This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.
spk17: Hello, ladies and gentlemen. Thank you for standing by and welcome to Xylabs full year 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 call 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.
spk32: Thank you, operator. Good morning, good evening and welcome to Xylabs full year 2023 earnings call. Today's call will be led by Dr. Samantha Dew, Xylabs founder, CEO and chairperson. She will be joined by Josh Smiley, President and Chief Operating Officer, Dr. Rafael Mato, 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. Ya-Jing 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 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 February 27, 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 Dew.
spk16: Thank you, Christine. In 2023, we had another year of significant achievements for Xylabs. We grew our top line by 31% on a constant exchange rate basis. We progressed several key late-stage programs. We added new global assets into our pipeline. Today, we're in a fundamentally stronger position than we have ever been with a growing base of revenues, a path to profitability, and a strong balance sheet with over 800 million USD in cash. We're now entering a period of high growth, and we are focused on three key corporate objectives to substantially grow revenues, achieve profitability, and build our global pipeline. Late last year, we launched VidGuard, and it's already off to an excellent start with sales expected to exceed 70 million USD this year in GMG. Beyond this, we have a series of other potential approvals, including repo checkmates and the Sodor data this year, followed by a series of other new product indications, including Asgard T-Smart in CIDP, Bima T-Smart, and Cardstip. Each of these products has the potential to meaningfully enhance the growth of our business. We are also already deeply committed to building our global pipeline by adding new assets to both our internal discovery efforts and external opportunities, and I look forward to providing updates on our progress in this regard throughout the year. And of course, we'll maintain disciplined cash allocation practices as we strive to achieve profitability. As we execute on these corporate objectives, we expect to deliver value not only to patients, but also to our shareholders. Thank you for your support as we continue on our journey of innovation and growth together. And with that, I'll pass the call over to Josh.
spk10: Thank you, Samantha, and thank you everyone for joining the call today. Zylab delivered strong full-year revenue growth of 25% -over-year and 31% on a constant exchange rate basis, driven by robust volume growth across our existing product portfolio and the launch of Vivgard. These revenue increases were partially offset by an increase in sales rebates, both in Q1 of 2023 in connection with new listings for our product on China's 2022 National Reimbursement Drug List, or NRDL, and in Q4 of 2023 in connection with new and renewed NRDL listings for our product on China's 2023 NRDL. A pivotal achievement for us was the approval and subsequent launch of Vivgard in September, followed by its inclusion in the NRDL, which became effective at the beginning of this year. Throughout the fourth quarter, we implemented comprehensive commercial strategies to drive awareness and adoption of Vivgard, and we entered 2024 with considerable momentum. I'm also pleased to announce that in 2023, we achieved our goal of having net product revenue exceed the cost of sales and sales and marketing expenses for our commercial products, which we refer to as commercial profitability. Our commitment to financial prudence remains steadfast as we work towards achieving and maintaining profitability. Lastly, we made substantial progress on key clinical development programs such as F-Cartesian Mod in CIDP and CAR XT in Schizophrenia, while further enriching our global pipeline with the introduction of a next-generation DLL3-ADC. In 2023, we announced our five-year strategic plan aimed at positioning XiLab as a leading global biopharmaceutical company characterized by substantial revenue growth, achievement of profitability, and a strong global pipeline. This strategic vision is underpinned by three corporate objectives. First, we are focused on accelerating top-line growth. With a strong foundation in place, supported by both new product approvals and label expansions within our existing portfolio, we anticipate substantial revenue growth in the coming years. By 2028, we aim to have a significantly larger commercial portfolio, with the launch of potential blockbusters such as VivGuard leading the way. Subsequent potential launches include Soldor later this year, and TivDax, Femuratoosimab, and CAR XT in 2025 and beyond. Such launches would further drive revenue growth, with our projections exceeding $2 billion in 2028, reflecting our estimated five-year compound annual growth rate of 50%. Furthermore, we are committed to building our global portfolio through internal discovery initiatives and strategic business development endeavors. Our goal is to advance at least one global IND into clinical trials annually as we continue to evaluate and pursue synergistic global and regional business development opportunities, leveraging XiLab's reputation as a trusted brand and preferred strategic partner. As we continue to grow and develop our commercial portfolio and pipeline, we remain focused on scaling with purpose, and this brings us to our third objective, which is to achieve corporate profitability by the end of 2025. To realize this objective, we will continue to enhance efficiency and productivity, prioritize research and development initiatives, and execute cost optimization strategies. Our existing infrastructure is agile and sized to support multiple new launches. We maintained a robust reserve of cash and cash equivalents of $807.6 million as of the end of 2023, providing ample financial resources to sustain our operations through profitability and beyond. Now I will briefly review the performance of each of our commercial products and our expectations for 2024. Zajula maintained its position as the leader in hospital sales for PARP inhibitors in ovarian cancer in China. Exhibiting growth in the fourth quarter and the entire year. In 2024, we will continue to focus on driving further growth in the first line setting and extending the duration of therapy. In 2023, Kinloch and the IV formulation of NeuZira joins Zajula on the NRDL, and these listings help drive substantial sales increases for these products. We expect this positive momentum to continue, supplemented by the additional listing for the oral formulation of NeuZira in January 2024. As Optune is a medical device and not eligible for NRDL inclusion, we are focused on expanding access and improving affordability for this important treatment through commercial health insurance coverage. Overall, we anticipate -over-year revenue growth in 2024 for these four products in aggregate to be comparable to that of 2023. Turning now to the recent launch of VivGuard. I want to take a moment to acknowledge the tremendous effort of our medical and regulatory and commercial teams behind VivGuard. We were able to reach important milestones at a swift pace, achieving our best-case scenario with regards to the timing for approval, launch, and NRDL listing. We were pleased to see the regulatory authorities recognize the innovation of VivGuard and its substantial clinical benefit to patients living with generalized myasthenia gravis. In China, where there are over 170,000 patients with GMG, many patients endure residual symptoms or inadequate treatment, making everyday tasks challenging and unpredictable. The scarcity of innovative therapies, the persistent shortage of IVIG therapy, and the chronic and progressive nature of the disease can present a formidable challenge for both patients and healthcare providers alike, further underscoring the significance
spk05: of VivGuard's approval.
spk10: Throughout the fourth quarter, our primary focus was on strategically targeting key hospitals and fostering awareness while delivering timely support to physicians and patients alike. And we made great progress. As of December, we had successfully engaged 100% of our top 200 target hospitals and over 90% of our top 100 physicians integrated VivGuard into their treatment protocols. Based on a survey of 250 physicians, awareness of VivGuard rose from 54% to 72% following four months of promotion, and we continue to see this rise. From launch in September through the end of the year, we estimate that nearly 1,000 patients were treated with VivGuard. Turning now to more recent updates on the launch, VivGuard listing on the NRDL became effective on January 1st this year with a price of $800 a vial or $32,000 per patient per year based on clinical study usage. We estimate that in January 2024 alone, nearly 1,000 new patients were treated with VivGuard, indicating promising progress at this early stage of the launch. This demand is being driven by an unmet need in the treatment of GMG,
spk29: a willingness
spk10: of physicians to adopt VivGuard into treatment protocols, and increased patient access as hospitals add VivGuard to their formularies. We're very pleased with the progress achieved thus far with the launch of VivGuard, and we anticipate sales to exceed $70 million in 2024. Our strategic focus for the year will be to expand outreach to approximately 1,000 hospitals with a concentrated effort on accelerating VivGuard listing at top tier hospitals. Already, as of the end of January, our team has engaged 100% of our top 600 hospitals in person. Supported by our dedicated sales force of approximately 150 reps, we anticipate robust coverage to facilitate this expansion. Additionally, pending regulatory approval, we expect to launch VivGuard's subcutaneous formulation for GMG later this year, which will offer enhanced dosing flexibility for physicians and patients. We're also excited about potential indication expansion for VivGuard. This year, we expect to submit a supplemental biologic license application, or SBLA, in China for CIDP, which presents another substantial growth opportunity. This marks an exciting period for XiLab, and an important year of execution for our team. And with that, I would like to pass the call to Rafael, who will provide an update on our oncology pipeline. Rafael?
spk20: 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 Benmarituzumab, our FGFR2B inhibitor in collaboration with Hamden. We are enrolling in both Fortitude 101 and Fortitude 102 Phase 3 studies, evaluating Benmarituzumab in FGFR2B positive gastric cancer as a doublet therapy with chemo, and a triplet with chemo, and a checkpoint inhibitor, respectively. We expect both studies to enroll well, and we're eager to introduce this much needed therapy to China, where we estimate an incidence of 126,000 FGFR2B positive gastric cancer patients each year. Next, our tumor-treating field franchise. In January 2024, our partner, NovoCure, announced that the FDA had accepted the filing of their pre-market approval application for TT fields in non-small cell lung cancer following progression on or after platinum-based therapy, and a regulatory decision is expected in the second half of this year. In China, we expect to file a marketing authorization application for TT fields in this indication later this year. We also expect two pivotal readouts for tumor-treating fields, including in brain metastasis from non-small cell lung cancer and in pancreatic cancer, both in the first-line setting. Also in lung cancer, repotrectinib is currently under priority review for the treatment of adult patients with locally advanced or metastatic ROS-1 positive non-small cell lung cancer in China. The filing was based on the results from the pivotal Trident1 study, which were published in the New England Journal of Medicine in January this year. Findings demonstrated the potential of repotrectinib to overcome limitations of first-generation tyrosin kinase inhibitors in terms of responses and durability in ROS-1 resistant mutations. We look forward to a potential regulatory approval and launch this year to bring this -in-class ROS-1 TRK inhibitor to patients in need in China. Now moving on to all aggressive, we will continue to accelerate the regulatory pathway for second-line non-small cell lung cancer monotherapy by leveraging the global data package for the FDA approval, the ongoing PK study in China, and the global confirmatory CRYSTAL-12 study, which Zai Lab joined in July 2022, and we await the results for a filing submission in China this year. In addition, our partner BMS announced this month that the FDA has accepted its supplemental NDA for priority review for Adagrassiv in combination with the Toxinab for the treatment of patients with previously treated KRAS-G12C mutated locally advanced or metastatic colorectal cancer with a Bidufal Gold date of June 21, 2024. For this indication, Adagrassiv has the potential to be the first to market KRAS-G12C inhibitor in China. We completed enrollment in the global Phase III CRYSTAL-10 confirmatory study in 2023. Lastly, for TIFTAC, we have participated in the confirmatory Phase III Innova TB-301 global trial in second-line cervical cancer and continuing an extension portion in China, and we intend to file a new drug application or NDA in China this
spk22: year.
spk20: In addition to our late stage programs, our -ZL-1310 has shown promising preclinical data and is progressing through a global Phase I study in relapse and refractory small cell lung cancer, who has progressed with their platinum-based treatment in the United States and in China. In March, we will present the preclinical data at the European Lung Cancer Congress in Prague, and depending on the dose escalation level, we could potentially see early clinical results at the end of 2024 or early 2025. We're also selecting internally discovered product candidates to achieve our goal of generating at least one IND per year, and we continue to assess external opportunities to introduce a new product in development this
spk01: year.
spk20: And now I will turn the floor over to Dr. Harold Reinhart to discuss the progress in our autoimmune infectious disease and neuroscience therapeutic areas. Harold?
spk02: Thank you, Rafael. This is truly a very exciting time for our neuroscience autoimmune infectious diseases or NSAID franchise, and we made significant progress in the past year, advancing our pipeline. Starting with Refguard or Refguard-Hedgimod, beyond what Josh shared about the progress for GMG, we are excited about the positive data for treating patients with CIDP or chronic inflammatory demyelinating polyneuropathy. There are an estimated 50,000 patients diagnosed with CIDP in China, and today only a small fraction are able to achieve remission on their current standard of care, and the majority of patients continue to be burdened with symptoms that 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 is worsened due to the persistent shortage of IVIG therapy. Our partner, Argenics, announced this month that the FDA had accepted for priority review the SBLA for -Q-administered Refguard-Hydrolo in CIDP, and was granted a PDUFA goal date of June 21st of this year. We plan to submit an SBLA to the NNPA in China for this indication in the first half of 2024. In addition, our SBLA for FGATG-MOD -AMG-MG is under regulatory review in China, with potential NNPA approval this year. This approval would give patients flexibility on treatment with either IV, homo-convenient sub-Q dosing. FGATG-MOD sub-Q has the advantage of simplicity and speed, as administration takes only 30 to 90 seconds for a single dose. We see significant potential for FGATG-MOD across multiple additional indications, and we will continue to work with our partner, Argenics, on indication expansion. For example, we expect to join them in the registration of study of FGATG-MOD in thyroid eye disease, or TED, in Greater China in the second half of this year. Turning to CAR XT, this is a -in-class antipsychotic, combining a centrally active muscarinic agonist called Xenomaline with a peripheral antagonist called Trospium, which we are developing with our partner, Corona, for patients with acute schizophrenia. In November 2023, the FDA accepted Corona's NDA for CAR XT for the treatment of schizophrenia in adults, with a PNUFA goal date of September 26, 2024. We continue to enroll patients in the registration of bridging study in mainland China, and we expect to complete enrollment this year. We believe that CAR XT could become an important new treatment option in China, where more than 8 million people are living with schizophrenia, and where severe under-treatment and inadequate symptom improvement, or even disease control, persists, despite currently available antipsychotics. We have yet another substantial opportunity for CAR XT, which is for the treatment and prevention of psychosis in Alzheimer's disease patients, or ADP for short. There are approximately 8 million people with Alzheimer's disease in China, and about 45% of these patients display psychotic symptoms. We believe that there is a significant unmet need for patients with ADP or Alzheimer's disease with psychosis in China, as there are no approved treatments. Corona initiated the Phase 3, Adept 2, and Adept 3 clinical trials in the third quarter of 2023, and we plan to participate in both studies in Greater China in mid-2024. Regarding our infectious diseases portfolio, sulbactam durulobactam, or SULDUR, is a treatment for hospital-acquired and ventilator-associated bacterial pneumonia caused by asinidobacter barmania. In China, there are 240,000 to 300,000 cases of asinidobacter infections annually, with the majority of strains being carbapenem-resistant. Latest countrywide surveillance data from China indicate a rise in overall resistance to approximately 80%. With limited treatment options for these patients, the mortality rate is around 43%, even with the best available therapy and care. The WHO has listed asinidobacter barmania as the number one problem pathogen, and the high incidence in China has prompted the Chinese government to prioritize efforts to combat this multidrug-resistant bacteria. Our NDA submission is under priority review, and we are looking forward to a potential approval later this year. Last but not least, ZL1102, our IL-17 humor body for the topical treatment of chronic plaque psoriasis, or CPP, is in the final stages of preparation for a global phase II dose-finding trial, and we intend to initiate the study in mid-2024. So, plenty of exciting progress within our NSAID portfolio, and I look forward to providing updates at our next earnings call. Now, Ya-Jing will provide an overview of our financial results. Ya-Jing?
spk15: Thank you, Harold. Now, I will discuss our four-year financial results compared to the prior year. In 2023, total net product revenues grew to $266.7 million. This represents -over-year growth of 25% or 31% on a constant currency basis. Our revenue growth was driven by increased sales volume, and the launch of ViviGuard partially offset by an increase in our sales rebate to distributors, resulting from price reductions in connection with additional NRADL listings. Sales rebates in connection with NRADL listings rose to $13 million for 2023. These NRADL listings play a crucial role in maintaining patient access to our existing products on NRADL, while significantly expanding access for our new products. Growth was also negatively impacted by the temporary effects on the hospital and the physician practices that resulted from industry-wide anti-corruption enforcement efforts in China in the second half of the year. Now, looking at each individual product, the Juna Net Product revenue increased 16% -over-year to $168.8 million in its third year on the NRADL, driven by increased hospital sales in first-line ovarian cancer and a duration of treatment improvement. Partially offset by an increase in sales rebates in the fourth quarter in connection with the renewal of the NRADL listing for the Juna as a maintenance treatment. ViviGuard Net Product revenue was $10 million following the launch in China in September 2023. We successfully negotiated for ViviGuard's first listing on the NRADL with pricing that took effect on January 1, 2024. Opt-in Net Product revenue were relatively flat -over-year at $47 million, as continuous growth in supplemental insurance coverage was offset by the disruption in hospital and physician practices resulting from anti-corruption efforts. QNLAC grew 29% -over-year to $19.2 million, and Nusaira increased 316% to $21.7 million. This growth was supported by the inclusion of QNLAC and the IV formulation of Nusaira in the NRADL in the first quarter of 2023. Partially offset by sales rebates in connection with this NRADL listing, as well as sales rebates in the fourth quarter in connection with the inclusion of the oral formulation of Nusaira, which became effective in January 2024. Turning now to our expenses. Research and developing expenses declined $21 million to $265.9 million, primarily due to decreased up-fund and milestone payments for our license and collaboration agreements, partially offset by an increase in personnel compensation and related costs. Selling, general and administrative expenses grew $23 million to $281.6 million, primarily due to higher general selling expenses to support the launch of Vivgard, partially offset by a decrease in professional services fees. Both R&D and FTA expenses significantly declined as a percentage of revenue, and we expect this trend to continue as a result of our growing revenues and our ongoing cost and efficiency initiatives. Zylark reported a net loss of $334.6 million for 2023, which improved by $108 million versus prior year. The decrease in net loss reflects our continued progress towards profitability, primarily driven our product revenue growing faster than net operating expenses, as well as increased interest income and decreased foreign currency loss. We are in a strong financial position, ending the year with a cash position of $807.6 million compared to $1 billion as of December 31, 2022. 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?
spk17: We would now like to open the line for questions. If you have a question, please press star 1 and 1 at this time. To withdraw your question, please press star 1 and 1 again. Please limit yourself to one or two
spk27: questions.
spk17: Our
spk27: first question
spk17: comes from the line of Michael Yee from Jeffreys. Please go ahead. Your line is open.
spk19: Hi, this is Jojie Wei on the line for Michael Yee. Thanks for taking my questions and giving a great safeguard guidance, which is obviously above the consensus. I have a couple of questions. Maybe first, can you comment on what your assumptions are for the $17 million in 2024 VIFGAR sales guidance? And what visibility do you have to be able to guide the $17 million? And for the $1,000 new patients added in January, were they a bonus waiting for the NIDL price to be treated or due to other factors in play? My second question is about the recent investor concerns and rhetoric in Washington, D.C. about the Committee on CCP. Maybe can you comment on what your confidence level is that you believe this won't impact biotech at all and what you're seeing out there? Thank you.
spk10: Great. Thank you for the questions. It's Jojie. I'll direct the question to our leadership team here, but I think for the first two, I'll direct them back to me. First on VIVGAR, as we said, we're really pleased with the uptake we've seen so far. We're monitoring all the normal leading indicators you would look at in the launch, but new patients starts is really important. So I think what gives us the confidence to say we're on a path to $70 million or greater in 2024 is the rate of new patients starts, the penetration we're seeing with hospitals. We focused in the fourth quarter on the top 600 hospitals, which make up about 80% of the sales opportunity. We'll expand that to a thousand hospitals here in the first half of the year. Now that we have NRDL listing, and one of the things we look at there is how quickly the hospitals adopt the NRDL national listing into their local formularies. We're off to a good start there. A thousand patients in January, as we mentioned, I think is a really good start. And I think it's obviously very early in the launch. To get into too many details there, we'll keep updating as we go through the quarters during the year. I think what we can say right now is with a thousand new patients, and of course, as we mentioned last year, some of those patients could have been patients that would have started in December, but were held for the reimbursement. But I think for the most part, we're quite pleased with the absolute magnitude and the number, and it gets us off to a good start in the year. And again, I would look at the $70 million as we know enough now to have confidence there, and we're looking forward to continued progress throughout the year. I think on the second question about the political environment in the U.S. and the Biosecure Act and or others, we've evaluated these bills and the tenor behind them closely. They don't touch on anything that we do, and we're quite confident that as proposed now, these bills or activities won't have any impact on what we do as a biotech company focused on bringing great innovative medicines to patients in
spk07: China and
spk09: over time to the rest of the world.
spk07: Thank you.
spk09: This is great. Thank you.
spk17: Thank you.
spk27: We'll now move on to our next question.
spk17: Our
spk27: next question comes
spk17: from the line of Anupam Rama from JP Morgan. Please go ahead. Your line is open.
spk18: Hey, guys. Thanks so much for taking the question. Maybe just a broader question for me. So what evidence or anecdotes do you have that some of the corruption efforts in China have kind of played out and won't have a lingering impact moving forward? Thanks so much.
spk10: Thanks, Anupam. It's Josh again. I think first, we look at how our sales reps are able to interact with their customers, hospitals and physicians and otherwise. And I think what we see now is we've got good access. We're able to communicate the medical benefits of our products in a way that's helpful to physicians and patients and so on. So I think that's what we tend to look at. I think on the broader level, of course, we can't predict the future. But for now, we feel good about the environment we're operating in and certainly our sales and marketing practices are of the highest standards and no impact that we've seen from the historical efforts there. So we're
spk11: looking forward to a good year operation later. Thanks so much for taking the question. Thank
spk27: you.
spk17: Thank you. We'll now move on to our next
spk27: question. Please stand by.
spk17: Our next question comes from the line off Louise Chen from Cantor. Please go ahead. Your line is open.
spk23: Hi, thanks for taking my questions here. So I wanted to ask you on CIDP, if you do get approval, how do you think the uptake will be relative to what you've seen right now from I have seen a Gravis? And then what's a bigger opportunity for you, MG or CIDP? Thank you.
spk10: Thanks Louise. I'm going to ask Harold to talk a little bit about the CIDP and answer your question. And if there's anything to wrap up on, I'll come back at the end. Please go ahead, Harold.
spk02: Yeah, hi. Thank you for the question. The CIDP indication is rather unique. It is an unmet medical need situation here, much more so than in many other indications for autoimmune diseases. These patients currently really lack something like an F-Cartigimod that helps improve symptomatology and to break the downslope of their disease. A lot of these patients end up in wheelchairs. So right now, as we said earlier, treatment is just steroids. And at the end of the rope, you get patients who are getting constantly IVIG infusions. So we see really a very, very important role for F-Cartigimod in that population. This F-Cartigimod treatment here is a weekly treatment for the duration of the symptomatology. So it has a major impact on our financials. Thank you.
spk07: I
spk10: would just add, as Harold mentioned, there's a significant unmet need here, and it's a very big opportunity. I don't think at this point, Louise, we're going to be excited about both of them. I think they both present large opportunities, both deep and CIDP. And we're looking forward to progressing the CIDP approval process and be ready to go there. Thanks.
spk17: Thank you. Thank you. We'll now move on to our next
spk27: question.
spk17: Our
spk27: next question comes from
spk17: the Lion of Yigal Nocimowicz from Citigroup. Please go ahead. Your line is open.
spk04: Yeah, hi. Thanks very much. On VivGuard, I think, Josh, you mentioned it was 32,000 per year based on clinical study usage. How is that syncing up with what you're seeing in the real world in terms of the average number of cycles and average vials per four-week cycle? Is that fairly consistent with the clinical trial experience so far?
spk10: Thanks. Thanks, Yigal. I'll ask Harold to comment, but I think it's early in the launch. We have no reason to believe that we're going to see things that are vastly different than what we're seeing around the world. We're excited about the starting point. But I don't know that we have a lot more to offer now. Harold, if you have any comments you want to make.
spk02: Not really. In this case, we are still too early in the use and the pattern and the numbers of cycles that we would expect to see right now, given the same labeling as in the US. We assume a very similar uptake. However, this needs to be further defined and only future updates here will be able to give you the details that you probably want to hear.
spk31: Okay, thanks.
spk04: And then, Josh, you sort of referenced that the -on-year growth for the four products in the market, not including Vivgard, would be comparable to 2023 -on-year growth. However, if you look at the trajectory from Q3 to Q4 in 2023 for Zajewa, Optune, and Qunlock, I guess it's a little unclear how you're going to be able to achieve the same -on-year growth for those products. For Nuzera, also, it was a very, very large number. Could you just kind of expand a little bit on how you're thinking about that -on-year growth number, given what we're seeing in the second half of 2023 for Qunlock, Optune, and Zajewa?
spk10: Thanks. Thanks, Hugo. Well, I think first, for Q4, I want to remind everybody that the Q4 growth rate for Zajewa certainly is impacted by rebates associated with NRDL. So I think if you look at the portfolio overall for Q4 and take out the rebate comparison or drag, growth is more like 19%. So I think certainly for Zajewa, we saw market share grow through the year,
spk09: and we expect to continue to grow in 2024. So I think that
spk10: product is performing well and will continue to push it. I think with the other three, between the three of them, there are some ups and downs, and otherwise, I think with Zajewa, with the NRDL listed now for the oral formulation, I think we're in a good position to continue to see good growth for that product in 2024. I think with Optune, it's a medical device, so there were some challenges, I think, for that product overall, but we expect to grow it. It provides an important benefit to patients, and we expect to continue to grow that in 2024. And Qunlock is performing about what we would expect. It's a small product, but it's an important foundational drug for us as we think about gastric cancer. So I think if you put those all together, there's no reason to believe that the overall sales growth we saw in 2023 can't be replicated in
spk04: 2024. Okay, thanks. And then just the last question on the IL-17. I think you mentioned you're starting the global study in plebs psoriasis. There were some discussion in past meetings over the years with respect to partnering that globally with a large pharma. Where does that stand? Can you just update us on your strategy for that product?
spk10: Harold, you can comment on the study. I think we're excited to get going and begin to create clinical data, and then we'll evaluate our options as we proceed. Harold, maybe you can give us an update.
spk02: Yeah, thank you. Yes, we are happy to go into phase two with this program. And as far as the question here about partnering, I think we're always open to partnering offers and looking at increasing value here for the product. Otherwise, I would like to defer the question to Jonathan who is on the call.
spk25: Yeah, I think we'll evaluate as the data come in, but it's probably too early at this stage to think about that.
spk03: Thanks, Igor. Okay. Okay, thank you.
spk17: Thank you. We'll now move on to our next question. Our next question comes from the line of Linhai Zhao from Goldman Sachs. Please go ahead. Your line is open.
spk30: Hi, thanks for taking my question. Just wondering for opting, we know that there are indication expansion opportunities. Particularly, we have two phase three readouts in 2024 and we're planning to file in for the second line of non-small cell lung cancer in China following our partners filing in FDA. So, wondering if the management can share a bit more on the indication expansions particularly for these three indications and also with all the debates on the second line non-small cell lung cancer with the LUNA data, can you share a bit more color on our communications with the China regulators about the potential concerns and how we are going to address their potential concerns on that aspect. And on that, for 2028, as part of our two billion revenue target, how much do you see revenue contribution from Optune in 2028?
spk08: Rafael, why don't you address the question, please.
spk21: Yes, thank you. This is Rafael. Maybe I'll start with Lunar 2. And as I said in the prepared remarks, EnoboCare has announced that the FDA has accepted the pre-market authorization in January. And as you know, the review time is 180 days. You asked about our interactions with regulatory authorities in China. We are starting those interactions and we have a really good collaboration with our partner. And our intention is to file this year. And we will need for that the China subset analysis. And we're collaborating, as I said, really well with our partners, EnoboCare, to be able to file this year. So obviously, we will see how it goes with the FDA. But as I said, the PMA has been accepted. And then with regards to additional indications, EnoboCare has announced some of those. I guess the one that's most immediate is the Lunar 2 study, which includes checkpoint inhibitors and chemotherapy, plus minus the device in frontline non-smosellone cancer, platinum-containing regimen. We are considering participating in that trial and in discussions with them. And then there's an ongoing study with a checkpoint inhibitor for patients with high GBM scores, which is a phase two study, which we're awaiting the result. But in terms of phase three studies, the most important readouts are medicine, non-smosellone cancer patients with brain metastasis, as well as locally advanced pancreatic cancer, and then we'll add accordingly. So this is sort of an overview of where we are with all these programs, the future programs that we may participate, the ones that we have that we are awaiting results. And definitely, we are committed to filing with Lunar and, as I said, start interactions already with the FDA.
spk10: As it relates to the 2028 composition, we looked at a range of outcomes here when we put together that guidance and that goal. It wasn't dependent on any single product, although what I can tell you for sure is that Vivgard is the start that we have there and our excitement
spk09: around GMG and CIDC, I think, is the biggest driver towards what puts us on the path to the 2028 goals. Thank
spk26: you. Thank you.
spk17: Thank you. We'll now move on to our next
spk27: question. Our next question comes from the line of Jonathan
spk17: Chang from LeoRink Partners. Please go ahead. Your line is open.
spk24: Hey, guys. This is Matt Calper on for Jonathan. Thanks for taking my question. I was just wondering if you can discuss how you see the pricing of Vivgard evolving over time, particularly in the context of NRDL renewal cycles and then also in the context of adding additional indications such as CIDP. Thank you.
spk10: Thanks, Matt. I'll ask Jonathan to take that one, please.
spk25: Sure. Thanks for the question. Look, I think first we achieved a good price at the end of last year in the NRDL negotiation. So we're off to a very good starting point. And I think NRDL is also evolving and we do see positive trends that the government increasingly supportive of innovative and differentiated products. Vivgard being the only in class and addressing a very large medical need in China is a program which we see that the government is supporting and we do expect to maintain good price. Also, if you look at the jeweler, we maintain very good price in the most recent negotiation. So we feel pretty good about the pricing at this stage.
spk09: Thanks, Jonathan.
spk17: Thank you. Thank you. We'll now move on to our next question. Our next question comes from the line of Jack Lin from Morgan Stanley. Please go ahead. Your line is open.
spk14: Hi. Good morning, everyone. And thank you for taking my question. I have a couple of quick questions. First one, again, on Vivgard. I'm curious to know if there's any color you could share in terms of the patient background that we've seen since the fourth quarter and also in January. What proportion of them were refractory versus kind of in the earlier setting? And for the refractory ones, what might be the breakdown between refractory to the conventional oral immunotherapies versus the alternative biologics? That's on the Vivgard. And just two really quick questions on commercialization. One, I think you mentioned earlier we're looking to break into 1,000 hospitals by end of this year. And I think we're at 150 right now. I'm curious to know about how the commercial team is in place or is it kind of an ongoing effort for more recruitment? And also for Optune, assuming that we have success from the PNLVL 3 studies and others, will we rethink in terms of the getting reimbursement coverage in China considering the significantly larger patient size? Thank you.
spk10: Thanks, Jack. And I'll ask Harold to talk a little bit about Vivgard patients. Obviously, it's very early in the launch, but
spk11: Harold, if you may make a comment.
spk02: Yeah. Thank you for the question. And again, the patient background that we've seen so far is really the background of those patients who were prior to NIDL reimbursement. So those patients, we would assume, are the patients who are somewhat more sick and more ill and possibly close to the refractory part of the disease cycle. However, this will all normalize, we believe, as NIDL pricing kicks in. And we should expect a similar kind of patient population going forward that has been seen in the studies and also in the United States. So this is a drug which comes in after, you know, steroid use. It's not a drug for the refractory patients. Only it is a patient selection that we see right in the middle is a bulk of patients with GMG that starts to lose control with steroids alone or runs into side effects with steroids. Thank you. It is fairly early in the day and we shall, you know, provide updates as time goes on and as we have a more normalized situation as far as under NIDL pricing conditions. Thank you.
spk10: Jack, your question about some of the commercialization efforts. So when we launched in September, we had 100 sales reps. We focused on the top 600 hospitals, which, as I mentioned earlier, were made up about 80% of the sales opportunity that we were focused on. With N or DL listing, we always plan to move from 100 reps to 150. We're in the middle of that expansion right now. And we would increase our target hospital list from 600 to 1000. And, you know, that comes with the expansion, the reps. We'd expect all that to be complete over the first half of this year. So I think as you get into the second half of the year, we'll be at what we believe to be full strength. And I think that's, you know, that's sufficient to cover the opportunity given how concentrated the prescribing and the patient base is here. So, again, we're excited about what we're seeing so far and we think the opportunity is well defined and in front of us. Jonathan, I don't know if you have any comments you want to make on sort of the longer term pricing, you know, policy opportunities for medical devices and how often they fit in there.
spk25: Yeah, it's also evolving very rapidly. As you recall, you know, about a year and a half ago, the government was having draft proposals on the medical device, you know, and ideal inclusion. So far, they haven't come up with a more formal, you know, guidelines yet. So we're eagerly waiting for that. We think if that does eventually, obviously, Optune would benefit. But, you know, for now, I think the commercial insurance is very important for Optune and the viable market just based on that. Thank you. Thank you.
spk17: Thank you. I am showing no further questions at this time. I will now turn the call back over to Xylab CEO Samantha Du for closing remarks.
spk16: Thank you, operator. I want to thank everyone for taking the time to join us on the call today. We appreciate your support and look forward to updating you again after the first quarter of 2024. Operator, you may now disconnect the call.
spk17: This concludes today's conference call. Thank you for participating. You may now disconnect. Speakers, please stand by.
spk00: Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you.
spk27: Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. you you Hello ladies and gentlemen thank you for
spk17: standing by and welcome to Xylabs full year 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 call is being recorded it is now my pleasure to turn the floor over to Senior Vice President of investor relations please go ahead.
spk32: Thank you operator good morning good evening and welcome to Xylabs full year 2023 earnings call. Today's call will be led by Dr. Samantha Dew Xylabs founder CEO and chairperson. She will be joined by Josh Smiley President and Chief Operating Officer, Dr. Rafael Mato 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. Ya-Jing 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 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 February 27th 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.
spk16: Thank you Christine. In 2023 we had another year of significant achievements for Xilai. We grew our top line by 31% on the constant exchange rate basis. We progressed several key late stage programs. We added new global assets into our pipeline. Today we're in a fundamentally stronger position than we have ever been with a growing base of revenues, a path to profitability, and a strong balance sheet with over 800 million USD in cash. We're now entering a period of high growth and we are focused on three key corporate objectives to substantially grow revenues, achieve profitability, and build our global pipeline. Late last year we launched VidGuard and it's already off to an excellent start with sales expected to exceed 70 million USD this year in GMG. Beyond this we have a series of other potential approvals including repo checkmates and the Sodor data this year. Followed by a series of other new products indications including Asgard T-Smart in CIDP, Bima T-Smart and Carg T. Each of these products have the potential to meaningfully enhance the growth of our business. We are also already deeply committed to building our global pipeline by adding new assets to both our internal discovery efforts and external opportunities and I look forward to providing updates on our progress in this regard throughout the year. And of course we maintain disciplined capital allocation practices as we strive to achieve profitability. As we execute on these corporate objectives we expect to our shareholders. Thank you for your support as we continue on our journey of innovation and growth together. And with that I'll pass the call over to Josh.
spk10: Thank you Samantha and thank you everyone for joining the call today. Xylab delivered strong full-year revenue growth of 25% -over-year and 31% on a constant exchange rate basis driven by robust volume growth across our existing product portfolio and the launch of Vivgard. These revenue increases were partially offset by an increase in sales rebates both in Q1 of 2023 in connection with new listings for our product on China's 2022 National Reimbursement Drug List or NRDL and in Q4 of 2023 in connection with new and renewed NRDL listings for our products on China's 2023 NRDL. A pivotal achievement for us was the approval and subsequent launch of Vivgard in September followed by its inclusion in the NRDL which became effective at the beginning of this year. Throughout the fourth quarter we implemented comprehensive commercial strategies to drive awareness and adoption of Vivgard and we entered 2024 with considerable momentum. I'm also pleased to announce that in 2023 we achieved our goal of having net product revenue exceed the cost of sales and sales and marketing expenses for our commercial products which we refer to as commercial profitability. Our commitment to financial prudence remains steadfast as we work towards achieving and maintaining profitability. Lastly, we made substantial progress on key clinical development programs such as F-Cartigia Mod in CIDP and CAR XT in Schizophrenia while further enriching our global pipeline with the introduction of a next generation DLL3 ADC. In 2023 we announced our five-year strategic plan aimed at positioning XiLab as a leading global biopharmaceutical company characterized by substantial revenue growth, achievement of profitability, and a strong global pipeline. This strategic vision is underpinned by three corporate objectives. First, we are focused on accelerating top-line growth with a strong foundation in place supported by both new product approvals and label expansions within our existing portfolio. We anticipate substantial revenue growth in the coming years. By 2028 we aim to have a significantly larger commercial portfolio with the launch of potential blockbusters such as VivGuard leading the way. Subsequent potential launches include Soldor later this year and TIVDAC, Femur Atozomab, and CAR XT in 2025 and beyond. Such launches would further drive revenue growth with our projections exceeding $2 billion in 2028, reflecting our estimated five-year compound annual growth rate of 50%. Furthermore, we are committed to building our global portfolio through internal discovery initiatives and strategic business development endeavors. Our goal is to advance at least one global IND into clinical trials annually as we continue to evaluate and pursue synergistic, global, and regional business development opportunities, leveraging Xilab's reputation as a trusted brand and preferred strategic partner. As we continue to grow and develop our commercial portfolio and pipeline, we remain focused on scaling with purpose and this brings us to our third objective which is to achieve corporate profitability by the end of 2025. To realize this objective, we will continue to enhance efficiency and productivity, prioritize research and development initiatives, and execute cost optimization strategies. Our existing infrastructure is agile and sized to support multiple new launches. We maintain the robust reserve of cash and cash equivalents of $807.6 million as of the end of 2023, providing ample financial resources to sustain our operations through profitability and beyond. Now I will briefly review the performance of each of our commercial products and our expectations for 2024. Zajula maintained its position as the leader in hospital sales for PARP inhibitors in ovarian cancer in China, exhibiting growth in the fourth quarter and the entire year. In 2024, we will continue to focus on driving further growth in the first line setting and extending the duration of therapy. In 2023, Kinloch and the IV formulation of Nusayra joined Zajula on the NRDL and these listings helped drive substantial sales increases for these products. We expect this positive momentum to continue, supplemented by the additional listing for the oral formulation of Nusayra in January 2024. As Optune is a medical device and not eligible for NRDL inclusion, we are focused on expanding access and improving affordability for this important treatment through commercial health insurance coverage. Overall, we anticipate year over year revenue growth in 2020. We expect to see a significant increase in the number of products we will be able to produce in 2024 for these four products in aggregate to be comparable to that of 2023. Turning now to the recent launch of VivGuard. I want to take a moment to acknowledge the tremendous effort of our medical and regulatory and commercial teams behind VivGuard. We were able to reach important milestones at a swift pace, achieving our best case scenario with regards to the timing for approval, launch and NRDL listing. We were pleased to see the regulatory authorities recognize the innovation of VivGuard and its substantial clinical benefit to patients living with generalized myasthenia gravis or GMG. In China, where there are over 170,000 patients with GMG, many patients endure residual symptoms or inadequate treatment, making everyday tasks challenging and unpredictable. The scarcity of innovative therapies, the persistent shortage of IVIG therapy and the chronic and progressive nature of the disease can present a formidable challenge for both patients and healthcare providers alike, further underscoring the significance
spk05: of VivGuard's approval.
spk10: Throughout the fourth quarter, our primary focus was on strategically targeting key hospitals and fostering awareness while delivering timely support to physicians and patients alike. And we made great progress. As of December, we had successfully engaged 100% of our top 200 target hospitals and over 90% of our top 100 physicians integrated VivGuard into their treatment protocols. Based on a survey of 250 physicians, awareness of VivGuard rose from 54% to 72% following four months of promotion, and we continue to see this rise. From launch in September through the end of the year, we estimate that nearly 1,000 patients were treated with VivGuard. Turning now to more recent updates on the launch, VivGuard listing on the NRDL became effective on January 1st this year, with a price of $800 a vial or $32,000 per patient per year based on clinical study usage. We estimate that in January 2024 alone, nearly 1,000 new patients were treated with VivGuard, indicating promising progress at this early stage of the launch. This demand is being driven by an unmet need in the treatment of GMG,
spk29: a willingness
spk10: of physicians to adopt VivGuard into treatment protocols, and increased patient access as hospitals add VivGuard to their formularies. We're very pleased with the progress achieved thus far with the launch of VivGuard, and we anticipate sales to exceed $70 million in 2024. Our strategic focus for the year will be to expand outreach to approximately 1,000 hospitals with a concentrated effort on accelerating VivGuard listing at top tier hospitals. Already, as of the end of January, our team has engaged 100% of our top 600 hospitals in person. Supported by our dedicated sales force of approximately 150 reps, we anticipate robust coverage to facilitate this expansion. Additionally, pending regulatory approval, we expect to launch VivGuard subcutaneous formulation for GMG later this year, which will offer enhanced dosing flexibility for physicians and patients. We're also excited about potential indication expansion for VivGuard. This year, we expect to submit a supplemental biologic license application, or SBLA, in China for CIDP, which presents another substantial growth opportunity. This marks an exciting period for XiLab, an important year of execution for our team. And with that, I would like to pass the call to Rafael, who will provide an update on our oncology pipeline. Rafael?
spk20: 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 Benmarituzumab, our FGFR2B inhibitor in collaboration with Hamden. We are enrolling in both Fortitude 101 and Fortitude 102 Phase 3 studies, evaluating Benmarituzumab in FGFR2B-positive gastric cancer as a doublet therapy with chemo and a triplet with chemo and a checkpoint inhibitor, respectively. We expect both studies to enroll well, and we're eager to introduce this much needed therapy to China, where we estimate an incidence of 126,000 FGFR2B-positive gastric cancer patients each year. Next, our tumor treatment field franchise. In January 2024, our partner, NovoCure, announced that the FDA had accepted the filing of their pre-market approval application for TTFEELS in non-small cell lung cancer following progression on or after platinum-based therapy, and a regulatory decision is expected in the second half of this year. In China, we expect to file a marketing authorization application for TTFEELS in this indication later this year. We also expect two pivotal readouts for tumor treatment fields, including in brain metastasis from non-small cell lung cancer and in pancreatic cancer, both in the first line setting. Also in lung cancer, repotrectinib is currently under priority review for the treatment of adult patients with locally advanced or metastatic -1-positive non-small cell lung cancer in China. The filing was based on the results from the pivotal Triton-1 study, which were published in the New England Journal of Medicine in January this year. Findings demonstrated the potential of repotrectinib to overcome limitations of first-generation tyrosine kinase inhibitors in terms of responses and durability in ROS-1 resistant mutations. We look forward to a potential regulatory approval and this year to bring this -in-class ROS-1 TRK inhibitor to patients in need in China. Now moving on to an aggressive, we will continue to accelerate the regulatory pathway for second-line non-small cell lung cancer monotherapy by leveraging the global data package for the FDA approval, the ongoing PK study in China, and the global confirmatory CRYSTAL-12 study, which Zai lab joined in July 2022. And we await the results for a filing submission in China this year. In addition, our partner, BMS, announced this month that the FDA has accepted its supplemental NDA for priority review for other aggressive in combination with the Toxin Lab for the treatment of patients with previously treated KRAS-G12C mutated locally advanced or metastatic colorectal cancer with a BDUFA goal date of June 21, 2024. For this indication, other aggressive has the potential to be the first to market KRAS-G12C inhibitor in China. We completed enrollment in the global phase three CRYSTAL-10 confirmatory study in 2023. Lastly, for TIFTAC, we have participated in the confirmatory phase three in NOVA TB-301 global trial in second-line cervical cancer and extension portion in China. And we intend to file a new drug application or NDA in China this
spk22: year.
spk20: In addition to our late stage programs, our -ADC-ZL1310 has shown promising preclinical data and is progressing through a global phase one study in relapse and refractory small cell lung cancer who has progressed with their platinum-based treatment in the United States and in China. In March, we will present the preclinical data at the European Lung Cancer Congress in Prague and depending on the dose escalation level, we could potentially see early clinical results at the end of 2024 or early 2025. We're also selecting internally discovered product candidates to achieve our goal of generating at least one IND per year and we continue to assess external opportunities to introduce a new product in development this
spk01: year.
spk20: 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?
spk02: Thank you, Rafael. This is truly a very exciting time for our neuroscience autoimmune infectious diseases or NSAID franchise and we made significant progress in the past year advancing our preclinical data and the preclinical data. We are excited about the progress for GMG. We are excited about the positive data for treating patients with CIDP or chronic inflammatory demyelinating polyneuropathy. There are an estimated 50,000 patients diagnosed with CIDP in China and today only a small fraction are able to achieve remission on their current standard of care and the majority of patients continue to be burdened with symptoms that 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 is worsened due to the persistent shortage of IVIG therapy. Our partner, Igenics, announced this month that the FDA had accepted for priority review the SBLA for sub-q administered Vivgard-Hydrolo in CIDP and was granted a PDUFA goal date of June 21st of this year. We plan to submit an SBLA to the NNPA in China for this indication in the first half of 2024. In addition, our SBLA for FGAT-CGMOD sub-q in GMG is under regulatory review in China with potential NNPA approval this year. This approval would give patients flexibility on treatment with either IV or more convenient sub-q dosing. FGAT-CGMOD sub-q has the advantage of simplicity and speed as administration takes only 30 to 90 seconds for a single dose. We see significant potential for FGAT-CGMOD across multiple additional indications and we will continue to work with our partner, Igenics, on indication expansion. For example, we expect to join them in a registration study of FGAT-CGMOD in thyroid eye disease or TED in Greater China in the second half of this year. Turning to CAR XT, this is a first in class antipsychotic combining a centrally active muscarinic agonist called traspinomaline with a peripheral antagonist called traspium which we are developing with our partner, Corona, for patients with acute schizophrenia. In November 2023, the FDA accepted Corona's NDA for CAR XT for the treatment of schizophrenia in adults with a PEDUFA goal date of September 26, 2024. We continue to enroll patients in the registration bridging study in mainland China and we expect to complete enrollment this year. We believe that CAR XT could become an important new treatment option in China where more than 8 million people are living with schizophrenia and where severe under treatment and inadequate symptom improvement or even disease control persists despite currently available antipsychotics. We have yet another substantial opportunity for CAR XT which is for the treatment and prevention of psychosis in Alzheimer's disease patients or ADP for short. There are approximately 8 million people with Alzheimer's disease in China and about 45% of these patients display psychotic symptoms. We believe that there is a significant unmet need for patients with ADP or Alzheimer's disease with psychosis in China as there are no approved treatments. Corona initiated the phase three, ADEPT2 and ADEPT3 clinical trials in the third quarter of 2023 and we plan to participate in both studies in greater China in mid 2024. Regarding our infectious diseases portfolio, sulbactam, duralobactam or suldur is a treatment for hospital acquired and ventilator associated bacterial pneumonia caused by asinidobacter barmamii. In China there are 240 to 300,000 cases of asinidobacter infections annually with the majority of strains being carbapenemal resistant. Latest countrywide surveillance data from China indicate a rise in overall resistance to approximately 80%. With limited treatment options for these patients the mortality rate is around 43% even with the best available therapy and care. The WHO has listed asinidobacter barmamii as the number one problem pathogen and the high incidence in China has prompted the Chinese government to prioritize efforts to combat this multi-drug resistant bacteria. Our NDA submission is under priority review and we are looking forward to a potential approval later this year. Last not least, CL1102, our IL-17 human body for the topical treatment of chronic plaque psoriasis or CPP is in the final stages of preparation for a global phase two dose finding trial and we intend to initiate the study in mid 2024. So plenty of exciting progress within our NSAID portfolio and I look forward to providing updates at our next earnings call. Now, Yajing will provide an overview of our financial results. Yajing.
spk15: Thank you Harold. Now I will discuss our four-year financial result compared to the prior year. In 2023 total net product revenues grew to $266.7 million. This represents -over-year growth of 25% or 31% on a constant currency basis. Our revenue growth was driven by increased sales volume and the launch of Vivigard partially offset by an increase in our sales rebate to distributors resulting from price reduction in connection with additional NRDO listings. Sales rebates in connection with NRDO listings rose to $13 million for 2023. This NRDO listings play a crucial role in maintaining patient access to our existing products on NRDO while significantly expanding access for our new products. Growth was also negatively impacted by the temporary effects on the hospital and physician practices that resulted from industry-wide anti-corruption enforcement efforts in China in the second half of the year. Now looking at each individual product, the total net product revenue increased 16% -over-year to $168.8 million in its third year on the NRDO. Driven by increased hospital sales in first-line ovarian cancer and the duration of treatment improvement. Partially offset by an increase in sales rebates in the fourth quarter in In terms of service clearance, the proportion of corridor Also, a renou而已 nril Blickard's firstkal及 Vivigard we supportednant. NRDO 164 million -over-year. More than a handful of our desired volume MATE numbers -over-year at $47 million. As continuous growth in supplemental insurance coverage was offset by the disruption in hospital and physician practices, resulting from anti-corruption efforts. TINLOCK grew 29% -over-year to $19.2 million, and Nusayra increased 316% to $21.7 million. This growth was supported by the inclusion of TINLOCK and the IV formulation of Nusayra in the NRDO in the first quarter of 2023, partially offset by sales rebates in connection with this NRDO listing, as well as sales rebates in the fourth quarter in connection with the inclusion of the oral formulation of Nusayra, which became effective in January 2024. Turning now to our expenses, research and developing expenses declined $21 million to $265.9 million, primarily due to decreased up-front and milestone payments for our license and collaboration agreements, partially offset by an increase in personnel compensation and related costs. Selling, general and administrative expenses grew $23 million to $281.6 million, primarily due to higher general selling expenses to support the launch of Vivibart, partially offset by a decrease in professional services fees. Both R&D and FTA expenses significantly declined as a percentage of revenue, and we expect this trend to continue as a result of our growing revenues and our ongoing cost and efficiency initiatives. Zylark reported a net loss of $334.6 million for 2023, which improved by $108 million versus prior year. The decrease in net loss reflects our continued progress towards profitability, primarily driven our product revenue growing faster than net operating expenses, as well as increased interest income and decreased foreign currency loss. We are in a strong financial position, ending the year with a cash position of $807.6 million, compared to $1 billion as of December 31, 2022. 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 lines of questions. Operator.
spk17: We would now like to open the line for questions. If you have a question, please press star 1 and 1 at this time. To withdraw your question, please press star 1 and 1 again. Please limit yourself
spk27: to
spk17: one or two
spk27: questions.
spk17: Our
spk27: first question
spk17: comes from the line of Michael Yee from Jeffreys. Please go ahead. Your line is open.
spk19: Hi, this is Joju on the line for Michael Yee. Thanks for taking my questions and giving great VivGuard guidance, which is obviously above the consensus. I have a couple of questions. Maybe first, can you comment on what your assumptions are for the 70 million in 2024 VivGuard sales guidance and what visibility you have to be able to guide the 70 million? And for the 1,000 new patients added in January, were they a bonus waiting for the NIDL price to be treated or due to other factors in play? My second question is about the recent investor concerns and rhetoric in Washington, D.C. about the Committee on CCP. Maybe can you comment on what your confidence level is that you believe this won't impact biotech at all and what you're seeing out there? Thank you.
spk10: Great. Thank you for the questions. It's Josh. I'll direct the question to our leadership team here, but I think for the first two, I'll direct them back to me. First on VivGuard, as we said, we're really pleased with the uptake we've seen so far. We're monitoring all the normal leading indicators you would look at in the launch, but new patient starts is really important. So I think what gives us the confidence to say we're on a path to 70 million dollars or greater in 2024 is the rate of new patient starts, the penetration we're seeing with hospitals where we focused in the fourth quarter on the top 600 hospitals, which make up about 80% of the sales opportunity. We'll expand that to a thousand hospitals here in the first half of the year now that we have NRDL listing. And one of the things we look at there is how quickly the hospitals adopt the NRDL national listing into their local formularies. We're off to a good start there. A thousand patients in January, as we mentioned, I think is a really good start. And I think it's obviously very early in the launch. To get into too many details there, we'll keep updating as we go through the quarters during the year. But I think what we can say right now is with a thousand new patients, and of course, as we mentioned last year, some of those patients could have been patients that would have started in December, but were held for the reimbursement. But I think for the most part, we're quite pleased with the absolute magnitude and the number, and it gets us off to a good start in the year. And again, I would look at the 70 million dollars as we know enough now to have confidence there. And we're looking forward to continued progress throughout the year. I think on the second question about the political environment in the U.S. and the Biosecure Act and or others, we've evaluated these bills and the tenor behind them. And I think that if we look at the bill closely, they don't touch on anything that we do. And we're quite confident that as proposed now, these bills or activities won't have any impact on what we do as a biotech company focused on bringing great innovative medicines to patients in
spk07: China and
spk09: over time to the rest of the world.
spk07: Thank you.
spk09: This is great. Thank you.
spk17: Thank you.
spk27: We'll now move on to our next question.
spk17: Our
spk27: next question
spk17: comes from the line of Anupam Rama from JP Morgan. Please go ahead. Your line is open.
spk18: Hey guys, thanks so much for taking the question. Maybe just a broader question for me. So what evidence or anecdotes do you have that some of the corruption efforts in China have kind of played out and won't have a lingering impact moving forward? Thanks so much.
spk10: Thanks, Anupam. It's Josh again. I think first, we look at how our sales reps are able to interact with their customers, hospitals and physicians and otherwise. And I think what we see now is we've got good access. We're able to communicate the medical benefits of our products in a way that's helpful to physicians and patients and so on. So I think that's what we tend to look at. I think on the broader level, of course, we can't predict the future. But for now, we feel good about the environment we're operating in and certainly our sales and marketing practices are of the highest standards and no impact that we've seen from the historical efforts there.
spk11: So we're looking forward to a good year operationally here. Thanks so much for taking the question. Thank
spk27: you.
spk17: Thank you. We'll now move on to our next question.
spk27: Please stand by.
spk17: Our next question comes from the line off Louise Chen from Cantor. Please go ahead. Your line is open.
spk23: Hi, thanks for taking my questions here. So I wanted to ask you on CIDP, if you do get approval, how do you think the uptake will be relative to what you've seen right now from I've seen a Gravis? And then what's a bigger opportunity for you, MG or CIDP? Thank you.
spk10: Thanks, Louise. I'm going to ask Harold to talk a little bit about the CIDP and answer your question. And if there's anything to wrap up on, I'll come back at the end. Please go ahead, Harold.
spk02: Yeah, hi. Thank you for the question. The CIDP indication is rather unique. It is an unmet medical need situation here, much more so than in many other indications for autoimmune diseases. These patients currently really lack something like an F-Cantigimod that helps improve symptom pathology and to break the downslope of their disease. A lot of these patients end up in wheelchairs. So right now, as we said earlier, treatment is just steroids. And at the end of the rope, you get patients who are getting constantly IVIG infusions. So we see really a very, very important role for F-Cantigimod in that population. This F-Cantigimod treatment here is a weekly treatment for the duration of the symptomatology. So it has a major impact on our financials. Thank you.
spk07: I
spk10: would just add, as Harold mentioned, there's a significant unmet need here. And it's a very big opportunity. I don't think at this point, Louise, we're going to be excited about both of them. I think they both present large opportunities, both GF and CIDP. And we're looking forward to progressing the CIDP approval process and be ready to go there. Thanks.
spk17: Thank you. Thank you. We'll now move on to our next
spk27: question. Our next question comes
spk17: from the line of Yigal Nocimowicz from Citigroup. Please go ahead. Your line is open.
spk04: Yeah, hi. Thanks very much. On Vivgard, I think, Josh, you mentioned it was 32,000 per year based on clinical study usage. How is that syncing up with what you're seeing in the real world in terms of the average number of cycles and average vials per four-week cycle? Is that fairly consistent with the clinical trial experience so far? Thanks.
spk10: Thanks, Yigal. I'll ask Harold to comment. But I think it's early in the launch. We have no reason to believe that we're going to see things that are vastly different than what we're seeing around the world. We're excited about the starting point. But I don't know that we have a lot more to offer now. Harold, if you have any comments you want to make.
spk02: Not really. In this case, we are still too early in the use and the pattern and the numbers of cycles that we would expect to see right now, given the same labeling as in the US. We assume a very similar uptake. However, this needs to be further defined and only future updates here will be able to give you the details that you probably want to hear.
spk04: Okay, thanks. And then Josh, you sort of referenced that the -on-year growth for the four products in the market, not including Vivgard, would be comparable to 2023 -on-year growth. However, if you look at the trajectory from Q3 to Q4 in 2023 for Zajula, Optune, and Klinglock, I guess it's a little unclear how you're going to be able to achieve the same -on-year growth for those four products. For Nizira also, it was a very, very large number. So could you just kind of expand a little bit on how you're thinking about that -on-year growth number, given what we're seeing in the second half of 2023 for Klinglock, Optune, and Zajula?
spk10: Thanks. Thanks, Jigal. I think first, for Q4, I want to remind everybody that the Q4 growth rate for Zajula certainly is impacted by rebates associated with NRDL. So I think if you look at the portfolio overall for Q4 and take out the rebate comparison or drag, growth is more like 19%. So I think certainly for Zajula, we saw market share grow through the year, and we expect to
spk09: continue to grow in 2024. So I think that product is
spk10: performing well and will continue to push it. I think with the other three, between the three of them, there are some ups and downs, and otherwise, I think with Zajula, with the NRDL listed now for the oral formulation, I think we're in a good position to continue to see good growth for that product in 2024. I think with Optune, it's a medical device, so there were some challenges, I think, for that product overall. But we expect to grow it. It provides an important benefit to patients, and we expect to continue to grow that in 2024. And Kinloch is performing about what we would expect. It's a small product, but it's an important foundational drug for us as we think about gastric cancer. So I think if you put those all together, there's no reason to believe that the overall sales growth we saw in 2023 can't be replicated in
spk04: 2024. Okay, thanks. And then just the last question on the IL-17. I think you mentioned just starting the global study in plebsoriasis. There were some discussion in past meetings over the years with respect to partnering that globally with a large pharma. Where does that stand? And can you just update us on your strategy for that product?
spk10: Thanks. Harold, you can comment on the study. I think we're excited to get going and begin to create clinical data, and then we'll evaluate our options as we proceed. Harold, maybe you can give us an update.
spk02: Yeah, thank you. Yes, we are happy to go into phase two with this program. And as far as the question here about partnering, I think we are always open to partnering offers and looking at increasing value here for the product. Otherwise, I would like to defer the question to Jonathan who is on the call.
spk25: Yeah, I think we'll evaluate as the data coming, but it's probably too early at this stage to think about partnering.
spk03: Thanks, Igor. Okay. Okay, thank you.
spk17: Thank you. We'll now move on to our next question. Our next question comes from the line of Linhai Zhao from Goldman Sachs. Please go ahead. Your line is open.
spk30: Hi, thanks for taking my question. Just wondering for opting, we know that there are indication expansion opportunities. Particularly, we have two phase three readouts in 2024, and we're planning to file in for the second line of most long cancer in China following our partners filing in FDA. So, wondering if the management can share a bit more on the case expansions, particularly for these three indications and also with all the debates on the second line, non-small cell lung cancer with the with the lunar data. Can you share a bit more color on our communications with the China regulators about the potential concerns and how we are going to address their potential concerns on that on that aspect. And on that for 2028 as part of our two billion revenue target, how much do you see revenue contribution from up to in 2028? Thanks.
spk08: Rafael, why don't you address the question, please?
spk21: Yes, thank you. This is Rafael. Maybe I'll start with lunar two. And as I said in the prepared remarks, another care has announced that the FDA has accepted the pre-market authorization in January. And as you know, the review time is 180 days. You asked about interactions with regulatory authority in China. We are starting those interactions and we have a really good collaboration with our partner. And our intention is to file this year and we will need for that the China subset analysis and we're collaborating, as I said, really well with our partners, to be able to file this year. So obviously, you know, we will see how it goes with FDA. But as I said, the PMA has been accepted. And then with regards to additional indications, that no book here has announced some of those. I guess the one that's most immediate is the lunar two study, which includes checkpoint inhibitors and chemotherapy plus minus the device in front line of small cell lung cancer, platinum containing regimen. We are considering participating in that trial and in discussions with them. And then there's an ongoing study with checkpoint inhibitor for patients with high GBM scores, which is a phase two study, which we're awaiting the results. But in terms of phase three studies, the most important one read out our medicine, no small cell lung cancer patients with brain metastasis, as well as locally advanced pancreatic cancer, a Panova trial. We participate in both of those studies to put sufficient patients and we're eagerly awaiting the results of those trials, which should be this year. And then we'll add accordingly. So this is sort of an overview of where we are with all these programs, you know, the future programs that we may participate, the ones that we have that we are waiting results. And definitely we are committed to filing with lunar and as I said, start interactions already with the device division of an NNPA.
spk10: I think as it relates to the twenty twenty eight composition, you know, we looked at a range of outcomes here when we put together that that guidance and that goal. It wasn't dependent on any single product. Although what I can tell you for sure is that Vivgard is, you know, the start that we have there and our excitement around
spk09: GMG and CIDC, I think is the biggest driver towards, you know, what what puts us on the path to the twenty twenty eight goals. Thank
spk26: you. Thank you.
spk17: Thank you. We'll now move on to our next
spk27: question. Our next question comes from the line of
spk17: Jonathan Chang from Learink Partners. Please go ahead. Your line is open.
spk24: Hey, guys, this is Matt Calper on for Jonathan. Thanks for taking my question. I was just wondering if you can discuss how you see the pricing of this evolving over time, particularly in the context of an RGL renewal cycles and then also in the context of adding additional indications such as the IDP. Thank you.
spk10: I'll ask John Jonathan to take that one, please.
spk25: Sure. Thanks for the question. Look, I think first we achieved a good price at the end of last year in the negotiation. So we're off to a very good starting point. And I think an idea is also evolving and we do see positive trends at the government increasingly supportive of innovative and differentiated products. Vivgard being the only in class and addressing a very large medical need in China is a program which we see that the government supporting and we do expect to maintain good price. Also, if you look at the jeweler, we maintain very good price in the most recent negotiation. So we feel pretty good about the pricing at this stage.
spk09: Thanks.
spk17: Thank you. We'll now move on to our next question. Our next question comes from the line of Jacqueline from Morgan Stanley. Please go ahead. Your line is open.
spk14: Hi, good morning, everyone. And thank you for taking my question. I have a couple of quick questions. First one again on the Vidgar. I'm curious to know if there's any color you could share in terms of the patient background that we've seen since the fourth quarter and also in January. What proportion of them were refractory versus kind of in the earlier setting? And for the refractory ones, how, what might be the breakdown between refractory to the conventional oral immunotherapies versus the alternative biologics? That's on the Vidgar. And just two really quick questions on commercialization. One, I think you mentioned earlier, we're looking to break into 1000 hospitals by end of this year. And I think we're at 150 right now. I'm curious to know about how the commercial team is, is the zone in place or is it kind of still ongoing effort to form more recruitment? And also for Optune, assuming that we have success from the Panovo 3 studies and others, will we rethink in terms of the getting reimbursement coverage in China concerning the significant larger patient size? Thank you.
spk10: Thanks, Jack. I'll ask Harold to talk a little bit about the Vidgar patients. Obviously, it's very early in the launch,
spk11: but Harold, if you may make a comment. Yeah,
spk02: thank you for the question. And again, the patient background that we've seen so far is really the background of those patients who were prior to NIDL reimbursement. So those patients, we would assume, are the patients who are somewhat more sick and more ill and possibly close to the refractory part of the disease cycle. However, this will all normalize, we believe, as NIDL pricing kicks in. And we should expect a similar kind of patient population going forward that has been seen in the studies and also in the United States. So this is a drug which comes in after, you know, steroid use. It's not a drug for the refractory patients. Only it is a patient selection that we see right in the middle is the bulk of patients with GMG that starts to lose control with steroids alone or runs into side effects with steroids. Thank you, Harold. It is fairly early in the day and we shall, you know, provide updates as time goes on and as we have a more normalized situation as far as under NIDL pricing conditions. Thank you.
spk10: Jack, your question about, you know, some of the commercialization efforts. So when we launched in September, we had 100 sales reps. We focused on the top 600 hospitals, which, as I mentioned earlier, were made up about 80% of the sales opportunity that we were focused on. With N or DL listing, we always plan to move from 100 reps to 150. We're in the middle of that expansion right now. And we would increase our target hospital list from 600 to 1,000. And, you know, that comes with the expansion, the reps. We'd expect all that to be complete over the first half of this year. So I think as you get into the second half of the year, we'll be at what we believe to be full strength. And I think that's, you know, that's sufficient to cover the opportunity given how concentrated the prescribing and the patient base is here. So again, we're excited about what we're seeing so far, and we think the opportunity is well defined and in front of us. Jonathan, I don't know if you have any comments you want to make on sort of the longer term pricing, you know, policy opportunities for medical devices and how often they fit in there.
spk25: Yeah, it's also evolving very rapidly. As you recall, you know, about a year and a half ago, the government was having draft proposals on the medical device, you know, and ideal inclusion. So far, they haven't come up with a more formal, you know, guidelines yet. So we're eagerly wait for that. We think if that does eventually, obviously, up to would benefit that, you know, for now, I think, you know, the commercial insurance is very important for for off tune and viable market just based on that. Thank you. Thank you.
spk17: Thank you. I am showing no further questions at this time. I will now turn the call back over to Zylab CEO Samantha Du for closing remarks.
spk16: Thank you, operator. I want to thank everyone for taking the time to join us on the call today. We appreciate your support. We look forward to updating you again after the first quarter of 2024. Operator, you may now disconnect the call.
spk17: This concludes today's conference call. Thank you for participating. You may now disconnect.
Disclaimer