Legend Biotech Corporation (LEGN) Q3 2026 Earnings Call Transcript

Operator: Hello, and welcome to Legend Biotech third quarter 2026 earnings call. This time, all participants are in a listen-only mode. After the speakers' presentation, there will be a question-and-answer session. To ask a question during the session, you will need to press star 1 on your telephone. You would then hear an automated message advising your hand is raised. To withdraw your question, please press star 1 again. I would now like to turn the call over to Caroline LeCates Paul senior director of investor relations. You may begin.

Caroline LeCates Paul: Good morning. This is Caroline LeCates Paul, senior director of investor relations at Legend Biotech. Thank you for joining us today to review our third quarter 2026 performance. Prior to this call, we issued a press release announcing our financial results which can be found on the Legend Biotech Investor Relations website. Joining me on today's call are Ingrid Zhang, our chief executive officer Alan Bash, president of CARVYKTI and Carlos Santos, chief financial officer. Following the prepared remarks, we will open the call for Q&A. Yuhong Qiu, our Interim Head of R and D, will also join us for the Q&A session. During today's call, we will be making forward looking statements, which are subject to risks and uncertainties that may cause our actual results to differ materially from those expressed or implied here within. These forward looking statements are discussed in greater detail in our SEC filings, we encourage you to read and can be found under the Investors section of our company website. In addition, adjusted net income or loss is a non-IFRS metric. This non-IFRS financial measure is in addition to and not a substitute for or superior to measures of financial performance prepared in accordance with IFRS. There are a number of limitations related to the use of these non-IFRS financial measures versus their closest IFRS equivalents. However, we believe that providing information concerning adjusted net income or loss and adjusted net income or loss per share enhances an investor's understanding of our financial performance. Our press release includes IFRS to non-IFRS reconciliations for these measures. With that, I will now turn the call over to Ingrid.

Ingrid Zhang: Thank you, Caroline, and good morning, everyone. Before reviewing our third quarter results, I would like to share a few thoughts as this is my first earnings call. As Legend's CEO. Over the past several weeks, I have spent time with colleagues across the entire organization and engage with physicians and other stakeholders working to bring connectivity to patients around the world. What has become clear to me is the strength of what Legend has built. Legend has demonstrated its ability to bring innovative cell therapy to market at meaningful scale through strong science, manufacturing excellence, and a deep focus on patients. This is incredibly difficult to accomplish. and speaks to the foundation that exists that we can leverage for the rest of the pipeline. I have been impressed by the quality of our people and the collaborative culture across the organization. Together, these strengths reinforce my confidence in Legend's future. I joined Legend because I believe the opportunity ahead is significant. CARVYKTI continues to expand its impact for patients with multiple myeloma. While our pipeline provides an opportunity to extend our leadership in cell therapy for years to come. My priorities as CEO are clear. Number 1, maximize capacity. Number 2, advance our next generation pipeline. Number 3, strengthen execution on all fronts to deliver sustained profitability. We enter this next chapter from a position of financial and commercial strength. With a differentiated asset that has extensive real world results and innovative platform and a team focused on delivering for patients and external stakeholders. With that, let me turn to our third quarter highlights. Slide 7, please. In the third quarter, CARVYKTI net trade sales increased approximately 36% year over year to $710 million. Growth was driven by continued adoption in the early line settings in The U. S and new country launches. With net trade sales increasing 19% in The US and 86% outside The US on a year over year basis. We also continue to expand global patient access. Reaching 373 activity treatment sites globally. During the quarter, we presented important long term follow-up data from the CARTITUDE-4 Cohort A study at the 26 International Myeloma Society Annual Meeting, or IMS. These results further strengthen the growing body of evidence supporting the potential impact of CARVYKTI in earlier line multiple myeloma. We also received FDA clearance of our IND application for LB2.5 thousand an investigational in vivo CD19/CD20 targeted therapy for B-cell malignancies. Including B cell non Hodgkin lymphoma. This represents an important achievement. As we advance our next generation of cell therapy programs. Slide 8, please. Turning to our IMS results. 1 of the most important data updates during the quarter came from a 5 year follow-up analysis of CARTITUDE-4 Cohort A in patients with relapsed or refractory multiple myeloma after 1-3 prior lines of therapy. The data demonstrated strong, durable responses. 5 years after single CARVYKTI infusion, half of the 20 patients from CARTITUDE-4 Cohort A remained alive and progression free without further anti myeloma treatment. With 33 percent in CARTITUDE 1. 5 year overall survival was 69% compared with 51% respectively. Importantly, the safety profile remain consistent. with the known profile of CARVYKTI with no new CAR-T cell related neurotoxicity reported during the extended follow-up period. Taken together, we believe these findings support the use of CARVYKTI in earlier line settings which may increase the likelihood of achieving durable treatment free remission for patients living with multiple myeloma. Early use of CARVYKTI was also reinforced by recent updates to NCCN guidelines, which Alan will explain in detail. As shown on next slide, we continue to evaluate cavity through the CARTITUDE-5, CARTITUDE-6, and 10 studies. These programs represent an important opportunity to evaluate CARVYKTI in frontline settings including transplant ineligible and transplant eligible patients. And essential to our long term strategy for that asset. Slide 9, please. Beyond CARVYKTI, we are advancing our in vivo CAR-T programs. along with additional programs across hematological malignancies, and solid tumors. Slide 10, please. During the quarter, we achieved FDA clearance of the IND for LB2.5 thousand representing an important step forward for our in vivo CAR-T platform. As you might recall from our EHA presentation over the summer, our NHL program designed as a CD19/CD20 dual-targeting therapy for relapsed or refractory B cell non Hodgkin lymphoma. Demonstrate compelling early data, with a 100% ORR, and 83% CR rate. for 6 patients at dose level 2. As you may have seen in the abstract for the upcoming American Society of Hematology annual meeting, We recently provided an update with 19 patients across 3 dose levels. Compared to the 12 patients across 2 dose levels at EHA. We are very pleased that LB2.5 thousand continues to demonstrate a favorable safety profile and encouraging efficacy. With remarkable 100% ORR and 100% CR rates at dose level 2, with a median follow-up of nearly 5 months. We intend to share additional updates across the dose levels at ASH. In terms of clinical development plans, the phase 1 a study for LB2.5 thousand is intended to confirm and further characterize dose selection in The US clinical setting based in part on insights from ongoing IIT study in China. Enabling the program to potentially transition quickly into phase 1b. Phase 1b is planned to broaden the evaluation of LB2.5 thousand across multiple B cell malignancies, including DLBCL, MCL, and CLL, as well as further informed patient selection. Following this, we intend to advance LB2.5 thousand into phase 2. In appropriately selected patient populations to further characterize and confirm efficacy. and safety. Regarding LB2.5 thousand our BCMA directed therapy for multiple myeloma, we do not have further updates to share at this time. But we may focus on dosing patients as soon as possible. As a reminder, this program falls under the terms of our agreement with Johnson and Johnson pertaining to BCMA directed CAR-T programs in multiple myeloma. Overall, we are encouraged by the breadth of opportunities represented across our pipeline and remain focused on disciplined execution. On slide 11, Legend remains well positioned for long term growth. Commercially, CARVYKTI remains the leading CAR-T therapy in multiple myeloma. Supported by expanding global demand, earlier line adoption, and a growing body of long term clinical evidence. Operationally, we ended the quarter with approximately $853 million in cash, cash equivalents and time deposits. And we remain focused on achieving company wide profitability for full-year 2026 on adjusted net income basis. Across our pipeline, we continue to advance our differentiated cell therapy programs. Including our next generation in vivo platform. Taken together, these strengths provide a solid foundation for sustainable long term growth and value creation. With that, I will turn the call over to Alan Bash, for commercial update.

Alan Bash: Thank you, Ingrid. CARVYKTI continued to deliver solid global growth during the quarter. Net trade sales increased approximately 36% year over year, approximately $710 million reflecting continued demand growth globally. In The United States, year over year growth was driven by ongoing adoption in earlier treatment settings, and continued expansion of our authorized treatment network. Outside The US, growth was supported by launch execution across 20 markets worldwide and continued treatment site activation. Turning to the next slide, we want to provide an update on how we are accelerating growth through our earlier line momentum. Although we do not intend to break this out every quarter, we wanted to provide another update on the traction we have made in earlier line settings in The United States in recent months. This provides clear evidence that we are executing across our objectives. As shown in teal on the far right, patients in the second and third lines represented 50% of CARVYKTI apheresis volume in The US in the third quarter of 2026, which is a significant increase from the 41 percent in the first quarter of 2026 and 29 percent in the first quarter of 2025. This trend reflects growing physician confidence in CARVYKTI's benefit risk profile earlier in the disease course and our ability to reliably support that shift at scale. More broadly, we continue to see meaningful opportunities to expand market penetration as physician familiarity grows and as increasing numbers of eligible patients are referred earlier in their treatment journey, supported by the recent updates to the National Comprehensive Cancer Network guidelines. Turning to the recent NCCN guideline updates from September, the guidelines state that all patients with myeloma should be referred to a CAR-T cell therapy capable center at the time of first relapse for consideration of available therapies. That when both BCMA CAR-T and T cell engagers are viable options, current data suggest that CAR-T is preferred. Given the established efficacy of TCEs following CAR-T cell therapy failure. And third, that prior BCMA directed therapies should be minimized in patients planning to receive BCMA CAR-T cell therapy. We have been highlighting the updates in our recent discussions with physicians and other stakeholders involved in the development of clinical pathways and will continue to emphasize this new set of recommendations in the coming months. In summary, we remain focused on operational execution, treatment center support and education, patient access, and ensuring that physicians and patients can benefit from CARVYKTI across the markets where it is available. With that, I will turn the call over to Carlos to walk through our financial performance.

Carlos Santos: Thank you, Alan. We have built a strong and scalable business model around CARVYKTI. Over the last several years, we have delivered revenue growth at a CAGR of 64% since 2023. While steadily improving operating efficiency across the organization. As revenue continues to scale, we are seeing increasing leverage throughout the business. Reflected in improving operating margins and adjusted earnings performance. Importantly, we are making progress while we continue investing in our commercial execution manufacturing network, and next generation pipeline opportunities. While quarterly results may fluctuate, our focus remains on the long term trajectory of the business. Based on the discipline with which we are managing our cost structure, we remain confident in our expectation of achieving company wide profitability for the full year on an adjusted net income basis. Our financial performance this quarter reflects continued global demand for CARVYKTI. Disciplined operating execution and the benefits of increasing scale within the organization. Revenue growth continues to be the primary driver of financial performance. Supported by ongoing expansion of CARVYKTI across geographies and treatment settings. Total revenue increased 32% year over year. Driven by CARVYKTI demand and commercial expansion. We continue to manage our investment profile thoughtfully. We remain committed to advancing our pipeline and supporting long term growth opportunities while maintaining a strong focus on operational efficiency. Moving down the income statement, gross margins performed much better than expected. Improving to 58%. Compared to our expectation in the low-50% range. The improvement is primarily due to manufacturing efficiencies. While there is still likely to be some quarter to quarter variability in gross margin, we are revising our outlook for fourth quarter gross margin on net product sales to be in the high-50% range for Q4. Research and development expense decreased 16% year-over-year. As the cost from the later stage BCMA frontline clinical studies roll off. This will be partially offset by increased spending on our in vivo assets as they move into phase 1 and later studies. Selling, general, and administrative expense decreased 20% and includes a $24 million 1-time credit, and decreased 8% year over year. Total operating expenses decreased 18% year-over-year. And similarly includes a $24 million 1-time credit related to share based compensation. Excluding this impact, operating expenses would have declined 6%. As a result, excluding the impact of the 1-time credit, related to share based compensation, operating margin improved to a positive 6% compared to a negative 16% in the third quarter of 2025. The result is a business that continues to demonstrate improving leverage as it grows. Although quarterly adjusted net income may vary from quarter to quarter, over the near term we are increasingly confident in the long term durability of our profitability profile. Adjusted net income for Q3 was $55.6 million, representing $0.14 per diluted share on a non-IFRS basis. Compared with an adjusted net loss of $18.7 million or a loss of $0.05 per diluted share in the same period last year. We view our balanced approach as critical to creating long term shareholder value. Investing where we see compelling opportunities while ensuring that revenue growth increasingly translates into earnings and cash generation over time. Our balance sheet remains an important strategic advantage. We ended the quarter with approximately $853 million in cash equivalents, and time deposits. And no long term debt. Providing considerable flexibility to support both growth and innovation. Capital allocation priorities remain unchanged. We will continue investing in programs that have the potential to strengthen our leadership in cell therapy including our in vivo CAR-T platform. While remaining disciplined in how we deploy capital. Looking ahead, our expectations for the remainder of the year are centered on 3 key priorities. First, continuing to drive CarlosVictee growth globally. As patient access expands and adoption continues to deepen. Second, advancing our pipeline and translating our innovation platform into future value creating opportunities. And third, delivering on our goal of achieving company wide profitability in 2026 on an adjusted net income basis. Given the global growth we are seeing today, the expanding body of clinical evidence supporting earlier use of CARVYKTI and the continued operational discipline across the organization, we believe we are on track to achieve company wide profitability for the full year on an adjusted net income basis and remain confident in the long term outlook for the business.

Ingrid Zhang: Thank you, Carlos. The third quarter was marked by continued execution across all business. We expanded global access to CARVYKTI, presented important long term CARVYKTI data at IMS, and advanced our next generation pipeline with FDA clearance of the LB2.5 thousand IND. We remain focused on executing our priorities and creating long term value for patients and shareholders. Operator, we are now ready to begin the Q and A session.

Operator: Thank you. When you are ready to ask a question, press star then 1 on your touchtone phone, then wait for your name to be announced. To withdraw your question, please press star 1 again. Please stand by while we compile the Q&A roster. Our first question comes from the line of Terrence Flynn with Morgan Stanley.

Terence Flynn: Great. Thanks so much for taking the questions. I guess, obviously, Ash is coming up here. So just was wondering, on your LB2.5 thousand program, If you can elaborate on how much more, excuse me, how much more data we are going to see versus the abstract in terms of time of follow-up, and then any more details on path to market, here. And then the other ASH question is just, there will be some updated data for a competitor, BCMA CAR-T. When we see their data at ASH, what you going to be most focused on? Thank you.

Alan Bash: This is Alan. I will answer the question about the competitor BCMA CAR-T. But first, let me turn it over to Yuhong to speak to the LB2.5 thousand data.

Yuhong Qiu: Yes. Thank you. Compared to what we are presenting, we have gone from 12 patients to 19. As shown in the ASH abstract. As of June 28, 6 patients were treated at dose level 1, 8 at dose level 2, 5 at dose level 3, The ORR and CR rate were both 100% at dose level 2. And both the OR and CR were 60% at dose level 3. With a median follow-up of 4.8 months for all patients no DLT, no ICANS, no non-ICANS neurotoxicity were reported. So the strong signal we reported for dose level 2 at EHA maintained and strengthened. So for the ASH presentation, we will have another data cut. And the details will be available at the time of the process.

Alan Bash: And, Terrence, this is Alan speaking to your question about the anito-cel data. You know, we saw the abstract, and I think we remain very confident in the unique profile that CARVYKTI provides. We are the only BCMA CAR-T with 5-year data, 15,000 patients treated, and we have demonstrated both in the later line setting and now in the early line setting based on the data that we presented at IMS the potential for cure with CARVYKTI based on a plateau of the curve and 5-year long-term progression free survival. We also note the fact that we have raised the efficacy bar in that fourth line setting based on the data set we presented at last year's ASH, which is that a 50-month PFS can be seen in our datasets across both CARTITUDE-1 and CARTITUDE-4 And on the safety front, I will note that I think we have made significant strides here in educating the community about the importance of bridging therapy to reduce tumor burden and reduce the risk of long term or delayed neurotoxicities And that has helped, I think, close this perceived gap based on what anito-cel had previously shown. Finally, I will just point out that I think it is important that as they do present their data, it is recognized that it is a limited data set You learn a lot about a therapy once you get into the real world. We treat more patients in a week than they have shown in their entire program. And I also think that, these are 2 different, very different studies. When you look at CARTITUDE 1, we had a very heavily pretreated population. 6 median prior lines, versus what the IMAGINE-1 study shows. So I think the differences will become evident now during the abstract and also over time.

Terence Flynn: Thank you.

Operator: Please stand by for our next question. Our next question comes from the line of Jonathan Miller with Evercore. Your line is open.

Jonathan Miller: Hi, guys. Thanks for taking my question. I was struck by the progress that you have made in driving CARVYKTI use in the earlier lines of therapy in The U. S. It seems like you are really accelerating that with the NCCN guideline, but it does not seem to be translating directly to sales growth in The U. S. So my question is with more patients in the other lines and better outcomes and a strong notion to get those patients on CARVYKTI as early as possible. When will this translate into resumption of US growth for the franchise? Then maybe just a follow-up on that LB2.5 thousand question. I am just seeing that there is going to be a new data cut at ASH. Should we be expecting evidence of dose responsiveness continuing as we increase dose to dose level 3, or is dose level 2 going to be the best efficacy that we are going to see?

Alan Bash: John, to your question about where we are focused, again, as you saw in the data, we have been strategically focused on the early line setting. And that has translated into more of our business coming from the second and third line And as you referenced, the fact that we are now reporting 50% of our mix is coming from second and third line. So we are gaining share in second and third line despite the continued, and I would say, strong uptake of the bispecifics. In earlier lines based on the approval of TECVAYLI earlier this year. So this is becoming an increasing competitive space both in the early line setting and the late line setting. But we do believe that based on the fact that, a, we are starting to see that migration of the business towards earlier lines. The NCCN guidelines which we are now educating the community on around the concept of CAR-T first, and the fact that earlier is better when it comes to BCMA CAR-T in terms of efficacy, safety, manufacturing, really selecting patients We are very confident that we will continue to gain share in the early lines. And that will ultimately translate into continued growth for the product. And do you want. Would you like to take the second question? About the what we can disclose at ASH?

Yuhong Qiu: In terms of. dose level 3 versus dose level 2 for LB2.5 thousand. I am sorry. So for ASH, right, as shown in the abstract, we have at dose level 2 we have 8 patients, all 8 of them have shown 100% response rate over response rate, complete response rate. For dose level 3, we have 5 patients and overall response rate and complete response rate are all 60%.

Operator: Please stand by for our next question. I am sorry. Did you have a response? Go ahead, operator. Our next question comes from the line of Jessica Fye with JPMorgan.

Jessica Fye: Wondering if you could just give us your latest estimate for when we could expect top line results for CARTITUDE-5 and for CARTITUDE-6 And maybe just following up on that last question, maybe last comment, Alan, about the increasing competitiveness in earlier lines with TECVAYLI it does seem well understood that BCMA CAR-T works better before and not after BCMA bispecifics. So why do you guys think it is competitive there? Thanks.

Alan Bash: Sure. So in terms of timing for CARTITUDE-5 and CARTITUDE-6, as we have said before, these are event driven and fortunately for patients, think outcomes continue to improve for patients in the newly diagnosed space. So we need to wait for the events to accrue. We previously said that the soonest that we would see a readout for CARTITUDE-5 would be in 2027. But again, I would just point to the fact that these are event driven and we need to wait for events to accrue. And then CARTITUDE-6 would be beyond that. Again, this is this is a space where there is a demonstrated based on the literature along PFS. I think we have also, as we have discussed before, continue to explore the concept, especially with CARTITUDE-6. The potential for leveraging MRD data in support of trying to get an early read that correlates very well with long term survival, both PFS and OS. In terms of your question about the competitive landscape, I think what we acknowledge is the fact that physicians have a choice here and that it is important that we continue to educate physicians on the concept exactly as you said that CAR-T before bispecifics is really a better choice for patients because of the fact that it allows both options to be used. The NCCN guidelines were very clear on this point. That the data suggests that CAR-T before bispecifics provide a better outcome versus the other way around where you potentially foreclose or forestall the option to ultimately get to BCMA CAR-T. So I think we are acknowledging the fact that there are choices out there. But again, I think we are very, very pleased with the NCCN guidelines validating this concept that CAR-T first is the best way to go for patients. And so we are doing everything we can along with our partner to educate both the community referral physicians as well as the treaters in the authorized treatment centers around this concept that it is really not about which product you choose. it is really about the sequence in which you offer them.

Jessica Fye: Thank you.

Operator: Thank you. Please stand by for our next question. Our next question comes from the line of Leonid Timashev with RBC. Your line is open.

Leonid Timashev: Hey, guys. Thanks for taking my question. I know we talked a lot about the commercial dynamics, but I was just wondering if you could maybe dive into them a little deeper, if we can get any kind of quantitative sense of what your expecting for the 2027 trajectory. Just balancing all the competitive headwinds, the bispecifics, the competitor CAR-Ts against where you are seeing the growth coming from and how you are thinking about the picture for 2027? Across US and Ex US? Thanks.

Carlos Santos: Thank you, Leonid. This is Carlos. I will take the and maybe Alan, you can then complement. As you know, we do not provide guidance, but what I can share is that we are still expecting substantial year over year growth on a global basis. And as Alan mentioned earlier, in the earlier line setting, CARVYKTI continues to gain share and momentum despite the fact of the faster uptake of bispecifics. So for Q4, we believe that the sales consensus is at the higher end of the range of scenarios that were actually seeing. And this is primarily driven by changes in launch dynamics outside of The US And as I mentioned earlier, a slower earlier line share growth in The US than we had previously anticipated. So that is for Q4. Now regarding the trajectory for 2027, we do expect to see double-digit growth year over year for Carvictee. In 27. However, the current net trade sales consensus for 2027 would be at the higher end of the scenarios that we are currently anticipating And again, this is in light of the launch delays in the OUS markets. And we are seeing a slower earlier line share growth in The US than we had initially anticipated. Having said this, we remain really very confident in the long term growth outlook for Carvicti. Know Alan, if you want to add some color to

Alan Bash: I will add simply that, when we go out and educate physicians about the concept of referring patients or using CAR-T in their second and third line patients. it is a longer term selling cycle, right? it is more education, We have to do more work to make sure that the broad spectrum of physicians understand this data that patients understand this data, and that will take a bit of a longer time patients to get in. To get their consultation, to be evaluated. And so this is what we are doing with the work throughout both teams across J and J and Legend are doing. And we now have the tools to do that, especially with the NCCN data with the with the earlier is better data that we have shown with CARTITUDE-4, with the bridging data from card 4. So I think we have the tools to be able to tell the story and educate the community. And I will say and I will remind you that, despite the increasing competitive nature of the space, only between 15 and 20 percent of patients in the second and third lines have been BCMA exposed. So that means that we still have up to 85%, between 80% and 85% of the patients in those early lines who have not been exposed to BCMA and that represents opportunity for us. To continue to grow long term. And that is why we do believe that we will continue to grow this business and continue to achieve the potential of it, is a $5 billion-plus potential.

Leonid Timashev: Thank you.

Operator: Our next question comes from the line of Etzer Darout with Barclays.

Etzer Darout: Great. Thanks for taking the question. A couple from me. I guess the first 1 the second line, third line shift, you are seeing do you have expectations that maybe starting in the fourth quarter, you can see incremental patients there versus primarily replacing later line volumes? Maybe are those expectations maybe more for a 2027 dynamic? that is 1. And then maybe a point of clarification because I did not hear the answer clearly, but will we see additional follow-up in the deal 3 cohort, dataset for 25 0 1 at ASH. Thank you.

Alan Bash: We are continuing to grow in the second line and third line. And so that been ongoing, and we will continue to see that. Throughout the rest of this year and into early next year and beyond. In terms of the DL3 and 2500 we will see additional updated data at ASH.

Operator: Thank you. Thank next question comes from the line of Edward Tenthoff with Piper Sandler.

Edward Tenthoff: Great. Thank you very much for taking the question. I am curious as we look forward with the IO candidate 25 0 1, What are your plans to develop this in autoimmune disease beyond B cell lymphoma and is this the right candidate, or is there potentially another IL candidate that you would anticipate developing in autoimmune disease? Thanks so much.

Yuhong Qiu: Yeah. We are exploring all the options. We are very interested in autoimmune diseases using our in vivo platform. And, of course, 25 0 1 is 1 of the candidates who are exploring.

Edward Tenthoff: Great. And what are the plans to advance it forward? Thank you. What are the plans to advance it forward?

Yuhong Qiu: Well, as a legend, as a leading cell therapy company, right, we have our capabilities to doing ITs in China. So the first step we are gonna do to explore anything would be to conduct IT study to achieve early proof of concept.

Edward Tenthoff: Great. That makes a lot of sense. Thanks so very much.

Operator: Thank you. Please stand by for our next question. Next question comes from the line of Linhai Zhao with Goldman Sachs. Your line is open.

Linhai Zhao: Thanks for taking my question. This is Linhai Zhao from Goldman. Just want to follow-up on the second and third line dynamics, so that it is more particularly given that in 3Q, we saw that US South going flat quarter over quarter, but we continue to see the continued shift in the pie chart where we see increasing patients in the earlier line versus the later line. Can you help us to understand the more colors regarding the overall market demand for Carvictee, And Also The Quality, Timing, Manufacturing Allocation, And, To Un. Understand The US growth, small And in addition to that, would you be concerned about the increasing earlier line TCE penetrations make the patients ineligible for late line for BCMA CAR-Ts. Thank you.

Alan Bash: Yeah. I think we have addressed some of these points, but let me just make. You know, just add a couple of points here. Again, we continue to gain share. And grow the business in the second and third line, and that is important because that really represents the best place for Carbixi, especially as we think about late line entrants coming into the market. The late line space is 1 where more patients, as you referenced, have been and will continue to be BCMA exposed. You have patients who are perhaps older, more frail, less willing to travel, And so it becomes, I think, the more favorable place for BCMA CAR-T is in fact the place where we are indicated, which is in the early lines. And so we will continue to emphasize the value of CAR-T first, that earlier is better and that our best place is in second and third line. Or as we also call it, at first relapse for patients. I think that really speaks to where we are strategically focused and where we believe we can continue to grow this business. And again, I think there will be continue to be competition, both we see the not only from the approved bispecifics, but there are additional coming onto the market. So yes, this marketplace will continue to become increasingly competitive. Yes.

Ingrid Zhang: Thank you, Alan. I would just add that we at Legend are very confident, you know, ability to reach $5 billion+ peak potential, really driven by penetration to earlier lines. We talked a lot about second and third line. there is also some lines that each, of course, we are waiting for the events to read out. And given the extension of our global footprint, And lastly, about bringing CARVYKTI closer to patients. I think we do this well. We are very confident on the future of this franchise. Thank you.

Operator: Thank you. Sean by for our next question. Our next question comes from the line of Yaron Werber with TD Cowen. Your line is open.

Yaron Werber: Great. Thanks so much. Maybe a quick question on 2500. Maybe can you give us a little bit of a sense how fast can you start that study, that Phase I in myeloma in China And then secondly, to advance into an IND in The US, do you need the green knot from J and J to actually do so? Per line, with your agreement? Thank you.

Yuhong Qiu: Yeah. With regarding to the IT, as we disclose previously, we are working to have the study started very soon. Regarding the IND as a reminder, this w 25 0 1 is subject to the collaboration agreement between Biogen Biotech and Johnson and Johnson. And we will not be able to disclose more of this point. When the time comes, we will share more.

Yaron Werber: Can you maybe can you comment what the J and J is officially in, or that has not happened at this point? Thank you.

Yuhong Qiu: it is not, we are not going to say anything more at this point. When the time's right, we are going to share more.

Operator: Thank you. Our next question comes from the line of Konstantinos Biliouris with OpCo.

Konstantinos Biliouris: Hi. Thank you for taking our questions. This is Joe Thomas on for Konstantinos. Just digging into the international growth bit, I am curious if you could give us some more color on if the growth reflected underlying demand at a established centers or what mix was in new launches or new reimbursement agreements? And then looking forward, as TECVAYLI begins to expand what gives you confidence that ex U. S. Growth is going to remain a durable offset to any potential headwinds in The U. S? Thank you.

Alan Bash: Yes. So as you saw from disclosures, we are now in 20 markets worldwide. And the growth that you are seeing in the ex U. S. Markets is really driven by both the combination of new markets launching but also continued growth in markets such as Germany, Spain, and more recently, 1 of the big contributors is Italy. So I think these markets are doing very well. We also see even some of the smaller European markets, Belgium, Denmark, Switzerland. These are all markets that are really starting to emerge as, growth contributors in the full global picture. I think to your question about as bispecifics enter Europe, it is obviously going to be a dynamic we are going to watch, but we do believe that there a couple of really favorable dynamics in Europe that support CAR-T. 1 is the geography. Obviously, it is easier for patients to get to some of the larger academic centers and get to the authorized treatment centers. And those referral patterns and those patterns are pretty well established in many especially the smaller markets around Europe, And the second point is that the single payer system really does provide this concept that the government is looking at the long term value of a 1 time infusion. The 1 time infusion is really cost effective and that is a story that really helps, I think, improve all of our support for reimbursement and education and uptake across some of these key markets. So we do expect that the, OUS contribution towards the global picture will continue to grow, and we do believe that going to be a significant driver of growth as we reach towards the $5 billion-plus potential for this product.

Konstantinos Biliouris: Thank you.

Operator: Our next question comes from the line of Mitchell Kapoor with H. C. Wainwright.

Analyst: This is Amit on for Mitchell. And congrats on a strong quarter. So 2 for me, 1 on CARVYKTI and 1 on 02/05/2001. So for within the community, are you seeing the incremental patients coming from physicians making their first, CARVYKTI thorough or from existing referrers sending more eligible patients. And for 02/05/2001, so we have seen dose dependent CAR-T expansion, and when you move into US development, are there any particular T cell characteristics baseline characteristics, or prior therapies that you were watching as predictors of T cell fitness and adequate expansion? Thank you.

Alan Bash: We are we are seeing both existing referrals as well as new physicians deciding to send their patients for consult and referral. And this has really been part of our educational effort to say, if you have a patient who is eligible even before they are relapsed, to really start to think about and plan out their treatment journey. And so part of that education is around sending patients for consult. Sending patients ultimately for referral. And so we are seeing both the growth in the number of referrers and the number of patients that are being referred.

Analyst: Okay.

Yuhong Qiu: So for 2500 from the IIT study, we have observed is that the expanded CAR-T cells were predominantly CD8-positive effector membrane cells with limited terminal differentiation and exhaustion associated transcriptional signature. In the samples that we analyzed. In the IND study, of course, we will continue with our translational analysis and keep a close eye on the phenotypes of the T cells. That we observe.

Operator: Thank you. Please stand by for our next question. Our next question comes from the line of Natalie McArthur with UBS. Your line is open.

Natalie McArthur: Hi there. This is Natalie on for Ash. Thanks for taking our question. We are just wondering how representative is the Cartitude 5 trial control arm of real world patients and current treatment patterns? Then how should we be thinking about efficacy benchmarks here as well? Thanks.

Alan Bash: Yeah. You referenced to the CAR-T. The CAR-T 5 control arm, which is VRD. We do see that this is an adequate control arm and an appropriate control arm and obviously 1 we consulted with the FDA on. Having said that, I think you are probably alluding to fact that more and more patients are getting quad therapy upfront, DVRD, And so we will also plan to support and supplement that filing with data that shows a benefit from a DVRD population as well. I think the important thing about CARTITUDE-5 is that there are about 3 quarters of the newly diagnosed patients are transplant ineligible or transplant deferred. And so I think as transplant becomes less of an option that patients want to go through, we do believe that CARTITUDE-5 will be a meaningful data set. Versus an appropriate control arm.

Natalie McArthur: Thank you.

Operator: Our next question comes from the line of Sean McCutcheon with Raymond James. Line is open.

Sean McCutcheon: Hi, guys. Thanks for the question. This is Sean McCutcheon on for Sean McCutcheon. We are curious about whether you can speak to the driver of the thresholding effect that you are seeing from DL1 to DL2 with 2500. I am specifically seeing much higher responses in dose level 2, and curious if you anticipate a meaningful addition of activity at higher doses moving forward.

Yuhong Qiu: Yeah. So most we are still very early in the in vivo study, and from what we can see, seems there is a threshold in terms of response. that is why we see nothing in dose level 1, and we see 100% in dose level 2. And what we can find later on whether we can continue to see those response we would have to wait for additional patients in those and but with longer follow-up, to get a better understanding on the relationship between dose CAR-T expansion, and response.

Sean McCutcheon: Okay. Great. Thanks.

Operator: Thank you. Ladies and gentlemen, I am showing no further questions in the queue. That concludes today's conference call. Thank you for your participation. You may now disconnect.