Q4 2024 Zai Lab Ltd Earnings Call

February 27, 2025

Operator 2: Hello, ladies and gentlemen. Thank you for standing by, and welcome to Zai Lab's Q4 and full year 2024 financial results conference call. At this time, all participants are in a listen-only mode. Later, we'll conduct a question-and-answer session, and instructions will follow at a 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.

Okay.

Operator: Thank you for standing by, and welcome to Zai Lab's Q4 and full year 2024 financial results conference call. At this time, all participants are in a listen-only mode. Later, we'll conduct a question-and-answer session, and instructions will follow at a 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: Hello, Ladies and gentlemen, thank you for standing by and welcome to Xylem fourth quarter and full year of 'twenty 'twenty four financial results conference call.

Speaker Change: At this time all participants are in a 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 Chou Senior Vice President of Investor Relations. Please go ahead.

Christine Chiou: Thank you, operator. Hello, everyone, and welcome to Zai Lab's Q4 and full year 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 Research and Development, and Dr. Yajing Chen, Chief Financial Officer. Jonathan Wang, our Chief Business Officer, will also be available to answer questions during the Q&A portion of the call. As a reminder, during today's call, we will be making certain forward-looking statements based on our current expectations. These statements are subject to numerous risks and uncertainties that may cause actual results to differ materially from what we expect due to a variety of factors, including those discussed in our SEC filings. We will also refer to adjusted loss from operations, which is a non-GAAP financial measure.

Speaker Change: Thank you operator, Hello, everyone and welcome to XI labs fourth quarter and full year 2024 earnings call today's call will be led by Dr. Samantha Du <unk> Lab's founder CEO and chair person she'll be joined by Josh Smiley, President and Chief operating Officer Dr. Rafael.

Motto, President and head of Global research and development and Dr. Yao Zhou Chen Chief Financial Officer.

Speaker Change: Jonathan Wang our Chief business 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 will be making certain forward looking statements based on our current expectations.

Speaker Change: These statements are subject to numerous risks and uncertainties that may cause actual results to differ materially from what we expect her to a variety of factors, including those discussed in our SEC filings.

Speaker Change: We will also refer to adjusted loss from operations, which is a non-GAAP financial measure.

Christine Chiou: Please refer to our earnings release furnished with the SEC on 27 February 2025 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: Please refer to our earnings release furnished with the SEC on February 27th 2025 for additional information on this non-GAAP financial measure.

Speaker Change: At this time it is my pleasure to turn the call over to Dr. Samantha Du.

Samantha Du: Thank you, Christine. Good morning and good evening, everyone. Thank you for joining us today. 2024 was a pivotal year for Zai Lab, marked by strong commercial performance, groundbreaking advancements in our global pipeline, and a clear path to profitability. In 2023, we outlined a bold vision for revenue growth, targeting a 5-year CAGR of 50% through the end of 2028. We are delivering on this vision. Our total revenue for 2024 grew 50% year-on-year, with an exceptional 66% growth in Q4. VYVGART had an excellent first full year of launch, generating $93.6 million in sales in 2024, making it one of the best immunology launches in China. We made substantial progress in advancing our original assets. We recently launched several new products, including VYVGART Hytrulo for gMG and CIDP, AUGTYRO for ROS1 non-small cell lung cancer, and XACDURO for pneumonia infections.

Samantha Du: Thank you Christine good morning, and good evening, everyone. Thank you for joining us today.

Speaker Change: Suddenly to before with a peaceful year for Ballard.

Speaker Change: Mark by strong commercial performance groundbreaking advancements in our global pipeline.

Speaker Change: Clear path to profitability.

Speaker Change: And putting this in Italy, we online a both visit revenue good talking to you if that'd be a paper a 50% through the <unk>.

Speaker Change: And the clinical niche.

Speaker Change: We are delivering on this vision.

Speaker Change: Our total revenue.

Speaker Change: <unk> grew 50% year on year with an exceptional 66 puts us girls in the fourth quarter.

Speaker Change: <unk> had an excellent first full year of lunch dinner, reaching $93 $6 million T cells.

Speaker Change: Suddenly for Nike.

Speaker Change: Making it one of the best <unk>.

Speaker Change: Taking China.

Speaker Change: We've made substantial progress.

Speaker Change: Thank you hover regional aspects.

Speaker Change: We recently launched several new products.

Speaker Change: We've got high school TMT T I D P.

Speaker Change: Well Ross one non small cell lung cancer in fact, too so both money infections.

Samantha Du: We also reported a series of positive data results, including KarXT for schizophrenia, TTFields for pancreatic cancer, and TIVDAK for cervical cancer, paving the way for multiple launches next year. Furthermore, we're advancing our other innovative assets, including bemarituzumab for first-line gastric cancer, povetacicept for IgAN, and ZL-1108 for several IIMs, on top of exploring additional indications for VYVGART and KarXT. These successes together set the stage for strong revenue growth over the next few years. As a key part of our mission to address unmet medical needs around the world, we took a significant step in 2024 to accelerate our global pipeline. In October, at ENA, we presented compelling early clinical results for ZL-1310, our potential first-in-class investigational DLL3 ADC in small cell lung cancer. Preliminary data demonstrated a 74% ORR, including both confirmed and unconfirmed responses.

Speaker Change: We also reported he was so positive data readouts, including car T Husky premia tumor treating fields, what type of bladder cancer.

Speaker Change: Keep that for cervical cancer.

Speaker Change: Paving the way for multiple launches next year.

Furthermore, we're a bunch of other even piggyback sites, including immature knob for first line gastric cancer.

Speaker Change: E coli them until 11 O eight.

Speaker Change: ITG on topple exploring additional indications with <unk> car T.

Speaker Change: Okay.

Speaker Change: Together set the stage for strong revenue growth over the next two years.

Speaker Change: As a key part of our mission to address unmet medical needs around the world too.

Speaker Change: But in particular for the salaries of our global platform.

Speaker Change: Cobra at E. Z go prevented compiling early clinical T cells with C L King Tim.

Speaker Change: Potential first in class and backing cloth T L. Three D in small cell lung cancer.

Speaker Change: Preliminary data demonstrated a 74% or are including both confirmed and unconfirmed responses.

Samantha Du: With further follow-up and additional patients, we continue to see high rates of confirmed responses, and we look forward to sharing detailed updates at a major medical conference in the first half of this year. The pace of progress with ZL-1310 has been remarkable, moving from phase 1 initiation in January 2024 to a potential pivotal trial this year, positioning us for possible FDA approval in small cell lung cancer in 2027, subject to ongoing regulatory discussions with FDA. As you know, DLL3 is expressed in various other tumor types. We have opened an IND to begin to explore additional indications this quarter to maximize the potential benefits for patients. Beyond ZL-1310, we're advancing a broader pipeline of globally differentiated assets, with plans to initiate global trials for an IL-13/IL-31 bispecific antibody for atopic dermatitis and an LRRC15 ADC for solid tumors.

Speaker Change: With further follow up and additional patients.

Speaker Change: Continued to see high rates of confirmed responses and we look forward to sharing detailed update at amazing medical comfort in the first half of this year.

Speaker Change: The pace of progress with G. Alternative Tim has been remarkable moving from phase one initiation in January 'twenty 'twenty four to a potential pivotal trial this year.

Speaker Change: Positioning us for what the approval is small cell lung cancer and <unk> 27.

Speaker Change: Subject to ongoing regulatory discussions with FDA.

Speaker Change: As you know D. L. Three is expressed in various other tumor types.

Speaker Change: We have opened 90 to begin to explore additional applications this quarter.

Mike: Mike the potential benefits for patients.

Speaker Change: PMT altered Heaton, we're advancing a broader pipeline of global a depreciated assets.

Mike: <unk> to initiate global trials.

Mike: Our 13 hour 31 specific antibody for atopic dermatitis.

Mike: L. R 15, ADC for solid tumors.

Samantha Du: Lastly, we have taken decisive actions to optimize our cost structure, improve efficiency across the organization while continuing to invest in key growth drivers. Our loss from operations in Q4 and for the full year improved year-over-year by 45% and 23% respectively. We are on track to reach profitability in Q4 of 2025, and we have a robust cash position of $879.7 million to support our next phase of growth. Today, Zai Lab is at a major value inflection point, with the team committed to entrepreneurship, innovation, and execution excellence. We look forward to delivering on our goals and capitalizing on the transformative opportunities that lie ahead in 2025 and beyond.

Mike: Lastly, we have taken decisive actions to optimize our cost structure and improve efficiency.

Mike: Optimization well.

Mike: Continuing to invest in key growth drivers.

Mike: Our loss from operations in the fourth quarter and for the full year, our improved year over year by 45% and putting it and 3% respectively.

Mike: We are on track to reach profitability in the fourth quarter could be 35.

Mike: We have a robust cash position of $879 $7 million to support our next phase of growth.

Today, <unk> had a major value inflection points the team committed to entrepreneurship.

Mike: <unk> and execution excellence.

Mike: We look forward to delivering on our goals and capitalizing on the transformative opportunity that lie ahead intermittently five and beyond.

Samantha Du: We remain confident in our ability to reach our $2 billion revenue target by 2028, supported by strong revenue growth in our current commercial portfolio and the expected launches of multiple additional products or indications in the next few years. With that, I'll pass the call to Josh. Josh?

We remain confident in our ability to reach our $2 billion revenue target by <unk> <unk>.

Mike: Supported by strong revenue growth in our current commercial portfolio and the expected launches of multiple additional product or indication in the next few years.

Mike: With that I'll pass the call to Josh Josh.

Josh Smiley: Thank you, Samantha, and thank you everyone for joining the call today. We had a good year in 2024, as demonstrated by our strong commercial execution, important advancements across our regional and global R&D pipeline, and multiple regulatory successes. In Q4, total revenue grew an impressive 66% year over year to $109.1 million. On a full year basis, total revenue increased 50% to $399 million, with growth driven by the strong adoption of VYVGART in its first year on the NRDL, along with the continued growth in ZEJULA and NUZYRA sales. We are proud of this outstanding top-line growth and with three new launches underway, including VYVGART Hytrulo, XACDURO, and AUGTYRO, we expect to continue to build strong momentum this year.

Speaker Change: Thank you Samantha and thank you everyone for joining the call today, we had a good year in 2024 as demonstrated by our strong commercial execution important advancements across our regional and global R&D pipeline and multiple regulatory successes in.

Speaker Change: In the fourth quarter total revenue grew an impressive 66% year over year to $109 1 million.

Speaker Change: On a full year basis total revenue increased 50% to $399 million with growth driven by the strong adoption of <unk> in its first year on the NR deal along with the continued growth in <unk> and new direct sales were.

Speaker Change: We are proud of this outstanding top line growth and with three new launches underway, including <unk> Gard High Trullo, Zach Tomorrow and on Cairo, We expect to continue to build strong momentum this year.

Josh Smiley: Let's start with VYVGART, which has had an exceptional launch year, delivering full year sales of $93.6 million and Q4 sales of $30 million. VYVGART is a testament to the outstanding execution of our commercial team, and we are excited about what this pipeline and product program will achieve in coming years. There are several factors contributing to this momentum with VYVGART: an expanding network of prescribers, greater access through hospital listings, new patient acquisition, and a growing number of patients starting treatment in the maintenance phase to manage symptoms and prevent relapses. Starting with physicians, we continue to grow the breadth and depth of our prescriber base, utilizing a strong scientific and data-driven approach to help educate our physicians. More than 2,000 physicians have prescribed VYVGART, including every one of our top 300 prescribers.

Speaker Change: Let's start with Zipcard, which has had an exceptional launch year delivering full year sales of $93 $6 million in fourth quarter sales up $30 million.

Speaker Change: <unk> is a testament to the outstanding execution of our commercial team and we're excited about what this pipeline in a product program will achieve in coming years.

Speaker Change: There are several factors contributing to this momentum with nib Clark.

Speaker Change: An expanding network of prescribers greater access through hospital listings, new patient acquisition and a growing number of patients starting treatment in the maintenance phase to manage symptoms and prevent relapses.

Speaker Change: Starting with physicians, we continue to grow the breadth and depth of our prescriber base utilizing our strong scientific and data driven approach to help educate our physicians.

Speaker Change: More than 2000 physicians have prescribed zipcard, including every one of our top 300 prescribers in.

Josh Smiley: In Q4, we saw a significant increase in the number of physicians who have prescribed three or more cycles for patients, highlighting the growing confidence in the treatment's long-term benefits. In addition, awareness of the FcRn mechanism across the physician community is growing. This momentum will be further amplified as we launch VYVGART Hytrulo for CIDP, unlocking additional opportunities for growth. On hospitals, we successfully achieved listings at all of our top targeted hospitals last year, covering approximately 65% of gMG market potential. We are now targeting the next wave of hospital listings, increasing our coverage to approximately 85% of the market. In parallel, we will focus on enhancing supplemental insurance coverage to offer additional support for the patient community. We're also seeing increased utilization of VYVGART as part of the maintenance treatment.

Speaker Change: In the fourth quarter, we saw a significant increase in the number of physicians, who have prescribed three or more cycles for patients highlighting the growing confidence in the treatment for long term benefits.

Speaker Change: In addition awareness of the <unk> mechanism across the physician community is growing.

Speaker Change: This momentum will be further amplified as we launch <unk> high trullo foresee IDP unlocking additional opportunities for growth.

Speaker Change: Our hospitals, we successfully achieved listing that all of our top targeted hospitals last year, covering approximately 65% of gmg market potential.

Speaker Change: We are now targeting the next wave of hospital listings, increasing our coverage to approximately 85% of the market.

Speaker Change: In parallel we will focus on enhancing supplemental insurance coverage to offer additional support for the patient community.

Speaker Change: We're also seeing increased utilization of <unk> as part of the maintenance treatment.

Josh Smiley: Approximately 40% of patients who initiated treatment in Q3 2024 returned for an additional cycle in Q4, which aligns with clinical trial findings and reinforces our confidence in long-term patient adherence. Additionally, new formulations such as VYVGART Hytrulo and the prefilled syringe have the potential to ease the treatment burden, enhancing the overall patient experience in improving DOT. We're making great progress, but there's still much to do. With over 170,000 gMG patients in China, our current market penetration is under 10%, indicating vast potential for growth. As we look to 2025, we have well-defined strategies in place to drive new patient growth and the duration of treatment for VYVGART and gMG. First, we will continue to establish infusion centers in top-tier hospitals, enhancing patient access and convenience for treatment.

Speaker Change: Approximately 40% of patients who initiated treatment in the third quarter of 2020 for return for an additional cycle in the fourth quarter, which aligns with clinical trial findings and reinforces our confidence in long term patient adherence.

Speaker Change: Additionally, new formulations, such as <unk> Gard high to low and the pre filled syringe had the potential to ease the treatment burden enhancing the overall patient experience and improving.

Speaker Change: We're making great progress, but there is still much to do with over 170000 gmg patients in China. Our current market penetration is under 10%, indicating vast potential for growth.

Speaker Change: As we look to 2025, we have well defined strategies in place to drive new patient growth and the duration of treatment for VF Garden Gmg.

Speaker Change: First we will continue to establish infusion centers and top tier hospitals, enhancing patient access and convenience for treatment.

Josh Smiley: Second, the upcoming mid-2025 update to the national gMG guidelines is expected to provide tailwinds, positioning VYVGART as a more prominent treatment option for gMG. We will use this opportunity to increase physician education and shift prescribing behaviors toward a more proactive usage of VYVGART in the maintenance phase. Third, we are promoting the regular activities of daily living or ADL assessments, reinforcing the importance of ongoing VYVGART maintenance therapy when ADL scores decline to ensure better long-term disease management. Lastly, we are establishing programs designed to enhance patient experience and to further optimize and extend treatment duration. As we execute on these strategies throughout the year, we anticipate a stronger ramp-up in the second half of 2025, driven by an expanding pool of both new and returning patients that will have a compounding effect on sales.

Speaker Change: Second the upcoming mid 2025 update to the National Gmg guidelines is expected to provide tailwind.

Speaker Change: Additionally, we have guard.

Speaker Change: <unk> treatment option for Gmg.

Speaker Change: We will use this opportunity to increase physician education and shift prescribing behaviors toward a more proactive usage of depth guard in the maintenance phase.

Speaker Change: Third we are promoting the regular activities of daily living or ADL assessments reinforcing the importance of ongoing <unk> maintenance therapy, when ADL scores declined to ensure better long term disease management.

Speaker Change: And lastly, we are establishing programs designed to enhance patient experience and to further optimize and extend treatment duration.

Speaker Change: As we execute on these strategies throughout the year, we anticipate a stronger ramp up in the second half of 2025, driven by an expanding pool of both new and returning patients that will have a compounding effect on sales.

Josh Smiley: While we do anticipate quarterly fluctuations due to seasonal factors such as holidays and hospital purchasing patterns, these dynamics are expected to balance out over the course of the year. Now moving on to our other commercial products. Starting with ZEJU LA, it continues to be the leading PARP inhibitor for ovarian cancer, and hospital sales in China. We are seeing sales increases driven by increased penetration in first-line BRCA-mutated patients. For NUZYRA, the strong sales growth this year was supported by the NRDL inclusion for both IV and oral formulations. The NRDL listing for the IV formulation was successfully renewed in January 2025. We will continue to promote ongoing access and support for patients who rely on this important treatment.

Speaker Change: While we do anticipate quarterly fluctuations due to seasonal factors such as holidays and hospital purchasing patterns. These dynamics are expected to balance out over the course of the year.

Speaker Change: Now moving onto our other commercial products starting with the July it continues to be the leading PARP inhibitor for ovarian cancer in hospital sales in China. We are seeing sales increase was driven by increased penetration in first line BRCA mutated patients.

Speaker Change: For news IRA the strong sales growth. This year was supported by the NRG all inclusion for both IV and oral formulations the.

Speaker Change: The <unk> listing for the IV formulation was successfully renewed in January 2025, we will continue to promote ongoing access and support for patients who rely on this important treatment.

Josh Smiley: In addition, we have three recent product launches that will further contribute to the total revenue growth in 2025. First, VYVGART Hytrulo, which is the subcutaneous formulation of efgartigimod, with a shorter administration time of 30 to 90 seconds for adult patients with gMG and CIDP. Hytrulo is not listed on NRDL this year, but is expected to be a meaningful growth driver over time. Second, AUGTYRO in ROS1-positive non-small cell lung cancer, which comprises between 2% and 3% of the approximately 900,000 new cases of non-small cell lung cancer per year in China. AUGTYRO achieved first-time NRDL listing at the beginning of this year. Third, XACDURO in hospital-acquired and ventilator-associated pneumonia caused by Acinetobacter baumannii infections, of which there are approximately 300,000 cases in China each year.

Speaker Change: In addition, we had three recent product launches that will further contribute to the total revenue growth in 2025.

Speaker Change: First <unk> Gard high Trullo, which is the subcutaneous formulation of <unk> with a shorter administration time of 30 to 90 seconds for adult patients with Gmg and <unk>.

Speaker Change: <unk> is not listed on NR deal this year, but it is expected to be a meaningful growth driver over time.

Speaker Change: Second our Cairo, and Ross one positive non small cell lung cancer, which comprises between 2% and 3% of the approximately 900000, new cases of non small cell lung cancer per year in China, Our Cairo cheap first time in our Dl listing at the beginning of this year.

Speaker Change: Third <unk> in hospital acquired and ventilator associated pneumonia caused by a Senate Baxter bahmani infections of which there are approximately 300000 cases in China each year.

Josh Smiley: We will leverage the industry-leading commercialization infrastructure of Pfizer in the anti-infective therapeutic area to help accelerate access to this important therapy for patients in need in Mainland China. With the confidence we have behind our business, driven by the expected growth of VYVGART, new product launches, and the continued strong performance of our base business, we are, for the first time, providing total revenue guidance for the full year. We anticipate total revenues for 2025 to be in the range of $560 million to $590 million. In parallel to strong top-line growth, we're also focused on operational efficiency and financial discipline.

Speaker Change: We will leverage the industry, leading commercialization infrastructure of Pfizer in the anti infective therapeutic area to help accelerate access to this important therapy for patients in need in mainland China.

Speaker Change: With the confidence we have behind our business driven by the expected growth of Zipcard, new product launches and the continued strong performance of our base business. We are for the first time, providing total revenue guidance for the full year. We anticipate total revenues for 2025 to be in the range of $560 million to $590 million.

Speaker Change: <unk>.

Speaker Change: In parallel the strong topline growth, we're also focused on operational efficiency and financial discipline.

Josh Smiley: Through our ongoing efforts on enhancing commercial efficiency, optimizing resource allocation, and increasing productivity throughout the entire organization, our loss from operations in the Q4 and full year 2024 declined by 45% and 23% year-over-year. We are on track to reach profitability in the Q4 of 2025, and we have a robust cash position of $879.7 million, which allows us to support our next phase of growth as we drive both revenues and profitability. In summary, our strong execution in 2024 reflects Zai Lab's commitment to deliver on our strategic goals. With a fast-growing Greater China business, expanding global pipeline, and prudent financial discipline, we expect to drive substantial value for our shareholders this year and through the remainder of the decade.

Speaker Change: Through our ongoing efforts on enhancing commercial efficiency optimizing resource allocation and increasing productivity throughout the entire organization our loss from operations in the fourth quarter and full year 2024 declined by 45% and 23% year over year.

Speaker Change: We're on track to reach profitability in the fourth quarter of 2025, and we have a robust cash position of $879 $7 million, which allows us to support our next phase of growth as we drive both revenues and profitability.

Speaker Change: In summary, our strong execution in 2024 reflects <unk> commitment to deliver on our strategic goals.

Speaker Change: With a fast growing greater China business, expanding global pipeline and prudent financial discipline, we expect to drive substantial value for our shareholders. This year and through the remainder of the decade.

Josh Smiley: With that, I'll now pass the call over to Rafael to discuss the great progress with our pipeline.

Speaker Change: And with that I'll now pass the call over to Raphael to discuss the great progress with our pipeline.

Rafael Amado: Thank you, Josh. Let me begin by highlighting some of the key progress updates in our global pipeline since our last earnings call, along with our next steps. Starting with ZL-1310, a potentially highly active first-in-class DLL3 ADC for small cell lung cancer. We presented promising preliminary monotherapy results from the ongoing phase 1 trial last year, suggesting that this next generation ADC therapy has the potential to deliver antitumor responses in the majority of patients with extensive stage small cell lung cancer, including brain lesions with good tolerability. As Samantha said, we expect to present detailed results at an upcoming major medical conference in the first half of 2025. In January 2025, the US FDA granted orphan drug designation to ZL-1310 for small cell lung cancer, reflecting its potential to treat patients with this aggressive disease.

Raphael: Thank you Josh let me begin by highlighting some of the key progress updates in our global pipeline since our last earnings call along with our next steps.

Raphael: We feel 13, Ken but thankfully highly active first in class CLO three ADC for small cell lung cancer with.

Raphael: We presented promising preliminary monotherapy results from the ongoing phase one trial last year, suggesting that this next generation ADC therapy has the potential to the later anti tumor responses in a majority of patients with extensive stage small cell lung cancer, including blame lesions with good tolerability.

Speaker Change: As Samantha said, we expect to present detailed results I don't know come in major medical conference in the first half of 2025.

Speaker Change: In January 2025, the U S. FDA granted orphan drug designation to <unk> for small cell lung cancer, reflecting its potential to treat patients with these aggressive disease.

Rafael Amado: Globally, small cell lung cancer affects around 372,000 patients each year, with a low five-year survival rate of 5% to 10%. Treatment options are limited when patients progress, with the current standard of care resulting in limited clinical benefit. Despite recent advancements such as tarlatamab, there remains a critical need for readily available treatment options that offer improved efficacy and manageable safety. We are working to address this critical gap with urgency. Enrollment in the monotherapy dose optimization study for second-line small cell lung cancer is progressing rapidly, with over 35 patients already dosed. We're also assessing potential combinations in the first-line setting, and we have initiated a global phase 1 dose escalation study evaluating ZL-1310 in combination with PD-L1 and PD-L1 plus chemotherapy. We expect to provide data this year.

Speaker Change: Globally small cell lung cancer effects around 372000 patients each year with a low five year survival rate of 5% to 10% treatment options are limited when patients progress with the current standard of care, resulting in limited clinical benefit. Despite recent advancements that just that Latam up there.

Speaker Change: Remains a critical need for our readily available treatment options that offer improved efficacy and manageable safety.

Speaker Change: We are working to address these critical gap with urgency.

Speaker Change: Enrollment in the monotherapy dose optimization study for second line small cell lung cancer is progressing rapidly with all the 35 basis already dose.

Speaker Change: We're also assessing potential combinations in the first line setting and we have initiated a global phase one dose escalation study evaluating <unk> in combination with BV outline and PDL, one plus chemotherapy.

Speaker Change: We expect to provide that after this year.

Rafael Amado: We also plan to initiate a registrational study in second-line plus small cell lung cancer this year, positioning us for a potential approval in 2027. Regulatory interactions with FDA related to accelerated approval for ZL-1310 are ongoing. DLL3 is also highly expressed in other neuroendocrine tumors, and after obtaining IND clearance earlier this month, we will start a global study soon to explore ZL-1310 in these indications. Beyond ZL-1310, we expect to advance at least two additional global assets into phase I development this year, including ZL-6201, a novel LRRC15 ADC for solid tumors, and ZL-1503, an IL-13, IL-31 bispecific antibody for atopic dermatitis. We expect to further expand our global pipeline and progress at least one global product into IND-enabling or IND submission stage this year.

Speaker Change: We also plan to initiate a registrational study in second line plus small cell lung cancer. This year positioning us for a potential approval in 2027.

Speaker Change: Regulatory interactions with FDA related to accelerated approval for the <unk> 10 are ongoing.

Speaker Change: CLO three is also highly expressing other neuroendocrine tumors.

Speaker Change: Obtaining IMD Prs earlier this month, we will start a global study soon to explore as the outsourcing 10 in these indications.

Speaker Change: Beyond <unk>, we expect to advance at least two additional global assets into phase one development this year, including <unk> a novel <unk>.

Speaker Change: <unk> ADC for solid tumors.

Speaker Change: <unk> and IL 17, IL 31, Bispecific antibody for atopic dermatitis.

Speaker Change: We expect to further expand our global pipeline and progress at least one global product into IND, enabling our IND submission states this year.

Rafael Amado: Now moving to our key late-stage programs. Starting with neuroscience, we achieved a major milestone with KarXT, our M1/M4 cholinergic receptor agonist for schizophrenia. In January 2025, China's NMPA accepted our NDA for KarXT, marking an important step towards bringing the first novel schizophrenia treatment to China in decades. Schizophrenia affects more than 8 million patients in China, with many patients unable to achieve adequate symptom control due to the limited effectiveness, and burdensome side effects of currently available treatments. In clinical trials, KarXT demonstrated robust efficacy, achieving statistically significant reductions in all study endpoints while maintaining a tolerable safety profile free of the side effects of classical antipsychotics. If approved, KarXT could redefine treatments for the millions of patients whose symptoms are inadequately managed by existing treatment options. Moving now to oncology for Tumor Treating Fields.

Speaker Change: Now moving to our key late stage programs.

Speaker Change: Starting with neuroscience, we achieved a major milestone with correct B R. N. One MLR culinary <unk> receptor agonists for schizophrenia.

Speaker Change: In January 2025, China, FDA accepted our NDA for Galaxy, marking an important step towards bringing the first novel schizophrenia treatment to China in decades.

Speaker Change: Affinia affects more than 8 million patients in China with many basis enabled to achieve adequate single control.

Speaker Change: The limited effectiveness and better than some side effects of currently available treatments.

Speaker Change: In clinical trials <unk> demonstrated robust efficacy achieved statistically significant reductions in all study endpoints.

Speaker Change: Maintaining a tolerable safety profile.

Speaker Change: It effects of classical anti Psychotics.

Speaker Change: If approved.

Speaker Change: <unk> could redefine treatment for the millions of patients with symptoms are inadequately managed by existing treatment options.

Speaker Change: Moving now to oncology for tumor treating fields in.

Rafael Amado: In December 2024, Zai Lab and Novocure announced that the pivotal phase 3 PANOVA-3 trial in unresectable locally advanced pancreatic cancer met its primary endpoint, demonstrating a statistically significant improvement in median overall survival versus control. This is the first phase 3 study to show a survival benefit in this patient population, and we plan to file for regulatory approval of tumor-treating fields in China in the second half of 2025. In China, approximately 134,000 new cases of pancreatic cancer are diagnosed each year, and these patients have limited effective treatment options and a poor prognosis, with a median survival of under 12 months. We hope to expand treatment options and improve outcomes for these patients in need. Turning to tisotumab vedotin or TIVDAK, our tissue factor ADC for recurrent or metastatic cervical cancer.

Speaker Change: In December 2020 for XI lab on Nokia announced that the pivotal phase III by another three trolleys in Unresectable locally advanced pancreatic cancer met its primary endpoint demonstrating a statistically significant improvement in median overall survival versus control.

Speaker Change: This is the first phase III study to show a survival benefit in this patient population and we plan to file for regulatory approval of tumor treating fields in China in the second half of 2025.

Speaker Change: In China, approximately 134000, new cases of pancreatic cancer are diagnosed each year and these patients have limited effective treatment options and a poor prognosis with a median survival of under 12 months.

Speaker Change: We hope to expand treatment options and improve outcomes for these patients in need.

Speaker Change: Turning to <unk>, our case that our tissue factor ADC for recurrent or metastatic cervical cancer.

Rafael Amado: In January 2025, we reported positive top-line results from the China subpopulation of the global phase 3 innovaTV 301 study. TIVDAK demonstrated a clinically meaningful improvement in overall survival compared to chemotherapy with a manageable safety profile as observed in the global study. Cervical cancer remains a leading cause of cancer-related deaths in women in China, with approximately 150,000 new cases annually. Patients currently have limited treatment options once their cancer recurs or spreads after initial treatment, and the current treatments have a different mechanism of action and toxicities. We plan to submit a biologics license application to the NMPA for recurrent metastatic cervical cancer in Q1 2025.

Speaker Change: In January 2025, we reported positive topline results from the China subpopulation of the global Phase III in Nova television studio one study.

Speaker Change: Data demonstrated a clinically meaningful improvement in overall survival compared with chemotherapy with a manageable safety profile as observed in the global study.

Speaker Change: Cervical cancer remains a leading cause of cancer related deaths and remain in China with approximately 150000, new cases annually.

Speaker Change: <unk> currently have limited treatment options once the cancer recurs or spreads after initial treatment and <unk>.

Speaker Change: Current treatments has a different mechanism of action and toxicities with.

Speaker Change: We plan to submit a biologics license application to the NPA for recurrent metastatic cervical cancer in the first quarter of 2025.

Rafael Amado: For Bemarituzumab, we're awaiting the results for both pivotal studies in gastric cancer, starting with FORTITUDE-101, which we expect in the first half of this year, and FORTITUDE-102 in the second half of the year. Bemarituzumab has the potential to become the first targeted therapy specifically for FGFR2b-positive gastric cancer in China. Next, with our immunology franchise. Eptacimab continues to demonstrate broad potential across IgG-mediated diseases. Our partner, argenx, announced in November 2024 the decision to advance VYVGART Hytrulo into the phase 2/3 ALKIVIA study for idiopathic inflammatory myopathies, IIM, or myositis, following promising phase 2 results. The subtypes of myositis evaluated in this study affect approximately 170,000 patients in China alone, with no targeted therapies currently approved. Zai Lab is actively participating in the Greater China cohort of this global registrational trial.

Speaker Change: Part of it like there's a map we're awaiting the results for both pivotal studies in gastric cancer.

Speaker Change: With 40 to 101, which we expect in the first half of this year. Unfortunately that one or two in the second half of the year.

Speaker Change: It doesn't matter has the potential to become the first targeted therapy.

Speaker Change: Typically for <unk> positive gastric cancer in China.

Speaker Change: Next with our immunology franchise.

Speaker Change: <unk> continues to demonstrate broad potential outgrowth IGT mediated diseases.

Speaker Change: Our partner <unk> announced in November 2020, before the decision to advance <unk> subcutaneously into the phase II <unk> <unk> study for idiopathic inflammatory myopathy.

Speaker Change: Our myositis following promising phase II results.

Speaker Change: The subtype of myositis evaluated in this side effect of approximately 170000 patients in China, along with no targeted therapies currently approved.

Speaker Change: Dialogue is actively participating in the greater China fault of this level Registrational trial.

Rafael Amado: We will continue to explore the pipeline and product potential of Eptacimab to treat other IgG-mediated autoimmune indications, including thyroid eye disease or TED, myositis, seronegative gMG, ocular gMG, and lupus nephritis. In 2025, we expect top-line results from the global phase 3 study of seronegative generalized myasthenia gravis and the phase 2 study of lupus nephritis. We also recently strengthened our regional immunology franchise with two late-stage assets that are highly synergistic with Eptacimab, Povetacicept in immunoglobulin A nephropathy, and ZL-1108 in thyroid eye disease. Povetacicept is a novel dual BAFF (B-cell activating factor) and APRIL (a proliferation-inducing ligand) antagonist with best-in-class potential in IgA nephropathy, supported by its compelling phase 2 data. In China, IgA nephropathy has an estimated prevalence of 3 to 5 million patients, yet there are currently no approved therapies targeting the underlying cause of the disease.

Speaker Change: We will continue to explore the pipeline in a product potash Hello expectation mode to treat other IBD mediated autoimmune indications, including thyroid eye disease or Ted Myositis are negative gmg ocular Mg in lupus nephritis and 2025, we expect topline results from the global Phase III study of <unk>.

Speaker Change: <unk> generalized myasthenia gravis and the phase II study of lupus nephritis, we all.

Speaker Change: Recently strengthened our original immunology franchise with two late stage assets that are highly synergistic with our strategy.

1000, <unk> immunoglobulin and nephropathy.

Speaker Change: <unk> 11, or eight inherited eye disease.

Speaker Change: <unk> is a novel dual Bath B cell activating factor in April a proliferation inducing ligand.

Speaker Change: Thank goodness with best in class.

Speaker Change: In Iga nephropathy.

Speaker Change: Supported by compelling phase II data.

Speaker Change: In China, Iga Nephropathy has an estimated prevalence of $3 million to $5 million basins. Yet there are currently no approved therapies targeting the underlying cause of the disease.

Rafael Amado: Despite standard of care treatments, including ACE inhibitors and steroids, 30 to 40% of patients eventually progress to end-stage renal disease, underscoring the significant need for innovative treatment options. China has already joined the global pivotal trial for Povetacicept in IgA, and we are leveraging our regional expertise and established footprint for renal diseases with Eptacimab to accelerate development timelines. We aim to bring this first-in-class therapy to patients expeditiously. ZL-1108 is an anti-IGF-1R antibody, which represents another valuable addition to our regional portfolio. It significantly reduces the treatment burden for thyroid eye disease through shorter infusion times and a more concise course of therapy compared to other anti-IGF-1R therapies. In its phase 3 studies, ZL-1108 has consistently demonstrated reductions in proptosis, diplopia, and CAS across both active and chronic thyroid eye disease.

Speaker Change: Despite standard of care three minutes, including the Ace inhibitors, and steroids, 30% to 40% of patients eventually progress to end stage renal disease underscoring the significant need for innovative treatment options.

Speaker Change: China has already joined the global pivotal trial for <unk> in Iga, and we are leveraging our regional expertise and established footprint for renal diseases with a strategic <unk>.

Speaker Change: The accelerated development timelines.

Speaker Change: We aim to bring this first in class therapy to patients expeditiously.

Speaker Change: <unk> 11 O eight.

Speaker Change: Hi.

Speaker Change: One our antibody, which represents another valuable addition to our regional portfolio.

Speaker Change: Significantly reduces the <unk> burden for thyroid eye disease through shorter infusion times had a more concise course of therapy compared to other anti IGF, one art therapies in its phase III studies, <unk> 11, or eight has consistently demonstrated a reduction in proptosis diplopia.

Speaker Change: CHS across both active and chronic thyroid eye disease.

Rafael Amado: We expect to initiate a China bridging study for TED patients in mid-2025. Thyroid eye disease affects approximately 3.3 million people in China, of which 1 million are diagnosed with moderate to severe forms of the disease. While estimates can vary, the active or acute phase of thyroid eye disease generally lasts between 6 and 24 months, roughly 20 to 30% of the overall disease course, before transitioning into a chronic phase that typically makes up the remaining 70 to 80%. Efcortizumab is under evaluation in active phase, and thus, ZL-1108 complements our franchise, creating synergies with Efcortizumab in both development and commercialization. The wealth of advancements reflects our relentless focus on delivering innovative potential best-in-class or first-in-class therapies to patients with high unmet needs. We will continue to execute with speed and precision, advancing our pipeline while exploring new opportunities.

Speaker Change: Expect to initiate a China bridging study for that patients in mid 2025.

Speaker Change: Thyroid eye disease affects approximately $3 3 million people in China of which 1 million are diagnosed with moderate to severe forms of the disease.

Speaker Change: While SMS can vary the active or acute phase of thyroid eye disease generally last between six and 24 months roughly 20% to 30% of the overall this is cars.

Speaker Change: Before transitioning into a chronic phase typically makes up the remaining 70% to 80%.

Speaker Change: <unk> is under evaluation.

Speaker Change: And thus the <unk> 11, our complement franchise, creating synergies with our strategic in both development and commercialization.

Speaker Change: The wells have advancements reflect our relentless focus on delivering innovative potential best in class or first in class therapies to patients with high unmet need.

Speaker Change: We will continue to execute with speed and precision advancing our pipeline, while exploring new opportunities.

Rafael Amado: I look forward to sharing further updates in the coming quarters. Now Yajing will give an overview of our financial results. Yajing.

Speaker Change: I look forward to sharing further updates in the coming quarters.

Speaker Change: Now Jim will give an overview of our financial results Jim.

Operator 1: Now, I will discuss highlights from our Q4 and full year 2024 financial results compared to the prior year periods. We had a strong top-line growth in the Q4 and the full 2024, driven by increased sales for VYVGART, ZEJULA, and NUZYRA. Total net product revenue grew 65% to $108.5 million in the Q4. For the full year, net product revenue was $397.6 million, reflecting robust growth of 49% year-over-year. Our focus on financial discipline and ongoing efficiency efforts was also reflected on the expenses side. R&D expenses for the Q4 declined 36% year-over-year, and the full year R&D expenses declined 12% as late-stage studies completed and as we continue to prioritize our investment to advancing high-value regional and global pipeline programs.

Yajing Chen: Now, I will discuss highlights from our Q4 and full year 2024 financial results compared to the prior year periods. We had a strong top-line growth in the Q4 and the full 2024, driven by increased sales for VYVGART, ZEJULA, and NUZYRA. Total net product revenue grew 65% to $108.5 million in the Q4. For the full year, net product revenue was $397.6 million, reflecting robust growth of 49% year-over-year. Our focus on financial discipline and ongoing efficiency efforts was also reflected on the expenses side. R&D expenses for the Q4 declined 36% year-over-year, and the full year R&D expenses declined 12% as late-stage studies completed and as we continue to prioritize our investment to advancing high-value regional and global pipeline programs.

Jim: Now I will discuss highlights from our fourth quarter and full year 2024 financial results compared to the prior year periods.

Jim: We had a strong topline growth in the fourth quarter and for 2024.

Jim: And by increased sales for <unk>.

Jim: And then IRA.

Jim: Total net product revenues grew 65% to $185 million in the fourth quarter for the full year net product revenue was $397 $6 million.

Jim: Collecting wilcox wells were 49%.

Jim: Our focus on financial discipline and ongoing efficiency efforts with also reflected on the expenses side.

Jim: R&D expenses for the fourth quarter declined 36% year over year and the full year R&D expenses declined 12% at late stage studies completed and.

Jim: As we continue to prioritize our investment into advancing high value regional and global pipeline programs.

Operator 1: SG&A expenses in Q4 were flat year-over-year, and the modest 6% increase for the full year was primarily due to higher general selling expenses related to the launch of VYVGART and the growing sales for NUZYRA, partially offset by a decrease in G&A expenses, and selling expenses for other products. Our loss from operations decreased 45% for Q4 to $67.9 million and 23% for the full year to $282.1 million. When you adjust our loss from operations to exclude certain non-cash items, specifically depreciation, amortization, and share-based compensation, we had adjusted loss from operations of $47.6 million in Q4 and $199.6 million for the full year, reflecting year-over-year improvement of 53% and 28% respectively.

Yajing Chen: SG&A expenses in Q4 were flat year-over-year, and the modest 6% increase for the full year was primarily due to higher general selling expenses related to the launch of VYVGART and the growing sales for NUZYRA, partially offset by a decrease in G&A expenses, and selling expenses for other products. Our loss from operations decreased 45% for Q4 to $67.9 million and 23% for the full year to $282.1 million. When you adjust our loss from operations to exclude certain non-cash items, specifically depreciation, amortization, and share-based compensation, we had adjusted loss from operations of $47.6 million in Q4 and $199.6 million for the full year, reflecting year-over-year improvement of 53% and 28% respectively.

Jim: SG&A expenses in the fourth quarter was flat year over year, and a modest <unk>, 6% increase for the full year was primarily due to higher selling expenses related to the launch of <unk> and grow yourself or <unk>.

Jim: <unk> should be offset by a decrease in G&A expenses and Sony expenses for other products.

Jim: Our loss from operations decreased 45% for the fourth quarter to $67 $9 million and 23% for the full year to $280 million to $21 million.

Jim: When you adjust our loss from operations to exclude certain noncash items, specifically depreciation amortization and share based compensation, we had adjusted loss from operations of $47 $6 million in the fourth quarter and $199 $6 million for the full year.

Jim: Reflecting year over year improvement of 53% and 28% respectively.

Operator 1: We are in a strong financial position, ending the quarter with a cash position of $879.7 million. Now, turning to our financial outlook for 2025. We expect our 2025 total revenues to be in the range of $560 million to $590 million. This revenue forecast reflects strong growth for the VYVGART franchise, continued growth across our other products, including ZEJU LA and NUZYRA, and contributions from our newly launched products, AUGTYRO and XACDURO. Lastly, based on our operating plan and our anticipated revenue growth, we expect to achieve profitability in Q4 2025. With that, I would now like to turn the call back over to the operator to open up the line for questions. Operator?

Yajing Chen: We are in a strong financial position, ending the quarter with a cash position of $879.7 million. Now, turning to our financial outlook for 2025. We expect our 2025 total revenues to be in the range of $560 million to $590 million. This revenue forecast reflects strong growth for the VYVGART franchise, continued growth across our other products, including ZEJU LA and NUZYRA, and contributions from our newly launched products, AUGTYRO and XACDURO. Lastly, based on our operating plan and our anticipated revenue growth, we expect to achieve profitability in Q4 2025. With that, I would now like to turn the call back over to the operator to open up the line for questions. Operator?

Jim: We are in a strong financial position ending the quarter with a cash position of $879 $7 million.

Jim: Now turning to our financial outlook for 2025.

Jim: We expect our 'twenty to 'twenty five total revenues to be in the range of $560 million to $590 million.

Jim: This revenue forecast, we flash chalk wells for the visa call franchise.

Jim: <unk> growth cross sell other products, including <unk> and <unk>.

Jim: <unk> contribution is following new launch products Tyra and Zach Doyle.

Jim: Lastly.

Jim: Our operating plan and our anticipated revenue growth, we expect to achieve profitability in the fourth quarter of 2025.

Jim: Yeah.

Jim: And with that I would now like to turn the call back over to the operator to open up the line for questions operator.

Operator 2: Thank you. We will now open the line for questions. To ask a question, press star one one on your telephone. You would then hear an automated message advising your hand is raised. To withdraw your question, please press star one one again. We will now take our first question from the line of Anupam Rama from J.P. Morgan. Please ask your question.

Operator: Thank you. We will now open the line for questions. To ask a question, press star one one on your telephone. You would then hear an automated message advising your hand is raised. To withdraw your question, please press star one one again. We will now take our first question from the line of Anupam Rama from J.P. Morgan. Please ask your question.

Speaker Change: Thank you.

Speaker Change: Your line.

Speaker Change: Good luck.

Speaker Change: Thanks, Chris.

Speaker Change: I think your telephone you will then hear an automated message advising yohan is raised.

Speaker Change: To withdraw your question. Please press star one again.

Speaker Change: We will now take our first question from the line of our new Palm Rahmat from Jpmorgan. Please ask your question.

Anupam Rama: Hey, guys. Thanks so much for taking the question, and congrats on all the progress. Just when it comes to the 2025 revenue guidance, which came in ahead of consensus, wondering if there are products beyond VYVGART that we should be thinking about outsized growth for the year. Thanks so much.

Palm Rahmat: Hey, guys. Thanks, so much for taking my question and congrats on all the progress.

Palm Rahmat: Just when it comes to the 2025 revenue guidance, which came in ahead of consensus wondering if there are products beyond the beef guard that we should be thinking about outsized growth for the year. Thanks, so much.

Rafael Amado: Hi, Anupam. It's Josh. No, I think if you look at our revenue range, we expect the base business to grow, you know, strongly. We'd point to ZEJULA and NUZYRA as particular growth drivers. VYVGART we expect to grow faster than the overall, you know, rate of growth implied in the $560 to 590. Of course, we're launching first full year launch for AUGTYRO and XACDURO. We'll expect some sales there. I think it's just strong performance across the brands. We're excited about the year. Next question, operator.

Palm Rahmat: Hi, Anthony It's Josh No I think if you look at our revenue range, we expect the base business to grow strongly.

Speaker Change: 0.2 is the jewel and news IRA as particular growth drivers at <unk>, we expect to grow faster than the overall rate of growth implied in the $560 to $5 90 and of course, we're launching.

Speaker Change: A full first full year launch for <unk> Tyro and that is that Dora. So we will expect some sales there, but I think there. It's just strong performance across the brands. We're excited about the year.

Speaker Change: Okay.

Speaker Change: Next next question operator.

Operator 2: Thank you. We will now take our next question from the line of Michael Yee from Jefferies. Please ask your question, Michael.

Operator: Thank you. We will now take our next question from the line of Michael Yee from Jefferies. Please ask your question, Michael.

Speaker Change: Thank you.

Speaker Change: We will now take our next question from the line of Michael <unk> from Jefferies. Please ask your question Michael.

Michael Yee: Thanks. Good morning. Thank you for the question. We had two. First was on VYVGART. While there's no specific revenue guidance for 2025 for that product line, I think you made some nice comments around the shape of the curve for this year. Can you just a little more color on the growth trajectory in the first half of the year versus the second half of the year? Is that driven by the treatment guidelines? Maybe just help us out a little bit about where the trajectory of ZEJULA could be by the end of the year. Then a R&D question around DLL3. Can you just confirm your thoughts about how fast you can move into a pivotal study?

Thanks. Good morning. Thank you for the question we had to first was on <unk>.

Speaker Change: While there is no specific revenue guidance for 2025 for that product line.

Speaker Change: I think you've made some nice comments around the shape of the curve for this year can you just.

Speaker Change: A little more color on the growth trajectory in the first half of the year versus the second half of the year and is that driven by treatment guidelines.

Speaker Change: Maybe just help us out a little bit about what the trajectory of Julia could be by the end of the year and then R&D question around DLL three.

Speaker Change: Can you just confirm your thoughts about how fast you can move into a pivotal study.

Michael Yee: I think there's another Chinese ADC that was recently in-licensed and put up some data around a 70% response rate. I'm just trying to think about the competitive dynamic there and the speed at which you can go. Thank you.

Speaker Change: I think there is another Chinese agency that was recently in licensed products.

Speaker Change: Some data around a 70% response rates from just trying to think about the competitive dynamic there and the speed at which you think you guys. Thank you.

Josh Smiley: Thanks, Mike. It's Josh. First on VYVGART. I think we're excited about the momentum we have coming into this year and, you know, expect us to have a really good growth year again in 2025. As you pointed out, I think what we particularly expect to see as we get through the year is the compounding effect of the new patients we're starting, particularly those in the maintenance or what we would call consolidation phase, where these are patients who are gonna expect to go on multiple cycles through the year. Of course, those build up and accumulate through the year. Mid-year, we do expect an official update to the myasthenia gravis treatment guidelines in China that more prominently features VYVGART. We'll get some benefits there.

Josh Smiley: Thanks, Mike It's Josh first on <unk> I think we're excited about the momentum we have coming into this year and expect us to have a really good growth here again in 2025.

Speaker Change: As you pointed out I think that what we.

Speaker Change: Particularly expect to see as we get through the year is the compounding effect of the new patients were starting particularly those in maintenance or what we would call consolidation phase where these are patients who are going to expect to go on multiple cycles through the year and of course, those those buildup and accumulate through the year midyear we do.

Speaker Change: We expect.

Speaker Change: Facial update to the myasthenia gravis treatment guidelines in China that more prominently features.

Josh Smiley: Of course, we're, while CIDP is not on the NRDL, we're in the process of launching that and making sure patients who do have the supplemental insurance or other ways of accessing the drug that they get it as well. I think those things, when you put them together, just lead to even stronger, I think, second half, you know, growth than we'll see in the first half. Certainly don't mean to imply that we won't, you know, see growth throughout the year. Again, very, very strong outlook for VYVGART for this year. Rafael will take the DLL3 question.

Speaker Change: Got it so we'll get some benefits there and of course, we're whilst the IBP is not on the <unk>. We're in the process of launching that and making sure patients who do have supplemental insurance or other ways of accessing that drive that they get it as well. So I think those those things when you put them together just lead to even stronger I think second half growth and we will see in the <unk>.

Speaker Change: But certainly don't mean to imply that we will see.

Speaker Change: The growth throughout the year and again very very strong outlook for vipin garg for this year.

Speaker Change: Raphael.

Rafael Amado: Yeah. Thank you, Michael. With regards to the regulatory pathway and speed, we think we have an opportunity to achieve accelerated approval. We are in discussions with regulators, and we plan to start that study this year. We've treated a number of patients already that will be presented in the first half of this year. Yes, there are other DLL3 products, but they're much earlier, probably a year and a half or so behind. We're confident that we could be the first ones to be approved. The properties are continuing to be very similar to what we started to observe with the first patients that we treated.

Speaker Change: We have all three questions.

Speaker Change: Thank you Michael with regards to the.

Speaker Change: Regulatory pathway.

Speaker Change: <unk>.

Speaker Change: We think we.

Speaker Change: An opportunity too.

Speaker Change: We've accelerated approval we are in discussions with regulators and we plan to start that study this year.

Speaker Change: Sure Ed.

Speaker Change: A number of patients already.

Speaker Change: During the first half of this year.

Speaker Change: And yes, there are other DLO ski products, but they're much earlier, probably a year and a half or so behind.

Speaker Change: So we're confident that we.

Speaker Change: We could be the first one.

Speaker Change: To be approved.

Speaker Change: <unk>.

Speaker Change: The properties.

Speaker Change: Continue to be very similar to what we started to observe with the first patients that we've treated so overall I'm very confident that we will start. This study this year and that accelerated up royalties survival pathway.

Rafael Amado: you know, overall, very confident that we will start the study this year and that accelerated approval is a viable pathway.

Michael Yee: Very good. Thank you.

Speaker Change: Very good thank you.

Operator 3: Thank you. We will now take our next question from the line of Jonathan Chang from Leerink Partners. Please ask your question, Jonathan.

Operator: Thank you. We will now take our next question from the line of Jonathan Chang from Leerink Partners. Please ask your question, Jonathan.

Speaker Change: Thank you.

Speaker Change: We will now take our next question from the line of Jonathan Chang from Leerink Partners. Please ask your question Jonathan.

Yen-Der Li: Hello, this is Yen-Der Li for Jonathan Chang. Thanks for taking my question. I have a follow-up question regarding the regulatory strategy for ZL-1310, the DLL3 program. For the pivotal study, could you share your current view on whether you can do a single arm study or you will need a randomized control study to support the accelerated approval? And how does that influence your thoughts on the 2023 BLA submission timeline? And I have a follow-up question after that. Thanks.

Young Lee: Hello. This is younger Lee for GAAP and <unk>. Thanks for taking my question. So I have a follow up question regarding the regs.

Young Lee: The regulatory strategy for a deal <unk> tend to be a big program. So for the pivotal study could you share. Your current view on whether you can do a single arm study.

Would need a randomized control study to support the accelerated approval and how does that influence your thoughts on the plenty of 'twenty three BLA submission timeline.

Young Lee: Follow up question after that.

Young Lee: Thanks.

Rafael Amado: Yeah. It's a good question, but obviously we don't discuss details of regulatory discussions with FDA. There's been two products approved as single arms, but there are other products that are approved as accelerated approval in randomized trials. The advantage of the latter is that one can confirm the approval with the definitive endpoint of survival. How will we proceed and you know, will be revealed once we launch that study. Whichever way we go forward, we will move expeditiously. As I said, we will start today.

Young Lee: Yes.

Speaker Change: It's a good question, but obviously, we don't discuss details of our regulatory discussions with FDA.

Speaker Change: Does it mean two products approved.

Young Lee: Single arms.

Young Lee: There are other products that are approved.

Young Lee: Accelerated approval and grown the my styles and their vendors have the latter as I won't kind of confirmed the approval with the definitive endpoint of survival. So how will you proceed then would it be reviewed once we launch.

Young Lee: That study.

Young Lee: Teva away, where you go forward.

Young Lee: We will move expeditiously as I said I will start today.

Rafael Amado: There's a lot of enthusiasm from investigators who accrued to this product and, you know, we're confident that we will be able to move this and potentially get approval in 2027. Stay tuned.

Young Lee: A lot of.

Speaker Change: And <unk> them from investigators so accrued to.

Young Lee: To this product on.

Speaker Change: We're confident that.

Young Lee: We will be able to move.

Young Lee: Most days and potentially get.

Young Lee: The approval.

Young Lee: In 2027 so.

Young Lee: Stay tuned.

Yen-Der Li: Oh, got it. Yeah. Can I just add a follow-up question? So, can you comment on, like, the 2026 BLA submission timeline relative to the timeline of potential tarlatamab for approval and the timeline of other B7-H3 ADC pivotal study readouts? Does that kind of align with what you're thinking? Thank you.

Young Lee: Okay got it and can I just ask a follow up question. So you.

Young Lee: Can't comment on.

Speaker Change: The 2023, Im sorry, 26, the BLA submission timeline relatively to timeline.

Speaker Change: Potential talk on that for approval and the timing of all other <unk> ADC clinical study readouts is that like kind of aligned with wider I think thank you.

Rafael Amado: Yeah. There are obviously other products there. Tarlatamab has accelerated approval. It's a very different agent. Obviously, there's been precedent that even with full approval in the same line of therapy, accelerated approval can be granted. There are multiple examples in the hematology field. The mechanism of action is different. The toxicity is different. You know, so far the level of activity of ZL-1310 is higher, it's in the 70% range, as opposed to 40%. We're not too concerned about you know the potential of Tarlatamab getting a full approval before our PDUFA date. That's with regards to Tarlatamab in second line.

Speaker Change: Yes.

Speaker Change: Obviously other other products there carload on that path for accelerated approval.

Speaker Change: It's a very different agent.

Speaker Change:

Speaker Change: Obviously.

Speaker Change: Theyre seeing precedence that.

Speaker Change: Even with full approval in the same line of therapy accelerated approval can be granted there are multiple examples in the hematology feel.

Speaker Change: The mechanism of action its differentiated toxicity is different.

Speaker Change: And.

Speaker Change: So far the level of activity.

<unk> 10.

Speaker Change: Hi areas in the 70% range as opposed to 40%.

Speaker Change: So.

Speaker Change: We're not too concerned about.

Speaker Change: The potential of <unk>.

Speaker Change: Latam up getting full approval before.

Speaker Change: Our <unk> date.

Speaker Change: So that's with regards to <unk> in second line.

Rafael Amado: With B7-H3, my sense is that they've started or they plan to start a pivotal trial. You know, we don't really comment on the details of competitors. I actually do not know what their timelines are. All I can say is that, you know, our plan is to move as fast as possible with an accelerated approval pathway.

Speaker Change: We'd be sitting in my and my sense is that.

Speaker Change: Started.

Speaker Change: The plan to start.

Speaker Change: Pivotal trial.

Speaker Change: No we don't really comment on the details of our competitors and I actually don't know what their timelines are.

Speaker Change: I can say is there.

Speaker Change: Our plan is to move as fast as possible with.

Speaker Change: And et cetera that approval.

Speaker Change: Pathway.

Yen-Der Li: Understood. Thank you so much for answering my questions.

Speaker Change: Understood. Thank you so much for answering my questions.

Operator 4: Thank you. Our next question comes from the line of Yigal Nochomovitz from Citi. Please ask your question, Igal.

Operator: Thank you. Our next question comes from the line of Yigal Nochomovitz from Citi. Please ask your question, Igal.

Speaker Change: Thank you.

Speaker Change: Our next question comes from the line of ego nurture moving from Citi. Please ask your question igo.

Reena Patel: Hi, this is Reena in for Yigal. Thanks for taking my question. I just wanted to ask, on DLL3, just wondering if you could talk about your strategy going into the first line setting, and then with the update expected at the upcoming medical congress. Just wondering what kind of data we should expect there, like how many patients, efficacy points, anything you could tell us there?

Speaker Change: Hi, This is Ryan on for Yigal. Thanks for taking my question I just wanted to ask on deal three just wondering if you could talk about your strategy going into the first line setting and then with the update expected at upcoming medical Congress, just wondering what kind of data we should expect there like how many patients.

Speaker Change: Efficacy claims.

Speaker Change: Thank you good Sir.

Rafael Amado: Yeah. Thank you for the question. I'll answer the second question first. We will have data on the various dose escalation doses. We should have a fair amount of maturity in the earlier doses. You know, definitely enough time for responses to have been confirmed. In addition to that, as we mentioned in the prior quarter, we started the dose optimization and we've accrued really fast to that randomized cohort of the study. That was 50 patients. We should have at least the opportunity to be confirmed in the vast majority of patients. We think we'll have data in about 75 patients or so at different levels of follow-up obviously. With regards to first line, we were pretty active in first line.

Speaker Change: Yes. Thank you for the question I'll answer the second question first.

Speaker Change: We will have data on the various dose escalation doses.

Speaker Change: And we should have.

Speaker Change: A fair amount of maturity in the earlier doses.

Speaker Change: And.

Speaker Change: Definitely enough time for responses to have been confirmed.

Speaker Change: In addition to that as we mentioned in the prior quarter, we started the dose optimization.

Speaker Change: And we have got a really fast too.

Speaker Change: To that.

Speaker Change: Randomize cohort of this study.

Speaker Change: That was 50 patients.

Speaker Change: And we should have.

Speaker Change: At least okay.

Speaker Change: Turning to reconfirm in the vast majority of patients. So we think we'll have data.

Speaker Change: 75 patients or so.

Speaker Change: Different.

Speaker Change: Levels of follow up obviously.

Speaker Change: With regards to first line, we were pretty active in first line.

Rafael Amado: We started a combination with PD-L1 inhibitor. Very soon, we're gonna start with carboplatin plus PD-L1 inhibitor, so a triplet. Our initial goal is to avoid etoposide because it's a very mild suppressive drug, and that's really what tends to limit the length of therapy. There's been precedent, as you know, of other ADCs that combine with PD-1 inhibitor. Checkpoint inhibitors have been able to supplant chemotherapy such as PADCEV in GU.

Speaker Change: We started.

Speaker Change: Combinations.

Speaker Change: With PDL one inhibitor.

Speaker Change: And then very soon we're going to start with Carboplatin plus PD one inhibitor. So a triplet.

Speaker Change: Our initial goal is to avoid a dump aside I think this is a very modest suppressive drug and that's really what tests to limit the length of therapy.

Speaker Change: But this theme precedence as you would know of other.

Speaker Change: ADC is that combined with PD, one inhibitor checkpoint inhibitors have been able to supplant chemotherapies such as Scott surfing to you.

Rafael Amado: If you think about the fact that we can get 70% in second line and the response rate in first line is slightly lower than that, in the 50% to 60%, you know, it's not very far-fetched to think that ZL-1310 plus PD-1 inhibitor could be potentially superior to the current standard of care. This is the way we're thinking. Nevertheless, we're going to test the combination with carbo, and then we will have to select a dose for ZL-1310 with that combination. We should have data this year on that dose optimization. We will have regulatory discussions as to how to move it into front line.

Speaker Change: So.

Speaker Change: If you think about the fact that we can get 70% in the second line. The response rate in first line is slightly lower than that is 50% <unk>.

Speaker Change: It's not.

Speaker Change: Various farfetched to thing that.

Speaker Change: VL 13, 10, plus a PD one inhibitor could.

Speaker Change: Could be.

Speaker Change: <unk> is superior to the current standard of care.

Speaker Change: This is the way we're thinking nevertheless, we're going to test upon the combination with Carnival and then we'll have to select the dose.

Speaker Change: Brazil, 13, 10 with that combination.

Speaker Change: Should have data this year on that.

Speaker Change: Dose optimization.

Speaker Change: And then we will have regulatory discussions as to how to move into frontline.

Reena Patel: That makes sense. Super helpful. Thanks for taking my question.

Speaker Change: That makes sense Super helpful. Thanks for taking my question.

Operator 4: Thank you. We will now take question from the line of Linhai Zhao from Goldman Sachs. Please ask your question, Linhai.

Operator: Thank you. We will now take question from the line of Linhai Zhao from Goldman Sachs. Please ask your question, Linhai.

Speaker Change: Thank you.

Speaker Change: We will now take question from the line of Linda Hi, Joe from Goldman Sachs. Please ask your question Lehigh.

Linhai Zhao: Thanks for taking my question. I have two questions. The first one is about VYVGART. So since we have the CIDP and also the SC formula approved in the second half of 2024, I'm curious what has been the observations of real world patient usage and adoptions we have observed so far? In terms of sales breakdown, what percentage of sales coming from the CIDP and subcutaneous formula? In the longer term, what percentage would you expect would come from this CIDP and subcu formula? That's the first question. The second question is about KarXT. Since we have our NDA has been accepted in January, that means that the China approval should be around roughly a year away.

Joe: Thanks for taking my question I have two questions. The first one is about <unk>.

Speaker Change: So since we have to see IDP and or so the assay formula or approved in the second.

Joe: Second half of 2024.

Joe: Curious what has been the preservation of a real world patient usage and adoptions.

Joe: We have observed so far and in terms of sales breakdown.

Joe: What percentage of sales coming from the.

Joe: <unk> subcutaneous formula and in the longer term.

Joe: What percentage would you expect.

Joe: Come from this.

Joe: <unk> Formula that's the first question and the second question is about car X T. Since we have our NDA has been accepted in January that means that.

Joe: China provoke should be around roughly a year away.

Linhai Zhao: Most recently, BMS has also shown that they have received a very encouraging feedback and the early trend has been pretty good. That's, but we all know that's in the US market. In the China market, can you share a bit more on the potential differences in the schizophrenia treatment between US and how would you see the potential commercial hurdles in China? And in addition, any updates on the ADP clinical development? Thank you.

Joe: And most recently <unk> has also shown that they have received very encouraging.

Joe: Feedback and the early trend has been pretty good.

Speaker Change: So that's but we arent all that in the U S market. So in the China market can you share a bit more on the potential differences in the schizophrenia treatment between you.

Speaker Change: U S and how would you see the potential commercial hurdles in China. Any addition, any update on the ADP clinical development. Thank you.

Josh Smiley: Thanks for the question. It's Josh. I'll start, and then Rafael can talk a little bit about data for KarXT. First on CIDP, your question about CIDP in VYVGART, just keep in mind that while we received approval, by the time we got the product up for commercial launch, it was right at the end of 2024. We do not have NRDL listing for Hytrulo or CIDP in 2025. I think we expect a, you know, relatively limited impact. It's only gonna be available through, you know, supplemental insurance or cash-paying market. We're really looking forward to listing in, you know, in later years and full benefit there.

Speaker Change: Got it thanks for the question, it's Josh I'll start and then Raphael can talk a little bit about ADP RXT at first on CIB.

Speaker Change: About <unk>.

Speaker Change: VF Guard just keep in mind that while we received approval by the time, we got the product up for <unk> commercial launch it was right at the end of 2024, we do not have in our Dl listing for hydro low or.

Speaker Change: See IDP in 2025, so I think we expect a relatively limited impact, it's only going to be available through supplemental insurance or a cash paying market.

Speaker Change: So we're really looking forward to listing in in later years and full benefit there. So our focus this year, while we do one patients with the IDP to have the opportunity to benefit from this product really the vast majority of our sales in effort to focus on gmg in 2025, and gmg in an IV formulation.

Josh Smiley: Our focus this year, while we do want patients with CIDP to have the opportunity to benefit from this product, really the vast majority of our sales and efforts will focus on GMG in 2025 and GMG in an IV formulation. To the question about KarXT, yeah, I think we are very excited about the commercial opportunity for KarXT in schizophrenia. Of course, we're, as you mentioned, we submitted at the end of last year and are looking forward to an approval and a launch. There are 8 million patients with schizophrenia in China, about 4 million of whom are seeking care in pretty intensive settings, typically using an atypical antipsychotic.

Speaker Change: <unk> about the car T I think.

Speaker Change: We are very excited about.

Speaker Change: The commercial opportunity for <unk> in schizophrenia of course, where as you mentioned, we submitted at the end of last year and are looking forward to to an approval and launch.

Speaker Change: There are 8 million patients with schizophrenia in China.

Speaker Change: <unk> 4 million of whom are seeking care in pretty intensive settings, typically using an atypical antipsychotic.

Josh Smiley: I think we know from the clinical trial experience, and certainly what BMS is seeing in the US, is that COBENFY or KarXT provides a really important opportunity to help patients who are not responding well to atypical antipsychotics or who, you know, can get more of the, you know, the negative symptom relief that you can get with COBENFY versus the atypical antipsychotic. We're just excited to get the product approved and start the launch. We'll launch with a sales force in about 150 person range focused on these big treatment centers, and we're looking forward to that, and I think it's gonna be a great product in China for schizophrenia. Rafael, maybe you can make some comments about Alzheimer's.

Speaker Change: And I think we know from the clinical trial experience and certainly what.

Speaker Change: BMS is seeing in the U S is that <unk> provides us a really important.

Speaker Change: Opportunity to help patients who are not responding well to atypical anti psychotics or who.

Speaker Change: We can get more of that.

Speaker Change: Positive negative symptom relief that you can get with Coco van fee versus the atypical antipsychotics. So we're just excited to get the product approved and start to launch we'll launch with Salesforce in about 150 person range focused on these big treatment centers and we're looking forward to that and I think it would be great.

Speaker Change: In China for schizophrenia, Raphael, maybe you can make some comments about that.

Speaker Change: Uh huh.

Speaker Change: Alzheimer's.

Rafael Amado: Sure. In dementia-related psychosis, there's a series of studies, they're called ADEPT studies, that are being executed by BMS. As you know, antipsychotics have a black box warning against the use in dementia, which KarXT doesn't have. In fact, we're seeking an indication in this setting, which is really an unmet need. We very much want to pursue this indication, and we're in discussions with BMS as to, you know, what the best regulatory pathway is, whether it's participating in ADEPT versus doing other, you know, separate bridging trial or other potential registration pathways. That will be performed this year. Just to reiterate that it's an indication that we will be pursuing.

Speaker Change: Sure.

Speaker Change: Dementia related psychosis.

Speaker Change: There is a series of studies.

Speaker Change: The color depth studies that are being executed by BMS.

Speaker Change: As you know.

Speaker Change: Got it.

Speaker Change: Black box warning against the use in dementia, which doesn't.

Speaker Change: It doesn't have an impact.

Speaker Change: We're seeking that indication.

Speaker Change: In this.

Speaker Change: Setting, which is really an unmet need.

Speaker Change: We very much want to.

Speaker Change: Pursue this indication and we are in discussions with BMS as to what the best regulatory pathways, whether is participating in a depth versus doing other.

Speaker Change: Separate bridging trial or.

Speaker Change: Or are there potential registration pathways, but that will that will it be performed this year.

Speaker Change: And just to reiterate that it's an indication that we'll be pursuing.

Speaker Change: Okay.

Josh Smiley: Thank you.

Operator 4: All right. Thank you. We'll now take the next question from the line of Li Watsek from Cantor Fitzgerald. Please go ahead.

Operator: All right. Thank you. We'll now take the next question from the line of Li Watsek from Cantor Fitzgerald. Please go ahead.

Speaker Change: Thank you Eric.

Speaker Change: Thank you.

Speaker Change: Well now take our next question from the line of Lee will shake from Cantor Fitzgerald. Please go ahead.

Li Watsek: Hey, guys. Thanks for taking our questions. I have one on pipeline, one on commercial. I guess for ZL-1310, DLL3 ADC, in terms of durability, where would you place ADC versus, you know, the other modalities such as T-cell engagers or radiation? Can you talk about chemosensitivity or radiation sensitivity in small cell lung cancer? If you align on approval path for second line, how should we think about the confirmatory study and the enrollment timeline there? Second, for VYVGART, anything you can share in terms of breakdown of new patient adds versus maintenance for Q4? How should we think about the sequential contribution from each group going forward?

Speaker Change: Hey, guys. Thanks for taking our questions I have one on pipeline and one on commercial.

Speaker Change: I guess for <unk> 13.

Speaker Change: <unk> 10 of dialysis three ADC in terms of your ability.

Speaker Change: Where would you place ADC first as you know the other modalities such as T cell caters a radial and can you talk about you know chemo sensitivity or sensitivity in small cell lung cancer.

Speaker Change: And then you know you feel aligned on a path for second line, how should we think about the confirmatory study and the enrolment timeline there.

Speaker Change: And then second for a big card anything you can share in terms of the breakdown of new location adds versus maintenance for Q4.

Speaker Change: And then how should we think about the sequential contribution from each group going for work.

Josh Smiley: Rafael, do you wanna start on?

Speaker Change: Okay.

Rafael Amado: Yeah. I'll start with DLL3. You know, I think the durability of response, which I think was your first comment, it's still early to be able to know what the median durability of response is going to be. I think that is a good thing. Perhaps by ASCO we may know, but we haven't reached it yet, last time we looked. I think a good DOR, you know, would be, you know, if, you know, 50% of patients are at six months or greater, you know, that would be, I think, something important, particularly given that there are so many patients that respond.

Rafael: Rafael do you want to comment on yes.

Speaker Change: Starting with <unk> three.

Speaker Change: I think the durability of response with testing what's your first comment.

It's.

Speaker Change: It's still early to be able to to know what the median durability of response going to be.

Speaker Change: And I think that is a good thing.

Speaker Change: Perhaps <unk>, we may now, but we haven't reached it yeah listen we look.

Speaker Change:

Speaker Change: I think a good deal or.

Speaker Change: Would be.

Speaker Change: If if if.

Speaker Change: Yes.

Speaker Change: 50% of patients are on six months or greater.

Speaker Change: That would be I think something important, particularly given that there are so many patients that respond.

Rafael Amado: If you look at tarlatamab, the response rate's in the 40s with DOR of 9 months. That's really what's in the label. We hope to be, you know, thereabouts those numbers. Hopefully, the longer, the better. In terms of chemosensitivity, I'm not sure exactly whether you're referring to patients who are platinum refractory or resistant. We've looked at that, and there's really no difference in sensitivity to ZL-1310. Patients tend to respond with the same proportion whether or not they are refractory or resistant to platinum. That is not the case with other agents, as you may know. With regards to the confirmatory trial, it depends on how the accelerated approval is obtained.

Speaker Change: You can look at their.

Their response rates in the Forty's with Dr of nine months, that's really what's in the label. So we hope to be.

Speaker Change: Thereabouts those number hopefully the longer.

Speaker Change: Better.

Speaker Change:

Speaker Change: In terms of Cumulus sensitivity I'm not sure exactly whether you are referring to whether patients were refractory or resistant.

Speaker Change: We've looked at that and Theres really no difference in sensitivity to 13 10 patients tend to respond.

Speaker Change: The same.

Speaker Change: Proportion whether or not.

Speaker Change: They are refractory or resistant to platinum and that is not the case with other agents.

Speaker Change: You may now.

Speaker Change: With regards to the confirmatory trial it depends on how the accelerated approval is obtained.

Rafael Amado: If it's obtained in the context of a randomized trial where accelerated approval is obtained by response, then the same study will confirm the approval using time to event endpoint, which tends to be overall survival in second line. Otherwise, one has to do a second study, which is what tarlatamab has done. You know, the regulatory pathway, we will disclose it once that study starts. You know, I hope that answers your questions with regards to ZL-1310. You know, obviously, we'll know more at the time of the presentation.

Speaker Change: If it's obtained in the context of around my style, where accelerated approval is obtained better response than the same study will confirm the approval using.

Speaker Change: Turning to event endpoint, which tends to be overall survival in second line.

Speaker Change: Otherwise.

Speaker Change: One has to do a second study, which is what sort of let the microphone.

Speaker Change: So.

Speaker Change: The regulatory pathway, we will disclose that once study.

Speaker Change: Study start so.

Speaker Change: I hope that.

Speaker Change: That answers your questions with regards to <unk> 10.

Speaker Change: And obviously, we'll know more.

Speaker Change: Some of that presentation.

Josh Smiley: Thanks, Rafael. Thanks, Lee. On VYVGART, your question about the proportion of patients, you know, where they're coming from. I think we continue to see about 1,000 patient initiations per month. So we're really pleased with that. And increasingly, those patients are being started in the maintenance or consolidation phase of their disease. So these, again, are the patients who will maintain treatment on VYVGART for, you know, 3 to 5 cycles per year based on, you know, what we know from the clinical trials and from real-world studies from argenx. I think that the majority of patients now that we're getting on a monthly basis are starting in that setting.

Speaker Change: Yeah.

Speaker Change: Thanks Raphael Thanks Lee.

Speaker Change: Thanks Lee.

Speaker Change: <unk> your question about the proportion of patients where they're coming from I think we continue to see about a 1000 patient initiations per month. So we're really pleased with that and increasingly those patients are being started in the maintenance or consolidation.

Speaker Change: Phase of their disease. So these are again are the patients who will.

Speaker Change: Maintain treating.

Speaker Change: Treatment on <unk> for three to five cycles per year based on what we know from the clinical trials and from reward studies for <unk> and I think that the majority of patients now that we're getting on a monthly basis are starting in that setting and so to your question the more that we get.

Josh Smiley: To your question, the more that we get, you know, as we progress through the year this year, you're gonna have that reservoir of existing patients coming back in for their second, third, and, you know, and fourth courses. As I mentioned at the beginning of the call, if we just look at patients who started on VYVGART in Q3 2023, about 40% of those patients had already come back in Q4, come back into their physicians to start a second course of therapy. We're really pleased with the progress we see here. This very much, I think, matches what argenx saw about this phase of their launch in the US. Again, gives us a lot of confidence about the long-term prospects here for VYVGART. Thanks.

Speaker Change: We progress through the year this year youre going to have that reservoir of existing patients coming back in for their second third and fourth courses and as I mentioned at the beginning of the call. We just look at patients who started on <unk> garden in the third quarter of 2023 about 40% of those patients had already come back in in the fourth quarter.

Speaker Change: <unk> come back into their their physicians to start a second course of therapy. So we're really pleased with the progress. We see here. This is very much I think matches, what argentic sad about this phase of their launch in the U S. So again gives us a lot of confidence about the long term prospects here for <unk>.

Operator 4: Right. Thank you. Our next question comes from the line of Jack Lin from Morgan Stanley. Please ask your question, Jack.

Operator: Right. Thank you. Our next question comes from the line of Jack Lin from Morgan Stanley. Please ask your question, Jack.

Speaker Change: Alright, thank you.

Speaker Change: Our next question comes from the line of Jack Lin from Morgan Stanley. Please ask your question Jack.

Speaker 17: Hi. Thank you for taking my question. I have two questions, one on povetacicept and the other on the catalyst. Povetacicept, I'm curious if you could share more. I mean, you mentioned earlier you'll be joining the global study, but in terms of timeline, what might we be looking at in terms of China launch? Following that, like, you know, given that there are some products that have been approved or are in the late stage of development, how do we see the kind of relatively later launch in China with, like, what's our strategy to kind of launch and push povetacicept in China? And kind of what the potential might be, especially with consideration of potential label expansion beyond IgA nephropathy. That's kind of the first question on povetacicept.

Jack Lin: Hi. Thank you for taking my question. I have two questions, one on povetacicept and the other on the catalyst. Povetacicept, I'm curious if you could share more. I mean, you mentioned earlier you'll be joining the global study, but in terms of timeline, what might we be looking at in terms of China launch? Following that, like, you know, given that there are some products that have been approved or are in the late stage of development, how do we see the kind of relatively later launch in China with, like, what's our strategy to kind of launch and push povetacicept in China? And kind of what the potential might be, especially with consideration of potential label expansion beyond IgA nephropathy. That's kind of the first question on povetacicept.

Speaker Change: Hi, Thank you for taking my question I have two question one on <unk> and the other on the catalyst. So it pulled the task with I'm curious if you could share more I mean, you mentioned earlier would be telling a global study, but in terms of timeline.

Speaker Change: We're looking at in terms of China launch and following the given that there is some product that have been approved or are in the late stage of development. How do we see the kind of relatively later launch in China with what's our strategy to.

Speaker Change: Kind of long term push pulp a task secondly, China and kind of what the potential might be especially with consideration of potential label expansion beyond the Nigerian So that's kind of the first question on pulp catastrophe and a second question. Just curious if you could help me summarized in the water the.

Speaker 17: The second question, I'm just curious if you could help me summarize, you know, what are the key top major catalysts that you most expect the company in this coming year? Thank you.

Jack Lin: The second question, I'm just curious if you could help me summarize, you know, what are the key top major catalysts that you most expect the company in this coming year? Thank you.

Speaker Change: Key top of major catalysts that you're the most excited effects accompanying this coming year.

Speaker Change: Thank you.

Rafael Amado: Perhaps I'll start with IgAN. In terms of participation in the China trial, you're right. We initiated it. I mean, there is enrollment already in China that was initiated, and actually is expected to end this year. We will file with a global trial, and we hope to actually be able to get accelerated approval. This is a disease where there really aren't, you know, active drugs and patients get immunosuppressive drugs in the form of steroids, when they develop proteinuria.

Speaker Change: So perhaps I'll start with <unk>.

Speaker Change: Tobey.

Speaker Change: In terms of.

Speaker Change: Participation in the China trial Youre right.

Speaker Change: We initiated that they're in.

Speaker Change: Is enrollment already in China that was initiated.

Speaker Change: And actually as expected to end this year.

Speaker Change: So we will file with the global trial.

Speaker Change: And we hope to actually be able to get axillary approval. This is a disease, where there really aren't.

Speaker Change: Active drugs and patients get the immunosuppressive.

Speaker Change: Drops in the form of steroids when when they develop proteinuria.

Rafael Amado: You know, being able to have an agent that can halt the natural history of the disease is really important because as I mentioned in the preparatory remarks, a lot of these patients end up in renal failure. There are other agents out there. This is a BAFF APRIL inhibitor. Others you know target other targets like BLIs. APRIL is commonly targeted with these agents. There are some properties of this product that I think you know may make it ideal. Obviously, we will have to see comparisons with regards to efficacy and safety, but it's given you know every four weeks. You know, we have data globally as opposed to local data from China only.

Speaker Change: And so.

Speaker Change: Being able to have an agent account of halt.

Speaker Change: The natural history of the disease is really important because as I mentioned in the preparatory remarks, Hello, this staging and set it up and renal failure.

Speaker Change: There are other agents out there. This is a bass April inhibitor are theirs.

Speaker Change: Target.

Speaker Change: All their targets.

Speaker Change: Pls.

Speaker Change: April was.

Speaker Change: <unk>.

Speaker Change: Commonly targeted with resurgence but.

Speaker Change: There are some.

Speaker Change: Properties of this product that I think.

Speaker Change: It may make it.

Speaker Change: Well, obviously, we will have to see comparisons with regards to efficacy and safety but.

Speaker Change: But its giving every four weeks.

Speaker Change: We have data globally as opposed to local data from China, only so we have sort of a more diverse population with regards to activity.

Rafael Amado: We have sort of a more diverse population with regards to activity and safety. You know, we have actually longer term data than some of the other products. You know, we're confident that, particularly if we get accelerated approval, this will be transformational for patients with this disease, particularly those that have the severe form of IgA nephropathy.

Speaker Change: Safety.

Speaker Change: And.

Speaker Change: We will we have actually longer term data that somewhat.

Speaker Change: The other product so.

Speaker Change: We are we're confident that.

Particularly if we get accelerated approval this will be transformational for patients with this disease, particularly those that have the severe form of <unk>.

Speaker Change: Okay.

Samantha Du: This is Samantha. I'll address our key catalysts in 2025. Which, since we have a very limited time left, I'll just give you a few very key highlights. I'll first of all on the pipeline side. On the global as we talk today at length about our DLL3 assets, ADC assets. We will have data updates for monotherapy in small cell lung cancer at a major conference in the first half this year. We will have data updates for ZL-1310 combo for first-line small cell lung cancer this year. Of course, we also will initiate a pivotal study in small cell lung cancer with possibility for an FDA approval in 2027. We'll initiate a global phase 1 study in other neuroendocrine cancers in first half this year.

Samantha Du: Thanks, Chad this is Samantha cross yellow cake hedges are intended to be flat.

Speaker Change: Since we have on there.

Speaker Change: At this time left I'll, just give you a few key highlights.

Speaker Change: Well first of all on the pipeline side on a global as we talk.

Speaker Change: Today in London.

Speaker Change: PL three FX ABC ethic.

Speaker Change: We'll have data updates for monotherapy in small cell lung cancer at a major conference in the first half of this year.

Speaker Change: So you'll have data updates for <unk>.

Speaker Change: In turn Commvault for first line small cell lung cancer this year.

Speaker Change: Of course, we also will initiate a pivotal study in small cell lung cancer with possibility for an FDA approval in 2027.

Speaker Change: Well you may shape.

Speaker Change: A global Phase III study in other.

Speaker Change: Correct.

Speaker Change: Neuroendocrine cancers in first half of year.

Samantha Du: We also, of course, as we mentioned in our news release, we have other preclinical data updates for at least two additional global assets that are moving into phase 1 development. Recently, the big news will be Bemarituzumab. We'll see data readouts followed by an NMPA submission in first half 2025. We also have five regulatory submissions in China this year. I won't give you the detail numbers, but Bemarituzumab is a big one, as you know, first line gastric cancer. On the BD side, we have additional global and, if appropriate, regional ex-licensing and, of course, if it's fit in with our strategy, it would be our licensing BD deals as well. Overall, we are very confident that we are going to achieve profitability in full quarter 2025.

Speaker Change: And we also of course as already mentioned in our news release, we'll have other preclinical data updates for at least two additional global access that are moving into phase one development.

Speaker Change: Listen early before the Big news of the B matures mob.

Speaker Change: Data Readouts and followed by <unk>.

Speaker Change: <unk> submission in first half 'twenty 'twenty five.

Speaker Change: And we also have five regulatory submissions in China, This year and I won't give you the detailed numbers but.

Speaker Change: BMO BMO is a big one in the first line gastric cancer.

Speaker Change: The BD side, we have additional global.

Speaker Change: Our prophage recently licensing and of course value.

Speaker Change: Paul.

Speaker Change: Fit with our strategy will be our licensing deals as well.

Speaker Change: So overall, we're very confident that we are going to achieve profitability your full quarter tended to be fine. Thank you.

Samantha Du: Thank you.

Speaker 18: Thanks.

Jack Lin: Thanks.

Speaker Change: Thanks.

Operator 2: Thank you. We have now reached the end of the question and answer session. Thank you all very much for your questions. I'll now turn the conference back to Dr. Samantha Du for her closing comments.

Operator: Thank you. We have now reached the end of the question and answer session. Thank you all very much for your questions. I'll now turn the conference back to Dr. Samantha Du for her closing comments.

Speaker Change: Thank you.

Speaker Change: We have now reached the end of the question and answer session. Thank you all very much for your questions I'll now turn the conference back to Dr. Smith to do for her closing comments.

Samantha Du: Thank you, operator. I want to thank everyone for taking the time to join us on the call today. We appreciate your support. Look forward to updating you again after Q1 2025. Operator, you may now disconnect this call.

Speaker Change: Thank you I'll take advantage.

Speaker Change: I want to thank everyone for taking the time to join us on the call today.

Speaker Change: Appreciate your support look forward to updating you again after the first half of 2025.

Speaker Change: Sorry, after first quarter to Nathan if I operator, you may now disconnect this call.

Operator 2: Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.

Operator: Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.

Speaker Change: Thank you for your participation in today's conference. This does conclude the program you may now disconnect.

Speaker Change: Okay.

Speaker Change: [music].

Speaker Change: Okay.

Speaker Change: [music].

Speaker Change: Okay.

Speaker Change: [music].

Speaker Change: Sure.

Speaker Change: [music].

Speaker Change: So.

Speaker Change: [music].

Speaker Change: Yes.

Speaker Change: [music].

Speaker Change: Okay.

Speaker Change: [music].

Speaker Change: Okay.

Speaker Change: Yes.

[music].

Speaker Change: Okay.

Speaker Change: [music].

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