Q1 2024 Zai Lab Ltd Earnings Call
Okay.
Yeah.
Speaker Change: Hello, Ladies and gentlemen, thank you for standing by and welcome to say labs first quarter 'twenty 'twenty four financial results conference call.
Unknown Executive: Hello, ladies and gentlemen. Thank you for standing by, and welcome to Zai Lab's first quarter 2024 financial results conference call.
Operator: At this time, all participants are in listen-only mode. Later, we will conduct a question and answer session, and instructions will follow at that time. As a reminder, today's call is being recorded. It is now my pleasure to turn the floor over to Christine Chiou, Senior Vice President of Investor Relations. Please go ahead.
Speaker Change: At this time, all participants are in listen only mode.
Speaker Change: Later, 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 over to Christine Chow Senior Vice President of Investor Relations. Please go ahead.
Christine Chiou: Thank you, operator. Good morning.
Christine Chiou: Thank you operator, good morning, good evening and welcome to dial up the first quarter of 2024 earnings call.
Christine Chiou: Today's call will be led by doctors never do <unk> founder CEO and chair person.
Christine Chiou: He will be joined by Josh Smiley, President and Chief operating Officer, Dr. Rafael Amado, President and head of Global Oncology Research and development Soccer, Howard Reinhart, President and head of global development neuroscience, autoimmune and infectious diseases and Dr. <unk> Chang Chief Financial Officer.
Christine Chiou: Jonathan Wang.
Speaker Change: This officer will also be available to answer questions. During the Q&A portion of the call.
Speaker Change: As a reminder, during today's call, we'll be making certain forward looking statements based on our current expectations. These statements are subject to numerous risks and uncertainties that may cause the actual results to differ materially from what we expect due to a variety of factors, including those discussed in our SEC filings.
Speaker Change: We will also refer to product revenue growth rates on a constant exchange rate basis, which is a non-GAAP financial measure.
Speaker Change: Please refer to our earnings release furnished with the SEC on May eight 2024 for additional information on these non-GAAP financial measure at this time. It is my pleasure to turn the call over to Dr. Samantha Du.
Christine Chiou: Good evening, and welcome to Zai Lab's first quarter 2024 earnings call. Today's call will be led by Dr. Samantha Du, Zai Lab's Founder, CEO, and Chairperson. She will be joined by Josh Smiley, President and Chief Operating Officer, Dr. Rafael Amado, President and Head of Global Oncology Research and Development, Dr. Harald Reinhart, President and Head of Global Development, Neuroscience, Autoimmune, and Infectious Diseases, and Dr. Yajing Chen, Chief Financial Officer.
Ying Du: Thank you Christine.
Ying Du: Good morning, and good evening to all who are joining us today.
Ying Du: I'm excited to be here.
Ying Du: Share with you.
Ying Du: Felt from our first quarter.
Christine Chiou: Jonathan Wang, 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 our actual results to differ materially from what we expect due to a variety of factors, including those discussed in our SEC filing. We will also refer to product revenue growth rates on a constant exchange rate basis, which is a non-GAAP financial measure.
Speaker Change: But before I do so I want to start with a few opening comments.
Christine Chiou: Please refer to our earnings release, filed with the SEC, on May 8, 2024, for additional information on this non-GAAP financial measure. At this time, it is my pleasure to turn the call over to Dr. Samantha Du.
Speaker Change: We started signing up without reaching debuted a truly innovative and integrated Biopharma company.
Speaker Change: Focused on bringing innovative medicines to address the unmet medical need.
Speaker Change: Patients in China and around the world.
Speaker Change: We have spent the past two years building, our infrastructure capability and pipeline.
Speaker Change: To get us where we are today.
Speaker Change: Well and you have a period of robots cool.
And by the late stage pipeline.
Speaker Change: Of course, I know best in class product.
Speaker Change: We're also advancing our global pipeline.
Speaker Change: Well, we have three in the clinic today.
Speaker Change: And we expect to add new China and globally.
Speaker Change: Each year through both internal discovery and business development.
Speaker Change: This year, we expect three new product approvals.
Speaker Change: Which follows the launch of Big Cock late last year.
Speaker Change: Over like two to three years.
Half the opportunity.
Speaker Change: Multiple potential blockbuster product.
Speaker Change: Many of those assets I expect it.
Speaker Change: They'll contribute significantly toward like Robyn.
Speaker Change: Beyond 'twenty to date.
Speaker Change: As we scale our business.
Speaker Change: We'll continue to expand our operational efficiency.
Speaker Change: Improve our productivity.
Ying Du: Team, and good morning and good evening to all who are joining us today. I'm excited to be here to share with you the results from our first quarter. But before I do so, I want to start with a few opening comments.
Speaker Change: Our first quarter results demonstrate our progress.
Speaker Change: Each of this area.
Speaker Change: Some commercial execution.
Speaker Change: Increasing productivity and pipeline.
Speaker Change: Pipeline progress.
Speaker Change: We expect them to Sidney for to be a strong year for satellite.
Speaker Change: We are on track to achieve the objectives outlined in our five year strategic plan.
Speaker Change: Including significant growth vehicle.
And achieving profitability by the <unk>.
Speaker Change: And the 10 day 25.
Speaker Change: With a strong balance sheet.
Speaker Change: Cash position of over 750 million U S D.
Speaker Change: Satellite is in a very good position.
Speaker Change: And with that I'll pass the call to Josh Josh.
Ying Du: We started Zai Lab with a vision to build a truly innovative and integrated biopharmaceutical company focused on bringing innovative medicines to address unmet medical needs for patients in China and around the world. We have spent the past few years building our infrastructure, capabilities, and pipeline to get us where we are today. We're entering a period of robust growth, driven by a late phase pipeline, and a first and best in class product.
Joshua L. Smiley: Thank you Samantha and thank you everyone for joining the call today, we had a good start to the year with robust revenue growth and continued advancements in our key clinical programs. Our total revenues grew 39% year over year to reach $87 $1 million. Our commercial performance was driven by strong execution with the launch of the guard and uptake across our exist.
Joshua L. Smiley: The portfolio.
Joshua L. Smiley: The July continues to maintain its leadership position in the PARP inhibitor class for ovarian cancer.
Joshua L. Smiley: The drivers of growth for us the jewel of remain increasing new patient penetration in first line ovarian cancer and extending the duration of treatment for patients in the maintenance setting Kim market New direct also showed solid growth benefiting from their NR Dl listings in 2023 together. These three products collectively grew 24% year over year.
Joshua L. Smiley: Opportune showed recovery some slowdowns in the second half of last year growing 49% sequentially from the fourth quarter.
Ying Du: We're also advancing our global pipeline. Well, we have three in the clinic today, and we expect to add new Chinese and global assets each year through both internal discovery and business development. This year, we expect three new product approvals, which follows the launch of Vivgard late last year. Over the next two to three years, we have the opportunity to launch multiple potential blockbuster products, and many of those assets are expected to contribute significantly to our revenue way beyond 2028, as we scale our business, continue to expand our operational efficiency, and improve our productivity.
Joshua L. Smiley: Now looking at <unk>. The launch is off to an excellent start in the first quarter alone. We estimate that nearly 2700, new patients were treated with mid garden.
Ying Du: Our first quarter results demonstrate our progress across each of these areas: Joint Commercial Execution, Increasing Productivity, and Pipeline Program. We expect 2024 to be a strong year for Zai Lab. We are on track to achieve the objectives outlined in our five-year strategic plan, including significant revenue growth and achieving profitability by the end of 2025, with a strong balance sheet and a CAD position of over 750 million USD. Satellite is in a very good position. And with that, I'll pass the call to Josh. Josh?
Joshua L. Smiley: Thank you, Samantha. And thank you, everyone, for joining the call today. We had a good start to the year with robust revenue growth and continued advancements in our key clinical programs. Our total revenues grew 39% year-over-year to reach $87.1 million. Our commercial performance was driven by strong execution with the launch of VivGuard and uptake across our existing portfolio. The Doula continues to maintain its leadership position in the PARP inhibitor class for ovarian cancer.
Joshua L. Smiley: Driving this strong initial uptake is our team's ability to execute on several important launch initiatives.
Joshua L. Smiley: Key drivers of growth for Zajula remain increasing new patient penetration in first-line ovarian cancer and extending the duration of treatment for patients in the maintenance settings. Kinloch and Uzira also showed solid growth, benefiting from their NRDL listings in 2023. Together, these three products collectively grew 24% year-over-year. Optune showed a recovery from slowdowns in the second half of last year, growing 49% sequentially from the fourth quarter.
Joshua L. Smiley: First <unk> NR Dl inclusion became effective on January one, which significantly enhances patient access.
Joshua L. Smiley: Now looking at VIVGARD. The launch is off to an excellent start. In the first quarter alone, we estimate that nearly 2,700 new patients were treated with VIVGARD. Driving the strong initial uptake is our team's ability to execute on several important launches. First, VivGuard's inclusion in the NRDL became effective on January 1st, which significantly enhances patient access. Since this inclusion, VIVGARD has been steadily added to hospital formularies, and we are making great progress in line with our expectations. Second, our targeted outreach to physicians has been very successful. We've engaged our top 1,000 hospitals, which account for 80% of the eligible patient population.
Inclusion with Gartner has been steadily added to hospital formularies, and we're making great progress in line with our expectations.
Joshua L. Smiley: Second our targeted outreach to physicians has been very successful.
Joshua L. Smiley: We have engaged our top 1000 hospitals, which account for 80% of the eligible patient population.
Joshua L. Smiley: Our highly specialized sales team of 150 reps is well equipped to support the launch in GMG but also upcoming launches of the subcutaneous formulation for this indication later this year and then for CIDP in 2025. Third, we are seeing high adoption from physicians. Nearly 900 healthcare professionals have now prescribed VIVGARD, and this number continues to climb. Feedback from physicians and patients continues to be positive, and we are focused on providing these key stakeholders with the best in class. We are tracking well to exceed $70 million in sales of Vivgart this year.
Joshua L. Smiley: Our highly specialized sales team of 150 reps is well equipped to not only support the launch in gmg, but also upcoming launches of the subcutaneous formulation for this indication later this year and then for <unk> in 2025.
Joshua L. Smiley: Third we are seeing high adoption from physicians nearly 900 health care professionals have now prescribed in garden and this number continues to climb.
Joshua L. Smiley: Feedback from physicians and patients continues to be positive and we are focused on providing these key stakeholders with best in class support.
Joshua L. Smiley: We are tracking well to exceed $70 million and sales of <unk>. This year.
Joshua L. Smiley: Our late stage pipeline also continues to advance nicely. We anticipate several approvals this year, including Repotrectinib in ROS1-positive non-small cell lung cancer, where we have seen a significant improvement in PFS versus current standard of care with CNS benefit.
Joshua L. Smiley: Our late stage pipeline also continues to advance nicely.
Joshua L. Smiley: We anticipate several approvals this year repo tracking nib and Ross <unk> positive non small cell lung cancer, where we have seen a significant improvement in PFS versus current standard of care with CNS benefit Salvador, the first pathogen targeted therapy addressing ABC infection, and the sub Q formulation of depth guard for Gmg.
Joshua L. Smiley: Saldor, the first pathogen targeted therapy addressing ABC infections, and the sub-Q formulation of Vivgart for GMG, which provides additional dosing flexibility for patients. Each of these opportunities has the potential to offer significant benefits to patients, and we look forward to launching these products in the second half of 2024. Looking ahead to next year, we have the potential to launch SubQ VIVGART in CIDP, followed by TIVDAC, CAR-XT, and Vemuratuzumab. Many of these potential blockbuster assets are relatively de-risked given their positive pivotal data or compelling proof-of-concept results, positioning us well for future growth.
Joshua L. Smiley: Which provides additional dosing flexibility for patients each.
Joshua L. Smiley: Each of these opportunities has the potential to offer significant benefit to patients and we look forward to launching these products in the second half of 2024 looking.
Joshua L. Smiley: Looking ahead to next year, we have the potential to launch <unk> and CIB P followed by Tim DAC, RXT and memory to the map.
Joshua L. Smiley: Many of these potential blockbuster assets, a relatively derisked given their positive pivotal data or compelling proof of concept results positioning us well for future growth.
Joshua L. Smiley: Now moving on to the cost and investment side of things, In 2024, we expect to maintain R&D expense at a similar level versus 2023 while modestly increasing sales and marketing. As we enter this next phase of significant revenue growth, we remain focused on efficient operations. This includes enhancing commercial efficiency, optimizing resource allocation, and increasing productivity throughout the entire organization. We will continue to execute financial discipline and cost management, and we expect significant operating leverage as our revenue growth meaningfully outpaces that of our operating expenses.
Speaker Change: Now moving on to the cost and investment side of the business.
Speaker Change: In 2024, we expect to maintain R&D expense at a similar level versus 2023, while modestly increasing sales and marketing expense.
Speaker Change: As we enter this next phase of significant revenue growth, we remain focused on efficient operations and this includes enhancing commercial efficiency optimizing resource allocation and increasing productivity throughout the entire organization. We will continue to execute financial discipline and cost management, and we expect significant operating leverage as our revenue growth.
Speaker Change: Meaningfully outpaces that of our operating expenses.
Joshua L. Smiley: This allows us to prepare for the next phase of growth for Zai Lab as we drive both revenues and profitability. I'm also pleased to announce that Andrew Zhu has joined as our chief commercial officer in Greater China. Andrew has more than 20 years of experience in marketing and sales management for innovative drug therapies and a proven track record of driving top line growth and managing large teams and product portfolios with significant revenue and competitive market.
Speaker Change: Laos us to prepare for the next phase of growth for XI lab, as we drive both revenues and profitability.
Speaker Change: I'm also pleased to announce that recently, Andrew joined as our Chief commercial officer, and Greater China, Andrew has more than 20 years of experience in marketing and sales management for innovative drug therapies, and a proven track record of driving topline growth and managing large teams and product portfolios with significant revenue in competitive markets.
Joshua L. Smiley: He brings rich experience in building innovative business models and resource integration, which will help us further enhance our commercial operations and drive sales and profit growth across Greater China. Overall, we continue to make great progress on each of our three corporate objectives, which are to drive revenue growth, achieve profitability, and expand our global pipeline. We are on track to reach profitability by the end of 2025, and with a cash position of over $750 million, we expect to be able to fund our operations and business development deals through profitability. And with that, I will now pass the call over to Rafael to discuss the great progress within our oncology.
Speaker Change: Rich experience in building innovative business models, and resource integration, which will help us further enhance our commercial operations and drive sales and profit growth across greater China.
Speaker Change: Overall, we continue to make great progress towards each of our three corporate objectives, which are to drive revenue growth achieve profitability and expand our global pipeline.
Speaker Change: We are on track to reach profitability by the end of 2025 and with a cash position of over $750 million, we expect to be able to fund our operations and business development deals through profitability and with that I will now pass the call over to Raphael to discuss the great progress within our oncology pipeline.
Rafael G. Amado: Thank you, Josh. Let me begin by highlighting some of the key progress updates in our oncology pipeline since our last earnings call, along with our next step. Starting with Fripotrexinib, our NDA was accepted by China NMPA with priority review status for ROS1 positive non-small cell lung cancer in both TKI naive and TKI pretreated patients, and we are expecting approval in the next few months. In China, gross wound rearrangement occurred in 2-3% of patients with advanced non-small cell lung cancer.
Raphael: 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.
Raphael: Starting with III protecting our NDA was accepted by China, and EMEA with priority review status for Russ one positive non small cell lung cancer in both <unk> and.
Raphael: And TK pretreated patients and we're expecting approval in the next few months.
Raphael: In China gross one way arrangements. According to two 3% of patients with advanced non small cell lung cancer.
Rafael G. Amado: There is a significant unmet need for these patients given the limited durability of clinical benefit due to the emergence of resistance to approved first-generation therapy. Treatment with Repotrectinib, a next-generation ROS1 and NTRK inhibitor, has been shown to result in high response rates with promising durability in patients with ROS1-positive non-small cell lung cancer, including in those with intracranial disease and in the post-first-line treatment setting Specifically, we've seen a durational response of 34.1 months and 14.8 months in TKI-nave and TKI-criterious patients, respectively.
It's a significant unmet need for these spaces given the limited durability of clinical benefit due to the emergence of resistance to approve first generation therapies.
Raphael: Fiddling with three protecting their next generation gross one and <unk> inhibitor has been shown to resulting in higher response rates with promising durability in basis with russwurm positive non small cell lung cancer, including in dose with intracranial disease and in the post first line treatment settings, which may address the limitations of first generation.
Raphael: Guy.
Specifically, we've seen a duration of response of $34, one months and $14 eight months take care.
Rafael G. Amado: With these results, we believe Reprotrectin has the potential to become a new standard of care for patients with ROS1-positive non-small cell lung cancer, including those whose tumors have developed mutations concerning resistance to previous treatment with ROS1 inhibitor therapy. Next, our tumor-treating peel franchise. This March, our partner NovoCure announced that the Phase 3 METIS clinical trial met its primary endpoint in patients with brain metastasis from non-small cell lung cancer. Patients treated with CT fields and supportive care exhibited a median time to intercranial progression of 21.9 months compared to 11.3 months in patients treated with supportive care alone, with a statistically significant p-value of 0.016.
Pre COVID-19 patients respectively.
Raphael: With these results we believe FIFA threatening that has the potential to become a new standard of care options for patients with west one positive non small cell lung cancer, including those with tumors has developed mutations confer resistance to previous treatment with <unk> inhibitor therapy.
Raphael: Next our tumor treating field franchise.
Raphael: This marks our partner Novocure announced that the phase III clinical trial met its primary endpoint in patients with brain metastases from non small cell lung cancer.
Raphael: Base yesterday with TTC, all sorts of border scare exhibited in median time to intracranial progression of $21 nine months compared to 11 three months in patients treated with supportive care alone with a statistically significant P value of <unk>.
Rafael G. Amado: PTCL therapy was well tolerated and was associated with sustained quality of life and neurocognitive function. Results from the method study will be presented at a late-breaking abstract at this year's American Society of Clinical Oncology annual meeting. We also expect another pivotal readout from T.T.
Raphael: One six.
Raphael: BT feel therapy was well tolerated and what's associated with sustained quality of life and neurocognitive function.
Raphael: We saw from them that this study will be presented at a late breaking abstract at this year's American Society of clinical oncology annual meeting.
Raphael: We also expect another pivotal readout from ticket yields in first line locally advanced pancreatic cancer by the end of this year.
Rafael G. Amado: Steele in first-line locally advanced pancreatic cancer by the end of this year. We continue to make great progress with Myotismab in collaboration with Amgen and are accruing to Fortitude 101 and 102 studies. These studies are evaluating a doublet and triplet combination, respectively, in first-line STFR2B-positive gastric cancer with overall survival as the primary endpoint. In addition to our late-stage partner programs, we have optimized our global development capabilities and are making excellent progress with our internal global programs, three of which we have disclosed and are in clinical studies. GL-1310 is our DLL-3 targeted homogeneous GAR-8 ADC with high affinity and specificity for DLL-3.
Raphael: We continue to make great progress with there Mike just a math in collaboration with Amgen and <unk> going to 42, one on one on one or two studies.
Raphael: These studies are evaluating a doublet and triplet combination respectively. In first line <unk> positive gastric cancer with overall survival as the primary endpoint.
Raphael: In addition to our late stage partnered programs, we have optimized our global development capability and are making excellent progress with our internal global programs three of which we have disclosed in our in clinical studies.
Raphael: <unk> 10 is DLR III targeted homogeneous.
Raphael: ADC with high affinity and specificity for CLO III.
Harald Reinhart: It utilizes a topoisomerase I inhibitor payload and has shown promising preclinical data, which we presented at the European Lung Cancer Congress in Prague. The program is advancing through a global phase I study in the United States and China for relapsed and refractory small cell lung cancer after progression on platinum-based therapy, and we expect to expand its geographic footprint as the trial progresses. This study will also include patients treated with a combination of our DLL3-ADC and a checkpoint inhibitor.
Raphael: It utilizes a topoisomerase one inhibitor payload unless shown promising preclinical data, which we presented at the European lung cancer Congress in Prague. The program is advancing through our global Phase III study in the United States or China for relapsed and refractory small cell lung cancer after progression on platinum based therapy.
Raphael: And we expect to expand its geographic footprint as the trial progresses.
Raphael: This study will also include patients treated with the combination of our DLL three ADC and a checkpoint inhibitor.
Harald Reinhart: Depending on the totality of the data, we could potentially see early clinical results at the end of 2024 or early 2025. Our discovery efforts are moving at a brisk pace, and we are progressing internally to discover product candidates. In addition, we continue to assess external opportunities across multiple modalities in focused areas of cancer biology with the goal of introducing new products in development this year as we continue to execute on our global development objective of generating at least one global IND per year.
Raphael: Depending on the totality of the data we could potentially see early clinical results at the end of 2024 or early 2025.
Raphael: Our discovery efforts are moving at a brisk space and we are progressing internally discovered product candidate.
Raphael: In addition, we continue to assess external opportunities across multiple modalities in focused areas of cancer biology with a goal of introducing new products in development. This year as we continue to execute on our global development objective of generating at least one global AMB per year.
Harald Reinhart: I am excited about the great progress we're making in oncology with our existing and future products. I look forward to the approval and filing of novel and best-in-class oncology drugs and to enhancing and executing on our regional and global pipeline. Now, I will turn the floor to Dr. Harald Reinhart to discuss the progress in our autoimmune, infectious disease, and neuroscience therapeutic areas.
Raphael: I am excited about the great progress, we're making in oncology with our existing and future products I look forward to the approval on filing of novel and best in class oncology drugs and to augment and execute on our regional and global pipeline.
Raphael: And now I will turn the floor to Dr. Harold Reinhart to discuss the progress in our autoimmune infectious disease neuroscience therapeutic area.
Harald Reinhart: Thank you, Rafael. Our Neuroscience Autoimmune and Infectious Diseases, or NSAID, franchise has also made significant progress in advancing our pipeline. Starting with RISC-V or FGAR-TGMOD, beyond what Josh shared about the progress of GMG, our Supplemental Biologics License Application for the Sub-Q formulation of RISC-V in CIDP was submitted to the National Medical Products Administration in China in April. There are approximately 50,000 patients diagnosed with CIDP in China, and today only a small fraction are able to achieve remission with available care.
Harald Reinhart: Thank you Rafael.
Speaker Change: Our neuroscience autoimmune and infectious diseases or <unk> franchise has also made significant progress advancing our pipeline.
Speaker Change: With regard to scar tissue Mont beyond what Josh said about the progress of TMT, our supplemental biologics license application for the sub Q formulation of misconduct in CIP was submitted to the National Medical products administration in China in April.
Speaker Change: There are approximately 50000 patients diagnosed with <unk> in China and today only a small fraction are able to achieve remission with available 10 <unk>.
Harald Reinhart: The majority of patients remain symptomatic, and the disease can have a debilitating impact on quality of life. Existing treatment options are limited and quite problematic given the general reliance on long-term steroid or chronic immunoglobulin therapy. In China, the situation is worsened due to the persistent shortage of IVIG therapy.
Speaker Change: The majority of patients remained symptomatic and the disease can have a debilitating impact on quality of life.
Speaker Change: Existing treatment options are limited and quite problematic given the general reliance on long term steroid or chronic immunoglobulin therapy.
Speaker Change: In China, the situation's worse due to the persistent shortage of IV therapy.
Harald Reinhart: As mentioned, we expect the approval of sub-q VFGaRT in GMG this year, which will provide patients with a second dosing option in addition to IV. Furthermore, we already know that FKTGMOD has great potential across multiple additional indications. Therefore, we will continue working with our partner IGENIX on indication expansion. We expect to join IGENIX in the registration study of efgatigimod in thyroid eye disease or TED in Greater China in the second half of this year.
Speaker Change: As mentioned, we expect the approval of <unk> in Gmg, this year, which will provide patients with the second dosing option. In addition to IV, we already know that <unk> has great potential across multiple additional indications. Therefore, we will continue working with our <unk>.
Speaker Change: <unk> an indication expansion.
Speaker Change: We expect to join our journey in the registration study of a scratchy two months in syros eye disease, or Ted ingredient, China in the second half of this year moving to car T. This is a first in class antipsychotic, combining centrally acting muscarinic agonist called <unk>.
Harald Reinhart: This is a first-in-class antipsychotic combining a centrally acting muscarinic agonist called xenomaline with a peripheral antagonist called traspium, which we are developing with our partner Corona, or now BNS, for patients with acute schizophrenia. In April 2024, BMS presented new interim long-term data from the Phase III Emergent Program at the Annual Congress of the Schizophrenia International Research Society. CARX-T demonstrated statistical and clinically meaningful improvement in the PANS score and a differentiated safety profile with continued lack of weight gain, metabolic dysfunction, and extrapyramide symptoms over a 52-week period of treatment.
Speaker Change: <unk> with a peripheral antagonist contrast, beam, which we are developing with our partner Corona or now BMS for patients with acute schizophrenia.
Speaker Change: In April 2020 for BMS presented new interim long term data from the phase III emerging program at the annual Congress of the schizophrenia International Research Society.
Speaker Change: <unk> T demonstrated statistical and clinically meaningful improvement in <unk> score.
Speaker Change: And a differentiated safety profile with continued lack of weight gain metabolic dysfunction and extra pyramidal symptoms over a 52 week period of treatment we.
Harald Reinhart: We expect to complete enrollment in a registrational bridging study in mainland China this year, the results of which would support our NDA filing for the treatment of schizophrenia in adults in early 2025. Additionally, we have yet another substantial opportunity for CAR-XT as a treatment for Alzheimer's disease with psychosis, 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, and there are no approved treatments for these patients.
Speaker Change: Expect to complete enrollment in the Registrational bridging study mainland China this year.
Speaker Change: Results of which would support our NDA filing for the treatment of schizophrenia in adults in early 2025.
Speaker Change: We have yet another substantial opportunity for car T as a treatment for Alzheimer's disease psychosis or ADP for short.
Speaker Change: Similarly, 8 million people with Alzheimer's disease in China, and about 45% of these patients displayed psychotic symptoms and there are no approved treatments for these patients.
Harald Reinhart: We will participate in the Phase 3 ADAPT2 and ADAPT3 clinical trials in ADP in Greater China starting in mid-2024. Regarding our infectious diseases portfolio, sulbactam, durlabactam, or suldur is a treatment for hospital-acquired and ventilator-associated bacterial pneumonia caused by Acinetobacter barmania. Our NDA submission is under priority review with the NMPA, with potential approval later this year. In China, there are 300,000 cases of Acinetobacter infections annually, with the majority of strains being carbapenem residue.
Speaker Change: We'll participate in the phase III adapt to ended at three clinical trials in ADP in greater China, starting mid 2024 regarding our infectious diseases portfolio saw back in <unk> <unk> is a treatment for hospital acquired and ventilator associated.
Speaker Change: Bacterial pneumonia caused by SCE tobacco Beaumont EI.
Speaker Change: Our NDA submission is under priority review with the MTA with potential approval later this year in China.
Speaker Change: 300000 cases of acinetobacter infections annually with the majority of screens being cobre Panama resistant.
Harald Reinhart: Patients have limited treatment options, and the mortality rate is around 43% even with the best available therapy. Last but not least, CL-1102, our IL-17 tumor body for the topical treatment of chronic plaque psoriasis, is in the final stages of preparation for a global phase two dose finding trial, and we intend to initiate the study in the second quarter of 2024.
<unk> have limited treatment options and the mortality rate is around 43%, even with the best available therapy and care less.
Speaker Change: Last but not least CL 11 O two our IL 17 tumor body for the topical treatment of chronic plaque psoriasis is in the final stages of preparation for a global phase II dose finding trial and we intend to initiate the study in the second quarter of <unk>.
Harald Reinhart: So, plenty of progress with clinical studies and two expected regulatory approvals from our NSAID portfolio in the near future. I look forward to providing updates at our next earnings call. And now, Yajing will give an overview of our financial results. Yajing. Thank you, Harald. Now, I will discuss our...
Speaker Change: 24 so.
Speaker Change: Plenty of progress with clinical studies, and two expected regulatory approvals from our <unk> portfolio in the near future I look forward to providing updates at our next earnings call.
Speaker Change: And now Jim will give an overview of our financial results. Jean. Thank you now I will discuss our first quarter 2024 financial results compared to the prior year period.
Yajing Chen: Thank you, Harald. Now I will discuss our first quarter 2024 financial results compared to the prior year period. Total net product revenues for the first quarter of 2024 were $87.1 million, compared to $62.8 million for the same period in 2023, representing year-over-year growth of 39%, or 43% on a constant currency basis. Our revenue growth was primarily driven by increased sales volumes, including from the launch of VizGuard, and decreased sales rebates to distributors, resulting from price reductions in connection with NIDO listings for certain products.
Yajing Chen: Now, looking at each individual product, the GMAT product sales were $45.5 million, an increase of 7% year-over-year from $42.7 million for the same period in 2023, due to increased hospital stays in first-line ovarian cancer and increased duration of treatment.
Jim: Total net product revenues for the first quarter of 'twenty 'twenty four were <unk> 87 on $1 million compared to $62 8 million.
Jim: Thank you Ed in 2010 leases representing year over year growth of 39% or 43% constant currency basis.
Jim: Revenue growth was primarily driven by increased sales volumes, including from the launch of these got any decrease self rebate to distributions, resulting from price reduction in connection with our IPO lifting.
Jim: Thanks.
Jim: Now looking at each individual product did you not products also were $45 5 million.
Jim: Kris of 7% year over year from $43 7 million for the same Q it in 2026.
Jim: June by increased hospital in first line ovarian cancer and increased duration of treatment.
Yajing Chen: ViviGuard's net product sales were $13.2 million for the first quarter of 2024, following the launch in China in September 2023 and its first listing on the NYBL, with pricing that took effect on January 1st, 2024. Our revenue growth was driven by extending physician and patient adoption, as well as increased patient access, as ViviGuard is added to hospital prominence, up to $12.5 million for the first quarter of 2024.
Jim: <unk> net product sales were $13 $2 million for the first quarter of 2024 following the launch in China in September 2023, and it first lifting and lobby young with pricing that took effect on January <unk> 2020 for our revenue growth was driven.
Jim: <unk> physician and patient adoption as well as increased patient access and maybe God is added to hospital formulary options.
Jim: <unk> net product sales was $12 $5 million for the first quarter of 2024, there was a sequential increase of 49% from the fourth quarter of 2023.
Jim: It continues the economy expected throughout 'twenty grateful.
Jim: Chuck Gorilla, 367% year over year to $6 1 million and then use IRI increased 81% to $9 99 for the first quarter 2024.
Yajing Chen: There was a sequential increase of 49% from the fourth quarter of 2023, with continued recovery expected throughout 2024. Chinlok grew 367% year-over-year to $6.1 million. And New Zaire increased 81% to $9.9 million for the first quarter of 2024. The growth was supported by the inclusion of Chinlok and the IV formulation of New Zaire in the NRDL in the first quarter of 2024, as well as the inclusion of the oral formulation of MISERA in the first quarter of 2024.
Jim: <unk> was supported by the inclusion of <unk> and the IV formulation of <unk> in the unlocking all in the first quarter of 'twenty closely.
Jim: As well as the inclusion of the oral formulation of <unk>.
Jim: In the first quarter of 2024.
Yajing Chen: Turning now to our expenses, research and development expenses were $54.6 million in the first quarter of 2024, compared to $48.5 million for the same period in 2023. This increase was primarily driven by increased clinical trial expenses, although partially offset by a decrease in milestone fees for our licensed product. Selling general and administrative expenses grew to $69.2 million from $62.5 million for the same period in 2023. This increase was primarily driven by higher general selling expenses and headcount growth associated with the VSCRA launch.
Jim: Turning now to our extensive.
Jim: Research and development expenses were $54 6 million in the first quarter of 2024 compared to $48 5 million for the same period in 2026.
Jim: The increase was primarily driven by increased clinical trial expenses.
Jim: Fully offset by a decrease in milestone fees for our licensed partner.
Jim: Selling general and administrative expenses grew to $69 2 million barrels.
Jim: Around 60 coupon finally on about the same in 2023.
Jim: The increase was primarily driven by higher <unk> expenses and head count growth associated with the <unk>.
Yajing Chen: Both R&D and SG&A expenses significantly declined as a percentage of revenue in the first quarter of 2024 compared to the same period in 2023. And, as Josh stated previously, we expect this trend to continue as a result of growing revenues and ongoing cost and efficiency initiatives. Zai Lab reported a net loss of $53.5 million in the first quarter of 2024, or a loss per ordinary share attributable to common shareholders of $0.05, compared to a net loss of $49.1 million for the same period in 2023, or a loss per ordinary share of $0.05.
Jim: Both R&D and SG&A expenses significantly declined as a percentage of revenue in the first quarter of 2024 compared to the same Trs in 2023 and as Josh stated previously we expect this trend continues to be sort of growing revenues.
Jim: And ongoing cost and efficiency initiatives.
Jim: <unk> reported a net loss of $53 5 million in the first quarter of 2024 or a loss per ordinary share attributable to common shareholders of.
$25 compared to a net loss of $49 1 million for the same pnas in 'twenty, two mutually well loss per ordinary share.
Yajing Chen: We are in a strong financial position, ending the quarter with cash and cash equivalents, current restricted cash, and short-term investments of $750.8 million, compared to $806.5 million as of December 31, 2023. Based on our operational plan and our anticipated revenue growth, we expect to be able to fund our business through profitability, which we expect to achieve by the end of 2025. And with that, I would now like to turn the call back over to the operators to open up the lines for questions. Operator.
Jim: Once again all $5.
And in a strong financial position ending the quarter with cash and cash equivalents current and restricted cash and short term investments of $758 million.
Jim: $806 $5 million as of December 31st 2023, based on our operating plan and our.
Jim: Anticipated revenue growth, we expect to be able to fund our business through profitability, which we expect to achieve by the end of 'twenty 'twenty five.
Speaker Change: And with that I would now like to turn the call back over to the operator to open up lines for questions operator.
Operator: We would now like to open the line for questions. If you do have a question at this time, please press star 1 and 1 on your telephone and wait for your name to be announced. To cancel the questions, please press star 1 and 1 again. Once again, please press star 1 and 1 for any questions or comments. Thank you. We are now going to proceed with our first question. The questions come from the line of Anupam Rama from JP Morgan. Please ask a question. Your line is open. Hey guys, thanks so much for taking the question. For Viscard, you know that
Speaker Change: Thank you.
Speaker Change: We would now like to open the line for questions. If you do have a question at this time. Please press star one and one on your telephone and wait for your name to be announced to kind of ask a question. Please press star one and one again once again, please press star one and one for any questions or comments. Thank you.
Speaker Change: We are now going to proceed with our first question.
Speaker Change: Okay.
Speaker Change: Our question comes from the line of <unk> Rama from Jpmorgan. Please ask your question. Your line is open.
Rama: Hey, guys. Thanks, so much for taking the question Perfect Guard you noted the hospital formulary listings R. R.
Rama: Tracking in line with your expectations posts in our deal can you quantify that a little bit in terms of.
The number of key hospitals, you're on formulary currently and the timeframe in which you would expect.
Speaker Change: Kind of to finish the process. Thanks, so much.
Joshua L. Smiley: Hey, good morning, Anupam. It's Josh.
Speaker Change: Hey, good morning antibody Josh Thanks for the question, we have 1000 hospitals that we're targeting for.
Speaker Change: Key accounts and that were targeting for NR deal pull through on the listing.
Speaker Change: Based on historical experience it takes about a year to pull the listings all the way down to the local hospitals.
Joshua L. Smiley: Thanks for the question. We have 1,000 hospitals that we're targeting as key accounts and that we're targeting for NRDL pull through on the listing. Based on historical experience, it takes about a year to pull the listings all the way down to the local hospitals. Our goal has been to, through the first half of this year, get at least two-thirds of those 1,000 hospitals to get the listings. And I'd say, you know, we're in mid-May; we're well on our way to that goal. Thanks. Unsponsored ADR
Speaker Change: Our goal has been to through the first half of this year get at least two thirds of those thousand hospitals to get the listing and I'd say were mid may we are well on our way to that to that goal.
Speaker Change: Thanks.
Operator: So, we are now going to proceed with the next question. The questions come from the line of Louise Chen from Canada.
Speaker Change: Next question operator.
Speaker Change: So we are not going to proceed with the next question.
Speaker Change: The question has come from the line of Louise Chen from Cantor. Please ask your question. Your line is open hi.
Louise Alesandra Chen: Please ask your question. Your line is open. Hi. Congratulations.
Louise Alesandra Chen: Hi, congratulations on the progress this quarter and thanks for taking my questions here. I had a few for you. The first question I had is if you can provide any more color on CAR XT's regulatory status and then any thoughts on this opportunity in light of the changing market landscape.
Louise Alesandra Chen: Congratulations on the progress this quarter and thanks for taking my questions here. So I had a few for you first question I had is if you can provide any more color on car X teens regulatory status and then any restocking with opportunity in light of the changing market landscape.
Harald Reinhart: Harald, why don't you take the regulatory piece, and then I can comment on the commercial opportunity? Yeah, thanks for the question.
Louise Alesandra Chen: Harold why don't you take the regulatory piece and then I can comment on the commercial opportunity yes. Thanks for the question.
Harald Reinhart: Yeah, thanks for the question. The regulatory update is that we are currently executing a bridging study. This was a study discussed and designed with the agency. We are almost in the final stages of completing that study on time and hope to be able to finish it this year, as mentioned before. So the regulatory status is that we will eventually have a dossier eventually with good results from our bridging study plus the dossier that was presented by Corona last year to the FDA, which contains the large emergent studies as a backup. In addition, we obviously have the PK study, which we executed in China just in order to complete the bridging program.
Harald Reinhart: The regulatory update is that we are currently executing a bridging study.
Harald Reinhart: A standard discussed and designed with the agency.
Harald Reinhart: Almost.
Harald Reinhart: The final stages of completing that study on time and hope to be able to.
Harald Reinhart: And as you can see it and as mentioned before so the regulatory stance is that we will have you don't see it eventually with good results from our bridging study plus the dossier that was preceded by Corona last year to the FDA.
Harald Reinhart: <unk>, which contains the large merchants studies.
Harald Reinhart: Backup. In addition, we have obviously the PK study between executing China chest in order to complete the <unk> program.
Joshua L. Smiley: Thanks, Harald. And hi, Louise, it's Josh.
Speaker Change: Thank you.
Speaker Change: Thanks Harold.
Speaker Change: Hi, Louise it's Josh I think on the commercial opportunity we are quite excited.
Joshua L. Smiley: As we've mentioned before we see somewhere in the range of 8 million patients with schizophrenia in China I think there is a strong emphasis.
Joshua L. Smiley: Emphasis on improving the care of patients with severe mental illness across China as you know with the car T drug based on the global data that we already have all seen theirs.
Joshua L. Smiley: I think about the commercial opportunity. As we've, I think, mentioned before, we see somewhere in the range of 8 million patients with schizophrenia in China. I think there's a strong emphasis on improving the care of patients with severe mental illness across China. As you know, with the CAR-XT drug, based on the global data that we already have all seen, there is, you know, strong efficacy performance and a really good profile of the drug from a safety perspective.
Joshua L. Smiley: <unk> efficacy performance and really good.
Joshua L. Smiley: So we think this is going to be an important option for treating patients. We're excited to get through the regulatory process, as Harald mentioned, and begin to get this to patients as quickly as possible. So we're quite excited. Thanks.
Joshua L. Smiley: Profile of the drug from a safety perspective. So we think this is going to be an important option for treating patients. We're excited.
Joshua L. Smiley: Get through the regulatory process as Harold mentioned and begin to get this to patients.
Joshua L. Smiley: As quickly as possible. So we're quite excited thanks.
Joshua L. Smiley: Okay, and can I just squeeze in one more question here? So on Vivgart, just curious about the sales ramp, I don't know if you give quarterly guidance, but second, third, fourth quarter, is it something sort of a steady growth or should it be more back end weighted? How should we think about modeling that? Thanks, Louise.
Speaker Change: Okay and can I just squeeze in one more question here so I'm.
Speaker Change: Just curious for the sales ramp I don't know, if we give quarterly guidance, but second third and fourth quarter or is it something sort of a steady grow our way to be more backend weighted how should we think about modeling that thank you.
Joshua L. Smiley: Thanks, Louise. First of all, we're really pleased with the first quarter performance. I think we're off to a good start. As you know, we said earlier in the year that, just based on what we were seeing as a function of the NRDL listing, we were comfortable and confident with sales potential for the product in 2024 of greater than $70 million.
Speaker Change: Thanks, Louise I think first.
Speaker Change: Really pleased with our first quarter performance I think we're off to a good start as you know we said earlier in the year that just based on what we were seeing.
Speaker Change: As a function of the <unk> listing we were comfortable confident with sales potential for the product in 2020 for a greater than $70 million. We think we're well on track for that with first quarter performance and yes, I think in general we would expect to see sequential growth through the quarters.
Joshua L. Smiley: We think we're well on track for that with the first quarter performance. And yeah, I think in general, we'd expect to see sequential growth through the quarters. Certainly, we see more in Q4 than Q3 and so on, but not back end loaded in terms of the sort of growth.
Speaker Change: Certainly we see more in Q4 than Q3, and so on but not back end loaded in terms of the sort of growth I think we expect this to be pretty steady we're seeing that in the patient.
Joshua L. Smiley: I think we expect this to be pretty steady. We're seeing that in patient initiations. I think when we look at the first quarter, we had fewer patient initiations in February, but that was a function of the Chinese New Year and healthcare utilization that always happens in that month. So, I think if we look at where we were in March, we continued to see steady acquisition of new patients and would expect that to continue through the year.
Speaker Change: Initiations I think when we look at the first quarter, we had fewer patient initiations in February but that was a function of Chinese new year.
Speaker Change: Health care utilization that always happens.
Speaker Change: That month, so I think if we look at where we were in March we continue to see steady.
Speaker Change: Acquisition of new patients and we'd expect that to continue through the year. So we're looking forward to quarter over quarter continued growth I think.
Joshua L. Smiley: So, we're looking forward to continued quarter over quarter growth. I think, as I say, we're comfortable with a greater than $70 million sales number. We're not going to give specific quarterly guidance, but again, off to a really good and exciting start.
Speaker Change: As I say.
Speaker Change: Comfortable with greater than $70 million sales number we're not going to give specific quarterly guidance, but again off to a really good and exciting start.
Speaker Change: Thank you.
Operator: Thank you. We are now going to proceed with our next question. The questions come from the line of Michael Yee from Jefferies. Please ask your question. Your line is open.
Speaker Change: Okay.
Speaker Change: Thank you we are now going to proceed with our next question.
Speaker Change: Two questions come from the line of Michael Yee from Jefferies. Please ask your question. Your line is open.
Michael Jonathan Yee: Hey, good morning, good afternoon. Thank you. We had two questions. One was about Vivgart.
Michael Jonathan Yee: Hey, good morning, good afternoon. Thank you.
Michael Jonathan Yee: We had two questions one was on the garden I know you commented about your confidence on the year I think that you mentioned 2700 patients and if you multiply that out times the price and maybe some compliance rate I think would imply that you already had a $70 million run rate.
Speaker Change: Could you comment on my math, and whether there's anything I need to consider there like compliance.
Speaker Change: Or you just think that you are already on that run rate and Thats why you could beat that number talk to that a bit and then the second question is on BD I know you've made some comments about business development and you've got the team. There can you maybe just prioritize the one or two things you would like to do is that of our U S pipeline deal is that a commercial deal would you do a.
Speaker Change: <unk> deal for example, maybe just talk a little bit about about that till we have some expectations. Thank you.
Speaker Change: Thanks, Mike, It's Josh I'll do the.
Joshua L. Smiley: <unk> question, and then ask Jonathan and maybe Raphael to comment on the business development piece.
Michael Jonathan Yee: I know you commented about your confidence during the year. I think that you mentioned 2700 patients. And if you multiply that times the price and maybe some compliance rate, I think it would imply that you're already at a $70 million run rate. So could you comment on my math and whether there's anything I need to consider there, like compliance? Or you just think that you are already on that run rate, and that's why you could beat that number.
Joshua L. Smiley: Yes, as I mentioned were with the 2700 patients in Q1 and continued hospital listing and good.
Joshua L. Smiley: I'll take from physicians and adoption I think we are on the $70 million a greater trend.
Jonathan: I think as it relates to the math and thinking about how the patients that are getting they've got now play out through the year I think it's early a little bit early to see what what we should assume for each patient who starts and of course any patient who starts later in the year's not going to necessarily benefit from the full number of cycles.
Joshua L. Smiley: The markets, where we've launched.
Joshua L. Smiley: Where our <unk> is launched the cycles have averaged about 5% per year.
Joshua L. Smiley: We have no reason to believe that won't be the case in China, but it's still very early most patients are just coming online now as you mentioned, so I think we'll have more to do.
Joshua L. Smiley: And talk about as we get into Q2 and Q3, but for now I think your math is fine we are on the trend and that's why we're saying we're quite confident that we're headed that way. So thanks for the question there and Jonathan maybe you can start on the business development piece.
Michael Jonathan Yee: Is that a US pipeline deal? Is that a commercial deal? Would you do a commercial deal, for example? Maybe just talk a little bit about that. We have some expectations.
Michael Jonathan Yee: Talk about that a bit. And then the second question is about business development. I know you made some comments about business development, and you've got the team there. Can you maybe just prioritize the one or two things you would like to do?
Jonathan: Yeah, Hi, Mike Thanks for the questions.
Jonathan: BD I think the two primary areas that we are focusing on one is to continue to do what we always do.
Jonathan J. Wang: Thanks, Mike and Strosh. I'll do the Vivgart question and then ask Jonathan and maybe Rafael to comment on the business development piece. I think on Vivgart, as I mentioned, we're with the 2,700 patients in Q1 and continued hospital listing and good uptake from physicians and adoption. I think we are on the $70 million or greater trend. I think as it relates to the math and thinking about how the patients that are getting Vivgart now will play out through the year, I think it's a little bit early to see what we should assume for each patient who starts. And, of course, any patient who starts later in the year is not going to necessarily benefit from the full number of cycles.
Jonathan: Which is late stage regional deals China Asia dose.
Jonathan J. Wang: As you know, in the markets where Argenix has launched, the cycles have averaged about five per year. We have no reason to believe that won't be the case in China, but it's still very early. Most patients are just coming online now, as you mentioned. I think we'll have more to see and talk about as we get into Q2 and Q3, but for now, I think your math is fine. We are on the trend, and that's why we're saying we're quite confident that we're headed that way. So thanks for the question there. Jonathan, maybe you can start on the business development piece. Yeah, hi, Mike. Thanks for the correction.
Jonathan: For Derisked assets, especially if they're synergistic without portfolio sometimes.
Jonathan J. Wang: Hi Mike. Thanks for the questions. On BD, I think there are two primary areas that we're focusing on. One is to continue to do what we always do, which is late-stage regional deals, you know, Chinese and Asian deals for de-risked assets, especially if they're synergistic with our portfolio. But sometimes, you know, when things like FCAR and CAXT come along, we could potentially expand beyond our therapeutic area of focus. And then also, we're spending a lot of time on assets that may broaden or accelerate our global ambitions.
Jonathan: Things like <unk> Telekom, we could potentially expand beyond.
Jonathan: Therapeutic area of focus.
Jonathan: And then also.
Jonathan J. Wang: These tend to be a bit more early stage, so maybe less de-risked. But, you know, we have a very strong scientific team. We have done deals in the past, even for regional rights, where the asset was still very early stage, such as BEMA and SOLDIR, to name some examples. So we want to continue to leverage that scientific expertise and bring assets that may give us potential global rights and fulfill those ambitions.
Jonathan: Spending a lot of time on assets.
Jonathan: It may broaden or accelerate our global ambitions.
Jonathan: These tend to be a bit more earlier stage, so maybe less de risk.
Jonathan: Have a very strong scientific team, we haven't done deals in the past.
Jonathan: Even for regional rights, where the asset we're still very early stage, such as bema soldier to name some examples.
Jonathan: Wanted to continue to leverage that scientific expertise and bringing assets.
Jonathan: That may give us essential global rights and fulfill those ambitions. Thank you.
Jonathan: Yeah.
Speaker Change: Thank you.
Speaker Change: Thank you.
Speaker Change: To proceed with our next question.
Operator: Thank you. We are now going to proceed with our next question, and the questions come from the line of Linhai Zhao from Goldman Sachs. Please ask your question.
Jonathan: And the question comes from the line of Lynn Zhao from Goldman Sachs. Please ask your question.
Linhai Zhao: Thanks for taking my question. I'm Linhai from GIS.
Linhai Zhao: Thanks for taking my question on behalf of <unk> I have two questions on non small cell lung cancers.
Linhai Zhao: First of all it's about <unk>.
Linhai Zhao: I recall that previous plan was to file the NDA this year.
Linhai Zhao: It does not seem to appear in the <unk>.
Linhai Zhao: I have two questions on non-small cell lung cancers. The first one is about aggressive. I recall that the previous plan was to file the NDA this year, but it does not seem to appear in the 1Q company appeal. And just wondering if there's any change of plans for Adagressive, and if there is, what would be the potential next steps for these assets? And the second question for Optum: I understand that Novacure has completed the day 100 meeting with FDA without indication of an advisory panel.
Linhai Zhao: And just wondering if there is any change of plans for <unk> and if there is what would be the potential next steps for these assets and the second questions or opt to understood that Novocure has completed the day 100 meeting with the FDA with all indications.
Linhai Zhao: Can you share a bit more on Zai Lab's visibility of China approval in the second line, not small cell lung cancer for Optum? And will Zai Lab wait for FDA approval before filing the MAA in China?
Linhai Zhao: Advisory panel can you share a bit more on <unk> visibility of China approval in second line non small cell lung cancer for <unk>, and where that way for the FDA approval before filing the NDA.
Linhai Zhao: In China.
Rafael G. Amado: Thanks. Rafael, why don't you go ahead and address both of those, please?
Linhai Zhao: Thanks.
al: Thanks, Rafi Al why don't you go ahead and address both of those please.
Rafael G. Amado: Sure. Thanks for the question. So on Adagrassive, as you know, there was single data that led to the approval of Adagrassive in the United States, and VMS recently announced the results of the CRISPR-12 trial. They announced just top-line data, which was that the primary endpoint, progression-free survival, was met. The primary endpoint was statistically and clinically meaningful.
Rafael G. Amado: Sure. Thanks for the question.
Rafael G. Amado: Another aggressive.
Rafael G. Amado: As you know there is.
Rafael G. Amado: Single data that led to the approval of aggressive in the United States and BMS recently announced the results of the Crystal 12.
Rafael G. Amado: Trial date.
al: We announced topline data.
al: Which was the.
al: Primary endpoint was met.
al: Primary endpoint was progression free survival.
al: Statistically and clinically meaningful.
Rafael G. Amado: And we are evaluating further data. VMS has announced that they are still evaluating the rest of the data, and they expect to present this to Congress in the future. And, of course, we need to await that evaluation as we make a decision on formulating a plan going forward. So we are essentially expecting further data as VMS looks at the totality of the data set. So that's the update on Adagrassive. With regard to DT fields, I mean, you're right.
al: And.
al: We are.
al: Evaluating.
al: Further data the EMS.
al: So they are still evaluating the rest of the data and they expect to present this in a congress in the future.
al: And of course, we need to await that evaluation.
al: Makeup.
al: Make a decision on formulating.
al: Our plan going forward so.
al: We are essentially.
al: And you're expecting further data as CMS looks.
al: It looks at the totality of the data set.
Rafael G. Amado: They filed in December. They had the 100-day meeting, which they stated as a very productive meeting. They don't expect an advisory committee. And they've also filed in Europe, and they're expecting CE marking as well. So there's no change in the plan with regards to our expectation to be able to file Luna this year for second line non-small cell lung cancer.
al: Thats the update on how the aggressor.
al: And with regards to the fields.
al: Youre right. They filed in December that had the 100 day meeting rich.
al: Peter.
al: A very productive meeting they don't expect an advisory committee.
al: And the.
al: We've also filed in Europe, and are expecting CE, marking as well.
al: And there are negotiations Statoil in Japan, so fully.
al: Have a global approach here to their submission.
al: Working very closely with them and we.
al: Back to actually submit ourself on EMEA and China This year.
al: <unk>.
al: On dose result, so.
al: No change in the plan with regard to our.
al: Our expectation to be able to file lunar this year for second line non small cell lung cancer.
Rafael G. Amado: It's just to clarify, for the China filing, we do not necessarily have to wait for potential FDA approval, right? Unsponsored ADR
Speaker Change: Yes, just to clarify for the China following.
Speaker Change: Not necessarily have to wait for the potential FDA approval rate.
Rafael G. Amado: Not necessarily; we don't have to wait for approval.
Speaker Change: Not necessarily we don't have to wait for therefore.
Speaker Change: Got it thanks.
Operator: Thank you. We are now going to proceed with our next question. The questions come from the line of Yigal Nochomovitz from Citigroup. Please ask your question.
Speaker Change: Yes.
Speaker Change: Thank you we are now going to proceed with our next question.
Citigroup: Our question comes from the line of vehicle not some of it's from Citigroup. Please ask your question.
Yigal Dov Nochomovitz: Another Vivgart question: what are you hearing in the marketplace in China with regard to physicians and patients that are interested in waiting for the sub-Q version before prescribing, or do you not see that as an impediment? And then once the subcue is launched, do you expect to... Acceleration in the launch or just a continued, you know, linear momentum?
Citigroup: Yes, hi, Thanks, and another question what are you hearing in the marketplace in China with regard to physicians that are patients that are interested in waiting for the sub Q version before prescribing or.
Speaker Change: Do not see that as an impediment.
Citigroup: And then once the sub Q as launch do you expect to.
Citigroup: Celebration and the launch or just to continue.
Yigal Dov Nochomovitz: And also, can you talk a little bit about the market for CIDP in China? What is the current standard of care there? Thank you.
Citigroup: Linear momentum and then also can you talk a little bit about the market for <unk> in China. What is the current standard of care there. Thank you.
Joshua L. Smiley: Thanks, Yigal. It's Josh.
Citigroup: Thanks, Yigal, it's Josh I'll start and then Harold.
Citigroup: If you can comment a little bit on standard of care for IDP.
Citigroup: Currently in Tau.
Citigroup: <unk> I think in terms of the IV versus sub Q right now patients do go to.
Citigroup: <unk> thousand hospitals that I mentioned, which cover the vast majority of patients with gmg. They go to the hospital for treatment. So right now the IV.
Joshua L. Smiley: I'll start, and then, Harald, maybe you can comment a little bit on the standard of care for CIDP currently and how VIVGARD will fit. I think in terms of the IV versus sub-Q, right now, you know, patients do go to these thousand hospitals that I mentioned, which cover the vast majority of patients with GMG. They go to the hospital for treatment. So, right now, the IV formulation is fine. I don't think there's a wait for sub-Q.
Citigroup: Formulation is fine I don't think Theres, a theres a wait for for sub Q and as I think.
Citigroup: We've mentioned in other settings, we're targeting patients initially who are not doing well either on standard of care or sooner.
Citigroup: <unk>.
Joshua L. Smiley: And, you know, as I think we've mentioned in other settings, we're targeting patients, you know, initially who are not doing well, either on standard of care or in a, you know, sort of a flare or rescue episode. So, they'd be coming into the hospitals for treatment anyway. And, of course, you know, the sub-Q version will still require physician administration. So, I don't think we see that as a barrier today.
Citigroup: Flair or rescue.
Citigroup: <unk>, so they'd be coming into the hospitals.
Citigroup: Or poor treatment anyway and of course, the sub Q version still require a physician administration. So I don't think we are.
Citigroup: We see that as a barrier today certainly we are excited about the opportunity for sub Q as it provides a dip.
Citigroup: Another dosing option and it's an important formulation for all of the future indications, but I don't think as it relates to gmg, we would expect to see some new inflection point with that without approval. We are quite excited about the patient capture and opportunities that we're seeing today and are looking forward to <unk>.
Joshua L. Smiley: Certainly, we are excited about the opportunity for sub-Q as it provides, you know, another dosing option, and it's an important formulation for all of the future indications. But I don't think, as it relates to GMG, we would expect to see some new inflection point with that, you know, with that approval. We're quite excited about the patient capture and opportunities that we're seeing today and are looking forward to CIDP. And, Harold, maybe you could give a few comments there.
Citigroup: And Harold maybe you could give a few comments there.
Harald Reinhart: Yeah, thank you. The question was about CIDP in the current standard of care treatment, and currently, there is no approved treatment for CIDP anywhere in the world. So the study that was done by Eugenics and Us in China is really a landmark study in the way that it, first of all, brings a larger number of patients into a study situation where you can make some kind of conclusions about treatment. The current treatment everywhere in the world is that these patients get steroids initially, and if they progress, and many of them do progress, they end up getting IVIG.
Citigroup: Yeah.
Harald Reinhart: Yes. Thank you.
Harald Reinhart: Question was about <unk> of the curve.
Harald Reinhart: This care treatment.
Speaker Change: Currently there is no approved treatment for CDP anywhere in the world.
Harald Reinhart: So the study that was done by <unk> in China is really a landmark study in a way that it.
Harald Reinhart: First of all brings in larger patient number into our studies situations, which you can make.
Harald Reinhart: Some kind of conclusions about treatment.
Harald Reinhart: Current treatment everywhere in the world is that these patients get steroids.
Harald Reinhart: Italy, and if the progressions many of them do progress and navigating IV AIG is nothing really in between there has shown to be.
Harald Reinhart: There's really nothing in between that has shown to be of benefit to patients. And as I said at some other meeting, the disease is really rather progressive and much more severe than GMRA, which is a shorter version of this neurologic disease. So we do believe that this guard will have a significant role to play here in CIDP. This is a totally unmet medical need situation and will have a major impact on treatment modality and the treatment paradigm.
Harald Reinhart: Benefit to patients and as I said.
Harald Reinhart: Some other meeting the disease, it's really around the progressive and much more severe than GM Berry, which is issued a version of this group.
Harald Reinhart: Two disease.
Harald Reinhart: So we do believe that.
Harald Reinhart: This guidance.
Harald Reinhart: We will have a significant role to play in CRT P. This is ed.
Harald Reinhart: Totally.
Yajing Chen: Medical need situation.
Harald Reinhart: And we'll have a major impact on the treatment modality in the treatment paradigms.
Joshua L. Smiley: Thank you. Okay. And then just to follow up, it sounds like, based on your comments, Josh, with the dynamics of IV versus sub-Q, that similar dynamics would apply for CIDP. Is that fair?
Speaker Change: Thank you, Okay, and then just a follow up it sounds like based on your comments just with the dynamics with IP versus sub Q.
Speaker Change: Similar dynamics would apply for CIBC is that fair.
Joshua L. Smiley: Well, CIDP will be approved in the sub-Q version. That's how it was submitted. So I think by the time we get to CIDP, that'll be the formulation for that indication. Okay, so there is no
Josh: Well <unk> will be approved in the sub Q version.
Joshua L. Smiley: That's how it was.
Joshua L. Smiley: Submitted so I think by the time, we get to see IDP that'll that'll be that'll be the formulation for that for.
Joshua L. Smiley: For that indication.
Joshua L. Smiley: Okay, so there is no ID for the CID. Okay, thank you.
Joshua L. Smiley: Okay. So there is no IV for the study.
Joshua L. Smiley: Alright.
Speaker Change: Okay. Thank you.
Operator: We are now going to proceed with our next question, and the questions come from the line of Jonathan Chang from Lyrinc Partners. Please ask your question.
Speaker Change: We are now going to proceed with our next question.
Operator: And the question is come from the line of Jonathan Chang from Leerink Partners. Please ask your question.
Jonathan J. Wang: Hi guys, thanks for taking my questions. First question, on ZL1310, your DLL3 ADC, can you help set expectations for the potential dose escalation data expected end of 24 or early 25? What types of patients are being enrolled in the study? How many may have seen a prior DLL3 targeting agent?
Jonathan J. Wang: Hi, guys. Thanks for taking my questions.
Jonathan J. Wang: First question on set out 13 10, your DLL 300, ADC can you help set expectations for the potential dose escalation data expected end of 'twenty for early 'twenty five what types of patients are being enrolled in the study.
Jonathan J. Wang: How many may have seen a priority <unk> targeting agents and how much duration data are you hoping to have and then second question zooming out.
Jonathan J. Wang: And how much duration data are you hoping to have? And then, second question, zooming out, how are you thinking about expanding your global portfolio over time? What are the considerations here beyond the business development comments that you made earlier? Thank you.
Jonathan J. Wang: How are you thinking about expanding on your global portfolio over time.
Jonathan J. Wang: What are the considerations here beyond the business development comments that you made earlier thank you.
Rafael G. Amado: Rafael, why don't you start, and I can close out with any final comments on this question. Thanks, Jonathan.
Jonathan J. Wang: Okay.
Speaker Change: Raphael why don't you start and I can.
Rafael: I can close out with any final comments on this question. Thanks Jonathan.
Rafael G. Amado: Yeah, Jonathan, thanks for the question. So, yeah, a few months ago, I mentioned before, we have three products that are global that are in the clinic at the moment. And one of them is 1310, our DLO3-ADC, which utilizes this T-mailing technology that has a bystander effect. So we see the promise based on preclinical results and have initiated a trial that started in the United States and then expanded to China. And we're going to continue to expand the global footprint and try to accelerate dose escalation.
Rafael: Yes, Jonathan Thanks for the question so yeah.
Rafael G. Amado: So I'm not as I mentioned before we have three products.
Rafael G. Amado:
Rafael G. Amado: That are global that are in the clinic at the moment at 113 10, DLL three ADC.
Rafael G. Amado: Which.
Rafael G. Amado: Utilizes.
Rafael G. Amado: <unk>.
Rafael G. Amado: Technology has.
Rafael G. Amado: Bystander said so.
Rafael G. Amado: We.
Rafael G. Amado: See the promise based on preclinical results and have initiated.
Rafael G. Amado: While that started in the United States and expanded to China.
Rafael G. Amado: We're going to continue to expand the global footprint.
Rafael G. Amado: I'll try to accelerate dose escalation.
Rafael G. Amado: I can say that we're proceeding well through dose escalation at the moment. And as we move forward, we will also, as I mentioned in the prepared remarks. Unsponsored ADR Unsponsored ADR, We also are going to enroll some patients that have been exposed to bispecifics as well against DLL-3, so those will be studied as well based on biology that has sort of informed us that DLL-3 remains expressive in patients that progress after bispecifics
Rafael G. Amado: I would say that we're proceeding well through dose escalation at the moment.
Rafael G. Amado: And as we move forward, we will also as I mentioned in the prepared remarks.
Rafael G. Amado: Also combining with checkpoint inhibitors.
Rafael G. Amado: And in terms of the patient population there are platinum.
Rafael G. Amado: Both.
Rafael G. Amado: Yes.
Rafael G. Amado: And.
Rafael G. Amado: We also are going to enroll some patients.
Rafael G. Amado: <unk>.
Rafael G. Amado: That have been exposed to bi specifics as well again CLO III.
Rafael G. Amado: So just would it be <unk> based on biology.
Rafael G. Amado: <unk> informed us the TLLP remains expressing an ambitious set of progress after by specific.
Rafael G. Amado: So we will have, I think, a wealth of data on platinum progressors in combination with Adeso as a single agent in DLL-3 in naive patients as well as patients who have been exposed to platinum. In terms of how much data we will have, as you know, this is a phase one study, and it depends on when we achieve DLTs and when we achieve a dose that we can then commence the expansion of that dose and understand the full potential of the drug.
Rafael G. Amado: We will have I think a wealth of data.
Rafael G. Amado: Bye.
Rafael G. Amado: <unk> in combination with <unk>.
Rafael G. Amado: So single agent.
Speaker Change: Hello <unk>.
Rafael G. Amado: Patients as well as be exposed patients in terms of how much data. We will have as you know this is a phase III study any depends on when we will achieve.
Rafael G. Amado: DLT.
Rafael G. Amado: We will achieve a dose that we can then comment.
Rafael G. Amado: Commenced the expansion.
Rafael G. Amado: That dose.
Rafael G. Amado: So we've guided towards the end of 2024 and potentially early 2025, at least with the initial data. So that's our expectation, and we're very pleased with the way that this program is progressing at the moment. And then, with regard to your broader question, Jonathan made some comments about business development. Perhaps I can just complement that with the fact that we are making what I believe is really good progress in discovery. We're focused on certain areas of cancer biology where we have expertise.
Rafael G. Amado: Understand the full potential of the drug so we've guided towards the end of 2024 and potentially.
Rafael G. Amado: Early 'twenty five.
Rafael G. Amado: With the initial data so that's our expectation.
Rafael G. Amado: Very pleased with the way that this program is progressing at the moment.
Rafael G. Amado: And then with regards to <unk>.
Speaker Change: Good question.
Rafael G. Amado: Jennifer I made some comments about business development, perhaps a county.
Rafael G. Amado: Implement that with the fact that we are making.
Rafael G. Amado: What I believe is really good progress in discovery, we're focused on with certain areas of cancer biology.
Rafael G. Amado: We're nominating candidates, and our goal is to have internal INDs coming from our laboratories at least one a year. And I'm very pleased, at least with the progress that we're making at the moment. So thanks for the question.
Rafael G. Amado: Where we have expertise.
Rafael G. Amado: Net income.
Rafael G. Amado: Our goal is to have it.
Rafael G. Amado: There are no <unk> coming from our laboratory is at least one year.
Rafael G. Amado: Very pleased obviously with the progress that we're making at the moment.
Rafael G. Amado: So thanks for the question.
Rafael G. Amado: Great, I think that, yeah, that covers it. So maybe next question, please, operator.
Rafael G. Amado: Great I think that's yes that's.
Rafael G. Amado: That covers it so maybe next question please operator.
Operator: We're now going to take our last question, and the questions come from the line of Jacqueline from Morgan Stanley. Please ask your question.
Rafael G. Amado: Sure.
Speaker Change: We're now going to take our last question.
Jacqueline: And the question is come from the line of Jack Lin from Morgan Stanley. Please ask your question.
Jacqueline: Hi, good morning, and thanks for taking my question. I have a quick one on VipGuard, and also, I think another one touching on the other pipeline. So for VipGuard, I think the other analyst brought up earlier in terms of patient profile. So I was wondering, we have 2,700 new patients that were dosed in the first quarter. What are we seeing in terms of the kind of their treatment profile prior? The breakdown between patients that were completely treatment naive compared to those that were refractory to conventional immunotherapy and also, I think that those that are refractory to say C5, which is probably low in China.
Operator: Okay.
Jacqueline: Hi, good morning, and thanks for taking my questions I have.
Jacqueline: Quick one on the card and also I think the other ones.
Jacqueline: Touching on the other pipelines so for boot barn.
Jacqueline: The other analyst brought up earlier in terms of patient profile. So I was wondering so we have 2700, new patient that was dosed over the first quarter. What are we seeing in terms of kind of their treatment profile. Prior like the breakdown between patients that were completely treatment naive compared to those that were refractory to the.
Jacqueline: Conventional immunotherapy and also I think those are refractory to say see pie, which is probably a low with China anyway.
Jacqueline: So, in terms of their prior treatment profile in that, and I think also wondering about the relative expectation in terms of opportunities that will compare from the indication expansions for VipGuard. So with CIDP coming and, I think also TD later on, how can we have a qualitative comparison as far as the Chinese market for these new indications coming out versus the GMG? Thank you.
Jacqueline: So in terms of their prior treatment profile in that and I think also wondering about in terms of the relative.
Jacqueline: Expectation in terms of opportunities that would compare from the indication expansions for zipcard, So with IDP coming and I think also TD later on.
Jacqueline: Two hubs calkins will have a qualitative comparison.
Jacqueline: As far as China market for these new indications coming out versus the.
Speaker Change: Thank you.
Joshua L. Smiley: Great. Thanks, Jack.
Jacqueline: Great. Thanks, Jack I'll start, it's Josh and then Harold can provide some more detail and color on the question I think first as it relates to the patient profiles.
Joshua L. Smiley: I'll start. It's Josh, and then Harald can provide some more detail and color on the question. I think first, as it relates to the patient profiles for the initial launch here, we are targeting, as part of the broader 170,000 GMG patients who could benefit from VivGuard, initially those who are, you know, haven't responded well to current treatment and, you know, as I say, could be in some type of rescue or flare situation.
Harald Reinhart: For the initial launch here we are targeting.
Joshua L. Smiley: As part of the broader 170000 gmg patients too.
Joshua L. Smiley: Benefit from from Zipcard, we're targeting initially those who are.
Joshua L. Smiley: Haven't responded well to current treatment and as I say it could be in.
Harald Reinhart: Some type of rescue or flare situations, so I would say without getting into too much detail. The majority of the patients are patients who have.
Joshua L. Smiley: So, I would say, without getting into too much detail, the majority of the patients are patients who are not naive to treatment. And the goal here, of course, is to get physicians to get comfortable using the product, to have a good initial experience. And, you know, from real-world experience, patients who are exposed to VivGuard who haven't responded well to other treatments or otherwise are going to show a good response, and we're seeing that.
Joshua L. Smiley: Are not naive to treatment they've been treated before.
Joshua L. Smiley: The goal here of course is to get physicians to get comfortable using the product to have a good initial experience and we know from real world experience that.
Joshua L. Smiley: Patients who are exposed to the guard.
Joshua L. Smiley: Who haven't responded well to other treatments or otherwise youre going to show a good response, and we're seeing that of course will expand.
Joshua L. Smiley: Of course, we'll expand the emphasis over time, but I think initially, the majority of patients are those who have already been under care, you know, and under some kind of pharmacological treatment for. As it relates to just the market opportunity, then Harald can provide some more comments. I think with all of the programs that we're participating in with Argenyx, we're similarly excited about the commercial opportunity in China for these next wave of indications.
Joshua L. Smiley: The emphasis over time, but I think initially that stuff.
Joshua L. Smiley: The majority of patients are those who have already been under care and under some kind of form a pharmacological treatment for for gmg.
Joshua L. Smiley: I think as it relates to just the market opportunity then Harold can provide some more comments I think with all of the programs that we're participating in with our Gen X we see.
Joshua L. Smiley: We are similarly excited about the commercial opportunity in China for this next wave of indications.
Joshua L. Smiley: So you can tell by our participation that we're seeing a very great need for VivGuard as a treatment option for many of these devastating diseases, including thyroid eye disease. And we're excited about the opportunity over time. But Harald, anything that you'd like to add to that, please? An unsponsored ADR
Joshua L. Smiley: So you can tell by the our participation that we're seeing.
Harald Reinhart: Very good need for <unk> as a treatment option for many of these.
Speaker Change: Devastating diseases, including.
Harald Reinhart: Thyroid eye disease, and we're excited about the opportunity over time, but Harold any anything that you'd like to add to that please do.
Harald Reinhart: Yeah, I have very little to add here. Thank you so much for the question. In essence, the labeling expansion to other indications is something we coordinate, obviously, with Argenix, and there is a regular interaction there as to what is a reasonable next step to take. TED is one of the things that we have announced is definitely coming to us, and we will start those programs fairly soon. There is discussion about other indications, and we've already committed to doing a myopathy, myositis study, and this includes dermatomyositis and polymyositis patients, for which we believe EFCA is a good option.
Speaker Change: Yes, very little to add here. Thank you so much for the question.
Harald Reinhart: Since the labeling expansion to other indications is Samsung Z coordinates, obviously with <unk>.
Harald Reinhart: There is now regularly interact to there as to what is a reasonable next step to take Ted is one of the things that we've announced.
Harald Reinhart: Definitely coming to us and we've been start those programs fairly soon.
Harald Reinhart: There is discussion.
Harald Reinhart: About other indications and we've recommitted to doing in myopathy.
Harald Reinhart: Myositis study.
Harald Reinhart: But there are more indications like that that could also be entertained, and you just heard from Bristol-Myers in a recent press release that they had good results in the Sjogren's Phase II study. The list is long. We will be selective, clearly, but for most of those indications, the frequency of the disease in China is just what you see everywhere else. And so we will engage in an appropriate fashion wherever it makes sense for us in the overall list of autoimmune diseases that could be tackled with efratigema.
Harald Reinhart: It includes dermatomyositis, probably myositis patients for which we believe <unk> is a good option and but theyre more indications like that that could also be entertained and you just heard from Bristol Myers in the recent press release, we had good results in the sugar and <unk> Phase III study.
Harald Reinhart: As long, we will be selective clearly, but for most of those indications the frequency of the disease in China is just what you see everywhere else.
Harald Reinhart: So we will engage in an appropriate fashion.
Harald Reinhart: It makes sense for us in the overall list of autoimmune diseases that could be tack on with <unk>.
Harald Reinhart: Thank you. Awesome. Thanks. Thanks, Harald. I think if there are no other questions, we can turn it back to Samantha.
Speaker Change: Thank you awesome. Thanks, Thanks, Harold I think if there are no other questions. We can turn it back to Samantha.
Operator: I am showing no further questions at this time, so I'll turn the call back to Zainab CEO Saman Fadju for closing remarks. Thank you.
Speaker Change: I am showing no further questions at this time, so I'll turn back the call to sorry, not CEO Samantha Du for closing remarks. Thank you.
Ying Du: Yeah, thank you, operator. I want to thank everyone for taking their time to join us on this call today. We appreciate your support and look forward to updating you again after the second quarter of 2024. Operator, you may now disconnect this call.
Operator: Ladies and gentlemen, this concludes today's conference call. Thank you all for participating. You may now disconnect your lines. Thank you, and have a great day.
Speaker Change: Yes, thank you operator.
Operator: I want to thank everyone for taking your time to join US on this call today.
Operator: We appreciate your support and look forward to updating you again after the second chorus to Nicholas <unk>.
Operator: Operator, you may now disconnect this call.
Operator: Yes.
Operator: Ladies and gentlemen. This concludes today's conference call. Thank you all for participating you may now disconnect. Your line. Thank you and have a great day.
Operator: Okay.
Operator: [music].
Operator: Okay.
Operator: Okay.