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DATE

Tuesday, May 12, 2026 at 8 a.m. ET

CALL PARTICIPANTS

  • Chief Executive Officer — Ying Huang
  • President, CARVYKTI — Alan Bash
  • Chief Financial Officer — Carlos Santos
  • Vice President, Investor Relations and Finance — Jessie Yeung
  • President of R&D — Guowei Fang

TAKEAWAYS

  • CARVYKTI Net Trade Sales -- $597 million, up 52% year over year, including 36% U.S. growth and more than 200% ex-U.S. growth driven by demand in earlier-line settings, geographic expansion, and manufacturing execution.
  • Sequential CARVYKTI Sales -- 8% increase from Q4 2025, attributed to site productivity and expanded penetration in earlier therapy lines.
  • U.S. Patient Mix (Second and Third Line) -- 41% of apheresis volume, rising from 29% a year ago, reflecting growing physician confidence in CARVYKTI’s earlier use.
  • Manufacturing Metrics -- Achieved a 99% manufacturing success rate, approximately 29-day median turnaround time, and over 95% on-time order release for delivered CARVYKTI product.
  • Global Treatment Footprint -- CARVYKTI is now available in 18 markets and over 300 global treatment sites, with 148 authorized centers in the U.S., about one-third being community or regional hospitals.
  • Gross Margin -- 41% on net product sales, down from 57% in prior quarter due to onetime manufacturing ramp expenses; projected to return to above 50% in Q2 as scale efficiencies are realized.
  • Revenue -- $305 million total, consisting of $298 million from collaboration revenue and $7 million from license and other revenue.
  • Research & Development Expense -- $86 million for the quarter, primarily allocated to In Vivo CAR-T and next-generation programs.
  • SG&A Expense -- $90 million, attributed to targeted commercial investment for CARVYKTI growth.
  • Adjusted Net Loss -- $11 million, or $0.03 per diluted share, improved from $27 million, or $0.07 per diluted share, year over year, after a non-IFRS adjustment mainly for share-based compensation and other non-cash items.
  • Cash Position -- $835 million in cash, cash equivalents, and time deposits; company has no long-term debt.
  • Profitability Outlook -- Management reaffirmed guidance for company-wide profitability on an adjusted basis in 2026.
  • Pipeline Advancement -- BCMA In Vivo and GPRC5D In Vivo programs both entered Phase I; first clinical data for a Non-Hodgkin's Lymphoma In Vivo CAR-T program expected for disclosure at a major medical meeting in midyear.
  • Scientific Advisory Engagement -- Six new scientific advisors with deep expertise in oncology, immunology, and cell therapy were recently engaged to consult on pipeline and R&D strategy.
  • Phase III Trial Status -- CARTITUDE-5 and CARTITUDE-6 trials fully enrolled, designed to assess CARVYKTI in frontline multiple myeloma, with timelines dependent on event accrual.

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RISKS

  • Gross margin dropped to 41% from 57% QOQ, explicitly attributed to onetime ramp-up expenses in manufacturing capacity expansion.
  • Carlos Santos confirmed, "If we wouldn't have had that onetime charge, we would have been profitable on an adjusted income basis," indicating profitability remains sensitive to fixed cost events.
  • No new timing guidance for pivotal CARTITUDE-5/CARTITUDE-6 readout due to event-driven design, possibly delaying clinical catalysts.

SUMMARY

Legend Biotech Corporation (LEGN +10.48%) reported rapid revenue growth driven by CARVYKTI's broadening adoption and increasing penetration in earlier multiple myeloma therapy lines across U.S. and global markets. Manufacturing infrastructure delivered high reliability, supporting expanded order fulfillment and shorter turnaround times. Early-stage pipeline progress included two in vivo CAR-T programs entering Phase I, with initial data for Non-Hodgkin’s Lymphoma expected midyear.

  • Legend’s balance sheet, with $835 million liquidity and no long-term debt, positions the company to fund pipeline innovation and absorb investment cycles tied to manufacturing expansion.
  • Adjusted net loss narrowed on a sequential and year-over-year basis despite a temporary gross margin dip attributed to facility ramp-up, with management reiterating confidence in achieving adjusted profitability in 2026.
  • Strategic engagement of six scientific advisors and ongoing trial enrollment underscore management’s focus on sustaining pipeline momentum and commercial execution.

INDUSTRY GLOSSARY

  • CARVYKTI: Brand name for ciltacabtagene autoleucel, a CAR-T therapy targeting BCMA in multiple myeloma.
  • In Vivo CAR-T: Gene therapy platform where the CAR-T modification occurs inside the patient, as opposed to ex vivo modification prior to reinfusion.
  • Apheresis Volume: Number of patients undergoing the initial cell collection process for CAR-T manufacturing.
  • BCMA: B-cell maturation antigen, a protein targeted in certain CAR-T therapies for multiple myeloma.
  • GPRC5D: G protein-coupled receptor, class C, group 5, member D, a novel multiple myeloma cell-surface antigen targeted by investigational cell therapies.
  • CARTITUDE Trials: Legend’s pivotal Phase III clinical studies evaluating CARVYKTI in various multiple myeloma patient populations.
  • SG&A: Selling, general, and administrative expenses.
  • Non-IFRS: Financial metrics that exclude certain income and expense items required under International Financial Reporting Standards, often for clarity on underlying operations.

Full Conference Call Transcript

Jessie Yeung: 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 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 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 loss and adjusted net loss per share enhances an investor understanding of our financial performance. We use adjusted net loss as a performance metric that guides management in its operation of and planning for the future of the business. In particular, we exclude unrealized gain or loss from foreign exchange rate changes. 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.

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

During the first quarter of 2026, CARVYKTI net trade sales were approximately $597 million, representing 52% 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 towards earlier use of CAR-T. In the recent social media poll for KOLs conducted by Dr. Ben Derman from University of Chicago, 66% of respondents indicated they would recommend CAR-T at first relapse for contemporary myeloma patients followed by 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 six distinguished scientific advisers, Renier Brentjens, Spencer Fisk, Carl June, Maximilian Konig, Tony 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 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 one to two 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.

Alan Bash: Thank you, Ying. I'll start with a high-level view of CARVYKTI's commercial performance and then spend time on what's driving growth beneath the surface. In Q1, CARVYKTI delivered another quarter of sequential growth, reflecting continued share gains, strong site productivity and increasing penetration in earlier lines of therapy. Demand remained healthy across all major geographies, supported by our expanding global footprint and consistently reliable manufacturing execution. CARVYKTI net trade sales in 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. Now importantly, although we do not intend to break this out every quarter since we think about our business on a longer-term basis, we wanted to provide a glimpse of the traction made in earlier line settings in the U.S. where nearly 80% 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.

Carlos Santos: 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 onetime 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 & 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, cash equivalents and time deposits and no long-term debt. We believe the 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.

Operator: [Operator Instructions] First question coming from the line of Terence Flynn with Morgan Stanley.

Terence Flynn: 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? And then how are you thinking about durability? And what will we learn from this first data set with respect to that question?

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

But we do expect a reasonable number of patients in this first disclosure. I hope that answers your question.

Operator: And our next question coming from the line of Umer Raffat with Evercore ISI.

Umer Raffat: I wanted to touch up on this In Vivo CAR-T theme in a little more detail, perhaps. And maybe for everyone listening in, Ying, because this is a new theme popping up beyond CARVYKTI beyond Arcellx, could you just remind everyone, first of all, that the CD19, CD20 CAR-T you have is not the gamma delta, which is Allo. We're talking about In Vivo, A, if you could just clarify that B, the name of the program, like the number? And number three, and I acknowledge you can't say if it will be at EHA or not and the scope of the data. But could you just give us a sense for what the trial design is that's being run?

And should we expect efficacy data as well? Or should the data disclosure only be limited to whether you dosed it and they developed CAR-T and then what the safety looks like? Or should there be some early efficacy as well?

Ying Huang: Umer, thanks for your question. I will answer the first two parts, and then I'll ask my colleague, Hui, President of R&D, to answer the third question regarding the design and everything else. So first of all, yes, we can confirm that this is not the Gamma Delta T program. This is actually an In Vivo CAR-T targeting CD19 and CD20, using a lentiviral vector delivery. So that's first. Secondly, I can confirm that the internal codename we use for the program is LB2501. And this program is already up on clinicaltrials.gov, if you want to search for the details on the protocol and enrollment. And on the third question, I'll ask for Guowei to answer.

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

Operator: Our next question coming from the line of Jessica Fye with JPMorgan.

Jessica Fye: A couple on kind of the existing business. First, I appreciate the additional detail on the breakdown of CARVYKTI use across lines of therapy. If we look out another year or two, what do you think that pie chart mix will look like? And then second, just on the higher COGS this quarter, how much of that about $100 million year-over-year increase was onetime versus sort of ongoing?

Alan Bash: It's Alan. Thanks for the question. So, in terms of our business mix, we're very pleased to show the data that reflects the fact that in earlier lines, specifically in second and third line, we have about 41% of our patients coming through those lines. And I think that's important for a couple of reasons. One is it does speak to the fact that we're getting community adoption because those earlier patients start in the community and are getting referred into the authorized treatment centers.

It also speaks to the fact that our clinical data is resonating with the earlier is better data both for efficacy, safety and manufacturing, all based on the data that we shared at ASH and in previous conferences that earlier is better. And I think it also sets us up well from a competitive standpoint to make sure we are penetrating the second and third line 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 second through fourth 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. So, all segments continue to grow, and we're very excited by the penetration in earlier lines.

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

Jessica Fye: Can you quantify the onetime impact a little more?

Carlos Santos: We do not disclose those particulars.

Ying Huang: 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 of the year.

Operator: Our next question coming from the line of Konstantinos Biliouris with Oppenheimer.

Konstantinos Biliouris: 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? And the second one on the In Vivo CAR-T, can you help us understand what the benchmarking is there, some investors are trying to compare your upcoming data to other ex Vivo CAR-T therapies in NHL. 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.

Alan Bash: Our business continues to grow. And as you saw from our report today, it continues to grow, particularly in the earlier lines. So, in terms of competition from TECVAYLI or the prevalence of bispecifics, I'll remind you that this is a large market in second and fourth line, about 100,000 patients, only about 5% have seen a BCMA. And so, there's significant growth potential for multiple options in the earlier lines. And I think that's also reflected by the IQVIA data that you see, while other products are growing, CARVYKTI has also shown healthy growth as well.

So, through potential competition with bispecifics, I think this is a large market that's severely underserved and underpenetrated, and that portends well for the opportunity for CARVYKTI.

Guowei Fang: So, for the second question, in terms of benchmark for In Vivo CAR-T program, this program is CD19, CD20 dual targeting In Vivo CAR-T program targeted for non-Hodgkin lymphoma patients. Our current thinking is that we are expecting or we are looking for deep and durable response, and therefore, the benchmark would be expected to align with that type of efficacy response. Currently still early, and we are accumulating more data.

Konstantinos Biliouris: And if I can add a follow-up here, if you see the 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?

Guowei Fang: Excellent question. Yes, we do think that the In Vivo CAR-T platform has a transformative potential by moving all the cell engineering and the cell expansion into the body of patients, therefore, generate better cell thinness. And therefore, that could translate into even better clinical response. That's our expectation across different disease areas.

Operator: And our next question coming from the line of Etzer Darout with Barclays.

Etzer Darout: 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. And then on the pipeline, just wondered if you could maybe talk about the scope of the BCMA trial that you're initiating with the In Vivo CAR-T, I think, LB2505. Maybe you can comment on the scope and then the trial design there.

Alan Bash: 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.

Guowei Fang: So, for In Vivo CAR-T program, we are excited about our platform and product. We are exploring this platform across different diseases. Multiple myeloma is an important disease area. 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 companies are working on. And therefore, at this point, there's nothing more we can share.

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

Operator: Our next question coming from the line of Eric Schmidt with Cantor Fitzgerald.

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

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

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

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

Carlos Santos: Yes. So, 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.

Operator: Our next question coming from the line of James Shin with Deutsche Bank.

James Shin: Circling back to the pipeline. There's three autologous and one In Vivo variant for the GPRC5Ds. Are these GPRC5D binders consistent across all the variants? Or are the FasTCAR variants using a different manufacturing process and therefore, have different binders? And then just following up on the onetime cost of collaboration question. If you exclude this onetime charge, would Q1 2026 been profitable on an adjusted basis?

Guowei Fang: On the GPRC5D front, all autologous program use the same binder. We are testing, have tried to validate the binder as well as try to understand how the patient responds using different design of the CAR-T molecule.

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

Operator: Our next question coming from the line of Leonid Timashev with RBC Capital.

Leonid Timashev: I wanted to ask on community adoption. I think before you've talked about how you've onboarded Virginia Oncology, Tennessee Oncology. I guess how is 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.

Alan Bash: It's Alan. So, as we've said before, the community adoption has a couple of components to it, one of which is the one you're speaking to, which is administration in the community among the community networks. And we're seeing positive responses from the clinicians in both those sites. We mentioned two of them, and we also have the West Clinic in Tennessee as well. So, there are additional sites that are coming online this year. I would say that it's a bit of a longer cycle to make sure that those sites are set up well and have the infrastructure, but we do expect additional sites this year.

And the experience has been quite positive, again, speaking to the fact that CARVYKTI can be administered in the outpatient setting relatively easily and clinicians are getting more and more comfortable with patient management dynamics. The other part of the community adoption is the referral piece, which you alluded to as well. And again, there, we're seeing strong indications that we are getting additional referrals, again, speaking to the fact that our earlier line business is growing significantly.

And then finally, as a point, we're up to 148 authorized treatment centers in the U.S., about 1/3 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.

Operator: And our next question coming from the line of Sean McCutcheon with Raymond James.

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

Ying Huang: Sean, this is Ying. So, if you look at the design for CARTITUDE-5, we are enrolling patients who are not eligible for stem cell transplant or eligible, but who choose to defer transplant for various reasons. So, if you look at comparison arm, it is RVd. So, it's a three-drug cocktail composing of Revlimid, 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 SO777 trial.

And if you look at the median PFS for RVD in this setting in those two Phase III trials, it's in the range of 35 to 40 months, and that is our assumption when we and J&J designed this trial for CARTITUDE-5, so if you look at, again, we're looking at cross-trial comparison, as you rightfully mentioned, 35 to 40. If you recall, Sean, in CARTITUDE-1, where we enrolled 97 patients with heavily pre-treated regimen, the median line of therapy prior therapy was 6.5, yet we still achieved a 35-month PFS for CARVYKTI treated patients.

So, this is why we and J&J are highly confident that we will be able to achieve the superiority against RVd in this specific patient population. Now if you compare that to CEPHEUS and other trials, of course, you do see certain numbers shifting because of better standard of care. On the other hand, still given what we know about CARTITUDE-1 and also CARTITUDE-4 where with a median follow-up of nearly three years, we have not reached median PFS yet in that second to fourth line patient population. So, we remain highly confident that CARVYKTI will demonstrate superior in PFS compared to RVd. That is our assumption here.

Operator: Our next question coming from the line of Ashwani Verma with UBS.

Ashwani Verma: Maybe just on the CD19, CD20 CAR-T. So, 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 three and above CRS and ICANS. And then just like secondly, on CARVYKTI, I mean, the 4Q to 1Q sequential growth in U.S. is up 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?

Guowei Fang: Thanks, Ash. Yes, 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 safety clinical safety profile at this point. We have to wait until the clinical data is presented. What I can say is that the safety is a key parameter we focus on from the get-go in the design phase. And our unique design mechanism as well as the CMC manufacturing process, I think that will provide a differentiated safety profile in the clinic. And in terms of how the research data correlate with the clinical data, let's wait, stay tuned until we are ready to disclose.

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

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

Operator: Our next question in the queue coming from the line of Yaron Werber with TD Cowen.

Yaron Werber: Maybe just the first question, Alan, for you, the seasonality that you mentioned in Q4 with some of the bags sort of remaining over and ultimately being infused in early Q1. And it seems like as you're moving upstream in Q1, J&J talked about having the same effect. Can you give us a little bit of a sense kind of net-net, how that worked out on a quarter-over-quarter basis? And is that sort of phenomenon of just a little bit of a delay to infusion will continue as you move into second line? And then a question for In Vivo, I mean, for BCMA. Can you maybe share a little bit about the construct itself?

Are you using sort of the same camelid antibody targeting BCMA with the same dual epitope targeting? Is it sort of the same stem? And are you doing any de-targeting through the LDL receptor and CD3 to try to avoid the sort of liver uptake in the sink and reduce some of the ICANS and inflammation?

Alan Bash: 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, as Ying mentioned, going into April and beyond. So, we do expect to continue to see the growth and in particular, in that earlier line setting, where we are gaining more and more patients, more and more referrals, setting us up well from a competitive standpoint as well.

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

Operator: Our next question coming from the line of Mitchell Kapoor with H.C. Wainwright.

Unknown Analyst: This is [Indiscernible] sitting in for Mitchell Kapoor. So, I have a question on the LB2501, the In Vivo CD19/20 program. You list the studies enrolling and you have pointed to this In Vivo data coming later in the year. But separately, you have J&J recently announcing that discontinued its ex vivo CD20 mono and CD19/20 bi-CAR-T programs in LBCL. Without asking you to comment on their program specifically, I just want to get a sense of how you're thinking about the competitive bar for LB2501.

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

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

Ying Huang: 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 deeper penetration in the community and also in second line. And we're actually all full speed on with our In Vivo programs. We look forward to seeing you all at upcoming major medical meetings. Thank you.

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