Hello, ladies and gentlemen. Thank you for standing by, and welcome to Zai Lab's First Quarter 2024 Financial Results Conference Call. .

[Operator Instructions] Later, we will conduct a question-and-answer session and instructions will follow at that time. As a reminder, today's call is being recorded. It is now my pleasure to turn the floor over to Christine Chiou, Senior Vice President of Investor Relations. Please go ahead. .

Thank you, operator. Good morning, good evening, and welcome to Zai Lab's First Quarter 2024 Earnings Call. Today's call will be led by Dr. Samantha Du, Zai Lab's Founder, CEO and Chairperson. She'll be joined by Josh Smiley, President and Chief Operating Officer; Dr. Rafael Amado, President and Head of Global Oncology Research and Development; Dr.

Harald Reinhart, President and Head of Global Development Neuroscience, Autoimmune and Infectious Diseases; and Dr. Yajing Chen, Chief Financial Officer. Jonathan Wang [Technical Difficulty] officer will also be available to answer questions during the Q&A portion of the call..

As a reminder, during today's call, we will be making certain forward-looking statements based on our current expectations. These statements are subject to numerous risks and uncertainties that may cause the actual results to differ materially from what we expect due to a variety of factors, including those discussed in our SEC filings.

We will also refer to product revenue growth rates on a constant exchange rate basis, which is a non-GAAP financial measure. .

Please refer to our earnings release furnished with the SEC on May 8, 2024 for additional information on this non-GAAP financial measure. At this time, it is my pleasure to turn the call over to Dr. Samantha Du. .

Thank you, Christine, and good morning, and good evening to all who are joining us today. I'm excited to be here to share with you the results from our first quarter. But before I do so, I want to start with a few opening comments..

We started Zai Lab with a vision to build a true innovative and integrated biopharma company focused on bringing innovative medicines to drive the unmet medical needs for patients in China and around the world. We have spent the past few years building our infrastructure, capabilities and pipeline to get us where we are today..

We're under a period of robust growth driven by a late-stage pipeline of first and our best-in-class product. We're also advancing our global pipeline, where we have 3 in the clinic today and we expect to add new China and global assets. Each year drove both internal discovery and business development..

This year, we expect 3 new product approvals which follows the launch of VYVGART late last year. Over the next 2 to 3 years, we have the opportunity. We launched multiple potential blockbuster products, and many of those assets are expected to contribute significantly to our revenue, way beyond 2028.

As we scale our business, we will continue to expand our operational efficiency we improved our productivity..

Our first quarter results demonstrates our progress across each of these areas. Strong commercial execution, increase in productivity and pipeline progress.

We expect 2024 to be a strong year for Zai Lab, and we are on track to achieve the objectives online in our 5-year strategic plan including significant revenue growth and achieving profitability by the end of 2025. .

With a strong balance sheet and a cash position of over USD 750 million Zai Lab is in a very good position. And with that, I'll pass the call to Josh.

Josh?.

Thank you, Samantha, and thank you, everyone, for joining the call today. We had a good start to the year with robust revenue growth and continued advancements in our key clinical programs..

Our total revenues grew 39% year-over-year to reach $87.1 million. Our commercial performance was driven by strong execution with the launch of VYVGART and uptake across our existing portfolio. ZEJULA continues to maintain its leadership position in the PARP inhibitor class for ovarian cancer.

Key drivers of growth for ZEJULA remain increasing new patient penetration in first-line ovarian cancer and extending the duration of treatment for patients in the maintenance setting. .

QINLOCK and NUZYRA also showed solid growth, benefiting from their NRDL listings in 2023. Together, these 3 products collectively grew 24% year-over-year. Optune showed a recovery from slowdowns in the second half of last year, growing 49% sequentially from the fourth quarter. Now looking at VYVGART. The launch is off to an excellent start.

In the first quarter alone, we estimate that nearly 2,700 new patients were treated with VYVGART. Driving the strong initial uptake is our team's ability to execute on several important launch initiatives..

First, VYVGART NRDL inclusion became effective on January 1, which significantly enhances patient access. Since this inclusion, VYVGART has been steadily added to hospital formularies, and we are making great progress in line with our expectations. Second, our targeted outreach to physician has been very successful.

We've engaged our top 1,000 hospitals, which account for 80% of the eligible patient population. .

Our highly specialized sales team of 150 reps is well equipped to not only support the launch in GMG, but also upcoming launches of the subcutaneous formulation for this indication later this year and then for CIDP in 2025. Third, we are seeing high adoption from physicians.

Nearly 900 health care professionals have now prescribed VYVGART, and this number continues to decline. Feedback from physicians and patients continue to be positive, and we are focused on providing these key stakeholders with best-in-class support. We are tracking well to exceed $70 million in sales of VYVGART this year..

Our late-stage pipeline also continues to advance nicely.

We anticipate several approvals this year, repotrectinib in ROS1-positive non-small cell lung cancer, where we have seen a significant improvement in PFS versus current standard of care with CNS benefit, SUL-DUR, the first pathogen targeted therapy addressing ABC infections and the subcu formulation of VYVGART for GMG, which provides additional dosing flexibility for patients.

Each of these opportunities has the potential to offer significant benefit to patients and we look forward to launching these products in the second half of 2024..

Looking ahead to next year, we have the potential to launch subcu VYVGART in CIDP, followed by TIVDAK, KarXT and bemarituzumab. Many of these potential blockbuster assets are relatively derisked given their positive pivotal data or compelling proof-of-concept results, positioning us well for future growth..

Now moving on to the cost and investment side of the business. In 2024, we expect to maintain R&D expense at a similar level versus 2023, while modestly increasing sales and marketing expense. As we enter this next phase of significant revenue growth, we remained focused on efficient operations.

And this includes enhancing commercial efficiency, optimizing resource allocation and increasing productivity throughout the entire organization. .

We will continue to execute financial discipline and cost management, and we expect significant operating leverage as our revenue growth meaningfully outpaces that of our operating expenses. This allows us to prepare for the next phase of growth for Zai Lab as we drive both revenues and profitability..

I'm also pleased to announce that recently Andrew Zhu joined as our Chief Commercial Officer in Greater China.

Andrew has more than 20 years of experience in marketing and sales management for innovative drug therapies and a proven track record of driving top-line growth and managing large teams and product portfolios with significant revenue in competitive markets.

He brings rich experience in building innovative business models and resource integration, which will help us further enhance our commercial operations and drive sales and profit growth across Greater China..

Overall, we continue to make great progress towards each of our 3 corporate objectives, which are to drive revenue growth, achieve profitability and expand our global pipeline.

We are on track to reach profitability by the end of 2025 and with a cash position of over $750 million, we expect to be able to fund our operations and business development deals through profitability. And with that, I will now pass the call over to Rafael to discuss the great progress within our oncology pipeline. .

Thank you, Josh. Let me begin by highlighting some of the key progress updates in our oncology pipeline, since our last earnings call, along with our next steps.

Starting with repotrectinib, our NDA was accepted by China NMPA with priority review status for ROS1 positive non-small cell case lung cancer in both TKI-naive and TKI-pretreated patients, and we are expecting approval in the next few months. .

In China, ROS1 rearrangements occurred in 2% to 3% of patients with advanced non-small cell lung cancer. There is a significant unmet need for these patients given the limited durability of clinical benefit due to the emergence of resistance to approve first-generation therapies.

Treatment with repotrectinib, a next-generation ROS1 and NTRK inhibitor has been shown to result in high response rates with promising durability in patients with ROS1-positive non-small cell lung cancer including in those with intracranial disease and in the post first-line treatment settings, which may address the limitations of first generation TKI..

Specifically, we've seen a directional response of 34.1 months and 14.8 months in TKI-naive and TKI-pretreated patients, respectively.

With these results, we believe repotrectinib has the potential to become a new standard of care options for patients with ROS1-positive non-small cell lung cancer including those whose tumors have developed mutations comparing resistance to previous treatment with ROS1 inhibitor therapy..

Next, our tumor treating field franchise. This March our partner, Novocure, announced that the Phase III METIS clinical trial made its primary endpoint in patients with brain metastases from non-small cell lung cancer.

Patients treated with TTFields on supportive care exhibited a median time to intracranial progression of 21.9 months compared to 11.3 months in patients treated with supportive care alone with a statistically significant p-value of 0.01. .

TTFields therapy was well tolerated and was associated with sustained quality of life and neurocognitive function. Results from the METIS study will be presented at a late-breaking abstract at this year's American Society of Clinical Oncology Annual Meeting.

We also expect another pivotal readout from TTFields in first-line locally advanced pancreatic cancer by the end of this year..

We continue to make great progress with bemarituzumab in collaboration with Amgen and are going to FORTITUDE-101 and 102 studies. These studies are evaluating a doublet and triplet combination, respectively, in first-line FGFR2b-positive gastric cancer with overall survival as the primary endpoint..

In addition to our late-stage partner programs, we have optimized our global development capabilities and are making excellent progress with our internal global programs, 3 of which we have disclosed and are in clinical studies. ZL-1310 is our DLL3 targeted homogeneous DAR 8 ADC with high affinity and specificity for DLL3. .

It utilizes our topoisomerase 1 inhibitor payload and have shown promising preclinical data, which we presented at the European Lung Cancer Congress in Prague.

The program is advancing through a global Phase I study in the United States and China for relapsed and refractory small cell lung cancer as a progression on platinum-based therapy, and we expect to expand its geographic footprint as the trial progresses.

This study will also include patients treated with the combination of our DLL3 ADC and a checkpoint inhibitor..

Depending on the totality of the data, we could potentially see early clinical results at the end of 2024 or early 2025. Our discovery efforts are moving at a brisk pace, and we are progressing internally discovered product candidates.

In addition, we continue to assess external opportunities across multiple modalities in focused areas of cancer biology with the goal of introducing new products in development this year as we continue to execute on our global development objective of generating at least one global IND per year..

I am excited about the great progress we're making in oncology with an existing and future products. I look forward to the approval and filing of novel and best-in-class oncology drugs and to augment and execute on our regional and global pipelines. And now I will turn the floor to Dr.

Harald Reinhart to discuss the progress in our autoimmune infectious disease and neuroscience therapeutic areas. .

Thank you, Rafael. Our neuroscience autoimmune and infectious diseases or NSAiID franchise has also made significant progress advancing our pipeline.

Starting with VYVGART efgartigimod beyond what Josh shared about the progress of GMG, our supplemental biologics license application for the subcu formulation of VYVGART in CIDP was submitted to the National Medical Products Administration in China in April..

There are approximately 50,000 patients diagnosed with CIDP in China. And today, only a small fraction are able to achieve remission with available care. The majority of patients remain symptomatic and the disease can have a debilitating impact on quality of life.

Existing treatment are [indiscernible] limited and quite problematic given the general reliance on long-term steroids or chronic immunocologylen therapy. In China, the situations worsened due to the persistent shortage of IVIg therapy..

As mentioned, we expect the approval of subcu VYVGART in GMG this year, which will provide patients with a second dosing option in addition to IV. We already know that efgartigimod has great potential across multiple additional indications. Therefore, we will continue working with our partner Argenx on indication expansion.

We expect to join Argenx in the registration study of efgartigimod in thyroid eye disease or TED in Greater China in the second half of this year..

Moving to KarXT. This is a first-in-class antipsychotic, combining centrally acting muscarinic agonist called xanomeline with a peripheral antagonist called trospium, which we are developing with our partner, Karuna or now BMS for patients with acute schizophrenia.

In April 2024, BMS presented new interim long-term data from the Phase III emergent program at the Annual Congress of the Schizophrenia International Research Society or SIRS. .

KarXT demonstrated statistical and clinically meaningful improvement in PANSS score and a differentiated safety profile with continued lack of weight gain, metabolic dysfunction and extrapyramidal symptoms over a 52-week period of treatment.

We expect to complete enrollment in the registrational bridging study in Mainland China this year, the results of which would support our NDA filing for the treatment of schizophrenia in adults in early 2025..

We have yet another substantial opportunity for KarXT as a treatment for Alzheimer's disease with psychosis or ADP for short. There are approximately 8 million people with Alzheimer's disease in China. And about 45% of these patients display psychotic symptoms, and there are no approved treatments for these patients.

We will participate in the Phase III ADAPT 2 and ADAPT 3 clinical trials in ADP in Greater China, starting in mid-2024..

Regarding our infectious disease portfolio, Sulbactam-Durlobactam or SUL-DUR is a treatment for hospital acquired and ventilator- associated bacterial pneumonia caused by Acinetobacter baumannii. Our NDA submission is under priority review with the NMPA with potential approval later this year..

In China, there are 300,000 cases of Acinetobacter infections annually with the majority of strains being carbapenem-resistant. Patients have limited treatment options, and the mortality rate is around 43%, even with the best available therapy and care.

Last but not least, ZL-1102 our IL-17 tumor body for the topical treatment of chronic plaque psoriasis is in the final stages of preparation for a global Phase II dose-finding trial, and we intend to initiate the study in the second quarter of 2024..

So plenty of progress with clinical studies and 2 expected regulatory approvals from our NSAiID portfolio in the near future. I look forward to providing updates at our next earnings call. And now Yajing will give an overview of our financial results.

Yajing?.

Thank you, Harald. Now I will discuss our first quarter 2024 financial results compared to the prior year period. Total net product revenues for the first quarter of 2024 were $87.1 million compared to $62.8 million for the same period in 2023, representing year-over-year growth of 39% or 43% on a constant currency basis.

Our revenue growth was primarily driven by increased sales volumes, including from the launch of VYVGART and the decreased sales rebates to distributors resulting from price reduction in connection with [ RB ] listings for certain products. .

Now looking at each individual products, ZEJULA's net product sale were $45.5 million, an increase of 7% year-over-year from $42.7 million for the same period in 2023. Driven by increased hospital sales in first-line ovarian cancer and increased duration of treatment.

VYVGART net product sales were $13.2 million for the first quarter of 2024, following the launch in China in September 2023 and its first listing on a [indiscernible] with pricing that took effect on January 1, 2024..

Our revenue growth was driven by expanding physician and patient adoption as well as increased patient access as VYVGART is added to hospital formularies. OPTUNE net product sales was $12.5 million for the first quarter of 2024. There was a sequential increase of 49% from the fourth quarter of 2023 with continued recovery expected throughout 2024.

QINLOCK grew 367% year-over-year to $6.1 million and NUZYRA increased 81% to $9.9 million for the first quarter of 2024..

The growth was supported by the inclusion of QINLOCK and the IV formation of NUZYRA in the NRDL in the first quarter of 2023, as well as the inclusion of the oral formulation of NUZYRA in the first quarter of 2024..

Turning now to our expenses. Research and development expenses were $54.6 million in the first quarter of 2024 compared to $48.5 million for the same period in 2023. This increase was primarily driven by increased clinical trial expenses, partially offset by an increase in milestone fees for our licensed partner..

Selling, general and administrative expenses grew to $69.2 million from $62.5 million for the same period in 2023. This increase was primarily driven by higher general selling expenses and head count growth associated with the VYVGART launch.

Both R&D and SG&A expenses significantly declined as a percentage of revenue in the first quarter of 2024 compared to the same period in 2023. And as just stated previously, we expect this trend to continue as a result of growing revenues and ongoing cost and efficiency initiatives..

Zai Lab reported a net loss of $53.5 million in the first quarter of 2024 or a loss per ordinary share attributable to common shareholders of $0.05 compared to a backlog of $49.1 million for the same period in 2023 or a loss per ordinary share of $0.05..

We are in a strong financial position, ending the quarter with cash and cash equivalents, current restricted cash and short-term investments of $758.8 million compared to $806.5 million as of December 31, 2023.

Based on our operating plan and our anticipated revenue growth we expect to be able to fund our business through profitability, which we expect to achieve by the end of 2025. And with that, I would now like to turn the call back over to the operator to open up the lines for questions. .

[Operator Instructions]. Our first question come from the line of Anupam Rama from JPMorgan. .

For VYVGART, you noted the hospital formulary listings are sort of tracking in line with your expectations post NRDL.

Can you help quantify that a little bit in terms of the number of key hospitals you're on formulary currently and the time frame in which you would expect kind of to finish the process?.

Anupam, it's Josh. Thanks for the question. We have 1,000 hospitals that we're targeting for key accounts and that we're targeting for NRDL pull-through on the listing. Based on historical experience, it takes about a year to pull the listings all the way down to the local hospitals.

Our goal has been to -- through the first half of this year, get at least 2/3 of those 1,000 hospitals to get the listing. And I'd say we're in mid-May, we're well on our way to that goal. .

The questions come from the line of Louise Chen from Cantor. .

Congratulations on the progress this quarter. So I had a few for you.

First question I had is if you could provide any more color on KarXT's regulatory status? And then any thoughts on this opportunity in light of the changing market landscape?.

Harald, why don't you take the regulatory piece and then I can comment on the commercial opportunity?.

Yes. Thanks for the question. The regulatory update is that we are currently executing a bridging study. This was a study discussed and designed with the agency. We are almost in the final stages of completing that study on time, hope to be able to finish it this year, as mentioned before..

So the regulatory status is that we will have a dossier eventually with good results from our bridging study plus the dossier that was presented by Kruna last year to the FDA and which contains the large merchant studies as a backup. In addition, we have obviously the PK study which we executed in China just in order to continue the bridging program.

.

Hi Louise, its Josh. I think on the commercial opportunity, we're quite excited as I think mentioned before, we see somewhere in the range of 8 million patients with schizophrenia in China. I think there's a strong emphasis on improving the care of patients with severe mental illness across China.

As you know, with KarXT drug based on the global data that we already have all seen, there's strong efficacy performance and really good profile of the drug from a safety perspective. .

So we think this is going to be an important option for treating patients. We're excited to get through the regulatory process as Harald mentioned and begin to get this to patients as quickly as possible. So we're quite excited. .

Okay. And can I just squeeze in one more question here. So on VYVGART, just curious for the sales rep.

I don't know, if you give quarterly guidance, but second, third, fourth quarter, is it something sort of a steady growth? Or would it be more back-end weighted? How should we think about modeling that?.

Thanks, Louise. I think first, we're really pleased with the first quarter performance. I think we're off to a good start.

As you know, we said earlier in the year that just based on what we were seeing as a function of the NRDL listing, we were comfortable, confident with the sales potential for the product in 2024, greater than $70 million, we think we're well on track for that with the first quarter performance.

And yes, I think in general, we'd expect to see sequential growth through the quarters..

Certainly, we'd see more in Q4 than Q3 and so on but not back-end loaded in terms of the sort of growth. I think we expect this to be pretty steady. We're seeing that in the patient initiations.

I think when we look at the first quarter, we had fewer patient initiations in February, but that was a function of Chinese New Year and the health care utilization that always happens in that month..

So I think, if we look at where we were in March, we continue to see steady acquisition of new patients, and we would expect that to continue through the year. So we're looking forward to quarter-over-quarter continued growth. I think we're -- as I say, we're comfortable with the greater than $70 million sales number.

We're not going to give specific quarterly guidance, but again, off to a really good and exciting start. .

The questions come from the line of Michael Yee from Jefferies. .

We had 2 questions. One was on VYVGART. I know you commented about your confidence on the year. I think that you mentioned 2,700 patients -- and if you multiply that out times the price and maybe some compliance rate, I think it would imply that you're already at a $70 million run rate.

So could you comment on my math and whether there's anything I need to consider there, like compliance? Or you just think that you are already on that run rate, and that's why you could beat that number? Just talk to that a bit..

And then the second question is on BD. I know you made some comments about business development, and you've got the team there. Can you maybe just prioritize the 1 or 2 things you would like to do? Is that a U.S.

pipeline deal? Is that a commercial deal? Would you do a commercial deal, for example? Maybe just talk a little bit about that so we have some expectations. .

Thanks, Mike. It's Josh. I'll do the VYVGART question and then ask Jonathan and maybe Rafael to comment on the business development piece. I think on VYVGART, as I mentioned, we're with the 2,700 patients in Q1 and continued hospital listing and good uptake from physicians and adoption. I think we are on the $70 million or greater trend..

I think as it relates to the math and thinking about how the patients that are getting VYVGART now play out through the year, I think it's early -- a little bit early to see what we should assume for each patient who starts. And of course, any patient that starts later in the years not going to necessarily benefit from the full number of cycles.

As you know, in the markets where we've launched -- where Argenx has launched the cycles have averaged about 5% per year. We have no reason to believe that won't be the case in China, but it's very early..

Most patients are just coming online now, as you mentioned. So I think we'll have more to see and talk about as we get into Q2 and Q3. But for now, I think your math is fine. We are on the trend, and that's why we're saying we're quite confident that we're headed that way. So thanks for the question there.

And Jonathan, maybe you can start on the business development piece. .

Mike, thanks for the questions. On BD, I think there are 2 primary areas that we're focusing on.

One is to continue to do what we always do, which is late-stage regional deals, China, Asia deals for derisked assets, especially if they're synergistic with our portfolio, but sometimes when things like [indiscernible], we could potentially expand beyond our therapeutic area of focus..

And then also, we are spending a lot of time on assets that may broaden or accelerate our global ambitions. These tend to be a bit more earlier stage, so maybe less derisk, but we had a very strong scientific team.

We have done deals in the past, even for regional rights where the asset was still very early stage, such as [ bema, soldier ] to name some examples. So we want to continue to leverage that scientific expertise and bring assets that may give us some potential global rights and fulfill those ambitions. .

The questions comes from the line of [ Lin Hisao ] from Goldman Sachs. .

On behalf of [ Zeyu's ], I have 2 questions on non-small lung cancer. The first one is about adagrasib. I recall that previous plan was to file the NDA this year. It does not seem to appear in the 1Q company materials.

And just wondering if there's any change of plans for Adagrasib and if there is, what would be the potential next steps for these assets?.

And the second question for Optune you understood that NovoCure has completed the day 100 meeting with the FDA without indication for advisory panel.

Can you share a bit more on Zai Lab's visibility of China approval in the second-line non-small cell lung cancer for Optune? And will that wait for the FDA approval before filing the MAA in China?.

Thanks, Rafael, why don't you go ahead and address both of those, please?.

Sure. Thanks for the question. So on adagrasib, as you know, there's a single data that led to the approval of adagrasib in the United States. And BMS recently announced the results of the KRYSTAL-12 trial. They announced just top-line data which was that the primary endpoint was met.

Primary endpoint was progression-free survival, and it was statistically and clinically meaningful. And we are evaluating further data..

BMS has announced that they are still evaluating the rest of the data, and they expect to present this in the [ Congress ] in the future. And of course, we need to await the evaluation as we make a decision on formulating a plan going forward. So we are essentially expecting further data as BMS looks at the totality of the data set.

So that's the update on adagrasib..

With regards to TTFields, I mean, you're right, they filed in December, they had the 100-day meeting, which they [indiscernible] a productive meeting. They don't expect an advisory committee. And they're also filing Europe and they're expecting to see margin as well and their negotiations as well in Japan.

So fully sort of a global approach here to their submission. And we're working very closely with them, and we expect to actually submit ourselves on MA in China this year based on those results. So no change in the plan with regards to our expectation to be able to file LUNAR this year for second-line some-cell lung cancer. .

Yes.

Just to clarify, for the China filing, we are not necessarily have to wait for the potential FDA approval, right?.

Not necessarily. We don't have to wait for the approval. .

The question come from the line of Yigal Nochomovitz from Citigroup. .

Another VYVGART question.

What are you hearing in the marketplace in China with regard to physicians that are -- and patients that are interested in waiting for the subcu version before prescribing or do not see that as an impediment? And then once the subcu is launched, do you expect an acceleration in the launch or just a continued linear momentum? And then also, can you talk a little bit about the market for CIDP in China? What is the current standard of care there?.

It's Josh. I'll start, and then Harald, maybe you can comment a little bit on standard of care for CIDP currently and how VYVGART will fit. I think in terms of the IV versus subcu, right now, patients do go to these 1,000 hospitals that I mentioned, which cover the vast majority of patients with GMG, they go to the hospital for treatment.

So right now, the IV formulation is fine. I don't think there's a wait for subcu..

And I think we mentioned in other settings, we're targeting patients initially who are not doing well, either on standard of care or in a suite of a flare or rescue episode. So they'd be coming into the hospitals for treatment anyway. And of course, the subcu version still will require physician administration.

So I don't think we're -- we see that as a barrier today..

Certainly, we are excited about the opportunity for subcu as it provides another dosing option, and it's an important formulation for all of the future indications. But I don't think as it relates to GMG, we would expect to see some new inflection point with that approval.

We are quite excited about the patient capture and opportunities that we're seeing today and are looking forward to CIDP. And Harald, maybe you could give a few comments there. .

Yes. The question was about CIDP and the current standard of care treatment. And currently, there is no approved treatment for CIDP anywhere in the world.

So the study that was done by Argenx announced in China is really a landmark study in a way that it, first of all, brings a larger patient number into a study situation, which you can make some kind of conclusions about treatment. .

The current treatment everywhere in the world is that these patients get steroids initially. And if they progress in -- many of them do progress, they end up getting IVIG, there's nothing really in between they have shown to be of benefit to patients.

And as I said, at some other meetings, the disease is really rather progressive and much more severe than [ GMA ], which is a shorter version of this neurologic disease..

So we do believe that VYVGART will have a significant role to play in CIDP. This is totally unmet medical need situation and will have a major impact on the treatment modality and the treatment paradigms. .

Okay. And then just a follow-up. It sounds like based on your comments, Josh with the dynamics with IV versus subcu, the similar dynamics would apply for CIDP.

Is that fair?.

Well, CIDP will be approved in the subcu version. That's how it was submitted. So I think by the time we get to CIDP, that will be the formulation for that indication. .

So there is no IV for the CIDP?.

Yes. .

The questions come from the line of Jonathan Chang from Leerink Partners. .

First question on ZL-1310, your DLL3 ADC.

Can you help set expectations for the potential dose escalation data expected end of '24 or early '25? What types of patients are being enrolled in the study? How many may have seen a prior DLL3 targeting agents? And how much duration data are you hoping to have?.

And then the second question, zooming out, how are you thinking about expanding on your global portfolio over time? What are the considerations here beyond the business development comments that you made earlier?.

Rafael, why don't you start and I can close out with any final comments on this question. .

Yes. Jonathan, thanks for the question. Yes. Samantha mentioned before, we have 3 products that are global, that are in the clinic at the moment and one of them is 1310 or DLL3 ADC, which utilizes it's team winning technology that have a bystander effect. .

So where -- we see the problem is based on preclinical results and have initiated a trial that started in the United States and expanded to China and we're going to continue to expand the global footprint and try to accelerate those escalation. I can say that we're proceeding well through dose escalation at the moment..

And as we move forward, we will also, as I mentioned in the prepared remarks, also combining with checkpoint inhibitors. And in terms of the patient population, they're all [ palm ] exposed, obviously. And -- we also are going to enroll some patients that have been exposed to bispecifics as well against DLL3.

So those will be study as well based on biology that sort of informed us the DLL3 remains expressing in patients that progress after bispecific. So -- we will have, I think, a wealth of data in the [ plan ] progressors in combination with ATEZO and it's a single agent in DLL3 naive patients as well as pre-exposed patients..

In terms of how much data we will have, as you know, this is our phase I study, and it depends on when we will achieve DLTs and when we will achieve a dose that we can then comment the expansion of that dose and understand the full potential of the drug.

So we've guided towards the end of 2024 and potentially early '25, at least with the initial data. So that's our expectation, and we're very pleased with the way that this program is progressing at the moment..

And then with regards to your broader question, Jonathan made some comments about business development. Perhaps I can just complement that with the fact that we are making what I believe it's really good progress in discovery. We're focused on certain areas of cancer biology, where we have expertise.

We're nominating candidates and our goal is to have our internal INDs coming from our laboratory is at least one a year and I'm very pleased at least with the progress that we're making at the moment. So thanks for the question. .

We're now going to take our last question. The questions come from the line of Jack Lin from Morgan Stanley. .

I have a quick one on the VYVGART also, I think another one, touching on the other pipeline. So for VYVGART the other analysts brought it earlier in terms of patient profile. So I was wondering, so we have 2,700 new patient that was over the first quarter.

What are we seeing in terms of kind of your treatment profile prior like the breakdown between patients that were completely treatment-naive compared to those that were refractory to the conventional immunotherapy?.

And also I think those are refractory to say, C5 which is probably low in China anyway.

So in terms of their prior achievement profile in that and I think also wondering about in terms of the relative expectation in terms of opportunities that will compare from the indication expansions for VYVGART so with CIDP coming and I think also on [indiscernible] later on, but how can you have a qualitative comparison as far as China market for these new indications coming out versus GMG?.

Thanks, Jack. I'll start. It's Josh, and then Harald can provide some more detail and color on the question. I think first, as it relates to the patient profiles, for the initial launch year. We are targeting as part of the broader 170,000 GMG patients who could benefit from VYVGART.

We're targeting initially those who are -- haven't responded well to current treatment. And as I say, it could be a some type of rescue or flare situation..

So I would say without getting into too much detail the majority of the patients are patients, who have -- are not naive to treatment. They've been treated before. And the goal here, of course, is to get physicians to get comfortable using the product to have a good initial experience.

And we know from real-world experience patients, who are exposed to VYVGART, who haven't responded well to other treatments or otherwise are going to show a good response, and we're seeing that. Of course, we'll expand the emphasis over time..

But I think initially, that's -- the majority of patients are those who have already been under care and under some kind of pharmacological treatment for GMG.

I think as it relates to just the market opportunity, then Harald can provide some more comments with all of the programs that we're participating in with Argenx, we see -- we're similarly excited about the commercial opportunity in China for this next wave of indications..

So you can tell by our participation that we're seeing very good need for VYVGART as a treatment option for many of these devastating diseases, including thyroid eye disease, and we're excited about the opportunity over time. But Harald, anything that you'd like to add on that, please do. .

Yes. Very little to add here. Thank you so much for the question. In essence, the enabling expansion to other indications is something we coordinate obviously with viewers Argenx and there is a regular interaction there as to what is a reasonable next step to take.

TED is one of the things that we have announced is definitely coming to us, and we will start those programs really soon. There is a discussion about other indications. And we very committed to doing a myopathy, myositis study..

This includes dermatomyositis, polymyositis patients, which we believe efgartigimod good option. And -- but there are more indications like that. And that could also be entertained and you just heard from Bristol Myers in the recent press release, they had good results in the [indiscernible] Phase II study..

The list is long. We will be selective clearly. But for most of these indications, the frequency of the disease in China is just what you see everywhere else. And so we will engage in an appropriate fashion, where it makes sense for us in the overall list of autoimmune diseases that could be tackled with efgartigimod. .

Awesome Thanks, Harald. I think if there are no other questions, we can turn it back to Samantha. .

I'm showing no further questions at this time. So I'll turn back the call to Zai Lab CEO, Samantha Du, for closing remarks. Thank you. .

Yes. Thank you, operator. I want to thank everyone for taking your time to join us on this call today. We appreciate your support and look forward to updating you again after the second quarter of 2024. Operator, you may now disconnect this call. .

Ladies and gentlemen, this concludes today's conference call. Thank you all for participating. You may now disconnect your lines. Thank you. Have a great day..