Legend Biotech Corporation

Legend Biotech second quarter 2025 earnings call. At this time, all participants are in the listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during this session, you would need to press the star 1-1 on your telephone, and then you will hear an automated message advising your hand is raised. And to withdraw your question, please press star 1-1 again. Please be advised that today's conference is being recorded. I would now like to turn your conference over to Caroline Paul, Associate Director of Investor Relations. Please go ahead.

Good morning. This is Caroline Paul, Associate Director of Investor Relations at Legend Biotech. Thank you for joining our conference call today to review our second 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 Carbecti, and Jesse Young, the company's interim chief financial officer. Following the prepared remarks, we will open up the call for Q&A. We have our President of R&D, Goi Fang, and Chief Medical Officer, Maithili Kaneru, 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 here within. These forward-looking statements are discussed in greater detail in our SEC filings which we encourage you to read and can be found under the Investors section of our company website. In addition, adjusted net income or 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. We believe that adjusted net income or loss provides a useful measure of our operating performance from period to period. Our press release includes IFRS to non-IFRS reconciliations for these measures. With that, I will now turn the call over to Yang.

Hello, everyone. Thank you for joining us today. We had quite an eventful second quarter as we made history with our long-term survival data at ASCO and achieved the most CAR-T sales ever during a single quarter. During the second quarter, CAR-VT net trade sales were approximately $439 million, which is 136% increase year over year. We have now treated over 7,500 patients with CAR-VT, and our launch remains the strongest CAR-T launch to date. In the US, more than half of our utilization is now in the earlier line setting. We continue to anticipate achieving operational break-even for CARBICTI by the end of 2025 and company-wide profitability in 2026, excluding unrealized foreign exchange gains or losses. On a regulatory front, we're excited about the FDA's decision to remove risk evaluation and mitigation strategies, or REVs, for currently approved BCMA and CD19-directed autologous CAR-T therapies. As a result of this change, CAR-VT's FDA label was also updated to reduce monitoring requirements, such as instructing patients to remain within proximity of a healthcare facility for at least two weeks instead of four weeks. and advising patients to avoid driving for at least two weeks following product administration compared to eight weeks previously. We expect these label updates to improve the patient experience and enhance access for patients in both the community and academic settings. On another overwhelmingly positive note, we received a lot of great publicity following our presentations at ASCO and EHA in June. starting with new data presented at ASCO on our pipeline candidates. In the Phase 1 study, LB1908, our autologous Claudine 18.2-targeted CAR T-cell product, demonstrated encouraging antitumor activity with manageable safety and tolerability, and CAR T-cell expansion was observed in all patients. Additionally, in the Phase 1 dose escalating study evaluating LB2102, our DLL3-targeting CAR-T candidate, no dose-limiting toxicity were reported, and a preliminary efficacy signal was observed up to four dose levels. As a reminder, we have an exclusive global licensing agreement with Novartis to develop and commercialize LB2102 and other DLL3-targeting CAR-T therapies discovered by legend. Turning to CAR-VICT, there were two different analyses I'd like to spend some time highlighting from ASCO. First, you'll recall that in the final protocol-specified analysis of cartitude 1, the median PFS was 35 months, and median overall survival had not been reached, which had already established a new benchmark for triple-class exposed patients with relapsed refractory multiple myeloma. Subsequently, at ASCO this year, in an analysis of remission and survival from cartitude 1, One-third of patients with heavily pretreated relapsed refractory multiple myeloma remain alive and progression-free for five years or more after being treated with CARVICTI without further multiple myeloma treatment. Furthermore, patients with high-risk cytogenetics and those with extramedullary plasmacytomas were equally likely to be progression-free. To put this into context, At the RSCO investor event, Dr. Sondar Jagnaz noted that some of his patients were deciding between hospice and CAR T therapy. The median overall survival of five years clearly set a new benchmark in this population. As a result of this groundbreaking data, numerous media outlets publicized these results as well as patient stories. A number of clinicians indicated to us that they have noticed increased patient awareness about CARVICTI following some of these articles and TV news stories. Second, based on analysis of subgroups in intent to treat population from CARTITUDE4, CARVICTI improved progression-free survival and overall survival versus the standard of care in all subgroups, including patients with standard and high-risk phylogenetics, EMD, and one prior line of therapy and beyond. For example, the median PFS for patients with high-risk fetal genetics was 37 months compared to 10 months for the standard of care. These data continue to support a positive benefit versus risk ratio for CARVICT in patients with lenalidomide refractory multiple myeloma as early as after first relapse. Turning to further improvements in CARVICTI safety profile, we continue to leverage our learnings on extensive data that's been generated on over 7,500 patients treated with CARVICTI. We are facilitating best practice sharing on predicting, mitigating, and managing neurologic events, and we continue to highlight new safety data to patients and physicians. Importantly, we do not see a mature impact on utilization and expect continued strong performance on CARVICTI. In a few moments, you'll hear from Alan on how we and our partner, Johnson & Johnson, are trying to bring CARVICTI to more patients in need of a CAR T therapy with a demonstrated survival benefit. On a final note on CARVICTI, before we turn to our pipeline, we continue to expect to complete enrollment for CAR T6 this year. We believe CAR T5 and 6 trials are key to moving CARVICTI into the frontline setting. Looking at long-term growth for Legend, in addition to looking toward moving CARV-X into the frontline, we remain focused on solidifying our leadership in the field of cell therapy. We're making progress in new indications, such as solid tumor programs, as you have seen with the recent ASCO data. Additionally, we remain excited about the new research facility currently being built in Philadelphia, where in vivo delivery will be one of its key focuses. positioning us well to pursue this area of innovation with the right infrastructure and resources. We believe this next-generation approach to off-the-shelf therapy holds a lot of promise for incurable diseases. Our new platform, TAVEC, which is short for T-Cell Activation Vector, is being used to target oncology and autoimmune indications. It provides T-cell specificity, activation, and safety through mutations in glycoprotein to block transduction of non-T-cells. We've already dosed a few patients in an IIT study for non-Hodgkin's lymphoma, and we're planning for multiple U.S. IND-enabling studies in the future. We're excited to be embarking on this next frontier of cell therapy innovation, and we look forward to providing additional updates as we make progress on this front. To sum up, Legend is the largest standalone cell therapy company with over 7,500 CARVIC-T patients treated as we forge the path to cure. With a cash position of approximately $1 billion, we are investing in our core differentiators in cell therapy and remain focused on delivering operational efficiency in order to ensure durable long-term growth. And with that, I'll pass it over to Alan to provide an update on CARVIC-T.

Thank you, Ying. As Ying mentioned, Carvicti is now the highest-selling CAR T therapy in a single quarter. Carvicti net trade sales of $439 million during the second quarter surpassed the previous CAR T industry record of $414 million in sales in a single quarter, and all of this was achieved in just 12 quarters, which is record-breaking in the industry. Diving deeper into our performance this quarter, Carvicti net trade sales grew 136 percent year-over-year and 19 percent from the first quarter. Our global growth was driven by continued share gains and capacity expansion. U.S. net trade sales of $358 million grew 114 percent year-over-year and 13 percent quarter-over-quarter. Quarter-over-quarter growth in the U.S. was primarily driven by continued strong demand with nearly 60% utilization in earlier line settings. Regarding OUS performance, we had sales of $81 million, which is four times the amount over the same period a year ago and represents a 59% increase quarter-over-quarter. Our OUS performance was driven by expansion in Germany, Switzerland, Austria, and Brazil, and we continue to be excited about bringing CARVICTI to more eligible patients in Spain, Denmark, Sweden, Belgium, Portugal, and the private markets of Israel and the UK, where we recently launched. Turning to tailwinds to build upon our CAR team market leadership in multiple myeloma, As it relates to manufacturing, we expect to receive approval for our physical expansion in Raritan by the end of the year. Our Tech Lane facility also remains on track to initiate commercial production later this year. This is another critical component of our plans for serving patients in Europe to meet the increasing demand. The progress we've made in executing our manufacturing plan and investments has enabled us to be among the best in class. Our manufacturing success rate remains at 97%, which we believe is the highest in the CAR T industry, and we are focused on continued reductions in our turnaround time, which stands at 30 days. We believe this turnaround time is more than sufficient based on our conversations with physicians. As we expand manufacturing capacity and enhance our efficiency, we expect to benefit from a number of demand tailwinds as well. First, of course, is the recent unprecedented long-term survival data that we presented at ASCO on CARTITUDE 1. Second is our demonstrated overall survival benefit. The superior efficacy we have compared to other CAR-Ts should be further aided by the recent REMS updates, which are an incremental positive for patients receiving CAR-T therapy and their quality of life post-CAR-T administration. Lastly, in the U.S., we have expanded access to CAR-VICTI in the community by continuing to activate more treatment sites. The number of authorized treatment centers has quickly increased since launch We now have 123 sites across the United States, and outside of the U.S., we will continue to benefit from the recent launches I mentioned earlier. I'd like to expand now on our strategy for second-line plus adoption in the U.S. and provide an update on our progress outside the U.S. First, the opportunity to offer CARVICTI to the second-line multiple myeloma patients and beyond remains significant. We estimate that there are about 80,000 patients globally in the second to fourth line who could potentially benefit from our treatment. Combined with the fifth line plus opportunity, this represents over 100,000 patients globally. Aside from targeting specific types of relapsed refractory patients who might benefit most from CAR T based on their prognosis, we have now implemented strategies to engage treaters referrers and patients. In parallel with educating physicians on CARVICTI's profile in order to increase referrals to CARVICTI sites, we are also working to increase patient awareness through advocacy efforts and even direct to consumer education efforts. In fact, we know that multiple myeloma patients and their caregivers are highly educated and engaged in their care, which is why we think engaging them directly will be impactful We recently launched an awareness campaign on multiple digital streaming and social platforms about the benefit versus risks of a one-time infusion of Carvicti. We are looking forward to building awareness through this first-ever patient campaign. While we engage community physicians and patients today, we are also looking ahead to continue to expand treatment into the community as well. Our launch took us from a concentrated set of tertiary care and academic centers to where we are today with an expanded footprint, about a third of which is made up of regional and community hospitals who have become local experts in CAR-T. And as we look to the rest of this year and beyond, we are embarking on bringing CAR-T even closer to the community with identifying community practices that can do CAR-T administration. We are pleased to announce that Virginia Oncology Associates, a network of practices serving a large part of the state, is one of our first partners in this effort. To sum up, I'm very pleased with our progress to date to reach more patients. Alongside Johnson & Johnson, we have activated 123 treatment sites since launch, and while practices in the community setting cannot be activated overnight, we have multiple strategies in place to make CARVICTI a more readily available treatment option in the future. CARVICTI has also seen significant international expansion. In 2024, we launched four markets, and we've more than doubled that for 2025, and we are only in August. Our growing footprint in markets outside the U.S. is supported by our manufacturing facility in Obelisk, and we will be further supported with the Tech Lane site, expected to start commercial production for Europe later this year. Globally, with the help of our partner, Johnson & Johnson, we have activated 213 treatment sites. The record-breaking pace at which we have moved to expand access and become the highest-selling CAR T therapy in a single quarter with a demonstrated overall survival benefit is a testament to our joint ability to trailblaze in the field of myeloma cell therapy. Now it's time to take a closer look at the financials, so I will turn the call over to Jessi.

Thank you, Alan, and good morning, everyone. During the second quarter, we delivered solid financial results with Kavikti net sales up 136% year-over-year. Total revenues were $255 million, driven by collaboration revenue growth of 136% year-over-year. Q2 delivered a $125 million net loss, but $10 million in adjusted net income, after excluding items that are not representative of the company's core business, such as a $111 million unrealized foreign exchange loss due to our Treasury Center based in Ireland. Importantly, our operating loss of $41 million in the same period one year ago was reduced by almost half to an operating loss of $22 million during the second quarter. The meaningful improvement in operating results was driven by our operational efficiency and disciplined expense management. Even though we continue to invest in our robust pipeline and supporting the second-line indication launch and our manufacturing capacity, our second-quarter growth margin on net product sales was 57%. As expected, R&D expense on an IFRS basis declined slightly to $98 million, or 39% of revenue, while SG&A on an IFRS basis grew 23% from the prior year to $81 million in the second quarter, or 32% of revenue. Overall, we believe we have been making strides towards positive operating cash flow generation and profitability. Our adjusted diluted earnings per share was $0.03 compared to negative $0.01 for the same period last year. Now turning to capital allocation. We continue to have a strong balance sheet with $1 billion in cash and equivalents and time deposits. We will continue to prioritize disciplined expense management as we fund our operating and capital expenditures, including future innovation, until we achieve profitability, which we anticipate in 2026, excluding unrealized foreign exchange gains or losses. In summary, our second quarter results demonstrate strong commercial execution, supported by CAFIC-T's differentiated clinical profile, along with increasing operational efficiency. We are also pleased with our progress towards pioneering next-generation cell therapy treatments for intractable and incurable diseases as we look to maximize our cell therapy platform. And now it's time to take your questions. Operator, we are ready for the first question, please.

thank you as a reminder to ask a question please press star one one on your telephone and wait for your name to be announced to withdraw your question please press star one one again the first question comes from terence flynn with morgan stanley your line is open hi uh congrats on the progress thanks for taking the question uh maybe two for me

I was just wondering if you can give us any update on potential timing of interim readouts from Carditude 5 and 6, recognizing the importance of these studies to moving into the first-line setting. And then on the efforts in the community oncology setting, can you provide us any more details about Virginia Oncology, like why they elected to lean in here and how you think about that as a template for maybe some other community oncology centers to follow and what the timeline might be? Thank you.

Thanks for your question. Regarding the interim readouts, I think we're monitoring the events closely and ultimately going to be driven by the events that we see. Obviously, we're in discussions also with the FDA about, you know, using MRD as a dual primary endpoint, and we don't have much to say beyond that, you know, that we will continue those discussions and see continue to see how the data evolves.

Hi Terrence, it's Alan. Yes, our efforts in Virginia Oncology is in fact a template for how we're thinking about the community adoption. As we talked about before, it has the following components. We want to make sure that we are expanding our footprint into the community and regional hospital setting. We want to make sure we're driving referrals from community practices, and as VOA demonstrated as a key milestone for us, also starting to activate in the network of community oncology practices. VOA is a leader in this space. They previously administered CAR-T, both in the lymphoma and the myeloma space. So, they're well respected in this area. They're part of the McKesson network, and they were very excited to partner with CARVIC-D.

And the next question will come from Gina Wong with Barclays. Your line is open.

Thank you. Also, congrats on the strong quarter. So maybe I will follow Taryn's question regarding the community expansion effort. So have you seen any percentage of revenue was driven by this effort into Q25? If not, when do you see this effort was started to be shown in the revenue? And then also related launch questions of 123 treatment centers What percentage has outpatient setting, you know, set up? And also for Q25 revenue, what percentage of patient or revenue were from outpatient settings?

I'll share a couple of factors here. First of all, 70% of patients come from the community setting. So that's why the community setting and our continued penetration in that space is very important. And as I mentioned, those efforts will include not only expanding the footprint within the community and regional hospitals, driving referrals, but also starting to administer in the community practices. I think it's a little early for us to pin specific numbers on each element or the contribution of each element or any particular site. In terms of outpatient, though, I'll also give an update. We continue to see that a little over half of our patients are administered in the outpatient setting. That is both across any of these community sites, as I mentioned, as well as in the academic centers, their ability to use an outpatient setting. And that's important because that frees up capacity from the inpatient constraints and infrastructure constraints and enables us to not only improve the experience for patients, but also improve the experiences for the centers. The other element that we've talked about before is earlier line treatment. And as we go into the community, we expect to be able to see more patients referred into the academic centers and the authorized treatment centers from the earlier lines of therapy.

Thank you. And the next question will come from John Miller with Evercore. Your line is open.

Hi, guys. Thanks so much for taking my question, and congrats on all the progress, too, for me. I would love to hear more about the breakdown of your currently treated patients in these early line settings. I know you talk about the Cartitude 4 label from second and fourth line, but what about patients in the second line specifically and the third line specifically where you won't be overlapping at all with competitors? What How much of your current revenues are driven by those second and third line patients specifically? And then just one on J&J's, by specific efforts, how do you expect that their next-gen T-cell engagers are going to interact with Carvicti eventually when they're competing on the market? And how do you expect J&J to be positioning them relative to cell therapy? Thank you.

John, we don't plan to break down any more detail around the various lines of therapy, but what I can say is, as we've said before, that nearly 60% of our orders are coming from the second through fourth line population. So those are the earlier line patients who we feel will provide us a significant advantage to any potential competitor who comes in in later lines, and that's from our ordering system. So that is self-reported data from physicians, and we're very excited about that growing each quarter and continuing to grow throughout the course of this year and certainly before any competitor launches. In terms of the biospecifics, I think we've seen that CAR-T is very well regarded as not only a treatment because of its one-time infusion, but also the overall survival benefit and the durability that CAR-T and specifically CARVICTI can provide. And so in terms of positioning, right now, Carvicti is really owning that second through fourth line opportunity within the J&J portfolio. This is an opportunity for us to really solidify our position with patients for whom they've already had one relapse. They're looking for overall survival. They're looking for long-term durability. And J&J and Legend are combined very committed to this positioning for Carvicti.

And also, John, this is Ian. I want to add to Alan's comments. If you notice that, you can find, actually, trials on clinicaltrials.gov, where our partner, J&J, is actually combining and or sequencing CARB-VT with some of the vitals in their portfolio. So you will see the direction of that development. It's a little bit too early and premature to comment on strategy on developing the tri-specific, because right now, it's still at a very early stage and phase one stage. Although we cannot disclose this breakdown of 2nd, 3rd, 4th and 5th line beyond. And plus, some of those are coming from actually insurance claims data. It's not necessarily coming from our own data, but I can tell you, if you combine 2nd and 3rd line, those are probably the fastest growing revenue contributor in the mix of. Also, if you talk to physicians, you will notice that. The large majority, probably seventy, eighty percent of patients are actually receiving a bridging therapy. So sometimes if you look at insurance claim that you will see a second line patient who comes in and then receives a bridging therapy for one or two cycle would actually be classified as a third line patient. That is another reason why we should look at second and third line combined.

One other comment regarding the tri-specific from J&J. If the data that was released, a lot of it was in the BCMA-naive population, which, as we know, is getting harder and harder to find. And so, as we move CAR-VT into earlier lines of therapy, you know, it's really going to be in other BCMA products or approved. It's going to be hard to find that patient population.

Thank you, and the next question will come from Jessica Phi with J.P. Morgan. Your line is open.

Hello, this is Adam on for Jess. Thank you for taking our question. I really had two. Can you comment on the recent blood paper as it relates to real-world rates of neurotoxin with CARVIC-D? And my second one, what is your latest perspective on CARVIC-D's penetration into the CARTITUDE-4 indication of second to fourth line Thank you.

Sure. Regarding the blood paper that you're referring to by Dr. DeKalb, in that large dataset, 98 patients were treated with cilta-cel at 20 various centers. And in those patients that used TALVI as bridging therapy to a single infusion of CARVIC-D, it was noted that there were no events Parkinsonism or Guillain-Barré syndrome. And there are only two reports of chronic palsies, both of which resolved. It really highlights the opportunity of an improved safety profile with strong bridging like with TauV. And if you compare that to the real-world data of about 2%, it decreases to 0% in this large data set.

In terms of the Cartitude 4 population, second through fourth line, again, as we said before, this is our main growth driver. We're focused on driving earlier lines of therapy. And as we said before, nearly 60% of our sales are coming from that population. But I would say, again, as we talked about before, this is a population that is about 80,000 patients worldwide. And so you can just, based on the numbers of patients that we treated to date, we still have a lot of opportunity in this space, a very large opportunity for us to continue to capture in the second through fourth line population globally.

Adam?

Thanks for this question on blood paper. We actually think it's a very important paper here, because if you compare this data set from the competing data set, you're looking at a total of 134 patients receiving Tauvi out of which 119 proceeded to get a CAR T and then 98 patients received commercial CARVIC-T. These are from multi centers, right? 20 centers, including 18 in the US and two in Germany. If you also look at patient baseline, they received a median of five prior lines of therapy. 44% had high-risk cytogenetics. 41% had EMD, extra-major disease. So 85% of those patients would not have qualified for CAR2-1. And yet still, if you look at the safety profile, we did not see any delayed neurotoxins such as Parkinsonism or GBS. There were only two cases of mild cranial nerve palsy, and both resolved. So if you compare this data set to the competing data set of about 120 patients, I would argue it's a very similar denominator here. And also, if you look at the neurotox, very similar as well. I think that is a very well-documented study, like I said, peer-reviewed on Blood Journal. So this gives you a sense of the real-world safety. Thank you.

Thank you. And the next question will come from Cassis Biluris with BMO Capital Markets. Your line is open.

Thanks for taking our question and congrats on the progress. We would love to hear your thoughts around the recent efficacy data from a competitor, and specifically the 18-month PFS, which appears to be similar to CarQ1. Any thoughts around that, although the follow-up is shorter than what you have presented? And how are you thinking about the positioning of CarVicti moving forward? Thank you.

Thanks for your question. I'd like to stress that CAR-VICT is really the best-in-class BCMA CAR-T. We've treated over 7,500 patients, as you've just heard earlier, and it's really demonstrated an overall survival benefit in this early second- to fourth-line patient population as reported in the CARTITUDE-4 study. So, in addition to that, the CARTITUDE-1 data from the ASCO has shown that with the one-time infusion, of a third of the patients in this very heavily pre-treated population actually didn't progress after five years. This is unprecedented data and shows the long follow-up that we have with patients treated with CARVICTI. I would argue that the patient population or study that you're referring to is really fundamentally a different patient population. The prior lines of therapy, the CARTITUDE-1 study is a much more heavily pretreated patient population. And as you have mentioned, their data is immature and still evolving with not sufficient follow-up. So based on some other conversations we've had with physicians, you know, they're really wondering, you know, how these patients have done when they reached the 18-month PFS, how many of them have actually reached that point. And without the evidence of the Kaplan-Meier curve, which actually the CARVICTI had reported around the 18-month timeframe, it's really hard to tell on the R-Select study how these patients did overall. That's why I think it's important that we see that data and stress the fact that CARVICTI is really we differentiate it and have very durable responses with the large amounts of data sets that we've provided to date.

Thank you. And the next question will come from Yaron Werber with TD Cohen. Your line is open.

Hi, this is Yaron from Bob's Recorder, and thanks for taking our questions. You noted on the call that you're on track to finish enrolling Cardi 2.6 this year. This seems incrementally pushed out versus mid-2025 previously. Is there any reason that enrollment might be progressing a little more slowly than expected? And does this mean that we're still going to see an impact on Q3 revenues from slots being diverted to Cardi 2.6? And overall, does that change your expectations that you said previously on accelerating growth for Cardi B in the second half of the year versus first half? Thanks so much.

Our enrollment in gratitude six has been progressing quite speedily. In fact, we've completed enrollment globally, except for, you know, continuing to complete in Japan, which is the last country. So we're very excited about the fact that physicians were enrolling on this study and it shows the excitement of this patient population with cardiac disease.

And just to add in terms of your second part of your question, we're very confident in our ability to continue to drive capacity expansion in the second half of this year. Novartis continues to ramp throughout the year. The TechLink clinical approval is taking on those patient slots and enabling more commercial capacity across the network, as well as we continue to get efficiencies from our network in terms of out-of-spec rates. improved turnaround time, and better manufacturing success rates across the network. And as we mentioned before, in the second half this year, we anticipate the physical expansion for Raritan, as well as the commercial approval for TechLane.

And, Jenna, maybe I'll just add that if you recall, for the CAR TG-1 trial, for that indication, we actually enrolled also very small, you know, less than 10 patients cohort, just specifically for the Japanese approval, because that's a requirement from PMDA. So, we're doing the same for our CAR TG-6. But like you just heard from our chief medical officer, that we have already completed global enrollment for CAR TG-6.

Thanks so much.

And the next question will come from Kelly Shee with Jefferies. Your line is open.

Congrats on another strong quarter. Curious, as the conviction has traded now over 7,000 patients, also follow up on your commentaries on overall safety profile, including delayed neurotox. Curious, any noticeable difference that has been observed in earlier line patients versus late line? If so, what are the factors that drive the difference? Thank you.

Thank you for your question. As we've shown from the CARTITUDE 1 to the CARTITUDE 4 data, the delayed neurologic events has decreased, particularly the Parkinsonism, from 6% to 1% in CARTITUDE 4. So we do believe that earlier line treatment does improve the safety profile quite significantly. And part of that success is the strong bridging therapy that is provided to these patients. And these patients just have more options for good bridging therapy in the earlier lines. As we discussed earlier in the call, Blood paper by Dr. shows that in a large data set that there was no evidence of Parkinsonism on further showing the importance of, you know, having good bridging therapy to decrease the neurologic events, but also improve the efficacy profile ultimately. Both of these things I think will be really important. I think as we continue the mitigation strategies that we put in place are important and treating physicians are using them and they continue to show improvement in these safety events.

Kelly, I'll just add a little color on what we're seeing from physicians and hearing from the field. The earlier the patients are referred in and treated, the better experience overall. The T cells are fitter, so that means that we have lower out of spec. We have better efficacy. We also, by virtue of what Mai outlined, also we have lower rates of any of the rare bacterias side effects. So we are in a situation where everything is better when you treat earlier, and that message is very much resonating. That's what the thought leaders are talking about from the podium. Get your patients in earlier, and you get the benefit of CAR T earlier in the treatment paradigm.

And Kelly, this is Yi. Maybe I'll just add the last point, which is everyone follows the FDA AER database. Again, if you look at the overall incidence, it's increasing, but that's because we're treating more than 7,500 patients. However, if you do the math using the denominator and numerator we just provided, you will see. In fact, I've seen a few cell site reports saying that the percentage incidence rate is actually coming down in terms of delayed neurotoxicities.

Thanks for the call, Erf.

Thank you. And the next question will come from Leonid Timishev with RBC. Your line is open.

Hey, guys. Thanks for taking my question. I wanted to ask on basically where demand is going to be coming from in the future. I guess in the past, you've talked about your ability to titrate demand. So I'm thinking, how are you guys thinking about 2026? specifically where the supply curve is going to be relative to the demand curve. And I'm curious if you can speak to that, maybe on a geography basis, I guess, U.S. and, you know, EU separately. Just given that CAR-2 historically have done well in Europe, I'm sure we'll be expecting more growth coming out of Europe in 2026 and ultimately approach relative parity with the U.S. I guess, just how are you thinking about the relative position of the supply and demand curves for U.S. versus EU? Thanks.

We will be driving both supply and demand simultaneously. They don't grow necessarily on a linear fashion each, but as both grow, we'll be able to support the market with supply. And in terms of the breakdown, in terms of geography, you saw in this quarter increasing contribution from Europe with the 11 markets outside of the U.S. now launched. We anticipate that that will continue to grow over 2026 and beyond. Additional major markets are planned for 2026. And so ex-U.S. contribution will continue to become an increasing and meaningful component of the Carvicti sales. And in terms of demand, just to provide a little bit more detail on some of the demand dynamics within the U.S., We talked about it in the opening remarks, but the ASCO data and the recognition of the overall survival benefit and the long-term survival is something that's going to continue to grow in terms of awareness, and that will translate into not only driving referrals, but also increasing utilization in the earlier lines. We also talked about the fact that the REMS removal will be an important component of improving the patient experience. Patients can then be treated in an authorized treatment facility, but then monitored back closer to home. As you heard from Ying, a lowered number of weeks in terms of monitoring. a fewer number of weeks in terms of the driving restriction. These things really do matter to patients and their family and caregivers when they're trying to get back into a normal functioning life. So you think about the REMS removal, you think about the overall survival, the ASCO data, and then as we talked about as part of the opening remarks, we've also started to directly engage patients So this is our DTC effort in a very targeted way, recognizing the fact that myeloma patients and their caregivers want to hear about CAR T. They want to learn about CAR T. They want to be able to have the conversation with their physicians, and that's what we've started to do. So I expect the demand to come from many of those drivers.

Thank you. And the next question will come from James Shin with DB. Your line is open.

Good morning, guys. Thank you for the question. Appreciate VOA coming online, but what does the partnership actually bring to legend? And I guess broader question is, what percentage of the smaller community practices like VOA are still pending CAR-VICTI slots? Secondly, is the biggest driver for community adoption getting a lighter version of FACT accreditation? Thank you.

Yeah, we're in the very early stages of having more penetration in the network practices like VOA. So VOA is the first key milestone for us. But as I mentioned, it's the first one in ones that are planned with J&J and Legend. In terms of FACT accreditation, there are several efforts underway, both industry groups as well as legislation at the state level, to lift the requirement for FACT accreditation. So we want to make sure that authorized treatment centers for cell therapy and for BCMA-CAR-T are of course, qualified to do so, experts in that area, but not necessarily facing all the significant burdens required with fact accreditation. So there are multiple efforts, as you mentioned, to provide some sort of either fact light or create a fact umbrella from an academic center such as UPenn to other community hospitals that are part of that umbrella. So again, these are all efforts that will continue to bring CAR T closer to patients. Patients don't want to have to travel into the cities or the major centers for their treatment, and so this enables them to get CAR T closer to home.

And, James, just to supplement what Alan just commented, in fact, Texas is the first state in the U.S. that actually passed a state legislature recently that in the state of Texas, there's no longer requirements for FACT accreditation for reimbursement by insurance carriers. And we do foresee that more and more states will follow suit. Thank you.

And our next question will come from Mitchell Kapoor with HC Wainwright. Your line is open.

Hey, team. Thanks for taking the questions. I have two. The first one, could you just talk about, since we're halfway through the third quarter at this point about now, can you talk about the importance the important CARBIC detrends that you're seeing since the end of June that may show up in the third quarter numbers. And then second, on geography and mix, could you talk about the ex-U.S. mixed trend and if the 30% U.S. to EU pricing delta is likely to hold as access broadens? Thank you.

Our demand trends are strong. We're very comfortable with where things are headed for the rest of this year. In terms of the mix, as I said before, we believe that the launches in Europe will continue to provide incremental demand. Germany is the largest of the markets, ex-US, and that is continuing to grow very nicely. And we continue to see that Europe will be a meaningful and increasing contribution to the overall sales picture for Perfect E. And unfortunately, we cannot comment on pricing, as you can understand.

We believe that Carvixi offers a very, very strong health economic benefit based on the survival and also the PFS benefits we have seen. In fact, if you follow last month's ODAC held by FDA to evaluate brain rep from GSK, I think one doctor, one KOL, Dr. Paul Richardson from Dana-Farber and Harvard Medical School actually pointed out in one of the slides that so far in the second line setting, there's only one trial and one drug that proved survival benefit significantly over standard of care, and that is CARVICT in CAR2-4. So we're very well positioned with all these benefits.

Okay, yeah, more specifically on the first question, is there anything since the end of June that you guys are seeing that is different than what we've heard on the call so far that may be a trend in BBQ?

The only thing I'll add is anecdotally, and Ying alluded to this earlier, since the ASCO presentation, we've heard more and more patients coming in and actually either holding up one of the local newspaper articles or the New York Times article or having heard about the data and it's reaching patients, they've started to have those conversations with physicians. We hear that from the physicians themselves that that's what patients are saying. So anecdotally, this is creating a lot of buzz and excitement both among the prescribing community. If you go to a medical conference, and there was one this past weekend, you'll see physicians start their talk. by showing the New York Times headlines from ASCO. And so, again, the anecdotes are showing that there's a lot of interest in the long-term survival benefit that you get from Carvicti, and we see that is starting to take shape in the marketplace as well.

Great. Thank you.

Thank you. And the next question will come from Justin Zeeland with BTIG. Your line is open.

Thanks for taking our questions and congrats on the strong record-breaking quarter here. You know, so with a billion dollars in cash here and you're approaching profitability, just curious, how do you think about approaching reinvestment with reaching profitability here across, you know, manufacturing your pipeline licensing once you're reaching profitability with your vision and your position in the, you know, global cell therapy landscape?

Hi, thank you for your question. We are committed to reach profitability with $1 million in cash. We are still very disciplined in spending, but we are committed to the next generation of cell therapies treatment for intractable and incurable diseases.

Thanks. And then just another question that we get is, you know, do you expect any material impacts from the recent tariff changes under, you know, manufacturing costs or supply chain and just any impact on how you're mitigating this?

Our understanding is that the details relating to any potential farmer-related tariffs are still being worked out, but because our U.S. products are predominantly made and sourced in the U.S., at this point we believe that any potential exposure to tariff will be immaterial based on our evaluation.

Great, thanks for taking our questions.

Thank you, and the next question will come from Ash Verma with UBS. Your line is open.

Hi, good morning. Thanks for taking our question. So just quickly, on the ramps of artists' commercial supply, is that more steady for the remainder of second half, or should we expect most of that to be reflected in the 3Q sales? And just on, secondly, on the first line data generation, for Cartier Youth 5, like, do you have line of sight that you can get this data in calendar year 2026. And I know you previously talked about this to cohort E and F, which we are still pending. Is that something that we could see later this year?

Thanks.

On Novartis, we got the approval earlier this year, as you know, for commercial production, and that has continued to ramp, and we expect it to be at full capacity by the end of this year. So that will continue to contribute to our growth over the course of the year.

Regarding your other parts of your question regarding Partitude 5, it will be events-driven, so we really need to monitor those closely, so we will not be able to provide more details beyond that. Regarding the CARTITUDE II E&F cohorts, looking at frontline patients, we cannot disclose what is being submitted to conferences later this year at this time.

Thank you.

And this does conclude today's question and answer session and also concludes today's conference call. Thank you so much for participating and you may now disconnect.