Zai Lab Limited

Hello, ladies and gentlemen. Thank you for standing by. Welcome to ZyLab's third quarter 2023 Financial Results Conference call. At this time, all participants are in listen-only mode. Later, we will conduct a question-and-answer session, and instructions will follow at that time. As a reminder, today's conference is being recorded. It is now my pleasure to turn the floor over to Christine Cho, Senior Vice President of Investor Relations. Please go ahead.

Thank you, operator. Good morning, good evening, and welcome to XyLab's third quarter 2023 earnings call. Today's call will be led by Dr. Samantha Du, XyLab'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. Harold 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 expectations. 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 November 7th, 2023 for certain disclosures regarding this non-GAAP financial measure. At this time, it is my pleasure to turn the call over to Dr. Samantha Du.

Thank you, Christine. Hello, everyone. Thank you all for joining us today. Throughout the year, we have continued to successfully advance our pipeline, including several important developments for key late-stage programs, such as FEMA, CAR-XT, SODOR, and ASGAR-TJMOT. In the third quarter, we were especially excited about the launch of our fifth commercial product, WISGAR, following months of strategic preparation. Although still early in the launch, we are encouraged by the initial demand for safeguards and by the positive feedback from both physicians and patients. Josh will provide more details on the progress of this very important product launch. We're well positioned to execute on our corporate strategic goals, including the launch of multiple new products and new indications over the next few years. Our pipeline of potential first-in-class and back-in-class products has significant potential to meaningfully improve the lives of patients, and we expect these product candidates to contribute to our long-term growth and drive shareholder value. And with that, I'll pass it to Josh. Josh?

Thank you, Samantha.

It is an exciting time at XyLab as we launch VivGuard, the first FCRN blocker approved for the treatment of generalized myasthenia gravis in China. There are over 170,000 patients in China living with GMG, many of whom continue to suffer from symptoms such as decreased muscle strength and mobility despite receiving treatment. DivGuard is an important new treatment option for GMG and has the potential to significantly change the way patients are treated today. We've already made significant progress through our outreach efforts, having engaged around 75% of our top 200 hospitals since launch in September. And while we are still in very early stages of the launch of DivGuard, we are encouraged by the positive feedback from neurologists and patients. We're seeing physicians gain experiences on DivGuard, and impressively, nearly 70% of our top 100 MG specialists have already prescribed VivGuard to a patient. Furthermore, many are repeat prescribers, and we are seeing the depth and breadth of prescribing continue to increase. We're focused on increasing awareness, providing education on the benefits of this important therapy, and building a strong support network for physicians and patients. Importantly, we're also working hard to increase patient access, and we're in the negotiation process for VivGuard's inclusion on the NRDL, which would allow many more patients to be able to benefit from this therapy. We're very excited by the potential of ZivGard, and not just in GMG, but across a wide range of new opportunities. Earlier this year, we saw positive pivotal data in CIDP, and by the end of 2023, we expect pivotal data in ITP and PV. Next year, we're expecting the approval of subcutaneous ZivGard in GMG, and we believe that being able to provide alternative dosing options, both IV and subcutaneous, is beneficial for patients and caregivers. These are just some of the near-term opportunities for VivGuard to add additional layers of growth to the franchise. Now turning to the rest of the commercial portfolio. We delivered year-over-year product revenue growth in the third quarter of 22% on a reported basis and 27% on a constant currency basis. In addition to the launch of VivGuard, the doula hospital sales grew, and it continued to be the leading PARP inhibitor in hospital sales for ovarian cancer in China. Kinloch and Uzaira continued to benefit from their inclusion in the NRDL, and our team was able to expand supplemental insurance coverage for Optune. Looking ahead, we'll continue to focus on the execution of our strategic goals. First, we are seeking to accelerate our medicines in the market and drive revenue growth. Over the next 12 to 18 months, we anticipate several important registrational data readouts, including for FBAR Digimod and tumor-treating fields in pancreatic cancer. And we expect to initiate several important trials, including Fortitude 102, a trial evaluating bemerituzumab in first-line gastric cancer. Next year, we could see three or more NMPA approvals and four NDA or supplemental NDA submissions in China. Second, we are focused on driving profitability by leveraging our existing capabilities and platforms and by increasing productivity across the organization. And third, we continue to focus on expanding our pipeline through internal discovery, and through regional and global collaborations. We entered into a strategic partnership with MediLink in April for a next generation DLL3 program, which we are currently advancing to a global phase one trial. And we also have our topical IL-17 Huma body, which is entering global phase two development. In parallel, we will continue to look for meaningful new external opportunities in strategic areas to further expand our pipeline. We are very excited by the depth and breadth of our portfolio, and we are confident that our commercial organization will be able to drive significant revenue growth over the next few years. We are well positioned financially with a cash position of $822 million as of September 30th, which we believe will support our business and operations until we reach profitability. And now we'll turn the call over to Dr. Amato. Rafael?

Thank you, Josh. Within oncology, our R&D teams are focused on the development of a late-stage pipeline, and we have had several updates during the third quarter, which I will briefly highlight. In August, Reprotrectinib received its fourth breakthrough therapy designation in China for the treatment of patients with advanced solid tumors that have a neurotrophic tyrosine receptor kinase, or NTRK gene fusion, and have progressed following treatment with tyrosine kinase inhibitors. In addition, for potential treatment of ROS1-positive non-small cell lung cancer, newly disclosed results from the Registrational Triton-1 study showed median duration of response of 34.1 months and median progression-free survival of 35.7 months in tyrosine kinase inhibitor naive patients. This impressive durability has the potential to be a major differentiating factor. The National Medical Products Administration has accepted our new drug application for Repotrectinib in ROS1-positive non-small cell lung cancer with priority review, and we look forward to bringing this important medicine to patients in need in China as early as feasible. Additionally, for Cresati or Adagracis, our partner, Miraki, presented two-year follow-up data from the CRYSTAL-1 study in September. In the pooled analysis, as aggressive demonstrated durable efficacy with a median overall survival of 14.1 months up from 12.6 months previously reported and a two-year overall survival rate of 31% in patients with previously treated KRAS G12C-mutated non-small cell lung cancer. Exploratory analysis suggested clinical benefit in patients with treated stable central nervous system metastasis at baseline with responses noted across most baseline commutations, highlighting the potential differentiation for adagracib in KRAS-G12C-mutated non-small cell lung cancer. We await the results of the CRYSTAL-12 trial of adagracib against docetaxel, which is the ongoing confirmatory phase three study, and which will form the basis for submission in China in 2024. In October, our partner C-GEN, announced that TSTAT demonstrated superior overall survival, progression-free survival, and objective response rate versus chemotherapy at a pre-specified interim analysis of the confirmatory phase 3 in NOVA-TB-C01 global trial in recurrent or metastatic cervical cancer patients with disease progression on or after frontline therapy. We have participated in the study and continue an extension portion in China. Moving to our internal global research and development programs regarding our DLL3 antibody drug conjugate, ZL1310, we just submitted an IND in the U.S. and are targeting to initiate a global phase 1 study in the first quarter of 2024. Looking ahead over the next 6 to 12 months, we expect several important updates from some of our key oncology programs. As we continue to expand and advance our oncology pipeline, I am pleased to announce that Dr. Robert Brown has joined XyLab as our Chief Medical Officer of Oncology. Robert's impressive medical and drug development background will further strengthen our global oncology research and development team. Dr. Brown will report to me, and he will provide strategic leadership and support with respect to the clinical development of our oncology pipeline. And now, I will turn the floor over to Dr. Harald Reinhardt to discuss the progress in our autoimmune infectious disease and neuroscience therapeutic areas. Harald?

Thank you, Rafael. We have made excellent progress across our autoimmune infectious diseases and neuroscience therapeutic areas this last quarter. Starting with RISCARD for efkartizumab, we launched the product for its first indication in GMT in mid-September. and already see significant market uptake. We're also very excited about its potential in treating patients with CIDP or chronic inflammatory demyelinating polyneuropathy. Data from the global trial we participated in showed a highly significant statistical and clinical benefit for patients, including the China subset. Indeed, in September, The CDE granted breakthrough therapy designation for SC sub-Q F-gratiated mod for the treatment of patients with CIDP. Existing treatment options are quite limited and problematic given the general reliance on long-term steroids or chronic immunoglobulin therapy. We have seen how F-gratiated mod sub-Q can meaningfully improve and stabilize disease symptoms in these patients. We look forward to working with regulatory authorities in China to bring this important medicine to patients as soon as possible. We also see significant potential of F-Gythium across multiple additional indications, and we will continue to work with our partner, Argenix, on indication expansion. Turning now to CAR-XT, we are on track enrolling patients in the clinical bridging study to support our China registration. CARX-T is the combination of xenomaline and traspion, which we are developing with our partner, Karuna, for acute schizophrenia. In September, Karuna submitted a new drug application to the FDA for this indication. As a new class antipsychotic, we believe that CARX-T could become an important new treatment option for schizophrenia patients in China. For Alzheimer's Disease-Associated Psychosis, or ADP, Corona initiated the Phase 3 ADEPT clinical trial program in the third quarter, and we plan to participate in these studies in Greater China next year. And now, Yajing will speak about progress with our commercial product and financial results. Yajing?

Thank you, Harold. Now I will discuss our third quarter 2023 financial results. compared to the prior year period. Total net profit revenues for the third quarter of 2023 was $69.2 million, compared to $57 million for the same period in 2022, representing year-over-year growth of 22%. On a constant currency basis, growth year-over-year was 27%. This increase was primarily driven by increased sales volume the launch of VidGuard, and the decreased next-stage effects from the COVID pandemic. Our revenue growth was slowed by the effects on the hospital and physician practices from the recent industry-wide anti-corruption enforcement efforts in China. Our total net private revenues included $41.6 million for the jeweler, which increased 6% from $39.2 million As for the Jula, which is in the third year of NRDL, continued to be the leading PARP inhibitor in hospital cells for ovarian cancer in China. $11.6 million for OpChem, which increased 8% from $10.7 million, supported by increased patient access to this product in the private pay market. $5.7 million for Chiniloc, which increased from $5.5 million supported by the NRDO listing in March 2023. $5.5 million for Muzaira, which increased $1.5 million, supported by NRDO listing in March 2023. And $4.9 million for VidGuard, which launched in September 2023. Research and development expenses were $58.8 million for the third quarter of 2023. compared to $99.5 million for the same period in 2022. This decrease was primarily due to a decrease in license fees for our licensed and collaboration agreement. Selling general and administrative expenses was $68.6 million for the third quarter of 2023, compared to $66.6 million for the same period in 2022. The slight increase was primarily due to higher general selling expenses to support new profit launches, partially offset by a decrease in professional services fees. Xilab reported a net loss of $69.2 million, or a loss per ordinary share of $0.07 for the third quarter of 2023. compared to a net loss of $161.2 million for the same period in 2022, or a loss per ordinary share of $0.17. This decrease in net loss was primarily due to increase of product revenue, the decrease of licensing fees, and the shift from foreign currency loss to gain. We are in a strong financial position. ending the quarter with $822.2 million in cash and cash equivalent, short-term investment, and restricted cash, compared to $876.4 million as of June 30th, 2023. Based on our operating plan and our anticipated revenue growth, we expect to be able to fund our business through profitability. And with that, I would now like to turn the call back over to the operator to open up the line for questions.

Operator?

Thank you.

We would now like to open the lines for questions. If you have a question, please press star 11 at your telephone at this time.

One moment for the first question. First question comes from the line of Luis Chen from Kent Hall.

Please go ahead.

Hi. Congratulations on the quarter, and thanks for taking my question. So I wanted to ask you on the NRDL if you've seen any efforts to promote innovation, and then also where is private insurance today or commercial insurance, and where do you think that will be over time? And then the second question I wanted to ask you is on VIVGAR. and what additional indications that you plan to move forward in the near term and what your next steps are there. Thank you.

Hi, Louise. This is Amanda Du. We're happy to answer your question. I think overall, in terms of the government on our deal, we have seen they have made several very serious measures to improve the health of the healthcare industry, including multiple updates to NRDR over the last two years. Recently, NRDR updates continued to support innovative medicine, especially in support medicines to address unmet medical needs and with a reasonable pricing. Of course, how reasonable, we are all going to see very soon, right? Specifically, the increase in the visibility and transparency on pricing, providing long-term stability of prices. So all of this give us more visible roadmaps for subsequent price cuts for novel drugs and also drugs like us, which treat patients with MS like this. That's what I all about, right? On the anti-corruption, I would say short-term, I think that impacts the whole industry. But medium and long-term, I think anti-corruption is a very positive force in the long run. In the medium and long-term run, especially for companies that have innovated, differentiated assets, and addressed unmet medical needs. I'll stop here. And Louis, sorry, thank you for asking the question.

Thanks, Samantha. It's Josh. Good morning, Louise, and thanks for the questions. I'll touch on the commercial insurance question briefly. I think this is probably an underappreciated positive also in the China market over the last few years. I think if you look back to end of 2020, I think about 40 million people were covered through some form of supplemental or commercial insurance. By the end of 2022, that number was 150 – I mean, yeah, about 150 million. We do see, Louise, that growing to somewhere above 200 – I mean, it's been growing this year and growing somewhere above 200 million by the middle of the decade. I think, you know, industry reports put that projection somewhere in the range of, you know, 200 to 300 million people. Of course, that size is, you know, as big as, you know, many of the – you know, bigger Western countries. And the supplemental insurance then supports reimbursement at rates, you know, for innovative drugs that are closer to U.S. or, you know, Western prices. So it's an important segment, and it's growing. For us, it's important for Optune. Optune is not eligible for NRDL listing because it's categorized as a medical device now. And we've had, you know, very good experience with supplemental insurance. We're covered on nearly 100 different supplemental insurance plans. That's grown from 73 a year ago. And by our count, we're second only to Katruda in terms of the number of plans we're covered by. So while we think for our portfolio overall, the NRDL listing is the, you know, primary sort of focus given the you know, important unmet needs we're addressing with our drug that Samantha referenced, this supplemental insurance market does provide an important backstop and supplemental, you know, sort of coverage for drugs while they're in the pre-NRDL phase or for things like Optune that aren't eligible yet. So thanks for that question. I think, Harold, you can cover the – I think the question, Louise, you had about next indications for DivGuard.

Yeah, thank you, Josh, and thanks for the question. There is indeed a lineup of new indications coming up in this year and next year for submission and later on, obviously, approval. You know, we've already spoken about the subcutaneous formulation of FGAR, which is in GMG, not really a new indication, but one with a new formulation. Following that is CIDP. It's a very important indication for us. It's a large market in China, three times larger than in the U.S., if I may say. And as such, it is a study also that has shown incredible benefit from F-GOT treatment in a patient population that is not well served currently with only IVIG. Following that, there are two other indications. One is ITP, the thermocytopenia indication. for which you've already seen study results earlier this year with the . And following that, or roughly at the same time, there should be . This is our third one that is coming through, and the results for ITP and the PV study are supposed to come the end of this year. So, this is our lineup. There's also one new indication that we, want to start next year, which is in TET thyroid eye disease, another exciting way of showing and highlighting the efficacy of . And that is, at least in the foreseeable future, a lineup. Thank you.

Thank you. Yeah. Also, I just want to add a quick point, please. And commercial insurance actually has been in discussion for a few years. And this year, it has to be more and more putting into agenda. But, of course, one will be effective, will he? But I think that's not somewhere has been ignored or not been lobbied. I think there are quite a strong group of people and a very influential group trying to lobby for the benefit of patients. So I'm very hopeful for that.

Thank you. Thank you for the questions. Next question comes from the line of Michael Yee of Jefferies. Please go ahead.

Hi. Thanks for taking the question. This is on the line for Michael Yee. I have two questions. First, can you tell us about the ongoing China anti-corruption campaign and, you know, what do you see there? Did you expect any kind of aftermath impact during Q4? And so forth. And secondly, I think I have a couple on VivGuard. First, I guess you have mentioned five medium sales in just two weeks after the September launch. So I wonder, you know, how much VivGuard is actually demand versus stocking inventory? And I guess you also mentioned that 70% of the top 100 specialists have already prescribed. So, how would you characterize the penetration there? Thanks.

So, Jack, do you want me to take the first question? Oh, you go ahead. Go ahead.

Okay. Well, Samantha provided some broader comments on anti-corruption, I think, to get to the specific point. a question around impacts, you know, for the remainder of the year. First, you know, as we've stated and as Samantha's talked about, you know, I think from a long-term perspective, focus on anti-corruption in healthcare is, you know, good for everyone, patients and companies and providers. and, you know, certainly for a company like us that focuses on bringing, you know, innovative drugs, you know, for unmet needs. But in the short term, there's no doubt in Q3 it had an impact on prescribing patterns and on healthcare utilization. We see that in our results, and I think all companies to varying degrees are seeing that. I think now, you know, there have been these focuses in the past in China. I think this one, given the You know, the sort of quick way it was rolled out, I think the generalities, you know, that were in it as opposed to very specific pieces did cause some, you know, some challenges in utilization in Q3, resulting in fewer patients being seen, fewer procedures. We saw healthcare practitioners who, you know, who otherwise would have attended educational events and other things who didn't do that in Q3 to the same degree. And we did have an impact on sales rep access where hospitals were, you know, sort of blocking access to reps. Now, we've seen much of that now begin to normalize as we're here into the fourth quarter. So, you know, we expect and hope that by the end of this year, we're back to sort of normal practices and, again, good for long-term, you know, for the industry and certainly for Zai. But we will see some lingering effect, I think, in the fourth quarter. relatively modest, you know, for the things that we're focused on, particularly the VivGuard launch, and I'll transition into that for your question. I think we've, you know, while this has been challenging, given those factors that I mentioned, we've been able to get off to, I think, a really good start in terms of the launch and launch activities. As you mentioned, you know, our sales in the third quarter for VivGuard you know, really represent just, you know, a few weeks of commercial activity. Just a reminder to everybody, we were approved right at the end of June. We shipped products from Suzhou in early September. So, you know, just a little bit more than 60 days from approval. You know, by our count, that's as, you know, small of a gap between approval and shipping as we have seen. So, we're quite proud of that. But again, it only represents a few weeks of utilization. from a commercial perspective, into three. So, of course, you know, a decent amount of those sales represent initial stocking. But, you know, now that we're, you know, through the end of October, we're seeing really good physician acceptance and patient prescribing and utilization of VivGuard. You know, as you referenced, if you look at just our top 100 prescribers, more than 70% have already written a prescription or used VivGuard for their patients. And of those physicians, I think approximately half have already become repeat prescribers. So, you know, for launch metrics, these are really good and exciting, I think, indicators of success. overall demand, and certainly we will expect as we get into the fourth quarter that utilization to continue, and we'll see, you know, certainly restocking. So, you know, we do expect, you know, to record sales in the fourth quarter for sure as the patients continue to use and get the benefits of VivCart. The one thing I would say for the fourth quarter is we are in the middle of NRDL negotiations now for potential listing next year. And, you know, to the extent that that leads to a favorable result, we have, you know, a couple of things that could impact, you know, for quarter sales for VivGuard. One would be to the extent that there is channel inventory, we would make a pricing adjustment in line with whatever that NRDL price is that's negotiated at the end. We also have seen in prior years, you know, as we have a lot of experience with drugs gaining NRDL access, I think if you have physicians who are, you know, ready to start a patient on the drug sometime in December and they know a listing is coming in January, you know, you may see some delays and starts. So I think those things could, you know, impact the fourth quarter utilization a little bit. But overall, I think all the initial operational metrics and leading indicators are really positive for DivGuard. We're really excited about the launch of this drug. That's very helpful. Thank you.

Thank you for the questions. One moment for the next question.

Next question comes from . Please go ahead.

Hi, Samantha, Josh, and team. Thanks for the questions. Just a few more on the VivGuard launch. You comment on whether these early adopters were community or academic centers. And then, were the patients new to therapy for MG or had they previously been on IVIG? And then, if you could comment overall in terms of how many patients are currently on and what the overall prescribing account number is. I know you mentioned the 100 top accounts, but how many total prescriber accounts are you focused on in China overall? Thank you.

Thanks, Josh. try to cover some of that as much as I can. I think first in terms of the accounts and how we're focused, there are about 600 hospitals. So just a reminder, there's like 200,000 patients with MG in China that are diagnosed and in some form of treatment. About 170,000 of those have GMG. So that's sort of the universe we're looking at. Of that 170,000, about 80% of those patients are treated at one of about 600 or about somewhere between 500 and 600 hospitals. So that's what we're really targeting over time is that 80% of the business. If you then look and you sort of get down to prescribers, it's, you know, coincidentally about the same. So we've got about 600 prescribers that are really our core, um, our core focus. And again, they're spread across, you know, about 600, um, uh, hospitals. Uh, so it's very concentrated. Um, we've got, uh, about 80 reps right now that are, are focused on those accounts. We'll, we'll grow that, that number to, um, about 150, uh, you know, post NRDL and that'll cover again, 80 plus percent of the prescribing, um, universe. Uh, so when we talk about top 100 hospitals, you know, that's, uh, or top 100 prescribers. That's, you know, it's a pretty concentrated group. In terms of patient numbers, again, I would just say that we're seeing really good utilization and prescribing patterns among our physicians. I think even given the challenges we've seen with anti-corruption in the third quarter, if you look at just the top 200 hospitals of that, you know, about 600 that I mentioned, I think at least 75% of those hospitals we have reps that are able to get in and have, you know, in-person discussions and education with physicians. So, I think we're off to a good start there. In terms of the, you know, what those patients who are getting F-carcinoma look like, most of them have had some kind of treatment for GMG. you know, it's a mix of IVIG, you know, steroids and other, you know, sort of older treatments. Again, I think the thing that, you know, we've said historically here is this is a well-diagnosed population, and they're treated just with older therapies. So, I think it's, you know, it's fair to assume that most of the patients who are getting VivGuard today are are getting it, you know, and have had other treatments for GMG for sure. So I think that, and that's really our focus with the initial patient group is to get those patients who are in, you know, not responding well to current therapies and in many cases could be in an acute phase of GMG. So, you know, sort of by, almost by definition, I think these are patients who have tried other and have been on other therapies before. Thanks, Nicole.

Okay, thanks. And then if I could just one quick follow-up, as you mentioned, with respect to the inventory, once you've had the negotiations with NDRL, you take a pricing adjustment. But if that inventory flows into the market before 2024, then it would reflect the NDRL price, or would it not? Could you just clarify how that works mechanically?

Yeah, it would represent, you know, channel inventory that had been shipped in that's already in the market and we just adjust, we would adjust the price to whatever the NRDL piece is. So, you know, you've seen this with the Jula over the last few years when we've had a, you know, a new price either as a function of an initial listing or, you know, subsequent negotiation. We, you know, we look at the channel inventory and make a price adjustment, you know, for that piece. So it'll be whatever, you know, whatever's in the market at the top. Again, I say that just to say that that is just a common effect. We'll describe that if and when this happens when we report our next quarter sales. Again, what I would say is we're seeing good patient utilization today. So we expect there's going to be a decent amount of patients who have already been on access and utilized VivGuard by the end of this year. All right, thanks.

Thank you for the questions. One moment for the next questions.

Next question comes from the line of from JP Morgan. Please go ahead.

Hey, guys. Thanks so much for taking the question. So on this discard launch in GMG, how should we be thinking about reimbursement dynamics going into next year? NRDL, self-pay, any sort of private insurance contribution, and how do you expect that to change over the next couple of years? Thanks so much.

Thanks, Dan, Paul, and Josh. First, we're in the middle of NRDL negotiations for 2024 listing, as you recall, our Big focus was to try to get an approval in the first half of 2023 so that we'd be eligible to roll right into these negotiations. We're in the middle of those now, so not going to comment on, you know, potential price. But if we end up with a mutually acceptable price and are able to move to a listing for NRDL for 2024, you know, in the past that generally happens in January of the calendar year, so January of 2024. And once then that happens, that would then supersede or take out any, you know, commercial or supplemental insurance or private pay. So, of course, that's why we're we're focused on, on, um, you know, making that happen because it, it opens up the market, you know, for the 170,000 patients who we believe can benefit from this therapy. So I think, I think what, what, you know, the next important milestone is to, you know, to conclude that negotiation and see where we end up on price. And if that's the case, then it becomes a matter in 2024 of, um, getting that listing and then getting that, uh, that access pushed down to the, as I mentioned, the 500 to 600 hospitals that are, you know, critical to our patient base. And that should, you know, based on historical experiences, that, you know, that takes a couple quarters to get that all the way, you know, pulled through to all the hospitals. But, you know, again, with an acceptable price and NRDL lifting in 2024, then we have, you know, basically open access for all of those patients who are suffering from GMG today. And, of course, then that's, you know, that's subject to the normal, you know, every two-year negotiation. But as Samantha mentioned in the upfront question, you know, there's been a lot of positive development in how you renew price and go through these pieces. This is the transparency and automatic renewal piece. So we're really focused on getting a good – price reflective of the value that VivGuard can bring to patients to get that for NRDL listing in 2024. And, of course, we can't say much more than that at this point, but more to come there as we proceed through the negotiations.

Thanks so much for taking our question. Thank you for the questions. One moment for the next question. Next question comes from Goldman Sachs.

Please go ahead.

Thank you for taking my questions. Just two questions. One is on the full-year guidance, because I remember that you previously, earlier this year, you gave the guidance of $300 million revenue target this year. Now, with all those anti-corruption disruptions in the third quarter, well, of course, there has been foreign exchange impacts. How should we think about the sales target for this year and what kind of level is really achievable? My second question is really on the margin because in the past few quarters, the margin has been relatively stable. But into the third quarter this year, on the year-over-year basis and the quarter-over-quarter basis, the margin has been declined by 2% to 3%. So, trying to understand whether that was really because of the runoff of the FGRP-TIJMOD. If that's the case, then how should we think about FGRP-TIJMOD gross margin and profit margin going forward? And particularly, this is going to be a really new drug, still need a lot of investment into sales and market commercialization. So, how think about the return on these assets? Are there any estimates on how big the drug could be to make it profitable? Thank you.

Thanks. I'll start with the question on, you know, sort of outlook for the year, and then, Yajeng, you can comment on the second question. Yeah, when we did our investor day in June, you know, what we said was consensus at the time for 2023 was approximately $300 million. dollars we weren't giving guidance. We said that, you know, we were comfortable with that outlook. I think the two things that have changed, and you mentioned them, you know, since then have been the, you know, sort of the full year effect of the currency decline, basically the weakening versus the U.S. dollar. So that's, you know, that's now fully, of course, reflected in, you know, our Q3 results and expected in Q4. And then the, you know, the impact from the anti-corruption policy efforts, which, again, I think will be mostly concentrated in Q3 with, as I mentioned, a little lingering effect into Q4. I think if you put both of those together, you know, I think we're – I think if I look at – and I know consensus is not fully updated, but I think if I see consensus today that's in maybe that $270 million range, I think that probably reflects those two events. Of course, you know, we're focused on, as I say, you know, getting back to full strength as it relates to, you know, sales reps in front of physicians, driving VivGuard uptake, you know, continuing to drive outperformance for Zedula relative to the class. So I think all those, you know, all the underlying dynamics that we talked about over the summer in our investor day, all good. We're just dealing with the, you know, the currency effect, which is what it is. And then, you know, the impact that we saw in Q3 with, you know, with that abating, I think, in Q4, but probably a little bit of an effect. So I think those things probably put us, you know, on a reasonable long-term trend. But, you know, we are absorbing those two impacts in Q3 and Q4. Eugene, you can comment on the profitability question.

Yes, thanks for the question. So first of all, I'm going to answer the question about the growth margin in the third quarter. So our growth margin is usually getting impacted by the product mix and sometimes the one-time adjustment in the quarter, so the timing of it. So we are going to see some variability quarter over quarter. So for third quarter, it is not because of that gap. So I just want you to know that. And then I think you can focus on year-to-date growth margin would be better than just picking up the one quarter. And then over the next couple of years, we are going to see a few new products launching, right? It's going to drive significant revenue growth. So our growth margin for the long run will continue to increase over time as the volume picks up. And coming to the specific question about FGA, at FGA it will be the same, the trend, right? The volume is going to increase. And our, I think, the partner and us working on the manufacturing process is scaling up to 20,000 liters. And that will drive the cost, the unit cost, very, very dramatically downwards. So we are going to continue to see EFGA growth margin to increase significantly over time. And then self-marketing efforts for EFGA, as Josh mentioned, is a very concentrated effort, right? We're talking about 600 hospitals. like, you know, just a limited number of specialty physicians. So we're talking about 150 reps, not a huge scale of reps. And so in my case, we're very confident that we are on the trajectory to achieve the profitability very soon for APA and also for the company as a whole.

Thank you.

Any questions? Our next question comes from the line of Jonathan Cheng from Learing Partners.

Please go ahead. Mr. Cheng, your line is open. You may unmute locally. Once again, Mr. Chang, your line is now open. Please unmute locally. If you would like to ask questions again, please press star 11. I'm showing you for the question at this time.

I'll now turn the call back over to Xylef's CEO, Samantha Tu, for closing remarks.

Thank you, Operator. I want to thank everyone for taking the time to join us on the call today. We appreciate your support. Look forward to update you again after the fourth quarter of 2023. We are very optimistic about the future of DynLab, and we will work hard towards achieving our three-hour end goal, as we all know what they are. Operator, you may now disconnect this call.

Thank you. Ladies and gentlemen, that concludes today's conference call. Thank you for your participation. You may now disconnect your lines.