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spk14: Hello ladies and gentlemen, thank you for standing by and welcome to Xylep's second 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 this time. As a reminder, today's call is being recorded. It is now my pleasure to turn the floor over to Christine Cho, Senior Vice President of Ambassador Relations.
spk13: Please go ahead. Thank you, operator. Good morning, good evening, and welcome to Xilab's second quarter 2023 earnings call. Today's call will be led by Dr. Samantha Du, Xilab'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 all 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 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 August 7, 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.
spk15: Hello, everyone. Thank you all for joining us today. In the second quarter of 2023, we continue to successfully execute across our business, achieving multiple key milestones. Our commercial products continue to deliver strong double-digit growth. we progressed several important day stage and early development programs within our pipeline. Most importantly, we gained NMP approval of VisGuard, a first-in-class therapy that has the potential to significantly transform the lives of patients living with GMG in China. And we were able to achieve this monumental milestone on June 30th. which makes us eligible for NRDL listing in 2024. Recently, we also had positive registrational data from the HEER trial, evaluating WeaveGuard hydrolow in CIDP, and the results were outstanding. Later this year, we anticipate two additional registrational data readouts for WeaveGuard, further supporting its potential as a blockbuster product. The NMP approval of YouthGuard exemplifies our ability to quickly develop novel first-in-class therapies addressing significant unmet needs of patients. And today, we have over 17 pivotal trials ongoing. And by 2028, we expect to more than triple the number of commercial products in our portfolio. Our world-class R&D team is a key part of our success. driving our remarkable accomplishments, consistently demonstrating an impeccable ability to identify and develop drugs of global quality. This impressive track record instills in us the confidence to bolster our global pipeline, both organically and collaboratively. In our early research efforts, we continue to pursue targets and modalities within specific areas of ecology and autoimmune disorders. We are focused in areas where there is opportunity for differentiation, where the unmet needs are high. However, make no mistake, we'll continue to be prudent and capital efficient, prioritizing our R&D efforts and driving increased productivity across the organization by leveraging our existing infrastructure and creating synergies across our business. We expect that this discipline, along with our expected revenue growth, will allow us to reach corporate profitability by the end of 2025. I'm also encouraged by the continued support of innovation within the life science industry in China, as evidenced by the recently published NRDL renewal guidelines and other policy updates. I'm confident that with our world-class team and the strong foundation we have built, we will be able to reach new heights, driven by our unwavering commitment to bring innovative medicines to patients in need with size, speed, quality, and efficiency, and bring significant value to our shareholders. as we deliver on our mission. And with that, I would like to now turn the call over to Josh. Josh? Thank you, Samantha.
spk07: As Samantha mentioned, because of the proactive steps taken by our team, XyLab has established a good foundation for future commercial execution and strong financial performance. Product revenues in the second quarter of 2023 grew 45% year-over-year to $69 million. This revenue growth was 53% on a constant currency basis. Each of our commercial products had continued revenue growth. Zyra experienced strong volume uptake as a result of their listings on the National Reimbursement Drug List, or NRDL, which became effective in March. We expect the successful NRDL inclusions will continue to drive significant sales growth for these two products in the remaining months of 2023 and beyond. Zejula continued to perform well, increasing 26% versus prior year quarter driven by growth in the sales of PARP inhibitors in ovarian cancer and Zejula's increased share of those sales. For Optune, our team further improved market access by expanding supplemental insurance coverage. We expect a strong momentum for both products to continue throughout the remainder of this year. We're also very excited to be launching our fifth approved product later this year, following the NMPA's approval of VivGuard as the first and only FCRN blocker to treat generalized myasthenia gravis, or GMG, in China. There are nearly 150,000 patients in China who have ostecholine receptor antibody positive GMG, and we are thrilled to be able to provide these patients with a new treatment option that has the potential to meaningfully improve their symptoms and subsequently have a positive effect on their quality of life. Our specialized and experienced team of about 100 employees in the field are already engaging key opinion leaders and healthcare professionals and are establishing a strong network across all sites of care. We are building brand awareness through activities that include broad-reaching campaigns and through our ongoing Named Patient Program, which is generating initial clinical data among Chinese patients. VivGuard, which is eligible for NRDL listing in 2024, would be our fourth product on the list. and we are ready for a full commercial launch later this year. Moreover, another significant milestone we achieved with VivGuard was the positive results from the Registrational Adhere Study in CIDP. The safety and efficacy profile of VivGuard represents a significant advancement for patients, one that has the potential to change the treatment paradigm for those living with CIDP. Similar to the ADHERE study, Zai is also participating in two registrational studies evaluating VivGuard in pemphigus and immune thrombocytopenia, where we expect data later this year. In these four indications alone, we have a total addressable population of over 400,000 patients, highlighting the significant opportunity we have with this product. Over the next few years, we expect to further drive innovation through our expertise in research and development. We intend to do this both as a trusted partner with our demonstrated capabilities in contributing to global, high-quality, multi-center trials, and through the successful execution of trials for our own assets with global rights. The strong foundation we have built puts us in an excellent position to execute our five-year strategic plan, which we announced at our investor day. By the end of 2028, we expect to have over 15 commercial-stage products, with at least one IND per year for global best-in-class, first-in-class assets. Our robust portfolio is expected to drive a revenue compound annual growth rate of over 50% from 2023 to 2028. As we launch new products and indications, we'll be able to leverage our infrastructure and scale to drive profitability, and we expect to be commercially profitable by the end of 2023 and to achieve corporate profitability by the end of 2025. And now I will turn the call over to Dr. Amato. Rafael?
spk11: Thank you, Josh. In the second quarter of 2023, Xylab's oncology franchise continued to make progress across all stages of development. Within oncology, our R&D team will remain sharply focused on the execution of our late-stage product development, and we expect several important updates from some of our key programs over the next 6 to 12 months. Starting with ripotrectinib, in June, we announced that the National Medical Products Administration in China has accepted a new drug application for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer after granting priority review in May 2023. Ripotrectinib is a potential next-generation best-in-class treatment for ROS1-positive non-small cell lung cancer in both TKI-naive and pretreated patients. We look forward to bringing this important medicine to patients in need as early as possible. For tumor-treating fields, in June, our partner, NovoCure, presented the full results of the lunar clinical trial evaluating TT fields in non-small cell lung cancer. The primary endpoint of median overall survival was med, and a meaningful overall benefit was demonstrated when TT field therapy was added to immune checkpoint inhibitors. With a median overall survival of 18.5 months, There's just alone of 10.8 months. Therapy was well tolerated with no added systemic toxicity, but also participating in several other pivotal trials, including matches in brain metastasis from lung cancer. As well as the Nova 3 in locally advanced pancreatic cancer and look forward to these data readouts over the next year. For benmarituzumab, Xi lab enrolled the first patient in the mainland China portion of the Global Phase III Fortitude 101 study, which was initiated by our partner Amgen, and is evaluating benmarituzumab plus chemotherapy versus placebo plus chemotherapy in first-line gastric cancer with FGFR2B overexpression. Gastric cancer is a significant burden in China, where nearly 90% of patients are HER2-negative patients, And of those, about 30% are FGFR2B positive. The marituzumab has the potential to become the standard of care as a first-line treatment for FGFR2B positive gastric cancer where no specific targeted therapies exist to date. For Adagracib, we're on track to finish accrual this year on the K12 trial against docetaxel and have completed the second-line CRC study K10. which will form the basis for the submissions in these indications together with the global single arm study. For TISDAQ, we also remain on track executing on the randomized study in cervical cancer, and we will also join the global study in squamous cell carcinoma of the head and neck, both also pivotal for registration in these indications in the greater China region. Moving to an internal global research and development program, In July 2023, we enrolled the first patient in the global phase 1 study for ZL1218, an anti-CCR8 antibody in solid tumors in the United States. Regarding our DLL3-ADC ZL1310, we remain on track and expect an IND submission by the end of the year. With many potential best-in-class and first-in-class products, both in China and globally, we are very excited about our expanding oncology pipeline at ViLab. And now, I will turn the floor over to Dr. Harald Reinhardt to discuss the progress in autoimmune infectious diseases and neuroscience therapeutic areas. Harald?
spk09: Yeah, thank you, Rafael. We have made excellent progress across our autoimmune infectious disease and neuroscience therapeutic areas. Starting with , we had several significant achievements in the second quarter. We received NMPA-approved intervenous injection for the treatment of generalized myasthenia gravis, or GMG, in adult patients who are acetylcholine receptor antibody positive. GMG is a chronic debilitating disease characterized by a loss of muscle function and severe muscle weakness. In China, patients are often treated with acetylcholine esterase inhibitors, steroids, Immunosuppressants and IVIG and acetylcholine esterase inhibitors and steroids are used as initial therapies. The current available treatments for GMG have limited efficacy and are associated with significant side effects. With a high prevalence of these diseases, coupled with the current unsatisfactory treatment options, patients are in urgent need of a safe and effective treatment option that can control symptoms faster. Furthermore, in July, we announced the NMPA's acceptance of the biologic license applications of BLA for the subcutaneous formulation of Vifgard for GMG. Once approved, this will provide patients with increased dosing flexibility and convenience. In July, we and our partner, Genics, were happy to announce positive top-line results in the ATIA study. a trial in patients with CIDP or chronic inflammatory demyelinating polyneuropathy. Before presenting the key results, I would like to provide background information on CIDP in China. In China, the prevalence of disease is estimated at approximately 50,000 patients. CIDP is a chronic progressive autoimmune disease that is characterized by weakness and impaired sensory function that often worsens over time. The disease is debilitating, causing immobility, difficulty with walking and balance, and patients are often left unable to perform simple daily tasks. Current treatment options are primarily steroids and intravenous immunoglobulin, IVIG, or plasma exchange, PLEX, generally reserved for refractory patients. There are limitations to each of these therapies, including the well-known shortage of IVIG as well as a significant burden associated with administration, especially for Plex and IVIG. With long-term steroid use, adverse events become a concern. As most patients require chronic treatment, there remains a significant unmet need for alternative treatment options that are effective, well-tolerated, and convenient for patients with CIDP in China. The ADHER study was the largest CIDP trial ever conducted. with 322 patients entering Stage A. The enrolled patient population was representative of the real world of CIDP patients and included treatment-naive patients, patients off treatment for at least six months, and those who have been on IVIG or steroids within the last six months. In Stage A, we saw that 67% of patients demonstrated evidence of clinical improvement, and up to 78% in patients that received a full series of four doses of Vivguard. In stage B, we met our primary efficacy endpoint, demonstrating a significantly lower risk of relapse with Vivguard Hytrulo. This was a well-designed placebo-controlled trial with time-to-first adjusted NCAT deterioration as its primary endpoint. The p-value was highly significant, driven by a hazard ratio of 0.39, indicating that Vivguard Hytrulo reduces the risk of relapse by 61%. This positive data provides strong clinical evidence that VivCut Hytrulo meaningfully improves and stabilizes disease symptoms in CIDP patients. As in other studies, EvCut Tigamot treatment had a favorable safety profile. We believe with this profile, there's a clear benefit over existing treatments. Therefore, VivCut Hytrulo has the potential to dramatically change the treatment paradigm for CIDP in China. We also see a significant potential of FGAT-Tigamot across multiple indications, and we will continue to work with our partner, Igenix, on indication expansion, similar to the ATIA study, where XAI contributed a significant number of patients. Regarding our infectious diseases portfolio, in May, our partner, Entasis, now InnoViva, announced that the FDA-approved Xac-Duoro, or Sulbactam, Duorlobactam, for the treatment of adults with hospital-acquired pneumonia and fatal inter-associated bacterial pneumonia caused by susceptible strains of Acinetobacter baumannii. Our NDA was accepted by the NMPA in China in February. It is now under priority review. We look forward to bringing this novel drug to China and Asia Pacific where severe carbapenem-resistant or crab infections are frequent. and often can no longer be adequately treated because of multi-drug resistance. Switching now to CAR-XT, we initiated a clinical bridging study in China in June to support China registration. CAR-XT is the combination of Xenomalin and Traspium, which we are developing with our partner, Corona, for acute schizophrenia. Corona plans to submit a new drug application to the FDA in the third quarter of 2023 with a potential launch in the second half of 2024 if approved. CARXT could be a very important treatment option as a new class of medicine for schizophrenia patients in China and globally. And now Yajing will speak about progress with our commercial products and financial results. Yajing.
spk02: Thank you, Harald. Now, I will discuss our second quarter 2023 financial result compared to the prior year period. Total net product revenue for the second quarter of 2023 was $69 million, compared to $48 million for the same year in 2022, representing year-over-year growth of 45%. On a constant currency basis, growth year-over-year was 53%. The increase in net profit revenue was primarily due to increased sales volume and a decrease in negative effects from the COVID-19 pandemic. Our total net profit revenue included $43 million for Zejula, which increased 26% year-over-year, $14 million for OpTune, which increased 18% year-over-year, $7.5 million for Chinrot, which increased from $.6 million for the same period in 2022. And $4.6 million for New Zyra, which increased from $1.3 million for the same period in 2022. Research and development expenses were $77 million for the second quarter of 2023, compared to $66 million for the same period in 2022. The increase in R&D expenses was primarily due to increased research activities and clinical pipeline advancements. Selling general and administrative expenses was $68 million for the second quarter of 2023, compared to $63 million for the same period in 2022. The increase was primarily due to higher general selling expenses to support new product launches. Zylab reported a net loss of $121 million, or a loss per ordinary share of 13 cents for the second quarter of 2023. compared to a net loss of $138 million for the same period in 2022, or loss per ordinary share of 14 cents. The decrease in net loss was primarily due to product revenue growing faster than net operating expenses. We are in a strong financial position, ending the quarter with $876 million in cash and cash equivalents, short-term investment, and restricted cash. compared to $931 million as of March 31st, 2023. Based on our operating plan and our anticipated revenue growth, we expected to be able to fund our business until we reach profitability, which is currently expected 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,
spk14: Thank you. We would now like to open the line for questions. If you have questions, please press star 1 1 at this time. To withdraw your question, please press star 1 1 again. Our first question comes from the line of Zi Chen from Goldman Sachs. Please ask your question, Zi.
spk03: Thank you for giving me the opportunity to raise the first questions. I've got two questions. I think in the past two weeks in China, the anti-corruption campaign has been one of the key topics in the healthcare industry. So we're trying to understand a bit more about that, and particularly the potential impact on Scilabs commercial activities, including Africa Tejima, the launch event. because we think that's going to be really important for not only this year, but also over the next few years. Our second question also regarding AFGAR-TEJMOD, well, the positive top-line data coming for CIDP is pretty encouraging, but we're trying to understand a bit more about the clinical practice difference in China versus in the U.S. and how that could potentially affect the clinical development in China and also the potential in China. Thank you.
spk07: Great. Thank you for the question. It's Josh Smiley. I'll take the anti-corruption question first, and it's important, and then I'll ask Carol to provide a little bit more color on current clinical practice and where we see F. cartilagemon fitting in in CIDP. On anti-corruption, first, we don't expect any impact operationally to our commercial business or practices. I'm In fact, I think we believe the anti-corruption focus is going to be a positive force in the healthcare industry, since it promotes high standards of care and it's a positive point of comparison for companies like Zylab. If you look at our portfolio, we've got highly innovated and differentiated products, so our commercial practices focus on medical education. And we believe those will be unaffected and unimpacted by any of this focus. I think, as you all know, we've always been committed to serving the needs of patients with highly innovative, first-in-class, best-in-class types of products. Our commercial practices adhere to the highest standards of ethics and regulations across China. And also, one of the things that has made us very attractive to global partners is our focus on commercial excellence and ethics and compliance. So again, I think from a general standpoint, we don't see any changes or operational impact as a result of this focus. And we think the more any country focuses on quality education and emphasis on differentiated products, I think, is a good thing long-term. As it relates specifically to F-Cartigimod, again, our focus here with this best-in-class and first-in-class product is educating the healthcare provider community. We've been doing that since the approval. We're in the process of of doing that now. We haven't stepped back or been impacted in any way by this emphasis, so we don't expect there to be any impact on the launch activities that we have planned, and we'll move into a full commercial launch later this year. But for now, we're educating physicians and providers in major cities, and we'll continue to do that. So again, overall, We are excited about the opportunity to bring VivGuard to Chinese patients. We think that the emphasis that we're seeing from the anti-corruption campaign will not impact that and, in fact, will help us from a differentiated perspective. I think transitioning now to CIDP, Harold, maybe you could provide a little bit more on current treatment paradigms and how VivGuard will fit.
spk09: Yeah, thank you. The question was about clinical practice, US versus China for CIDP treatment. And overall, the treatment is fairly similar. It is, as we said before, it usually starts with steroids, long-term steroids in those milder patients. And if necessary, the next step would be IVIG. This is by guidelines that were recently, you know, promulgated. in Europe and in the U.S., and China is using the same kind of regimen. So steroids followed by IVIG based on supply, this is a treatment in these patients that is oftentimes required for a long, long time. Let me just add a sentence about the disease because it's not so well understood and often spoken about. This is a chronic demyelinating disease, and the progression is usually over months to These patients, once they have the damage to the neurons and to the myelin sheaths, they have a downhill course. And having only IVIG as a resort at the current time, F-catecholamines really fits nicely into the treatment paradigm here. I do believe that we have very, very underserved disease here. And as such, it has a really high potential to be used and Africa Tiki Mode is filling a gap. Thank you so much for the question.
spk07: Thanks, Harold.
spk03: Thank you, Josh, and thank Harold. Thank you.
spk14: Thank you. Our next question comes from the line of Igor Notovmovic from Citi. Please ask your question, Igor.
spk10: Hi. Thank you very much for taking the question. Just a few specific ones on FGART and then one on finances. For VIGART, for MG, is there any potential to sell this product on a private pay basis in the second half of the year before you get the NDRL listing?
spk07: Hey, DeGaulle, it's Josh. Yes, for sure. You know, we are, as I mentioned, we're in the midst of educating providers now. We'll have a full commercial launch later this year, and we do certainly expect commercial sales in the fourth quarter. Of course, we're very excited about the opportunity to list on NRDL early in 2024, so we've got a lot of activity going into that preparation. But in the meantime, we will look to the private pay and supplemental insurance market for primarily the third and fourth quarter of this year.
spk10: Okay. And then I'm not sure if I saw it, but when are you planning to file for CIDP in China and the timing to launch that?
spk07: I'll ask Harold to provide some comment, but we participated in the trial and we'll follow our GenX FDA submission. Harold, if you want to add anything to that.
spk09: No, you pretty much said it. We will follow the path that IGENIX will use for CIDP, and we will file in due time afterwards.
spk07: Okay. So 2024, first half filing, I think.
spk09: That's pretty much what we are currently anticipating, yes.
spk10: Okay. And then, you know, I was looking at the slides from the analyst from June. I noticed that myositis was one of the indications that's got about a threefold higher representation in China, but it's not part of the global phase three registration. I'm just wondering what the thoughts are there, because it looked like a potentially attractive opportunity, but it doesn't seem to be emphasized right now. Harold, if you want to.
spk09: Yeah, thanks for the question. It's indeed one of those many, many autoimmune diseases. for which has a wonderful way of hopefully turning around the course for patients. My aside is like many of those indications are being considered by us. They have been considered by us. We cannot do all of them, but we have decided instead to go with the TED or other indications going forward. These decisions, you know, are being made with a partner, and we are in constant discussions with Argenix here to select the next indications if we indeed go into myositis or into TED. So these kinds of indications are open fields for treatment. And we believe that we will, over time, address the needs of patients in these diseases, which are clearly all antibody driven.
spk10: Okay, thanks, Harold. And then just two very quick ones. You mentioned the IVIG shortage in China. Is that sort of a permanent feature of the landscape there, or is that expected to resolve at some point? And then lastly, on the finances, I think this is the first time you've reported sales on a constant currency basis, if I recall. Is there just a reason for the change there, and should we expect that metric going forward? Thank you.
spk07: Just briefly, I think on IBIG, I think it's a perpetual challenge, I think, in terms of supply. Jonathan, if you want to add anything to that when I'm done here, you can. But I think then on constant currency, it was really just the fact that we've seen over the course of the last year a pretty significant depreciation. relative to the U.S. dollar. And we wanted to make sure that, you know, given the fact that we report in dollars here, but, you know, are translating from RMB, we just want to make sure that it was clear here. So you should expect to see both going forward. We do, you know, expect some volatility in the currency and want to make sure that you get as clear, investors get a clear picture of the overall operational impact of the business in China as we move forward.
spk10: Okay, thank you.
spk07: I think we can go to the next question, please, Amber.
spk14: Thank you. Our next question comes from the line of Michael Nguyen from Jefferies. Please ask your question, Michael.
spk12: Hey, guys. Good morning. Good afternoon. It's Michael Nguyen from Jefferies. We had two questions. One was on F-Cart Tidget Mod. If you could just take a step back for us. Remind us how we should think about reimbursement and pricing structure for rare orphan diseases. Here I know, for example, I think if you look at Spinraza, it's a pretty low number compared to the U.S. pricing. So just kind of walk us through the bookends on how to think about orphan pricing for F-Cortegemod, given that there's a potential big impact there on how to think about peak sales. and then um second question is going back to julia i know there was a little bit of a slowdown here in the second quarter versus the first quarter could you just remind us how to think about future growth here for the next year or so i can't remember if uh obviously the gsk compound may go generic or how to think about that if there's any impact we should be aware of uh in 2024. thank you great thank you uh michael and i guess first would say that uh uh
spk07: you know, when you look at the patient populations across China for the various indications we're pursuing with DivGuard, you know, it's sort of not really all that rare. I mean, we're, you know, we're looking at probably 400,000 patients across, you know, four lead indications now. And, you know, so pricing, of course, is going to, you know, reflect those kind of patient volumes opportunities. I will say that we're, as I mentioned, we're preparing for a full commercial launch, but we do have a pre-NRDL price that's in U.S. dollar terms, at least for GMG. When we look at cycles and otherwise, it's about $47,000 per year. So that'll be our starting pre-NRDL price. And as we've been very clear with everyone with the approval by June 30th of this year, we expect to enter and be successful with NRDL negotiations for 2020, for 2024. So I think, you know, if you look at price ranges for drugs that are highly differentiated and, you know, first in class in rarer conditions that bring the kind of benefits that we believe VIFGAR does and that the data supports, You know, you think about, you know, pricing on a net basis that's, you know, it's going to be less than the launch, you know, $47,000 price, but certainly we see a robust pricing opportunity on a relative basis in China. And, of course, we'll have more to disclose on that as we work through the negotiations for next year. I think, you know, as we talked about at the investor day, Given the patient volumes that we're talking about, the unmet need and the benefit that VivGuard can bring first with GMG, followed by CIDP and hopefully other indications, we definitely see a billion-dollar opportunity and more for this product. And we expect, with an NRDL listing at a good price, we expect to see a kind of launch uptake you know, that you have come to expect from F-Gar Digimod in other markets around the world. So we're really excited about that opportunity. I think then moving on to Zejula. Yeah, so first, you know, we're pleased with the performance of Zejula so far this year. Current market share, value share across all indications for Zejula in the park class is 44%. given that we're, you know, we're focused in ovarian and Lemparsa's got broader indications. We're clearly the market share leader in ovarian cancer for PARP inhibitors. Any way you cut it, whether it's by value or by number of prescriptions. So, you know, we had said we were on track to become the market share leader and we have in fact done that. We've seen really good growth in share over the last year. I think in terms of growth, you know, we, you know, it's not a surprise. We've known for a long time that Limparza will go, you know, will face generic competition at the end of 2024. And, you know, as you know, we've got a differentiated label. We've got all comers in first line where Limparza only got the BRCA mutation. So while there will be, of course, some generic impact in second line and maybe in the more targeted first line setting, we still see lots of room for growth for Zajula into 24 and beyond. If you look at our sales today, about 60% of Zajula sales are in the first line setting. And penetration in the first line for CARPS is also somewhere around around 60% or so. So we still got a lot of room to grow penetration in the first line setting where there's, you know, great, great data. And that's where we'd expect to see the good growth, even in the face of, you know, generic competition in 2025 and beyond.
spk12: Good. Thank you. And particularly in the 47,000 number. Appreciate that. Thank you.
spk14: Thank you. Our next question comes from the line of Anupam Rama from JP Morgan. Please ask your question, Anupam.
spk05: Hi. Thank you for taking the question. This is actually Malcolm Kuno on for Anupam. Just one question from us. Across your commercial portfolio, where are you seeing the most growth in terms of private pay?
spk07: Thanks, Malcolm. I'll ask maybe Jonathan, who's on the line here, to take the question on private pay and how it's impacting our portfolio.
spk04: Yeah, thanks for the question. So for us, the main product since the beginning of the year, which is on private pay, is Optune, because both Shinglock and Uzaira entered into the NIPL as of June the 1st. So we see pretty good growth for Optune. That growth is coming from an increasing, you know, KOL patient adoption that is particularly driven by the growth in supplemental health insurance. You know, Optune today is available in something like 68, 70 major cities across China with supplemental insurance. When we started the program in early 2021, the first half of that year, You fast forward, you know, almost two years. So at the beginning of that, you know, we were low single-digit penetration with supplemental insurance. Today, we're about 30% of, you know, our total sales, and we project that to continue to grow quite rapidly. So, you know, you should expect continued strong growth for Optune. Thank you. Great. Thank you. Appreciate it.
spk07: Thanks, Jonathan. Amber, next question.
spk14: Thank you. Our next question comes from the line of Jonathan Chang from Leverink Partners. Please ask your question, Jonathan.
spk01: Hi, guys. Thanks for taking the questions. Can you please confirm that XyLab did not participate in the Innovate 3 study? And if that is true, can you provide some color around that? And what does that mean for XyLab if the Innovate 3 study reads out positively? Thank you.
spk07: Rafael, you want to go ahead with that one?
spk11: Yes. Thank you, Jonathan, for the question. You are correct that I did not participate on INNOVEY3. And just as a reminder, this is a study, a survival study, of TTCOS plus taxol versus taxosolone in patients with climate-resistant ovarian cancer. and it's supposed to report soon. We did participate on METIS, which is a brain metastasis from lung cancer study, as well as Panova-3. You may have heard Novavir reported that the study is continuing to completion of survival after a DMC review. And with regards to the consequences were the study to be positive, which hopefully will be, We have options to register with an MPA for the indication of ovarian cancer. And the most logical way to go is to, after consultation with an MPA, is to do a bridging study. Obviously, there's no PK study because this is a device. It's to do a bridging study and submit that together with the global package of Innovate3. for approval, the equivalent of pre-market approval in the United States, in China. So we are eagerly awaiting the results as well, and we will make the decision as we see them.
spk08: Got it. Thank you.
spk14: Our next question comes from the line of Jason Lilt from Credit Suisse. Please ask your question, Jason.
spk06: Two questions from my end. One on just overall kind of policy. We do know that for national reimbursement that there has been kind of changes in rules lately as well. So going forward based on some of these renewal rules updates, how does that impact Zai's products and products that may be up for renewal going forward? And then second question just on the strategic plan for five years. We've mentioned again that the break-even target is by 2025, so I was wondering if there can be any more color as to how we plan to meet that target. Thanks.
spk07: Thanks, Jason. I think on NRDL, you know, we've been pretty clear that the renewal policies are, I think, very favorable, good transparency. should yield lower reductions on a, you know, on a biannual basis. Samantha, I don't know if you want to make any comments on NRDL or policy environment more generally. I think we may have a... Oh, okay. Okay, you got it? Okay, you got it.
spk15: Okay, thanks. I actually have a thunderstorm on my background. If you cannot hear me better, I'm sorry about that. So, yes, I think I agree with Josh. It's actually, especially in terms of we have new indications coming in with an updated NRDL guidance will really help us to stay the price we initially developed. But there are other things like the questions raised about for the, you know, for the opportunities, new indications. Some of them we participated, some we don't. But just be clear, even the first approval in China, and that was based on, that data was based on the U.S. data. And so there are a lot of potentials based on the unmet needs. We need to work with the regulator locally. So that's just a few comments, quick comments. Thank you all.
spk07: Thanks, Samantha. And Jason, on your second question around the five-year strategic plan and our cash position and profitability, first, we're certainly on track for the guidance that we gave out in June at our investor day, which is a 50% compound annual growth rate in sales from 23 to 28. profitability by the end of 2025 and, of course, increasing margins from there on. And I think if you look at the quarter, I think you can see the beginnings of that, greater than 50% growth in sales and good expense management. Of course, that's the formula that will lead to profitability in 2025 and beyond. I think if you look at our cash position and our cash burn and It's coming down significantly, so we feel good about where we are from that perspective, and I think have plenty of capacity to invest in all of our new launches, starting with FBAR Digimod this year, continue to pursue good targeted business development opportunities. And I think we've got plenty of capacity within the R&D line to finish the studies that we're participating in now for registration. and be able to bring new ones on board within that same envelope of R&D spend. I'll ask Yajing Chen to make a couple comments specifically about the balance sheet and cash position.
spk02: Thank you, Josh. Yeah, so we have a very strong position in terms of our cash flow right now. So we are $876 million right now of cash. For the next few years, the way that we're looking at the productivity gain is first of all the revenue growth, 50% year-over-year. That's a huge leverage for us to go down the path to profitability. Secondly, when we look at our sort of commercial organization, there are a lot of new launches that there are a lot of synergies for us to shoot for, right? So we're going to optimize our commercial growth in the next five years. And then when we look into all the expenditures in the R&D side, We have 17 pivotal trials. We see slight increase in R&D expenses this year, but that doesn't continue for the next two years. So we're going to continue to drive productivity in R&D organizations. And on the other DNA side, the infrastructure, we already have a strong infrastructure right now. We don't expect any growth in that, so we're going to leverage that. So with all that, very, very high revenue growth and much, much smaller for the expenditure extension. And that's how we get to the profitability by the end of 2020.
spk07: Thank you, Yijing. And thanks for the question. I think at this point, I'll turn it back over to Samantha to close out the call.
spk15: Sure. Operator, do you want to say something? OK. Thank you, Josh. I want to thank everyone for taking the time for joining us on the call today. We appreciate your support and look forward to updating you again after the third quarter of 2023. Operator, you may now disconnect this call.
spk14: This concludes today's conference call. Thank you for participating. You may now disconnect.
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