Q1 2026 Legend Biotech Corp Earnings Call

May 12, 2026

Operator: Good day and thank you for standing by. Welcome to the Legend Biotech Q1 2026 Earnings Conference Call. At this time, all participants on listen-only mode. After the speaker presentation, there will be a question-and-answer session. Today's conference is being recorded. I will now hand the conference over to your speaker host for today, Jessie Yeung, Vice President of Finance and Investor and Public Relations. Please go ahead.

Speaker #1: Good day, and thank you for standing by. Welcome to the Legend Biotech first-quarter 2026 earnings conference call. At this time, all participants on the list and only mode.

Speaker #1: After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session, you will need to press star 11 on your telephone.

Speaker #1: You will then hear an automated message advising that your hand is raised. Today's conference is being recorded. I will now hand the conference over to your speaker host for today, Jessie Yeung, Vice President of Investor Relations and Finance.

Speaker #1: Please go ahead.

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 reveal our first-quarter of 2026 performance.

Jessie Yeung: 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 Q1 2026 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 Carlos Santos, the company's Chief Financial Officer. Following the prepared remarks, we will open up the call for Q&A. We also have our President of R&D, Guowei Fang, joining the Q&A session. During today's call, we will be making forward-looking statements, which are subject to risks and uncertainties that may cause our actual results to differ materially from those expressed or implied herein.

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 Cafeti; and Carlos Santos, the company's Chief Financial Officer.

Speaker #2: Following the prepared remarks, we will open up the call for Q&A. We also have our President of R&D, Guangwei Fan, joining the Q&A session.

Speaker #2: During today's call, we will be making forward-looking statements, which are subject to risk and uncertainties that may cause our actual results to defer materially from those expressed or implied herewithin.

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 Investor section 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 Investor session of our company website. In addition, adjusted net loss is a non-IFRS metric. This non-IFRS financial measure is in addition to, and not a substitute for or superior to, measures of financial performance prepared in accordance with IFRS. There are a number of limitations related to the use of this non-IFRS financial measures versus those IFRS equivalents. However, we believe that providing information concerning adjusted net loss and adjusted net loss per share enhances an investor understanding of our financial performance. We use adjusted net loss as a performance metric that guides management in its operation of and planning for the future of the business. In particular, we exclude unrealized gain or loss from foreign exchange rate changes.

Speaker #2: In addition, adjusted net 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 this non-IFRS financial measures. First is that it closes IFRS equivalents. However, we believe that providing information concerning adjusted net loss and adjusted net loss per share enhances an investor's understanding of our financial performance.

Speaker #2: We use adjusted net loss as a performance metric that guides management in its operation of and planning for the future of the business. In particular, we exclude unrealized gain or loss from foreign ign exchange rate changes.

Speaker #2: 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 reconciliations for these measures.

Jessie Yeung: We believe that adjusted net income or loss provide a useful measure of our operating performance from period to period. Our press release includes IFRS to non-IFRS reconciliations for these measures. With that, I will now turn the call over to Ying.

Speaker #2: With that, I will now turn the call over to Ying.

Speaker #3: Hello, everyone. Thank you for joining us today. We began 2026 with strong momentum as we executed commercially and continue to advance our pipeline. Legend is the largest standalone cell therapy company anchored by Carvity, our market-leading and profitable CAR-T therapy for multiple myeloma.

Ying Huang: Hello, everyone. Thank you for joining us today. We began 2026 with strong momentum as we executed commercially and continued to advance our pipeline. Legend is the largest standalone cell therapy company anchored by CARVYKTI, our market-leading and profitable CAR T therapy for multiple myeloma. In parallel, we're working to advance CARVYKTI into the first-line treatment setting to help reach more patients and further broaden its long-term opportunity. Beyond CARVYKTI, we also have a strong pipeline of potentially transformative cell therapies across additional therapeutic areas where curative options remain limited. As this pipeline matures and generates more meaningful clinical data, we're looking forward to presenting some of this data at upcoming medical conferences this year. During Q1 2026, CARVYKTI net trade sales were approximately $597 million, representing 62% growth compared to Q1 2025.

Speaker #3: In parallel, we're working to advance Carvity into the first-line treatment setting to help reach more patients and further broaden its long-term opportunity. Beyond Carvity, we also have a strong pipeline of potentially transformative cell therapies across additional therapeutic areas where curated options remain limited.

Speaker #3: As this pipeline matures and generates more meaningful clinical data, we're looking forward to presenting some of this data at upcoming medical conferences this year.

Speaker #3: During the first quarter of 2026, Carvity net trade sales were approximately $597 million. Representing 62% growth compared to the first quarter of 2025. This was comprised of 36% growth in the US year-over-year and more than 200% growth from ex-US sales.

Ying Huang: This was comprised of 36% growth in the US year over year and more than 200% growth from ex-US sales. This performance reflects strong demand in early line settings, continued global expansion, and consistently best-in-class manufacturing execution. Importantly, the myeloma treatment paradigm continues to shift toward earlier use of CAR T. In a recent social media poll for KOLs conducted by Dr. Ben Derman from University of Chicago, 66% of respondents indicated they would recommend CAR T at first relapse for contemporary myeloma patient followed by D-RVd induction and maintenance, assuming daratumumab resistance. We view this sentiment as further validation that CARVYKTI is increasingly considered a foundational therapy earlier in the disease course. Before transitioning to the pipeline, I want to highlight an important step we announced earlier this month.

Speaker #3: This performance reflects strong demand in early-line settings, continued global expansion, and consistently best-in-class manufacturing execution. Importantly, the myeloma treatment paradigm continues to shift toward earlier use of CAR-T.

Speaker #3: In the recent social media post for KOLs conducted by Dr. Ben Derman from the University of Chicago, 66% of respondents indicated they would recommend CAR-T at first relapse for contemporary myeloma patients followed by DRVD induction and maintenance.

Speaker #3: Assuming daratumumab resistance. We view this sentiment as further validation that Carvity is increasingly considered a foundational therapy earlier in the disease course. Before transitioning to the pipeline, I want to highlight an important step we announced earlier this month.

Speaker #3: We recently engaged six distinguished scientific advisors. Renier Brentjens, Spencer Fisk, Carl Jung, Maximilian Konig, Tony Povarino, and George Shett. Who bring deep expertise across oncology, immunology, and in particular, cell therapy as well as translational research.

Ying Huang: We recently engaged 6 distinguished scientific advisors, Renier Brentjens, Spencer Fisk, Carl June, Maximilian Konig, Tony Bhardwaj, and Geoff Scheidt, who bring deep expertise across oncology, immunology, and in particular cell therapy, as well as translational research. As we broaden our pipeline, we believe their input and advice will help guide critical scientific and clinical decisions and strengthen the rigor behind our long-term R&D strategy. At the top of pipeline, we have some of the larger active CARVYKTI trials. Most importantly, CARTITUDE-5 and CARTITUDE-6 are pivotal phase III studies designed to assess CARVYKTI in frontline multiple myeloma following its label expansion in earlier lines. Turning to our earlier stage pipeline, you're going to start to hear more about these programs as the clinical data starts to mature from our next-generation cell therapy platforms. Our BCMA in vivo program in autoimmune diseases has entered phase I.

Speaker #3: As we broaden our pipeline, we believe their input and advice will help guide critical scientific and clinical decisions and strengthen the rigor behind our long-term R&D strategy.

Speaker #3: At the top of the pipeline, we have some of the larger active Carvity trials, most importantly, CARTUDE 5 and CARTUDE 6 are pivotal phase three studies designed to assess Carvity in frontline, multiple myeloma.

Speaker #3: Following its label expansion in earlier lines, turning to our earlier stage pipeline, you're going to start to hear more about its programs as a clinical data starts to mature from our next-generation cell therapy platforms.

Speaker #3: Our BCMA in vivo program in autoimmune diseases has entered phase one. Beyond BCMA, our GPRC5D in vivo program in multiple myeloma has also entered phase one.

Ying Huang: Beyond BCMA, our GPRC5D in vivo program in multiple myeloma has also entered phase I. In parallel, our other in vivo CAR T programs continue to progress, and we remain on track to report initial data this year in non-Hodgkin's lymphoma. We continue to expect to file one to two US INDs in 2026 and are excited by the differentiated potential of our approach. Financially, our strong balance sheet provides us with flexibility to invest in our priorities while maintaining a clear focus on profitability. We believe this combination of commercial leadership, pipeline innovation, and financial discipline positions Legend well to deliver durable value for patients and shareholders over the long term. With that, I will turn the call over to Alan.

Speaker #3: In parallel, our other in vivo CAR-T programs continue to progress, and we remain on track to report initial data this year in non-Hodgkin's lymphoma.

Speaker #3: We continue to expect to file one, two—two US INDs in 2026 and are excited by the differentiated potential of our approach. Financially, our strong balance sheet provides us with flexibility to invest in our priorities while maintaining a clear focus on profitability.

Speaker #3: We believe this combination of commercial leadership, pipeline innovation, and financial discipline positions Legend well to deliver durable value for patients and shareholders over the long term.

Speaker #3: With that, I will turn the call over to Alan.

Speaker #1: Thank you, Ying. I'll start with a high-level view of Carvity's commercial performance and then spend time on what's driving growth beneath the surface. In Q1, Carvity delivered another quarter of sequential growth, reflecting continued share gains, strong site productivity, and increasing penetration in earlier lines of therapy.

Alan Bash: Thank you, Ying. I'll start with a high-level view of CARVYKTI's commercial performance and then spend time on what's driving growth beneath the surface. In Q1, CARVYKTI delivered another quarter of sequential growth, reflecting continued share gains, strong site productivity, and increasing penetration in earlier lines of therapy. Demand remained healthy across all major geographies, supported by our expanding global footprint and consistently reliable manufacturing execution. CARVYKTI net trade sales in Q1 were approximately $597 million, representing 8% sequential growth from Q4 2025. In the US, growth was driven primarily by increased utilization in earlier line settings, continued activation of new authorized treatment centers, and steady throughput at existing sites.

Speaker #1: Demand remained healthy across all major geographies, supported by our expanding global footprint and consistently reliable manufacturing execution. Carvity net trade sales in the first quarter were approximately $597 million, representing 8% sequential growth from Q4 2025.

Speaker #1: In the US, growth was driven primarily by increased utilization in earlier line settings, continued activation of new authorized treatment centers, and steady throughput at existing sites.

Speaker #1: Outside the US, demand was supported by continued uptake in established European markets and contributions from recent launches with Carvity now available across 18 global markets and more than 300 global treatment sites.

Alan Bash: Outside the US, demand was supported by continued uptake in established European markets and contributions from recent launches, with CARVYKTI now available across 18 global markets and more than 300 global treatment sites. As expected, international growth continues to scale as site experience, manufacturing slots, and referral patterns mature. Turning to the next slide, we want to highlight how we are accelerating growth through our manufacturing optimization and earlier line momentum. From a manufacturing standpoint, we continue to optimize. This past quarter, we achieved a 99% manufacturing success rate and a median turnaround time of approximately 29 days with delivering more than 95% on-time order releases for final product delivery. We believe these metrics are a testament to our commitment to broadening adoption, particularly as physicians move CAR T earlier in the treatment paradigm.

Speaker #1: As expected, international growth continues to scale as site experience, manufacturing slots, and referral patterns mature. Turning to the next slide, we want to highlight how we are accelerating growth through our manufacturing optimization and earlier line momentum.

Speaker #1: From a manufacturing standpoint, we continue to optimize. This past quarter, we achieved a 99% manufacturing success rate and a median turnaround time of approximately 29 days with delivering more than 95% on-time order releases for final product delivery.

Speaker #1: We believe these metrics are a testament to our commitment to broadening adoption, particularly as physicians move CAR-T earlier in the treatment paradigm. Now, importantly, although we do not intend to break this out every quarter, since we think about our business on a longer-term basis, we wanted to provide a glimpse of the traction made in earlier line settings in the US where nearly 80% of patients are treated in the community setting.

Alan Bash: Importantly, although we do not intend to break this out every quarter since we think about our business on a longer-term basis, we wanted to provide a glimpse of the traction made in earlier line settings in the US where nearly 80% of patients are treated in the community setting. As you can see on the far right-hand part of the slide in the color teal, patients in second-line and third-line represented 41% of CARVYKTI apheresis volume in the US in Q1 2026 compared to 29% in the same period a year ago. This trend reflects growing physician confidence in CARVYKTI's benefit risk profile earlier in the disease course and our ability to reliably support that shift at scale.

Speaker #1: As you can see on the far right-hand part of the slide, in the color teal, patients in second line and third line represented 41% of Carvity apheresis volume in the US in the first quarter of 2026 compared to 29% in the same period a year ago.

Speaker #1: This trend reflects growing physician confidence in Carvity's benefit-risk profile earlier in the disease course and our ability to reliably support that shift at scale.

Speaker #1: We expect this trend to continue and be a major driver of future growth, especially as we advance towards a potential label expansion into the first-line setting.

Alan Bash: We expect this trend to continue and be a major driver of future growth, especially as we advance towards a potential label expansion into the first-line setting. With that, I will turn the call over to Carlos to walk through our financial performance.

Speaker #1: With that, I will turn the call over to Carlos to walk through our financial performance.

Speaker #3: Thank you, Alan, and good morning, everyone. I'm pleased to walk you through our financial performance, which reflects an important quarter of commercial growth and disciplined investment.

Carlos Santos: Thank you, Alan. Good morning, everyone. I'm pleased to walk you through our financial performance, which reflects an important quarter of commercial growth and disciplined investment. Turning to the next slide, this chart highlights our progress towards profitability. As you can see, revenue has continued to scale, driven by CARVYKTI performance, and profitability metrics have improved steadily over time. We anticipate company-wide profitability on an adjusted basis in 2026 and expect continued margin improvements from our ongoing expense discipline. Regarding Q1, the next slide illustrates how revenue growth is translating into operating leverage. Collaboration revenue was approximately $298 million in Q1, primarily driven by CARVYKTI net trade sales under our collaboration with Johnson & Johnson. License and other revenue was approximately $7 million, resulting in total revenue of $305 million for the quarter.

Speaker #3: Turning to the next slide, this chart highlights our progress towards profitability. As you can see, revenue has continued to scale, driven by Carvity performance, and profitability metrics have improved steadily over time.

Speaker #3: We anticipate company-wide profitability on an adjusted basis in 2026 and expect continued margin improvements from our ongoing expense discipline. Regarding Q1, the next slide illustrates how revenue growth is translating into operating leverage.

Speaker #3: Collaboration revenue was approximately $298 million in the first quarter. Primarily driven by Carvity net trade sales under our collaboration with Johnson & Johnson. License and other revenue was approximately $7 million resulting in total revenue of $305 million for the quarter.

Speaker #3: Gross margin on net product sales was 41%. The decline from the fourth quarter at 57% was primarily due to one-time expenses associated with ramping up manufacturing in the newly expanded section of our Raritan site, and the ongoing tech lane facility ramp.

Carlos Santos: Gross margin on net product sales was 41%. The decline from the Q4 at 57% was primarily due to one-time expenses associated with ramping up manufacturing in the newly expanded section of our Raritan site and the ongoing Tech Lane facility ramp. Looking ahead to the Q2, we expect gross margin to be back over 50% as the economies of scale from our manufacturing investment are realized with increasing utilization. Research and development expense was $86 million, reflecting continued investment in our in vivo CAR T platform and next generation programs. As the phase III CARTITUDE-5 and CARTITUDE-6 studies for CARVYKTI mature, we expect a substantial decline in the associated R&D expenses.

Speaker #3: Looking ahead to the second quarter, we expect gross margin to be back over 50%. As the economies of scale from our manufacturing investment are realized with increasing utilization.

Speaker #3: Research and development expense was $86 million. Reflecting continued investment in our in vivo CAR-T platform and next-generation programs. As the phase three CAR-Titude V and VI studies for Carvity mature, we expect a substantial decline in the associated R&D expenses.

Speaker #3: This allows an increasing proportion of the R&D budget to be reinvested into the pipeline as we leverage the benefit of Carvity profitability to fund the future growth of Legend, that will come from the promising in vivo programs and extensive earlier stage pipeline that Ying showed earlier.

Carlos Santos: This allows an increasing proportion of the R&D budget to be reinvested into the pipeline as we leverage the benefit of CARVYKTI profitability to fund the future growth of Legend Biotech that will come from the promising in vivo programs and extensive earlier stage pipeline that Ying Huang showed earlier. SG&A expense was $90 million, driven by targeted commercial investments supporting CARVYKTI growth. Operating loss narrowed compared to the prior year, with an adjusted net loss of $11 million in Q1. We feel very comfortable in maintaining our projection for achieving company-wide profitability on an adjusted basis in 2026. On a non-IFRS basis, this represents $0.03 per diluted share, compared with an adjusted net loss of $27 million or $0.07 per diluted share in the same period last year.

Speaker #3: As DNA expense was $90 million, driven by targeted commercial investment supporting Carvity growth. Operating loss narrowed compared to the prior year. With an adjusted net loss of $11 million in Q1.

Speaker #3: We feel very comfortable in maintaining our projection for achieving company-wide profitability on an adjusted basis in 2026. On a non-IFRS basis, this represents $0.03 per diluted share, compared with an adjusted net loss of $27 million, or $0.07 per diluted share, in the same period last year.

Speaker #3: Turning to the next slide, we ended the quarter with approximately $835 million in cash, cash equivalents, and time deposits, and no long-term debt. We believe this strong balance sheet provides us with flexibility to advance our in vivo CAR-T pipeline, support continued Carvykti profitability expansion, pursue focused business development opportunities, and fund modest capital expenditures tied to manufacturing capacity.

Carlos Santos: Turning to the next slide, we ended the quarter with approximately $835 million in cash equivalents, and time deposits, and no long-term debt. We believe this strong balance sheet provides us with flexibility to advance our in vivo CAR T pipeline, support continued CARVYKTI profitability expansion, pursue focused business development opportunities, and fund modest capital expenditures tied to manufacturing capacity. Based on our recent progress, we remain confident in our company-wide profitability trajectory as we continue to invest prudently in long-term growth. In summary, Q1 reflects a business that is scaling efficiently, generating increasing operating leverage, and approaching sustained profitability. With that, we're happy to take your questions.

Speaker #3: Based on our recent progress, we remain confident in our company-wide profitability trajectory as we continue to invest prudently in long-term growth. In summary, the first quarter reflects a business that is scaling efficiently generating increasing operating leverage and approaching sustained profitability.

Speaker #3: With that, we're happy to take your questions.

Speaker #1: Thank you, Lisa and gentlemen. Do I have a question at this time? You will need to press star 11 on your telephone keypad and wait for your name to be announced.

Operator: Thank you. Ladies and gentlemen, to ask a question at this time, you will need to press star one one on your telephone keypad and wait for your name to be announced. To withdraw your question, simply press star one one again. Please stand by while we compile the Q&A roster. First question coming from the line of Terence Flynn with Morgan Stanley. Your line is now open.

Speaker #1: So, we draw your question. Simply press *11 again. Please stand by while we compile the Q&A roster. Now, first question, coming from the line of Terrence Lynn with Morgan Stanley. Alan, line is now open.

Terence Flynn: Great. Thanks so much for taking the question. Obviously, there's a growing focus on in vivo programs, platforms. Maybe, Ying, you could give us a little bit of update in terms of how much data we should expect from your lymphoma program and any more specifics on timing. Is EHA a possibility or is it more likely ASH? Then how are you thinking about durability and what will we learn from this first data set with respect to that question? Thank you.

Speaker #4: Great, thanks so much for taking the question. Obviously, there's a growing focus on in vivo programs and platforms. Maybe, Ying, you could give us a little bit of an update in terms of how much data we should expect from your lymphoma program, and any more specifics on timing—is EHA a possibility?

Speaker #4: Is there more likely ASH? And then how are you thinking about durability and what will we learn from this first data set with respect to that question?

Speaker #4: Thank you.

Speaker #5: Good morning, Terrence. Thank you for that question. So as typical without disclosure practice, we cannot really comment on the data without the abstract being officially accepted and also published by the major medical meeting.

Ying Huang: Morning, Terence. Thank you for that question. As typical with our disclosure practice, we cannot really comment on the data without the abstract being officially accepted and also published by the major medical meeting. The only thing I can confirm is that we are planning to potentially present this data set for the first time in patients with non-Hodgkin's lymphoma at a major medical meeting around mid-year. That's the only thing I can confirm right now. In terms of, you know, durability, I guess it's really depending on how many patients and how much follow-up we have. In general, because this is the first disclosure for our clinical data here, I wouldn't expect a very, very long follow-up. We do expect a reasonable number of patients in this first disclosure.

Speaker #5: The only thing I can confirm is that we are planning to potentially present this data set for the first time in patients with non-Hodgkin's lymphoma at a major medical meeting around mid-year.

Speaker #5: So that's the only thing I can confirm right now. In terms of durability, I guess it's really depending on how many patients and how much follow-up we have.

Speaker #5: But in general, because this is the first disclosure for our clinical data here. So I wouldn't expect a very, very long follow-up. But we do expect a reasonable number of patients in this first disclosure.

Ying Huang: I hope that answers your question, Terence.

Speaker #5: I hope that answers your question, Terrence.

Ying Huang: I hope that answers your question, Terence.

Speaker #1: Thank you. And our next question coming from the line of Umar Assad with EverQuest. Hi, Alan is now open.

Operator: Thank you. Our next question coming from the line of Umer Raffat with Evercore ISI. Your line is now open.

Speaker #6: Hi, guys. Thanks for taking my question. I wanted to touch up on this in vivo CAR-T theme in a little more detail.

Umer Raffat: Hi, guys. Thanks for taking my question. I wanted to touch up on this in vivo CAR T theme in a little more detail, perhaps. Maybe for everyone listening in, Ying, because this is a new theme popping up beyond CARVYKTI, beyond our CellX, could you just remind everyone, first of all, that the CD19/CD20 CAR T you have is not the gamma delta, which is allo. We're talking about in vivo, A, if you could just clarify that. B, the name of the program, like the number.

Speaker #6: Perhaps. And maybe for everyone listening in, Ying, because this is a new theme popping up beyond Carvity beyond ourselves, could you just remind everyone, first of all, that the CD19, CD20 CAR-T you have is not the gamma delta, which is allo.

Speaker #6: We're talking about in vivo. A, if you could just clarify that. B, the name of the program, like the number. And number three—and I acknowledge you can't say if it'll be at EHA or not, and the scope of the data—but could you just give us a sense for what the trial design is that's being run? And should we expect efficacy data as well, or should the data disclosure only be limited to whether you dosed it and they developed CAR-T, and then what the safety looked like?

Umer Raffat: Number 3, I acknowledge you can't say if it'll be at EHA or not, and the scope of the data, but could you just give us a sense for what the trial design is that's being run? Should we expect efficacy data as well, or should the data disclosure only be limited to whether you dosed it and they developed CAR T, and then what the safety looked like? Should there be some early efficacy as well? Thank you.

Speaker #6: Or should there be some early efficacy as well? Thank you.

Speaker #5: Umar, thanks for the question. I will answer the first two parts and then I'll ask my colleague Huawei, President of R&D, to answer the third question regarding the design and everything else.

Ying Huang: Umer, thanks for your question. I'll answer the first two parts, and then I'll ask my colleague, Guowei, President of R&D, to answer the third question regarding the design and everything else. First of all, yes, we can confirm that this is not the gamma delta T program. This is actually in vivo CAR T targeting CD19 and CD20, using a lentiviral vector delivery. That's first. Secondly, I can confirm that the internal code name we use for this program is LB2501. This program is already up on ClinicalTrials.gov, if you want to search for the details on the protocol and the enrollment. On the third question, I'll ask Guowei to answer.

Speaker #5: So first of all, yes, we can confirm that this is not the gamma delta T program. This is actually in vivo CAR-T targeting CD19 and CD20.

Speaker #5: Using a lentiviral vector delivered. So that's first. Secondly, I can confirm that the internal code name we use for this program is LB2501. And this program is already up on ClinicalTrust.gov.

Speaker #5: If you want to search for the details on the protocol and the enrollment. And on the third question, I'll ask Huawei to answer.

Speaker #6: Yeah. In terms of the clinical data to be released, the trial was initiated last year. We do expect to release both safety and efficacy data.

Guowei Fang: Yeah. In terms of the clinical data to be released, the trial was initiated last year. We do expect to release both safety and efficacy data. We have to wait and share the data presentation to really disclose the specific information. In terms of our internal expectation, our expectation for in vivo program is to have manageable safety and promising efficacy, including deep response. That's our expectation.

Speaker #6: We have to wait and cheer the data presentation to really disclose the specific information. But in terms of our internal expectation, our expectation for the in vivo program is to have manageable safety and promising efficacy, including deep response.

Speaker #6: That's our expectation. Thank you very much.

Umer Raffat: Thank you very much.

Speaker #1: Thank you. Now, our next question coming from the line of Jessica Fai with JPMorgan. Alan is now open.

Operator: Thank you. Next question coming from the line of Jessica Fye with JPMorgan. Your line is now open.

Speaker #7: Hey guys, good morning. Thanks for taking my question. A couple on the existing business. First, appreciate the additional detail on the breakdown of Carvity used across lines of therapy.

Jessica Fye [Managing Director, Equity Research Analyst: Hey, guys. Good morning. Thanks for taking my questions. A couple on kind of the existing business. First, you know, appreciate the additional detail on the breakdown of CARVYKTI used across lines of therapy. If we look out another year or two, what do you think that pie chart mix will look like? Second, just on the higher COGS this quarter, how much of that, about $100 million year-over-year increase was one-time versus sort of ongoing? Thank you.

Jessica Fye: Hey, guys. Good morning. Thanks for taking my questions. A couple on kind of the existing business. First, you know, appreciate the additional detail on the breakdown of CARVYKTI used across lines of therapy. If we look out another year or two, what do you think that pie chart mix will look like? Second, just on the higher COGS this quarter, how much of that, about $100 million year-over-year increase was one-time versus sort of ongoing? Thank you.

Speaker #7: If we look at another year or two, what do you think that pie chart mix will look like? And then second, just on the higher COGS this quarter, how much of that about 100 million year-over-year increase was one-time versus sort of ongoing?

Speaker #7: Thank you.

Speaker #6: Hi, it's Alan. Thanks for the question. So in terms of our business mix, we're very pleased to show the data that reflects the fact that in earlier lines, specifically in second and third line, we have about 41% of our patients coming through those lines.

Alan Bash: Hi, it's Alan. Thanks for the question. In terms of our business mix, we're very pleased to show the data that reflects the fact that in earlier lines, specifically in second and 3rd line, we have about 41% of our patients coming through those lines. I think that's important for a couple of reasons. One is it does speak to the fact that we're getting community adoption because those earlier patients start in the community and are getting referred into the authorized treatment centers. It also speaks to the fact that our clinical data is resonating with the earlier is better data, both for efficacy, safety, and manufacturing, all, you know, based on the data that we shared at ASH and previous conferences, that earlier is better.

Speaker #6: And I think that's important for a couple of reasons. One is, it does speak to the fact that we're getting community adoption, because those earlier patients start in the community and are getting referred into the authorized treatment centers.

Speaker #6: It also speaks to the fact that our clinical data is resonating with the early. There is better data both for efficacy safety and manufacturing all based on the data that we shared at ASH in previous conferences that earlier is better.

Alan Bash: I think it also sets us up well from a competitive standpoint to make sure we are penetrating the 2nd and 3rd line businesses in the face of whether it's bispecifics or potential future BCMA CAR T competition. To answer your question, we've also shown progression in the overall 2nd through 4th line at about 2/3 of our business, and we do expect that that will continue to grow, probably to about 3/4 of our business is where we would anticipate that emerging over the next year or so. All segments continue to grow, and we're very excited by the penetration in the earlier lines.

Speaker #6: And I think it also sets us up well from a competitive standpoint to make sure we are penetrating the second and third line businesses in the face of whether it's bispecifics or potential future BCMA CAR-T competition.

Speaker #6: To answer your question, we've also shown progression in the overall second through fourth line. At about two-thirds of our business, and we do expect that that will continue to grow.

Speaker #6: Probably to about three-quarters of our business is where we would anticipate that emerging over the next year or so. So all segments continue to grow, and we're very excited by the penetration in earlier lines.

Carlos Santos: Related to the gross margin question, we did see a sequential decline in Q1 since we brought new capacity into our network, specifically to our Raritan site. This, together with one-time expenses associated with the expansion, resulted in this one-time impact to gross margin. However, we do expect that gross margins will return to over 50% in Q2.

Speaker #8: Related to the gross margin question, we did see a sequential decline in the first quarter. Since we brought new capacity into our network, specifically to our raritant site.

Speaker #8: And this together with one-time expenses associated with the expansion resulted in this one-time impact to gross margin. However, we do expect that gross margins will return to over 50% in Q2.

Jessica Fye [Managing Director, Equity Research Analyst: Can you quantify the one-time impact a little more?

Jessica Fye: Can you quantify the one-time impact a little more?

Speaker #7: Can you quantify the one-time impact a little more?

Carlos Santos: We do not disclose those particulars.

Speaker #8: We do not disclose those particulars.

Jessica Fye [Managing Director, Equity Research Analyst: Thank you.

Jessica Fye: Thank you.

Speaker #7: Okay. Thank you.

Ying Huang: Jess, this is Yi. I just want to add that you heard from Carlos that we fully expect the gross margin to recover to prior level in the second and also the ensuing quarters for the year.

Speaker #5: Jess, this is Dean. I just wanted to add that you heard from Carlos that we fully expect the gross margin to recover to prior level in the second and also the ensuing quarters of the year, so.

Jessica Fye [Managing Director, Equity Research Analyst: Thanks.

Jessica Fye: Thanks.

Speaker #7: Thanks.

Operator: Thank you. Now next question coming from the line of Kostas Biliouris with Oppenheimer. Your line is now open.

Speaker #1: Thank you. Now, our next question is coming from the line of Costas Bayers with Oppenheimer. Alan, you are now open.

Kostas Biliouris: Thanks for taking our question. Congrats on the progress. Maybe a couple of quick questions from us. One on the commercial side, do you see any meaningful impact after TECVAYLI approval in the second line now, perhaps on any particular segments of patients or any particular geographies? The second one on the in vivo CAR T, can you help us understand what the benchmarking is there? Some investors are trying to compare your upcoming data to other ex vivo CAR T therapies in NHL. Some other investors are looking to benchmark it to in vivo CAR T from multiple myeloma. Any thoughts on where the benchmarking is in your view would be helpful. Thank you.

Speaker #6: Thanks for taking our question. Congrats on the progress. Maybe a couple of quick questions from us. One on the commercial side: Do you see any meaningful impact after the Tech Data approval in the second line now, perhaps on any particular segment of patients or any particular geographies?

Speaker #6: And the second one on the in vivo CAR-T. Can you help us understand what the benchmarking is there? Some investors are trying to compare your upcoming data to other ex vivo CAR-T therapies in NHL.

Speaker #6: Some other investors are looking to benchmark it to in vivo CAR-T from multiple myeloma. Any thoughts on where the benchmarking is in your view would be helpful?

Speaker #6: Thank you. Our business continues to grow, and as you saw from our report today, it continues to grow, particularly in the earlier lines. So in terms of competition from TechDara or the presence of bispecifics, I'll remind you that this is a large market in second through fourth line, about 100,000 patients, only about 5% have seen a BCMA.

Alan Bash: Our business continues to grow, and as you saw from our report today, it continues to grow particularly in the earlier lines. In terms of competition from TECVAYLI or the presence of bispecifics, I'll remind you that this is a large market in 2nd through 4th line, about 100,000 patients. Only about 5% have seen a BCMA, there's significant growth potential for multiple options in the earlier lines. I think that's also reflected by the IQVIA data that you see. While other products are growing, CARVYKTI has also shown healthy growth as well. Through potential competition with bispecifics, I think this is a large market that's severely underserved and under-penetrated, and that portends well for the opportunity for CARVYKTI.

Speaker #6: And so there's significant growth potential for multiple options in the earlier lines. And I think that's also reflected by the IQVIA data that you see.

Speaker #6: While other products are growing, Carvyti has also shown healthy growth as well. So, through potential competition with bispecifics, I think this is a large market that's severely underserved and underpenetrated, and that portends well for the opportunity for Carvyti.

Guowei Fang: For the second question in term of a benchmark for in vivo CAR T program, all these program is CD19/CD20 dual targeting in vivo CAR T program targeted for non-Hodgkin lymphoma patients. Our current thinking is that we are expecting, or we are looking for deep and durable response, and therefore, the benchmark would expected to align with that type of efficacy response. Currently that's still early, and we are accumulating more data.

Speaker #7: So for the second question, in terms of a benchmark for in vivo CAR-T program, are these programs CD19, CD20 due targeting in vivo CAR-T program?

Speaker #7: Targeted for non-Hodgkin lymphoma patients. Our current thinking is that we are expecting or we are looking for deep and durable response and therefore the benchmark would expect it to align with that type of efficacy response.

Speaker #7: Clinical data is still early, and we are accumulating more data.

Kostas Biliouris: If I can add a follow-up here. If you see these type of responses in NHL, deep responses, as you call it, would that translate to multiple myeloma, to some extent as well for the in vivo CAR T platform? Thank you.

Speaker #6: And if I can add a follow-up here, if you see these type of responses in NHL, deep responses, as you call it, would that translate to multiple myeloma to some extent as well for the in vivo CAR-T platform?

Speaker #6: Thank you.

Guowei Fang: Excellent question. Yeah, we do think that the in vivo CAR T platform has the transformative potential by moving all the cell engineering and the cell expansion into the body of patients, therefore generate a better cell fitness. Therefore, that could translate into even better clinical response. That's our expectation across different disease areas. Thank you.

Speaker #7: Excellent question. Yeah. We do think that the in vivo CAR-T platform has transformative potential by moving the all-cell engineering and the cell expansion into the body of patients.

Speaker #7: Therefore, generate better cell fitness. And therefore, that could translate into even better clinical response. That's our expectation. Across different disease areas. Thank you.

Operator: Thank you. Our next question coming from the line of Gena Wang with Barclays. Your line is now open.

Speaker #1: Thank you. Now, our next question coming from the line of etcetera with Barclays. Alan is now open.

Gena Wang: Great. Thanks for taking the question. Congrats on the quarter. A couple of questions, maybe on the CAR T side, if you could maybe provide any updates, new updates on the timing for CARTITUDE-5 or 6. On the pipeline, just wondered if you could maybe talk about the scope of the BCMA trial that you're initiating with the in vivo CAR T, I think LB2505. Maybe if you can comment on the scope and then the trial design there. Thank you.

[Analyst] (Barclays): Great. Thanks for taking the question. Congrats on the quarter. A couple of questions, maybe on the CAR T side, if you could maybe provide any updates, new updates on the timing for CARTITUDE-5 or 6. On the pipeline, just wondered if you could maybe talk about the scope of the BCMA trial that you're initiating with the in vivo CAR T, I think LB2505. Maybe if you can comment on the scope and then the trial design there. Thank you.

Speaker #9: Great. Thanks for taking the question. Congrats on the quarter. A couple of questions, maybe on the Carvity side. If you could maybe provide any updates, new updates on the timing for Carvity 5 or 6, and then on the pipeline, just wondered if you could maybe talk about the scope of the BCMA trial that you're initiating with the in vivo CAR-T.

Speaker #9: I think, LB2505—maybe if you can comment on the scope and then the trial design there. Thank you.

Alan Bash: Yeah, CAR T 5 and CAR T 6 are fully enrolled. These are event-driven. We don't have an update here on the timing, and we'll continue to monitor in terms of how the events accrue.

Speaker #6: Yeah, CAR-5 and CAR-6 are fully enrolled. But these are event-driven, so we don't have an update here on the timing, and we'll continue to monitor in terms of how the events accrue.

Guowei Fang: For the in vivo CAR T program, we are excited about our platform and product. We are exploring this product platform across different diseases. Multiple myeloma is an important disease area. BCMA certainly is a top target within the multiple myeloma disease space. Our partnership with Johnson & Johnson cover all and any BCMA-directed cell therapy in multiple myeloma that both company are working on. Therefore, at this point, there's nothing more we can share.

Speaker #7: So for the in vivo CAR-T program, we are excited about our platform and product. We are exploring this platform across different diseases. Multiple myeloma is an important disease area.

Speaker #7: BCMA certainly is a top target within the multiple myeloma diseases space. Our partnership with Johnson & Johnson covers all and any BCMA-directed cell therapy in multiple myeloma.

Speaker #7: They're both companies are working on. And therefore, at this point, there's nothing more we can share.

Carlos Santos: Gena, this is Ying. I also want to add that we are initiating another trial for the same construct, LB2505, targeting BCMA, and this will be in autoimmune diseases. You will learn in the near future about that program once we include that in ClinicalTrials.gov.

Ying Huang: Gena, this is Ying. I also want to add that we are initiating another trial for the same construct, LB2505, targeting BCMA, and this will be in autoimmune diseases. You will learn in the near future about that program once we include that in ClinicalTrials.gov.

Speaker #5: Peter, this is Dean. I also want to add that we are initiating another trial for the same construct, LB2505, targeting BCMA. And this will be in autoimmune diseases.

Speaker #5: And you will learn in the near future about that program once we include that in clinicaltrials.gov.

Gena Wang: Great. Thank you.

[Analyst] (Barclays): Great. Thank you.

Speaker #9: Great. Thank you.

Operator: Thank you. Our next question coming from the line of Yaron Werber with Canaccord Genuity. Your line is now open.

Speaker #1: Thank you. Our next question is coming from the line of Eric Smith with Cantor Fitzgerald. Alan, the line is now open.

Yaron Werber: Thanks for taking my question. Maybe just a quick follow-up on the CARTITUDE-5 event rate. I think at one point we had expected it would be possible to have data toward the end of this year. Is that still the case, Alan? A financial question on the adjusted net income guidance for profitability in 2026. The adjustments in Q1 are about $40 million, $44 million to net income. Is that sort of a non-GAAP adjustment that we'll see on an ongoing basis? I guess I'm looking for some help on the differential between adjusted and GAAP financials. Thank you.

[Analyst] (Cantor Fitzgerald): Thanks for taking my question. Maybe just a quick follow-up on the CARTITUDE-5 event rate. I think at one point we had expected it would be possible to have data toward the end of this year. Is that still the case, Alan? A financial question on the adjusted net income guidance for profitability in 2026. The adjustments in Q1 are about $40 million, $44 million to net income. Is that sort of a non-GAAP adjustment that we'll see on an ongoing basis? I guess I'm looking for some help on the differential between adjusted and GAAP financials. Thank you.

Speaker #10: Thanks for taking my question. Maybe just a quick follow-up on the CARTitude 5 event rate. I think at one point we had expected it would be possible to have data toward the end of this year.

Speaker #10: Is that still the case, Alan? And then a financial question on the adjusted net income guidance for profitability in 2026. The adjustments in Q1 are about 44 million dollars to net income.

Speaker #10: Is that sort of a non-GAAP adjustment that we'll see on an ongoing basis? I guess I'm looking for some help on the differential between adjusted and GAAP financials.

Speaker #10: Thank you.

Alan Bash: On CARTITUDE-5, Yaron, we would plan to see data at some point in either 2026 or 2027. Again, this is event-driven, so it's really reflective of how the events accrue.

Speaker #6: On CARTitude 5, Eric, we would plan to see data at some point in either '26 or '27. Again, this is event-driven, so it's really reflective of how the events accrue.

Carlos Santos: Yes. On the adjusted net income, as we approach profitability, we wanted to be more specific with our definition. As we mentioned when we introduced the non-IFRS reconciliation last year, we view adjusted net income as a more accurate reflection of profitability and our financial performance since it excludes certain non-cash items that are not representative of our core business operations. This is aligned with the way most of the industry reports, and it will also allow better comparison both with peers and consistently year-over-year.

Speaker #5: Yes. So, on the adjusted net income, as we approach profitability, we wanted to be more specific with our definition. And as we mentioned when we introduced these non-IFRS reconciliations last year, we view adjusted net income as a more accurate reflection of profitability and our financial performance.

Speaker #5: Since it excludes certain non-cash items, these are not representative of our core business operations. And this is aligned with the way most of the industry reports, and it will also allow better comparison both with peers and consistently year over year.

Yaron Werber: Okay, I understand why you're doing it. Is the $44 million differential between the two metrics, something that might exist on an ongoing basis?

[Analyst] (Cantor Fitzgerald): Okay, I understand why you're doing it. Is the $44 million differential between the two metrics, something that might exist on an ongoing basis?

Speaker #10: Okay. I understand why you're doing it. Is the $44 million differential between the two metrics something that might exist on an ongoing basis?

Carlos Santos: Yeah. As I mentioned, we do exclude the certain non-cash items. This would be primarily share-based compensation, depreciation, amortization, and impairments, and foreign exchange.

Speaker #6: Yeah, so as I mentioned, we do exclude these certain non-cash items. So this would be primarily share-based compensation, depreciation, amortization and impairments, and foreign exchange.

Yaron Werber: Thank you.

Speaker #10: Thank you.

Operator: Thank you. Our next question coming from the line of James Shin with Deutsche Bank. Your line is now open.

Speaker #1: Thank you. Our next question coming from the line of James Shen with Deutsche Bank. Alan is now open.

James Shin: Good morning. Thank you for the questions. Circling back to the pipeline, there's three autologous and one in vivo variant for the GPRC5Ds. Are these GPRC5D binders consistent across all the variants, or are the FasTCAR variants using a different manufacturing process and therefore have different binders? Just following up on the one-time cost of collaboration question.

Speaker #11: Good morning. Thank you for the questions. Circling back to the pipeline, there are three autologous and one in vivo variant for the GPRC5Ds. Are these GPRC5D binders consistent across all the variants?

Speaker #11: Or are the fast CAR variants using a different manufacturing process and therefore have different binders? And then just following up on the one-time cost of collaboration question, if you exclude this one-time charge, would Q1 ’26 have been profitable on an adjusted basis?

James Shin: If you exclude this one-time charge, would Q2 2026 been profitable on an adjusted basis? Thank you.

Speaker #11: Thank you.

Ying Huang: On the GPRC5D front, all our toxic program use the same binder. I've tried to validate the binder as well as try to understand how the patient responds using different design of the CAR T molecule.

Speaker #7: On the GPRC5D front, all autologous programs use the same binder. We are testing this. I've tried to validate the binder as well as try to understand how the patient responds using different designs of the CAR-T molecule.

Carlos Santos: Yes, on the one-time charge, question, the answer is yes. If we wouldn't have had that one-time charge, we would have been profitable on an adjusted income, basis.

Speaker #6: Yes. And on the one-time charge, question, the answer is yes. If we wouldn't have had that one-time charge, we would have been profitable on an adjusted income basis.

Operator: Thank you. Our next question coming from the line of Leonid Timashev with RBC Capital. Your line is now open.

Speaker #1: Thank you. Our next question coming from the line of Leonid Tymshev with RBC Capital. Alan is now open.

Leonid Timashev: Hey, guys. Thanks for taking my question. I wanted to ask on community adoption. I think before you've talked about how you've onboarded Virginia Oncology, Tennessee Oncology. I guess how's uptake looking in those centers? I guess I'm specifically curious about, you know, actual use of CAR T in those centers, not necessarily referrals and sort of what the plan and cadences of adding additional community centers that can actually administer the CAR T. Thanks.

Speaker #11: Hey, guys. Thanks for taking my question. I wanted to ask on community adoption. I think before you've talked about how you've onboarded Virginia Oncology, Tennessee Oncology.

Speaker #11: I guess, how's uptake looking in those centers? I'm specifically curious about actual use of CAR-T in those centers, not necessarily referrals, and sort of what the plan and cadence is for adding additional community centers that can actually administer the CAR-T.

Speaker #11: Thanks.

Alan Bash: Hey, it's Alan. As we said before, the community adoption has a couple of components to it, one of which is the one you're speaking to, which is administration in the community among the community networks. We're seeing positive responses from the clinicians in both those sites. You mentioned two of them, we also have the West Clinic in Tennessee as well. There are additional sites that are coming online this year. I would say that it's a bit of a longer cycle to make sure that those sites are set up well and have the infrastructure, we do expect additional sites this year. The experience has been quite positive, again, speaking to the fact that CARVYKTI can be administered in the outpatient setting relatively easily.

Speaker #6: Hey, it's Alan. So, as we've said before, the community adoption has a couple of components to it, one of which is the one you're speaking to, which is administration in the community among the community networks.

Speaker #6: And we're seeing positive responses from the clinicians in both those sites. You mentioned two of them, and we also have the West Clinic in Tennessee as well.

Speaker #6: So there are additional sites that are coming online this year. I would say that it's a bit of a longer cycle to make sure that those sites are set up well and have the infrastructure, but we do expect additional sites this year and the experience has been quite positive.

Speaker #6: Again, speaking to the fact that Carvicti can be administered in the outpatient setting relatively easily. And clinicians are getting more and more comfortable with patient management dynamics.

Alan Bash: Clinicians are getting more and more comfortable with patient management dynamics. The other part of the community adoption is the referral piece, which you alluded to as well. Again, there we're seeing strong indications that we are getting additional referrals, again, speaking to the fact that our earlier line business is growing significantly. Finally, just as a point, we're up to 148 authorized treatment centers in the US. A third of those are community and regional hospitals, and that's an important component to our mix because that means that we're bringing CARVYKTI closer to patients in those settings as well.

Speaker #6: The other part of the community adoption is the referral piece, which you alluded to as well. And again, there we're seeing strong indications that we are gaining additional referrals.

Speaker #6: Again, speaking to the fact that our earlier line business is growing significantly. And then finally, just as a point, we're up to 148 authorized treatment centers in the US, about a third of those are community and regional hospitals.

Speaker #6: And that's an important component to our mix because that means that we're bringing Carvicti closer to patients in those settings as well.

Operator: Thank you. Our next question coming from the line of Sean McCutcheon with Raymond James. Your line is now open.

Speaker #1: Thank you. And our next question coming from the line of Sean McCutcheon with Raymond James. Alan is now open.

Sean McCutcheon: Hey, guys. Thanks for the question. One on CARTITUDE-5 for me. Can you speak to how you're framing, and you know, what you need to show to drive utilization in the frontline transplant-eligible or transplant not intended population on a cross-trial basis relative to CEPHEUS, and how you think about the scale and opportunity that could be unlocked by CARTITUDE-5? Thanks.

Speaker #10: Hey, guys. Thanks for the question. One on CARTitude 5 for me. Can you speak to how you're framing and what you need to show to drive utilization in the frontline transplant and eligible or transplant not intended population on a cross-trial basis relative to CPS and how you think about the scale and opportunity that could be unlocked by CARTitude 5?

Speaker #10: Thanks.

Ying Huang: Morning, Sean. This is Ying. If you look at the design for CARTITUDE-5, we are enrolling patients who are not eligible for stem cell transplant or who are eligible but who choose to defer transplant for various reasons. If you look at comparison arm, it is RVD, so it is a 3-drug cocktail composing of Revlimid, Velcade, and dexamethasone. Historically, if you look at RVD in the frontline setting in this transplant ineligible population, you have 2 trials. One is the IFM trials, run by Celgene. The other one is the SWOG S0777 trial. If you look at the median PFS for RVD in this setting in those 2 phase II trials, it's in the range of 35 to 40 months.

Speaker #12: Good morning, Sean. This is Ying. So if you look at the design for CARTitude-5, we are enrolling patients who are not eligible for stem cell transplant, or who are eligible but choose to defer transplant for various reasons.

Speaker #12: So if you look at comparison arm, it is RVD. So it's a three-drug cocktail composing of Revlimid, Velcade, and dexamethasone. Historically, if you look at RVD in the frontline setting in this transplant ineligible population, you have two trials.

Speaker #12: One is the IFM trials, run by Xelgene. The other one is a SWOG 777 trial. And if you look at the median PFS for RVD in this setting in those two phase II trials, it's in the range of 35 to 40 months.

Ying Huang: That is our assumption when we at J&J designed this trial for CARTITUDE-5. Again, we're looking at cross-trial comparison, as you rightfully mentioned, 35 to 40. If you recall, Sean, in CARTITUDE-1, where we enrolled 97 patients with heavily pretreated regimen, the median line of therapy prior therapy was 6.5, yet we still achieved 35-month PFS for CARVYKTI-treated patients. This is why we at J&J are highly confident that we will be able to achieve the superiority against RVD in this specific patient population. If you compare that to CEPHEUS and other trials, of course, you do see certain numbers shifting because of better standard of care.

Speaker #12: And that is our assumption when we engage a design this trial for CARTitude 5. So if you look at, again, we're looking at cross-trial comparison as you rightfully mentioned.

Speaker #12: 35 to 40. If you recall, Sean, in CARTitude 1, where we enrolled 97 patients with heavy depreciated regimen, the median line therapy prior therapy was 6.5.

Speaker #12: Yet, we still achieved 35 months PFS for Carvicti-treated patients. So this is why we and J&J are highly confident that we will be able to achieve the superiority against RVD in this specific patient population.

Speaker #12: Now, if you compare that to Cepheus and other trials, of course, you do see certain numbers shifting because of better standard of care. On the other hand, still, given what we know about CARTitude 1 and also CARTitude 4, where with the median follow-up of nearly three years, we have not reached the median PFS yet in that second to fourth line patient population.

Ying Huang: On the other hand, still, given what we know about CARTITUDE-1 and also CARTITUDE-4, where, with a median follow-up of nearly 3 years, we have not reached median PFS yet in that 2nd to 4th line patient population. We remain highly confident that CARVYKTI will demonstrate superiority in PFS compared to RVD. That is our assumption here.

Speaker #12: So we remain highly confident that Carvicti will demonstrate superiority in PFS compared to RVD. That is our assumption here.

Operator: Thank you. Our next question coming from the line of Ashwani Verma with UBS. Your line is now open.

Speaker #1: Thank you. Our next question coming from the line of Asperma with UBS. Alan is now open.

Ashwani Verma: Hi. Yeah, thanks for taking our question. Maybe just on the CD19, CD20 CAR T. Can you talk about the safety differentiation with some of the other programs out there? Some of these programs have seen CRS or ICANS or neutropenia. Are you confident that your program can have minimal to no cases of grade 3 and above CRS and ICANS? Then, just like secondly, on CARVYKTI, I mean, the Q4 to Q1 sequential growth in US is at 3%. Any seasonality dynamic going on there? Just like trying to understand what is the growth trajectory from here. Can you continue to see sequential growth for the rest of 2026? Any impact of MajesTEC-3 on CAR T cell? Thanks.

Ash Verma: Hi. Yeah, thanks for taking our question. Maybe just on the CD19, CD20 CAR T. Can you talk about the safety differentiation with some of the other programs out there? Some of these programs have seen CRS or ICANS or neutropenia. Are you confident that your program can have minimal to no cases of grade 3 and above CRS and ICANS? Then, just like secondly, on CARVYKTI, I mean, the Q4 to Q1 sequential growth in US is at 3%. Any seasonality dynamic going on there? Just like trying to understand what is the growth trajectory from here. Can you continue to see sequential growth for the rest of 2026? Any impact of MajesTEC-3 on CAR T cell? Thanks.

Speaker #13: Hi. Yeah. Thanks for taking our question. Maybe just on the CD19, CD20, CAR-T. So can you talk about the safety differentiation with some of the other programs out there?

Speaker #13: Some of these programs have seen CRS or ICANS or neutropenia. Are you confident that your program can have minimal to no cases of grade three and above CRS and ICANS?

Speaker #13: And then just like secondly, on Carvicti, I mean, the 4Q to 1Q sequential growth in the US is at 3%. Any seasonality dynamic going on there?

Speaker #13: Just trying to understand, what is the growth trajectory from here? Can you continue to see sequential growth for the rest of 2026? And any impact of Majestic-3 on Carvicti sales?

Speaker #13: Thanks.

Guowei Fang: Thanks, Ash. Yeah. I can answer the first question on the safety side. Certainly, safety is paramount for our novel platform in oncology patients. I cannot disclose specifically the clinical safety profile at this point. We have to wait until the clinical data is presented. What I can say is that safety is a key parameter we focus on from the get-go in the design phase. Our unique design mechanism as well as the CMC manufacturing process, I think that will provide differentiate the safety profile in clinic. In terms of how the research data correlates with the clinical data, let's wait, stay tuned until we are ready to disclose clinic data. Thank you.

Speaker #6: Thanks, Ash. Yeah. I can answer the first question on the safety side. Certainly, safety is paramount for novel platform in oncology patients. I cannot disclose specific safety clinical safety profile at this point.

Speaker #6: We have to wait until the clinical data is presented. What I can say is that safety is a key parameter we focus on from the get-go in the design phase.

Speaker #6: And our unique design mechanism as well as the CMC manufacturing process, I think that well-provided differentiated safety profile in clinic. And in terms of how the research data correlates with the clinical data, that's where to stay tuned until we are ready to disclose clinical data.

Speaker #6: Thank you.

Alan Bash: On the CARVYKTI performance in Q1, yes, you know, coming out of the holidays, there is a little bit of a lag in patient appointments as patients get re-upped in their insurance and they get rescheduled. We're very encouraged with the trends that we've seen in the patient bookings through the progress of the quarter and even beyond that. I would say that we would expect to see sequential growth, quarter on quarter, both in the US and OUS for the remainder of this year.

Speaker #13: And on the Carvicti performance in Q1, yes, coming out of the holidays, there is a little bit of a lag in patient appointments as patients get re-upped in their insurance and they get rescheduled.

Speaker #13: But we're very encouraged by the trends that we've seen in patient bookings through the progress of the quarter and even beyond that. And I would say that we would expect to see sequential growth, quarter on quarter, both in the US and OUS for the remainder of this year.

Ying Huang: Ash, maybe, this is Ying. I want to add that you guys all follow IQVIA weekly scripts and weekly sales. As you can see, we had a very strong March, followed by a very strong April, and now we're early in May, but again, ordering looks quite strong. You guys can track that every week. As we have mentioned before, it's not a zero-sum game. You see both Techdara and you see CARVYKTI steadily growing in second line.

Speaker #12: And Ash, maybe this is Ying. I want to add that you guys all follow IQVIA weekly scripts and weekly sales. As you can see, we had a very strong March followed by a very strong April.

Speaker #12: And now we're early May. But again, ordering looks quite strong. So you guys can track that every week. As we have mentioned before, it's not a zero-sum game.

Speaker #12: You see both Tecdera and you see Carvicti steadily growing in second line.

Ashwani Verma: Thank you.

Ash Verma: Thank you.

Speaker #13: Thank you.

Operator: Thank you. Our next question in the queue coming from the line of Yaron Werber with TD Cowen. Yaron, it is now open.

Speaker #1: Thank you. Our next question in the queue coming from the line of Iran Warber with TD Collin. Alan is now open.

Yaron Werber: Great. Thanks so much for taking my question. Maybe just the first question, Alan, for you, the seasonality that you mentioned in Q4 with some of the bags sort of remaining over and ultimately being infused in early Q1, and it seems like as you're moving upstream in Q1, J&J talked about having the same effect. Can you give us a little bit of a sense, kind of net-net, how that worked out on a quarter-over-quarter basis? Is that sort of phenomenon of just a little bit of a delay to infusion will continue as you're moving to second line? A question for in vivo, I mean, for BCMA. Can you maybe share a little bit about the construct itself? Are you using sort of the same camelid antibody targeting BCMA with the same dual epitope targeting?

Speaker #14: Great. Thanks so much, for taking my question. Maybe just the first question, Alan, for you. The seasonality that you mentioned in Q4 with some of the bags sort of remaining over and ultimately being infused in early Q1.

Speaker #14: And it seems like as you're moving upstream in Q1, J&J talked about having the same effect. Can you give us a little bit of a sense kind of net-net how that worked out on the quarter over quarter basis?

Speaker #14: And is that sort of phenomenon of just a little bit of a delay to infusion—will that continue as you're moving to second line? And then a question for in vivo, I mean, for BCMA.

Speaker #14: Can you maybe share a little bit about the construct itself? Are you using sort of the same CamoLite antibody targeting BCMA, with the same dual epitope targeting?

Yaron Werber: Is it sort of the same stem? Are you doing any de-targeting through the LDL receptor, and CD3 to try to avoid the sort of liver uptake and the sink and reduce some of the ICANS and inflammation? Thank you.

Speaker #14: Is it sort of the same STIM? And are you doing any detargeting through the LDL receptor and CD3 to try to avoid the sort of liver uptake and the sink and reduce some of the ICANS and inflammation?

Speaker #14: Thank you.

Alan Bash: Yaron, it's Alan. I'll just go back to what I said previously, which is that we do continue to see strong order flow, both as the quarter progresses as well as Ying mentioned, going into April and beyond. We do expect to continue to see the growth and in particular in that earlier line setting, where we are, you know, gaining more and more patients, more and more referrals, setting us up well from a competitive standpoint as well.

Speaker #6: Your Honors, Alan, I'll just go back to what I said previously, which is that we do continue to see strong order flow both as the quarter progresses, as well as, as Ying mentioned, going into April and beyond.

Speaker #6: So we do expect to continue to see the growth. And in particular, in that earlier line setting, where we are gaining more and more patients, more and more referrals, setting us up well from a competitive standpoint as well.

Guowei Fang: With regard to the BCMA compound, in term of the binder design, we are not ready to disclose special information at this point. On the platform side, I do want to add that we generate glycosylation mutations on the virus itself, and therefore the virus, engineered virus does not recognize the receptor. We use internally discovered and optimized the CD3 binder for T-cell targeting, which is differentiated from many other players in the space where they use existing CD3 binder borrowed from other purpose.

Speaker #14: So we've got to the BCMA compound in terms of the binder design. We are not ready to disclose specific information at this point. On the platform side, I do want to, yeah, add that we generate glycol mutations on the virus itself.

Speaker #14: And therefore, the virus engineered virus does not recognize LDL receptor. And we use internally discovered and optimized the CD3 binder for T-cell targeting. Which is differentiated from many other players in the space.

Speaker #14: Really use existing CD3 binder, borrowed from other purposes.

Yaron Werber: Thank you so much.

Speaker #15: Thank you so much.

Operator: Thank you. Our next question coming from the line of Mitchell Kapoor with H.C. Wainwright & Co. Your line is now open.

Speaker #1: Thank you. Our next question is coming from the line of Mitchell Kapoor with HC Wenright. Alan, the line is now open.

Yan Zi: Hi, thank you for taking my question. This is Yan Zi sitting in for Mitchell Kapoor. I have a question on the LB2501, the in vivo CD19/20 program. You list the studies enrolling, and you have pointed to this in vivo data coming later in the year. Separately, you know, you have J&J recently announcing it discontinued its ex vivo CD20 mono and CD19 20 bi-CAR-T programs in LBCL. Without asking you to comment on their program specifically, I just want to get a sense of how you're thinking about the competitive bar for LB2501.

Speaker #16: Hi. Thank you for taking my question. This is Yan Z setting in for Mitchell Kapoor. So I have a question on the LB2501, the in vivo CD1920 program.

Speaker #16: You list the studies enrolling, and you have pointed to this in vivo data coming later in the year. But separately, you have J&J recently announcing a discontinued ex vivo CD20 mono and CD19/20 bi-CAR-T programs in LBCL.

Speaker #16: Without asking you to comment on their program specifically, I just want to get a sense of how you're thinking about the competitive bar for LB2501.

Guowei Fang: This is a dual targeting mechanism and cumulative data across autologous cells clinical data on the autologous front comparing CD19 versus CD19 CD20 dual targeting mechanism do point to the promise of dual targeting in term of driving deeper and the more durable response. J&J recently announced that they discontinued their development program for the dual targeting mechanism. I will not be able to comment on their specific rationale. We do believe that the dual targeting mechanism provide benefit over the mono targeting. The in vivo data is evolving and we are very much looking forward to disclose our clinical program.

Speaker #14: So this is a dual targeting mechanism. And cumulative data across all targets the cell-cell clinical data on the all targets front comparing CD19 versus CD19-CD20 dual targeting medicine.

Speaker #14: Due point to the promise of dual targeting in terms of driving deeper and the more durable response. J&J recently announced that they discontinued their development program for the dual targeting mechanism.

Speaker #14: And I will not be able to comment on their specific rationale. But we do believe that the dual-targeting medicine provides benefit over the mono-targeting.

Speaker #14: And in vivo data is evolving. And we are very much looking forward to disclose our clinical program.

Yan Zi: Thank you.

Speaker #16: Thank you.

Operator: Thank you. I'm showing no further questions in the queue at this time. I will now turn the call back over to the CEO, Ying Huang, for any closing remarks.

Speaker #1: Thank you. And I'm showing no further questions in the queue at this time. I will now turn the call back over to the CEO, Ying Huang, for any closing remarks.

Ying Huang: Well, it's great hearing from everyone this morning. We are really pleased with the momentum of CARVYKTI. As you heard from Alan, we look forward to stronger quarters in the rest of the year. We do expect sequential growth in both US and ex-US. We continue to see deepening penetration in the community and also in second line. We're actually all full speed on with our in vivo programs. We look forward to seeing you all at the upcoming major medical meetings. Thank you.

Speaker #12: Well, it's great hearing from everyone this morning. We are really pleased with the momentum of Carvicti. As you heard from Alan, we look forward to stronger quarters in the rest of the year.

Speaker #12: And we do expect sequential growth in both US and the FCUS. We continue to see deepening penetration in the community and also in second line.

Speaker #12: And we're actually all full speed on with our in vivo programs. We look forward to seeing you all at the upcoming major medical meetings.

Speaker #12: Thank you.

Operator: Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect.