Q4 2023 Zai Lab Limited Earnings Call
Operator: Unsponsored ADR Hello, ladies and gentlemen, thank you for standing by and welcome to Zai Lab's full year 2023 financial results conference call. At this time, all participants are in listen only mode.
Okay.
Speaker Change: Hello, Ladies and gentlemen, thank you for standing by and welcome to sign ups full year 2023 financial results conference call.
Speaker Change: At this time, all participants are in listen only mode.
Speaker Change: At this time, all participants are in listen only mode.
Operator: 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.
Speaker Change: We will conduct a question and answer session and instructions will follow at that time.
Speaker Change: As a reminder, today's call is being recorded.
Speaker Change: It is now my pleasure to turn the floor rate that you Christine Chou Senior Vice President of Investor Relations.
Christine Chou: Please go ahead.
Billy Cho: Thank you, operator. Good morning, good evening, and welcome to Zai Lab's full year 2023 earnings call. Today's call will be led by Dr. Samantha Du, Zai Lab's Founder, CEO, and Chairperson. She will be joined by Josh Smiley, President and Chief Operating Officer, Dr. Rafael 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. Yajing Chen, Chief Financial Officer. Jonathan Wang, our Chief Business Officer, will also be available to answer questions during the Q&A portion of the call. As a reminder, during today's call, we will be making certain forward-looking statements based on our current expectations. These statements are subject to numerous risks and uncertainties that may cause actual results to differ materially from what we expect due to a variety of factors, including those discussed in our SEC filings.
Christine Chou: Thank you operator, good morning, good evening and welcome to Bylaw <unk> full year 2023 earnings call.
Christine Chou: Today's call will be led by Dr. Samantha Du, <unk> founder CEO and chair person.
Christine Chou: 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. Hal Brian Hart, President and head of global development neuroscience, autoimmune and infectious diseases and Dr. Yao Zhou Chen Chief Financial Officer.
Christine Chou: Jonathan Wang our Chief business Officer will also be available to answer questions. During the Q&A portion of the call.
Christine Chou: As a reminder, during today's call, we will be making certain forward looking statements based on our current expectations.
Christine Chou: 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.
Billy Cho: 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 filed 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 Du. Thank you, Christine.
Christine Chou: We will also refer to product revenue growth rate on a constant exchange rate basis, which is a non-GAAP financial measure.
Christine Chou: Please refer to our earnings release furnished with the SEC on February 27, 2024 for additional information on this non-GAAP financial measure.
Doctor Samantha: At this time it is my pleasure to turn the call over to Doctor Samantha do.
Ying Samantha Du: Thank you Christine.
Ying Samantha Du: In 2023, we had another year of significant achievements for Zai Lab, which grew our top line by 31% on a constantly changing basis. We progressed several key late-stage programs. We added new global assets to our pipeline. Today, we're in a fundamentally stronger position than we have ever been, with the current base of Ramyu News.
Ying Samantha Du: In terms of data look great.
Ying Samantha Du: We had another year of significant achievements for satellite.
Ying Samantha Du: We grew our topline by three 1%.
Ying Samantha Du: On the constantly chancery basis.
Ying Samantha Du: They talk with several key late stage programs.
Ying Samantha Du: New global assets into our pipeline.
Ying Samantha Du: Today, we're in a fundamentally stronger position than we have ever been.
Ying Samantha Du: With a growing base of revenues.
Ying Samantha Du: The path to profitability with a strong balance sheet and 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. [inaudible] 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 Ripple Tractomate and Sodor, later this year, followed by a series of other new product indications, including Ascotizumab in CIDP, Bimutuzumab, and CAR We are also already deeply committed to building our global path by adding new assets to bolster 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 will maintain disciplined capital allocation practices as we strive to achieve profitability.
Ying Samantha Du: Path to profitability and a strong balance sheet with over 800 million USD cash.
Ying Samantha Du: We're now entering a period of high growth.
Ying Samantha Du: And we are focused on three key corporate objectives.
Ying Samantha Du: So substantially girl revenues achieved profitability until.
Ying Samantha Du: Our global pipeline.
Late last year, we launched leak guard.
Ying Samantha Du: It's already off to an excellent start with sales expected to exceed 70 million U S. D. This year in T M T.
Ying Samantha Du: Beyond this we have a series of other provincial approvals, including repo checkmate <unk> and the soda.
Ying Samantha Du: Or this year.
Ying Samantha Du: Followed by the here is the other new products indications.
Ying Samantha Du: Including a school teacher mob in C. S E T.
Ying Samantha Du: People are too small and card scheme.
Each of these products have the potential to meaningfully enhance the growth of our business.
Ying Samantha Du: We're also already deeply committed to building our global pipeline by adding new assets to bolster our internal discovery efforts and external opportunities.
Ying Samantha Du: And I look forward to providing updates on our progress in this regard throughout the year.
Ying Samantha Du: And of course.
Ying Samantha Du: We will maintain disciplined capital allocation practices.
We strive to achieve.
Ying Samantha Du: Perfect.
Josh Smiley: 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.
Ying Samantha Du: As we execute on this corporate objectives, we expect to deliver value not only to patients, but also to our shareholders.
Speaker Change: Thank you for your support.
Speaker Change: We continue on our journey of innovation and girls together.
Speaker Change: And with that I'll pass the call over to Josh Josh.
Josh Smiley: Thank you, Samantha. And thank you, everyone, for joining the call today. Zai Lab delivered strong full-year revenue growth of 25% year over year and 31% on a constant exchange rate, 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 A pivotal achievement for us was the approval and subsequent launch of VivGuard 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 VivGuard, 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 and unsponsored ADR, which we refer to as commercial profitability.
Josh Smiley: Thank you Samantha and thank you everyone for joining the call today.
Josh Smiley: Di lab delivered strong full year revenue growth of 25% year over year, and 31% on a constant exchange rate basis, driven by robust volume growth across our existing product portfolio and the launch of <unk>.
Josh Smiley: 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 <unk>.
Josh Smiley: And in Q4 of 2023 in connection with new and renewed NRT listings for our products on China 2023, and our deal.
Josh Smiley: Our pivotal achievement for US was the approval and subsequent launch of <unk> Garden September followed by its inclusion in the <unk>, which became effective at the beginning of this year.
Josh Smiley: The fourth quarter, we implemented comprehensive commercial strategies to drive awareness and adoption of gift card and we entered 2024 with considerable momentum.
Josh Smiley: 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.
Josh Smiley: 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-cartigemod 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 Zai Lab 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.
Josh Smiley: Our commitment to financial Prudence remains steadfast as we work towards achieving and maintaining profitability.
Josh Smiley: Lastly, we made substantial progress on key clinical development programs, such as F Cartage, and modern CIBC and car XT in schizophrenia, while further enriching our global pipeline with the introduction of our next generation DLL three ADC.
Josh Smiley: In 2023, we announced our five year strategic plan aimed at positioning XI lab 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.
Josh Smiley: 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 year. 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, FEMRA, Tuzimab, and CAR XT in 2025 and beyond.
Josh Smiley: 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 Zipcard, leading the way.
Josh Smiley: Subsequent potential launches include Salvador later, this year and tip that member to use the map in car T in 2025 and beyond.
Josh Smiley: 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 percent. 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 Zai Lab's reputation as a trusted brand and preferred strategic partner.
Josh Smiley: Such launches with 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.
Josh Smiley: Our goal is to advance at least one global IMD in the clinical trials annually as we continue to evaluate and pursue synergistic global and regional business development opportunities.
Josh Smiley: Leveraging the <unk> reputation as a trusted brand and preferred strategic partner.
Josh Smiley: As we continue to grow and develop our commercial portfolio on PIPE, 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.
Josh Smiley: 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.
Josh Smiley: To realize this objective we will continue to enhance efficiency and productivity prioritize research and development initiatives and execute cost optimization strategies.
Josh Smiley: 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 Nuthira join Joola 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 NUSIRA 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.
Josh Smiley: Our existing infrastructure as agile and size to support multiple new launches.
Josh Smiley: We maintained a robust reserve with 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.
Josh Smiley: Now I will briefly review the performance of each of our commercial products and our expectations for 2024.
Josh Smiley: <unk> 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.
Josh Smiley: In 2024, we will continue to focus on driving further growth in the first line setting and extending the duration of therapy.
Josh Smiley: In 2023, Qin lock and the IV formulation of news IRA joined the jeweler on the NRG out and these listings helped drive substantial sales increases for these products.
Josh Smiley: We expect this positive momentum to continue supplemented by the additional listing for the oral formulation of new direct in January 2024.
Josh Smiley: As opportune as a medical device and not eligible for NR deal inclusion we are focused on expanding access and improving affordability for this important treatment through commercial health insurance coverage.
Josh Smiley: Overall, we anticipate year-over-year revenue growth in 2024 for these four products in aggregate to be comparable to that in 2023. Now, turning now to the recent launch of VivGuard. I want to take a moment to acknowledge the tremendous effort of our medical, regulatory, and commercial teams behind VIMCAR. We were able to reach important milestones at a swift pace, achieving our best-case scenario with regard to the timing for approval, launch, and NRDL list. We were pleased to see the regulatory authorities recognize the innovation of VIVGARD and its substantial clinical benefit to patients living with generalized myasthenia gravis, or G Many patients endure residual symptoms or inadequate treatment, making everyday tasks challenging and unpredictable.
Josh Smiley: Overall, we anticipate year over year revenue growth in 2024 for these four products in aggregate to be comparable to that of 2023.
Josh Smiley: Turning now to the recent launch of <unk> Garg.
Josh Smiley: I want to take a moment to acknowledge the tremendous effort of our medical and regulatory and commercial teams behind them Guard.
Josh Smiley: 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 our Dl listing.
Josh Smiley: We are pleased to see the regulatory authorities recognize the innovation of <unk> and its substantial clinical benefit to patients living with generalized myasthenia gravis or gmg and.
Josh Smiley: In China, where there are over 170000 patients with gmg, many patients into a residual symptoms or inadequate treatment, making everyday tasks challenging and unpredictable.
Josh Smiley: 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 health care providers alike, further underscoring the significance of VIFGARD's approval. 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 have successfully engaged 100% of our top 200 target hospitals, and over 90% of our top 100 physicians have 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.
Josh Smiley: The scarcity of innovative therapies, the persistent shortage of IV therapy, and the chronic and progressive nature of the disease can present, a permit of both challenge for both patients and healthcare providers alike. Further underscoring the significance of the Zipcard approval.
Josh Smiley: 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.
Josh Smiley: 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 position integrated <unk> into their treatment protocols.
Josh Smiley: Based on a survey of 250 physicians awareness of <unk> rose from 54% to 72% following four months of promotion and we continue to see this rise.
Josh Smiley: From launch in September through the end of the year, we estimate that nearly 1,000 patients have been treated with Vivgard. Turning now to more recent updates on... 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 studies. We estimate that in January 2024 alone, nearly 1,000 new patients were treated with Vivgard, indicating promising progress at this early stage of the war.
Josh Smiley: From launch in September through the end of the year, we estimate that nearly 1000 patients were treated with <unk>.
Josh Smiley: Turning now to more recent updates on the launch <unk> Gard listing on the <unk> became effective on January one this year with a price of $800, a vial or $32000 per patient per year based on clinical study usage.
Josh Smiley: We estimate that in January 2024 alone nearly 1000, new patients were treated with depth guard, indicating promising progress at this early stage of the launch.
Josh Smiley: This demand is being driven by an unmet need in the treatment of GMG, a willingness of physicians to adopt VivGuard into treatment protocols, and increased patient access as hospitals add VivGuard to their formula. 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.
Josh Smiley: This demand is being driven by an unmet need in the treatment of gmg, a willingness of physicians to adopt zipcard into treatment protocols and increased patient access as hospitals add <unk> to their formularies.
Josh Smiley: We're very pleased with the progress achieved thus far with the launch of their cart and we anticipate sales to exceed $70 million in 2024.
Josh Smiley: Our strategic focus for the year will be to expand outreach to approximately 1000 hospitals with a concentrated effort on accelerating their guard listing at top tier hospitals.
Josh Smiley: Already as of the end of January our team is engaged 100% of our top 600 hospitals in person.
Rafael Mato: 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 VIVGARD'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 VIVGARD. Additionally, this year, we expect to submit a Supplemental Biologics License Application, or SBLA, in China for CIDP, which presents another substantial growth opportunity. This marks an exciting period for Zai Lab and an important year of execution for our team. And with that, I would like to pass the call to Raphael, who will provide an update on our oncology pipeline. Rafael.
Josh Smiley: Supported by our dedicated sales force of approximately 150 reps, we anticipate robust coverage to facilitate this expansion.
Josh Smiley: Additionally, pending regulatory approval, we expect to launch <unk> subcutaneous formulation for <unk> later, this year, which will offer enhanced dosing flexibility for physicians and patients.
Josh Smiley: We're also excited about potential indication expansion for gift card.
Josh Smiley: This year, we expect to submit a supplemental biologics license application or SPL law in China, foresee IDP, which presents another substantial growth opportunity.
Josh Smiley: This marks an exciting period for XI lab and.
Josh Smiley: And an important year of execution for our team.
Josh Smiley: And with that I would like to pass the call to Raphael, who will provide an update on our oncology pipeline.
Josh Smiley: Raphael.
Raphael: Thank you Josh let me begin by highlighting some of the key progress updates in our oncology pipeline.
Raphael: Earnings call along with our next steps.
Starting with <unk> our <unk>.
Raphael: <unk> inhibitor in collaboration with Amgen, we are enrolling in both 43 101. Unfortunately, the one or two phase III study evaluating <unk> in <unk> positive gastric cancer as a doublet therapy with chemo and a triplet with chemo and a checkpoint inhibitor respectively.
Rafael Mato: 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 marituzumab, our FTFR2B inhibitor, in collaboration with Anupam, we are enrolling in both Fortitude 101 and Fortitude 102 Phase 3 studies, evaluating Merituzumab in STFR2B positive gastric cancer as a doublet therapy with chemo and a triplet with chemo and a checkpoint inhibitor, respectively.
Raphael: 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 126000 fts tied to <unk> positive gastric cancer patients each year.
Raphael: Next our tumor treating field franchise in January 2020 for our partner Novocure announced that the FDA had accepted the filing of their pre market approval application for <unk> in non small cell lung cancer following progression on or after platinum based therapy and a regulatory decision is.
Rafael Mato: 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 FGS Part 2V positive gastric cancer patients each year. Next, our tumor treating field franchise. In January 2024, our partner Novacure 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 study.
Expected in the second half of this year in China, we expect to file a marketing authorization application for <unk>. In this indication later this year. We also expect to pivotal readouts for tumor treating fields, including in brain metastases from non small cell lung cancer and in pancreatic cancer. Both in the first line setting.
Raphael: Also in lung cancer <unk> is currently under priority review for the treatment of adult patients with locally advanced or metastatic breast <unk> positive non small cell lung cancer in China.
Raphael: The filing was based on the results from the people without Trident, One study, which were published in the New England Journal of Medicine in January of this year.
Rafael Mato: Also in lung cancer, ripotrectinib is currently under priority review for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-moster 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 reprotractinase to overcome limitations of first-generation tyrosine kinase inhibitors in terms of responses and durability in ROS1-resistant mutations.
Raphael: Finding demonstrated the potential of repo attractiveness to overcome limitations of first generation tyrosine kinase inhibitors in turn sell responses and durability in gross one resistant mutation.
Raphael: We look forward to a potential regulatory approval and launch this year to bring this best in class Russ one TRT inhibitor to patients in need in China.
Raphael: Now moving on to other 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.
Rafael Mato: We look forward to a potential regulatory approval and launch this year to bring this best-in-class ROS1 TRK inhibitor to patients in need in China. Now, moving on to Adagrassif, we will continue to accelerate the regulatory pathway for second-line non-small cell lung cancer monotherapy by leveraging the global data package for FDA approval. The ongoing PK study in China and the global confirmatory CRISPR-12 study, which Zai Lab joined in July 2022.
Raphael: The ongoing PK study in China, and the global Confirmatory Crystal 12 study with XI lab joined in July 2022, and we await the results for our filing submission in China. This year.
Raphael: In addition, our partner BMS.
Raphael: Now this month that the FDA has accepted its supplemental NDA for priority review or other aggressive in combination with rituximab for the treatment of patients with previously treated <unk> mutated locally advanced or metastatic colorectal cancer with a <unk> of June 'twenty one 'twenty.
Rafael Mato: And we await the results of 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 adagrassis in combination with cetuximab for the treatment of patients with previously treated KRAS G12C mutated locally advanced or metastatic colorectal cancer with a PDUFA goal date of June 21st, 2024. For this indication, Allergrastif has the potential to be the first to market a KRAS G12C inhibitor in China.
Raphael: 24.
Raphael: For this indication other aggressive has the potential to be the first to market K recipe growth being pivotal in China.
Raphael: Completed enrollment in the global Phase III resold 10 confirmatory study in 2023.
Raphael: Lastly for <unk>, we have participated in the confirmatory phase III in Nova TV, One global trial in second line cervical cancer and continue on an extension portion in China, and we intend to file a new drug application or NDA in China. This year.
Rafael Mato: We completed enrollment in the Global Phase III Crystal Chain Confirmatory Study in 2020. Lastly, for TIFDAC, we have participated in the confirmatory phase three of the NOVA-TV-301 global trial in second-line cervical cancer and continue an extension portion in China, and we intend to file a new drug application, or NDA, in China this year. In addition to our late-stage programs, our DLL-3-ADC-ZL-1310 has shown promising preclinical data and is progressing through a global phase one study in relapsed and refractory small cell lung cancer who have progressed after platinum-based treatment in the United States and in China.
Raphael: In addition to our late stage programs, our DLL three ADC.
Raphael: Intel has shown promising preclinical data and is progressing through a global phase III study in relapsed and refractory small cell lung cancer, who have progressed since their platinum based treatment in the United States and in China.
Raphael: March we will present 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 'twenty 'twenty four 'twenty five.
Raphael: We're also collecting internally discovered product candidate 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 year.
Rafael Mato: 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 year. 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.
Raphael: And now I will turn the floor over to Dr. Harald Reinhart will discuss the progress in our autoimmune infectious disease and neuroscience therapeutic area Karl Thank you Roxanne.
Harald Reinhart: This is truly a very exciting time for our neuroscience ordering new and infectious diseases or <unk>.
Harald Reinhart: Each franchise.
Harald Reinhart: We made significant progress in the past year advancing our pipeline.
Harald Reinhart: Starting with Lescott if granted demand.
Speaker Change: What Josh said about the progress with Gmg.
Speaker Change: Excited about positive data for treating patients with CDP.
Dr. Harold Reinhart: Thank you, Rafael. This is truly a very exciting time for our Neuroscience Autoimmune Infectious Diseases or NSAID franchise, and we have made significant progress in the past year advancing our pipeline. Signing off, I am Yigal Nochomovitz.
Speaker Change: Chronic inflammatory demyelinating polyneuropathy.
Speaker Change: Yes.
Speaker Change: To meet its 50000 patients diagnosed with <unk> in China and today only a small fraction I E between achieve remission on their current standard of care and the majority of patients continued to be very good with symptoms that can have a debilitating impact on quality of life.
Dr. Harold Reinhart: 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 with 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.
Speaker Change: Existing treatment options are limited and quite problematic given the general reliance on longitude steroid or chronic immunoglobulin therapy.
Speaker Change: In China, the situations worst due to the persistent shortage of IV therapy.
Speaker Change: Our partner <unk> announced this month.
Speaker Change: The FDA had accepted for priority review the SPN, a true sub Q administered with <unk> <unk> and was granted a <unk> goal date of June 21st of this year, we plan to submit an <unk> to the NPA in China for this indication in the first half of <unk>.
Speaker Change: <unk> four.
Speaker Change: In addition, our SBA leave for efficacy.
Speaker Change: Q in Gmg is under regulatory review in China with potential and NPA approval this year.
Dr. Harold Reinhart: In China, the situation has worsened due to the persistent shortage of IVIG therapy. Our partner, Argenix, announced this month that the FDA had accepted for priority review the SBLA for sub-Q administered Vifgard Hydrolo in CIDP. It was granted a PDUFA goal date of June 21, this year. We plan to submit an SBLA to the NMPA in China for this indication in the first half of 2024. In addition, our SBLA for FKC GMOD sub-Q in GMG is under regulatory review in China with potential NMPA approval this year. This approval would give patients flexibility in treatment with either IV or more convenient sub-Q dosing. FKT GMODSAP Q has the advantage of simplicity and speed, as administration takes only 30 to 90 seconds for a single dose.
Speaker Change: This approval would give patients flexibility to treatment with either IV, who more convenient sub Q dosing.
Speaker Change: If that tells you about sub Q has the advantage of simplicity and speed as administration takes only 32 90 <unk>.
Speaker Change: We see significant potential for <unk> across multiple additional indications and we will continue to work with our partner genetics an indication expansion.
Speaker Change: For example, we expect to join them in the Registrational study of Nyx two months in thyroid eye disease would taint in greater China in the second half of this year.
Turning to <unk> T. This is a first in class anti psychotic combining a centrally acting muscarinic agonist called anomaly with a peripheral antagonist called trust team, which we are developing with our partner Corona for patients with acute schizophrenia.
Dr. Harold Reinhart: We see significant potential for FKTGMOD across multiple additional indications, and we will continue to work with our partner IGENIX on indication expansion. For example, we expect to join them in a registration study of African ketchum mud in thyroid eye disease or TED in greater China in the second half of this year. Turning to CAR-T, this is a first-in-class antipsychotic combining a centrally-acting muscarinic agonist called xanomalene with a peripheral antagonist called traspium, which we are developing with our partner Corona for patients with acute schizophrenia.
Speaker Change: In November 2023, the FDA accepted <unk> NDA for <unk> T for the treatment of schizophrenia in adults with <unk>.
Speaker Change: <unk> goal date of September 26, 2024.
Speaker Change: We continue to enroll patients in the Registrational bridging study in mainland China, and we expect to complete enrollment this year.
Speaker Change: We believe that <unk> could become an important new treatment option in China were more than 8 million people are living with schizophrenia addressed via under treatment and inadequate symptom improvement or Mdc's control precise. Despite currently available anti psychotics.
Dr. Harold Reinhart: In November 2023, the FDA accepted Corona's NDA for CAR-XT for the treatment of schizophrenia in adults with a PDUFA goal date of September 26, 2024. We continue to enroll patients in the Registrational Bridging Study in Mainland China. And we expect to complete enrollment this year. We believe that calx tea 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 being available in the psychotic, 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.
Speaker Change: Yet another substantial opportunity for <unk>, which is for the treatment and prevention of psychosis, and Alzheimers disease patients who at ADP for short.
Speaker Change: Approximately 8 million people with Alzheimer's disease in China, and about 45% of these patients display psychotic symptoms.
Speaker Change: We believe this is a significant unmet need for patients with ADP Alzheimer's disease psychosis in China.
Speaker Change: Approved treatments.
Speaker Change: Corona initiated the phase III adapt to three.
Speaker Change: Three clinical trials in the third quarter of 2023, and we plan to participate in both studies ingredient China in mid 2024.
Speaker Change: Regarding our infectious disease portfolio soon back to <unk> as a treatment for a hospital acquired and ventilator associated bacterial pneumonia caused by asking you back to Beaumont.
Speaker Change: In China.
Dr. Harold Reinhart: 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, 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, durlabactam, or suldor is a treatment for hospital-acquired and ventilator-associated bacterial pneumonia caused by Acinetobacter baumannia.
Speaker Change: 240 to 300000 cases, I'm asking you to back to you thanks with annually.
Speaker Change: With the majority of screens being kind of a penny resistant.
Speaker Change: Latest countrywide surveillance data from China indicated a rise in global resistance to approximately 80%.
Speaker Change: With limited treatment options for these patients the mortality rate is around 43%, even with the best available therapy and Ken.
Speaker Change: The <unk> has listed <unk> as the number one problem pathogen and the high incidents in China has prompted the Chinese government to prioritize efforts to combat this multi drug resistant bacteria.
Speaker Change: Our NDA submission is under priority review and we are.
Dr. Harold Reinhart: In China, there are 240,000 to 300,000 cases of assay-needed bacterial infections annually, with the majority of strains being carbapenem-resistant. The latest country-wide surveillance data from China indicate a rise in overall resistance to approximately 80 percent. 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 S-neurobacter baumannii 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, CL1102, our IL-17 tumor 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, Yajin will provide an overview of our financial results. Yajin.
Speaker Change: Looking forward to a potential approval later this year.
Not least CL 11 O two our IL seventeens humour body for the topical treatment of chronic plaque psoriasis or CPP.
Speaker Change: In the final stages of preparation for our global phase II dose finding trial and we intend to initiate this study in mid 2024.
Speaker Change: Plenty of exciting progress within our <unk> portfolio.
Speaker Change: I look forward to providing updates in our next earnings call now Jim will provide an overview of our financial results.
Jim: Thank you.
Jim: Now I will discuss our full year financial results compared to the prior year.
Speaker Change: In 2023 total net product revenues grew to 266 $370 million.
Speaker Change: This represents.
Jim: The equivalent of 25%.
Jim: Oh, a steady 1% constant currency basis.
Jim: Our revenue growth was driven by increased sales volumes in the launch of <unk>.
Jim: Partially offset by an increase in our sell through ebay TD securities.
Jim: Resulting from price reductions in connection with the additional <unk> deals.
Jim: South Rebase in connection with our lifting rose to $13 million for 2023.
Jim: This is not the only play a crucial role in maintaining patient access to our existing products.
Jim: Why don't you significantly expanded access for all the new product.
Dr. Yajing Chen: Thank you, Howard. Now I will discuss our four-year financial results compared to the prior year. Being 2023 total not part of that, it grew to 266.7 million. This represents year-over-year growth of twenty five, or 31% in constant currency.
Growth was also negatively impacted by the temporary effects of the hospital and the physician practices that resulted from industrywide anticorruption enforcement efforts in China in the second half.
Dr. Yajing Chen: Our revenue growth was driven by increased sales volumes and the launch of this grant, possibly offset by an increase in our sales rebate to distribute, resulting from price reduction in connection with additional unideal. Self rebates in connection with an ideal distance rose to $13 million for 2020. This NRBL listing plays a crucial role in maintaining patient access to our existing products on NRBL while significantly expanding access to our new products. Growth was also negatively impacted by the temporary effects on the hospital and the physician practice that resulted from industry-wide anti-corruption enforcement efforts in China during the second half of the year.
Jim: Now looking at each individual product.
Speaker Change: Thank you.
Speaker Change: Net product revenue increased 16% year over year.
Speaker Change: Year to $168 8 million exclude deal.
Driven by increased confidence in first line ovarian cancer and the duration of treatment improvement.
Speaker Change: Partially offset by an increase in sales in the fourth quarter in connection with the renewal.
Speaker Change: And are the only full.
Speaker Change: As a maintenance treatment.
Speaker Change: <unk> net product revenue.
Speaker Change: Following the launch in China in September 23 screens.
Speaker Change: We successfully negotiated for VB got strength and his team on that.
Dr. Yajing Chen: Now looking at each individual product. The Juna Net Product Revenue increased 16% year-over-year to $168.8 million in its third year on the net, driven by increased hot blood cells in first-line OVNQ.
Speaker Change: With pricing that took effect on January 1st 2024.
Speaker Change: <unk> net product revenue organically flat year over year at $47 million.
Dr. Yajing Chen: Any duration of treatment improved, although partially offset by an increase in sales rebates in the fourth quarter in connection with the renewal of the NRBL listing for ZJULA as a maintenance treatment. We've got net product revenue of $10 million following the launch in China in September 2020. We successfully negotiated for Vivigard's first listing on the NRBL with pricing that took effect on January 1st, 2024. Up to net product revenue was relatively flat year over year at $47 million.
Speaker Change: As continued growth in supplemental insurance coverage was offset by the disruption in hospital and physician practices, resulting from anti corruption.
Speaker Change: <unk> grew 29% year over year to $19 2 million increase and then this increased 316% to $21 $7 million.
Speaker Change: This growth was supported by the inclusion of HELOC.
Dr. Yajing Chen: As continuous growth in supplemental insurance coverage was offset by the disruption in hospital and physician practices resulting from anti-corruption activities. Chin Luck grew 29% year-over-year to $19.2 million, and the enemy's IRA increased 316% to $21.7 million. This growth was supported by the inclusion of Chinluck and the IV formulation of Mucira in the NRBL in the first quarter of 2020, partially offset by sales rebates in connection with the scenario listing, as well as sales rebates in the fourth quarter in connection with the inclusion of the oral formulation of Muzira, which became effective in January 2024. Turning now to our expenses, research and development expenses declined $21 million to $265.9 million, primarily due to decreased upfront and mileage payments for our license and collaboration agreement.
Speaker Change: Formulation can you say that in the end.
Speaker Change: In the <unk>.
Speaker Change: First quarter of 'twenty three.
Speaker Change: Partially offset by sales rebate ETF.
Speaker Change: Listing.
Speaker Change: Well as Dallas, maybe in the fourth quarter in connection with the inclusion of the oral formulation of <unk>, which became effective in January.
Speaker Change: Turning now to our expenses research and development expenses declined $21 million to $265 $9 million.
Speaker Change: Primarily due to decreased upfront and milestone payments from our license and collaboration.
Speaker Change: <unk> agreements.
Speaker Change: Partially offset by an increase in personnel compensation and related costs.
Speaker Change: General and administrative expenses grew $23 million to 281 $6 million, primarily due to higher general Sony.
Dr. Yajing Chen: Partially offset by an increase in personnel compensation and related expenses, Selling, general, and administrative expenses grew $23 million to $281.6 million, primarily due to higher general selling expenses to support the launch of VIVIBOX. 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 ongoing cost and efficiency initiatives. Zai Lab reported a net loss of $334.6 million for 2020, which improved by $108 million versus the prior year.
Speaker Change: To support the launch of this cost.
How should we offset a decrease in professional services fee.
Both R&D and SG&A expenses.
Speaker Change: Can you just may be declining as a percentage of revenue.
Speaker Change: And we expect this trend to continue after we thought about growing revenues in our ongoing cost efficiency initiatives.
Speaker Change: <unk> reported net loss of $334 $6 million for 2023, which improved by $108 million versus prior year.
Speaker Change: The decrease in NAV reflect our continued progress towards profitability, primarily achieving our product revenue growing faster.
Dr. Yajing Chen: The decrease in net loss reflects our continued progress towards profitability, primarily driven by 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 the property business. And with that, I would now like to turn the call back over to the operator to open up the line for the question. Operator.
Speaker Change: Net operating expenses.
Speaker Change: As increased interest income and decreased foreign currency.
Speaker Change: We are in a strong financial position ending the year with a cash position of <unk> $760 million.
Speaker Change: Compared to $1 billion as of December 30 <unk>.
Speaker Change: 2022.
Speaker Change: Based on our operating plan and our anticipated revenue growth.
Speaker Change: We expect to be able to fund our business.
Speaker Change: A new property.
Speaker Change: And with that I would now.
Speaker Change: I'd like to turn the call back over to the operator to open up the line for questions.
Speaker Change: Okay.
Speaker Change: Okay.
Operator: We would now like to open the line for questions. If you have a question, please press stars 1 and 1 at this time. To withdraw your question, please press stars 1 and 1 again.
Speaker Change: We would now like to open the line for questions. If you have a question. Please press star one and one at this time to withdraw your question. Please press star one on one again please.
Operator: Please limit yourself to one or two questions. Our first question comes from the line of Michael Yee from Jeffreys. Please go ahead; your line is open. Hi, this is Zhao Jingwen on the line for Michael E. Thanks for taking my questions and giving the great VIVGARD guidance, which is obviously above the consensus. I have a couple of questions. First, can you comment on what your assumptions are for the 17 million in 2024 VIVGARD sales guidance and what visibility you have to be able to guide the 17 million? And for the 1K, 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 recent investor concerns and rhetoric in Washington, D.C. about the Committee on CCP.
Speaker Change: Please limit yourself to one or two questions.
Our first question comes from the line of Michael <unk> from Jefferies. Please go ahead. Your line is open.
Speaker Change: Hi, this is charging with other life for Michael Thanks for taking my questions and given the great <unk>.
Michael: <unk>, which is obviously above the consensus I have a couple of questions maybe first.
Michael: Can you comment on what your assumptions are for the $17 million in 2020 for the core sales guidance.
Michael: And what visibility you have to be able to guide 70 mid <unk> for.
Michael: For the one K 1000, new patients added in January.
Michael: They are bolus waiting for and that would be a price to be treated or due to other factors in play.
My second question is about the recent investor concerns that a retiree in Washington, DC about the committee or CCP.
Josh Smiley: 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. Great. Thank you for the questions. It's Josh.
Michael: Maybe can you comment on what your confidence level is that you believe this won't impact biotech at all and what Youre seeing out there. Thank you.
Michael: Great. Thank you for the questions. This is Josh I'll.
Josh Smiley: I'll direct the questions to our leadership team here, but I think for the first two, I'll direct them back to me. First, on Vivgard. 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 a launch, but new patient starts are 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 patient starts, and 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.
Josh Smiley: Direct the questions to our leadership team here, but I think for the first two I'll direct them back to me.
Josh Smiley: First of all on <unk> as we've said, we're really pleased with the uptake we've seen so far.
Josh Smiley: We're monitoring all the normal leading indicators you would look at it in the launch but new patient starts is really important so I think our.
Josh Smiley: What gives us the confidence to say, we're on a path for $70 million or greater in 2024 is the rate of new patient starts that penetration.
Josh Smiley: We're seeing with <unk>.
Josh Smiley: <unk>, we focused in the fourth quarter on the top 600 hospitals, which make up about 80% of the sales opportunity will expand that to a 1000 hospitals out there in the <unk>.
Josh Smiley: We'll expand that to 1,000 hospitals here in the first half of the year now that we have the 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. 1,000 patients in January, as we mentioned, is a really good start. And I think it's obviously very early in the launch.
Josh Smiley: First half of the year.
Josh Smiley: Now that we have in our Dl listing.
Josh Smiley: And one of the things we look at there is how quickly the hospitals adopt the <unk>.
Josh Smiley: National listing into their local formularies, we're off to a good start there.
Josh Smiley: Patients in January as we mentioned I think is a really good start and it's I think it's.
Josh Smiley: It's obviously, it's very early in the launch.
Josh Smiley: 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 that we have 1,000 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 reimbursement. But I think, for the most part, we're quite pleased with the absolute magnitude of the number, and it gets us off to a good start this year.
Josh Smiley: To get into too many details there we'll keep updating.
Josh Smiley: As we go through the quarters during the year, but I think I think what we can say right now is with a 1000, new patients and of course as we mentioned last year. Some of those patients could have been patients that would have started.
Josh Smiley: In December but were held for the for the reimbursement, but I think for the most part where we are quite pleased with the absolute magnitude of the number and it gets us off to a good start in the year and again I would I would look at the $70 million as we know enough now to have confidence there and we're looking forward to continued progress.
Josh Smiley: 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 others, we've evaluated these bills and the tenor behind them closely. They don't touch on anything that we do.
Josh Smiley: Throughout the year.
Josh Smiley: I think on the second the second question about the political environment and the bio secure act or others.
Josh Smiley: We've evaluated these these bills and the tenor behind them closely.
Josh Smiley: They don't touch on anything that we do and where we're quite confident that the.
Josh Smiley: 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 China and, over time, to the rest of the world. Thank you.
Josh Smiley: As proposed now.
Josh Smiley: Those are activities won't have any impact on what we do as a biotech company focused on bringing great innovative medicines to patients in China and overtime to the rest of the world.
Josh Smiley: Yes.
Speaker Change: This is great. Thank you.
Josh Smiley: Thank you. We'll now move on to our next question. Our next question comes from the line of Anupam Rama from J.P. Morgan. Please go ahead; your line is open. 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 anti-corruption efforts in China have kind of played out and won't have a lingering impact moving forward?
Speaker Change: Thank you.
Speaker Change: We will now move on to our next question.
Speaker Change: Our next question comes from the line of <unk> Rama from Jpmorgan. Please go ahead. Your line is open.
Rama: Hey, guys. Thanks, so much for taking my question.
Rama: Maybe just a broader question for me, but evident 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.
Josh Smiley: Thanks so much. 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 that 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 a 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, you know, have had no impact that we've seen from the historical efforts there. So we're, you know, we're looking forward to a good year of operation. Thanks so much for taking the question. Thank you. Thank you. We'll now move on to our next question. Please stand by.
Rama: Thanks, Dan.
Rama: Josh again.
I think burst.
Rama: 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.
Rama: In a way that.
Rama: Both of us.
Rama: <unk> is in patients and so on so I think that's what we tend to look at I think on a broader level.
Rama: 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.
Rama: The highest standards.
Rama: No impact that we've seen.
Rama: The historical efforts there. So we're looking forward to a good year operationally here.
Speaker Change: Thanks, so much for taking my questions. Thank you.
Speaker Change: Thank you we will now move onto our next question.
Speaker Change: Please stand by.
Josh Smiley: Our next question comes from the line of Louise Chen from Cantor. Please go ahead, your line is open. Hi, thanks for taking my questions here. So I wanted to ask you about CIDP. If you do get approval, how do you think the uptake will be relative to what you've seen right now for myosinogravis? And then which is a bigger opportunity for you, MG or CIDP? Thanks, Louise
Speaker Change: Our next question comes from the line of Louise Chen from Cantor. Please go ahead. Your line is open.
Louise Chen: Hi, Thanks for taking my questions here. So I wanted to ask you on <unk>, if you do get approval.
Louise Chen: Do you think the uptake will be relative to what you're seeing right now for myasthenia gravis and then what's the bigger opportunity for you engineer see IDP. Thank you.
Dr. Harold Reinhart: 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. Please go ahead, Harold.
Speaker Change: Thanks, Louise I'm going to ask Harold to talk a little bit about <unk>.
Harold: Answer your question and if Theres anything to wrap up on I'll come back with yet.
Dr. Harold Reinhart: 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. Patients currently really lack something like an F-contagion mod that helps improve symptomatology and break the downslope of their disease. A lot of these patients end up in wheelchairs.
Harold: Please go ahead Sir.
Harold: Yes, hi, Thank you for the question.
See IDP into cases, rather unique it is.
Harold: Medical need situation here much more so than in many other indications for auto immune diseases.
Speaker Change: These patients currently really lacked something Nike <unk>, it helps improve symptomatology and to break the.
Speaker Change: Yes.
Speaker Change: Slope of a disease and lot of these patients end up in regions. So.
Dr. Harold Reinhart: So right now, as we said earlier, treatment is just steroids. And at the end of the rope, you get patients who are constantly getting IVIG infusions. So we see really a very, very important role for efgart-kittumot in that population. This efgart-kittumot treatment here is a weekly treatment for the duration of the symptomatology.
Speaker Change: So right now as we said earlier excuse me is just steroids and at the end of the rope you get patients who are getting constantly IV infusions. So we see really a very very important role for <unk> in that population.
Speaker Change: This effort to teach them a treatment here is a weekly treatment for the duration of the symptomatology. So it has a major impact on our financials. Thank you.
Dr. Harold Reinhart: So it has a major impact on our financials. Thank you. I would just add, as Harold mentioned, there's a significant unmet need here and it's a very big opportunity. But I don't think at this point, Louise, we're going to be excited about both of them.
Speaker Change: I would just add as Eric mentioned, there is a significant unmet need here.
Speaker Change: It's a very big opportunity I don't I don't think at this point.
Speaker Change: We're going to be excited about both of them I think they both present large opportunity for <unk>.
Josh Smiley: I think they both present large opportunities, both GSA and CIDP, and we're looking forward to progressing the CIDP approval process and being ready to go there. Thanks. Thank you. Our next question comes from the line of Yigal Nochomovitz from Citigroup. Please go ahead, your line is open. Yeah, hi.
Speaker Change: The IBP and we're looking forward to progressing the tid.
Speaker Change: Pete.
Speaker Change: Approval process, and we'll be ready to go there. Thanks.
Speaker Change: Thank you.
Speaker Change: Thank you, we'll now move on to our next question.
Speaker Change: Our next question comes from the line of vehicle not sure Mohit <unk> from Citigroup. Please go ahead. Your line is open.
Josh Smiley: Thanks very much. On Vivgard, I think Josh 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?
Mohit: Yes, hi, thanks very much.
Mohit: On the <unk> I think Josh you mentioned it was 32000 per year based on clinical study usage.
Mohit: Thinking up with what Youre seeing in the real world in terms of the average number of cycles and average vials for four week cycle or is that fairly consistent with the clinical trial experience so far thanks.
Josh Smiley: Thanks, Yigal. I'll ask Harold to comment, but I think, you know, it's early in the launch. We have no reason to believe that, you know, we're going to see things that are vastly different than what we're seeing around the world.
Speaker Change: Thanks a.
Speaker Change: I'll ask Carol 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 are excited about the starting point, but I don't know that we have a lot more of that.
Dr. Harold Reinhart: 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, not really.
Speaker Change: Offer now Harold if you have any any comments you want to make.
Dr. Harold Reinhart: In this case, we are still too early in the use of this vaccine and the pattern and the numbers of cycles that we would expect to see. Right now, given the same labeling as in the U.S., 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. Okay, next. And then, Josh, you sort of referenced that the year-on-year growth for the four products in the market, not including Vivgard, would be comparable to 2023 year-on-year growth. However, if you, you know, if you look at the trajectory from Q3 to Q4 in 2023 for Zajula, Optune, and Cleanlock, I guess it's a little unclear how you're going to be For Nazira also, you know, it was a very, very large number.
Harold: Not really in this case, we are still too early in the youth and the pattern and the numbers of cycles that we would expect to see.
Speaker Change: Right now given the same labeling in the U S is soon we assume very similar uptake. However, this needs to be further defined in <unk> future updates here.
Be able to give you the details that you probably want to hear.
Speaker Change: Okay. Thanks.
Speaker Change: And then Josh you sort of referenced that the year on year growth for the four products in the market not including <unk>.
Speaker Change: Would be comparable to 2023 year on year growth.
Speaker Change: However, if you look at the trajectory from Q3 to Q4 and 2023 for the upturn in Clinton lock.
Speaker Change: I guess, it's a little unclear how you how you are going to be able to achieve the same year on year growth for those.
Speaker Change: <unk>.
Zero.
Speaker Change: It was a very very large number so.
Josh Smiley: So could you just kind of expand a little bit on how you're thinking about that year-on-year growth number given what we're seeing in the second half of 2023 for Cleanlock, Optune, and Zajula? Thanks, Yigal. 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 you take out the rebate comparison or drag, growth's more like 19%.
Speaker Change: Could you just kind of expand a little bit on how you are.
Speaker Change: Thinking about that year on year growth number given given what we're seeing in the second half of 2023 for for Clinton lock up to and into July.
Speaker Change: I think first for Q4, when I remind everybody that the.
Speaker Change: Q4 growth rate for the jeweler certainly impacted by <unk>.
Speaker Change: Rebates associated within our Dl. So I think if you look at the portfolio overall for Q4, and you take out the rebate comparison or drag.
Speaker Change: Growth's more like 19%, so I think.
Josh Smiley: So I think certainly for Zajula, we saw market share grow through the year, and we expect it to continue to grow in 2024. So I think that product is performing well, and we will continue to push it. I think with the other three, I mean, between the three of them, there are some ups and downs and otherwise.
Speaker Change: Certainly for <unk>, we saw market share growth through the year.
Speaker Change: And we expect to continue to grow in 2024, so I think that that product is performing well and we'll continue to push it.
Speaker Change: I think with the other three I mean between the three of them. There are some ups and downs and otherwise I think we as IRA.
Josh Smiley: I think with Zyra, with the NRDL listing 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. Kinmok is performing about as we would expect.
Speaker Change: With the NRG holistic now for the oral formulation I think we are in good position to continue to see.
Speaker Change: Good growth for that product in 2024.
Speaker Change: With opportune at the medical device. So there were some.
Speaker Change: Challenges I think.
Speaker Change: For that product overall, but we expect to grow grow.
Speaker Change: <unk> is an important benefit to patients.
Speaker Change: We expect to continue to grow that 24, Ken Mark is performing about what we would expect it's a small product, but it's an important foundational.
Josh Smiley: It's a small product, but it's an important foundational drug for us as we think about gastric cancer. So I think you put those all together, and there's no reason to believe that the overall sales growth we saw in 2023 can't be replicated. Okay, thanks. And then just the last question on the IL-17, I think you mentioned you're starting a global study on plexoriasis. There was some discussion, you know, in past meetings over the years with respect to partnering that globally with a large pharma. Where does that stand?
Speaker Change: Drug for us as we think about gastric cancer. So I think you put those all together there's no reason.
Speaker Change: To believe that the overall sales growth we saw in 2023 can't be replicated in 'twenty four.
Speaker Change: Okay. Thanks, and then just last question on the on the IL 17.
Speaker Change: I think you mentioned youre, starting the global the global study in psoriasis.
Speaker Change: There was some discussion and passed and passed.
Speaker Change: Meetings over.
Speaker Change: Over the years with respect to partnering that globally with a large pharma.
Jonathan Wang: And can you just update us on your strategy for that product? Harold, you can comment on the study. I think we're excited to get going, begin to create clinical data. Unsponsored ADR, Harold, maybe you can give us a couple more.
Speaker Change: Does that stand and can you just update us on your strategy for that product. Thanks.
Speaker Change: As you can comment on the on the study I think we were excited to get going in.
Speaker Change: I'll begin to create clinical data then we will evaluate our options as we proceed.
Speaker Change: Harold that you can give us an update.
Jonathan Wang: Yeah, thank you. Yes, we are happy to, you know, 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. Yeah, I think, you know, we'll evaluate as the data comes in, but it's probably too early at this stage to think that part. Thank you, Yigal.
Harold: Yes. Thank you, yes, we are happy to go into phase III with this program and as far as the question about partnering.
Harold: <unk> always open to partnering offers and looking at increasing value here for the product.
Otherwise I would like to do for the question to Jonathan who is on the call.
Jonathan Wang: Yes. Thank you.
Jonathan Wang: Evaluate as the data coming but it's probably too early at this stage to think about partnering.
Jonathan Wang: Okay. Okay. Thank you. Thank you. We'll now move on to our next question. Our next question comes from the line of Lin Hai Zhao from Goldman Sachs. Please go ahead; your line is open.
Jonathan Wang: Thank you okay.
Jonathan Wang: Okay. Thank you.
Speaker Change: Thank you.
We will now move onto our next question.
Speaker Change: Our next question comes from the line of Lin Hi, Zhao from Goldman Sachs. Please go ahead. Your line is open.
Rafael Mato: Hi, thanks for taking my question. Just wondering about opt-in, we know that there are indication expansion opportunities, particularly we have two phase three readouts in 2024, and we're planning to file for the second line of most outline cancers in China following our partners filing in FDA. So wondering if 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 Chinese 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 Raphael, why don't you address the question? Yes, thank you. This is Rafael.
Speaker Change: Alright, Thanks for taking my question just wondering for opt in and we know that.
Speaker Change: There are indication expansion opportunities, particularly we have two phase III readouts in 2024, and we are planning to following.
Speaker Change: For the second line non small cell lung cancer in China following our partners following FDA.
Speaker Change: So.
Speaker Change: I'm wondering if the management can share a bit more on the indication expansions, particularly for these three indications and or so.
Speaker Change: With all the debates on the second line non small cell lung cancer with the law with the aluminum data.
Speaker Change: Can you share a bit more color on our communications with the.
Speaker Change: China regulators about the potential.
Speaker Change: <unk> and how we are going to address potential concerns on that on that aspect and on that for 2028.
And as part of our 2 billion revenue target how much do you see revenue contribution from <unk> in 2028.
Speaker Change: Raphael why don't you address the question please.
Yes.
Raphael: Yes. Thank you this is rafael.
Rafael Mato: Maybe I'll start with Lunar 2. And, as I said in the prepared remarks, another company has announced that the FDA accepted the pre-market authorization for Lunar 2 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 the China subset analysis for that. And we're collaborating, as I said, really well with our partners, NovoCure, 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 regard to additional indications, NovoCure has announced some of those. I guess the one that's most immediate is the LUNAR2 study, which includes checkpoint inhibitors and chemotherapy plus the device in frontline non-small cell lung cancer, a plain non-containing regimen.
Raphael: I'll start with lunar two.
Raphael: As I said in the prepared remarks.
Raphael: Another player has announced.
Raphael: The FDA has accepted the.
Raphael: Pre market authorization in January.
Raphael: And as you know the review time is on their 90 day.
Raphael: You ask about <unk>.
Raphael: So with the regulatory authorities.
Raphael: In China, we are.
Raphael: Our starting dose interaction. So we have a really good collaboration with our partner.
Raphael: And our intention is to file this year.
Raphael: And we will need for that.
Raphael: Uh huh.
Raphael: China subset analysis.
Raphael: And we're collaborating.
Raphael: Ted.
Raphael: It really work with our partners network here too.
Raphael: Be able to file this year.
Raphael: So.
Raphael: Obviously.
Raphael: We'll see how it goes with FDA, but as I said.
Raphael: You may have seen acceptance and then with regards to additional indications.
Raphael: Novacare Hasan al.
Raphael: Some of those I guess the one that's most immediately send lunar two study.
Raphael: Which includes checkpoint inhibitors, and chemotherapy plus or minus the device in front line non small cell lung cancer.
Raphael: Platinum containing regimen.
Rafael Mato: We are considering participating in that trial and having discussions with them. And then there's an ongoing study with, I think, checkpoint inhibitors for patients with high DBM scores, which is a phase 2 study, which we're awaiting the results. But in terms of phase 3 studies, the most important readouts are medicine for small cell lung cancer patients with brain metastasis, as well as locally advanced pancreatic cancer, a PANOVA trial.
We are considering participating in that trial and any discussions with them.
Raphael: And then there are some ongoing study.
Raphael:
Raphael: Okay.
Checkpoint inhibitor for patients with <unk>, which is self paced society, which we're awaiting the results, but in terms of phase III studies.
Raphael: Important readouts are medicine, non small cell lung cancer patients with brain metastases.
Raphael: As well as locally advanced pancreatic cancer trial, we participate in both of those studies have put sufficient patients.
Rafael Mato: We participated in both of those studies. We put in 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 in, the ones that we have that we are awaiting results on. And definitely, we are committed to filing with Lunar and, as I said, have already started interactions with the device division of NMDA. As it relates to the 2028 composition, you know, we looked at a range of outcomes when we put together that guidance and that goal.
Raphael: We are waiting the results of those trials, which should be this year and then we'll add a coordinating so.
Raphael: Is it sort of.
Raphael: An overview of where we are with all of this.
Raphael: Programs.
Raphael: Future programs that we may participate the ones that we have that we are awaiting results and definitely we are committed to.
Raphael: Filing with lunar and as I said started interactions already with the device division of the NMDA.
Raphael: I think as it relates to the 2028 composition, we looked at a range of op.
Raphael: 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.
Josh Smiley: It wasn't dependent on any single product, although what I can tell you for sure is VivGuard is, you know, the start that we have there and our excitement around GMG and CIDC is, I think, the biggest driver towards what puts us on the path to the 2028 goals. Thank you. Thank you. Thank you. We'll now move on to our next question. The next question comes from the line of Jonathan Chang from Lear Inc. Partners. Please go ahead, your line is open. Hey guys, this is Matt Kalper on behalf of Jonathan.
Raphael: With regard is.
Raphael: The start that we have there and our excitement around <unk>.
Raphael: CMG and CIBC I think is the biggest driver towards.
What puts us on the path to the 2028 goals. Thank you.
Speaker Change: Thank you.
Speaker Change: Thank you, we'll now move on to our next question.
Speaker Change: Our next question comes from the line of Jonathan Chang from Leerink Partners. Please go ahead. Your line is open.
Speaker Change: Hey, guys. This is Matt copper 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 NR deal renewal cycles, and then also in the context of adding additional indications such as <unk>.
Jonathan Wang: Thanks for taking my question. I was just wondering if you could discuss how you see the pricing of VISGARD 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. I'll ask Jonathan to take that one, please.
Speaker Change: Thank you.
Speaker Change: Thanks, Matt I'll ask John Jonathan to take that one.
Jonathan Wang: Thanks for the question. First, we achieved a good price at the end of last year in the NRDR negotiations, so we're off to a very good starting point. I think NRDL is also evolving, and we do see positive trends that the government is increasingly supportive of innovative and differentiated products.
Jonathan: Sure. Thanks for the question look I think first we achieved a good price at the end of last year and the amount of the negotiation.
Jonathan: So we're off to a very good starting points.
Jonathan: And I think <unk> is also evolving and we do see positive trends at the government increasingly supportive of innovative and differentiated products.
Jonathan Wang: Vivgard being the only in class and addressing a very large medical need in China is a program which, you know, we see that the government supporting and we do expect to maintain a good price. Also, if you look as a jeweler, we maintain a very good price in the most recent negotiation. You know, so we feel pretty good about the pricing at this time. Got it. Thank you. Thank you. We'll now move on to our next question, which comes from the line of Jacqueline from Morgan Stanley. Please go ahead; your line is open. Hi, good morning, everyone.
Jonathan: They've got being the only cost and addressing a very large unmet medical need in China.
Jonathan: Is a program, which we see that the government supported and we do expect to maintain good price.
Jonathan: So if you look at the July we maintained very good price in the most recent negotiation.
Jonathan: So we feel pretty good about the pricing at this stage.
Speaker Change: Thanks, Sean.
Speaker Change: Got it.
Speaker Change: Thank you.
Speaker Change: We will now move onto our next question.
Speaker Change: Our next question comes from the line of Jacqueline from Morgan Stanley. Please go ahead. Your line is open.
Jacqueline: Hi, Good morning, everyone and thank you for taking my questions I have a couple of quick questions first one again on the fifth car I'm curious to know if theres any color you could share in terms of the patient background.
Operator: And thank you for taking my question. I have a couple quick questions. First one, again, on the VivCar. 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?
Jacqueline: That we've seen since the fourth quarter and also in China.
Jacqueline: What proportion of them were refractory versus kind of in the early on it's really upsetting ancillary refractory ones in the hall.
Dr. Harold Reinhart: And for the refractory ones, you know, what might be the breakdown between those refractory to conventional oral immunotherapies versus alternative biologics that are on the VEDCAR? And just two really quick questions on commercialization. One, as you mentioned earlier, we're looking to break into 1,000 hospitals by the end of this year, and I think we're at 150 right now. Curious to know about how the commercial team is in place, or is it kind of still an ongoing effort for more recruitment? And also for Optune, you know, assuming that we have success in the Panovo 3 studies and others, will we rethink in terms of getting reimbursement coverage in China, considering the significantly larger patient population? Thank you. Thanks, Jack.
Jacqueline: What might be the breakdown between refractory to the conventional oral immuno therapies versus the alternative biologics.
Speaker Change: And just two really quick question on commercialization one I think you mentioned earlier, we're looking to break.
Speaker Change: <unk> 1000 hospitals by end of this year and I think we're at 150 right now curious to know about how the commercial team is in place or is it kind of showed ongoing effort to more recruitment.
Speaker Change: So for <unk>, assuming that we have.
Speaker Change: Access from the <unk> studies and others.
Speaker Change: We rethink in terms of the getting reimbursement coverage in China, considering the significant larger patient size.
Speaker Change: Thank you.
Josh Smiley: I'll ask Harold to talk a little bit about Vivgart patients, obviously, very early in the launch, but Harold, if you want to make a comment. 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 NRDL 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 mobilize, we believe, as NRDL 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 that comes in after steroid use. It's not a drug for refractory patients. Only it is a patient selection that we see right in the middle is a bulk of patients with GMG that start to lose control with steroids alone or run into side effects with steroids.
Speaker Change: Thanks, Jack I'll ask Harold.
Harold: Talk a little bit about the patients obviously, it's very early in the launch but their argument to make a comment.
Harold: Yes.
Speaker Change: You for the question again.
Speaker Change: Patient.
Harold: Patient background.
Harold: We see so far is treated as a background of those patients who were prior to any idea reimbursement. So those patients we would assume.
Harold: In patients who are somewhat more seeking more.
And possibly close to the refractory.
Harold: Part of the disease cycle. However, this will all normalize we believe in.
Harold: And at the end of pricing kicks in and we should expect a similar kind of patient population going forward that has been seen in the studies and also as the United States. So this is a drug which comes in after <unk>.
<unk> yeah.
Harold: The truck for the refractory patients.
Harold: Only.
Harold: The selection that we see right in the middle is the bulk of patients before with TMT.
Harold: Two.
Harold: Lose control with steering Salone, a run through just trying to fix with steroids.
Dr. Harold Reinhart: Thank you. It is fairly early in the day, and we shall provide updates as time goes on and as we have a more normalized situation as far as under NIDL pricing conditions. Thank you. 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 of about 80% of the sales opportunity that we were focused on. With NRDL listing, we always planned 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 and the reps. We'd expect all of that to be complete by the first half of this year.
Speaker Change: Thank you.
Speaker Change: Yes, it's fairly early in the day and we shall provide updates as time goes on and as we have a more normalized situation as far as.
Speaker Change: NPL pricing conditions. Thank you alright.
Speaker Change: To your question about.
Speaker Change: The commercialization effort. So when we launched in September we had 100 sales reps will be focused on the top 600 hospitals with as I mentioned earlier were made up of.
Speaker Change: About 80% of the sales opportunity that we were focused on.
Speaker Change: Within our Dl listing we always plan to move from 100 reps to 150 were in the middle of that expansion right now and we would increase our target Hospital list from 600 to 1000 and that comes with the expansion of the reps. We would expect all of that to be complete over the first half of this year. So.
Josh Smiley: So I think as we 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. Yeah, it's also evolving very rapidly. As you recall, 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.
Speaker Change: As you get into the second half of the year will be at what we believe to be full strength and I think thats, that's sufficient to cover the the opportunity given how concentrated the.
Speaker Change: Prescribing and the.
Speaker Change: The patient basis here so.
Speaker Change: So again, we're excited about what we're seeing so far and we think the opportunities well defined and in front of us.
Speaker Change: Jonathan I don't know if you have any comment you want to make on sort of a longer term pricing policy opportunities for for medical devices and our team they put in there yes.
Jonathan: It's also evolving very rapidly.
Jonathan: As you recall.
Jonathan: About a year and half ago, the government, what's having dropped proposals on the medical device.
Jonathan: An ideal inclusion.
Jonathan: They haven't come up with a more formal.
Jonathan Wang: So we eagerly wait for that. We think if that happens eventually, obviously, Optune would benefit. But, you know, for now, I think, you know, commercial insurance is very important for Optune, and, you know, it's a viable market, just based on the, Thank you. I'm showing no further questions at this time. I will now turn the call back over to Zai Lab CEO Samantha Du for closing remarks. Thank you. 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. This concludes today's conference call. Thank you for participating. You may now disconnect. Speakers, please stand by. Thank you for watching!
Jonathan: Guidelines, yet so we're equally away for that we think that that debenture, obviously option.
Jonathan: Benefit for now I think.
Jonathan: Moshe insurance is very important for four of June.
Jonathan: And I as the viable market just based on that.
Speaker Change: Thank you.
Speaker Change: Thank you.
Speaker Change: Thank you.
Speaker Change: I am showing no further questions at this time I will now turn the call back over to sign that CEO Samantha Du for closing remarks.
Ying Samantha Du: Thank you operator.
Ying Samantha Du: I wanted to thank everyone for taking the time to join us.
Ying Samantha Du: On the call today.
Ying Samantha Du: Yes, Chris.
Ying Samantha Du: We look forward to updating you again after the first quarter of <unk>.
Speaker Change: Operator, you may now disconnect the call.
Speaker Change: This concludes today's conference call. Thank you for participating you may now disconnect speakers. Please standby.
Speaker Change: Okay.
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Speaker Change: Okay.
Speaker Change: Yes.
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