ask how you're thinking about potential economic sensitivity here affecting end demand in your for oncology products in the China market and just sort of what your thoughts are on sensitivity to the economic broader economic situation? And then following up on your comments on the SYK inhibitor and partnering potentially for next generation or follow on molecule here. Can you maybe just comment on how what your timing you think could be for, initial entry into the clinic there? I know that's contingent upon a partner, but just sort of what potential time frame you're thinking about there, that would be helpful. Thank you very much.

[Weiguo Su, CEO, Chief Scientific Officer & Executive Director at HUTCHMED (China)]

Alright. Thank you, Paul. On the, on the commercial China commercial, as you know, it's been a bit turbulent because of the, anti corruption and the compliance requirements also for HutchMet in particular. Obviously, the team the the whole the the commercial team has gone through a lot of changes as well. Overall, I think the market remains there.

[Weiguo Su, CEO, Chief Scientific Officer & Executive Director at HUTCHMED (China)]

Competition may be up, as George pointed out, particularly in CRC. But if anything, actually, unlabeled CRC, we actually saw growth over last year, first half of last year, for fruquintinib, as well as for, surufatinib in in neuroendocrine tumors. So I think that what we need to, I think George's team now sorted out the marketing strategy, and it seems it's it's working. And and I think we just need to, take you know, to adapt. The team needs to adapt to the, to the marketing driven strategy and and help, physicians understand our products and also, to help patients, obviously.

[Weiguo Su, CEO, Chief Scientific Officer & Executive Director at HUTCHMED (China)]

I think I ex obviously expressed the optimism for the, for the second half, and and that and that's built on the, strong performance or, you know, strong recovery, of these products in China, in the in the last in the past three months. So, it's been challenging. We, you know, we just want to be transparent, but we are seeing good momentum at the moment. And I I I believe that the moment that the momentum will continue, in the, you know, in the second half. The demand, obviously, is is there.

[Weiguo Su, CEO, Chief Scientific Officer & Executive Director at HUTCHMED (China)]

On the sick, yeah, this is gonna be a a a very interesting approach. I think I hope we can talk more about it. It will be very rapid. I we expect the new entity will be in clinic or IND submission, maybe second quarter next year. So, you know, hopefully, in the clinic, before, end of second quarter.

[Weiguo Su, CEO, Chief Scientific Officer & Executive Director at HUTCHMED (China)]

And and most important is that this is going to be a we believe it's gonna be a very rapid clinical development. Mike, sometime we'll be able to share with all of you. And, you know, clearly with with with a high probability of success, because, this is, you know, this is an unknown target, and we have a lot of data to support. So the probability of success should be very high. So I think, yeah, by the time we are ready to go to clinic go into clinic, hopefully, we, you know, we have a partner to to either co develop or or or license. Yeah.

[Paul Choi, Biotechnology Analyst at Goldman Sachs]

Okay. Great. Thank you.

[Weiguo Su, CEO, Chief Scientific Officer & Executive Director at HUTCHMED (China)]

Thank you.

[David Ng, VP, Head - IR & Capital Strategies at HUTCHMED (China)]

Thank you, Paul. Thank you, Doctor. Su. We just have one last question because of time. We'll try UBS, Chen Chen, once more time.

[David Ng, VP, Head - IR & Capital Strategies at HUTCHMED (China)]

Chen Chen, your line is now open. Please go ahead.

[Chen Chen, Director - Healthcare Equity Research at UBS Group]

Thank you. Can you hear me now?

[David Ng, VP, Head - IR & Capital Strategies at HUTCHMED (China)]

Yes. Yes. Thank you.

[Chen Chen, Director - Healthcare Equity Research at UBS Group]

Oh, that's good. So thanks to management for taking my questions. My first question is on tariff. Earlier this week, Trump said that pharma tariff is going to be imposed starting from small next week and then up to 250% ultimately. So can management please comment on the impact of your frequent nip cells in The US?

[Chen Chen, Director - Healthcare Equity Research at UBS Group]

And my second question is, for your solvonatinib, when can we expect its NDA submission in third line gastric cancer in China? And also for your EZH two, will you consider, like, an RDL negotiation or commercial insurance drug list this year? Thanks.

[Weiguo Su, CEO, Chief Scientific Officer & Executive Director at HUTCHMED (China)]

Okay. Thank you, for the questions. Tariffs, to be honest, we don't have any idea. But but given, you know, the exporting, or the manufacturing cost cost of, for for the fluquintinib is is relatively low. So to be honest, I don't I don't I don't, have any idea about the impact.

[Weiguo Su, CEO, Chief Scientific Officer & Executive Director at HUTCHMED (China)]

I'm sure it's gonna be higher. They have to pay something, to pay the to have to pay the tariffs. But I think the the the personally, I think the impact, won't be, won't be that much. But until we we actually understand the details, yeah, I think it's very difficult to to to estimate. Your second question on GC, for salivolitinib.

[Weiguo Su, CEO, Chief Scientific Officer & Executive Director at HUTCHMED (China)]

NDA filing is planned later this year, rough likely, end of this year. This is for second, for late stage gastric cancer with MET amplification. EZH two product, Tesveric, of of course, we we are preparing for NRDL, discussion later this year. And and, you know, obviously, this is a very different product. It's at the moment, it's still imported drug.

[Weiguo Su, CEO, Chief Scientific Officer & Executive Director at HUTCHMED (China)]

The cost is higher. So, and and the patient population is serves. The first indication we got approved for is third line follicular cancer, follicular lymphoma, which is a relatively rare, form of lymphoma. So so overall, I think, we have a lot to, to talk about, when we go up to the, when we when we engage with the NRDL. But, yeah, you know, that's that's our plan at the moment. Thank you.

[Chen Chen, Director - Healthcare Equity Research at UBS Group]

That's very clear. Thank you.

[David Ng, VP, Head - IR & Capital Strategies at HUTCHMED (China)]

Thank you, Chen Chen. Thank you, doctor Su. Sorry. We ran over time a little bit, but and I noticed there may be some questions still outstanding. So do feel free to reach out to us, and we will try to answer your questions maybe offline.

[David Ng, VP, Head - IR & Capital Strategies at HUTCHMED (China)]

So thank you everyone for supporting us and listening to the call. Thank you, doctor Su, doctor Shi, Johnny, and George for attending the call. And that's all for the call. Thank you.

[Michael SHI, EVP - Head of R&D & Chief Medical Officer at HUTCHMED (China)]

Thank you.

[Weiguo Su, CEO, Chief Scientific Officer & Executive Director at HUTCHMED (China)]

Thank you all.

Participants

Executives

• David Ng, VP, Head - IR & Capital Strategies
• Weiguo Su, CEO, Chief Scientific Officer & Executive Director
• Johnny Cheng, CFO & Executive Director
• George Yuan, EVP & Head of Commercial
• Michael SHI, EVP - Head of R&D & Chief Medical Officer

Analysts

• Matthew Yan, Analyst at CITIC CLSA
• Paul Choi, Biotechnology Analyst at Goldman Sachs
• Chen Chen, Director - Healthcare Equity Research at UBS Group