Zai Lab Limited (NASDAQ:ZLAB) reported significant growth in its first-quarter 2024 financial results, with total revenues increasing by 39% year-over-year to $87.1 million. The company's optimism is underpinned by its innovative late-stage pipeline, including three new product approvals anticipated this year. Zai Lab is on track to achieve profitability by the end of 2025, backed by a strong cash position exceeding $750 million. With the successful launch of VYVGART and a focus on expanding its global development capabilities, Zai Lab is positioning itself for continued success in the oncology, neuroscience, autoimmune, and infectious disease markets.
Key Takeaways
- Zai Lab's total revenues for Q1 2024 grew by 39% year-over-year, reaching $87.1 million.
- The company expects three new product approvals in the current year and several potential blockbusters in the next two to three years.
- R&D expenses will remain consistent with the previous year while sales and marketing expenses will increase.
- Zai Lab aims to be profitable by the end of 2025 and holds a cash reserve of over $750 million.
- The company is making progress in various therapeutic areas, with notable updates on oncology and neuroscience pipelines.
- Zai Lab is excited about the commercial opportunity in China, especially for treatments like VYVGART and KarXT.
- A focus on business development aims to broaden and accelerate Zai Lab's global ambitions.
Company Outlook
- Zai Lab is confident in its growth trajectory, with plans to launch several potential blockbuster products.
- The company is working towards profitability by 2025 and will continue to invest in R&D and marketing efforts.
Bearish Highlights
- While the company did not explicitly mention any bearish aspects, maintaining R&D expenses and increasing sales and marketing expenses could impact short-term profitability.
Bullish Highlights
- Zai Lab's growth is driven by strong sales volumes and a robust pipeline of innovative products.
- The company's oncology pipeline, including repotrectinib and ZL-1310, shows promise, with positive clinical trial results and ongoing studies.
- Neuroscience, autoimmune, and infectious disease franchises are advancing, with VYVGART submitted for approval in China for CIDP and KarXT showing potential in schizophrenia and Alzheimer's disease psychosis.
Misses
- The summary did not indicate any specific misses or shortfalls in the earnings report.
Q&A Highlights
- The company discussed the bridging study completion, regulatory dossier updates, and the strong commercial potential in China.
- Executives expressed enthusiasm for the subcutaneous version of VYVGART and its opportunity in CIDP.
- Zai Lab plans to expand its patient base for VYVGART over time and explore further indications.
- There is a focus on business development to expand Zai Lab's global portfolio.
In summary, Zai Lab's first-quarter earnings call painted a picture of a company poised for substantial growth, with a strong financial position and a promising pipeline. The company's focus on innovative treatments and expansion into global markets, particularly China, underscores its strategic vision for the future. With a commitment to research and development and a strategic increase in marketing efforts, Zai Lab is gearing up to meet its ambitious profitability and product launch goals in the coming years.
InvestingPro Insights
Zai Lab Limited (ZLAB) has demonstrated robust financial health and growth potential in its Q1 2024 results, with a 39% year-over-year revenue increase. As the company continues to innovate and expand its product pipeline, here are some insights based on real-time data and InvestingPro Tips:
InvestingPro Data:
- The market capitalization of Zai Lab stands at $2.08 billion, reflecting the company's significant presence in the biotech industry.
- With a P/E ratio of -6.01 and an adjusted P/E ratio for the last twelve months as of Q1 2024 at -5.9, the company's current earnings do not cover its stock price, which is typical for many growth-focused biotech firms.
- Revenue growth for the last twelve months as of Q1 2024 is at a strong 25.94%, indicating the company's ability to increase its sales effectively.
InvestingPro Tips:
- Zai Lab holds more cash than debt on its balance sheet, which is a positive sign of financial stability and provides flexibility for future investments and operations.
- Analysts anticipate sales growth in the current year, supporting the company's optimistic outlook and aligning with the reported revenue increase.
For investors looking for more in-depth analysis and additional insights, there are 12 more InvestingPro Tips available for Zai Lab. These tips offer a comprehensive view of the company's financial health, market performance, and growth prospects. To access these tips and enhance your investment strategy, visit InvestingPro at https://www.investing.com/pro/ZLAB and use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription.
Full transcript - Zai Lab (ZLAB) Q1 2024:
Operator: Hello, ladies and gentlemen, thank you for standing by and welcome to Zai Lab's First Quarter 2024 Financial Results Conference Call. At this time, all participants are in a listen-only mode. Later we will conduct a question-and-answer 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.
Christine Chiou: 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 will 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, our Chief Business 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 expectation. These statements are subject to numerous risks and uncertainties that may cause 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 rate 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.
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 truly innovative and integrated biopharma company, focused on bringing innovative medicines to address 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 are entering a period of robust growth driven by a late-stage pipeline of first and best-in-class products. We're also advancing our global pipeline where we have three in the clinic today and we expect to add new China and global assets each year through both internal discovery and business development. This year we expect three new product approvals, which follows the launch of VYVGART late last year. Over the next two to three years we have the opportunity to launch 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'll continue to expand our operational efficiency. We improve our productivity. Our first quarter results demonstrate our progress across each of these areas. Some commercial execution, increasing productivity from pipeline progress. We expect 2024 to be a strong year for Zai Lab. We are on track to achieve the objectives outlined in our five-year strategic plan including significant revenue growth and achieving profitability by the end of 2025. We have a strong balance sheet and the cash position of over US$750 million, Zai Lab is in a very good position. And with that I'll pass the call to Josh. Josh?
Josh Smiley: 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 three products collectively grew 24% year-over-year. OPTUNE showed 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's NRDL inclusion became effective on January 1, which significantly enhances patient access. Since its 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 physicians 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 healthcare professionals have now prescribed VYVGART and this number continues to climb. Feedback from physicians and patients continues 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+ non-small cell lung cancer, where we have seen a significant improvement in PFS versus current standard of care with CNS benefits. 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 and CIDP followed by TIVDAK KarXT and bemarituzumab. Many of these potential blockbuster assets are relatively de-risked 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 expenses. As we enter this next phase of significant revenue growth, we remain 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 and competitive marketing. 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 for each of our three 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.
Rafael Amado: 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+ non-small cell 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 approved first-generation therapy. Beginning 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 our 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 market our partner, Novocure, announced that the Phase 3 METIS clinical trial made its primary endpoint in patients with brain metastases from non-small cell lung cancer. Patients with TTFields on supportive care exhibited a median time during the 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 0.016. 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 (NASDAQ:AMGN) and are acquaint 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 three of which we have disclosed and are in clinical studies. ZL-1310 is our DLL3 targeted homogeneous ADC with high affinity and specificity for DLL3. It utilizes a topoisomerase I inhibitor payload and has shown promising preclinical data, which we presented at the European Lung Cancer Congress in Prague. The program is advancing through a global Phase 1 study in the United States and China for relapsed and refractory small cell lung cancer after 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 a combination of a 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 a 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 our 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.
Harald Reinhart: Thank you, Rafael. Our neuroscience autoimmune and infectious diseases, or NSAiID franchise has also made significant progress advancing our pipeline. Starting with VYVGART or 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 is 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 options are limited and quite problematic, given the general reliance on long-term steroid or chronic immunoglobulin therapy. In China, the situation has 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 registrational 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 a 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 emerging 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 in psychosis or ADP (NASDAQ:ADP) for short. There are approximately eight 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 ADEPT-2 and ADEPT-3 clinical trials in ADP in Greater China starting in mid-2024. Regarding our infectious diseases' portfolio, sulbactam-durlobactam or SUL-DUR, is 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 resistance. 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 Humabody 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 two expected regulatory approvals from our NSAiID portfolio in the near future. I look forward to providing updates at our next earnings call. And Yajing, will give an overview of our financial results. Yajing?
Yajing Chen: 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 a decrease sales rebates to distributors resulting from price reduction in connection with NRDL listing for certain products. Now looking at each individual product. ZEJULA's net product sales 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's net product sales were $13.2 million for the first quarter of 2024, following the launch in China in September 2023 and express listings on the NRDL 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's 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 formulation 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 a decrease 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 headcount 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 Josh stated previously we expect this trend to continue as a result of growing revenues and ongoing cost 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 net loss 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 $750.8 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 line for questions. Operator?
Operator: Thank you. We would now like to open the line for questions. [Operator Instructions] We are now going to proceed with your first question. The question come from the line of Anupam Rama, JP Morgan. Please ask your question. Your line is open.
Anupam Rama: Hey, guys. Thanks so much for taking the question. For VYVGART you noted the hospital formulary listings or are tracking in line with your expectation post NRDL? Can you quantify that a little bit in terms of the number of key hospitals you're on formulary currently and the timeframe in which you would expect to finish the process? Thanks so much.
Josh Smiley: Hey, good morning. Anupam, it's Josh. Thanks for the question. We have 1,000 hospitals that we're targeting for as key accounts 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 two-thirds of those 1,000 hospitals to get the listing. And I'd say, we're mid-May we're well on our way to that goal. Thanks. Next question operator?
Operator: Sure. We’re now going to proceed with the next question. The questions come from the line of Louise Chen from Cantor. Please ask your question. Your line is open.
Louise Chen: Hi. Congratulations on the progress this quarter and thanks for taking my questions here. So I had a few for you. First question I had is, if you can provide any more color on KarXT's regulatory status and then any thoughts on this opportunity in light of the changing market landscape?
Josh Smiley: Harald, why don't you take the regulatory piece? And then I can comment on the commercial opportunity.
Harald Reinhart: Yeah, thanks for the question. The regulatory update is that we are currently executing a bridging study. This is a study discussed and designed with the agency. We are almost in the final stages of completing that study on time and 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 Karuna last year to the FDA and which contains the large emerging studies as a backup. In addition, we have obviously the PK study which we executed in China just in order to complete bridging program. Thank you.
Josh Smiley: Thanks, Harald. And hi Louise. It's Josh. I think on the commercial opportunity, we're quite excited. As we've I think mentioned before, we see somewhere in the range of eight 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 a 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. Thanks.
Louise Chen: Okay. And can I just squeeze in one more question here? So on VYVGART, just curious for the sales ramp. I don't know if you give quarterly guidance, but second, third, fourth quarter, is that something a steady growth or would it be more back-end weighted? How should we think about modeling that? Thank you.
Josh Smiley: 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 of greater than $70 million. We think we're well on track for that with first quarter performance. And yeah I think in general, we'd expect to see sequential growth through the quarters, certainly would see more in Q4 than Q3 and so on. But not back end loaded in terms of the 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 would expect that to continue through the year. So we're looking forward to quarter over quarter continued growth. I think as I say, we're comfortable with a 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.
Louise Chen: Thank you.
Operator: Thank you. We’re now going to proceed with our next question. The questions come from the line of Michael Yee from Jefferies. Please ask your question. Your line is open.
Michael Yee: Hey, good morning, good afternoon. Thank you. We had two 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. 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 to one or two things you would like to do? Is that a US pipeline deal? Is that a commercial deal? Would you do a commercial deal for example? Maybe just talk a little bit about that too, so we have some expectations. Thank you.
Josh Smiley: Thanks Mike. It's Josh. I'll do VYVGART question and then ask Jonathan and maybe Rafael to comment on the business development piece. I think on VYVGART, yes, as I mentioned we're with a 2700 patients in Q1 and continued hospital listing and good uptake from physicians and adoption. I think we are on $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 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 five per year, we have no reason to believe that won't be the case in China, but it's still 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.
Jonathan Wang: Yes, hi Mike. Thanks for the questions. On BD, I think there are two primary areas that we're focusing on. One is to continue to do what we always do on which is late-stage regional deals China, Asia deal for de-risked assets especially if they're synergistic with our portfolio. And sometimes when things like efgar and KarXT come 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 early stage so maybe less de-risk but we have 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, [indiscernible] to name some examples. So, we want to continue to leverage that scientific expertise and bring assets on that may give us some potential global rights and fulfill those ambitions. Thank you.
Michael Yee: Thank you.
Operator: Thank you. And the questions come from the line of Linhai Zhao Goldman Sachs (NYSE:GS). Please ask your question.
Linhai Zhao: Thanks for taking my question. On behalf of Ziyi. I have two questions on non-small cell lung cancers. The first one is about adagrasib. I recall that previous plan was to file NDA this year. It does not seem to appear in the 1Q accompanying 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 is for OPTUNE. Understood that a normal Q has completed the day 100 meeting with FDA without indication for advisory panels. Can you shed a bit more on Zai Lab's visibility of China approval in second line non-small cell lung cancer for OPTUNE and will Zai Lab wait for the FDA approval before filing the MAA in China? Thanks.
Josh Smiley: Thanks. Rafael why don't you go ahead and address both of those please?
Rafael Amado: Sure. Thanks for the question. So, on adagrasib as you know there's single data that led to the approval of adagrasib in the United States and BMS recently announced the results of KRYSTAL-12 trial. They announced just top-line data, which was the primary endpoint was met. The primary endpoint was progression-free survival and was statistically and clinically meaningful and we are evaluating further data. BMS has announced that they're still evaluating the rest of the data and they expect to present this in a congress in the future. And of course, we need to await their evaluation as we make a decision on formulating plan going forward. So we are essentially going to expecting a further data as BMS looks at the totality of the dataset. So that's the update on adagrasib. With regards to TT field I mean you're right. They filed in December. They had the 100-day meeting which they stated as very productive meeting. They don't expect an advisory committee and have also filed in Europe and are expecting CE Marking as well and their negotiations as well in Japan. So fully global approach here to their submission and we're working very closely with them. And we expect to actually submit ourselves MAA 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 non-small cell lung cancer.
Q – Unidentified Analyst: Just to clarify for the China following we are not necessarily have to wait for the potential FDA approval right?
Josh Smiley: Not necessarily. We don't have to wait for the approval.
Linhai Zhao: Got it. Thanks.
Operator: Thank you. We are now going to proceed with our next question. The question comes from the line of Yigal Nochomovitz from Citigroup. Please ask your question.
Yigal Nochomovitz: Yeah, hi. Thanks and 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 you not see that as an impediment? And then once the subcu is launched do you expect acceleration in the launch or just the 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? Thank you.
Josh Smiley: Thanks, Yival. 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 thousand 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 some for subcu. And as 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 suit or 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 a physician administration. So I don't think 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 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.
Harald Reinhart: Yeah, thank you. The question was about CIDP in the current standard of care treatment. And currently there is no approved treatment for CIDP anywhere in the world. And so the study that was done by argenx and us 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 and many of them do progress they end up getting IVIg. It's nothing really in between that has shown to be of benefit to patients. And as I said at some other meeting the disease is really rather progressive and much more severe than Guillain-Barre, which is a shorter version of this neurologic disease. So we do believe that VYVGART will have a significant role to play here in CIDP. This is totally unmet medical need situation and will have a major impact on the treatment modality in the treatment paradigms. Thank you.
Yigal Nochomovitz: Okay. And then just a follow-up. It sounds like based on your comments Josh with the dynamics with IV versus subcu that similar dynamics would apply for CIDP. Is that fair?
Josh Smiley: 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.
Yigal Nochomovitz: Okay. So there's no IV for the CIDP. Okay. Thank you.
Operator: We are now going to proceed with our next question. And the question comes from the line Jonathan Chang from Leerink Partners. Please ask your question.
Jonathan Chang: Hi, guys. Thanks for taking my questions. First question on ZL-1310 your DLL3 ADC. Can you help set expectations for the potential dose escalation data expected end of 2024 or early 2025? 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 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? Thank you.
Josh Smiley: Rafael, why don't you start and I can close out with any final comments on this question? Thanks Jonathan.
Rafael Amado: Yeah, Jonathan thanks for the question. Yeah, as I mentioned before we have three products that are global, that are in the clinic at the moment and one of them is 1310 DLL3 ADC which utilizes its teen technology that have a bystander effect. So we see the promise 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 dose 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 platinum exposed obviously. And we also are going to enroll some patients that have been exposed to bispecifics as well against DLL3. So this will be steady as well based on biology that informed us that DLL3 remains expressive in patients that progress after bispecific. So, we will have, I think a wealth of data in the platinum progressors in combination with atezo as a single agent in DLL3-naive patients as well as pre-exposed patient. In terms of how much data we will have. As you know this is a Phase 1 study and it depends on when we will achieve DLTs and when we will achieve a dose that we can then commence 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 2025 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 is really good progress in discovery. We're focused on certain areas of cancer biology where we have expertise where nominating candidates and our goal is to have by internalizing these coming from our laboratories at least once a year. And I'm very pleased with the progress that we're making at the moment. So thanks for the question.
Josh Smiley: Great. I think that covers it. So, maybe next question please operator.
Operator: Sure. We’re now going to take our last question. And the questions come from the line of Jack Lin from Morgan Stanley (NYSE:MS). Please ask your question.
Jack Lin: Hi, there. Good morning and thanks for taking my question. I have a quick one on VYVGART. And also, I think another one touching on the other pipeline. So VYVGART, I think the other analysts brought up earlier in terms of patient profile. So I was wondering, so we have 2,700 new patient that were dosed over the first quarter. What are we seeing in terms of their treatment profile prior line? The breakdown between patients that were completely treatment-naive compared to those that were refractory to the conventional immunotherapy. And also, I think those that are refractory to say C5, which is probably low in China anyway. So, in terms of their prior to profiling 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 CD later on how to have a qualitative comparison as far as China market for these new indications coming out versus gMG? Thank you.
Josh Smiley: Great. 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 here. We are targeting as part of the broader 170000 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 could be in some type of some rescue or flare situation. So I would say without getting into too much detail the majority of the patients are patients who 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 that 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 will expand on the emphasis overtime. But I think initially that's the majority of patients are those who have already been under care and under some form of pharmacological treatment for gMG. I think as it relates to just the market opportunity then Harald can provide some more comments. I think with all of the programs that we're participating in with argenx, 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, a Thyroid Eye Disease. And we're excited about the opportunity overtime. But Harald, anything that you'd like to add to that please do.
Harald Reinhart: Yeah. Very little to add here. Thank you, so much for the question. In essence the labeling expansion to other indications is something we coordinate obviously with argenx and there is regulator action 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 fairly soon. There is discussion about other indications. And we've recommitted to doing a myopathy, Myositis study as this includes Dermatomyositis polymyositis patients for which we believe [indiscernible] good options. But there are more indications like that that could also be entertained. And you just heard from Bristol-Myers in the recent press release they had good results in the, Sjögren's Phase 2 study. The list is long. We will be selective clearly, but for most of those indications the frequency of the disease in China is just what you see everywhere else. And so we will engage in an appropriate fashion wherever it makes sense for us in the overall list of Autoimmune Diseases that could be tackled with Efgartigimod.
Jack Lin: Thank you.
Josh Smiley: Awesome. Thanks Harald. I think if there are no other questions we can turn it back to, Samantha.
Operator: I am showing no further questions at this time, so I'll turn back the call to Zai Lab's, CEO Samantha Du, for closing remarks. Thank you.
Samantha Du: Yeah. 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.
Operator: Ladies and gentlemen, this concludes today's conference call. Thank you all for participating. You may now disconnect your line. Thank you. And have a great day.
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