HUTCHMED (China) Limited (HCM) Earnings Call Transcript & Summary

Hello, and welcome to the Deutsche Bank Depositary Receipts Virtual Investor Conference, dbVIC. I'm pleased to announce that our next presentation will be from HUTCHMED (China) Limited from Hong Kong. Before I introduce our speaker, a few points to note. Please submit your questions in the questions box at the right of the slide. All of today's presentations will be recorded and can be accessed via the Deutsche Bank website, adr.db.com. At this point, I'm very pleased to welcome David Ng, VP, Head of Investor Relations and Capital Strategy of HUTCHMED, which trades on the Hong Kong Stock Exchange under the symbol 13 and in the U.S. on the NASDAQ as HCM. Over to you, David.

Thank you very much, everyone. My name is David Ng, I'm the Head of Investor Relations of HUTCHMED. We are a company that is listed in multiple exchange, including the AIM in the U.K., the NASDAQ in the U.S. as well as the Hong Kong Stock Exchange. So thank you very much for joining us. We'll give you a quick update on our -- about our company, and then we'll follow up with the Q&A at the very end. So let me go through. So this is our safe harbor statement and disclaimer. I won't go over in details, but basically, the message is the performance and the results of operation presented here are historical in nature, and past performance is no guarantee of future results. For those of us who may not know us that well, I think we want to focus on a couple of key messages to start with. First of all, we are a company focusing on innovative drugs, especially the small molecule drugs. And the second thing is that we have been in existence for over 20 years. And our product, our innovative drug has been recently launched overseas, including the U.S. FDA approval last November. And just earlier this year in Europe, the United Kingdom just last Friday, and Japan just this afternoon a couple of hours ago. So our colorectal cancer drug is now successfully commercialized in China as well as in overseas. We do have a great pipeline of products. I'll go over them in a little bit detail a little bit later. But these products not just support our operation, but also present significant upside to our future development. So first of all, our key product, this is a molecule called fruquintinib and the brand name is FRUZAQLA, our partner who is responsible for marketing and all the regulatory approval overseas is Takeda, and they have been doing a fantastic job. As you can see, our last reported figures is about USD 130 million sales during the first half of this year and we expect continued good momentum in the coming years. This is a product which is superior to some of the existing products that has already been commercialized in the market for the last decade. We present better efficacy and lower toxicity for the colorectal cancer patient in the third-line setting. As I have just mentioned earlier, we got the U.S. approval last November. The first prescription was written, it's just 48 hours. We also got into the inclusion of the usage guideline called NCCN just 1 week after launch. And the European approval happened in June this year. We are expecting potential insurance coverage in selective jurisdiction in the upcoming months and quarters. Japan, as I said just a moment ago, got approval today. And again, we will be hoping to get insurance coverage some time later. Back to our home base, China. This product has been already selling in the market for the last 5 years, and it has been doing very well. If you look at the bottom right chart, you can see our market share at around 40% plus in the latest survey in the second quarter this year, much better than our closest peers at around 26%. And also, we are starting to see some generic of our competitor appearing in the market, the very last row of this box is basically a competitor in the generic form, and that's about 17%. It's a very sizable market in China. Of course, the pricing has been under control by the government authorities, but we aim to serve as many patients as possible. I think, since day 1, we have been proactively trying to get inclusion into the insurance coverage. Now we, of course, sacrifice some of the price upside, but we ensure that our product is made available to as many patients as possible in China. So during the first half of this year, the growth rate is at about 13% which I think is not too bad for a drug that is already on the market for about 5 years and with some generic competitors in the similar space. We continue to maintain the market share in this year for this product. The second product, which we have commercialized also in China successfully is called SULANDA and as you may have seen, again, our market share continue to be in a very decent second position. Now the very first -- the biggest market share is actually by some of our competitors, which are already genericized. So if we just compare against the brand name drugs available in the market, we are still much better than the closest peers. This is a product that has been approved for neuroendocrine tumors in China with about 40,000 new patients in every year. Again, we got included in the government insurance program. It's been made available to the mass public and we continue to do a good job in gaining a very good market share. The third product that we have commercialized successfully in China, and hopefully, soon to be overseas is a product called savolitinib. This is a drug that we call the MET inhibitor, targeting a biomarker, genomic biomarker called MET. This has already been selling in China, about $25 million sales entering first half of this year. But I think what the market has been focusing a lot on for this particular product is in the coming months, hopefully, by the end of this year which we hope to have like positive data readout from our ongoing trial called SAVANNAH. This SAVANNAH trial target second-line non-small cell lung cancer patients. which have over-expressed or amplify of this genomic marker called MET. And with -- if the data is positive, this drug can very well be filed to the U.S. FDA by the end of this year. Our overseas partner is AstraZeneca. Actually, our domestic partner is also AstraZeneca. They will be responsible to push forward for the regulatory pathway if the data is positive. We have already got the fast track destination for this product, for this particular indication. So there's a possibility that if the drug can be successfully filed with the U.S. FDA by the end of this year, the approval won't be that far away in the U.S. And again, this is a very important, another big milestone for us. We already have commercialized our fruquintinib for colorectal cancer indication in the U.S. and overseas. This is potentially the second product we can commercialize overseas. And just to maybe just take everyone back to our core competitive strength. We are an innovative drug. We focus on small molecule, but that's not just it. We want to make sure our product is of good enough standard and quality not just the molecule itself, but also the data, the clinical data, the development progress are robust enough to be able to satisfy the most stringent regulatory authorities around the world such that our drug can be not just selling in China, but also be commercialized successfully and bringing the benefits to patients all around the world. So hopefully, this will be our second major product that we can bring to the overseas market. The fourth product here has not been commercialized in China yet, but we are hoping that this won't be too far away. This is our fourth in-house product that we hope to commercialize in China. The drug is called sovleplenib. It's a slightly different class of drug. First of all, it doesn't target cancer. All the other previous three products we've just gone over target oncology. This one target a chronic disease called immune thrombocytopenia. Basically, your body self attack your own body's blood platelets, which is responsible for blood clotting. So if you don't have enough of these blood platelets, then you can bleed very easily or uncontrollably. Unfortunately, there's no permanent cure for this particular disease. So this is a chronic disease. We have already done all the major clinical trial, and we have also presented very impressive data from this clinical trial. We have also filed this data to the Chinese regulatory authorities and we hope to get the approval and product launch sometime in 2025. Again, this is a new arena for us. It's not just in oncology. This is kind of entering into the space of both hematology as well as autoimmune diseases. And this is also a chronic disease which means that the usage tends to be longer per patient going forward. So this is a chart that summarizes all the late-stage trials that we are working on. In my just the presentation just now, I covered most of them. And there's two more that I would like to mention at the very bottom of this table. One is a product which just we're calling HMPL-453. This is another product that is entering into late stage so called registration cohort, which has already started last year. It targets a indication called intrahepatic carcinoma. It's a biomarker specific, FGFR2 biomarker specific. And the very last one, called HMPL-306, is also in the late-stage trial so-called registration trial which we have already recruited the first patient back in May this year. This is a -- belongs to a family of molecules called IDH1 and 2. For those who may be familiar with this class of drug, you have actually commercialized product overseas for IDH1 or IDH2 for the cancer indication. But for having -- but having both IDH1 and 2 in one molecule, it covers the oncology indication better and it's targeting a disease indication called AML, which is a hematological condition. And we hope that, again, this is a product that will bring a lot of benefits to the patients in need. For some of these slides coming forward, I may not go over in the details. But just to mention that our key product we are right now selling, a lot of the investors sometimes ask us how come the ramp-up is so impressive in the first few quarters. I think it still goes back to the data that we have against our peers. If you look at the PFS data, it's -- our product fruquintinib is at close to 4 months of PFS. And if you compare against the monotherapy for our two competitors, they're basically just half the way we were -- we are. And if you look at the overall survival, it's also a very impressive 2.6 months, much better than the placebo group. Now of course, this is not new data. This drug has already been -- this data has already been presented and the drug has already been proved but in the actual rollout of this product, the recognition of doctors, the benefits that we can bring to the patients, we think those are the key factors that has been driving the commercial success of this product. And again, this is something that we think HUTCHMED is very good at, not necessarily jumping quickly into some very crowded track, but focusing on areas where there's unmet needs or even for tracks which have already existing products out there, we want to make sure that our product is of much better efficacy or much lower toxicity than the existing products in order to have a competitive edge out there and to bring real benefits to patients. For the same molecule in China, we are working on the next indication called endometrial cancer. This is a second line setting in combination with another drug called sintilimab. The status of this particular project, we have already filed to the China authorities earlier this year and we expect the approval later this year or early next year. So this will continue to strengthen the sales momentum of this particular product in the China market. And we hope that this will continue to extend the lifespan of this particular molecule in China. And then the other indication after endometrial cancer is renal cell carcinoma, basically kidney cancer. Again, this is a second-line setting. We are combining the usage of fruquintinib with also the same molecule called sintilimab. This -- the status of this project is in the last phase, the Phase III registrational trial. We are waiting for data to come out or the completion of this trial hopefully by the end of this year. If there's any percent of delay of this trial, it is very likely that the efficacy is better than expectations, so people live longer or they progress much later which we are showing even better data. So hopefully, by the end of this year, we can see the data coming out of this clinical trial for kidney cancer. And then next year, we can file for approval in China. Now going back to our fourth product, the sovleplenib, this is a drug targeting a disease indication that may not be too familiar with for a lot of the investors out there. Immune thrombocytopenia, ITP. We estimate a total market size, again, this is not our guidance of our peak sales. This is basically the entire market size, we estimate around USD 500 million to USD 700 million for China. But that's not -- that's a conservative measurement because we only focus -- this number basically is derived from patients who are being actively treated on this disease indication at this stage. Due to a lack of therapies for those who do not respond to existing treatment, a lot of these patients basically just went missing. They are lost to follow up. The mortality is very low, so people continue to live, but they just have to live with this kind of very unpleasant conditions. And because of a lack of treatment, a lot of these patients are not tracked by the statistics. So we estimate there's another 200,000 people out there which is not on active treatment. And these, again, people, which can be targeted by our drugs. In our clinical trial, in our Phase III trial, 70% of these -- of the patients who have taken our -- have already taken the existing common therapy called TPO. And after these people fail to respond to the existing type of treatment called TPO and they try our product, sovleplenib, they still can achieve close to 50% durable response rate. So this is a very impressive durable response rate. If you look at some of these, our alternative out there for so-called later line treatment, they are only at about 15% to 20% response rate. So at 48%, we think that, again, this can capture a lot of the unmet needs out there. And going back to that chart where we see there's another 200,000 patients, which is kind of lost to follow up, for these people, finally, there is an option for them to continue the next phase of treatment, which is our product. So this is what I've just mentioned, the durable response rate is 48% but for some of our peers or some of the products being under development at this stage, they are at much lower response rate. So we believe that it does present a very compelling profile out there for the patients. Another thing that's worth mentioning is that the toxicity profile is also quite manageable. For some of these other existing therapies, they may boost up the production of blood platelet too excessively to cause the opposite effect, which is thrombosis. Basically, you have like too much blood clots and it may result in very severe consequences like heart attack or stroke. But for our product, we don't actually excessively boost the production. We basically use a different mechanism of action to prevent the destruction of blood platelets. So as a result, you see that the statistics, the thromboembolic events is basically very minimal for our product versus still a certain percentage for some of our competitors out there. For the same molecule, sovleplenib, we're working on another indication called warm AIHA, which is kind of the abbreviation of a longer name called warm antibody autoimmune hemolytic anemia. Now remember, ITP your body attack your blood platelets; for warm AIHA, your body attacks your own red blood cells. So this is a smaller market size, but this one have no drugs out there at all. For ITP, there may be still one, first line, second line therapies available out there. But for warm AIHA, there is none. So if we can successfully commercialize this product, this may very well be the only drug, not just in China, but also around the world, approved for this particular indication. The status of this project in China, we are entering -- we have already started the registrational Phase III trial. And we hope to see some good data coming out, which will potentially lead us to overseas trial as well as partnership for this product. Now for the sake of time, I think I'll just give a couple of slides and go straight to this product called savolitinib. Remember I said earlier, this may be one of the most -- much watched event by the end of this year. This is the product for second-line lung cancer with the biomarker called MET being overamplified. We have an ongoing trial called SAVANNAH which is a single-arm study, having patients which have already failed the so-called TKI -- EGFR TKI treatment and then they try our product in combination with TAGRISSO. The data we expect to see those by the end of this year. And again, if this is -- if they are positive, we can file to the U.S. FDA. Now that's the second line setting. For the first-line setting, we have already kickstarted some -- a trial in China, which we call the SANOVO study, which is ongoing. Of course, this is the first-line setting, it will be a much longer trial. And at the same time, in China, we also have a concurrent second-line lung cancer trial, which we have ongoing called SACHI. Again, hopefully, we can complete the enrollment by the end of this year and if everything goes smoothly, I think the China approval may be roughly 1 year behind that of the U.S. potential approval. Of course, everything for us, still pending positive data coming out from this trial. So this win can become a very interesting product that will generate a lot of excitement in the next 6 to 18 months. The market size, again, this is not the guidance of our peak sales. This is just a rough estimate of the entire market size. In this second-line EGFR-mutated aberration setting, we estimate around USD 1 billion market for China. We also estimate a similar amount of $1 billion for the global market. And the reason why these two numbers are very similar is that the assumption of the pricing is much lower than China, despite having much higher prevalence of this type of lung cancer in China. This is a very noisy slide, but I think one of the key message or one of the key questions we continue to receive is that there seems to be a couple of competitors on the horizon targeting a similar second-line lung cancer indication. Our explanation is that for our product is specific to a genomic mutation called MET, whereas so far as we have seen, the late-stage trials or the recently approved products not for MET biomarker-specific, so-called all comers. So if our product can get approved out there, it may very well be the first and the only one that is specific for MET biomarker, which do not necessarily compete with the so-called non MET-specific lung cancer product. And at the same time, we do have very decent efficacy figures. Our PFS is at around 7.2 months. And you can look across -- the green part is basically some of the competing products under development and the PFS is -- some of them are lower, some of them are higher. But -- and basically, our key message continue to be that we are MET specific. And to add to that, we have one more advantage being that we are free from chemotherapy. Meaning that we have -- the patients should have much less toxicity. And we are also an oral pill combination, which should make it more convenient and more easily for the patients to comply to the regimen. Perhaps in view of the time, I think maybe I'll just finish off my official presentation with this slide here. So for surufatinib, we have another potential indication that we are working on, is called pancreatic cancer. As you may know, this is a very tough to treat cancer, so-called a cold tumor. We have started a Phase II trial. It's a combination with chemo and PD-1. The data, the early interim data may come in maybe a year from now. Hopefully, it can work but right now, following our tradition, we are very prudent until we see the data. So we are hopeful -- we're optimistic about this, but we are also prudent at the same time. So if this product works for this indication, it's definitely going to target a very sizable market. So let me stop here for now and see -- try to answer some of the questions out there. Just hold on. Sorry, I don't -- I see there's -- in the chat box, there is some like 4 questions or something like that, but I don't seem to be able to see the questions. Okay. All right. So the first question is, can you provide insight into the design and expected outcome of the latest clinical trial in fruquintinib, especially in the context of its efficacy in second-line gastric cancer. So as some of you may be already aware, we were trying to work in the gastric cancer second-line indication. But at the end of the day, we did score a very nice number in the PFS, but the OS is just numerically improved, but not statistically significant. For the upcoming indication in endometrial cancer and renal cell carcinoma, we hope it's much more straightforward. This is a space that we will be just using the ORR as the primary end point for some of the trials and some of them are just single arm. So that should be much more straightforward than the gastric cancer indication. We will know very soon, I think, for endometrial cancer by the end of this year or early next year, we will know the outcome for the regulatory decision. My second question is what novel technologies or methodologies is HUTCHMED employing in its drug discovery and development processes, especially for targeted therapies and immunotherapy. So it's a very good question, but I may not be the -- I may not have the perfect answer for that one. But I think one thing I would like to emphasize is that in contrast to a lot of our peers, we spent a lot of time in the discovery stage and the preclinical stage before we put the product into human trials. And sometimes it may take a little bit longer than our peers. But as a result, the selectivity of our molecules is much better. We used to have a slide to talk about our savolitinib affinity for some of these biomarkers and low affinity for some of the other molecules, resulting in very limited off-target toxicity. So well, I mean, like we have a small molecule. So a lot of chemistry. We -- our CEO and as well as our CSO, who is also the one who invent our fruquintinib molecule, is a very reputable chemist himself, he has built a very good team of people who are good in chemistry in our company. And we also have a very sizable database of small molecules, which we can screen for desirable products. And then the third question is, can you discuss any recent or upcoming partnership and the strategic importance? So the one that I think we hope to work on is for our fourth product, sovleplenib, just as a recap, right? So our very first molecule, fruquintinib, which is commercialized in China, Eli Lilly is our partner. However, we took back the marketing and we do the sales and marketing by ourselves. The overseas is with Takeda for fruquintinib. For surufatinib, we don't have a partner. If the pancreatic cancer data comes out to be quite promising a year from now, we may consider to look for overseas partnership. The third molecule, the savolitinib for lung cancer, AstraZeneca is the partner for both domestic and overseas market. And for the fourth product, sovleplenib, we have already completed our Phase III data. We are working on a dose finding study in the U.S. So again, like maybe a year from now, we can see the data and then there may be an optimal time to get the best valuation for partnership. Let's see. I think we're running out of time. Sorry for the remaining questions.