Thank you. Good morning. We are excited to kick off the next session with Zai Lab. We have the Chief Operating Officer, Josh Smiley, with us. Exciting times at Zai Lab. Obviously, been executing on the commercial front in China. That is an important thing we want to talk about with Vivgaard and all the commercial success in China, because you got guidance and all these other things. We are going to talk about that. Obviously, we want to talk about the pipeline, particularly the wholly owned pipeline, which is a big change for Zai Lab, because now you have global wholly owned drugs. You just came away from ASCO. Great, great ASCO. I do not know how often Zai Lab is at ASCO, but you have presenting your own data. Let us start with just 2025. Josh, you reported first quarter, you gave guidance. First quarter, to be fair, and I'm not the only sell-side analyst writing, a little bit challenging. I'm going to miss consensus. You reiterated some pretty bullish guidance. Can you tie together how you're going to hit $560-$590 million this year and how you're going to do all that? Talk about what's going on with your guidance and your confidence on 2025. Yes. Yeah. Thank you, Mike. Thanks for having us. For 2025, we've given the guidance for sales of $560-$590, which would imply sales growth in the 40+% range. I think the range of $30 million is mostly driven by, you know, we've got a couple new launches this year, Oqtiro and Zacdoro. You know, estimating where they come out is, you know, it's a new launch. It's challenging. We reaffirmed that. We gave that guidance at the beginning of the year. We reaffirmed it in our Q1 earnings call. I think how you get there from here is we expect strong sequential quarterly growth, Q2, Q3, and Q4. I think the dynamics that will lead to that start with Vivgaard. As you alluded to, Vivgaard was a relatively light Q1. I just remind everybody we had approval for Vivgaard in 2023, but started with NRDL listing in January of 2024. Last year was really the effective launch year for Vivgaard. We sold $93 million, which I think is quite impressive for a first-year immunology product. First quarter sales were $18 million, which was lower than sequentially down. Which was sequentially down. I'll give you the two reasons for that. I think we now have plenty of rearview mirror analysis time to confirm this. We did see seasonality around Chinese New Year. I know many of you follow the Chinese market and have seen seasonality for a long time. We see patients, you know, do not go to the doctors or hospitals as much. We see lots of that. We saw it in a pretty pronounced way with Vivgaard, driven by the fact that currently on NRDL, Vivgaard is only reimbursed through an IV formulation. Patients have to go into the hospital to get the IV treatment. Vivgaard's a great drug, but, you know, it's not, I wouldn't say, I think patients felt okay skipping a dose or two, going on their holidays, whatever they had planned, in a way that you don't see probably with IV oncology products. We did see very low patient utilization in January and February. What we did see, though, in March was a back to normal, by normal meaning levels of patient utilization, hospital consumption that were in line with Q4 of last year. We also then said on the call that April was our best month ever. Growth versus any month in every measure that you would look at. Totally bounced back. April was the best month ever. That's right. January, February were seasonal impacts that were right there. That's right. What we've said is you should expect very strong sequential growth for Vivgaard itself through the year with accelerating sequential growth in the second half of the year. That's driven both by just the compounding effect of patients getting onto therapy and coming back in for second, third, fourth, and fifth cycles. There is also a pretty significant change to guidelines for GMG treatment in China that'll be rolled out in June. We've seen. What is the change? It gets added to the guideline? Yeah. Right now, FcRn and, of course, Vivgaard being the FcRn, are recommended in the national guidelines for more acute and refractory usage. In these guidelines, they'll be moved up for patients who do not respond well to current therapies or are seeking rapid MSC improvements. Really move it to a maintenance type of setting. This will be important for our efforts to educate physicians. There still is a big education factor here. Although we were pleased with the start last year, we still only have about 12,000 patients on Vivgaard. There are 150,000 patients who are on label in China. There is a huge opportunity here and we are quite excited about that. Okay. April record level and then continued strong growth May, June, guideline changes that take place in the summer. If you add steady new, I mean, are you saying, are you still kind of holding to the around 1,000 a month type of thing? Is that still going on? Yes, that's still going on. Again, as you get those thousand, they begin to, I say there's a cumulative effect then of those patients staying on therapy and that's why you'll see. Patients come back in because the way it works for Vivgaard is you take a break and then they come back based on symptoms. Most people, if you look at the US numbers, come back for a certain number of cycles per year. You think that that should totally be on pace so that in our model there would be actually acceleration sequentially. Some pretty big jumps in third and fourth quarter for Vivgaard. Yes. We are confident that what we are seeing now will lead to that. Now, within that for Vivgaard, also there is an adjustment based on not everyone is familiar with the rules that after year two, there is NRDL year two negotiation. When does that happen and when do we find out what, if any, price adjustment would occur? Yeah. As you mentioned, Mike, we're coming up on the two-year renegotiation or reset of price that would go into effect in January of 2026. Typically, there's about a six-month process of renegotiation during the year. If that process follows historical patterns, it's, you know, we're in the process now, but it's sort of September through early December is when the, you know, the sort of rubber meets the road and December is usually when you hear the price. Now, what we know and have seen from the last few years is there have been some significant positive improvements in how these renegotiations work. Talk about that. Yeah. There's something called simplified renewal now, which is basically an algorithm for products that are facing a mandatory renegotiation. It looks at the budget impact and the budget numbers that you projected as part of your initial price setting. If you're within sort of, you know, if you're over anywhere from zero to 200% of that initial projection, there's a grid you can follow that gives you a mandatory price reset. To give some context, if you're somewhere between 10% and 40% higher than what you projected for that period, the price reduction is between 5% and 15%. Okay. That's a significant, it's a big change from like a couple of years ago where people saw this and like, "Oh, you're over the budget." You can get a pretty big price discount. Here, it's a more modest adjustment based on time. What we have said is based on what we know and how we're, you know, seeing sales and otherwise, we think a single-digit price decline in this reset is a reasonable expectation. Okay. Good. Where are the additional indications or things like obviously you have the SubQ and obviously a second indication that came, CIDP. How does that play into some of the growth for 2026 or 2027? Yeah. The two big ones that are in front of us for NRDL first-time inclusion with Vivgaard would be Haitrulo, which is the SubQ version. It's been approved, but it's not yet on NRDL. We'll pursue a separate negotiation and price setting for that. Is that not supposed to be a similar price? The reference price will be IV, but it is looked at as a separate product. We'll have to go through that process. CIDP is also approved. It also will need to, because of when it was approved, it's not on NRDL yet. That'll also go through a separate price setting. Again, the reference starting point will be the IV GMG price. We'll work through all of that. Yeah, so the SubQ's approved. That should be referenced to a similar price to whatever the IV is. Yes. Yes. Yes. Yes. That is nice because people with MG can get the SubQ. Now CIDP is a new indication that happens to use the SubQ. That should be pretty straightforward then. That should be pretty straightforward. We see a good opportunity with CIDP. There are about 50,000 patients with CIDP in China, but they do use more doses and they use it more chronically. They also are in more need of therapy even than gMG. We are, you know, excited to pursue a listing for that. That drives like 27 sales? Yeah. I think that's, you know, I think it's realistic to think of CIDP, you know, kicking in in a meaningful way later in the decade. The last part about this for 2025 is your idea that if you hit this $560-$590, which you and I have discussed, I mean, I personally believe a good chunk of that range is Vivgaard. You've alluded to the idea that, you know, with just modest growth of Vivgaard, you should still come in that range. And that you somehow could be profitable later this year within that guidance range. What's that? Because OpEx is mostly flattish and you're going to particularly pay keen attention to profitability. How important is that at the end of the year and what should we take away from it? Yeah. It's really important. We established the marker and the goal about two years ago that we would be profitable by the end of 2025 and have taken, I think, significant actions to get us in that place, including, you know, things like productivity and infrastructure change and otherwise. Right now where we are is I think what you should expect is if you look at our Q1 OpEx, we're where we need to be to drive the sales and the R&D pipeline progress in terms of overall spend. If you think about sort of a flat, you know, sequential OpEx base and growing sales, that gets you to profitability in Q4. We do not need any heroic actions or new things. We just need to continue to scale the portfolio. I mean, that's important and I'm not saying about 2026, but generally once you're at that level, revenues that you're seeing should continue to be faster than any OpEx goal. So once you hit that, you should be in a sustainable. Yeah. This is Yeah. This is opening the door to long-term profitability. That's a milestone we look forward to this year. Again, let's look for continued strong Vivgaard sales. Q1 was a little bit seasonal. I do expect a nice big bounce back in Q2 and Q3. We got to show that to get people on track with that. Now, the other part that's very important is obviously you guys just hosted a conference call webcast from ASCO. I think that was yesterday. I've lost track of time. Monday. Monday. I've lost track of time. I think your week all blends together. That was Monday morning. Importantly, you guys put up some very strong data at ASCO. I just came from the Amgen fireside and they talk about how Tarlatamab, Imdelltra, is going to be a billion-dollar product. Here you are on their word of your product about your response. Tell me what the data at ASCO showed for your DLL3 small cell lung cancer ADC and how fast is this thing moving? This thing looks like it could be one of the best small cell lung cancer drugs. You claim that you're already going to be in a pivotal study. Right. Yeah. Yeah. On Monday, as Mike mentioned, we did an investor event and we had a poster at ASCO that provided an update on our DLL3 ADC program. In second line small cell lung cancer in the 1.6 mg/kg dose, we saw an overall response rate of 79% and a very, I think, mild safety profile, 6% grade three or higher TRAE. I think if you look at that relative to Imdelltra, which is also a DLL3 targeted, it's a bispecific, really significant difference in terms of safety. You know, we were encouraged to see the New England Journal paper from there. They have a conditional approval right now in the U.S. for second line small cell lung cancer. They presented the data on the overall survival study. They showed meaningful overall survival, but still show, I think, some pretty significant safety challenges, which make the product challenging to use in the U.S. I think they're off to a good start commercially, but our view is less than 40% of patients in the U.S. can even access the drug in a second line setting because of the inpatient hospital monitoring required and the logistics that go with that. FDA has been quite favorable, I think, to finding another maybe safer or alternative. What we have said is based on the data that we presented at ASCO, we're in a position to start a second line registrational study in using hopefully the 1.6 dose that I mentioned. This will be a two-arm study that will. This is a randomized control study. Randomized control study. It's not single-arm accelerated. Not single-arm. That's right. We will be able to use ORR data that we can generate in 2026 for an accelerated approval. That same trial will roll on for survival and serve as the basis. Yeah. Let me clarify. I did not appreciate that. The 2026 data, you put up strong numbers at ASCO that is supporting a pivotal study, randomized controlled study. The data that would read out in 2026 is, I do not know, they call it an interim look at the response rates. Those response rates would support statistically significantly better data than the control arm, which is chemo. That data is also better cross-trial comparison to Tarlatamab. That should set a filing. The confirmatory survival will continue. You would not cross people over. I do not even know what happened there, but you will read out survival in 2027. That will support the approval. I think, you know, what we would say is we'll read out. When would the ORR? I think survival may be later than 27. I mean, you know, if you look at the survival in the Tarlatamab trial, I think it was 13 months. 13 months in the New England Journal on Monday. Right. Yeah. So, you know, that may be later. But I think what we've been clear about is enroll the trial by the end of this year. Follow patients for ORR for somewhere in the range of six months. Be able to generate that data for a, you know, for an accelerated approval, have an accelerated approval in hand in 2027. And then convert that to a full approval once you have all the survival data. Okay. That's impressive. Now, also just to clarify for people, you believe, because there is competition coming too, we'll get to that in a second, but that people who are looking at Tarlatamab are seeing, you know, potential billion dollars. You believe that that only is going to be able to target half the market because that drug, as we've appreciated now too, because we had a lung cancer doc dinner, that's at least a two, three-day stay in the hospital with Tarlatamab. You don't believe that you're going to have to require that. The challenges of administering Tarlatamab are really limiting that agent. You're not going to have in-hospital stays. Yeah. There's nothing we've seen in any of the data that would indicate that. So yeah. How does your, okay, that's, I mean, that's a big difference. You believe there's a clear value proposition commercially. And the efficacy too is better. What about competition? There's another company, IDEAYA. They have a DLL3. That product also came from China. Your product came from China, by the way. Congrats. It's business development. They got that. We'll get to the other ones. They have a very similar ADC and they're kind of like right behind you. Is that a competitor? Do you have any differences to that product? You're ahead. I think you're ahead. Yeah. I think when you say they're right behind us, they're behind us. I think it's probably, you know, a year to 18 months behind. So meaningfully behind. As a function of that, we haven't seen a lot of data. We really like the product that we have. We like the Metalink. This is based on. I think all their data is in China. You have China and U.S. And the data you put out at ASCO, like half of that is U.S. patients? Yeah. Yeah. Yes. Yeah. Our phase one data, you know, again, we've had about 79 patients of data. That's all from global studies. Includes China, but it. I think like half of it's U.S. That's right. Yeah. Okay. Yeah. Yeah. They're behind. Again, I think as we look at the ADC platforms in China, we really like Metalink. We've worked with them. I think they have seven programs for them. This program came from Metalink? Yes. Okay. And then you've in-licensed, I think, a couple more for you as well. Yeah. Yeah. We have an LCCR five that we've also in-licensed from Metalink. I think their platform's good. We know it well. I think you guys can all, you know, assess that. We don't know, you know, that because they're early, the IDEAYA and Roche programs that have been licensed from Chinese companies, which don't have a lot of, we just don't have a lot of data to compare, but I think we're quite confident that we have a first-in-class ADC here and, you know, most likely a best-in-class as well. What are the next steps? Would you also, just to close out on DLL3, particular advantage is kind of interesting because you're trying to get a second line label. However, Tarlatamab has a second line approval. They are basically quickly moving into first line, or they have a first line study going on. Therefore, this idea that they're technically ahead, does that complicate either the regulatory path or the commercialization because there's already people that will be getting Tarlatamab, and then by the time your drug is on the market in 2027-2029, many people will have already had the opportunity to get Tarlatamab. Does your drug work in those patients? Does that complicate things? How do you think about that? Yeah. In the data that we've seen so far, we do have patients who've been exposed to Tarlatamab who do respond to our DLL3. Can you give me some numbers? Is that like five people or ten people? I think we had four patients, two of which. Had responses. Had responses. The other two have had, you know, have had some tumor shrinkage or stable disease. I think from what we have seen, we're, you know, I think we're encouraged that the patients can respond after Tarlatamab. I think as we think about the path forward, first in the second line study, FDA hasn't asked us to include in the control arm Tarlatamab as a choice. It's basically a dealer's choice of chemo. If they do ask us based on the data that's just been released, we're okay with that. I wouldn't suggest. That's interesting because they don't have the confirmatory study just read out. Right. Right. So they're not. Like that was literally this week. They have to file for the confirmatory. That could take a while. At that point, you've already completed enrollment in your study. The point is like they could allow that as one of the dealer choice chemos in the control arm, which could, you know, it's a good drug. It could impact the design of your power and things like that. Not significantly. I don't think so. We're not, you know, again, we're not, we would not be nervous that they may ask that. If they do, that's fine. It's more that they're in the first line and maybe when you get out to market that there's drugs ahead of you. Maybe they will start to see some, you know, some first line utilization. Again, what we see is we, you know, patients respond even after prior DLL3 targeted. It's a big market too. Now, of course, we're pursuing a first line indication as well. We're doing dose optimization. With chemo? Yeah. Yes. With chemo. Again, I think given the profile of the drug, this looks like a really good first line opportunity. What we've said is we'll have data by the end of this year in our dose escalation and optimization work in first line and look to start a first line study next year. Right. So you're right there. And you'll be there too. Okay. All right. That's the kind of DLL3. Maybe I could just shift to more of a strategy question because you do have other pipeline products. If we think that Zai has done a great deal here on the DLL3, you have at least one or two other, I think they're antibodies and in some cases bispecifics or ADCs. CCRA, I think, is an ADC. IL-1331 is a bispecific. Let's talk about those two because those are right behind. If you think you did a good job here and people are just trying to figure out how this is going to play out, next year we could be paying attention to those. Tell me about those two. I guess I'm focused on IL-1331. Like, tell me about that, and is that a differentiated drug in immunology? We think so. We have an IL-1331 bispecific that came out of our own labs. It'll start a phase one study later this year in both healthy volunteers, but also in patients with atopic dermatitis. We have three potential differentiating factors here versus Dupi or Levaquizumab. The first would be dosing. This has a long half-life. We think we can get to once every, at the minimum, once every two months, but maybe as long as once every six months dosing. I think we know dosing is a differentiating factor. I think we see it with Levaquizumab, you know, in the market today. We also think there could be a faster onset of action. We need, you know, again, this is based on preclinical work. I guess the home run differentiating factor would be differentiation on itch. I think, you know, we know for atopic dermatitis, that's the, you know, that's the most compelling unmet need. We'll have to see that in, you know, in. Because you're combining two mechanisms. Because we're combining mechanisms. You have IL-1331, Levaquizumab is out there. Dupixent is out there. If you go take a look, we were positively surprised. Levaquizumab has actually been putting up hundreds of millions of dollars already. The efficacy is similar to Dupixent, but it is a monthly. There is some advantage there, but it is doing hundreds of millions. Also on its way to become a blockbuster drug, here you have a dual bispecific, could be more efficacious or faster on itch. Faster, could be faster. Longer acting, excuse me, less frequent dosing. So all of that. Right. That's right. And we'll generate, you know, as you say, we'll get it into patients this, you know, this year, early next year and begin to generate data. We'll have to see. I think there are lots of reasons to be excited about that opportunity. That would be a second wholly owned global rights drug. This is not just selling into China. That's right. That's right. How are you thinking about commercialization of your DLL3? Are you actually going to field a sales force in the United States next year? You'd be a year in advance. In the next year, you're going to have to figure out as Chief Operating Officer what you want to do. That could be trying to sell your own and come up with your own sales force in the United States against other big cancer companies like Amgen. Would you partner? What would you do there? You're going to be a fully commercial company in the United States. Yeah. I think first we do not have any sort of a priority thing that says we have to have our own sales force in the US or anything there. We will do what is best for patients and for shareholders. We are open to partnerships. I think what we know and what I know from having done business development for a long time, the longer you hold on to an asset, the more leverage you have and the better the economics are. We certainly are prepared in the U.S. to take this all the way to launch and to field our own sales force. I am not saying that is, you know, we are, you know, have blinders on. That is all we are going to do. In 18 months, this thing is going to be filed to the FDA. There is nothing that needs to be hard. You are going to have a much more big value creation once you get it. Once we get to that, what if a pharma company says, hey, we want that asset? Or Or want to partner with you? If the economics look good, if the NPV is, you know, better than we think we can do on our own, of course, we'll, you know, entertain that and look to do it. I think as we think about the markets, I think the U.S., frankly, is, you know, it's worth the effort. Again, it doesn't mean that we couldn't partner, but it's worth the effort. I think our view is it's probably less than a 100 person sales force. I think, Mike, you've probably written some stuff on this, but I've seen if you look at like the last 20 launches in the U.S. and rank them by success, I think 10 of the top 20 have come from biotech companies who otherwise hadn't had a commercial presence. If you have a good drug, you know, there are lots. I'm impressed. Verona, TG Therapeutics, Madrigal. Yeah. So I do not think we shy away from that. At the same time, you know, if there is a good partner who wants to pay for the rights and partner with us, we are certainly interested in doing that. In Europe and Japan, we will need some kind of partner. It is not worth it to do it ourselves. China, of course, we have got our own very commercial engine. I would say IL-1331 is probably a little bit different story. This is a, you know, there are lots of subtle differences that go into how you run registration trials. There are lots of payer impacts and otherwise. A lot of money, big studies. We would love to partner with the right, you know, we need to generate the right data, but I think that's one that we would need more into. This speaks to whether Zai Lab has an ability to not just sell drugs in China, which is obviously important and we're going to be profitable. Do you have the capabilities to bring in innovative drugs from China or elsewhere to do good business developments that you have your own drugs? And you feel like we're going to go do more deals and you feel like you have a good edge in China or other regions to pick up good drugs? Yeah. I think first look at our history over 10 years and the drugs that we brought in for China. I think we've got a great success rate in terms of identifying products early. I think Jonathan's here somewhere who's done a lot of this. I think our instincts and scientific acumen is really good. Whether you're looking at that for China or for the globe, these were global products that we partnered early, you know, all biotech. They ended up getting, most of them get acquired by a big pharma. I think if you look at our deal with Metalink on DLL3, we did that early and it moved fast. There's good emerging innovation in China. We're well positioned to tap into that. I think, yeah, you should expect over the next number of years that we're active on the business development front, that we use our scientific expertise and instincts to do good deals, mostly probably in the early phase where we can, you know, where they're affordable and we can add our own value from a development perspective. I don't think, you know, we have any money to do that. If you were to bring in something, are you focused on oncology? Bring in something meaning you're going to probably do another deal to bring in, again, a potential blockbuster drug around the world. I've been like, oh my gosh, if you took one of the 10 GLP-1s, what's wrong with that? That doesn't take a lot to get to phase one. And you see everyone's laughing, but hey, you never know. If you had a VEGF PD-1, there's 20 of those, you know. You want to do oncology? I think our expertise certainly is oncology and immunology. That's, you know, and we're going to launch Cobimetinib in China. I think scientifically those are the places we'll start. Doesn't mean we won't branch out. Yeah, of course, you know, everybody looks at weight loss and metabolic and otherwise. I think you should more often than not expect us to play to our strengths, which is oncology and immunology. Josh, thank you very much. Fantastic. Appreciate it. Thank you for the update to ASCO and look forward to the progress this year. Great. Thank you. Thank you. Thank you, Josh.