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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 a listen-only mode. 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 one one 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 your speaker host for today, Jessie Yeung, Vice President of Investor Relations and Finance. Please go ahead.

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 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 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.

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 metrics. 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 that closes 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 particularly, we exclude unrealized gain or loss from foreign exchange rate changes.

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.

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 it 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, CARVYKTI 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 patient followed by DVRd 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.

We recently engaged 6 distinguished scientific advisors, Renier Brentjens, Spencer Fisk, Carl June, Maximilian F. Konig, Anthony Polverino, and Georg 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 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.

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 1 to 2 U.S. 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.

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 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 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.

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% 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 U.S. in the first quarter of 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.

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.

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. 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 the first quarter, 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.

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. 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-5 and 6 studies for CARVYKTI 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 CARVYKTI 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. 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.

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, 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.

First question coming from the line of Terence Flynn with Morgan Stanley. Your line is now open.

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? How are you thinking about durability, and what will we learn from this first data set with respect to that question? Thank you.

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 patient 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.

I hope that answers your question, Terence.

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

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 cell x, 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. 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.

Umer, thanks for your question. I will answer the first two parts, 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 codename 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 Wei to answer.

Yes. In terms of 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 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.

Thank you very much.

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

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.

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 third 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.

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.

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. 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.

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

We do not disclose those particulars.

Thank you.

Jess, this is Ying. 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.

Thanks.

Thank you. Our next question coming from the line of Kostas Biliouris with Oppenheimer.

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.

Our business continues to grow, 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, that portends well for the opportunity for CARVYKTI.

For the second question, in term 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-Hodgkin's lymphoma patient. 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.

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.

Excellent question. We do think that 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.

Thank you. Our next question coming from the line of Ed Sauder with Barclays. Your line is now open.

Great. Thanks for taking the question. Congrats on the quarter. A couple of questions, maybe on the CARVYKTI side, if you could maybe provide any updates, new updates on the timing for CARVYKTI 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 the trial design there. Thank you.

Yeah. CARTITUDE-5 and CARTITUDE-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.

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 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.

Ed, 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.

Great. Thank you.

Thank you. Our next question coming from the line of Eric Schmidt with Cantor Fitzgerald. Your line is now open.

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? Then 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.

On CARTITUDE-5, Eric, 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.

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.

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?

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

Thank you.

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

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 FasT CAR variants using a different manufacturing process and therefore have different binders? Then just following up on the one-time cost of collaboration question, if you exclude this one-time charge, would 1Q 2026 been profitable on an adjusted basis? Thank you.

On the GPRC 5D front, all autologous program use the same binder. We are testing the, have tried to validate the binder as well as try to understand how the patient respond using different, design of the CAR T molecule.

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.

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

Hey, guys. Thanks for taking my question. 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 the 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.

Hey, it's Alan. As we've said before, the community adoption has 2 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 2 of them, we also have the West Cancer Center 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, but we do expect additional sites this year. The experience has been quite positive.

Again, speaking to the fact that CAR T 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. 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. Then finally, just 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 CARVYKTI closer to patients in those settings as well.

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

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.

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, 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. 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 two phase II trials, it's in the range of 35-40 months. That is our assumption when we at JNJ designed this trial for CARTITUDE-5.

Again, we're looking at cross-trial comparison, as you rightfully mentioned, 35-40. 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 and JNJ 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.

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, second to fourth line patient population. We remain highly confident that CARVYKTI will demonstrate superiority in PFS compared to RVd. That is our assumption here.

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

Hi. 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 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 MajesTEC-3 on CARVYKTI sales?

Thanks.

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 disclose specific 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 term of how the research data correlates with the clinical data, let's wait, stay tuned until we are ready to disclose clinical data. Thank you.

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 U.S. and OUS for the remainder of this year.

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. 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 TECVAYLI and daratumumab and you see CARVYKTI steadily growing in second-line.

Thank you.

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

Great. Thanks so much for taking my question. Maybe just the first question, Alan, for you, the those 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 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?

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.

Yaron, 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 Yin 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.

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 glycoprotein mutations on the virus itself, and therefore the engineered virus does not recognize the receptor. We use internally discovered and optimize 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.

Thank you so much.

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

Hi, thank you for taking my question. This is Mitchell Kapoor sitting in for Mitchell Kapoor. 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. Separately, you know, you have Johnson & Johnson 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 wanna get a sense of how you're thinking about the competitive bar for LB2501.

This is a dual targeting mechanism and cumulative data across all targets cells clinical data on the targets 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, and I will not be able to comment on their specific rationale. But 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.

Thank you.

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.

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, and we do expect sequential growth in both U.S. and ex-U.S. 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.

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

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

Good morning. This is Jessie Yeung, Vice President of Investor Relations and Finance at Legend Biotech. Thank you for joining our conference call today to review our fourth quarter of 2025 performance. Prior to this call, we issued a press release announcing our financial results for the quarter. You can find the press release on our IR website at legendbiotech.com. Joining me on today's call are Ying Huang, the company's Chief Executive Officer, Alan Bash, the company's President of CARVYKTI, and Carlos Santos, the company's Chief Financial Officer. Following the prepared remarks, we will open up the call for Q&A. During today's call, we will be making forward-looking statements, which are subject to risks and uncertainties that may cause our actual results to differ materially from those expressed or implied herein.

These forward-looking statements are discussed in greater detail in our SEC filings, which we encourage you to read and can be found under the Investors sections of our company website. In addition, adjusted net income loss is a non-IFRS metric. This non-IFRS financial measure is in addition to, and not a substitute for or superior to, measures of financial performance prepared in accordance with IFRS. There are a number of limitations related to the use of these non-IFRS financial measures versus their closest IFRS equivalents. However, we believe that providing information concerning adjusted net income or loss and adjusted net income or loss per share enhances an investor's understanding of our financial performance. We use adjusted net income or loss as a performance metric that guides management in its operation of and planning for the future of the business.

In particular, we exclude unrealized gain or loss from foreign exchange rate changes. We believe that adjusted net income or loss provides a useful measure of our operating performance from period to period. Our press release includes IFRS to non-IFRS reconciliation for these measures. With that, I will now turn the call over to Ying.

Hello, everyone. Thank you for joining us today. We closed out 2025 as the largest standalone cell therapy company with both commercial scale and next-gen pipeline optionality, and we look forward to becoming a fully scaled CAR-T leader this year and presenting new data at upcoming medical conferences this year. We are pleased to have achieved CARVYKTI profitability in 2025 and believe we are poised to achieve company-wide profitability in 2026. You'll hear from Alan shortly about the impact that CARVYKTI has had on a global scale in recent months, but I wanted to share a few highlights on this front. During the fourth quarter of 2025, CARVYKTI net trade sales were approximately $555 million, which is a 66% increase year-over-year.

We have brought hope to patients worldwide with more than 10,000 multiple myeloma patients who have chosen to be treated with CARVYKTI. With the physical expansion of the Raritan facility, we have the installed capacity to support annual production of 10,000 doses across all our manufacturing nodes. CARVYKTI's launch remains the strongest CAR-T launch to date. The majority of its utilization is now in earlier line settings. CARVYKTI has a 97% overall manufacturing success rate and is offered in 14 global markets. Not only is CARVYKTI raising the bar for manufacturing excellence and site growth, it's also setting new standards for survival outcomes in relapsed refractory multiple myeloma. Recently, at the 67th American Society of Hematology annual meeting and the 2026 Tandem meeting, we presented compelling data on CARVYKTI's efficacy and our manufacturing success.

Before we dive deeper into this, I want to highlight that we also presented at ASH on Lucar-G39D, our first-in-class allogeneic gamma delta CAR-T cell therapy targeting CD19 and CD20 in adults with relapsed refractory B-cell non-Hodgkin's lymphoma, or NHL. As you may have seen, we're pleased that it demonstrated manageable safety and encouraging antitumor activity. Turning to the recent CARVYKTI presentations, new long-term CARVYKTI data demonstrated durable responses in key subgroups and reinforced the improved outcomes associated with earlier treatment with CARVYKTI. Importantly, triple class-exposed multiple myeloma patients with three prior lines of therapy in CARTITUDE-1 and CARTITUDE-4 achieved a median PFS of 50.4 months after single infusion of CARVYKTI. This represents one of the longest PFS outcomes for BCMA-targeting CAR-T therapy.

Given that more than 50% of patients enrolled in the competing trial had only three prior lines of therapy, we believe the 50.4-month median PFS sets a new standard in this population. Additionally, an analysis of patients with standard-risk cytogenetics from CARTITUDE-4 shows that earlier treatment with CARVYKTI improved survival outcomes, reinforcing its curative potential. 80% of the patients remained progression-free and off treatment after 2.5 years. Of standard-risk patients in CARTITUDE-4 who were progression-free at one year, 93% remained alive and progression-free at 2.5 years. Furthermore, translational analysis of patients from CARTITUDE-1 and CARTITUDE-4 demonstrated stronger immune fitness and a more immunocompetent tumor microenvironment for patients earlier in their treatment journey. Again, adding to the body of clinical evidence that earlier treatment with CARVYKTI leads to better outcomes.

Finally, commercial CARVYKTI manufacturing data from July 2024 through October 2025 were analyzed to examine manufacturing outcomes across multiple prior lines of therapy. Overall, 99% of products were successfully manufactured when using cells from patients with one-three prior lines of therapy, with 6.5% out-of-spec product, compared to 97% for the fourth line and beyond, with 9.2% out-of-spec product. Not only are we unconstrained from a capacity standpoint, but we have also made significant progress on our manufacturing success rates. We are reinforcing this message about our manufacturing capabilities and, of course, the importance of earlier treatment and effective bridging therapy in the KOL community. To sum up, we believe these recent presentations from ASH and Tandem further strengthen our robust body of clinical evidence supporting the long-term benefits of CARVYKTI in multiple myeloma.

This is one of the many reasons why we and our partner, Johnson & Johnson, are moving full steam ahead on our capacity expansion plans. Our partnership with Johnson & Johnson is built to scale CARVYKTI to its anticipated potential of more than $5 billion in peak annual sales. Beyond current indications of CARVYKTI, we are continuing to advance our earlier line studies to potentially expand our addressable market. Notably, CARTITUDE-5 and -6 studies have both completed enrollment already. Based on the data presented recently, earlier treatment may deliver greater durability at lower lifetime cost. We look forward to sharing data when the number of pre-specified events is reached. Looking ahead at our long-term growth, in addition to moving CARVYKTI into the frontline, we remain focused on our R&D pipeline besides CARVYKTI.

We have developed a lean approach to leveraging investigator-initiated trials in China, or IIT, to rapidly establish clinical proof of concept, and each of our programs is gated by clear evidence thresholds, which avoids inefficient use of capital. For example, we advanced one of our first in vivo CAR-T programs from candidate selection to first patient dosing in six months. We continue to anticipate that we will present clinical data this year. Additionally, we continue to invest in other blood cancer, solid tumor, and autoimmune programs that we view as having transformative potential. Our plan is to file one to two U.S. INDs by the end of this year. In addition to investing in our own in-house R&D efforts, we will be opportunistic this year about generating new revenue through business development efforts.

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

Thank you, Ying. Turning to our fourth quarter results, CARVYKTI net trade sales grew 66% year-over-year and 6% from the third quarter due to seasonality of shipments. Our global growth was driven by continued share gains, site expansion, and growing geographic footprint, now reaching 294 global treatment sites across 14 markets worldwide. U.S. net trade sales of $420 million grew 38% year-over-year and 6% quarter-over-quarter. We continue to move our business toward earlier line settings and are pleased to report that approximately 65% of our patients are from the second to fourth line setting. Outside the U.S., we achieved sales of $135 million, representing an over 3x increase compared to the same period a year ago and a 5% increase quarter-over-quarter.

This performance was supported by continued growth in key markets such as Germany, Spain, and Belgium, and bolstered by the Tech Lane facility in Belgium, which came online in September 2025 for commercial production to serve ex-U.S. markets. Looking at the broader multiple myeloma opportunity, BCMA-directed therapies remain significantly under-penetrated in earlier lines, with less than 5% of patients in the second through fourth line setting treated with a BCMA targeting agent in 2025. The majority of patients in this population are BCMA treatment naive, providing a unique opportunity for CARVYKTI to address unmet needs. Our strategic focus on earlier line use is strongly supported by evidence showing that earlier intervention yields better outcomes. As Ying highlighted earlier with data from the ASH and Tandem meetings, CARVYKTI demonstrated durable long-term benefits and improved outcomes are associated with earlier use.

No other BCMA targeting CAR-T therapy has matched this depth of long-term survival data or overall survival benefit over standard therapies. CARVYKTI's foundation of unrivaled evidence, coupled with our capacity to manufacture 10,000 doses annually with high success rates, positions us well to capture this sizable market potential. Before turning to how this unique profile serves the community setting, I wanna shed light on the patient management strategies we have been able to implement and explore with our patient data sets and how things have changed since we and J&J launched CARVYKTI. Importantly, as we recently saw at the ASH and Tandem meetings, there is definitive evidence that effective bridging therapy can debulk tumor burden, mitigating the risk of neurotoxic events such as Parkinsonism. It is associated with both improved safety outcomes as well as efficacy outcomes.

In a study across more than 20 academic centers, published by Dr. Dhakal from Medical College of Wisconsin, there were no cases of colitis or Parkinsonism following at least one cycle of talquetamab bridging therapy and CARVYKTI infusion. The study included more than 130 patients, with 98 patients treated with CARVYKTI. Furthermore, Dr. Sidana from Stanford published a very large study that looked at a total of 761 CARVYKTI-treated patients across 15 large tertiary academic centers. Of the 22 patients with Parkinsonism, 21 of these cases occurred in patients who did not have a response to bridging therapy. Clearly, implementing effective bridging therapy results in better patient outcomes, and we are educating physicians on the importance of this strategy. Turning to the community adoption, we believe CARVYKTI is well positioned for success here.

There is no other CAR-T with over five years of progression-free outcomes in late-line myeloma and a demonstrated overall survival benefit in earlier lines. CARVYKTI keeps raising the bar on efficacy as well, and as you saw at ASH, the median PFS was 50.4 months for triple-class-exposed patients with relapsed refractory multiple myeloma and three prior lines of therapy from CARTITUDE-1 and CARTITUDE-4. As it relates to safety, CARVYKTI's profile is well understood at this point. Multiple CAR-Ts have had cases of Parkinsonism documented. Patients and physicians don't have to ask when class effects might emerge, as they can simply refer to CARVYKTI's data set. Furthermore, physicians have been using this data to improve patient management, and now we know the impact of effective bridging on safety outcomes, which can further reduce risks.

Lastly, CARVYKTI is suitable for appropriate multiple myeloma patients looking for a one-time infusion, regardless of the treatment setting, since it can be administered in outpatient settings as well. Given all these factors, you can see why CARVYKTI has had steady traction in the community setting. Community hospitals now comprise 1/3 of the 145 CARVYKTI-authorized treatment centers in the U.S., with 80% of myeloma patients living within 50 mi of a treatment site. Additionally, we continue to see the outpatient setting comprise about 1/2 of CARVYKTI prescribing volume, further supporting broad accessibility. In summary, CARVYKTI remains the undisputed leader of CAR-T sales and is the only CAR-T with this sales execution track record as we focus on reaching its peak sales potential of more than $5 billion.

Our core focus remains on unlocking the curative potential of CARVYKTI and accelerating adoption in earlier lines where we see the greatest impact for patients. Over the course of this year, we expect to benefit from the following growth drivers, unmatched data maturity and survival data that is not seen in the class, extensive real-world experience treating more than 10,000 patients, far outpacing peers, educating physicians and patients on the benefits of CARVYKTI and advantages of earlier use, global expansion supported by capacity for 10,000 annualized doses, additional adverse event mitigation strategies to improve outcomes for CARVYKTI patients. Now I will turn it over to Carlos Santos.

Thank you, Alan, and good morning, everyone. I'm pleased to walk you through our financial performance, which reflects another quarter of progress towards company-wide profitability. During the fourth quarter, we delivered strong top-line growth driven by the continued momentum of CARVYKTI and the expanding global footprint that Alan outlined. Revenue reached $306 million, representing 64% year-over-year growth. Our gross margin remained consistently strong at 61%, with a gross margin on CARVYKTI net product sales of 57%. What is most important is that this growth is increasingly translating into operating leverage. Our operating margin has improved dramatically. From -142% in the second quarter of 2023 to just -6% in the fourth quarter of 2025. This improvement has been steady across 10 consecutive quarters. This reflects two things.

First, the scalability of the CARVYKTI franchise, and second, our disciplined approach to managing the cost structure as we grow. Given this trajectory, the CARVYKTI franchise became profitable in 2025, and we believe we remain on track to achieve enterprise-wide profitability in 2026. With a revenue compounded annual growth rate of 77% since the second quarter of 2023, and gross margins starting to stabilize at 55% or more over the past four quarters, we have a clear line of sight to achieving this milestone. Turning to the next slide, revenue growth of 64% significantly outpaced our 6% growth in total operating expenses, reflecting our commitment to scaling responsibly. R&D declined 3% year-over-year as our BCMA frontline clinical programs mature, and we increasingly shift investment into our next-generation in vivo platform.

SG&A grew 22%, driven by targeted investments to reinforce our leadership position in BCMA CAR-T, such as sustaining share of voice leadership by expanding our sales force, as well as investing in direct-to-consumer campaigns. Back office and administrative functions continue to scale efficiently as the business grows, reflecting strong internal cost discipline. Our operating loss improved by 75% versus the prior year to approximately -$20 million. After excluding items that are not representative of our company's core business, including stock-based compensation and unrealized FX gains or losses, we have reported positive adjusted net income of $2.5 million, a meaningful transformation from a $59 million adjusted net loss a year ago. Our adjusted diluted income per share was $0.01 compared to -$0.15 for the same period last year.

We ended the year with $949 million in cash equivalents, and time deposits. Operating cash flows continues to trend in the right direction, as evidenced by our $12 million in operating cash flow outlays this quarter, compared to $82 million in operating cash flow outlays for the same period last year. This cash position provides us with optionality as we focus on the following investment priorities. First, advancing our in vivo programs. Second, focused synergistic business development. Third, supporting CARVYKTI profit expansion through focused commercial and medical investment. And finally, modest capital expenditures tied to manufacturing capacity expansion. We will continue to prioritize disciplined expense management as we invest in our future. Importantly, we believe we remain on track to achieve our expectations for company-wide profitability this year.

In summary, our financial performance reflects the collective strength of Legend's differentiated cell therapy platform, the scalability of the CARVYKTI franchise, and our disciplined approach to growth. We have a market-leading CAR-T therapy in a vast multiple myeloma market, a robust balance sheet, expanding margins, and an innovation engine that is advancing at speed. With more than 10,000 patients treated globally and a growing footprint of treatment centers, we believe we are well-positioned to translate our clinical leadership into long-term sustainable value. Now it's time to take your questions. Operator, we're ready for the first question, please.

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

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

Hey, good morning, Terence. This is Ying. Thank you for the questions. On your first question, we are planning and also we're committed to sequential growth throughout the year. That includes all four quarters of 2026. We have said that, you know, we feel reasonably confident of delivering CARVYKTI according to the street consensus number, which is about 50% top line growth from last year, right? That's what we're feeling confident about. On the second question about BD, I think it's two directions, right? We obviously are interested in certain technologies that are complementary to what we have in-house. As you know, we have a couple in vivo CAR-T programs that are in the clinic today, those in patients already, and those are lentiviral vector-based delivery.

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

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

Hi, guys. Thanks so much for taking my question, and congrats on the progress. I guess I would ask, now that we've had a couple of months post-MagnetisMM-3 for you to get feedback from the actual providers and commercial sites, how are you hearing that docs are gonna position the use of bispecifics in early lines relative to CARVYKTI? I mean, Ying, you went through some of the differences in the trials, but in the real world, how has the feedback been in terms of positioning, and how do you foresee driving growth in those early line settings where, Alan, you mentioned adoption is still very modest?

Hi. Yes, this is Alan. Obviously the MagnetisMM-3 data is good news for patients, but I would remind you, and we have heard multiple times that this is a very large opportunity in second and third line. In fact, there are over 100,000 patients, second line plus, globally. That means that there is a significant unmet need and a significant opportunity for the CAR-T adoption in second and third line. We have seen, as our business has evolved, the fastest growing segment of our business has been in second and third line, and we expect that to continue.

We continue to hear very significantly that there is a very unique value proposition for CARVYKTI in these earlier line settings as a one-time infusion, delivering overall survival and five-year treatment-free remissions in the later line patients as well. We also have heard very significantly that the IMWG guidelines really help physicians understand that the sequencing here is important, that you wanna get patients as quickly to CAR-T as you can, and that putting a BCMA bispecific in front could diminish the efficacy that you could get from CAR-T. A very strong alignment with the IMWG sequencing guidelines, the significant opportunity, and the unique profile of CAR-T is what we're hearing in the marketplace.

Thank you. Our next question comes from Edzer Darault with Barclays. Your line is open.

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

In terms of the community adoption, we're very pleased with where we've been. As I've mentioned earlier, we have about a third of our activated treatment centers are community or regional hospitals, and this is an important part of the community story. For example, I'll just give you a few examples. Orlando Health in Florida or Sutter Health in California, these are examples where we've been able to bring CARVYKTI closer to patients. Another example is we had an academic medical center activated Hackensack University Medical Center in the northern part of New Jersey, and now we have the southern part of the state covered with a regional affiliate, the Jersey Shore University Medical Center. Those are examples where we are hearing very significantly that bringing CARVYKTI closer to patients with these community hospitals is a value add.

We are also expanding the use in the physician practices, and I'm very excited to announce that in addition to the Virginia Oncology Associates activation that we had in 2025, we have now activated in Tennessee Oncology in Nashville, and that helps us again as we step forward into these community practices. We also have seen the referrals increase, and we are having more and more conversations between the activated centers and the referring base. These are all the steps that we are heading towards. I think, to your question, it's all about continued education and making sure that the community physicians understand that as they refer patients in, they are going to be getting their patients back without the REMS now in place.

We've heard that again as a significant gaining factor that without the REMS in place, more patients can be monitored closer to home. More community physicians are more comfortable getting their patients back and monitoring them locally, and that is enabling the referral base as well.

Great. Thank you.

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

Hi. Thanks for taking my question. This is Linhai Zhao from Goldman Sachs. You mentioned about the current CAR-T penetrations, less than 10% in the fifth line and also less than 5% in second to fourth line multiple myeloma. Just curious, what would be your practical target or can you further comment on the potential ceiling values for this CAR-T penetration seeing this both late line and early line multiple myeloma? That's the first question. The second question is about [TECVAYLI]. Just wondering, given that [TECVAYLI] may also not be a favorable treatment option in community setting, would you consider the community hospitals as a bigger growth opportunity, or are you going to still capture the majority of the growth in the academic centers? Thank you.

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

Now, in terms of, you know, what we're trying to target, obviously I think, number one, we can lead with our efficacy because it is better efficacy in both progression-free survival and also survival. That resonates really well with both patients and also the physicians in the community setting. Secondly, we also talk about the one-time convenience, which is a great quality of life improvement for patients because, if they invest about one month with us, and then we can provide years of progression-free survival and also treatment-free remission here. That's our second selling point. Then lastly, even in terms of health economic benefit, right? If you look at the total treatment cost, we're providing savings, significant savings over standard of care, over a certain period of time, given the clinical evidence we have accumulated from CARTITUDE-4 trial.

That is our strategy, how we can completely go into the community. Now, in terms of you know, our assumption, right? I think, first of all, we're getting to that important milestone of delivering annual supply of 10,000 doses per year from all of our network in the supply chain. Secondly, with the current and ongoing CapEx, we and J&J are planning to supply up to 20,000 doses into both U.S. and European markets. That is our plans, and these plans obviously are based on our projection of the demand and also the real-time market research. We have a lot of confidence in the penetration of CAR-T into this market. I'll ask Alan to answer the second part of the question.

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

Got it. Thank you so much.

Thank you.

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

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

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

Gross margins?

Yeah, Eric, with re-

Yeah.

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

Thank you.

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

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

Good morning, Kostas. Thank you for the questions. First of all, I think the acquisition you referred to validates the value of this market, right? Because we're looking at the multiple myeloma market for autologous CAR-T, and certainly that lends to this support of the valuation of the market we're targeting. We have already said, right, how much the market is. You're looking at a $35+ billion market for multiple myeloma and CAR-T will become an increasing portion of that pie. Secondly, as you correctly pointed out, the PDUFA date is December 23rd by FDA, assigned on anitocabtagene autoleucel. As you know, based on the FDA-published guidance document, there are only two criteria when the agency decides whether application of certain drug candidates merits standard review or priority review.

The first criterion here is, whether the disease or target is a serious life-threatening disease. I think it goes without saying, multiple myeloma is a life-threatening disease. The second criterion is, whether the agency deems the candidate has any clinical differentiation over existing therapies. Now, clearly, based on the FDA determination of standard review, you know the answer how FDA views this application, based on the data supplied in that package. We feel this is really another validation of that CARVYKTI really has the unmatched efficacy and durability in the field. We agree with the FDA view on this point. That's pretty much what I can say about this. In terms of the competition implication, I'll ask my colleague, Alan Bash to comment.

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

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

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

It sounds like, I guess the question is Legend set on leveraging its lentiviral infrastructure and focusing on viral delivery platforms for its in vivo efforts? Or is it early enough that Legend is also exploring non-viral platforms such as nanocarriers? Thank you.

Thanks, James, for your questions. On your first question about CAR-T, we certainly do not believe this is a zero-sum game for all CAR-Ts, because if you look at our growth, right, we have been treating already more than 10,000 patients, and we think there are still tens of thousands of more patients that will be treated by CARVYKTI. We are on a pace to increase our capacity from annualized 10,000 to 20,000. Meanwhile, we're also looking at other options, for example, automation, to increase efficiency and also output within the current square foot footprint, right? We believe others, including AZ and Gilead, are using similar approaches. Clearly, we all believe that this is a space that is worth investing.

Given, again, the efficacy, we believe that more and more patients will opt for CAR-T. We still think there's a lot more to come in terms of supply to the market, and also obviously that will be matched by demand from the market. On your second question about lenti. As you know, since the company was founded in 2014, we have been working on lenti vector as a delivery vehicle for CAR-T. We have accumulated a lot of experience and expertise on this, and our first couple in vivo CAR-T programs in the clinic today are using lenti vector as a delivery for the in vivo CAR-T programs in both large lymphoma and also the multiple myeloma indications respectively.

Now, on the other hand, we also realize that there are other competing technologies, including what you mentioned, the LNP, encapsulated RNA or DNA. That's another way to look at it. We're obviously interested in other technologies as well. On the other hand, I believe that if we can show safety proven in the clinic, then there's no reason why lenti vector cannot be used in other indications such as autoimmune disease as well. We look at the space with a very broad net, and we're very open mind in terms of you know, potentially partnership or business development activity to bringing other technologies here.

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

Hey, guys. Thanks for the question. One for me. With Iberdomide NDA now accepted by FDA on MRD results and Vinay Prasad leaving soon, how does this alter your calculus on potential for filing on MRD results for product 26? Thanks.

Thanks, Sean, for your question. I think you have seen the agency published recently a draft guidance document for the industry based on MRD as a registration endpoint for accelerated approval in multiple myeloma. On the other hand, there is a footnote in the FDA document that says that the ODAC discussion was based on meta-analysis for modalities such as small molecules and also on injectable antibodies, right? To date, there's no data out there that actually suggests a correlation between the clinical outcomes, such as PFS and survival and MRD activity in CAR-T modality. We're very much aware of that. In fact, we are probably the trailblazer in this field because we will expect CARTITUDE-5 top-line data in the near future, right? This year or next year.

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

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

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

On your second question, the split that we've shared is that the second through fourth line population continues to grow, and that is now 65% of our business, which is exciting because it shows an evolution, and it shows that the majority of the patients in our mix are getting it in earlier lines. The only other sort of color on that one that we've shared is that we have seen this very significantly that second and third line patients, while all lines are growing, second and third line continues to grow the fastest. As far as your question about CAR-T data ex-U.S., I can't speak to the J&J plans there. I would just say that for CARVYKTI, we continue to see significant uptake in the ex-U.S. markets.

We are now in 13 markets outside the U.S. More major markets are coming online in 2026 and beyond. The uptake has been very significant in markets such as Germany, Spain, and Belgium and others. That's because, number one, they've been taking the learnings from the U.S. launches, applying them to patient selection, and management of patients, as well as, you know, the healthcare systems really support this concept around a one-time infusion and getting patients from a budget impact into a long-term remission based on a single infusion. There's very strong support ex-U.S. for the CAR-T model and CARVYKTI specifically.

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

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

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

As you develop these new programs, in spaces that already have existing CAR-T options such as myeloma or lymphoma, I guess, how do you get confident that what you show, what you're gonna see early on in terms of response rates is actually gonna translate to better long-term outcome data and make it worthwhile to move that program forward? Thanks.

Morning, Leo. Thanks, for your questions. On your first question, yes, you're right. We have explored, obviously all modalities in the field CAR-T, including autologous, allogeneic, that includes alpha beta and the CAR modality, and then most recently, also NK, as well as our latest entry into the field that is in vivo. I think based on the clinical data we have seen to date. Also based on what we're seeing in the field, yes, we are particularly interested and also excited about in vivo CAR-T approach because, on one hand, in vivo CAR-T approach can provide a ready-to-go off-the-shelf version that is very convenient for both patients and physicians. In the meantime, you don't have to worry about rejection, right? Because that is the biggest hurdle for allogeneic modalities in T cell therapy.

Here, you're leveraging the patient's own immune cells, therefore, you really don't have to worry about rejection. That is why, I think the field is very excited about the promise of in vivo CAR-T. Obviously, you have seen some clinical data, and we have not published any clinical data yet, but based on data we have seen in patients so far, we're also quite excited about the manageable safety and also the preliminary efficacy signal as well. Although we need more time to follow up in terms of durability compared to autologous. There are certain metrics, for example, we can look at. In multiple myeloma, you can look at MRD negativity. That is a very early but also very reliable sign for a longer-term clinical outcome.

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

Again, so that is something that we track in the clinic as well. I think the prior clinical experience in CAR-T really taught us a lot how to look at the efficacy in the very beginning of the program. That's how we track the clinical progress.

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

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

The CITADEL study, which is a multicenter study looking at ALC monitoring and then management and treatment approaches, should have data presented some point this year. I would also point out that another significant data set are the data sets around bridging therapy, because as we hear more and more, this becomes a crucial strategy for physicians both in the community and at the activated treatment centers to adopt. We see very strong support for and significant acceptance of bridging as a standard of care. In fact, we were very pleased in January to see the NCCN guidelines updated to include the use of talquetamab as a bridging therapy and a larger discussion about the need for bridging therapy, in advance of a reinfusion of manufactured CAR-T cells.

This is important because this is what is actually helping debulk the tumor and then get to better outcomes both on a safety and efficacy standpoint. Both the study that I referenced earlier from Stanford with Dr. Sidana, as well as the publication from Dr. Dhakal and ongoing new studies from Dr. Dhakal, reinforce this concept that bridging therapy is really helping mitigate some of these concerns.

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

Thank you.

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

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

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

Great. Thank you.

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