Legend Biotech Corporation

Good day, and welcome to the Legend Fourth Quarter 2025 Earnings Call. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a question and answer session. Instructions will be given at that time. Please note this call is being recorded. I would like to turn the call over to Jessie Young, Vice President of Best Relations and Finance. Please go ahead.

Good morning. This is Jessie Young. Vice President of Investment Relations and Finance at Legend Biotech. Thank you for joining our conference call today to review our fourth quarter of 2025 performance. Prior to this call, we issued a press release announcing our financial results for the quarter. You can find the press release on our IR website at legendbiotech.com. Joining me on today's call are Ying Huang, the company's chief executive officer, Alan Bash, the company's president of Kavikti, and Carlos Santos, the company's chief financial officer. Following the prepared remarks, we will open up the call for Q&A. 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, which we encourage you to read and can be found under the investor sessions of our company website. In addition, Adjusted net income 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 this 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. We use adjusted net income or loss as a performance metric that guides management in its operation of and planning for the future of the business. In particular, we exclude unrealized gain or loss from foreign exchange rate exchanges. We believe that adjusted net income or loss provides a useful measure of our operating performance from period to period. Our first release includes IFRS to non-IFRS reconciliation for these measures. With that, I will now turn the call over to Ying.

Hello, everyone. Thank you for joining us today. We closed out 2025 as the largest standalone cell therapy company with both commercial scale and next-gen pipeline optionality. And we look forward to becoming a fully scaled CAR T leader this year and presenting new data at upcoming medical conferences this year. We are pleased to have achieved CAR-VT profitability in 2025 and believe we are poised to achieve company-wide profitability in 2026. You'll hear from Alan shortly about the impact that Carvicti has had on a global scale in recent months, but I want you to share a few highlights on this front. During the fourth quarter of 2025, Carvicti net trade sales were approximately $555 million, which is a 66% increase year over year. We have brought hope to patients worldwide with more than 10,000 multiple myeloma patients who have chosen to be treated with Carvicti. And with the physical expansion of the Ryotan facility, we have the installed capacity to support annual production of 10,000 doses across all our manufacturing nodes. Carvicti's launch remains the strongest CAR-T launch to date. The majority of its utilization is now in earlier line settings. Carvicti has a 97% overall manufacturing success rate and is offered in 14 global markets. Not only is CARVICTI raising the bar for manufacturing excellence and site growth, it's also setting new standards for survival outcomes in relapsed refractory multiple myeloma. Recently, at the 67th American Society of Hematology Annual Meeting and the 2026 Tandem Meeting, we presented compelling data on CARVICTI's efficacy and our manufacturing success. Before we dive deeper into this, I want to highlight that we also presented at ASH on LUCA-G39D, our first-in-class allogeneic gamma-delta CAR-T cell therapy targeting CD19 and CD20 in adults with relapsed refractory B-cell non-Hodgkin's lymphoma, or NHL. As you may have seen, we're pleased that it demonstrated manageable safety and encouraging anti-tumor activity. Turning to the recent CARVIC-T presentations, new long-term CARVIC-T data demonstrated durable responses in key subgroups and reinforced the improved outcomes associated with earlier treatment with CARVIC-T. Importantly, triple class exposed multiple myeloma patients with three prior lines of therapy in CARTITUDE 1 and CARTITUDE 4 achieved a median PFS of 50.4 months after single infusion of CARVIC-T. This represents one of the longest PFS outcomes for BCMA targeting CAR-T therapy. Given that more than 50% of patients enrolled in the competing trial had only three prior lines of therapy, we believe the 50.4-month median PFS sets a new standard in this population. Additionally, an analysis of patients with standard risk cybergenetics from CAR-T4 shows that earlier treatment with CAR-VICT improved survival outcomes. reinforcing its curative potential. 80% of the patients remained progression-free and off-treatment after 2.5 years. Off-standard risk patients in CART2-4 who were progression-free at one year, 93% remained alive and progression-free at 2.5 years. Furthermore, translational analysis of patients from CAR-T1 and CAR-T4 demonstrated stronger immune fitness and a more immunocompetent tumor microenvironment for patients earlier in the treatment journey. Again, adding to the body of clinical evidence that earlier treatment with CAR-VT leads to better outcomes. Finally, Commercial CARVICT manufacturing data from July 2024 through October 2025 were analyzed to examine manufacturing outcomes across multiple prior lines of therapy. Overall, 99% of the products were successfully manufactured when using cells from patients with one to three prior lines of therapy with 6.5% out-of-spec product. compared to 97% for the fourth line and beyond, with 9.2% out-of-spec product. Not only are we unconstrained from a capacity standpoint, but we have also made significant progress on our manufacturing success rates. We are reinforcing this message about our manufacturing capabilities and, of course, the importance of earlier treatment and effective bridging therapy in the KOL community. To sum up, we believe these recent presentations from ASH and Tandem further strengthen our robust body of clinical evidence, supporting the long-term benefits of CARVICT in multiple myeloma. This is one of the many reasons why we and our partner, Johnson & Johnson, are moving full steam ahead on our capacity expansion plans. Our partnership with Johnson & Johnson is built to scale CARVICT to its anticipated potential of more than $5 billion in peak annual sales. Beyond current indications of CAR-VICT, we are continuing to advance our earlier line studies to potentially expand our addressable market. Notably, CAR-VICT 5 and 6 studies have both completed enrollment already. Based on the data presented recently, earlier treatment may deliver greater durability at lower lifetime cost. We look forward to sharing data when the number of pre-specified events is reached. Looking ahead at our long-term growth, In addition to moving Carvicti into the frontline, we remain focused on our R&D pipeline besides Carvicti. We have developed a lean approach to leveraging investigator-initiated trials in China, or IIT, to rapidly establish clinical proof-of-concept, and each of our programs is gated by clear evidence thresholds, which avoids inefficient use of capitals. For example, we advanced one of our first in vivo CAR T programs from candidate selection to first patient dosing in six months. We continue to anticipate that we will present clinical data this year. Additionally, we continue to invest in other blood cancer, solid tumor, and autoimmune programs that we view as having transformative potential. Our plan is to file one to two US INDs by the end of this year. In addition to investing in our own in-house R&D efforts, we will be optimistic this year about generating new revenues through business development efforts. To recap, we have several important milestones ahead this year as we look to increase connectivity penetration in earlier lines and advance our next-generation cell therapies. With a cash position of $949 million, we're balancing investment in future growth with disciplined expense management. We are pleased that Carvicti became profitable in 2025 and anticipate company-wide profitability in 2026. And with that, I'll pass it over to Alan to provide an update on Carvicti.

Thank you, Ying. Turning to our fourth quarter results, Carvicti net trade sales grew 66% year-over-year and 6% from the third quarter due to seasonality of shipment. Our global growth was driven by continued share gains, site expansion, and growing geographic footprint, now reaching 294 global treatment sites across 14 markets worldwide. U.S. net trade sales of $420 million grew 38% year-over-year and 6% quarter-over-quarter. We continue to move our business toward earlier line settings and are pleased to report that approximately 65% of our patients are from the second to fourth line setting. Outside the U.S., we achieved sales of $135 million, representing an over threefold increase compared to the same period a year ago, and a 5% increase quarter over quarter. This performance was supported by continued growth in key markets such as Germany, Spain, and Belgium, and bolstered by the Tech Lane facility in Belgium, which came online in September 2025 for commercial production to serve ex-US markets. Looking at the broader multiple myeloma opportunity, BCMA directed therapies remain significantly under-penetrated in earlier lines, with less than 5% of patients in the second through fourth line setting treated with a BCMA targeting agent in 2025. The majority of patients in this population are BCMA treatment naive, providing a unique opportunity for CARVICTI to address unmet needs. Our strategic focus on earlier line use is strongly supported by evidence showing that earlier intervention yields better outcomes. As Ying highlighted earlier with data from the ASH and TANDEM meetings, CARVICTI demonstrated durable long-term benefits and improved outcomes are associated with earlier use. No other BCMA-targeting CAR-T therapy has matched this depth of long-term survival data or overall survival benefit over standard therapies. CAR-VICTI's foundation of unrivaled evidence coupled with our capacity to manufacture 10,000 doses annually with high success rates positions us well to capture this sizable market potential. Before turning to how this unique profile serves the community setting, I want to shed light on the patient management strategies we have been able to implement and explore with our patient data sets and how things have changed since we and J&J launched CARVICTI. Importantly, as we recently saw at the ASH and Tandem meetings, there is definitive evidence that effective bridging therapy can debulk tumor burden, mitigating the risk of neurotoxic events such as Parkinsonism. It is associated with both improved safety outcomes as well as efficacy outcomes. In a study across more than 20 academic centers published by Dr. DeKalb from Medical College of Wisconsin, there were no cases of colitis or Parkinsonism following at least one cycle of talquetamab bridging therapy and Carvicti infusion. The study included more than 130 patients with 98 patients treated with Carvicti. Furthermore, Dr. Sedana from Stanford published a very large study that looked at a total of 761 carbicty-treated patients across 15 large tertiary academic centers. Of the 22 patients with Parkinsonism, 21 of these cases occurred in patients who did not have a response to bridging therapy. Clearly, implementing effective bridging therapy results in better patient outcomes, and we are educating physicians on the importance of this strategy. Turning to the community adoption, we believe Carvicti is well positioned for success here. There is no other CAR T with over five years of progression-free outcomes in late-line myeloma and a demonstrated overall survival benefit in earlier lines. Carvicti keeps raising the bar on efficacy as well, and as you saw at ASH, the median PFS was 50.4 months, for triple class exposed patients with relapsed refractory multiple myeloma and three prior lines of therapy from CARTITUDE 1 and CARTITUDE 4. As it relates to safety, CARVICTI's profile is well understood at this point. Multiple CAR-Ts have had cases of Parkinsonism documented. Patients and physicians don't have to ask when class effects might emerge as they can simply refer to CARVICTI's dataset. Physicians have been using this data to improve patient management, and now we know the impact of effective bridging on safety outcomes, which can further reduce risks. Lastly, CARVICTI is suitable for appropriate multiple myeloma patients looking for a one-time infusion, regardless of the treatment setting, since it can be administered in outpatient settings as well. Given all these factors, you can see why CARVICTI has had steady traction in the community setting. Community hospitals now comprise one-third of the 145 CARVICTI-authorized treatment centers in the U.S., with 80% of myeloma patients living within 50 miles of a treatment site. Additionally, we continue to see the outpatient setting comprise about half of CARVICTI prescribing volume, further supporting broad accessibility. In summary, Carvicti remains the undisputed leader of CAR-T sales and is the only CAR-T with this sales execution track record as we focus on reaching its peak sales potential of more than $5 billion. Our core focus remains on unlocking the curative potential of Carvicti and accelerating adoption in earlier lines where we see the greatest impact for patients. Over the course of this year, we expect to benefit from the following growth drivers. unmatched data maturity and survival data that is not seen in the class, extensive real-world experience treating more than 10,000 patients, far outpacing peers, educating physicians and patients on the benefits of CARBIC-D and advantages of earlier use, global expansion supported by capacity for 10,000 annualized doses, additional adverse event mitigation strategies to improve outcomes for CARBIC-D patients.

now i will turn it over to carlos santos thank you alan and good morning everyone i'm pleased to walk you through our financial performance which reflects another quarter of progress towards company-wide profitability during the fourth quarter we deliver strong top-line growth driven by the continued momentum of carvicti and the expanding global footprint that Alan outlined. Revenue reached $306 million, representing 64% year-over-year growth. And our gross margin remained consistently strong at 61%, with a gross margin on Carvicti net product sales of 57%. What is most important is that this growth is increasingly translating into operating leverage. Our operating margin has improved dramatically from negative 142% in the second quarter of 23 to just negative 6% in the fourth quarter of 25. And this improvement has been steady across 10 consecutive quarters. This reflects two things. First, the scalability of the Carvicti franchise. And second, our disciplined approach to managing the cost structure as we grow. Given this trajectory, the Carvicti franchise became profitable in 2025, and we believe we remain on track to achieve enterprise-wide profitability in 2026. With a revenue compounded annual growth rate of 77% since the second quarter of 23, and gross margins starting to stabilize at 55% or more over the past four quarters. we have a clear line of sight to achieving this milestone. Turning to the next slide, revenue growth of 64% significantly outpaced our 6% growth in total operating expenses, reflecting our commitment to scaling responsibly. R&D declined 3% year over year. as our BCMA frontline clinical programs mature, and we increasingly shift investment into our next generation in vivo platform. SCNA grew 22%, driven by targeted investments to reinforce our leadership position in BCMA CAR T, such as sustaining share of voice leadership by expanding our sales force, as well as investing in direct to consumer campaigns. Back office and administrative functions continue to scale efficiently as the business grows, reflecting strong internal cost discipline. Our operating loss improved by 75% versus the prior year to approximately negative $20 million. And after excluding items that are not representative of our company's core business, including stock-based compensation and unrealized FX gains or losses, we have reported positive adjusted net income of $2.5 million, a meaningful transformation from a $59 million adjusted net loss a year ago. Our adjusted diluted income per share was one cent compared to negative 15 cents for the same period last year. we ended the year with 949 million dollars in cash cash equivalents and time deposits operating cash flows continues to trend in the right direction as evidenced by our 12 million dollars in operating cash flow outlays this quarter compared to 82 million dollars in operating cash flow outlays for the same period last year this cash position provides us with optionality as we focus on the following investment priorities. First, advancing our in vivo programs. Second, focused synergistic business development. Third, supporting CARVICTI profit expansion through focused commercial and medical investment. And finally, modest capital expenditures tied to manufacturing capacity expansion. We will continue to prioritize disciplined expense management as we invest in our future. Importantly, we believe we remain on track to achieve our expectations for company-wide profitability this year. In summary, our financial performance reflects the collective strength of Legend's differentiated cell therapy platform, the scalability of the Carvicti franchise, and our disciplined approach to growth. We have a market-leading CAR T therapy in a vast multiple myeloma market, a robust balance sheet, expanding margins, and an innovation engine that is advancing at speed. With more than 10,000 patients treated globally and a growing footprint of treatment centers, we believe we are well-positioned to translate our clinical leadership into long-term sustainable value. And now it's time to take your questions. Operator, we're ready for the first question, please.

Thank you. If you'd like to ask a question, please press star 1-1. If your question has been answered and you'd like to remove yourself from the queue, press star 1-1 again. Our first question comes from Terrence Flynn with Morgan Stanley. Your line is open.

Great. Thanks for taking the question, maybe two for me. I was just wondering if you can comment broadly on your expectations for the pace of Carvicti growth in 2026 and maybe how to think about U.S. relative to rest of world. And then the second was on your business development comments. You mentioned focused, synergistic business development. Just what exactly does that look like? What are the types of assets, stage, size that you guys are potentially considering?

Thank you.

Hey, good morning, Terrence. This is Ying. Thank you for the questions. So on your first question, we are planning and also we're committed to sequential growth throughout the year. That includes all four quarters of 2026. And we have said that, you know, we feel reasonably confident of delivering CARVIC-T according to the street consensus number, which is about 50% of top-line growth from last year, right? So that's what... we're feeling confident about. And then on the second question about BD, I think it's two directions, right? We obviously are interested in certain technologies that are complementary to what we have in-house. As you know, we have a couple in vivo CAR T programs that are in the clinic today, those in patients already, and those are lentiviral vector-based delivery. So certainly there are other technologies that are out there, which may be useful for other indications besides oncology and hematology. So those are certain technologies we're interested in bringing in-house or potentially co-developing with other partners. And then I think by the same vein, there are also other interests in potentially partnering with our existing assets, right? As you have seen, Terrence, there's a lot of transactions recently in the in vivo CAR T field. So we're also thinking ways to potentially accelerate the global development of our own in vivo assets as well. And obviously, there's no lack of interest on that. So that's what we mean by business development and being trying to be focused. Thank you.

Thank you. Our next question comes from John Miller with Evercore. Your line is open.

Hi, guys. Thanks so much for taking my question, and congrats on the progress. I guess I would ask, now that we've had a couple of months post-Majestic for you to get feedback from the actual providers and commercial sites, How are you hearing that docs are going to position the use of bispecifics in early lines relative to Carvicti? I mean, you went through some of the differences in the trials, but in the real world, how has the feedback been in terms of positioning, and how do you foresee driving growth in those early line settings where, Alan, you mentioned adoption is still very modest?

Hi, yes, this is Alan. So obviously the majestic data is good news for patients, but I would remind you, and we have heard multiple times, that this is a very large opportunity in second and third line. In fact, there are over 100,000 patients second line plus globally, and that means that there is a significant unmet need and a significant opportunity for the CAR T adoption in second and third line. We have seen, as our business has evolved, The fastest-growing segment of our business has been in second and third line, and we expect that to continue. We continue to hear very significantly that there is a very unique value proposition for Carvixi in these earlier line settings as a one-time infusion delivering overall survival and five-year treatment-free remissions in the later line patients as well. We also have heard very significantly that the IMWG guidelines really help physicians understand that the sequencing here is important, that you want to get patients as quickly to CAR T as you can, and that putting a BCMA bispecific in front could diminish the efficacy that you could get from CAR T. So, a very strong alignment with the IMWG sequencing guidelines, the significant opportunity and the unique profile of CAR-T is what we're hearing in the marketplace.

Thank you. Our next question comes from Edson Durault with Barclays. Your line is open.

Hi, this is Luke. Thanks for taking my question. Quick on the community What do you see as some of the bigger hurdles for continued expansion there? Like is it just site opening or is it like training those community physicians?

So in terms of the community adoption, we're very pleased with where we've been. And as I've mentioned earlier, we have about a third of our activated treatment centers are community or regional hospitals. And this is an important part of the community story. For example, I'll just give you a few examples, Orlando Health in Florida or Sutter Health in California. These are examples where we've been able to bring CARVIC closer to patients. Another example is we had an academic medical center activated Hackensack University in the northern part of New Jersey, and now we have the southern part of the state covered with a regional affiliate, the Jersey Shore Medical Center. So those are examples where we are hearing very significantly that bringing CAR-VAC-D closer to patients with these community hospitals is a value add. We are also expanding the use in the physician practices, and I'm very excited to announce that in addition to the Virginia Oncology Associates activation that we had in 2025, we have now activated in Tennessee Oncology in Nashville, and that helps us again as we step forward into these community practices. We also have seen the referrals increase, and we are having more and more conversations between the activated centers the referring base so these are all the steps that we are heading towards I think to your question it's all about continued education and making sure that the community physicians understand that as they refer patients in they are going to be getting their patients back without the REMS now in place and we've heard that again as a significant gaining factor that without the REMS in place more patients can be monitored closer to home more community physicians are more comfortable getting their patients back and monitoring them locally, and that is enabling the referral base as well. Thank you.

Thank you. Our next question comes from Linhe Zhao with GS. Your line is open.

Hi, thanks for taking my question. This is Linhai from Goldman Sachs. You mentioned about the current CAR T penetrations less than 10% in the 5th line and also less than 5% in 2nd to 4th line ophthalmoloma. Just curious what would be your practical target or Can you further comment on the potential ceiling values for these CAR-T penetrations in this both late Lyme and early Lyme multiple myeloma? And that's the first question. And the second question is about Tecdera. Just wondering, given that Tecdera may also not be a favorable treatment option in community setting, would you consider the community hospitals as a bigger growth opportunity, or are you going to still purchase the majority of the growth in the academic centers? Thank you.

Hi, Lin. Hi. This is Ying. So I'll answer the first part of your question in terms of current clarity penetration. We and our partner, J&J, are firmly believers that newer drugs, including Carvicti and also Tectara, should be the preferred option based on the clinical data that shows superiority of these regimens over the triplet standard of care, right? And as Alan mentioned, if you look at community practice, in the second to fourth line setting in the U.S., Still, all targeting modalities only account for about 5% market share that shows that there's plenty of growth for this new regimens in the community setting right now, in terms of what we're trying to target. Obviously, I think number 1, we can lead with our efficacy because. It is better efficacy in both progression-free survival and also survival, and that resonates really well with both patients and also the physicians in the community setting. Secondly, we also talk about the one-time convenience, which is a great quality of life improvement for patients because If they invest about one month with us, and then we can provide years of progression-free survival and also treatment-free remission here. That's our second selling point. And then lastly, even in terms of health economic benefit, right, if you look at the total treatment cost, we're providing savings, significant savings over standard of care over a certain period of time, given the clinical evidence we have accumulated from CAR-D4 trials. So that is our strategy, how we can completely go into the community. Now, in terms of our assumption, right? I think, first of all, we're getting to that important milestone of delivering annual supply of 10,000 doses per year from all for our network in the supply chain. Secondly, with the current and ongoing CapEx, we and J&J are planning to supply up to 20,000 doses into both the U.S. and European markets. So that is our plans, and these plans obviously are based on our projection of the demand. and also the real-time market research. So we have a lot of confidence in the penetration of CAR T into this market. And then I'll ask Alan to answer the second part of the question.

Because CAR T in general is underpenetrated across all the segments, we see significant growth across all the segments I outlined previously, the academic medical centers, the regional and community hospitals, as well as the community practices. So I think all three segments represent significant growth opportunity for us.

Got it. Thank you so much. Thank you.

Thank you. Our next question comes from Eric Schmidt with Cancer. Your line is open.

Thanks for taking my question. It's on the Raritan facility. Congrats. It sounds like you got full approval earlier this year. Just wondering when exactly that happened and your initial efforts to fill up demand for that facility, how those are going. And then on gross margins, we've seen Corvicti gross margins kind of flattened out in the last few quarters at 57%. With that facility now potentially being utilized, are we going to see that ramp up over time? Thank you.

Thanks, Eric. Yes, we have the installed capacity to support 10,000 doses, as Ying outlined. And we are now, as we've outlined earlier, have all four commercial nodes supplying the marketplace. Raritan is continuing to expand, and we anticipate a high utilization rate to support the growing demand. So, our capacity is fully meeting the demand. We have high utilization across all four nodes, and that is supporting the 10,000-dose achievement that we have.

Eric, with regards to gross margin, I mean, we've seen an improvement of gross margin year over year. the utilization improving in all of our manufacturing nodes. However, we did ramp up the Tech Lane facility in 2025, and as you see, as that starts to grow at volume, we will see the cost of goods manufacturing coming down in Tech Lane, then adding to the overall network improvement.

Thank you.

Thank you. Our next question comes from Kostas Bilouris with Oppenheimer. Your line is open.

Thanks for taking our question and congrats on the progress. Maybe a question on recent M&A in the space. One of your competitors was recently acquired by a larger company, Gilead. Do you foresee any changes in the competitive dynamics there following this acquisition and a follow-up on... the review of their application, it wasn't a priority review. Any comments or thoughts around that? Thank you.

Good morning, Kostas. Thank you for the questions. First of all, I think the acquisition you referred to validates the value of this market, right? Because we're looking at the multiple myeloma market for autologous CAR T. And certainly, that lends to the support of the valuation of the market we're targeting. And we have already said, right, how much the market is. You're looking at a $35 billion plus market for multiple myeloma, and CAR T will become an increasing portion of that pie. Secondly, as you correctly pointed out, the PDUFA date is December 23rd by FDA assigned on a needle cell. And as you know, based on the FDA published guidance document, there are only two criteria when the agency decides whether application of certain drug candidate marries standard review or prior review. The first criteria here is whether the disease your target is a serious life-threatening disease. I think it goes without saying multiple myeloma is a life-threatening disease. And the second criteria is whether the agency deems the candidate has any clinical differentiation over existing therapies. Now, clearly, based on the FDA determination of standard review, you know the answer how FDA views this application based on the data supplied in that package. So we feel this is really another validation of that CARVIC really has the unmatched efficacy and durability in the field. And we agree with the FDA view on this point. And that's pretty much what I can say about this. In terms of the competition implication, I'll ask my colleague Alan to comment.

We are prepared and continue to prepare for any timing for a need to sell. And again, I think as Ying mentioned, we feel very strongly that the data maturity that we have, the 10,000 patient experience, the length of follow-up, and the data that we presented to ASH around the three prior lines and triple class exposed patients having a median PFS of 50.4 months really raises the bar on the efficacy story. So as any other potential competitor comes to market, that's the bar that they're going to be looking at.

Thank you. Our next question comes from James Shin with DB. Your line is open.

Hey, good morning. Thank you for the questions. I have two. First one is for Ying and the team. Appreciate the comments on CAR-Ts being underpenetrated in the runway for CAR-50 meeting. It's $5 billion or north of $5 billion bogey. But there's a lot of discussion on competitive dynamics on clinical profiles amongst CAR-Ts. I'm talking about Alex Cartiz. Is it feasible for Legend, Kai, and even maybe AstraZeneca down the line to manufacture enough BCMA Cartiz to really saturate the market or make one player the dominant? Is there a way to make this a zero-sum game? And then secondly, I appreciate the comments on BizDev as well. And it sounds like, well, I guess the question is, is Legend set on leveraging its lentiviral infrastructure and focusing on viral delivery platforms for its in vivo efforts, or is it early enough that Legend is almost exploring non-viral platforms such as nanocarriers? Thank you.

Thanks, James, for the questions. On your first question about CAR-T, we certainly do not believe this is a zero-sum game for all CAR-Ts because if you look at our growth, right, we have been treated already more than 10,000 patients, and we think there are still tens of thousands of more patients that will be treated by CARVICTI. So we are on the pace to increase our capacity from annualized 10,000 to 20,000. Meanwhile, we're also looking at other options, for example, automation to increase efficiency and also output. within the current square foot footprint, right? And we believe others, including AZ and Gilead, are using similar approaches. So clearly, we all believe that this is a space that is worth investing. And given, again, the efficacy, we believe that more and more patients will opt for CAR T. So we still think there's a lot more to come in terms of supply to the market. And also, obviously, that will be matched by demand from the market. On your second question about LEN-T, so as you know, since the company was founded in 2014, we have been working on LEN-T vector as a delivery vehicle for CAR-T. So we have accumulated a lot of experience and expertise on this. And our first couple in vivo CAR-T programs in the clinic today are using LEN-T vector as a delivery for the in vivo CAR-T programs in both nausea, lymphoma, and also the multiple myeloma indications, respectively. Now, on the other hand, we also realize that there are other competing technologies, including what you mentioned, the LNP, encapsulated RNA or DNA. That's another way to look at it. So we're obviously interested in other technologies as well. On the other hand, I believe that if we can show safety proven in the clinic, then there's no reason why lentivector cannot be used in other indications such as autoimmune disease as well. So, we look at the space with a very broad net and we're very open mind in terms of, you know, potentially partnership or this development activity to bring in other technologies here.

Thank you. Our next question comes from Sean McCutcheon with Raymond James. Your line is open.

Hey, guys. Thanks for the question. One for me. With the Ibertamide MDA now accepted by FDA on MRD results and Vinay Prasad leaving soon, how does this alter your calculus on potential for filing on MRD results for Partitude 6? Thanks.

Thanks, John, for your question. I think you have seen the agency published recently a draft guidance document for the industry based on MRD as a registration endpoint for accelerated approval in multiple myeloma. On the other hand, there is a footnote in the FDA document that says that The ODAC discussion was based on meta-analysis for modalities such as small molecules and also on injectable antibodies, right? So to date, there's no data out there that actually suggests a correlation between a clinical outcome such as PFS and survival. and MRD inactivity in CAR T modality. And we're very much aware of that. In fact, we are probably the trailblazer in this field because we will expect CAR T35 top line data in the near future, right, this year or next year. And based on that, we did actually prospectively include some MRD inactivity in the measurement. So we might be the first one actually in front of the FDA to discuss the correlation between MRD negativity and a clinical outcome such as PFS and survival in a CAR-T trial. And based on that, of course, if FDA agrees, we potentially can accelerate the FDA filing time for CAR-T6, which is the frontline trial that is comparing CAR-BD head-to-head against stem cell transplant in the frontline setting. So that is how we view this MRD endpoint and how that potentially can accelerate the CARB-VT entry into the frontline for patients who are eligible for transplant.

Thank you. Our next question comes from Ash Verma with UBS. Your line is open.

Yeah. Hi there, guys. This is Natalie. I'm for Ash, and thanks for taking our question. Just two quick questions from us. The first is, can you provide any color on how you're thinking of a potential Techdara launch ex-US? And then our second question is just, could you provide the current breakdown of how many Carvicti patients are second and third line? Thanks so much.

So on your second question, the split that we've shared is that the second through fourth line population continues to grow, and that is now 65% of our business, which is exciting because it shows an evolution, and it shows that the majority of the patients in our mix are getting it in earlier lines. And the only other sort of color on that one that we've shared is that, and we have seen this very significantly, that second and third line patients, while all lines are growing, Second and third line continues to grow the fastest. As far as your question about tech there at XUS, I can't speak to the J&J plans there. I would just say that for Carvicti, we continue to see significant uptake in the XUS markets. We are now in 13 markets outside the U.S. More major markets are coming online in 2026 and beyond. The uptake has been very significant in markets such as Germany, Spain, and Belgium and others. And that's because, number one, they've been taking the learnings from the U.S. launches, applying them to patient selection. and management of patients, as well as the healthcare systems really support this concept around a one-time infusion and getting patients from a budget impact into a long-term remission based on a single infusion. So there's very strong support, XUS, for the CAR-T model and CARB-ICT specifically.

And also, I just want to add to Alan's comments. For example, we only launched Carvicti in Spain last year in 2025. But right now, you're looking at 75% of the use already in second, third line in Spanish market. So clearly, there's a very quick update in European market for the early line use of Carvicti. And I think that position is really well, you know, in this early line indication in Europe.

Thank you. Our next question comes from Leona Timoshev with RBC. Your line is open.

Hey, thanks for taking my question. I'm sure I have two on the pipeline in terms of broad strategy. I guess first, you guys have explored ALO approaches, Gamma Delta, NK, NVivo. I guess, how are you thinking about what the winner is going to be? Are you leaning into NVivo? Is that sort of the direction you're going to go in? And then second, You've talked a lot about the importance of long-term data and follow-up, especially as it relates to CAR-VICT and multiple myeloma. But as you develop these new programs in spaces that already have existing CAR-T options, such as myeloma or lymphoma, how do you get confident that what you're going to see early on in terms of response rates is actually going to translate to better long-term outcome data and make it worthwhile to move that program forward? Thanks.

Good morning, Leo. Thanks for your questions. On your first question, yes, you're right. We have explored, obviously, all modalities in the field of CAR T, including autologous, allogeneic, that includes alpha-beta and alpha-modality, and then most recently, also NK, as well as our latest entry into the field that is in vivo. So, I think based on the clinical data we have seen to date, And also based on what we're seeing in the field, yes, we are particularly interested and also excited about the in vivo CAR-T approach. Because on one hand, the in vivo CAR-T approach can provide a ready-to-go off-the-shelf version that is very convenient for both patients and physicians. In the meantime, you don't have to worry about rejection, right? Because that is the biggest hurdle for allogeneic modalities in T cell therapy. Here, you're leveraging the patient's own immune cells. Therefore, you really don't have to worry about rejection. So that is why I think the field is very excited about the promise of in vivo CAR T. And obviously, you have seen some clinical data. And we have not published any clinical data yet. But based on data we have seen in patients so far, we're also quite excited about the manageable safety and also the preliminary efficacy signal as well, although we need more time to follow up in terms of durability compared to autologous. So there are certain metrics, for example, we can look at. In multiple myeloma, you can look at MRD negativity. That is a very early but also very reliable sign for a longer-term clinical outcome. And that is how we can measure whether a in vivo CAR T targeted myeloma is effective or not, right? We also look at PKPD, for example. If you look at the copies of T cell transduced in circulation, does that match the level we see, for example, in CARVICT in the CAR T program? So there are certain matches we can compare and contrast between our in vivo program in the clinic and also our experience with CARVICT in the clinic. On your second question about, you know, the long-term data, I think, If you look at the informer, right, just taking a page from the ESCADA clinical development program, you know that the six-month CR, the six-month computer remission rate, is actually quite predictive for longer-term outcome. Again, so that is something that we track in the clinical as well. So I think the prior clinical experience in CAR T really taught us a lot how to look at the efficacy in the very beginning of the program. That's how we track the clinical progress.

Thank you. Our next question comes from Yiren Werber with CD Cowan. Your line is open.

Hi, this is Jane. Thanks for taking our questions. Two from me. One, I remember you have several multi-center trials looking, investigating different strategies to mitigate some of the delayed neurotoxicity events that we see with CARVICTI, including the FITIDAL trial and other trials at Wisconsin and Moffitt. Can you give us a sense of how those are progressing and the early signals you're seeing and when we might see data from that trial or those trials And then secondly, on the in vivo programs, you said that we could see data in 2026. So how many patients, how much follow-up would you want to see, would you need to see to share that data at a medical conference? Thanks so much.

The Citadel study, which is a multicenter study looking at ALC monitoring and then management and treatment approaches, should have data presented at some point this year. And I would also point out that another significant data set are the data sets around bridging therapy, because as we hear more and more, this becomes a crucial strategy for physicians both in the community and at the activated treatment centers to adopt. And we see very strong support for and significant acceptance of bridging as a standard of care. In fact, we were very pleased in January to see the NCCN guidelines updated to include the use of talcetamab as a bridging therapy and a larger discussion about the need for bridging therapy in advance of a reinfusion of manufactured CAR T cells. And this is important because this is what is actually helping debulk the tumor and then get to better outcomes, both on a safety and efficacy standpoint. Both the study that I referenced earlier from Stanford with Dr. Sedana as well as the publication from Dr. DeKalb and ongoing new studies from Dr. DeKalb reinforce this concept that bridging therapy is really helping mitigate some of these concerns.

Good morning, Jane. On your second question, as you know, it is our corporate policy not to comment on ASRAC until they're officially accepted by a major medical meeting. However, we are planning the first batch of clinical data in patients for our first in vivo program to be published and presented at a major medical meeting potentially in the middle of this year. That's the plan. So please stay tuned.

Thank you. And our last question comes from Mitchell Kapoor with HC Wainwright. Your line is open.

Hi, good morning. This is Katie on for Mitchell. I was thinking about your manufacturing scale-up. And what I'm trying to get my head around is, do those 10,000 doses represent the number of samples processed or the number of transfusable doses produced? Are you making adjustments to patient selection as you learn more moving into the clinic, or are you kind of expecting that rate to be about the same going forward?

That figure represents our overall capacity to produce doses. Of course, from there, there are some drop-offs. There are... You know, we also account for, you know, days of shutdown. We account for non-clinical runs. We account for out of spec, which actually, you know, those numbers are going down. So that's a lower portion of it. But so the 10,000 represents our overall capacity to support the marketplace. And then there are some adjustments from that number.

Great. Thank you.

Thank you. And this concludes our question and answer session. Thank you for your participation. You may now disconnect. Everyone, have a great day.