Q4 2025 Legend Biotech Corp Earnings Call

March 10, 2026

Operator: Good day, and welcome to the Legend Q4 2025 Earnings Call. At this time, all participants are in listen-only mode. After the speaker's presentation, there'll be a question and answer session. Instructions will be given at that time. Please note this call is being recorded. I'd like to turn the call over to Jessie Yeung, Vice President of Investor Relations and Finance. Please go ahead.

Speaker #1: Good day and welcome to the Legend Fourth Quarter 2025 earnings call. At this time, all participants are listen-only mode. After the speaker's presentation, there'll be a question-and-answer session.

Speaker #1: 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 Investor Relations and Finance.

Speaker #1: Please go ahead.

Jessie Yeung: Good morning. This is Jesse Young, Vice President of Investor Relations and Finance at Legend Biotech. Thank you for joining our conference call today to review our Q4 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 CARVYKTI, and Jessie Yeung, 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 herein.

Speaker #2: Good morning. This is Jessie Yeung, Vice President of Investor Relations and Finance at Legend Biotech. Thank you for joining our conference call today to review our fourth quarter 2025 performance.

Speaker #2: 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.

Speaker #2: Joining me on today's call are Ying Huang, the company's Chief Executive Officer; Alan Bash, the company's President of Caviti; and Carlos Santos, the company's Chief Financial Officer.

Speaker #2: 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 herein.

Speaker #2: 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 Investors sections of our company website.

Jessie Yeung: 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 Investors section 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 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. 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.

Speaker #2: 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.

Speaker #2: 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.

Speaker #2: 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.

Speaker #2: 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.

Jessie Yeung: 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 press release includes IFRS to non-IFRS reconciliation for these measures. With that, I will now turn the call over to Ying.

Speaker #2: Our press release includes IFRS to non-IFRS reconciliation for these measures. With that, I will now turn the call over to Ying.

Speaker #3: 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.

Ying Huang: 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 CARVYKTI 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 CARVYKTI has had on a global scale in recent months, but I wanted to share a few highlights on this front. During the Q4 of 2025, CARVYKTI net trade sales were approximately $555 million, which is a 66% increase year-over-year.

Speaker #3: 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-Victi profitability in 2025 and believe we are poised to achieve company-wide profitability in 2026.

Speaker #3: You'll hear from Alan shortly about the impact that CAR-Victi has had on the global scale in recent months, but I want you to share a few highlights on this front.

Speaker #3: During the fourth quarter of 2025, CAR-Victi net trade sales were approximately $555 million. Which is a 66% increase year over year. We have broad hope to patients worldwide with more than 10,000 multiple myeloma patients who have chosen to be treated with CAR-Victi.

Ying Huang: We have brought hope to patients worldwide with more than 10,000 multiple myeloma patients who have chosen to be treated with CARVYKTI. With the physical expansion of the Littleton facility, we have the installed capacity to support annual production of 10,000 doses across all our manufacturing nodes. CARVYKTI's launch remains the strongest CAR T launch to date. The majority of its utilization is now in earlier line settings. CARVYKTI has a 97% overall manufacturing success rate and is offered in 14 global markets. Not only is CARVYKTI raising the bar for manufacturing excellence and site growth, it is 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 CARVYKTI's efficacy and our manufacturing success.

Speaker #3: And with the physical expansion of the Brighton facility, we have the installed capacity to support annual production of 10,000 doses across all our manufacturing nodes.

Speaker #3: CAR-Victi's launch remains the strongest CAR-T launch to date. The majority of its utilization is now in earlier line settings. CAR-Victi has a 97% overall manufacturing success rate and is offered in 14 global markets.

Speaker #3: Not only is CAR-Victi raising the bar for manufacturing excellence and site growth, it’s also setting new standards for survival outcomes in relapsed, refractory multiple myeloma.

Speaker #3: Recently, at the 67th American Society of Hematology annual meeting and the 2026 tender meeting, we presented compelling data on CAR-Victi's efficacy and our manufacturing success.

Speaker #3: 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.

Ying Huang: Before we dive deeper into this, I want to highlight that we also presented at ASH on Lucar-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 antitumor activity. Turning to the recent CARVYKTI presentations, new long-term CARVYKTI data demonstrated durable responses in key subgroups and reinforced the improved outcomes associated with earlier treatment with CARVYKTI. 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 CARVYKTI. This represents one of the longest PFS outcomes for BCMA-targeting CAR T therapy.

Speaker #3: As you may have seen, we're pleased that it demonstrated manageable safety and encouraging anti-tumor activity. Turning to the recent CAR-Victi presentations, new long-term CAR-Victi data demonstrated durable responses in key subgroups and reinforced the improved outcomes associated with earlier treatment with CAR-Victi.

Speaker #3: Importantly, triple-class exposed multiple myeloma patients with three prior lines of therapy in CAR-T21 and CAR-T24 achieved a median PFS of 50.4 months after a single infusion of CAR-Victi.

Speaker #3: 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.

Ying Huang: 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 cytogenetics from CARTITUDE-4 shows that earlier treatment with CARVYKTI improved survival outcomes, reinforcing its curative potential. 80% of the patients remained progression free and off treatment after 2.5 years. Of standard risk patients in CARTITUDE-4 who were progression free at one year, 93% remain alive and progression free at 2.5 years. Furthermore, translational analysis of patients from CARTITUDE-1 and CARTITUDE-4 demonstrated stronger immune fitness and a more immunocompetent tumor microenvironment for patients earlier in their treatment journey. Again, adding to the body of clinical evidence that earlier treatment with CARVYKTI leads to better outcomes.

Speaker #3: Additionally, an analysis of patients with standard-risk cytogenetics from CAR-T24 shows that earlier treatment with CAR-Victi improved survival outcomes, reinforcing its curative potential. 80% of the patients remained progression-free and off treatment after 2.5 years.

Speaker #3: Off-standard risk patients in CAR-T24 who were progression-free at one year, 93% remained alive and progression-free at 2.5 years. Furthermore, translational analysis of patients from CAR-T21 and CAR-T24 demonstrated stronger immune fitness and a more immunocompetent tumor microenvironment for patients earlier in the treatment journey.

Speaker #3: Again, adding to the body of clinical evidence that earlier treatment with CAR-Victi leads to better outcomes. Finally, commercial CAR-Victi manufacturing data from July 2024 through October 2025 were analyzed to examine manufacturing outcomes across multiple prior lines of therapy.

Ying Huang: Finally, commercial CARVYKTI manufacturing data from July 2024 through October 2025 were analyzed to examine manufacturing outcomes across multiple prior lines of therapy. Overall, 99% of 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 CARVYKTI in multiple myeloma.

Speaker #3: 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.

Speaker #3: Not only are we unconstrained from a capacity standpoint, but we're 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.

Speaker #3: 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 CAR-Victi in multiple myeloma.

Speaker #3: This is one of the many reasons why we and our partner, Johnson & Johnson, are moving full steam ahead on our capacity expansion plans.

Ying Huang: 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 CARVYKTI to its anticipated potential of more than $5 billion in peak annual sales. Beyond current indications of CARVYKTI, we are continuing to advance our earlier line studies to potentially expand our addressable market. Notably, CARTITUDE-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 CARVYKTI into the frontline, we remain focused on our R&D pipeline besides CARVYKTI.

Speaker #3: Our partnership with Johnson & Johnson is built to scale CAR-Victi to its anticipated potential of more than $5 billion in peak annual sales. Beyond current indications of CAR-Victi, we are continuing to advance our earlier line studies to potentially expand our addressable market.

Speaker #3: Notably, CAR-T25 and 6 studies have both completed enrollment already. Based on the data presented recently, earlier treatment may deliver greater durability at lower lifetime cost.

Speaker #3: 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 CAR-Victi into the front line, we remain focused on our R&D pipeline besides CAR-Victi.

Speaker #3: We have developed a lean approach to leveraging investigator-initiated trials in China, or IITs, to rapidly establish clinical proof of concept. Each of our programs is gated by clear evidence thresholds, which avoids inefficient use of capital.

Ying Huang: 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 capital. 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 1 to 2 US INDs by the end of this year. In addition to investing in our own in-house R&D efforts, we will be opportunistic this year about generating new revenue through business development efforts.

Speaker #3: 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.

Speaker #3: 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 U.S. INDs by the end of this year.

Speaker #3: In addition to investing in our own in-house R&D efforts, we will be opportunistic this year about generating new revenue through business development efforts. To recap, we have several important milestones ahead this year as we look to increase CAR-Victi penetration in earlier lines and advance our next-generation cell therapies.

Ying Huang: To recap, we have several important milestones ahead this year as we look to increase CARVYKTI penetration in earlier lines and advance our next-generation cell therapies. With cash position of $949 million, we're balancing investment in future growth with disciplined expense management. We are pleased that CARVYKTI became profitable in 2025 and anticipate company-wide profitability in 2026. With that, I'll pass it over to Alan to provide an update on CARVYKTI.

Speaker #3: With a cash position of $949 million, we're balancing investment in future growth with disciplined expense management. We are pleased that CAR-Victi became profitable in 2025 and anticipate company-wide profitability in 2026.

Speaker #3: And with that, I'll pass it over to Alan to provide an update on CAR-Victi.

Speaker #1: Thank you, Ying. Turning to our fourth-quarter results, CAR-Victi net trade sales grew 66% year over year and 6% from the third quarter due to seasonality of shipments.

Alan Bash: Thank you, Ying. Turning to our Q4 results, CARVYKTI net trade sales grew 66% year-over-year and 6% from Q3 due to seasonality of shipments. 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. US 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 settings. Outside the US, 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.

Speaker #1: Our global growth was driven by continued share gains, site expansion, and a growing geographic footprint, now reaching 294 global treatment sites across 14 markets worldwide.

Speaker #1: US 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.

Speaker #1: Outside the US, 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.

Speaker #1: 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 XUS markets.

Alan Bash: 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 CARVYKTI 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, CARVYKTI demonstrated durable long-term benefits, and improved outcomes are associated with earlier use.

Speaker #1: Looking at the broader multiple myeloma opportunity, BCMA-directed therapies remain significantly underpenetrated in earlier lines, with less than 5% of patients in the second through fourth-line setting treated with a BCMA-targeting agent in 2025.

Speaker #1: The majority of patients in this population are BCMA treatment-naive, providing a unique opportunity for CAR-Victi 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.

Speaker #1: CAR-Victi 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.

Alan Bash: No other BCMA targeting CAR T therapy has matched this depth of long-term survival data or overall survival benefit over standard therapies. CARVYKTI'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 wanna shed light on the patient management strategies we have been able to implement and explore with our patient datasets and how things have changed since we and J&J launched CARVYKTI. 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.

Speaker #1: 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.

Speaker #1: 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 datasets, and how things have changed since we and J&J launched CAR-Victi.

Speaker #1: 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.

Speaker #1: 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 talketamab bridging therapy and CAR-Victi infusion.

Alan Bash: Mattia D'Agostino from Medical College of Wisconsin, there were no cases of colitis or Parkinsonism following at least one cycle of Talquetamab bridging therapy and CARVYKTI infusion. The study included more than 130 patients, with 98 patients treated with CARVYKTI. Furthermore, Dr. Surbhi Sidana from Stanford University published a very large study that looked at a total of 761 CARVYKTI-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 CARVYKTI is well positioned for success here.

Speaker #1: The study included more than 130 patients with 98 patients treated with CAR-Victi. Furthermore, Dr. Sadana from Stanford published a very large study that looked at a total of 761 CAR-Victi-treated patients across 15 large tertiary academic centers.

Speaker #1: 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.

Speaker #1: Turning to community adoption, we believe CAR-Victi 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.

Alan Bash: There is no other CAR T with over 5 years of progression-free outcomes in late-line myeloma and a demonstrated overall survival benefit in earlier lines. CARVYKTI 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 3 prior lines of therapy from CARTITUDE-1 and CARTITUDE-4. As it relates to safety, CARVYKTI's profile is well understood at this point. Multiple CAR T's 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 CARVYKTI's dataset. Furthermore, 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.

Speaker #1: CAR-Victi 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.

Speaker #1: As it relates to safety, CAR-Victi'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 CAR-Victi's dataset.

Speaker #1: Furthermore, 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.

Speaker #1: Lastly, CAR-Victi 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.

Alan Bash: Lastly, CARVYKTI 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 CARVYKTI has had steady traction in the community setting. Community hospitals now comprise 1/3 of the 145 CARVYKTI authorized treatment centers in the US, with 80% of myeloma patients living within 50 miles of a treatment site. Additionally, we continue to see the outpatient setting comprise about 1/2 of CARVYKTI prescribing volume, further supporting broad accessibility. In summary, CARVYKTI remains the undisputed leader of CAR T cells 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.

Speaker #1: Given all these factors, you can see why CAR-Victi has had steady traction in the community setting. Community hospitals are now comprised of one-third of the 145 CAR-Victi-authorized treatment centers in the US, with 80% of myeloma patients living within 50 miles of a treatment site.

Speaker #1: Additionally, we continue to see the outpatient setting comprise about half of CAR-Victi prescribing volume, further supporting broad accessibility. In summary, CAR-Victi 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.

Speaker #1: Our core focus remains on unlocking the curative potential of CAR-Victi and accelerating adoption in earlier lines, where we see the greatest impact for patients.

Alan Bash: Our core focus remains on unlocking the curative potential of CARVYKTI 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 CARVYKTI and advantages of earlier use, global expansion supported by capacity for 10,000 annualized doses, additional adverse event mitigation strategies to improve outcomes for CARVYKTI patients. Now I will turn it over to Jessie Yeung.

Speaker #1: 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 CAR-Victi and the advantages of earlier use; global expansion supported by capacity for 10,000 annualized doses; and additional adverse event mitigation strategies to improve outcomes for CAR-Victi patients.

Speaker #1: Now I will turn it over to Carlos Santos.

Speaker #2: 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.

Jessie Yeung: 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 Q4, we delivered strong top-line growth driven by the continued momentum of CARVYKTI 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 CARVYKTI 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 -142% in Q2 2023 to just -6% in Q4 2025. This improvement has been steady across 10 consecutive quarters. This reflects two things. First, the scalability of the CARVYKTI franchise.

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 Q4, we delivered strong top-line growth driven by the continued momentum of CARVYKTI 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 CARVYKTI 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 -142% in Q2 2023 to just -6% in Q4 2025. This improvement has been steady across 10 consecutive quarters. This reflects two things. First, the scalability of the CARVYKTI franchise.

Speaker #2: During the fourth quarter, we delivered strong top-line growth driven by the continued momentum of CAR-Victi and the expanding global footprint that Alan outlined. Revenue reached $306 million, representing 64% year-over-year growth.

Speaker #2: And our gross margin remained consistently strong at 61%, with a gross margin on CAR-Victi net product sales of 57%. What is most important is that this growth is increasingly translating into operating leverage.

Speaker #2: Our operating margin has improved dramatically, from -142% in the second quarter of '23 to just -6% in the fourth quarter of '25. And this improvement has been steady across 10 consecutive quarters.

Speaker #2: This reflects two things. First, the scalability of the CAR-Victi franchise, and second, our disciplined approach to managing the cost structure as we grow. Given this trajectory, the CAR-Victi franchise became profitable in 2025.

Jessie Yeung: Second, our disciplined approach to managing the cost structure as we grow. Given this trajectory, the CARVYKTI 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 Q2 2023, 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.

Carlos Santos: Second, our disciplined approach to managing the cost structure as we grow. Given this trajectory, the CARVYKTI 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 Q2 2023, 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.

Speaker #2: 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.

Speaker #2: 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.

Speaker #2: As CNA 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.

Jessie Yeung: SG&A 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 -$20 million. 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 $0.01 compared to -$0.15 for the same period last year.

Carlos Santos: SG&A 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 -$20 million. 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 $0.01 compared to -$0.15 for the same period last year.

Speaker #2: Back office and administrative functions continued to scale efficiently as the business grows, reflecting strong internal cost discipline. Our operating loss improved by 75% versus the prior year, to approximately -20 million.

Speaker #2: 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.

Speaker #2: A meaningful transformation from a $59 million adjusted net loss a year ago. Our adjusted diluted income per share was $0.01 compared to -15 cents for the same period last year.

Speaker #2: We ended the year with $949 million in cash, cash equivalents, and time deposits. Operating cash flows continued to trend in the right direction, as evidenced by our $12 million in operating cash flow outlays this quarter, compared to $82 million in operating cash flow outlays for the same period last year.

Jessie Yeung: We ended the year with $949 million in cash equivalents, and time deposits. Operating cash flows continues to trend in the right direction, as evidenced by our $12 million in operating cash flow outlays this quarter compared to $82 million 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 CARVYKTI profit expansion through focused commercial and medical investment. Finally, modest capital expenditures tied to manufacturing capacity expansion.

Carlos Santos: We ended the year with $949 million in cash equivalents, and time deposits. Operating cash flows continues to trend in the right direction, as evidenced by our $12 million in operating cash flow outlays this quarter compared to $82 million 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 CARVYKTI profit expansion through focused commercial and medical investment. Finally, modest capital expenditures tied to manufacturing capacity expansion.

Speaker #2: 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.

Speaker #2: Third, supporting CAR-Victi 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.

Jessie Yeung: 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 CARVYKTI 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. Now it's time to take your questions. Operator, we're ready for the first question, please.

Carlos Santos: 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 CARVYKTI 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. Now it's time to take your questions. Operator, we're ready for the first question, please.

Speaker #2: 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 CAR-Victi franchise, and our disciplined approach to growth.

Speaker #2: 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.

Speaker #2: With more than 10,000 patients treated globally, and a growing footprint of treatment centers, we believe we are well-positioned to drive long-term sustainable value. And now, it's time to take your questions.

Speaker #2: Operator, we're ready for the first question, please.

Speaker #1: Thank you. If you'd like to ask a question, please press star 11. If your question has been answered and you'd like to remove yourself from the queue, press star 11 again.

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

Speaker #1: Our first

Speaker #1: The question comes from Terrence Flynn with Morgan. Please translate for our clinical leadership. Stanley, your line is open.

Terence Flynn: 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 CARVYKTI growth in 2026 and maybe how to think about US relative to rest of world. The second one 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, you know, size that you guys are potentially considering? Thank you.

Speaker #3: 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 CAR-Victi growth in 2026, and maybe how to think about US relative to rest of world.

Speaker #3: 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?

Speaker #3: Thank you.

Speaker #2: Take the money, Terrence. This is Ying. Thank you for the questions. So, on your first question, we are planning to also work—committed to sequential growth throughout the year.

Ying Huang: Hey, good morning, Terence Flynn. This is Ying Huang. Thank you for the questions. 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. We have said that, you know, we feel reasonably confident of delivering CARVYKTI according to the street consensus number, which is about 50% top line growth from last year, right? That's what we're feeling confident about. 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.

Speaker #2: That includes all four quarters 2026. And we have said that we feel reasonably confident of delivering CAR-Victi according to the strict consensus number, which is about 50% top-line growth from last year, right?

Speaker #2: 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.

Speaker #2: 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.

Speaker #2: 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.

Ying Huang: Certainly there are other technologies that are out there, which you know may be useful for other indications besides oncology and hematology. Those are certain technologies we're interested in bringing in-house or potentially co-developing with other partners. Then I think in the same vein, there are also other interest in potentially partnering with our existing assets, right? Because as you have seen, Terence, there's a lot of transactions recently in the in vivo CAR T field. We're also thinking ways to potentially accelerate the global development of our own in vivo assets as well. Obviously, there's no lack of interest on that. That's what we mean by business development and being trying to be focused. Thank you.

Speaker #2: 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?

Speaker #2: Because 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.

Speaker #2: And obviously, there's no lack of interest in that. So that's what we mean by this development and by trying to be focused. Thank you.

Speaker #1: Thank you. Our next question comes from John Miller with Evercore. Your line is open.

Operator: Thank you. Our next question comes from Jonathan Miller with Evercore. Your line is open.

Speaker #3: 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 CAR-Victi?

Jonathan Miller: 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-MajesTEC for you to get feedback from the actual providers and commercial sites, how are you hearing that docs are gonna position the use of bispecifics in early lines relative to CARVYKTI? I mean, Ying, 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?

Speaker #3: I mean, Ying, 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?

Jessie Yeung: Hi. Yes, this is Alan. Obviously the MajesTEC 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. 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.

Alan Bash: Hi. Yes, this is Alan. Obviously the MajesTEC 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. 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.

Speaker #2: 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.

Speaker #2: 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.

Speaker #2: 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.

Jessie Yeung: We continue to hear very significantly that there is a very unique value proposition for CARVYKTI 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 wanna 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. 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.

Alan Bash: We continue to hear very significantly that there is a very unique value proposition for CARVYKTI 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 wanna 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. 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.

Speaker #2: We continue to hear very significantly that there is a very unique value proposition for CAR-Victi in these earlier line settings. As a one-time infusion, delivering overall survival and five-year treatment-free remissions in the patient set in the later line patients as well.

Speaker #2: So 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.

Speaker #2: So 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.

Operator: Thank you. Our next question comes from Edgar de Rout with Barclays. Your line is open.

Speaker #1: Thank you. Our next question comes from Edsa Durout with Barclays. Your line is open.

Luca: Hi, this is Luca from France here. Thanks for taking my question. Quick on the community setting expansion, 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?

[Analyst] (Barclays): Hi, this is Luca from France here. Thanks for taking my question. Quick on the community setting expansion, 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?

Speaker #4: Hi, this is Luke. I'm Francis. Thanks for taking my question. Quick one on the community setting expansion. What do you see as some of the bigger hurdles for continued expansion there?

Speaker #4: Is it just site opening, or is it training those community physicians?

Alan Bash: In terms of the community adoption, we're very pleased with where we've been. As I've mentioned earlier, we have about a third of our activated treatment centers are community or regional hospitals. 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 CARVYKTI closer to patients. Another example is we had an academic medical center activated Hackensack University Medical Center 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 University Medical Center. Those are examples where we are hearing very significantly that bringing CARVYKTI closer to patients with these community hospitals is a value add.

Speaker #2: So, in terms of the community adoption, we're very pleased with where we've been, and as I mentioned earlier, about a third of our activated treatment centers are community or regional hospitals.

Speaker #2: 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.

Speaker #2: These are examples where we've been able to bring CAR-Victi closer to patients. Another example is we had an academic medical center activated—Hackensack University in the northern part of New Jersey.

Speaker #2: 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-Victi closer to patients with these community hospitals is a value add.

Alan Bash: 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 and the referring base. 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.

Speaker #2: 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.

Speaker #2: 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 and the referring base, so these are all the steps that we are heading towards.

Speaker #2: 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.

Alan Bash: 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.

Speaker #2: And we've heard that again as a significant gating factor: that without the REMS in place, more patients can be monitored closer to home, and more community physicians are more comfortable getting their patients back and monitoring them locally.

Speaker #2: And that has enabled the referral base as well.

Luca: All right. Thank you.

[Analyst] (Barclays): All right. Thank you.

Speaker #4: All right. Thank you.

Operator: Thank you. Our next question comes from Linhai Zhao with GS. Your line is open.

Speaker #1: Thank you. Our next question comes from Lynn Hejiao with GS, your line is open.

Linhai Zhao: Hi, thanks for taking my question. This is Linhai Zhao from Goldman Sachs. You mentioned about the current CAR-T penetrations less than 10% in the fifth line and also less than 5% in second to fourth line multiple myeloma. Just curious, what would be your practical target? Or can you further comment on the potential ceiling values for these CAR-T penetrations in both late line and early line multiple myeloma? That's the first question. The second question is about TECVAYLI. Just wondering, given that SC TECVAYLI 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 capture the majority of the growth in the academic centers? Thank you.

Speaker #5: Hi, thanks for taking my question. This is Ling Hai from Goldman Sachs. You mentioned that the current CAR-T penetration is less than 10% in the fifth line and also less than 5% in the second to fourth line multiple myeloma.

Speaker #5: Just curious, what would be your practical target, or can you further comment on the potential ceiling values for these CAR-T penetrations in both late-line and early-line multiple myeloma?

Speaker #5: And that's the first question. And the second question is about Tecdera. Just wondering given that Tecdera may not 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?

Speaker #5: Thank you.

Ying Huang: Hi, Linhai, this is Gene. I'll answer the first part of your question in terms of current CAR-T penetration. We and our partner, J&J, are firmly believers that newer drugs, including CARVYKTI and also TECVAYLI, should be the preferred option based on the clinical data that shows superiority of these regimens over the triplet standard of care, right? As Alan mentioned, if you look at community practice in the second to fourth line setting in the US, still all BCMA targeting modalities only account for about 5% market share. That shows us there's plenty of growth for these new regimens in the community setting right?

Speaker #2: Hi, Ling Hai. This is Ying. So I'll answer the first part of your question. In terms of current CAR-T penetration, we and our partner GNJ are firmly believers that newer drugs, including Carvykti and also Tecderi, should be the preferred option based on the clinical data that shows superiority of these regimens over the triplet standard of care, right?

Speaker #2: And as Alan mentioned, if you look at community practice, in the second to fourth line setting in the US, still all BCMA targeting modalities only account for about 5% market share.

Speaker #2: That shows us 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 one, we can lead with our efficacy because it is better efficacy in both progression-free survival and also survival.

Ying Huang: Now, in terms of, you know, what we're trying to target, obviously, I think, number one, we can lead with our efficacy because it is better efficacy in both progression-free survival and also survival. That resonates really well with both patients and 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. 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 CARTITUDE-4 trial.

Speaker #2: 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.

Speaker #2: 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-T before trial.

Ying Huang: That is our strategy, how we can completely go into the community. Now, in terms of, you know, our assumption, right? I think, first of all, we're getting to that important amount of delivering annual supply of 10,000 doses per year from all four of 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 US and European markets. That is our plans. These plans obviously are based on our projection of the demand and also the real-time market research. We have a lot of confidence in the penetration of CAR-T into this market. I'll ask Alan to answer the second part of your question.

Speaker #2: 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 four of our network in the.

Speaker #2: Supply chain. Secondly, with the current and ongoing CAPEX, we and GNJ are planning to supply up to 20,000 doses into the both US and European market.

Speaker #2: 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.

Speaker #2: And then I'll ask Alan to answer the second part of your question.

Alan Bash: 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. I think all three segments represent significant growth opportunity for us.

Speaker #3: Well, 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 community hospitals, as well as the community practices.

Speaker #3: So, I think all three segments represent significant growth opportunity for us.

James Shin: Got it. Thank you so much.

Linhai Zhao: Got it. Thank you so much.

Speaker #5: Got it. Thank you so much.

Ying Huang: Thank you.

Operator: Thank you. Our next question comes from Eric Schmidt with Cantor. Your line is open.

Speaker #2: Thank you.

Speaker #1: Thank you. Our next question comes from Eric Schmidt with Cancer, your line is open.

Eric Schmidt: 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. On gross margins, we've seen CARVYKTI gross margins kinda flatten out in the last few quarters at 57%. With that facility now potentially being utilized, are we gonna see that ramp up over time? Thank you.

Speaker #2: 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 CAR-Victi gross margins kind of flatten out in the last few quarters at 57%.

Speaker #2: With that facility now potentially being utilized, are we going to see that ramp up over time? Thank you.

Ying Huang: Thanks, Eric. Yes, we have the installed capacity to support 10,000 doses, as Ying outlined, and we now have all four commercial nodes supplying the marketplace, as we've outlined earlier. Raritan is continuing to expand, and we anticipate a high utilization rate to support the growing demand. 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.

Alan Bash: Thanks, Eric. Yes, we have the installed capacity to support 10,000 doses, as Ying outlined, and we now have all four commercial nodes supplying the marketplace, as we've outlined earlier. Raritan is continuing to expand, and we anticipate a high utilization rate to support the growing demand. 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.

Speaker #3: 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.

Speaker #3: 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.

Speaker #3: We have high utilization across all four nodes. And that is supporting the 10,000-dose achievement that we have.

James Shin: Gross margin.

Eric Schmidt: Gross margin.

Ying Huang: Yeah, Eric.

Alan Bash: Yeah, Eric.

James Shin: Yep.

Ying Huang: Yep.

Ying Huang: Yeah, with regards to gross margin, I mean, we've seen an improvement of gross margin year over year from 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.

Alan Bash: Yeah, with regards to gross margin, I mean, we've seen an improvement of gross margin year over year from 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.

Speaker #2: And gross margins.

Speaker #4: Eric, yeah, with regards to gross margin, I mean, we've seen an improvement of gross margin year over year from the utilization improving in all of our manufacturing nodes. However, we did ramp up the tech lane facility in 2025.

Speaker #4: 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.

Eric Schmidt: Thank you.

Speaker #2: Thank you.

Operator: Thank you. Our next question comes from Kostas Biliouris with Oppenheimer. Your line is open.

Speaker #1: you. Our next question comes from Costas Biloras with Oppenheimer, your line is open.

Kostas Biliouris: 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? A follow-up on the review of the application. It wasn't a priority review. Any comments or thoughts around that? Thank you.

Speaker #5: 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.

Speaker #5: Do you foresee any changes in the competitive dynamics there following these acquisitions? And a follow-up on the review of their application—it wasn't a priority-thank review. Any comments or thoughts around that?

Speaker #5: Thank you.

Ying Huang: 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 this as support of the valuation of the market we're targeting. 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. Second, as you correctly pointed out, the PDUFA date is 23 December by FDA, assigned on anitocabtagene autoleucel. 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 merits standard review or priority review.

Speaker #2: So good morning, Costas. Thank you for the questions. First of all, I think the acquisition you referred to validates the value of this market, right?

Speaker #2: Because we're looking at the multiple myeloma market for autologous CAR-T. And certainly, that lends to this support of the valuation of the market we're targeting.

Speaker #2: 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.

Speaker #2: Secondly, as you correctly pointed out, the proliferative data 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 candidates marries standard review or priority review.

Ying Huang: The first criterion here is whether the disease or target is a serious life-threatening disease. I think it goes without saying, multiple myeloma is a life-threatening disease. 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 CARVYKTI really has the unmatched efficacy and durability in the field. We agree with the FDA view on this point. That's pretty much what I can say about this. In terms of the competition implication, I'll ask my colleague, Alan to comment.

Speaker #2: The first criterion here is whether the disease you're targeting is a serious life-threatening disease. I think it goes without saying multiple myeloma is a life-threatening disease.

Speaker #2: And the second criterion 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.

Speaker #2: So we feel this is really another validation of that CAR-Victi really has the unmatched efficacy and durability in the field. And we agree with the FDA view on this point.

Speaker #2: 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.

Ying Huang: We are prepared and continue to prepare for any timing for anitocabtagene autoleucel. 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 3 prior lines in triple-class exposed patients having a median PFS of 50.4 months really raises the bar on the efficacy story. As any other potential competitor comes to market, that's the bar that they're gonna be looking at.

Alan Bash: We are prepared and continue to prepare for any timing for anitocabtagene autoleucel. 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 3 prior lines in triple-class exposed patients having a median PFS of 50.4 months really raises the bar on the efficacy story. As any other potential competitor comes to market, that's the bar that they're gonna be looking at.

Speaker #3: We are prepared and continue to prepare for any timing for a needle cell. 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 in triple-class exposed patients having a median PFS of 50.4 months—really raises the bar on the efficacy story.

Speaker #3: So, as any other potential competitor comes to market, that's the bar that they're going to be looking at.

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

Speaker #1: Thank you. Our next question comes from James Shen with DB, your line is open.

James Shin: Hey, good morning. Thank you for the questions. I have two. First one is for Ying and the team. Appreciate the comments on CAR T being under-penetrated and the runway for CARVYKTI meeting its $5 billion or north of $5 billion bogey. There's a lot of discussion on competitive dynamics on clinical profiles amongst CAR Ts. You're talking about poly CAR Ts. Is it feasible for Legend, Kite, and even maybe AstraZeneca down the line to manufacture enough BCMA CAR T to really saturate the market or make one player the dominant? Like, is there a way to make this a zero-sum game? Then secondly, appreciate the comments on biz dev as well.

Speaker #5: Hey, good morning. Thanks for the questions. I have two. First one is for Ying and the team. Appreciate the comments on CAR-T being underpenetrated and the runway for CAR-Victi meeting its $5 billion or north of $5 billion bogey.

Speaker #5: But there's a lot of discussion on competitive dynamics on clinical profiles amongst CAR-Ts. But this is—we're talking about autologous CAR-Ts. Is it feasible for Legend, Kai, and even maybe AstraZeneca down the line to manufacture enough BCMA CAR-T to really saturate the market or make one player the dominant?

Speaker #5: Is there a way to make this a zero-sum game? And then secondly, 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?

James Shin: It sounds like, well, I guess the question 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 also exploring non-viral platforms such as nanocarriers? Thank you.

Speaker #5: Or is it early enough that Legend is also exploring non-viral platforms such as nanocarriers? Thank you.

Ying Huang: 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 treated already more than 10,000 patients, and we think there are still tens of thousands of more patients that will be treated by CARVYKTI. We are on 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? We believe others, including BMS and Gilead, are using similar approaches. Clearly, we all believe that this is a space that is worth investing.

Speaker #2: 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?

Speaker #2: We have been treating already more than 10,000 patients, and we think there's still tens of thousands more patients that will be treated by CAR-Victi.

Speaker #2: So, we are on a 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?

Speaker #2: 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.

Ying Huang: That given, again, the efficacy, we believe that more and more patients will opt for CAR T. 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 lenti. As you know, since the company was founded in 2014, we have been working on lenti vector as a delivery vehicle for CAR T. We have accumulated a lot of experience and expertise on this. Our first couple in vivo CAR T programs in the clinic today are using lenti vector as a delivery for the in vivo CAR T programs in both non-Hodgkin lymphoma and also the multiple myeloma indications respectively.

Speaker #2: 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.

Speaker #2: On your second question about lenti—so as you know, since the company was founded in 2014, we have been working on lenti vector as a delivery vehicle for CAR-T.

Speaker #2: So we have accumulated a lot of this. And our first couple in vivo CAR-T programs in the clinic today are using lenti vector as a delivery for the in vivo CAR-T programs.

Speaker #2: In both knowledge of 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 LMP, encapsulated RNA or DNA.

Ying Huang: 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. 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 lenti vector cannot be used in other indications such as autoimmune diseases as well. We look at the space with a very broad net, and we're very open-minded in terms of you know, potentially partnership or business development activity to bring other technologies here.

Speaker #2: 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 lenti vector cannot be used in other indications, such as autoimmune diseases, as well.

Speaker #2: So we look at the space with very broad net. And we're very open-minded in terms of potentially partnership or business development activity to bring in other technologies here.

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

Speaker #1: Thank you. Our next question comes from—your line is open.

Speaker 15: Hey, guys. Thanks for the question. One for me. With the Iberdomide NDA 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 CARVYKTI? Thanks.

Sean McCutcheon: Hey, guys. Thanks for the question. One for me. With the Iberdomide NDA 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 CARVYKTI? Thanks.

Speaker #4: Hey, guys. Thanks for the question. One for me. With Iberdomide NDA 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 CART2/6?

Speaker #4: Thanks.

Ying Huang: Thanks, Sean, 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? To date, there's no data out there that actually suggests a correlation between the clinical outcomes such as PFS and survival and MRD activity in CAR T modality. We're very much aware of that. In fact, we are probably the trailblazer in this field because we will expect CARTITUDE-5 top-line data in the near future, right? This year or next year.

Speaker #2: Thanks, Sean, for your question. I think you have seen the agency publish recently a draft guidance document for the industry based on MRD as a registration endpoint for accelerated approval in multiple myeloma.

Speaker #2: 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?

Speaker #2: So, to date, there's no data out there that actually suggests a correlation between the clinical outcomes, such as PFS and survival, and MRD inactivity in the CAR-T modality.

Speaker #2: And we're very much aware of that. In fact, we are probably the trailblazer in this field because we will expect CART2/5 top-line data in the near future, right?

Ying Huang: Based on that, we did actually prospectively include some MRD activity in the measurement. We might be the first one actually in front of the FDA to discuss the correlation between MRD activity and a clinical outcome such as PFS and survival in a CAR T trial. Based on that, of course, if FDA agrees, we potentially can accelerate the FDA filing time for CARTITUDE-6, which is the frontline trial that is comparing CARVYKTI head-to-head against a stem cell transplant in the frontline setting. That is how we view this MRD endpoint and how that potentially can accelerate the CARVYKTI entry into the frontline for patients who are eligible for transplant.

Speaker #2: 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 inactivity and a clinical outcome such as PFS and survival in a CAR-T trial.

Speaker #2: And based on that, of course, if FDA agrees, we potentially can accelerate the FDA filing time for CART2/6, which is the frontline trial that is comparing CAR-Victi head-to-head against stem cell transplant in the frontline setting.

Speaker #2: So that is how we view this MRD endpoint and how that potentially can accelerate CAR-Victi entry into the frontline. For patients who are eligible for transplant.

Operator: Thank you. Our next question comes from Ashwani Verma with UBS. Your line is open.

Speaker #1: Thank you. Our next question comes from Ash Verma with UBS, your line is open.

Speaker 16: Yeah. Hi there, guys. This is Natalie on 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 TECVAYLI launch ex US? Our second question is just could you provide the current breakdown of how many CARVYKTI patients are second, and third line? Thanks so much.

Natalie Barron: Yeah. Hi there, guys. This is Natalie on 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 TECVAYLI launch ex US? Our second question is just could you provide the current breakdown of how many CARVYKTI patients are second, and third line? Thanks so much.

Speaker #5: Yeah. Hi there, guys. This is Natalie on 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 Tecdara launch xUS?

Speaker #5: And then our second question is just, could you provide the current breakdown of how many CAR-Victi patients are second and third line? Thanks so much.

Alan Bash: 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. The only other sort of color on that one that we've shared is that 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 TECVAYLI ex-US, I can't speak to the J&J plans there. I would just say that for CARVYKTI, we continue to see significant uptake in the ex-US markets.

Speaker #3: 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.

Speaker #3: 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.

Speaker #3: As far as your question about Tecdara xUS, I can't speak to the J&J plans there. I would just say that for CAR-Victi, we continue to see significant uptake in the xUS markets.

Alan Bash: We are now in 13 markets outside the US. 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. That's because, 1, they've been taking the learnings from the US launches, applying them to patient selection, and management of patients, as well as, you know, 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. There's very strong support ex-US for the CAR T model and CARVYKTI specifically.

Speaker #3: We are now in 13 markets outside the US. 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.

Speaker #3: And that's because, number one, they've been taking the learnings from the US launches and applying them to patient selection and management of patients, as well as the healthcare systems really supporting this concept around a one-time infusion and getting patients from a budget impact into a long-term remission based on a single infusion.

Speaker #3: So there's very strong support xUS for the CAR-T model and CAR-Victi specifically.

Ying Huang: I just want to add to Alan's comment. For example, we only launched CARVYKTI in Spain last year in 2025, but right now you're looking at 70-75% of the use already in second and third line in Spanish market. Clearly there's a very quick uptake in European market for the early line use of CARVYKTI, and I think that positions really well in this early line indication in Europe.

Speaker #2: And also, I just want to add to Alan's comment. For example, we only launched the CAR-Victi in Spain last year, in 2025. But right now, you're looking at 70–75% of the use already in second and third line in Spanish markets.

Speaker #2: So clearly, there's a very quick uptake in European markets for the early line use of CAR-Victi. And I think that position is really well in this early line indication in Europe.

Operator: Thank you. Our next question comes from Leonid Timashev with RBC. Your line is open.

Speaker #1: Thank you. Our next question comes from Leona Timashev with RBC, your line is open.

Speaker 17: Hey, thanks for taking my question. I just want to ask too on the pipeline just in terms of broad strategy. I guess first, you guys have explored allo approaches, gamma delta, NK, in vivo. I guess, how are you thinking about what the winner is going to be? Are you leaning into in vivo? Is that sort of the direction you're going to go in? And then second, you know, you've talked a lot about the importance of long-term data and follow-up, you know, especially as it relates to, you know, CARVYKTI and multiple myeloma.

Leonid Timashev: Hey, thanks for taking my question. I just want to ask too on the pipeline just in terms of broad strategy. I guess first, you guys have explored allo approaches, gamma delta, NK, in vivo. I guess, how are you thinking about what the winner is going to be? Are you leaning into in vivo? Is that sort of the direction you're going to go in? And then second, you know, you've talked a lot about the importance of long-term data and follow-up, you know, especially as it relates to, you know, CARVYKTI and multiple myeloma.

Speaker #3: just going to ask two on the pipeline just in terms of broad strategy. I guess first, you guys have explored allo approaches, gamma delta, NK, in vivo.

Speaker #3: I guess how are you thinking about what the winner is going to be? Are you leaning into in vivo? Is that sort of the direction you're going to go in?

Speaker #3: And then, hey, thanks for taking my question. I'm second. You've talked a lot about the importance of long-term data and follow-up, especially as it relates to CAR-Victi and multiple myeloma.

Speaker 17: As you develop these new programs, in spaces that already have existing CAR T options such as myeloma or lymphoma, I guess, 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.

Leonid Timashev: As you develop these new programs, in spaces that already have existing CAR T options such as myeloma or lymphoma, I guess, 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.

Speaker #3: But as you develop these new programs in spaces that already have existing CAR-T options, such as myeloma or lymphoma, I guess how do you get confident that what you're showing 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?

Speaker #3: Thanks.

Ying Huang: 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 the gamma delta, and then most recently, also NK, as well as our latest entry into the field that is in vivo. 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 in vivo CAR T approach. Because on one hand, 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.

Speaker #4: Good morning, Leo. Thanks for your questions. On your first question, yes, you're right. We have explored the obviously all modalities in the field of CAR-T, including autologous, allogeneic, that includes alpha beta and the thermodality.

Speaker #4: 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 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 interested and also excited about the in and physicians.

Speaker #4: 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.

Ying Huang: Here you're leveraging the patient's own immune cells, therefore, you really don't have to worry about rejection. That is why I think the field is very excited about the promise of in vivo CAR T. 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. 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 longer term clinical outcome.

Speaker #4: 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.

Speaker #4: 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.

Speaker #4: 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 inactivity.

Speaker #4: 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?

Ying Huang: That is how we can measure whether a in vivo CAR T targeted myeloma is effective or not, right? We also look at PK/PD, for example. If you look at the copies of T-cell transduced in circulation, does that match the level we see, for example, in CARVYKTI, in the CAR T program? There are certain metrics we can compare and contrast between our in vivo program in the clinic and also our experience with CARVYKTI in the clinic. On your second question about, you know, the long-term data, I think if you look at lymphoma, right, just taking a page from the Yescarta clinical development program, you know that the 6-month CR, the 6-month complete remission rate is actually quite predictive for longer term outcome.

Speaker #4: We also look at PKBD, for example. If you look at the copies of T-cell transduced in circulation, does that match the level we see, for example, in CAR-Victi in the CAR-T program?

Speaker #4: So there are certain metrics we can compare and contrast between our in vivo program in the clinic and also our experience with CAR-Victi in the clinic.

Speaker #4: On your second question about the long-term data, I think if you look at lymphoma, right, just taking a page from the Yescada clinical development program, you know that the six-month CR, the six-month computer remission rate is actually quite predictive for a longer-term outcome.

Ying Huang: That is something that we track in the clinic as well. 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.

Speaker #4: Again, so that is something that we track in the clinic 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.

Speaker #4: That's how we track the clinical progress.

Operator: Thank you. Our next question comes from Yaron Werber with TD Cowen. Your line is open.

Speaker #1: Thank you. Our next question comes from Yarin Werber with CD Cowan, your line is open.

Speaker 18: Hi, this is Janelle on for Yaron. Thanks for taking our questions. Two from me. One, I know that you have several multicenter trials investigating different strategies to mitigate some of the delayed neurotoxicity events that we see with CARVYKTI, including the CITADEL trial and other trials at Wisconsin and Moffitt. Can you give us a sense of how those are progressing and any early signals you're seeing and when we might see data from that trial or those trials? Secondly, on the in vivo programs, you said that we could see data in 2026. How many patients, how much follow-up would you need to see to share that data at a medical conference? Thanks so much.

Janelle Williams: Hi, this is Janelle on for Yaron. Thanks for taking our questions. Two from me. One, I know that you have several multicenter trials investigating different strategies to mitigate some of the delayed neurotoxicity events that we see with CARVYKTI, including the CITADEL trial and other trials at Wisconsin and Moffitt. Can you give us a sense of how those are progressing and any early signals you're seeing and when we might see data from that trial or those trials? Secondly, on the in vivo programs, you said that we could see data in 2026. How many patients, how much follow-up would you need to see to share that data at a medical conference? Thanks so much.

Speaker #5: Hi. This is Jana on for your own. Thanks for taking our questions. Two from me. One, I remember you have several multicenter trials looking investigating different strategies to mitigate some of the delayed neurotoxicity events that we see with CAR-Victi, including the Citadel trial and other trials at Wisconsin and Moffitt.

Speaker #5: Can you give us a sense of how those are progressing in the early signals you're seeing and when we might see data from that trial or those trials?

Speaker #5: 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?

Speaker #5: Would you need to see—to share that data at a medical conference? Thanks so much.

Ying Huang: The CITADEL study, which is a multicenter study looking at ALC monitoring and then management and treatment approaches, should have data presented some point this year. 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. 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 Talquetamab as a bridging therapy and a larger discussion about the need for bridging therapy, in advance of a reinfusion of manufactured CAR T cells.

Speaker #3: 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.

Speaker #3: And I would also point out that another significant dataset are the datasets 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.

Speaker #3: 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 talketamab as a bridging therapy and a larger discussion about the need for bridging therapy in advance of a reinfusion of manufactured CAR-T cells.

Ying Huang: 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. Surbhi Sidana, as well as the publication from Dr. Mattia D'Agostino and ongoing new studies from Dr. Mattia D'Agostino reinforce this concept that bridging therapy is really helping mitigate some of these concerns. Good morning, Janelle. On your second question, you know, as you know, it is our corporate policy not to comment on abstracts 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.

Speaker #3: And this is important because this is what is actually helping feed both 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. Sadana, 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.

Speaker #4: And good morning, Jana. On your second question, as you know, it is our corporate policy not to comment on abstract until they're officially accepted.

Speaker #4: 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.

Ying Huang: That's the plan. Please, stay tuned.

Speaker #4: That's the plan, so please stay tuned.

Operator: Thank you. Our last question comes from Mitchell Kapoor with H.C. Wainwright & Co. Your line is open.

Speaker #1: Thank you. And our last question comes from Mitchell Kapoor with HC Wainwright. Your line is open.

Speaker 19: 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 transfusible doses produced? Are you making adjustments to patient selection and as you learn more moving into the clinic, or are you kind of expecting that rate to be about the same going forward?

Katie Lutze: 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 transfusible doses produced? Are you making adjustments to patient selection and as you learn more moving into the clinic, or are you kind of expecting that rate to be about the same going forward?

Speaker #5: Hi, good morning. This is Katie Yun 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?

Speaker #5: Are you making adjustments to patient selection in how you as you learn more moving into the clinic? Or are you kind of expecting that rate to be about the same going forward?

Alan Bash: That figure represents our overall capacity to produce doses. Of course, from 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. The 10,000 represents our overall capacity to support the marketplace, and then, there are some adjustments from that number.

Speaker #3: That figure represents our overall capacity to produce doses. Of course, from there, there are some drop-offs. We also account for days of shutdown.

Speaker #3: We account for non-clinical runs. We account for out-of-spec which actually 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.

Speaker #3: And then there are some adjustments from that number.

Speaker 19: Great. Thank you.

Katie Lutze: Great. Thank you.

Speaker #5: Great. Thank you.

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

Q4 2025 Legend Biotech Corp Earnings Call

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