HUTCHMED (China) - H2 2025
March 5, 2026
Transcript
David Ng (Head of Investor Relations and Capital Strategies)
Hello everyone. Welcome to HUTCHMED 2025 full year result and business update. Today we're going to go through our results in a formal presentation by our senior management. It will be followed by Q&A. Before I start, let's turn to page two with our usual safe harbor statement. Basically, the performance and results of our operation contained within this presentation are historical in nature. The past performance is no guarantee of future results. The information in this presentation is subject to changes. HUTCHMED has no liability for any loss arising from the use of this content. My name is David Ng. I'm the head of IR of HUTCHMED. We are very happy that we're going to have our senior management to present the results.
Let me hand off the time to our Acting Chief Executive Officer and Chief Financial Officer, Johnny Cheng. Johnny?
Johnny Cheng (Acting CEO and CFO)
Thank you, David, and thank you everyone for attending HUTCHMED's 2025 results webcast. Joining me today is our Deputy CFO, Lorenso Chiu, who will give us an overview of our financial performance. Our Head of Commercial, George Yuan, who will share with you our commercial performance, and our Head of Discovery, Dr. Guangxiu Dai, who will provide an update on our R&D pipeline progress. Next slide, please. A quick highlight of our 2025 achievements. We are pleased with our ex-China FRUZAQLA sales, which had 26% growth versus last year, resulting in $366 million in in-market sales. More importantly, FRUZAQLA has rolled out to over 38 countries already. As for our China sales, it has rebounded in the second half of the year, achieving 21% in-market sales growth versus our first half interim results.
In terms of our cash position, we have about $1.4 billion, which allows us to accelerate our global ATTC development and provide resources to explore potential in-licensing and M&A opportunities. On the right-hand side, we have now advanced two of our ATTC programs into the clinic, which we believe will have huge market potential. In addition, we are pursuing potential business development opportunities with multinational companies. In terms of the progress of our pipeline, I will leave it to Dr. Dai to share with you later on. I will now turn it over to Lorenso for the financial review and outlook. Lorenso?
Lorenso Chiu (Deputy CFO)
Yeah. Thanks, Johnny. Let me give an overview of our key financial highlights for 2025. On total oncology revenue was $286 million. This includes $71 million R&D-related up front and milestone revenues. For oncology products revenue, as Johnny already mentioned, there was a rebound from our China oncology products, which recorded 21% growth in in-market sales in the second half, while FRUZAQLA continues its global expansions. On net income, we recorded a profits of $457 million for 2025, mainly due to the SHPL divestment gain of $160 million. Excluding this one-time gain, our core operations remain profitable. Next, please. Our R&D expenses for 2025 was $148 million. Expenses were lower versus 2024, as many of our late-stage trials are in the completion stage, with multiple NDAs now awaiting approvals.
We began shifting our investments into our early-stage ATTC assets, with two candidates already in the clinic. Our cash position has been further strengthened to about $1.4 billion. That positions us well to accelerate both investments and developments of our ATTC programs. Next. Looking forward to 2026, our oncology revenue guidance is in a range of $330 million-$450 million. This reflects a strong solid growth from 2025, driven by strong growth in our China commercial products, with contributions from new indications as well as the FRUZAQLA continuous global expansions. Let's consider the potential partnership opportunities for our new drug candidates, including ATTC. I'd like to hand over to George to give an overview of the China commercial.
George Yuan (Head of Commercial)
Thanks, Lorenso. First, let's look at FRUZAQLA, our business partner, Takeda's performance. They deliver a very strong 2025 with 26% growth. If you look at the Q2 or the second half, the second half of the growth actually is accelerate mainly due to the market expansion. We launched some of the new market like Portugal, Belgium and South Korea. Also, the strong Japanese performance and some of the Europe performance uptake also contribute a second half strong growth. This reflect a market needs for safe and effective medicine in the later line mCRC treatment. Also, the physicians' experience enhancement and also the reimbursement progress contribute to those growth.
If you look at the U.S., we do see some of the headwind mainly due to the Medicare Part D redesign. Next slides. For China performance under the brand name of ELUNATE. In China, we post -13% growth mainly due to soft performance in the first half as we scale back some of the sales force after our GC second-line setback, and also some of the productivity improvement programs. We successfully turn around the business with more efficient approach to focus on the top-tier cities and hospitals, where in second half we deliver 33% growth and successfully renew our NRDL with no price cut and include our EMC second line. Also, we submit NDA for RCC with those, all contribute to our future growth. Next slide.
If look at the ORPATHYS and the SULANDA, which is 11% of our total 2025 in-market sales, they are relatively soft due to the fierce competition. For SULANDA, we also face multiple PRRT, those nuclear medicine moving to the clinical stage and fighting with us with limited patient pool. Although we have some kind of headwinds, we do see some progress. First is, for ORPATHYS, we have a first-line METex14 adding to the NRDL. We have a such approval to drive future growth. Our SAFFRON/SANOVO will read out what we are expecting in this year. For SULANDA, we maintain our market leader position in net performance in the TKI markets. We have renewed our own NRDL with no price cut. Our phase III PDAC study is on track. Next slides.
We are building on behalf of our in addition to our solid tumor, we are building our hematology portfolio. We get our first medicine, first-in-class treatment for EZH2 mutation and follicular lymphoma approved. This is our first hematology products launched in China. This also give us a beachhead in the hematology. On the TAZVERIK include our China's first commercial insurance drug list, where one of the 19 medicine included this drug list. This give us a kind of future growth opportunity to explore the commercial insurance. On the other side, those TAZVERIK provide us a beachhead in the hematology. To leverage these products, we can engage our hematology opinion leaders, establish our core team with expertise in the hematology to prepare the future hematology launch. Our sovleplenib is prepared to launch early 2027.
Our ITP is already resubmit. The wAIHA indication, we are potentially submit in the first half of 2026. Also, we have additional pipeline in the hematology, the IDH1 and 2 inhibit for the AML and also the BTK in the DLBCL also start our phase III study. In long run, we are aiming to build our very strong hematology portfolio. Now let's turn over to our Dr. Dai.
Guangxiu Dai (Head of Discovery)
Thank you, George. I'll provide an update on our R&D pipeline progress. The 2025 proved to be a great year for our pipeline, featured by fast regulatory movement and high impact clinical data. We have achieved major progresses across our core areas, oncology, hematology, and our next generation technology platforms. In oncology, savolitinib has reached critical regulatory and clinical milestones in both China and global markets. SACHI was approved in China in a speed record for second line EGFR mutant MET amplified non-small cell lung cancer. SANOVO and SAFFRON completed phase III re-enrollment and third line gastric cancer filed NDA in China in late December 2025. In hematology, sovleplenib, our Syk inhibitor, has solidified its position with ITP NDA resubmission and robust post positive phase III data readout in wAIHA.
Perhaps most excitingly, our antibody therapy conjugate ATTC platform is now a clinical reality, with our lead assets A251 and A580 moving into global clinical development. A251 has started patient enrollment in China and in the U.S., closely followed by our second ATTC drug candidate, A580, which was first dosed in patients just yesterday. Beyond this, we are seeing broad success with fruquintinib EMC included in NRDL, fruquintinib RCC and fanregratinib IHCC gaining NDA acceptance, and surufatinib moving into phase III for first-line PDAC. Next, I'll dive deep into how these progresses define our growth trajectory. Next slide, please. With savolitinib, we have dual focuses here, maintaining leadership in China and expanding the global footprint.
In non-small cell lung cancer, savolitinib has been approved in China for first- and second-line METex14 alteration as a single agent. For second line, the combination of savolitinib and osimertinib represents a promising chemo-free oral treatment strategy to address mechanisms of resistance due to MET alteration following EGFR TKI treatment in this advancing setting. In this setting, SACHI has been approved in China and SAFFRON is expected to have a readout in May 2026. For first line, SANOVO, a phase III study of savolitinib and osimertinib will read out in the first half of in the second half of 2026 or early 2027. Savolitinib is more than just a lung cancer drug. We also reached an important milestone in gastric cancer with China NDA for third line MET-amplified gastric cancer being accepted and priority review granted.
Next, please. The data from SACHI is compelling. In 2026 The Lancet publication, SACHI study demonstrated a clinically meaningful OS benefit, 22.9 months versus 7.9 months in ITT patients who didn't receive subsequent MET inhibitor treatment. The hazard ratio of 0.32 is a clear indicator of OS benefit. Earlier, we have presented at ASCO that combination of savolitinib and osimertinib shows a clinically meaningful improvement in overall response rate and duration of response versus chemotherapy as second-line treatment. In particular, SACHI demonstrated clinically and statistically meaningful PFS improvement in ITT patients as well as in patients with failed third-generation EGFR TKI treatment. Next slide, please. Turning to sovleplenib, a second inhibitor, our focus is on addressing the large unmet medical needs in immune-mediated hematological disorders. In ITP, we have resubmitted our NDA in China.
NDA has been accepted and granted with a breakthrough therapy designation and priority review. The clinical profile of sovleplenib is highly competitive. In the three-year follow-up study, the median duration of exposure is over 86 weeks. The cumulative durable response reaches over 66 weeks. Over 51% of patients achieved durable response. This is highly consistent with 48.4% durable response rate in a double-blind phase of ESLIM-01 study. Sovleplenib shows a superior durable response rate compared to many existing ITP therapies, including second inhibitor fostamatinib and BTK inhibitor rilzabrutinib, as well as efgartigimod, an FcRn drug approved for ITP in Japan. Sovleplenib's durable response rate is comparable to or better than TPO/TPO-RA drugs. A key differentiation for sovleplenib is its safety, particularly regarding vascular risks.
It's well known that TPO/TPO-RA drugs have been associated with thromboembolic and thrombolic complications in ITP patients. Sovleplenib clearly demonstrates a highly competitive clinical profile in the safety and efficacy. Next slide, please. The ITP market potential is significant and growing. In China alone, there are over 250,000 actively treated ITP patients, representing addressable market of $500 million-$700 million. Next, please. Next is our innovation engine, the ATTC platform. This platform is designed to combine the precise delivery of antibodies with the potency of targeted inhibitors. A251 is the first-in-class ATTC consisting of a potent PI3K/PIKK inhibitor conjugated to an HER2 antibody with a DAR of 4 through a cleavable linker. Next slide.
A251 targets a massive global market across several HER2-expressing solid tumors, including breast cancer, gastric, gynecologic cancer, and many other HER2-expressing cancer types. Next, please. The scientific and strategic importance of this platform targeting the PAM pathway cannot be overstated. The PAM pathway is the most frequently altered pathway in solid tumors, appearing in 38%-50% of all tumor cases, much higher than the other major drivers like RAS, HER2, EGFR, and ALK. For instance, PAM alterations are often seen in breast cancer, gastric, ovarian, and prostate cancers. This gives A251 and other assets from this platform a massive total addressable market. Next slide. While small molecule inhibitors targeting PAM pathway and PIKK pathway have historically faced issues with high toxicities and poor DMPK properties. It is always challenging to balance clinical efficacy and safety.
The ATTC platform is designed to reduce these on-target off-tumor toxicities by delivering the payload directly to the tumors. The A251 payload is a potent inhibitor targeting multiple nodes in PAM pathway and PI3K pathway, with high affinities in PI3Kα, other PI3K isoforms, and in mTOR, ATR, and ATM. Its biochemical profile significantly differentiates from the profiles of the others targeting PAM and PI3K. We believe this is an advantage of the ATTC approach. The payload demonstrates high kinase specificity in a broad kinase panel, hitting targets in the two families only. Next slide. A251 demonstrates strong HER2-dependent inhibitory activities, meeting IC50s in the range of 0.2 nanomolar in HER2-positive cells, regardless of PAM status, in a single-digit nanomolar in HER2 low compared to 36 nanomolar in HER2 null cells.
The HER2 expression level really determines how much of the payload is delivered to the tumor cells, and how potent A251 can be. Crucially, A251 exhibits a bystander effect that allows it to overcome HER2 heterogeneity by killing neighboring HER2 null cells. The preclinical data has been published at the 2025 EORTC conference. Next slide, please. A251 has started the global phase I study in the U.S. and in China. The dose escalation and the building dose expansion and optimization is essentially one study in China and U.S. following the same protocol. We believe this is the fastest way to define a global dose. The trial targets HER2 expressing solid tumors with PAM status being tested virtual respectively. This will inform the biomarker strategy for future development.
The strategy includes utilizing A251 as a monotherapy for later-line treatment and exploring combination therapies in frontline setting. Next slide. We are accelerating discovery and development of ATTC and ADCs, this is the next-generation innovation timeline. Our second ATTC asset, A580, has started the phase I, opening sites and recruiting patients in China and in the U.S. The third ATTC asset, A830, is anticipated to enter global phase I this year. We are committed to maintain the momentum from the innovative platform in the coming years. Next slide. Looking ahead next 15 months, the upcoming milestones include for savolitinib, we expect readouts for both SAFFRON and SANOVO. We anticipate the label expansion with China NDA approval for the third line gastric cancer indication.
For savolitinib, our phase III trial in wAIHA successfully met its primary endpoint, clearing the path for the next regulatory filing, which will happen in the coming months. Our next major milestone will be the China NDA approval for ITP. For the innovation platform, three ATTCs will all be in the clinical development in 2026. Beyond these highlights today, we expect China NDA approvals for fruquintinib RCC and fanregratinib in IHCC, as well as surufatinib PDAC enrollment completion within the next 15 months. We look forward to another great year. With that, I'll turn back to our acting CEO, John.
Johnny Cheng (Acting CEO and CFO)
Thank you, Dr. Dai. In summary, we are very excited about our outlook for 2026 and beyond. We have multiple potential NDA filings upcoming, including from SAFFRON and SANOVO readouts later this year. In addition, our new hematology products are expected to drive future sales growth in China. On the innovation side, our strategic efforts will be focused on accelerating global development of our ATTC programs. At the same time, exploring business development opportunities to further validate and add value to this platform. Finally, our oncology revenue guidance of $330 million-$450 million factors in our FRUZAQLA ex-China commercial growth and the positive impact of adding new indications for ELUNATE. With that, I will turn it over to David to start our Q&A session.
David Ng (Head of Investor Relations and Capital Strategies)
Thank you, Johnny. Thank you, everyone for the presentation. We will now do the Q&A session. First a little bit of the instructions. If you look at the bottom of your screen, you can see the Raise Hand button. If you have a question, please press the Raise Hand button, and I will call your name and unmute your line. Another way that you can ask question is in the chat box. Also, at the bottom of your screen, you can press that chat button, and then you can type in your questions, and then I can read out the questions. The first question come from CLSA, Matthew Yan. Matthew, your line is now unmuted. You can ask your question.
Matthew Yan (Analyst)
Hello. Thanks for taking my questions and the comprehensive elaboration of the results. Congratulate on the result then. Got a few questions. First is regarding the oncology, you know, guidance in 2026. Because in 2025 you see the multiple, you know, for example, sales team restructuring or kind of stuff. The growth is actually a decrease. The 2026 guidance, it seems to be imply something 15%-16% year-over-year oncology growth. Can you elaborate a bit more, little bit more about how I should be modeling the kind of the key drugs sales from this? Yes. This is my first question. I will aggregate, ask my question in one batch. Second thing is about the SAFFRON's kind of readout.
Do you have any color why the top line readout has been delayed from first half to second half? The third question is, the last question is about can you elaborate more on the indication of the ATTC platform, the first two candidates into the clinics, for example, the A251 uses. Am I understanding right that it's more like on the post in HER2, the refractory breast cancer setting or what kind of a setting we are looking at in the future? Thanks.
Johnny Cheng (Acting CEO and CFO)
Thank you, Matthew. For the first question, I would refer to Lorenso, and the second and third questions to, Guang, Dr. Dai. Lorenso?
Lorenso Chiu (Deputy CFO)
Yep. about the guidance as. Hi, Matthew. Thanks for your questions. about the guidance, as you pointed out, for 2025, there was a decline in the product sales. As you can see, in the second half, we saw a seed strong momentum of recovery. We expect that this will continue in the 2026. Together we'd like to highlight that we're expecting more growth coming from the new indications. As you can see, we have the NDA RCC, which is currently under reviewed. We believe that with that approval that will bring in more revenue under growth. Also, about the FRUZAQLA, there's a strong growth in 2026 expected due to the continued expansions, particularly.
Also, we can see that there are more and more countries now in the market. With that full year penetrations in 2026, they will continue the growth. Yes. Johnny, do you have anything to add?
Johnny Cheng (Acting CEO and CFO)
Okay. second and third question, Guangxiu, Dr. Dai?
Guangxiu Dai (Head of Discovery)
Yes. The SAFFRON readout is expected to happen in mid 2026. The third question, A251 now is enrolling HER2 expressing solid tumor patients, now restricted to post in HER2 patients.
Matthew Yan (Analyst)
Great. Thank you.
Johnny Cheng (Acting CEO and CFO)
All right. David?
David Ng (Head of Investor Relations and Capital Strategies)
Okay. Thank you, Matthew. The next question comes from Matthew Guggenbiller. Matthew, your line is now unmuted. You can ask your question now. Go ahead, Matthew.
Matthew Guggenbiller (Equity Research Associate)
Hey, can you hear me okay?
David Ng (Head of Investor Relations and Capital Strategies)
Yes.
Matthew Guggenbiller (Equity Research Associate)
Great. This is Matthew on for Alec Stranahan from Bank of America. I guess two questions from us. On the SAFFRON readout, you said, expected May 2026. Could you maybe clarify, you know, expected location of that medical meeting versus company event? For ATTC readouts, can you just maybe clarify, you know, expected patient number, sort of follow-up we can expect from those? Thanks.
Johnny Cheng (Acting CEO and CFO)
Dr. Dai?
Guangxiu Dai (Head of Discovery)
Okay. The SAFFRON readout will be in, like I said, in the mid-2026. We'll share the data as soon as, you know, AZ informs us of the results. What's your second question? Sorry. Can you repeat your question?
Matthew Guggenbiller (Equity Research Associate)
Yeah. In terms of initial clinical data for the ATTC assets, sort of size and scope of those in terms of patient number follow-up.
Guangxiu Dai (Head of Discovery)
The trial is still at early stage. We don't have a definitive timeline for the data readouts.
Matthew Guggenbiller (Equity Research Associate)
Gotcha. Maybe one on commercial dynamics as well. You know, I think first half had some headwinds from off-label sales, increased generic competition, and sort of sales force turnover. I guess, can you speak to, you know, how those trends are looking in the second half and whether you expect those to stabilize throughout 2026? Thanks.
Johnny Cheng (Acting CEO and CFO)
Okay. Matthew, we'll invite our Head of Commercial, George, to answer this question.
George Yuan (Head of Commercial)
Yeah. We, because we cannot, the, for the GC, last year, we faced some GC setback. The indication is not get approved. That's why if you look at our sales force, the original setting is we prepare for the GC, so the field force is a little bit over capacity when we lost the GC indication. That's why we rationalize the team and also when we try to focus more on the top hospitals. That's why we have some kind of reorg in the team, which lead to some kind of performance issue in the Q1 and the first half. Everything is moving into the right direction. The turnover rate is significantly reduced. Also, the vacancy is already filled.
That's why we have a very strong team now, and those kind of momentum will carry over to 2026.
Matthew Guggenbiller (Equity Research Associate)
Thank you, George.
Johnny Cheng (Acting CEO and CFO)
Okay. No follow-up question, David.
David Ng (Head of Investor Relations and Capital Strategies)
Yeah. Thank you. Next question from Cavendish, Adam. Adam, your line is now unmuted. You can ask your question.
Adam McCarter (Equity Research Associate Director - Healthcare)
Thanks very much. Thanks, thanks for the presentation. A couple of questions. Just in today's announcement, I noticed that you mentioned that AstraZeneca continues its effort, its efforts to increase MET testing as a standard of care in late stage non-small cell lung cancer. Could you comment on how the pace of MET testing adoption might influence the potential uptake of savolitinib in the SACHI setting in China, and then globally if SAFFRON is successful?
Johnny Cheng (Acting CEO and CFO)
Yeah. Dr. Dai, and yep.
Guangxiu Dai (Head of Discovery)
Oh, we do not have additional information on this question.
Adam McCarter (Equity Research Associate Director - Healthcare)
Okay. No, no problem. Thanks very much. Just on a second question. On the ATTC platform, could you elaborate on your partnering strategy, you're pursuing with the multinational pharmaceutical companies? More specifically, are you considering out-licensing certain assets earlier in development to accelerate validation of the platform while potentially regaining greater control over other assets to maximize longer term value?
Johnny Cheng (Acting CEO and CFO)
Well, I think I will answer these questions. In terms of our strategy for the partnering with the ATTC program. First of all, I think, as you can see, we have a strong pipeline already building up for this ATTC platform. We now have positive responses from potential partners, and many of which are multinational companies. We have ongoing discussion with all those potential partners. With our large portfolio that we anticipate that we will build on, I think, we want to advance and accelerate this development. Hence, we have considered to potentially license out some of these programs.
Also in addition, I think, we also have this AI capability, which we can further develop some more candidates into our platform as a result. I think this is why we also consider potential partnering opportunities. Furthermore, I think, as this platform is really one of our next wave, we would also like to validate this through this partnering strategy.
Adam McCarter (Equity Research Associate Director - Healthcare)
That's great. Thank you. I guess just if I could try my hand at a third, final question. It's just sort of maybe a broader one. As we think about the HUTCHMED story going forward, how should investors balance the contribution of the existing commercial portfolio against the emerging opportunity from the ATTC platform? In particular, do you see the next phase of value creation increasingly driven by the pipeline and the platform assets rather than the marketed product?
Johnny Cheng (Acting CEO and CFO)
Well, we see as we have our second wave of as we mentioned hematology asset that will be going into the commercial side that would adding to our existing already commercialized portfolio. That would increasing our balance of our investment in R&D. We will continue to ramp up our R&D expenditure. Last year in 2025, in terms of our investment in R&D was probably the lowest in recent years, mainly due to a lot of programs were waiting for approval, pending for approval. We are also at the early stage of development of this ATTC program. Going forward, we do take this accelerate our global development strategy for ATTC.
At the same time, with the expanded commercial assets, we will be able to generate more income so we can balance out our ATTC investment.
Adam McCarter (Equity Research Associate Director - Healthcare)
That's excellent. Thank you very much, and thanks for taking my questions.
Johnny Cheng (Acting CEO and CFO)
Thank you, Adam. The next question is coming from UBS, Chen Chen. Chen Bo, your line is now unmuted. You can ask your question.
Chen Chen (Executive Director, Head of China Healthcare)
Thank you for taking my question. Well, my first question is on surufatinib. We see that it has started this patient enrollment. I'm interested in is like partner strategy. Are you considering like a BD, like after data result? You are now in talks with any potential partners right now? The phase III will enroll like a few hundred people, so it would be very expensive. Thank you.
Johnny Cheng (Acting CEO and CFO)
Okay. I will answer from a strategic side. Then I will invite Dr. Dai to comment further. We have no... at the moment, no intentions to partner this program out. Dr. Dai, in terms of the status of our development, perhaps you can comment a little bit.
Guangxiu Dai (Head of Discovery)
Sure, Johnny. The phase III first patient in has was achieved in December 2025, we hope to finish the phase III enrollment in the next 15 months. We hope that surufatinib can provide another therapeutic option for the first time PDAC patients. Agree with Johnny that currently we don't have a licensing plan.
Chen Chen (Executive Director, Head of China Healthcare)
I see. That's very clear. Well, my second question is on your, like, R&D guidance in this year. We noticed that you have started, like, a few phase III trials such as, like, surufatinib, as we discussed just now. Also, like BTK, DLBCL, and also a few, like, early-stage trials such as ATTC candidates. I'm just wondering, like, what's your guidance for your R&D expense this year?
Johnny Cheng (Acting CEO and CFO)
Okay, just to clarify, we do not give out any public guidance on R&D expenditure. But as we mentioned that 2025 was the lowest level. We do intend to ramp up, as you also mentioned a number of programs that we are actually advancing, as well as our strategy on accelerating our ATTC program. Going forward, in the next few years, we do want to ramp up to a very reasonable kind of a higher level of investment on R&D. In the range of, you know, in the range of $250 million-$300 million, I think that would be the ideal level of R&D investment. Of course, we will be stick to our commitment to the investors that we will be profitable in a sustainable situation.
Therefore, we will be investing as we will be able to generate sufficient commercial income to cover our R&D investment.
Chen Chen (Executive Director, Head of China Healthcare)
Okay, great. maybe, the last question from me. I saw that you have very strong cash position by the end of 2025, and you also mentioned that you are planning to do some, like, in-license and also some M&A. Can you please elaborate a bit more on that side? Thank you.
Johnny Cheng (Acting CEO and CFO)
Yes. We have $1.4 billion of cash on hand. Our priority is of course, as we mentioned, accelerating our global development for ATTC program. We are open because with this cash resources, we are open if the opportunity arise for in-licensing late-stage commercial assets or potentially some assets that is complementary to our portfolio. I think, I think M&A and this in-license opportunity, we are open-minded because we are in a good financial position, but we have no fixed target at this stage.
Wilfred Yuen (Head of China Healthcare)
Okay. That's very clear. Thank you so much.
David Ng (Head of Investor Relations and Capital Strategies)
Thank you, Chen Bo. The next question, come from, Panmure, Julie Simmonds. Julie, your line is now unmuted. You can ask your question.
Julie Simmonds (Managing Director)
Thank you very much. I was just wondering on the move into hematology products, whether this changes what you're investing in sales and marketing and what changes to the sales infrastructure it requires. Thank you.
Johnny Cheng (Acting CEO and CFO)
Thank you, Julie. George.
George Yuan (Head of Commercial)
Yeah.
Johnny Cheng (Acting CEO and CFO)
Would you like to comment on this? Thank you.
George Yuan (Head of Commercial)
Because hematology is a very specialized team, that's why we already start up a new business unit with dedicated sales, marketing, and medical capability to address this kind of market opportunity. With the future pipeline adding to the business, we will expand the team.
Julie Simmonds (Managing Director)
Lovely. Thank you. Secondly, just on the impact in the U.S. of the Medicare Part D changes, just wondering how much impact you expect that to have on sales in 2026, whether you can make any comment?
Johnny Cheng (Acting CEO and CFO)
Sorry, I didn't hear your question. Could you repeat again?
Julie Simmonds (Managing Director)
Yes. Just questioning about the changes to Medicare Part D that went on in the States, that were obviously impacting your sales, there. If you've got any thoughts on what impact that might have into 2026.
Johnny Cheng (Acting CEO and CFO)
We have received no new changes so far. The impact factors into 2025 has been reflected. Despite that impact for U.S., I mean, we still achieve a 26% growth for our FRUZAQLA through our partners. We do anticipate that in 2026, we will be expanding, rolling out of all the ex-U.S. countries. So far, already 38 countries have been commercialized in terms of this FRUZAQLA. We continue to see that the NRDL in those countries will be expanded.
Julie Simmonds (Managing Director)
Okay.
Johnny Cheng (Acting CEO and CFO)
The total impact for ex-China sales, we see that, U.S. will continue to grow, but also outside of U.S., that is the key driver also.
Julie Simmonds (Managing Director)
Thank you.
David Ng (Head of Investor Relations and Capital Strategies)
Thank you, Julie. Next question coming from Daiwa, Wilfred Yuen. Wilfred, your line is now unmuted. You can ask your question.
Wilfred Yuen (Head of China Healthcare)
Thanks. Thanks for taking my question. I want to follow up on the revenue guidance that range from $330 million-$450 million, which is a wider range, first to last year anyway. Maybe can you give us more color as to the breakdown between the oncology product sales and the R&D milestones payment? Are you expecting some additional milestone, you know, maybe to hit the high end of the guidance $450? Thanks.
Johnny Cheng (Acting CEO and CFO)
Lorenso, would you like to tackle this question? I will add to it.
Lorenso Chiu (Deputy CFO)
Yep. Further to what I explained earlier, I think you can look in this way, because we do not give any guidance of particular items within this revenue guidance. For your information, I think it would be worth to note that in 2025, our revenue has included some of the upfront and milestones, which, if you exclude those, the base would be lower. For the 2026, the guidance reflect a kind of a solid growth from 2025. In addition, I think some of the factors that I've mentioned, the growth from our China trial products with the new label expansions and also the new indications, will drive further growth. I hope that could address the questions.
Johnny, do you want to add some more comments on this?
Johnny Cheng (Acting CEO and CFO)
Wilfred, I think, basically, you should take the guidance as the middle of this range, right? The low end potentially if some of the, you know, at this I think the low end of the guidance is where we are very confident, and we are also very confident that to achieve higher of this guidance. $330 has factored in, as Lorenso said, many of the organic growth. In addition, we also factor in for a base, kind of baseline growth for our ex China sales, which of course is run by our partner.
Conservative speaking, we are very conservative to give this low-end guidance. You can expect the mid-range of that is almost like a 36% growth between $330 million to $450 million is about $390 million. That is more like 36% growth versus this year's 2025's performance. I think this is guidance that basically can reflect the business growth as well as the potential. If we have licensing, of course we won't take all the upfront income. We will potentially apportion part of the upfront income and factoring into the upside.
Wilfred Yuen (Head of China Healthcare)
Got it. Thanks for the color. Thanks.
David Ng (Head of Investor Relations and Capital Strategies)
Thank you, Wilfred. next question coming from Goldman Sachs, Paul Choi. Paul, your line is now unmuted. You can ask your question.
Paul Choi (Biotechnology Analyst)
Hello. Thank you for taking our question. My question is on savolitinib assuming, you know, clinical success coming up here with SAFFRON. Can you maybe comment on how you think a TAGRISSO savolitinib combination would be sequenced in the treatment paradigm given the recent launch of J&J's RYBREVANT bispecific? Just, you know, how you think about guidelines involving directing oral options versus bispecific options. Thank you very much for taking our question.
Johnny Cheng (Acting CEO and CFO)
Yeah, thank you. George, you have any color to share on this?
George Yuan (Head of Commercial)
Yeah. I think this first thing is this provides an oral, two oral products for those EGF resistant MET amplification patients. This is, we provide very efficacy and as well as convenience. We do know the J&J bispecific monoclonal antibody do provides another options. All depends on doctor's perception regarding how the treatment paradigm shifts. Is still precision medicine winning the game or not? The testing, the second, third testing win the game or not? It depends on how AstraZeneca shaping the treatment.
Paul Choi (Biotechnology Analyst)
Okay. Thank you.
David Ng (Head of Investor Relations and Capital Strategies)
Thank you, Paul. I see a couple of questions on in the chat box. Some of that actually has been kind of answered already. There's a question, this is Johnny. The question is, what is the thoughts about the need to decide appointment of a permanent CEO, or are we happy with the current situation?
Johnny Cheng (Acting CEO and CFO)
Okay. I think we have the company have made an announcement in August. I think no status change as yet regarding the announcement. Dr. Su is focusing on his health right now and yep. We have this interim arrangement and as you can see, we have a lot of talents within our management team. Today, we have Dr. Dai and also we have Lorenso Chiu joining this webcast. The company have been running for 20 odd years, and we have a very loyal and also capable talents within our talent pool. Everything has been running very, very smoothly and also progressing in terms of our pipeline as well as our commercial strategy. Everything it is now working as per plan.
David Ng (Head of Investor Relations and Capital Strategies)
Thank you, Johnny. I don't see any outstanding questions right now. Just as a reminder, if anyone has any question, please press the raise hand button or type your question in the Q&A box. There's another question talking about SAFFRON read-out delay from first half to second half. As you know, Dr. Dai has mentioned the most likely scenario will be around mid-2026. If no further questions, Johnny, would you like to do a concluding remark?
Johnny Cheng (Acting CEO and CFO)
I think thank you again, everyone for spending the time to attend this webcast. If you have further questions, please, by all means, to feed through our IR colleagues. Thank you.
David Ng (Head of Investor Relations and Capital Strategies)
Thank you, everyone. This concludes our results, presentation. Thank you very much.