All right, welcome everybody to the JPMorgan Healthcare Conference. My name's Anupam Rama. I'm one of the Senior Biotech Analysts here at JPMorgan. I'm joined by my squad, Priyanka Grover, Malcolm Kuno, and Rathi Penhe. Our next presenting company is Zai Lab, and presenting on behalf of the company, we have CEO Samantha Du. Samantha?
Thank you, Anupam. Good afternoon, everyone. And I'm really pleased to be here today with all of you. And for the next 20 minutes, I'll update you about Zai Lab. Oh, yeah, I'm Samantha Du, Founder, CEO, and Chairperson of Zai Lab. Next one, please. Maybe I'll do it myself, huh?
Yeah.
Yeah, this is Safe Harbor slide. So now for the next this one, I'll focus on our major milestones achieved for Zai Lab in 2024. I think this is a truly exciting year. Last year, Zai Lab has delivered very strong regional business from regulatory to commercial. And we also have an exciting lead global pipeline. The first one entering phase already completed phase I data readout. And in addition, we advanced three other global pipelines into later stage preclinical. Two of them are ADCs, and one is bispecific. As you know, in 2023, we have already achieved commercial profitability. And we are going to have this year's financial revenue with 40% year-over-year growth. And we also narrowed the loss by 40% year-over-year.
We are very well positioned to achieve our commercial profit, our overall corporate profitability by fourth quarter this year, 2025. We currently still have $330 million cash. This also well positions us for supporting our ongoing programs and the commercial launches. As you see, in the near term and midterm, Zai Lab will enjoy tremendous growth. We have now already, as I mentioned, in 2024, launched our first blockbuster drug. We already have eight approved products in our commercial stage. From 2025- 2026, in the next 12- 24 months, we'll have three new product launches. We also will see substantial growth with Vyvgart just for gMG and CIDP, two indications alone. Our lead global asset, ZL-1310, is already in pivotal stage with the potential to submit an NDA to FDA in 2026.
On top of that, we have multiple in-house global assets that will reach POC data point. Looking forward to 2027 to 2028, we not only have the first global asset, ZL-1310, in commercial stage in the U.S. as a potential first- and best-in-class DLL3 ADC, we will also have more than 15 launch products with $2 billion revenue expected in 2028. Other in-house global assets will also reach pivotal data points. So 2029 and beyond, we are really well positioned for growth through internal discovery effort and also through business development. We will also have our projects' patent protection will last us way beyond 2035. For the next two slides, I'll elaborate further on our first global asset, ZL-1310. ZL-1310 has the potential to be the global first- and best-in-class ADC targeting DLL3.
In last quarter, in a major medical conference, we presented compelling efficacy and safety data on our anti-tumor activity across all those levels with significant reduction to reduce tumor burden in second-line plus small cell lung cancer. What we're also very pleased to see, we not only we have based on the patient enrollment, we achieved confirmed and unconfirmed ORR of 74%, but as data maturing, we're expecting consistent confirmed ORR. We have also shown not only the patients have seen activity in second-line plus small cell lung cancer, but also we have seen patients showing activity, efficacy in patients with brain metastasis and also in patients with prior DLL3 TCE. The drug is very well tolerated at therapeutic dose levels. The longest patient in the lowest dose cohort has already been on study for more than nine months.
Of course, we plan to provide update in this quarter as with the data are more mature. Further touch upon the timeline of DLL3 and ADC. As you've seen from this slide, we currently in second-line plus small cell lung cancer, we have already in dose optimization, we initiated a pivotal trial mid-year 2025. On the first line, small cell lung cancer, we're in dose escalation stage. And we plan to start a pivotal trial after we received positive data. We also started a basket trial for DLL3 in other tumor types, and especially in other neuroendocrine tumors in the phase I basket trial. Of course, we'll provide meaningful updates throughout the year as the data came out. Well, we also, as I mentioned at the beginning of the slide, we have built a globally differentiated pipeline with three IND submissions this year.
They are ZL-6301 is ROR1 ADC, and ZL-6201 is LRRC15 ADC, and ZL-1310, ZL-1503 bispecifics. All three will be filed IND, and again, with data coming out, we'll present, we update you. Now let's touch upon our regional business. This last year was the first full year we launched our first blockbuster drug. We're off to an excellent start. In the first nine months, we already treated 10,000 patients. But that's still at the top, the tip of the iceberg, because overall, even in gMG and CIDP alone, there are more than 20,000 patients with this need to be treated. So we have plenty of room to expand this year and beyond. Another thing is about the duration of treatment. We have already seen the patient return rate increase from 10%- 30% from second quarter to third quarter.
Continuously, this year, we'll see more patient return rate, higher patient return rates. This can be done by many initiatives. I listed a few here. But nevertheless, we are fully committed to make this product to realize this blockbuster potential. Vyvgart, on top, it's indication in gMG and CIDP, which are approved. There are also many other indications that can be potentially approved. We are working with our partner, argenx, to join multiple trials, especially trials, where t hey are also, if you look at the market opportunities, they are tremendous. Many of them, patients suffer. There are millions of patients suffering renal disease and also suffering other disease listed here. So we, as time goes by, will provide updates on all of this. Again, this is truly a pipeline and a product opportunity with the blockbuster potential. We recently announced a collaboration with Vertex on a project called povetacicept.
This is a phase III asset with a potential to give a transformative approach to IgAN with best-in-class and pipeline of product potential. There are many reasons for us. Of course, we love this asset. We love the data. We love the patients with medical needs, but also this one can leverage Zai Lab's existing R&D and commercial capabilities, and thirdly, we provide a synergy with Zai's Vyvgart franchise, and I also want to mention that we have in China already joined global phase III pivotal trial, so we are very close to bringing this product to the market in China. As you know, there are 3 million-5 million prevalence in IgAN alone in China, and also no approved therapies targeting the underlying cause of IgAN.
Of course, you know all. I'm sure you know more than us about all the data in this product already, I'm sure, explained by our partner, Vertex. But this is another. Actually, what I want to highlight is this one further demonstrates Zai Lab's capacity and capability and also partner of choice status recognized by partners in the U.S. and not only in the biotech community, but also in MNC, in the biopharma community. Because over the years, we have done many global multiple center trials together with our partners. We also demonstrated our commercial capability to successfully launch this product to reach their maximum potential in China. We also in China, our original business, will launch additional three blockbuster drugs in 2025-2026. I mentioned efgartigimod, but also we have bemarituzumab. This has the potential to be the first-in-class FGFR2b targeted therapy for gastric cancer patients.
The overall PFS for this drug is more than 30 months already. We have high incidence for in China alone, we have more than 359,000 annual incidents. Of those, 30% have FGFR2b overexpression. We are working with our partner to complete our phase pivotal trial with a potential to file NDA to China and U.S. this year. Another one I would like to highlight is Cobenfy. This is a new commercial name. I used to call this KarXT. This also, as you know, has been approved by FDA with the first new MOA in decades for schizophrenia, demonstrated not only safety, but also not only efficacy, but also no black box warning on this product. In China alone, there are 8 million patients need to be treated. We already completed a phase three study last year. We filed NDA in December 2024.
Last, certainly not the least, right, Bill. Our partner's Executive Chairman Bill is here. And we have seen the potential pan-tumor treatment options for TTFields addressing multiple tumor types, and especially the difficult to treat. The first phase III study to show significant OS benefit in locally advanced pancreatic cancer data has already been published by our partner. And we're very glad to see this benefit to patients. And also this, as you know, for second-line plus non-small cell lung cancer, this drug has already been approved. Well, you can call it a drug or this therapy has already been approved by FDA with no added systemic toxicity. A lot of people would say, well, we have many treatment options for second-line non-small cell lung cancer. What is the benefit? Yeah, you do. You have many options. But to add a therapy with non-systemic toxicity is really impressive.
The prevalence is very high for pancreatic cancer, more than 134,000 patients. Of course, for non-small cell lung cancer, close to 1 million in China alone. We are planning to submit both indications in China this year. When I mentioned the last three blockbusters, I also want to show how even though we have the best products, we have a blockbuster product, we still working continuously on improving our profitability, both individually through top-line growth and operational efficiency. We will continuously, for example, for Zai Lab, when we first launched in the third quarter 2022, we had less than 10% margin. Now in 2024, third quarter, we already had 37% margin. With the addition of a synergistic product Tivdak, we believe we definitely will be the margin will further improve, significantly improve. In the meantime, we also we're mindful of cost of goods. We mindful of.
We also have done our head of R&D and Dr. Rafael Amado has done a lot of great work about prioritizing our high-value programs, and continuously, Rafa, Josh, and all of us have been working on managing SG&A cost, managing those expenses. So all of this give us you can see the reduced SG&A expenses from year- over- year, and also while keeping very high productivity in R&D, we're also managing to support all programs, development, discovery, and launches, so as I mentioned earlier, in 2023, we already achieved commercial profitability. But by end of this year, fourth quarter this year, we would like we have seen a clear path to achieve overall corporate profitability, and we see a very clear path through all the efforts and again, through the synergistic products we brought in. 2025 is really an exciting year.
I think this is a transforming year for Zai Lab with multiple major catalysts, not only from data to readouts. These are. I'm mentioning data readouts about global trials, regional trials, but also from regulatory approval. We have multiple NDA approvals. We have multiple submissions. We have multiple global trial and submissions as well. And all of this shows, first of all, we are also in a state we paved the road to launch our blockbuster, additional blockbuster drugs. Our commercial team are ready and already demonstrated through last few years' excellence, commercial excellence. And of course, we'll leverage our existing infrastructure for Zai Lab to launch Vyvgart, the Tivdak. Sorry for my language. And additionally, we'll work more. We'll work more on business development. So not only Jonathan will do in-licensing, but also you're going to deliver out-licensing as well, right? You promised.
We're again in a very good cash position to reach cash profitability Q4 this year. You've always asked why invest in Zai Lab. What is your investment thesis? I think Zai Lab, since inception, we are now reaching major value inflection points, not only by growing our global pipeline of potential first-in-class and best-in-class assets, with the first one to be approved in 2027. But also we have multiple projects all in R&D enabling stage. They'll reach pivotal data readouts in 2027- 2028. We also see we've already seen a commercial profitable China business, but there are tremendous growth opportunities with the addition of all these additional blockbuster drugs to launch throughout 2025 and 2026. Not even mentioning Vyvgart, we will continue to shape the treatment landscape in gMG and CIDP alone.
And of course, all of this will provide significant margin improvement driven by highly synergistic product launches. And a strong cash position will lead us to many achievements, again, from discovery, clinical, BD, and commercialization. So this one really, Zai Lab, I would say, is we have multiple shots on the goal. We are very uniquely positioned as a leading biopharma with multiple shots on the goal. Our risk is manageable, and our upside is unlimited. Now I always like to climb mountains. Of course, I like to climb mountains with my colleagues and partners. So now let's do the Q&A. Am I okay with time?
Okay. That was good.
Okay. Thank you.
I just want to remind folks that there are three ways to ask a question. You can do the traditional old school path where you raise your hand and I'll call on you. You can email me a question, or there's a question portal, Josh, if you could hand that to me, the iPad. It'll come through, and I can ask on your behalf. So we do actually have an email question. With a little bit of administration change here politically in the United States and a view that perhaps the administration is less China-friendly, how do you think that was going to impact as you started becoming more global, especially on the R&D side, right, with DLL3 and other products?
Okay. Yeah. Well, first of all, I think we are in a business to address the unmet medical needs for patients, and we are not in a business related to military operations related to getting people genomic data, right? And I think, like multinational, all these years throughout Cold Wars, throughout all these wars, medicine is always needed, innovative medicines to address unmet medical needs needed more than any time in history, so I don't see personally, I'm optimistic. I don't understand. I wouldn't see why any administration wants to stop the pay to address the patients with unmet medical needs. They are unfair.
Josh, anything to add?
I think that's good.
I wanted to ask a quick question of you talked about that $2 billion of revenues by 2028. As you look out now, you've outlined the Vyvgart growth, some products that will be coming online in the next couple of years. How do we think about the key contributors to getting to that $2 billion number?
Sure. I'll go. It starts with Vyvgart in terms of growth. I think the full year results for Vyvgart are going to be among the best immunology launches in China history, and we expect that momentum to continue in gMG through the next number of years. We're just at the tip of the iceberg, as Samantha mentioned, in terms of the number of patients who have benefited from Vyvgart in China. Remember, they're about 170,000. We will have treated somewhere in the range of 10,000-12,000 or so this year, so there's a lot to go there. We have an approval for CIDP, a huge unmet need in China, really patients who don't have good treatment options, and they'll now have an option with Vyvgart, and we have more indications to come, as Samantha illustrated on the chart, so we need to continue to do well with this product.
But the opportunity to impact patients and to realize sales as a result is really significant. The second big driver, Anupam, is KarXT. As was highlighted in the presentation, we submitted at the end of the year. So we'd expect an approval in the near future, eight million patients with schizophrenia in China. Current standard of care is atypical antipsychotics. This is the first new mechanism in 30+ years. I think a lot of interest in China in this opportunity. So there's no reason this product shouldn't be in schizophrenia, have the opportunity to be a huge growth driver and $1 billion in annual sales. We're also participating in these psychosis associated with the Alzheimer's trial and are looking forward to that readout later this year. Third big driver is bemarituzumab in gastric cancer. And gastric cancer is a significant overrepresented tumor in Asian and Chinese patients.
We expect data in the first of two first line trials early this year, and we'll look to convert, hopefully, positive results in both that trial and the second trial later this year into a submission and into a launch in that time period, so those three products alone, I think, have the potential to contribute more than $2 billion on an annual basis over their lifetime. We have a series of other products that will help to supplement that as well, including launches like Tivdak that we expect in the near term here as well.
Yeah. As I mentioned, I probably didn't touch upon two other launches we had and we have done last year. And we just launched Augtyro. We launched bemarituzumab . We, of course, have TTFields to launch with a tremendous medical needs in pancreatic and also non-small cell lung cancer. So many blockbuster launches. And even when we talk, we haven't included actually the ZL-1310. That's a global launch in 2027.
Questions from the audience? Feel free to raise your hand. I wanted to dig in a little bit on the Vertex transaction for povetacicept. There were a range of B-cell modulators out there that you could have gotten your hands on, some with maybe even later stage GFR data and some maybe even similar stages povetacicept, right? So what differentiation do you see with povetacicept that made you excited?
First, I think we've followed this asset for quite some time, even when it was in Alpine's hands, and have been interested in this therapeutic area for quite some time. As Samantha mentioned, 3 million- 5 million patients with IgAN in China alone. I think when we look at POV, certainly the opportunity to be disease modifying. I think it is in the lead in terms of the mechanism and opportunity in China. I think we can also look to our partner, Vertex, who I think has been very clear that this is an area that they're interested in, and they had looked at the landscape and put their money where their mouth is with a close to $5 billion acquisition at Alpine earlier this year.
So I think we're really excited, Anupam, about the size of the opportunity, the ability to impact the disease progression, and the synergies that this will have with our immunology and Vyvgart franchise.
My understanding is Vertex has also talked about POV as a pipeline drug, right? I totally understand IgAN and the Asian prevalence and why that's hugely synergistic with Vyvgart. Are there any next level of indications that could also be very relevant to the region?
Yeah.
Yeah. Yeah. No, I think there are. I think we see with, for example, going back to our Vyvgart and our argenx partnership, I think when we look at many of the immunology diseases and look at them on an epidemiologic basis and otherwise, we tend to see very similar types of dynamics in Asian patients. In other words, take the U.S. numbers multiplied by three or four. I think we see similar types of dynamics here with the opportunity with APRIL and BAFF to treat many of the diseases. So I think we're, at least from the starting point here, very interested and aligned with how Vertex is thinking about the next generation of indications. So we definitely see this as a pipeline and a product type of opportunity.
Questions from the audience? Yep.
Without the need to get into any detail, can you just talk about your DLL3 ADC data update this quarter, just sort of the level of updates we should expect to see?
The question is DLL3 data update this quarter, what we should expect to see?
You want me to go or do you want to?
Go ahead.
Okay. I mean, Samantha can jump in after. Obviously, we've.
If you need more, we have our President, R&D, here too.
We want the dose escalation data to be completely mature and complete when we provide an update, so you should expect an update as you ask in the early part of this year. What do we see so far? Obviously, at the triple meeting, we presented data that included ORR of 74%, but given the timing of that data, much of that was unconfirmed. I think as we continue to see the data mature, we're confident that that number is going to hold up in confirmed responses. Safety continues to look good in line with what we presented at ENA or at the triple meeting, so, of course, we want to present this at a major medical meeting and have a chance. This is one of the leading, I think, programs and certainly in lung cancer.
So we want the community to have a chance to understand and debate those data. So we'll be mindful about where and how we do that, but do expect a full and complete data set from the dose escalation phase. And that will include the confirmed ORR duration and full safety data. And again, I guess I would say sitting here today with a few months more of data, we're really excited about the opportunity here. And now it's a function of continuing to execute. We're in the dose optimization phase. We've started the first line study. So we're really excited about this opportunity. And we'll present those data as they are complete and mature.
Yeah. Also basket trials for other high expression and neuroendocrine tumor types. We are in basket trials. Yeah.
Questions from the audience?
I have a quick question on there was a period in the last couple of years where business development has kind of not been a core part of the story, but now deals have kind of picked up again. How do we think about where your pipeline is now? Like the overall and maybe verticals that you're interested in when you're thinking about immunology or CNS or oncology?
I think overall we do not opportunistically do just two deals because we have to do deals. When we do a deal, it has to add synergy, but also stand alone. It provides blockbuster potential that's worthy of our effort to build another pillar, right? For example, the recent one with Vertex, we see not only blockbuster potential, but also synergy with our IgAN efgartigimod franchise. Deals like this, we are very welcoming. However, we will not be interested in deals that do not fit well with our capabilities and our therapeutic interests or market potentials. Having said so, you never say never, right? You never know what comes, how it can be transformative. We keep our eyes open. Our BD team is very dynamic and always looks out for the best products to potentially come either globally or regionally.
Questions from the audience?
Your pipeline has expanded a ton, right? And now you also have many of your internal programs coming into the mid stage, right? So how do we think about sort of R&D expenses next year? And then you're about to enter a period of maybe some blockbuster-ish launches too. So SG&A for the next couple of years.
I'll start with Joshua. I think, first of all, if you look at the therapeutic areas we pick, and they're very concentrated. For example, for Vyvgart, and with less than 200 sales reps, say 150 sales reps, you can pretty much cover all the major hospitals you need. Because again, for that disease, it's really focused on the top tier of disease and hospitals and cities. And even say for our schizophrenia drug, KarXT, and it's very much even with 8 million patients, it's still very concentrated in psych wards in hospitals and also in just psych hospitals in every city and every county. So and also a lot of those have to go through the channel, government channel to be controlled. So those looks massive.
But if you think about what we already have in terms of our team capacity, then we wouldn't think that requires tremendous amount of money to do so. And also tremendous new talent to bring in. We are already well in the position. In terms of R&D spending, we'll continue to invest in our R&D and maximize with full speed to maximizing, for example, opportunity like DLL3 ADC. We will full speed moving the project to not only second line, first line, but also other potential other indications which have the expression and tumor expression on DLL3. And we have the team. Rafael and his team has very demonstrated drug developers, not only in working with our partners over the last few years, but also in their previous lives. So we have the capacity. We have the know-how.
Financially, if you look at those trials, they are not like with the addition of recruitment speed. We are very good at recruitment patient speed and quality from time to time. Our partners actually ask us to do more recruitment because we can provide faster, more cost-effective recruitment for R&D and for patients. I think all of those as together. We'll continue to invest in R&D. As we become overall profitable, plus we do have a good cash position, we think nothing will hurt us from moving the project as fast as forward as anyone can do. Of course, Jonathan can do our licensing too, right? Bring additional revenues.
Maybe just to put a little bit of math against that, we'll give guidance during our year-end call and results. We'll give 2025 guidance. But what we can say for R&D is for all taking Samantha's comments and putting them into numbers, R&D will be pretty flat in 2025. That's because we've already built in all the expenses and anticipation around the things we've said around DLL3 and our other emerging global pipeline assets. But we do have a pretty big bolus of spend coming off from our regional assets as we get things like KarXT and bemarituzu mab, and PANOVA, TTFields across the finish line. So that capacity, in effect, Anupam, in 2025 gets recycled back into the global pipeline. Of course, over time, we want to have all kinds of problems around how to prioritize and spend.
But I think given the top line growth and other things we see, we see plenty of capacity to be profitable, drive good margins in the second half of this decade, and invest fully behind the exciting assets that we have.
All right. Any final questions? All right. Thank you, Samantha and Josh.
Thank you. Thanks, everybody.
Thank you, everyone.