5/12/2026

speaker
Operator
Conference Operator

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 listen-only mode. After this 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. 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 our speaker host for today, Jessie Young, Vice President of Investor Relations and Finance. Please go ahead.

speaker
Jessie Young
Vice President of Investor Relations and Finance

Good morning. This is Jessie Young, Vice President of Investor Relations and Finance at Legend Biotech. Thank you for joining our conference call today to review our first quarter of 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 Catharty, 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, Guangwei Feng, 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 herewithin. 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 matrix. 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 the closest 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. 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. We believe that adjusted income or loss provide a useful measure of our operating performance from period to period. Our press release includes IFRS to non-IFRS recommendations for these measures. With that, I will now turn the call over to Ying.

speaker
Ying Huang
Chief Executive Officer

Hello, everyone.

speaker
Ying Huang
Chief Executive Officer

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 Carvicti, our market-leading and profitable CAR-T therapy for multiple myeloma. In parallel, we're working to advance Carvicti into the first-line treatment setting to help reach more patients and further broaden its long-term opportunity. Beyond Carvicti, 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 the first quarter of 2026, CARVIC-T 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 U.S. year-over-year and more than 200% growth from ex-U.S. 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 patients followed by DRVD induction and maintenance, assuming thiatumamide resistance. We view this sentiment as further validation that CAR-VT 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. We recently engaged six distinguished scientific advisors, Rania Brentjens, Spencer Fisk, Carl Jung, Maximilian Koenig, Tony Poverino, and George Schett, 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 the pipeline, we have some of the larger active CARVIC-T trials. Most importantly, CARVIC-T5 and CARVIC-T6 are pivotal phase 3 studies designed to assess CARVIC-T 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 one. Beyond BCMA, our GPRC5D in vivo program in multiple myeloma has also entered phase one. 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-torsion 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, 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
Alan Bash
President of Catharty

Thank you, Ying. I'll start with a high-level view of Carvicti's commercial performance and then spend time on what's driving growth beneath the surface. In Q1, CARVICTI 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. CARVICTI net trade sales in the first quarter were approximately $597 million, representing 8% sequential growth from Q4 2025. In the U.S., growth was driven primarily by increased utilization in earlier line settings, continued activation of new authorized treatment centers, and steady throughput at existing sites. Outside the U.S., demand was supported by continued uptake in established European markets and contributions from recent launches, with CARVICTI 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 percent 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. 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 U.S. where nearly 80 percent 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 percent of CARVICTI apheresis volume in the U.S. in the first quarter of 2026 compared to 29 percent in the same period a year ago. This trend reflects growing physician confidence in CARVICTI's benefit-risk profile earlier in the disease course and our ability to reliably support that shift at scale. 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
Carlos Santos
Chief Financial Officer

Thank you, Ellen, 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. Turning to the next slide, this chart highlights our progress towards profitability. As you can see, revenue has continued to scale, driven by CARVICTI 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 the first quarter. primarily driven by CARVICTI 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. Gross margin and 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. 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. 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 V and VI studies for CARVICTI mature, we expect a substantial decline in the associated R&D expenses. This allows an increasing proportion of the R&D budget to be reinvested into the pipeline as we leverage the benefit of CARVICTI profitability to fund the future growth of Legends. that will come from the promising in vivo programs and extensive earlier stage pipeline that Ying showed earlier. SCNA expense was $90 million, driven by targeted commercial investment supporting Carvicti 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 3 cents per diluted share, compared with an adjusted net loss of $27 million, or 7 cents per diluted share, in the same period last year. 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 CARVICTI 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, the first quarter 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
Operator
Conference Operator

Thank you. Ladies and gentlemen, to ask a question at this time, you will need to press star 1-1 on your telephone keypad and wait for your name to be announced. To withdraw your question, simply press star 1-1 again. Please stand by while we compile the Q&A roster. Now, first question coming from the line of Terrence Flynn with Morgan Stanley. Your line is now open.

speaker
Terrence 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? Is it 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? Thank you.

speaker
Ying

Morning, Terrence. Thank you for that question.

speaker
Ying Huang
Chief Executive Officer

So, 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-horses lymphoma at a major medical meeting around mid-year. So, 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. 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. I hope that answers your question, Terrence.

speaker
Operator
Conference Operator

Thank you. And our next question coming from the line of Umar Afad with EverQuest. Hi, Yolanda. It's now open.

speaker
Umar Afad

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. And maybe for everyone listening in, Ying, because this is a new theme popping up beyond CAR-VICT, beyond Arcelix. 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. And number three, and I acknowledge you can't say if it'll be at eHow 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, or should there be some early efficacy as well? Thank you.

speaker
Ying

Omer, thanks for your question.

speaker
Ying Huang
Chief Executive Officer

I will answer the first two parts, and then I'll ask my colleague, my friend of R&D, to answer the third question regarding the design and everything else. 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 using a lentiviral vector delivery. So that's first. Secondly, I can confirm that the internal codename we use for this program is LB2501. And this program is already up on clinicaltrucks.gov. if you want to search for the details on the protocol and the enrollment. And on the third question, I'll ask for a way to answer.

speaker
Guangwei Feng
President of R&D

Yes. In terms of the 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 specific information. But 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
Umar Afad

Thank you very much.

speaker
Operator
Conference Operator

Thank you. Our next question coming from the line of Jessica with JP Morgan. Your line is now open.

speaker
Morgan

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 CARVIC-T use across lines of therapy. 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? Thank you.

speaker
Alan Bash
President of Catharty

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. 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. 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 based on the data that we shared at ASH in previous conferences. that earlier is better. And I think it also sets us up well from a competitive standpoint to make sure we are penetrating the second and third line of businesses in the face of whether it's by specifics or a potential future BCMA CAR T competition. 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 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.

speaker
Carlos Santos
Chief Financial Officer

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 Raritan site. 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.

speaker
Morgan

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

speaker
spk05

We do not disclose those particulars.

speaker
Morgan

Thank you.

speaker
Ying Huang
Chief Executive Officer

Jess, this is Dean. 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 interim quarters of the year.

speaker
Morgan

Thanks.

speaker
Operator
Conference Operator

Thank you. Our next question coming from the line of Costas Berrios with Oppenheimer here on his mouth.

speaker
spk07

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 tech data approval in the second line now, perhaps on any particular segment of patients or any particular geographies? 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 in 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
Alan Bash
President of Catharty

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 Buy Specifics, 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. 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. While other products are growing, Carvicti 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 CARB-T.

speaker
Guangwei Feng
President of R&D

So for the second question, in terms of a benchmark for in vivo CAR-T program, our lead program is CD19, CD20, dual-targeting in vivo CAR-T program, targeted for non-hygiene lymphoma patients. Our current thinking is that we are expecting or we are looking for deep and durable response, and therefore, the benchmark would be expected to align with that type of efficacy response. Currently, that's still early, and we are accumulating more data.

speaker
Ying

And if I can add a follow-up here,

speaker
spk07

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
Guangwei Feng
President of R&D

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

speaker
Operator
Conference Operator

Thank you. And our next question coming from the line of with Barclays. Yolanda is now open.

speaker
spk20

Great. Thanks for taking the question. Congrats on the quarter. A couple of questions, maybe on the CARVIC-T side, if you could maybe provide any updates, new updates on the timing for CARVIC-T5 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, I think LB2505, maybe if you can comment on on the scope and then the trial design there. Thank you.

speaker
Alan Bash
President of Catharty

Yeah, CART 5 and CART 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.

speaker
Guangwei Feng
President of R&D

So for the in vivo CATI program, we are excited about our platform and product. We are exploring this platform across different diseases. Multiple melanoma is an important disease area. BCMA certainly is a top target within the multiple melanoma disease space. Our partnership with Johnson & Johnson cover all and any BCMA directed cell therapy in multiple melanoma that both companies are working on. And therefore, at this point, there's nothing more we can share.

speaker
Ying Huang
Chief Executive Officer

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

speaker
spk20

Thank you.

speaker
Operator
Conference Operator

Thank you. Our next question coming from Delaina. Thanks for taking my question.

speaker
spk09

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? And then a financial question on the adjusted net income guidance for profitability in 2026. The adjustments in Q1 are about $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
Alan Bash
President of Catharty

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.

speaker
Carlos Santos
Chief Financial Officer

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 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. 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.

speaker
spk09

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
Carlos Santos
Chief Financial Officer

Yeah. So, as I mentioned, we do exclude the certain non-cash items. So, this would be primarily share-based compensation.

speaker
spk05

depreciation, amortization, and impairments and foreign exchange.

speaker
spk09

Thank you.

speaker
Operator
Conference Operator

Thank you. Our next question coming from the line up. Jameson with Deutsche Bank. Your line is now open.

speaker
spk14

Good morning. Thank you for the questions. Circling back to the pipeline, There's three autologous and one in vivo variant for the GPR C5Ds. Are these GPR C5D binders consistent across all the variants, 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 1Q26 been profitable on an adjusted basis? Thank you.

speaker
Guangwei Feng
President of R&D

On the GPRC5D front, all autopsies program use the same binder. We are testing the, 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
spk05

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. Thank you.

speaker
Operator
Conference Operator

Our next question coming from the line of Leonid Timoshev with RBC Capital. Your line is now open.

speaker
Leonid Timoshev

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 actual use of CAR T in those centers, not necessarily referrals, and sort of what the plan and cadence is of adding additional community centers that can actually administer the CAR T. Thanks.

speaker
Alan Bash
President of Catharty

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. 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. 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, 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. 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 getting additional referrals, again, speaking to the fact that our earlier line business is growing significantly. And then finally, as a point, we're up to 148 authorized treatment centers in the U.S. About 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 PerfectD closer to patients in those settings as well.

speaker
Ying Huang
Chief Executive Officer

Thank you.

speaker
Operator
Conference Operator

And our next question coming from the line up, Shawn McCutcheon with Raymond James here.

speaker
Shawn 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 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
Ying

Thanks. Morning, Sean. This is Ying.

speaker
Ying Huang
Chief Executive Officer

So, if you look at the design for CAR2D5, 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. So, if you look at comparison arm, it is RVD. So, it's a three drug cocktail composing of Revlimid, Valcade, and dexamethasone. Historically, if you look at RVD in the frontline setting in this transplant ineligible population, you have two trials. One is the ISM trials run by Celgene. The other one is the SLOC 777 trial. And if you look at median PFS or RBD in this setting, in those two phase three trials, it's in the range of 35 to 40 months. And that is our assumption when we and J&J designed this trial for CAR-2 size. So if you look at, again, we're looking at cross-trial comparison, as you rightfully mentioned, 35 to 40. If you recall, Sean, in Carditude 1, where we enrolled 97 patients with heavily pre-treated regimen, the median life therapy prior therapy was 6.5. Yeah, we still achieved 35-month PFS for CARB-DT-treated patients. This is why we and J&J are highly confident that we will be able to achieve the superiority against RBD in this specific patient population. 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 CAR T1 and also CAR T4, where with a median follow-up of nearly three years, we have not reached the median PFF yet in that second to fourth-line patient population. So, we remain highly confident that will demonstrate superiority in TFS compared to RBD. That is our assumption here.

speaker
Operator
Conference Operator

Thank you. Our next question coming from the line of with UBS.

speaker
spk17

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 ICANNs or neutropenia. Are you confident that your program can have minimal to no cases of grade 3 and above CRS and ICANNs? And then just like secondly, on Carvicti, I mean, the 4Q to 1Q sequential growth in U.S. 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 and any impact of Majestic 3 on Carvicti sales? Thanks.

speaker
Guangwei Feng
President of R&D

Thanks, Ash. Yeah, I can answer the first question on the safety side. Certainly, safety is paramount for a novel platform in oncology patients. I cannot discuss specific safety profile, 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. And our unique design mechanism, as well as the CMC manufacturing process, I would say that well-provided differentiates the safety profile in CLINIC. And in terms of how the research data is carried with the CLINIC data, that's where we stay tuned until we are ready to discuss CLINIC data. Thank you.

speaker
Alan Bash
President of Catharty

And on the CARVIC, the 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. But 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. And I would say that we would expect to see sequential growth quarter-on-quarter both in the U.S. and OUS for the remainder of this year.

speaker
Ying Huang
Chief Executive Officer

And Ash, maybe this is Ian. I want to add that you guys all follow IQVIA weekly scripts and weekly sales. As you can see, we're in a very strong March, followed by a very strong April. And now we're early in 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. You see both Tectera and you see Kaviti steadily growing in the second line.

speaker
Ying Huang
Chief Executive Officer

Thank you.

speaker
Operator
Conference Operator

Thank you. Our next question in the queue coming from the line of Yaron Werber with TD Cohen. Yolan, it's now open.

speaker
TD Cohen

Great. Thanks so much for taking my question. Maybe just the first question, Alan, for you. The analysis 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? And is that sort of phenomenon of just a little bit of a delay to infusion will continue as you're moving to second line? And then 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 Camelite antibody targeting BCMA with the same dual epitope targeting? Is it sort of the same stims? 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 ICANNs and inflammation? Thank you.

speaker
Alan Bash
President of Catharty

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

speaker
Guangwei Feng
President of R&D

So we've got to the BCMA compound in terms 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 glycomutations on the virus itself, and therefore, the virus does not recognize the 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 where they use existing cities to find them, far from other purpose.

speaker
Ying

Thank you so much.

speaker
Operator
Conference Operator

Thank you. Our next question coming from the line of Mitchell Kapoor with HC Wainwright. Your line is now open.

speaker
spk06

Hi. Thank you for taking my question. This is Yonzi sitting in for Mitchell Kapoor. So I have a question on the LB2501, the in vivo CD1920 program. You list the studies enrolling, and you have pointed to this in vivo data coming later in the year. But separately, you know, you have J&J recently announcing that it discontinued its ex vivo CD20 mono and CD1920 bicar T programs in the 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
Guangwei Feng
President of R&D

So, this is a dual targeting mechanism, and cumulative data across autologous cells of clinical data on the autologous front comparing CD19 versus CD19, CD20 dual targeting mechanism. do point to the promise of dual targeting in terms of driving deeper and the more durable response. J&J recently announced that they discontinued the development program for the dual targeting mechanism. And I will not be able to comment on their specific rationale. But we do believe that the dual-targeting medicine provide benefit over monotargeting, and in vivo data is evolving, and we are very much looking forward to disclose our clinical work.

speaker
Ying Huang
Chief Executive Officer

Thank you.

speaker
Operator
Conference Operator

Thank you. And I'm showing up for the 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
Ying Huang
Chief Executive Officer

Well, it's great hearing from everyone this morning. We are really pleased with the momentum of CAR-80. As you heard from Alan, we look forward to stronger quarters in the rest of the year, and we do expect sequential growth in both the U.S. and the FCS. We continue to see deep penetration in the community and also in second lines. 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. Thank you.

speaker
Operator
Conference Operator

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

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