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Image source: The Motley Fool. Tuesday, Aug. 11, 2026 at 8:00 a.m. ET Interim Chief Executive Officer - Alan Bash Chief Financial Officer - Carlos Santos Interim Head of R&D - Yuhong Qiu Director of Investor Relations - Caroline LeCates Paul Operator: Good day, everyone, and thank you for standing by. Welcome to Legend Biotech Second Quarter 2026 Earnings Call. [Operator Instructions] Please be advised that today's conference is being recorded. Now it's my pleasure to hand the conference to Caroline Paul, Director of Investor Relations. Please go ahead. Caroline LeCates Paul: Good morning. This is Caroline Paul, Director of Investor Relations at Legend Biotech. Thank you for joining our conference call today to review our second quarter 2026 performance. Prior to this call, we issued a press release announcing our financial results for the quarter, which can be found on the Legend Biotech Investor Relations website. Joining me on today's call are Alan Bash, the company's Interim Chief Executive Officer; 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 Interim Head of R&D, Yuhong Qiu, 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. Our press release includes IFRS to non-IFRS reconciliations for these measures. With that, I will now turn the call over to Alan. Alan Bash: Thank you, Caroline, and good morning, everyone. I want to start by briefly addressing the leadership transition announced last month. As you all know, Dr. Ying Huang stepped down as Chief Executive Officer and member of the Board, and the Board appointed me to serve as Interim Chief Executive Officer. On behalf of the Board and all our employees, I want to thank Ying for his leadership over many years and his many contributions to Legend Biotech. We want to be very clear. This is a leadership transition, not a strategy transition. Our priorities remain unchanged. We remain focused on 3 main objectives: maximizing CARVYKTI, advancing our next-generation pipeline and strengthening our execution on all fronts. My commitment is to provide continuity, transparency and disciplined execution, working closely with Carlos, our senior R&D team, the Board and the broader leadership team to maintain momentum across the business. We are operating from a strong foundation with continued CARVYKTI momentum, meaningful progress across our in vivo CAR-T platform and as you are about to see from the Q2 results, the financial flexibility to continue investing in growth, innovation and long-term value creation. Notably, during the second quarter, we generated adjusted net income of $63 million, and we believe we will maintain adjusted net income profitability for the second half of 2026. Now let's turn to our second quarter highlights. We had a strong second quarter at Legend as CARVYKTI continues to expand globally, maintaining its market leadership in CAR-T. Additionally, we recently presented compelling early efficacy and safety data from our in vivo CAR-T platform and plan to provide meaningful updates to these programs at future medical conferences. During the quarter, CARVYKTI delivered worldwide net trade sales of approximately $657 million, representing 50% year-over-year growth, driven by strong demand globally and increasing adoption in earlier lines of therapy. In the United States, sales increased 32% year-over-year, while ex U.S. sales grew 128% year-over-year. Beyond commercial execution, we continue to advance our innovative next-generation cell therapy pipeline, particularly in our in vivo CAR-T platform, as highlighted by our participation at the ASCO Annual Meeting and the European Hematology Association Congress. We will turn to these updates in just a moment. Finally, we strengthened our balance sheet through the successful completion of a public equity offering, resulting in approximately $212 million of net proceeds and a cash position of approximately $965 million at the end of the second quarter. Drilling deeper on CARVYKTI's second quarter performance, CARVYKTI global net trade sales increased 50% year-over-year to $657 million, delivering strong global sequential growth of 10% compared to the first quarter. In the United States, quarter-over-quarter growth of 9% was primarily driven by accelerating adoption in earlier lines of therapy. We continue to increase the usage in second and third lines, up from the 41% we discussed last quarter. We have also been expanding treatment access with more than 150 authorized treatment centers, of which approximately 40% are community hospitals. Outside the United States, quarter-over-quarter growth of 13% was primarily driven by continued launch uptake across 19 markets and expansion of the activated treatment site network. We recently launched CARVYKTI in Ireland, further expanding availability to 348 global treatment sites, reflecting continued geographic expansion with our partner, J&J. Across geographies, we continue to see encouraging trends in both market penetration and earlier line utilization. These dynamics support our belief that CARVYKTI remains a durable growth opportunity. Turning to our recent clinical data, we shared encouraging updates across both our solid tumor and multiple myeloma programs at ASCO this year. LB2102 is our DLL3 targeted CAR-T therapy being evaluated in small cell lung cancer and large cell neuroendocrine carcinoma. LB2102 demonstrated a manageable safety profile and encouraging clinical activity in a heavily pretreated patient population. Higher dose levels achieved an objective response rate of 28.6% and a disease control rate of 78.6% with durable responses observed. Solid tumors remain difficult to treat with limited therapeutic options. So this is an encouraging sign. 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. We also reported additional CARTITUDE program data supporting the durable efficacy and consistent safety profile of CARVYKTI in multiple myeloma. These data included sustained progression-free and overall survival benefit across cytogenetic risk groups, along with a low incidence of immune effector cell-associated enterocolitis. Notably, in the CARTITUDE-4 subgroup analysis, patients who responded to bridging therapy demonstrated 30-month overall survival rates exceeding 85% with no cases of IEC-associated Parkinsonism. Taken together, these presentations further reinforce both the strength of the CARVYKTI clinical profile and the breadth of our innovation pipeline. The most notable recent pipeline update was our Phase I LB2501 study with data presented at the European Hematology Association Congress in June. LB2501 is a CD19/CD20 dual-targeting in vivo CAR-T therapy for the treatment of relapsed/refractory non-Hodgkin's lymphoma. The new results were the first human data with our in vivo platform and from an ongoing dose escalation Phase I study. The data presented at EHA included 12 patients with 6 patients in each of the 2 dose cohorts as part of an investigator-initiated trial conducted in China. We had compelling results at dose level 2, achieving a 100% objective response rate and an 83.3% complete response rate across the 6 patients with diffuse large B-cell lymphoma, mantle cell lymphoma and follicular lymphoma. We also observed impressive in vivo CAR T cell persistence in peripheral blood with cells detectable up to 116 days based on these early results. From a safety perspective, LB2501 was well tolerated with no dose-limiting toxicities, no serious adverse events and no deaths reported. We anticipate filing a U.S. IND for LB2501 by the end of the year to initiate a U.S.-based clinical program in NHL and plan to report additional data from the China study in due course. These results represent an important milestone for our entire in vivo CAR-T platform, which has broad applicability and includes other candidates with other targets in additional indications and supports our continued investment and development of candidates using our in vivo platform. Beyond LB2501, we continue to advance a broad and diversified pipeline spanning autologous, allogeneic and in vivo cell therapies. As it relates to CARVYKTI, multiple frontline multiple myeloma studies remain ongoing, including CARTITUDE-5, CARTITUDE-6 as well as others, which could potentially expand our market opportunity into the first-line setting. Across our autologous portfolio, we continue to develop therapies targeting Claudin 18.2, DLL3, GPRC5D and dual target approaches for multiple myeloma. We are also advancing several off-the-shelf CAR-T programs ranging from allogeneic programs for autoimmune disease and B-cell malignancies as well as additional in vivo CAR-T candidates beyond LB2501, which I just described for its impressive first human data in a Phase I trial at EHA. Overall, we believe this portfolio reflects a balanced approach to innovation across the different modalities of CAR-T while leveraging our expertise in cell therapy, development and manufacturing. Looking ahead, we believe Legend is well positioned for sustainable long-term growth. We continue to advance our pipeline and are working towards an IND submission for LB2501 by the end of the year. We ended the period with approximately $965 million in cash, cash equivalents and time deposits. And commercially, CARVYKTI remains a leading franchise in multiple myeloma and continues to demonstrate strong global momentum, expanding into new markets on a regular basis. We also continue to believe CARVYKTI has a peak annual sales potential exceeding $5 billion, and we are making meaningful steps to reach that goal. Supported by a durable commercial business, a deep pipeline and a focus on execution, we remain committed to achieving company-wide profitability in 2026. And with that, I will turn over the call to Carlos. Carlos Santos: Thank you, Alan. This quarter's financial results continue to demonstrate the operating leverage inherent in our business model. Revenue has scaled at a CAGR of 74% since the second quarter of 2023, supported by growing demand for CARVYKTI and continued commercial execution. At the same time, operating margins have improved significantly from negative 142% in the second quarter of 2023 to a positive 15% in the second quarter of 2026. This now marks a major milestone objective for Legend as the first quarter of company-wide profitability on both an IFRS and an adjusted basis. Going forward, we will continue to focus on adjusted net income as the metric for sustained profitability. While we remain focused on investing in the future growth of Legend, we are doing so with increasing discipline and operating efficiency. Turning to our quarterly financial performance. Total revenue increased 52% year-over-year, driven by continued CARVYKTI demand and commercial expansion. Given the recent increases in international sales, we wanted to note that we are using Legend's foreign exchange rates for CARVYKTI collaboration revenue, which we also plan to use going forward. Each quarter, Legend receives the collaboration revenue through a profit split analysis in U.S. dollars as constant currency. From an accounting perspective, the revenue is then converted to the appropriate functional currency using Legend's foreign exchange rates, which may differ from our partners. While we expect the differences each quarter to be small over the near term, we wanted to specifically call it out this quarter as international sales are becoming an increasing percentage of the overall revenue and in any given quarter, an increase in international revenue and/or a significant movement in foreign exchange rates between the euro and the U.S. dollar could result in additional divergence between the revenues reported by our collaboration partner and the revenue that Legend reports. As we look at collaboration revenue growth for the remainder of the year, we wanted to offer some thoughts on quarterly progression in Q3 and Q4. As we have been consistently saying, we are pleased with the steady increasing rate of CARVYKTI penetration into the second to the fourth lines of treatment, which is our focus and has now grown to be over 70% of our volume. With the increasing penetration into earlier lines has also come increasing usage in the outpatient setting and with a higher percentage of outpatient volume contributing to the revenue mix comes a different set of gross margin dynamics. Additionally, we expect to see an increase in Q4 revenue from an extra selling week in this calendar year and greater international expansion compared to Q3. Despite these fluctuations, we remain confident in our adjusted net income profitability projections for both Q3 and Q4. Moving down the income statement. Gross margin on net product sales grew 1% year-over-year improving to 58%, which was an improvement of 17% compared with 41% for the first quarter of 2026, which, as you may recall, was artificially low primarily due to onetime costs associated with manufacturing expansion, which we unwound in the second quarter, adding additional onetime favorability of a few percentage points to our Q2 gross margin. Going forward, gross margin on net product sales will be more reflective of volume as we continue to expect improvements over time by leveraging our investments in manufacturing to scale and increasing utilization across all nodes. However, it is important to realize that there is still likely to be quarter-to-quarter variability in gross margin, and we expect Q3 gross margin on net product sales to be in the lower 50% range with a rebound into the mid-50% range anticipated for Q4. Total operating expenses increased only 7% year-over-year, reflecting our continued focus on disciplined investment and operating leverage. Research and development expenses decreased 2% year-over-year as the costs from the later-stage BCMA frontline clinical studies roll off. This will be partially offset by increased spending in our in vivo assets as they move into Phase I and later studies. Selling, general and administrative expenses increased 19%, primarily driven by investments supporting sustained leadership in BCMA CAR-T markets. As a result, operating margin improved to a positive 15% compared with negative 9% in the second quarter of 2025. Regarding taxes, we had an income tax expense of $22.3 million during the second quarter compared to an income tax expense of approximately $600,000 for the same quarter last year. The year-over-year increase was primarily driven by an increase in taxable income across our U.S., Belgium and PRC entities. As we have now achieved company-wide profitability on a quarterly basis for the first time, I wanted to provide more detail on our tax rate and the effect of various tax jurisdictions as you develop your longer-term financial models. We are in the process of negotiating a unilateral advanced pricing agreement with the Chinese tax authorities as part of our proactive tax governance strategy. Although a formal agreement has not yet been formally executed, we have now reflected the expected impact of the agreement as a component of income tax expense in our Q2 numbers. We expect to report income tax in each quarter that we are profitable. And although we are not yet at a point that we can provide more precise guidance, we anticipate a tax rate in the high 20% range over the next several quarters. In addition, although quarterly adjusted net income may vary from quarter-to-quarter over the near term, primarily driven by some expected fluctuations in gross margins I mentioned earlier, we are increasingly confident in the long-term durability of our profitability profile. With adjusted net income of $650 million in Q2, we feel comfortable in maintaining our projection for adjusted net income profitability on an adjusted basis in 2026. On a non-IFRS basis, this represents $0.16 per diluted share compared with adjusted net income of $10 million or $0.03 per diluted share in the same period last year. Turning to our balance sheet, which remains a significant strategic asset. As of June 30, 2026, we held approximately $965 million in cash, cash equivalents and time deposits and have no long-term debt. The equity offering in June contributed meaningfully to this strong cash position, allowing for additional flexibility to fund our pipeline programs and pay down our loan to Johnson & Johnson under the terms of our agreement. Our investment priorities have remained consistent, and our strategy has not changed. We remain committed to delivering sustainable profitability on adjusted net income while still advancing our in vivo CAR-T pipeline and making modest capital investments to support manufacturing capacity expansion. Our key objectives include: first, continued quarter-over-quarter CARVYKTI growth through 2026 with a growing portion of our business coming from second to fourth-line patients. Second, adjusted net income profitability for the second half of 2026. Third, an IND submission for LB2501 in Q4 and lastly, presenting additional in vivo data at future medical conferences. We believe our strong financial position provides the flexibility needed to execute on all of these priorities. Let me end in the same way that Alan started this call. This is a period of leadership transition and not strategy transition. Our Q2 financial results support this. And you can expect that this leadership team will continue to deliver on the clear objectives that we just laid out and to provide transparency for the investment community as we move into the second half of 2026. With that, I will turn the call back to the operator to open the line for questions. Operator: [Operator Instructions] It comes from Eric Schmidth with Cantor. Eric Schmidt: Congrats on achieving the milestone of profitability. My question is on the in vivo CAR-T side and the BCMA program in particular. I think Alan mentioned you're working on a variety of different targets. So I assume that's still one of them. Can you provide for us kind of an update on your strategy with your partner, J&J and when we may hear something in addition on BCMA? Alan Bash: Thanks, Eric, for the question. Yes, previously, we had said that BCMA CAR-T programs were subject to the terms of Legend Biotech's collaboration agreement with J&J and previously, we cannot say more. We can now share an update that Legend will be conducting an investigator-initiated clinical study in China. Evaluating LB2505, which is an investigational BCMA-targeted in vivo CAR-T therapy for multiple myeloma. This program is subject to terms of Legend Biotech's collaboration agreement with J&J. So we're not able to share additional details at this time, but we do look forward to providing updates on LB2505 when appropriate. Operator: [Operator Instructions] It comes from Terence Flynn with Morgan Stanley. Unknown Analyst: Great. This is Chris on for Terence. On LB2501, can you remind us of what the minimum duration of response you think is needed to be confident in the durability of a complete response? And is ASH a reasonable expectation for when you could release the updated Phase I data? Alan Bash: Yes. Previously, at the EHA conference, we had shared durability as long as 120 days. We would be targeting ultimately to be able to share data at the 6-month CR rate. And we will be able to provide updates at future medical conferences in terms of the 2501 program. Operator: One moment for our next question that comes from John Miller with Evercore ISI. Unknown Analyst: This is [indiscernible] on for Jon. I wanted to touch on the recent announcement for the MonumenTAL-6 top line data where we saw a hazard ratio of 0.11. This seems like physicians are gradually getting comfortable with anticipating and managing the tox in the study. And there are also some commentary that on the GPRC5? Alan Bash: I'm sorry. Unknown Analyst: Hello? Yes, can you hear me? Alan Bash: Your line isn't coming in as clearly, if you could just repeat the question, please. Unknown Analyst: Yes. So I would like to ask a question on the recent announcement for the MonumenTAL-6 top line data. So it seems like physicians are gradually getting comfortable with managing and anticipating the tox in the study. And then there are also some commentary that the combo might be preferentially sequenced for later line usage. So I'd like to ask what kind of feedback have you been hearing from physicians on your end in terms of managing the tox and the sequencing that relative to CAR-T? Alan Bash: Yes. Thanks for the question. So yes, the MonumenTAL study was looking at the combination of TEC and TAL and as J&J has shared publicly, they intend for that combination to be primarily used in later lines, as you point out. I think more generally, as we've seen the bispecific data and indications emerge, we've been very focused on educating physicians and patients on the key points of differentiation of CARVYKTI relative to other options in myeloma, in particular, other BCMA options. Of course, one is that one and done, right, versus continuous therapy. That's a very important driver of patient preference, of quality of life and of the opportunity for a long-term treatment-free interval and a long-term remission. The second thing that we've been really emphasizing relative to the landscape is that the data really suggests that earlier is better with CAR-T. You get better efficacy, better safety and improved manufacturing when you get CAR-T earlier and really where the conversation has gone is not really about CARVYKTI versus bispecific. It's really about the sequencing. And I think if you hear KOLs and the feedback we've been getting from KOLs, the storyline is really about the optimal sequencing and the data, both in the real world as well as additional studies or if you look at the biology, it really does point to the fact that patients will benefit if they can get to CAR-T first before other options in BCMA. Operator: Our next question is from Leonid Timashev with RBC. Leonid Timashev: I just wanted to clarify some of the comments on the gross margins. Can you maybe just elaborate on why having more outpatients is going to change the gross margin dynamics? And then looking ahead, I think in the past, you've talked about aiming for large molecule like cost of goods. Is that still the plan here? Any sense of when you might achieve that with some of these CapEx -- modest CapEx spend plans? Alan Bash: Yes. Thanks for the question. All we would say at this point is that as outpatient grows and outpatient is starting to become approximately 60% of our overall mix. It does come with various dynamics, which could potentially impact gross margin. So that's all we're able to say at this point on that. But let me turn it to Carlos to your second question. Carlos Santos: Yes. So Leonid, in terms of the path for gross margin, we are still expecting our cost of goods sold to decline over time. We have to get to a certain level of volume to keep up the consistency. But once all of our nodes are at a steady state, our gross margins will be in line with what we believe is industry standards of around 75%. And we actually have -- we see a clear path to 75% over time. Operator: One moment for our next question that comes from Jessica Fye with JPMorgan. Jessica Fye: I had 2 kind of on the financial side. First, can you just expand a little bit on the comments you made about how to think about the revenue cadence in 3Q and 4Q? And second, can you just recap the motivation behind the recent equity raise given that the company is still very committed to achieving profitability this year? Carlos Santos: Let me start with talking about the raise. The follow-on was an opportunistic equity raise following the strong in vivo data that we presented at EHA. This additional capital really gives us greater flexibility to accelerate the development of LB2501 and our broader in vivo platform. This really allows us to be able to take our in vivo platform further in the development process, and this will provide us better BD optionality down the road. We continue to be confident in our profitability goals, and we will be in a stronger position to fund our R&D efforts following the loan repayment to J&J now that we have completed this raise. Alan Bash: And related to your first question, as we heard earlier in the call from Carlos, we are indicating a global growth on a sequential basis across the balance of the 2 quarters in the second half of 2026. Operator: Our next question comes from Yaron Werber with TD Cowen. Yaron Werber: Congrats on moving towards the IIT with in vivo in China. I have maybe just a 2-part question on the tax rate in China. That would be applied, it sounds like to the global profits from now on. Is that actually going to be a cash payment? Or is that an accounting tax rate? And then secondly, just to answer your answer to Jessica's question on the raise, and you said that the payment after the payment to J&J, can you just clarify, is that relating to historical CapEx and how big that is? Carlos Santos: Sorry, Yaron, could you repeat your second question? Yaron Werber: I think you mentioned that there was a -- I might have misunderstood a payment to J&J when you were talking about the financing. I just wanted to make sure, is there any historical sort of cell balance sheet cleanup that you need to do as part of CapEx? Or did you never actually borrow capital from J&J for building manufacturing facilities that's still outstanding? Carlos Santos: Yes. So let me start there. So as part of our collaboration agreement, there was a loan of around $300 million and that accrued interest over time that became a current liability this year. So we have been paying down both principal and interest on that loan this year. And it's a combination of cash repayments to J&J as well as recoupment of profits from our collaboration. We expect to fully settle that liability this year. So with regards to the tax provision, we have reflected the expected impact of an agreement based on the information we have today as a component of our income tax expense in Q2. So this provision not only includes the China portion, but also profitability that's realized in other legal entities for Legend. Operator: One moment for our next question that comes from Kostas Biliouris with Oppenheimer. Konstantinos Biliouris: Maybe a couple of quick questions. One on the CEO search. We are wondering whether the Board is focused on a commercial operator for the CARVYKTI ramp or perhaps a platform CEO for the in vivo CAR-T development? And the second question is on the in vivo CAR-T development and commercialization. You already touched a little bit on the BCMA, but we are wondering how are you thinking about perhaps the lead program in NHL? Are you thinking to develop this by yourself? Or are you still looking for a partnership there? What is the latest status? Alan Bash: Thanks, Kostas. Yes. So as we previously announced, the Board has initiated a search and is conducting a thorough process for the full-time permanent CEO position. And I don't think the Board wants to put an artificial deadline on that process. They're also looking holistically and looking at various qualities that would provide for the best long-term leader given the stage of the growth of the company. So I don't think there's anything specific that they wanted to share at this point about that. As it relates to your second question, as we mentioned on the call here, we are excited to say that we will be moving towards an IND with 2501 in the second half of 2026. And our intention is to be able to conduct that Phase I ourselves. We have the capabilities, and we obviously have the financial flexibility and the resources to do that. We continue to remain open to various options around partnership long term across the in vivo platform. We obviously made the announcement this morning with 2505 moving forward in multiple myeloma and BCMA, and we'll continue to assess all of our options to maximize the value, both in terms of maintaining economics, but also ensuring speed and scale to maximize the opportunity with in vivo. Operator: One moment for our next question that comes from Etzer Darout with Barclays. Please proceed. Unknown Analyst: This is [indiscernible] on for Etzer. Real quick on the J&J partnership. How does that impact your in vivo development in immune disease? Will that change what you're able to pursue? And then maybe can you highlight any differences between your in vivo CAR-T platform and sales? Alan Bash: Sure. So yes, the announcement that we're making today is around BCMA CAR-T in multiple myeloma. That's the aspect of the program that is subject to the agreement with J&J. So at this point, now Legend will look and step back and assess our options for autoimmune disease. We remain very interested in autoimmune disease with multiple targets. We obviously have been looking at potentially BCMA, potentially CD19, CD20 and other targets in autoimmune, and we think in vivo can play a meaningful role there. As it relates to the J&J deal that you mentioned with Sail, I'll remind you that Sail has a preclinical platform around circular mRNA and LNP. And so that's very different from our program, which is LV-based. And we've also already shown clinical data in a very meaningful market, which is non-Hodgkin's lymphoma. So I think these are 2 very different opportunities. And I think it speaks to the excitement across the industry in vivo. Many large pharma companies are looking at multiple platforms, and we're very excited about the platform that we have to offer. Operator: Our next question comes from Edward Tenthoff with Piper Sandler. Edward Tenthoff: Thanks for the updates on the in vivo side and all the great progress with CARVYKTI. My question has to do with the rest of the pipeline, sort of the allogeneic approaches. It really sounds like the focus is in vivo going forward. So should we be expecting updates on either some of the other autologous CAR-Ts or some of the allogeneic CAR-Ts in the next year or so? Can you give us a sense for when to expect those updates? Alan Bash: Let me turn this over to you, Yuhong to answer your question. Yuhong Qiu: So the in vivo platform and allogeneic platform each have a strength. We prioritize in vivo, but we still believe that allogeneic have a good place. We previously provided our G39D program in ASH last year, and we continue to provide additional updates in future conferences on that program. Operator: It comes from Mitchell Kapoor with H.C. Wainwright. Unknown Analyst: This is Ahmed on for Mitchell. Congrats on the strong quarter. Just a couple of questions from us. One on how much of CARVYKTI's current 2L to 4L mix is in 2L and 3L versus fourth line? And how has that shifted Q-over-Q? And if any of these Sail launches in fourth line, what portion of CARVYKTI's current business would face direct overlap at launch? And the second one, I was wondering with Tyvek showing clinical proof of concept and LB2102 validating DLL3 CAR activity in small cell lung cancer, how are you thinking about extending the in vivo platform into solid tumors? And would DLL3 be the logical target? And would that fall within the Novartis agreement? Alan Bash: Let me answer your second question first and just say that we're looking across a range of potential solid tumor targets. A solid tumor obviously has its own unique characteristics, and I think there are challenges that we and other companies are continuing to try to solve with in vivo in solid tumors. So more to come on that one. We do think that the DLL3 auto CAR T data set was meaningful. And as you know, we have a partnership with Novartis where we will be having Novartis take the asset forward into full clinical development. As it relates to your question about line of therapy, yes, you did hear us share a report -- an update today that our 2L through 4L now comprises 70% in fact, over 70% of our mix in the U.S. And that's exciting because that means that we are making significant progress in getting CARVYKTI to be used earlier in the treatment paradigm. And as you mentioned, where needle will be potentially indicated in later lines, depending, of course, on what label they do receive, our foothold in second through fourth line, I think, provides a meaningful opportunity for CARVYKTI going forward. We -- last quarter, we did break down and share an insight that within the 2L and 3L specifically that, that represented 41% of the overall mix. And we did that because we wanted to share a point in time reference to the fact that we've made significant growth and significant progress in early lines, specifically 2L, 3L. And we said at the time, and we maintain today, we don't intend to provide that update on every single quarter. Really, it is an opportunity to share that we are growing in second and third line. It continues to be the fastest-growing part of our business, and we're excited with the fact that we do continue both from a clinical standpoint and a commercial execution standpoint to focus on the early line opportunities. Operator: Our next question comes from Ash Verma with UBS. Ashwani Verma: Congrats on the progress here. So maybe just the first one, can you talk about the potential impact on CARVYKTI from J&J's growing body of clinical data, seen this MonumenTAL-6 data that for TECVAYLI/TALVEY showed a hazard ratio of 0.11 on PFS in second to fifth line patients. So just help us understand. I know you're growing a lot in second to third line, but just if competition catches up to that. And then secondly, I know you commented on the sequential global sales growth, but can you confirm that if it applies to the U.S. sales growth as well going into 3Q and 4Q? Alan Bash: Yes. At this point, and again, we are -- we stay very close to our partner, J&J here on this. So we wanted to just maintain the comment that we had previously, which is around global sequential growth quarter-on-quarter. But to answer your first question on the bispecifics, again, I pointed this out earlier, but I think it's important to emphasize that the bispecifics do have, I think, very compelling data, but they offer a very different value proposition for patients. And what we're focused on is the fact that -- and jointly with J&J, and J&J has reiterated the fact that CARVYKTI, even on their recent earnings call that CARVYKTI has the potential to be a $5 billion-plus peak sales asset, and we very much are in lockstep with them on that. Both J&J and Legend are committed to the fact that CARVYKTI provides a very unique value proposition to patients, to physicians and to the market. One and done versus continuous therapy, the opportunity for a long-term remission and really meeting the definition of cure as defined by the IMWG guidelines, really, we have a potential for cure here based on the CARTITUDE-1 long-term 5-year data. We look forward to presenting updates in earlier lines over the next year or so, and we do believe that this one-and-done opportunity with long-term remissions and the potential for cure is what patients and physicians ultimately want. And I would also add to your question, which is I mentioned earlier, there's really been a very robust conversation now at all the medical conferences and all the follow-on conferences about sequencing. And I think the real-world evidence that was presented at ASCO, whether it's the Germany registry or whether it's the Mountain West U.S. registry from TriNetX or whether it's other data sets, institution-specific real-world data suggests that when patients get CAR-T first, they have prolonged survival, they have better outcomes and you have less opportunity for antigen escape or antigen mutation. So you really have an opportunity to get CAR-T first, and that's really where the KOLs are on this topic. Operator: We have a question from the line of Sean McCutcheon, Raymond James. Sean McCutcheon: And speaking to earlier line, with the iberdomide PDUFA coming up in about a week on the MRD negativity results, how does this inform your calculus on potential for filing on MRD for CARTITUDE-6 and accelerating the time to market for CARVYKTI in the frontline transplant eligible population? Alan Bash: Let me ask you, Yuhong to comment about MRD as an endpoint. Yuhong Qiu: As with the advancement of frontline therapies for multiple myeloma patients, the median PFS gets longer, longer, which is very good news for patients. But for the development of new therapies, some of those patients still relapse. So MRD become a necessary surrogate in order for those effective therapies to reach patients earlier. Although in the MRD ODAC, the correlation analysis does not include any of the CAR-T data set. We continue to work with FDA on the probability -- the possibility of MRD as a surrogate for registration purpose for the CAR-T therapy. So CAR-6 will continue on this effort. Operator: Thank you. And as I see no further questions in the queue, I will conclude the Q&A session and conference for today. We want to thank everyone for participating, and you may now disconnect. 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This article is a transcript of this conference call produced for The Motley Fool. While we strive for our Foolish Best, there may be errors, omissions, or inaccuracies in this transcript. As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability. The Motley Fool has positions in and recommends Legend Biotech. The Motley Fool has a disclosure policy. Legend Biotech (LEGN) Q2 2026 Earnings Call Transcript was originally published by The Motley Fool

Legend Biotech Corporation (NASDAQ:LEGN) shares gained 5.5% in pre-market trading on Tuesday after the pharmaceutical company delivered better-than-expected second-quarter earnings and revenue, supported by continued growth in CARVYKTI sales. Adjusted earnings came in at $0.16 per share, more than double the analyst consensus of $0.07. Revenue reached $387.5 million, ahead of the $362.81 million estimate and up 52% from $255.1 million in the second quarter of 2025. The results also showed a significant improvement in profitability, with Legend Biotech moving from an operating loss a year ago to positive operating income. CARVYKTI net trade sales reached approximately $657 million during the quarter, representing year-on-year growth of 50%. U.S. sales increased 32%, while sales outside the U.S. jumped 128%, reflecting the continued expansion of the therapy’s international commercial footprint. Legend Biotech said CARVYKTI is now available through 348 sites across 19 markets following its recent launch in Ireland. Collaboration revenue increased to $326.1 million from $219.7 million a year earlier, primarily driven by higher CARVYKTI sales under the Janssen collaboration agreement. “Our second quarter results demonstrate the strength of our commercial and innovation engines at Legend Biotech,” said Alan Bash, Interim Chief Executive Officer. “CARVYKTI continued to deliver growth as we expand patient access globally, including the most recent launch in Ireland, our 19th market.” The higher revenue base translated into a substantial improvement in Legend Biotech’s financial performance. Operating income reached $57.7 million, compared with an operating loss of $21.9 million in the second quarter of 2025. Net income was $33.2 million, reversing a net loss of $125.4 million a year earlier, while adjusted net income increased to $63.1 million from $10.1 million. For investors, the shift into operating profitability adds another dimension to the CARVYKTI growth story, showing that expanding product sales are increasingly translating into stronger company-level earnings. Alongside the commercial progress, Legend Biotech reported its first clinical proof-of-concept for LB2501, an investigational in vivo CD19/CD20 dual-targeting CAR-T therapy. At the higher dose level, the treatment produced a 100% overall response rate among patients with relapsed or refractory B-cell non-Hodgkin lymphoma. While the data remain an early clinical development milestone, the result adds another program for investors to monitor beyond CARVYKTI. Legend Biotech ended June with approximately $965 million in cash, cash equivalents and time deposits. The balance was supported by approximately $212 million in net proceeds from a public offering. For investors, the second-quarter report combines three important developments: continued CARVYKTI sales growth, a move into operating profitability and progress within the company’s broader CAR-T pipeline. Future CARVYKTI adoption, particularly outside the U.S., and further clinical development of LB2501 are likely to remain key measures of whether Legend Biotech can sustain its current commercial and operational momentum. Legend Biotech Corporation stock price

Interested in Legend Biotech Corporation Sponsored ADR? Here are five stocks we like better. CARVYKTI sales rose sharply: Worldwide net trade sales increased 50% year over year to approximately $657 million, driven by earlier-line treatment adoption in the U.S. and international expansion across 19 markets and 348 treatment sites. Legend reached profitability: The company reported its first quarter of company-wide IFRS and adjusted profitability, including $63 million in adjusted net income, and expects to remain adjusted-profitable through the second half of 2026. Pipeline and financial flexibility strengthened: Early LB2501 in vivo CAR-T data showed an 83.3% complete-response rate at one dose level, with a U.S. IND filing planned by year-end 2026. Legend ended the quarter with approximately $965 million in cash and no long-term debt. CPI Data Sparks Rally in Biotech Stocks Legend Biotech (NASDAQ:LEGN) reported second-quarter 2026 results marked by continued global growth for CARVYKTI and the company’s first quarter of company-wide profitability on both an IFRS and adjusted basis, management said during its earnings call. Interim Chief Executive Officer Alan Bash said the company generated approximately $657 million in worldwide net trade sales for CARVYKTI during the quarter, up 50% from a year earlier and 10% sequentially. He also said Legend generated adjusted net income of $63 million and expects to remain adjusted-net-income profitable during the second half of 2026. → SoundHound AI Sends a Loud Signal After Its Q2 Earnings Beat Why Legend Biotech Stock Is Having Its Best Month Yet The call followed the departure of former CEO Dr. Ying Huang last month. Bash said the leadership change does not represent a change in strategy, with the company remaining focused on expanding CARVYKTI, advancing its next-generation pipeline and strengthening execution. CARVYKTI sales in the U.S. increased 32% year over year, while sales outside the U.S. rose 128%, according to Bash. U.S. sales grew 9% sequentially, supported primarily by accelerating adoption in earlier treatment lines. International sales increased 13% sequentially as launches continued across 19 markets and the company expanded its activated treatment-site network. → 3 Dividend Champion Utilities for a Market That Can't Sit Still Legend said CARVYKTI is now available through 348 treatment sites globally. More than 150 authorized treatment centers are in the U.S., including community hospitals representing roughly 40% of those sites. Management said use in the second through fourth lines of treatment now accounts for more than 70% of CARVYKTI’s U.S. volume. The company had previously said second- and third-line use represented 41% of total mix, but said it does not plan to provide that more detailed breakout every quarter. → Take-Two’s Q1 Results Leave GTA 6 Bulls Stuck in the Fog of War Bash said the company and its partner, Johnson & Johnson, continue to position CARVYKTI as a “one-and-done” treatment option compared with continuous therapies. Management also cited clinical and real-world data suggesting patients may have better outcomes when they receive CAR-T therapy before other BCMA-directed treatment options. Legend reiterated its view that CARVYKTI has peak annual sales potential above $5 billion. The company highlighted early clinical data for LB2501, a CD19/CD20 dual-targeting in vivo CAR-T therapy being studied in relapsed or refractory non-Hodgkin’s lymphoma. Data presented at the European Hematology Association Congress included 12 patients in an ongoing China-based investigator-initiated Phase I dose-escalation trial. At the second dose level, six patients with diffuse large B-cell lymphoma, mantle cell lymphoma or follicular lymphoma had a 100% objective response rate and an 83.3% complete response rate, Bash said. CAR-T cells were detected in peripheral blood for as long as 116 days. The treatment was reported to be well tolerated, with no dose-limiting toxicities, serious adverse events or deaths reported in the data set. Legend expects to file a U.S. investigational new drug application for LB2501 by the end of 2026 and intends to conduct the initial U.S. Phase I study itself. The company said it plans to present additional data from the China study at future medical conferences and is ultimately targeting an update on six-month complete-response rates. During the question-and-answer session, management also disclosed that Legend will conduct an investigator-initiated study in China of LB2505, an investigational BCMA-targeted in vivo CAR-T treatment for multiple myeloma. The program is subject to the company’s collaboration agreement with Johnson & Johnson, and management did not provide additional details. Legend said it remains interested in pursuing in vivo CAR-T opportunities in autoimmune disease across multiple potential targets. Management distinguished its lentiviral vector-based platform from Sail’s preclinical circular mRNA and lipid nanoparticle platform. Beyond in vivo programs, the company said it continues to advance autologous CAR-T candidates targeting Claudin 18.2, DLL3, GPRC5D and other targets, as well as allogeneic programs for autoimmune disease and B-cell malignancies. Interim Head of R&D Yuhong Qiu said Legend continues to see a role for allogeneic therapies and expects to provide future updates on its LUCAR-G39D program. Chief Financial Officer Carlos Santos said total revenue increased 52% year over year, while operating margin improved to positive 15% from negative 9% in the prior-year period. He said revenue has grown at a 74% compound annual growth rate since the second quarter of 2023, while operating margin has improved from negative 142% over that span. Gross margin on net product sales was 58% in the second quarter, compared with 41% in the first quarter. Santos said the first-quarter figure had been affected by one-time manufacturing-expansion costs that were reversed in the second quarter, along with other one-time favorability. Management expects gross margin on net product sales to fall into the lower-50% range in the third quarter before rebounding to the mid-50% range in the fourth quarter. Santos said a growing outpatient mix, which is approaching 60% of total volume, introduces different margin dynamics. Over time, the company expects manufacturing scale and utilization to support gross margins of about 75%. Research and development expense declined 2% year over year as costs from later-stage BCMA frontline studies declined, partly offset by increased investment in in vivo assets. Selling, general and administrative expense increased 19%, primarily reflecting investments supporting CARVYKTI’s position in BCMA CAR-T markets. Income tax expense was $22.3 million, compared with about $600,000 a year earlier, reflecting higher taxable income in the U.S., Belgium and China. Santos said Legend expects its tax rate to be in the high-20% range over the next several quarters, although the company is still negotiating a unilateral advanced pricing agreement with Chinese tax authorities. As of June 30, Legend held approximately $965 million in cash equivalents and time deposits and had no long-term debt. The balance included about $212 million in net proceeds from a June public equity offering. Management described the financing as opportunistic following the LB2501 data release and said the proceeds provide flexibility to accelerate development of the in vivo platform. The company also expects to fully settle a roughly $300 million loan obligation to Johnson & Johnson, including accrued interest, during 2026 through a combination of cash payments and collaboration-profit recoupments. Legend maintained its objectives of sequential CAR-T growth through the rest of 2026, adjusted-net-income profitability in the second half, a fourth-quarter IND filing for LB2501 and additional in vivo data presentations at future medical meetings. Legend Biotech (NASDAQ: LEGN) is a commercial-stage biopharmaceutical company specializing in the development and commercialization of chimeric antigen receptor T-cell (CAR-T) therapies for oncology. Headquartered in Somerset, New Jersey, with research and development operations in Shanghai, the company leverages a global infrastructure to advance innovative cellular therapies. Legend Biotech pursues a strategy of strategic collaboration to extend its reach, most notably through its partnership with Janssen Biotech, a subsidiary of Johnson & Johnson. The company's lead asset, ciltacabtagene autoleucel (commercially marketed as Carvykti), is a B-cell maturation antigen (BCMA)–directed CAR-T therapy for the treatment of relapsed or refractory multiple myeloma. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Legend Biotech Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.

CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) net trade sales increased 50% versus second quarter of 2025 to approximately $657 million Expanded CARVYKTI® availability to 348 global sites and 19 global markets with the launch of Ireland Achieved first clinical proof-of-concept for LB2501, an investigational in vivo CD19/CD20 dual‑targeting CAR-T therapy with 100% ORR and 83.3% CR at the higher dose level (DL2) in patients with relapsed or refractory B-cell non-Hodgkin lymphoma Strengthened balance sheet through successful public offering of 7,700,000 American Depository Shares ("ADS") with net proceeds of approximately $212 million, after deducting underwriting discounts and commissions and estimated offering expenses Cash and cash equivalents, and time deposits of approximately $965 million, as of June 30, 2026 BRIDGEWATER, N.J., Aug. 11, 2026 (GLOBE NEWSWIRE) -- Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global leader in cell therapy, today reported its second quarter 2026 unaudited financial results and key corporate highlights. "Our second quarter results demonstrate the strength of our commercial and innovation engines at Legend Biotech," said Alan Bash, Interim Chief Executive Officer of Legend Biotech. "CARVYKTI continued to deliver growth as we expand patient access globally, including the most recent launch in Ireland, our 19th market. Commercial momentum of CARVYKTI provides the foundation to advance a diversified portfolio of next-generation cell therapies designed to expand the reach and impact of CAR-T. During the quarter, we achieved a significant innovation milestone with the first-in-human clinical readout for LB2501, validating our in vivo CAR-T platform. These advances demonstrate the breadth of our pipeline across hematologic malignancies and solid tumors and our commitment to bringing transformational cell therapies to patients beyond multiple myeloma. Our focus remains the same. Ensuring continuity across the business, maintaining strong execution, and advancing the strategic priorities that position Legend Biotech for long term growth. With meaningful commercial and clinical momentum and a strengthened balance sheet, we remain confident in our ability to advance innovation and progress toward company-wide profitability." Recent Data Highlights     LB2501 EHA 2026 - in vivo CD19/CD20 dual targeting CAR-T Achieved first clinical proof-of-concept with a 100% ORR (6/6) and 83.3% CR (5/6) at the higher dose level (DL2) following a single infusion in patients with relapsed or refractory B-cell non-Hodgkin lymphoma, with all responses ongoing at data cutoff. Dose-dependent in vivo CAR-T expansion generated without lymphodepletion. No dose-limiting toxicities, serious adverse events, immune effector cell-associated neurotoxicity syndrome (ICANS), or deaths were reported; infusion-related reactions and cytokine release syndrome (CRS) were Grade 1–2, and none required glucocorticoids for CRS management. LB2102 ASCO 2026 - DLL3-targeted CAR-T therapy Announced first-in-human data for LB2102, the Company’s investigational DLL3-targeted CAR-T therapy for relapsed or refractory small-cell lung cancer (SCLC) and large-cell neuroendocrine carcinoma (LCNEC). Legend has a license agreement with Novartis for the development, manufacture, and commercialization of LB2102 and other potential CAR-T therapies selectively targeting DLL-3. At higher dose levels, LB2102 achieved an ORR of 28.6% and a DCR of 78.6%, with durable responses observed in some patients. Demonstrated a manageable safety profile and encouraging clinical activity in heavily pretreated patients. New CARTITUDE program data ASCO 2026 New CARTITUDE program data continued to support durable efficacy and a consistent safety profile for CARVYKTI® in multiple myeloma, including sustained PFS/OS benefit across cytogenetic risk groups and a low incidence (1.2%) of immune effector cell-associated enterocolitis (IEC-EC). Key Business Developments Compared to the second quarter of 2025, CARVYKTI® net trade sales increased 50% in the second quarter of 2026 to approximately $657 million, with U.S. net trade sales growth of 32% and ex-U.S. net trade sales growth of 128% year-over-year. Launched CARVYKTI® in Ireland, bringing availability to 348 global sites and 19 global markets. Appointed Alan Bash, previously President of CARVYKTI®, Interim Chief Executive Officer. Closed public offering of 7,700,000 American Depositary Shares (“ADS”), with net proceeds of approximately $212 million, after deducting underwriting discounts and commissions and estimated offering expenses. Cash and cash equivalents, and time deposits of approximately $965 million as of June 30, 2026, which Legend Biotech believes will provide financial runway beyond 2026, when Legend Biotech believes it will achieve a company-wide profit1. Second Quarter 2026 Financial Results Cash Position: Cash and cash equivalents, and time deposits were approximately $965 million as of June 30, 2026. Collaboration Revenue: Collaboration revenue was $326.1 million for the three months ended June 30, 2026, compared to $219.7 million for the three months ended June 30, 2025. The increase of $106.4 million was due to an increase in revenue generated from sales of CARVYKTI® in connection with the Janssen collaboration and license agreement (the “Janssen Agreement”). License and Other Revenue: License revenue was $61.4 million for the three months ended June 30, 2026, compared to $35.4 million for the three months ended June 30, 2025. The increase of $26.0 million was driven by milestones of $56.0 million achieved under the Janssen Agreement for the three months ended June 30, 2026, compared to no milestones achieved under the Janssen Agreement for the three months ended June 30, 2025.This license increase was offset by a decrease in license revenue recognized in the three months ended June 30, 2026, under an exclusive agreement with a related party. No related party license revenue was recognized during the three months ended June 30, 2026 compared to $20.0 million in related party license revenue for the three months ended June 30, 2025.Additionally, a decrease of $10.1 million from $15.4 million for the three months ended June 30, 2025 to $5.3 million for the three months ended June 30, 2026 was primarily attributable to revenue recognized pursuant to our license agreement with Novartis for the development, manufacture, and commercialization of LB2102 and other potential CAR-T therapies selectively targeting DLL-3 (the “Novartis License Agreement”). This revenue is recognized over time in connection with our Phase 1 clinical trial for LB2102. Cost of Collaboration Revenue: Cost of collaboration revenue was $136.0 million for the three months ended June 30, 2026, compared to $94.9 million for the three months ended June 30, 2025. The increase of $41.1 million was primarily due to Legend Biotech’s share of the cost of sales in connection with CARVYKTI® sales under the Janssen Agreement. Research and Development Expenses: Research and development expenses were $96.0 million for the three months ended June 30, 2026 compared to $98.3 million for the three months ended June 30, 2025. The decrease of $2.3 million was primarily driven by lower expenditures in the cilta-cel clinical program as the patient dosing phases of major trials substantially concluded, partially offset by higher pipeline related research and development activities. Administrative Expenses: Administrative expenses were $33.0 million for the three months ended June 30, 2026, compared to $32.6 million for the three months ended June 30, 2025, remaining relatively flat. Selling and Distribution Expenses: Selling and distribution expenses were $63.4 million for the three months ended June 30, 2026, compared to $48.1 million for the three months ended June 30, 2025. The increase of $15.3 million was primarily due to higher commercial costs, including sales force expansion and Janssen-related marketing and market access activities, which rose with collaboration revenue. Operating Income (Loss): Operating income for the three months ended June 30, 2026 was $57.7 million compared to operating loss of $21.9 million for the three months ended June 30, 2025. The year-over-year improvement of $79.6 million was primarily due to higher gross profit from CARVYKTI® and higher license and other revenue. Income Tax Expense: Income tax expense was $22.3 million for the three months ended June 30, 2026, compared to $0.6 million for the three months ended June 30, 2025. The increase of $21.7 million was primarily driven by an increase in taxable income across our U.S., Belgium and PRC entities. We continue to negotiate an advance pricing agreement with the Chinese Tax Authority, which will determine a transfer pricing methodology between its legal entities. Although a formal agreement has not yet been executed, we have reflected management's best estimate of the expected tax consequences including the cumulative impact of a change in estimate based on the information available as of June 30, 2026.While we have accrued for matters we believe are probable and estimable, the final outcome with a tax authority may result in a tax liability that is materially different from that reflected in the consolidated financial statements. Net Income (Loss): Net income was $33.2 million for the three months ended June 30, 2026, compared to a net loss of $125.4 million for the three months ended June 30, 2025. The year-over-year improvement of $158.6 million was primarily driven by lower unrealized foreign currency exchange losses compared to the prior period, as well as improved operating performance reflecting higher gross profit from CARVYKTI®. Adjusted Net Income (Loss): Adjusted net income was $63.1 million for the three months ended June 30, 2026, compared to an adjusted net income of $10.1 million for the three months ended June 30, 2025. The year-over-year improvement of $53.0 million was primarily driven by improved operating performance, reflecting higher gross profit from CARVYKTI®. _____________________1 Company-wide profit defined as Adjusted Net Income Webcast/Conference Call Details: Legend Biotech will host its quarterly earnings call and webcast today at 8:00am ET. To access the webcast, please visit this weblink. A replay of the webcast will be available on Legend Biotech’s website at https://investors.legendbiotech.com/events-and-presentations. About Legend Biotech With over 3,200 employees, Legend Biotech is the largest standalone cell therapy company and a pioneer in treatments that change cancer care forever. Legend Biotech is at the forefront of the CAR-T cell therapy revolution with CARVYKTI®, a one-time treatment for relapsed or refractory multiple myeloma, which it develops and markets with collaborator Johnson & Johnson. Centered in the United States, Legend Biotech is building an end-to-end cell therapy company by expanding its leadership to maximize CARVYKTI’s patient access and therapeutic potential. From this platform, Legend Biotech plans to drive future innovation across its pipeline of cutting-edge cell therapy modalities. Learn more at https://legendbiotech.com and follow us on X, Instagram, and LinkedIn. CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS Statements in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, constitute “forward-looking statements” within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to Legend Biotech’s strategies and objectives; statements relating to the expected timing of initiation, completion, and results and data of Legend Biotech’s early-stage cell therapy portfolio; statements relating to CARVYKTI®, including Legend Biotech’s expectations for CARVYKTI® and its therapeutic potential; statements relating to the potential of LB2102 and LB2501, including the reproducibility and durability of any favorable results initially seen in patients dosed to date in clinical trials; statements related to Legend Biotech’s ability to fund its operations beyond 2026 and to achieve profitability in 2026; and the potential benefits of Legend Biotech’s product candidates. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Legend Biotech’s expectations could be affected by, among other things, uncertainties involved in the development of new pharmaceutical products; unexpected clinical trial results, including as a result of additional analysis of existing clinical data or unexpected new clinical data; unexpected regulatory actions or delays, including requests for additional safety and/or efficacy data or analysis of data, or government regulation generally; unexpected delays as a result of actions undertaken, or failures to act, by Legend Biotech’s third party partners; uncertainties arising from challenges to Legend Biotech’s patent or other proprietary intellectual property protection, including the uncertainties involved in the U.S. litigation process; government, industry, and general product pricing and other political pressures; as well as the other factors discussed in the “Risk Factors” section of Legend Biotech’s Annual Report on Form 20-F for the year ended December 31, 2025 filed with the Securities and Exchange Commission (SEC) on March 10, 2026 and Legend Biotech’s other filings with the SEC. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described in this press release as anticipated, believed, estimated or expected. Any forward-looking statements contained in this press release speak only as of the date of this press release. Legend Biotech specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. INVESTOR CONTACT:Caroline PaulTel: (973) [email protected] PRESS CONTACT:Kim FoxTel: (848) [email protected] *Certain prior year amounts included within other revenue have been combined into the license and other revenue line for comparative purposes. ** Certain prior year amounts have been reclassified to present loss on asset impairment into the other operating expenses line for comparative purposes. RECONCILIATION OF IFRS TO NON-IFRS MEASURES We use Adjusted Net Income (Loss) and Adjusted Net Income (Loss) per Share (which we sometimes refer to as “Adjusted EPS” or “ANI per Share”, respectively) as performance metrics. Adjusted Net Income (Loss) and ANI per share are not defined under IFRS, are not a measure of operating income, operating performance, or liquidity presented in accordance with IFRS, and are subject to important limitations. Our use of Adjusted Net Income (Loss) has limitations as an analytical tool, and you should not consider it in isolation or as a substitute for analysis of our results as reported under IFRS. For example: Although depreciation and amortization are non-cash charges, the assets being depreciated and amortized may have to be replaced in the future, and Adjusted Net Income (Loss) does not reflect cash capital expenditure requirements for such replacements or for new capital expenditure requirements. Adjusted Net Income (Loss) excludes unrealized foreign exchange gain or loss. Adjusted Net Income (Loss) does not reflect changes in, or cash requirements for, our working capital needs. In addition, Adjusted Net Income (Loss) excludes items such as share-based compensation expense, which has been, and will continue to be for the foreseeable future, non-cash expense for our business and an important part of our compensation strategy. Also, our definition of Adjusted Net Income (Loss) and ANI per Share may not be the same as similarly titled measures used by other companies. However, we believe that providing information concerning Adjusted Net Income (Loss) and ANI per Share enhances an investor’s understanding of our financial performance. We use Adjusted Net Income (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 (Loss) provides a useful measure of our operating performance from period to period by excluding certain items that we believe are not representative of our core business. We define Adjusted Net Income (Loss) as net income (loss) adjusted for (1) non-cash items such as depreciation and amortization, share-based compensation, impairment loss, and (2) unrealized foreign exchange gain or loss. ANI per Share is computed by dividing Adjusted Net Income (Loss) by the weighted average shares outstanding. A reconciliation between Adjusted Net Income (Loss) and Net Income (Loss), the most directly comparable measure under IFRS, has been provided in the table below. *The diluted weighted average shares outstanding used in the calculation of the diluted ANI per share for the three months ended June 30, 2026 is 387.6 million shares, and for the six months ended June 30, 2026, is 386.0 million shares. (1) Included in Other operating expenses(2) Included in Other expense, net

This article first appeared on GuruFocus. Total Revenue: Increased 52% year over year, driven by continued CARVYKTI demand and commercial expansion. CARVYKTI Net Trade Sales: Approximately $657 million worldwide, representing 50% year-over-year growth and 10% sequential growth. U.S. CARVYKTI Sales: Increased 32% year over year and 9% quarter over quarter. Ex-U.S. CARVYKTI Sales: Grew 128% year over year and 13% quarter over quarter. Gross Margin on Net Product Sales: Improved to 58%, up 1% year over year and 17% sequentially from Q1 2026. Operating Margin: Positive 15%, compared with negative 9% in the second quarter of 2025. Adjusted Net Income: $63 million, or $0.16 per diluted share, compared with adjusted net income of $10 million, or $0.03 per diluted share, in the same period last year. Research and Development Expenses: Decreased 2% year over year. Selling, General, and Administrative Expenses: Increased 19% year over year. Income Tax Expense: $22.3 million in Q2, compared to approximately $600,000 in the same quarter last year. Cash Position: Approximately $965 million in cash, cash equivalents, and time deposits as of June 30, 2026, with no long-term debt. Equity Offering Proceeds: Approximately $212 million in net proceeds from a public equity offering completed in June. Warning! GuruFocus has detected 4 Warning Signs with LEGN. Is LEGN fairly valued? Test your thesis with our free DCF calculator. Release Date: August 11, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Legend Biotech Corp (NASDAQ:LEGN) achieved its first quarter of company-wide profitability on both IFRS and adjusted basis, with adjusted net income of $63 million in Q2 2026. CARVYKTI global net trade sales grew 50% year-over-year to $657 million, driven by strong demand and increasing adoption in earlier lines of therapy, with ex-US sales up 128%. The in vivo CAR-T platform showed promising early data, with LB2501 achieving a 100% objective response rate and 83.3% complete response rate at dose level two in a Phase 1 study. The company strengthened its balance sheet with a public equity offering, raising approximately $212 million in net proceeds, ending Q2 with about $965 million in cash and no long-term debt. Management reaffirmed confidence in achieving adjusted net income profitability for the second half of 2026 and maintained CARVYKTI peak annual sales potential exceeding $5 billion. The company experienced a leadership transition with the CEO stepping down, which could create uncertainty despite assurances of continuity. Gross margin on net product sales is expected to fluctuate, with Q3 projected in the lower 50% range due to increasing outpatient volume and other dynamics. The company faces potential competitive pressure from bispecific antibodies, such as the MonumenTAL-6 data, which may impact CARVYKTI's market position in later lines. Income tax expense increased significantly year-over-year to $22.3 million, and the company anticipates a tax rate in the high-20% range, which could affect future profitability. The company noted potential divergence in reported revenue due to foreign exchange rate differences between Legend and its partner J&J, especially as international sales grow. Q: Can you provide an update on the in vivo CAR-T BCMA program and its strategy with partner J&J?A: Alan Bash (Interim CEO): Legend will be conducting an investigator-initiated clinical study in China evaluating LB2505, an investigational BCMA-targeted in vivo CAR-T therapy for multiple myeloma. This program is subject to the terms of the collaboration agreement with J&J, so additional details cannot be shared at this time, but updates will be provided when appropriate. Q: What is the minimum duration of response needed to be confident in the durability of a complete response for LB2501, and is ASH a reasonable expectation for updated Phase 1 data?A: Alan Bash (Interim CEO): Previously at EHA, durability was shared as long as 120 days. The target is to share data at the six-month CR rate, with updates to be provided at future medical conferences. Q: What feedback are you hearing from physicians regarding the MonumenTAL-6 data, managing toxicities, and sequencing relative to CARVYKTI?A: Alan Bash (Interim CEO): J&J intends for the tec/tal combination to be used primarily in later lines. Legend is focused on educating physicians on CARVYKTI's key differentiators: one-and-done versus continuous therapy, long-term treatment-free intervals, and the potential for cure. The conversation has shifted to sequencing, with real-world evidence suggesting patients benefit from receiving CAR-T first before other BCMA options. Q: Can you elaborate on why having more outpatients changes gross margin dynamics, and is the goal of large molecule-like cost of goods still the plan?A: Alan Bash (Interim CEO) & Carlos Santos (CFO): Outpatient volume is now approximately 60% of the overall mix and comes with various dynamics that could impact gross margin. Carlos added that COGS is still expected to decline over time, with a clear path to industry-standard gross margins of around 75% once all nodes are at a steady state. Q: Can you expand on the revenue cadence for Q3 and Q4, and recap the motivation behind the recent equity raise?A: Carlos Santos (CFO) & Alan Bash (Interim CEO): The follow-on was an opportunistic raise following strong in vivo data at EHA, providing flexibility to accelerate LB2501 and the broader in vivo platform, and to fund R&D efforts after repaying the J&J loan. Alan indicated global sequential growth across the balance of the second half of 2026. Q: Is the China tax rate applied to global profits a cash payment or an accounting tax rate, and is there a historical payment to J&J for CapEx?A: Carlos Santos (CFO): The tax provision reflects the expected impact of an agreement as a component of income tax expense in Q2, including profitability realized in other legal entities. Regarding J&J, a loan of around $300 million with accrued interest became a current liability this year, and it is being paid down through cash repayments and recoupment of profits, with full settlement expected this year. Q: Is the CEO search focused on a commercial operator or a platform CEO, and how are you thinking about developing the lead NHL in vivo program?A: Alan Bash (Interim CEO): The Board is conducting a thorough search without an artificial deadline, looking holistically for the best long-term leader. For LB2501, the intention is to conduct the Phase 1 study ourselves, while remaining open to partnership options long-term across the in vivo platform to maximize value. Q: How does the J&J partnership impact in vivo development in autoimmune disease, and what are the differences between your platform and Sail?A: Alan Bash (Interim CEO): The announcement today is around BCMA CAR-T in multiple myeloma, which is subject to the J&J agreement. Legend remains very interested in autoimmune disease with multiple targets. The Sail platform is preclinical, using circular mRNA and LNP, which is very different from Legend's LV-based program that has already shown clinical data in non-Hodgkin's lymphoma. Q: Should we expect updates on allogeneic or other autologous CAR-Ts in the next year, given the focus on in vivo?A: Yuhong Qiu (Interim Head of R&D): The in vivo and allogeneic platforms each have their strengths. While in vivo is prioritized, allogeneic still has a place. Updates on the G39D program will be provided at future conferences. Q: What is the current 2L to 4L mix breakdown, and how are you thinking about extending the in vivo platform into solid tumors?A: Alan Bash (Interim CEO): The 2L through 4L mix now comprises over 70% of US volume, with 2L and 3L being the fastest-growing part of the business. For solid tumors, Legend is looking across a range of potential targets, with more to come. The DLL3 auto CAR-T data was meaningful, and Novartis will take that asset forward into full clinical development. Q: What is the potential impact on CARVYKTI from J&J's MonumenTAL-6 data, and does the sequential global sales growth apply to US sales?A: Alan Bash (Interim CEO): Bispecifics offer a very different value proposition. J&J reiterated that CARVYKTI has the potential to be a $5 billion-plus peak sales asset. The focus is on the one-and-done opportunity, long-term remissions, and potential for cure. Real-world evidence suggests patients get better outcomes when receiving CAR-T first. The company maintains its comment on global sequential growth quarter-on-quarter. Q: With the iberdomide PDUFA upcoming, how does this inform the potential for filing on MRD for CARTITUDE-6 and accelerating time-to-market in frontline?A: Yuhong Qiu (Interim Head of R&D): MRD has become a necessary surrogate for effective therapies to reach patients earlier. Although the MRD ODAC correlation analysis does not include CAR-T data sets, Legend continues to work with the FDA on the possibility of using MRD as a surrogate for registration purposes for CAR-T therapy, and CARTITUDE-6 will continue this effort. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

LEGN surged 6% as Q2 revenue of $388M beat estimates and adjusted EPS of $0.16 doubled consensus, marking the company's first-ever profitable quarter. CARVYKTI net sales hit $657M, up 50%, with JNJ co-developer Janssen supporting management's target of over $5B in peak annual sales. Alan Bash, interim CEO following Ying Huang's departure, emphasized continuity as Wall Street's $52 consensus target sits well above current share prices. Act now: the analyst who called NVIDIA in 2010 just named his top 10 AI stocks — and Legend Biotech didn't make the cut. Grab the names FREE today. Shares of Legend Biotech (NASDAQ:LEGN) are climbing 6% to $21.88 Tuesday midday after the company reported Q2 2026 results that paired a solid revenue beat with the first quarter of company-wide profitability in its history. LEGN stock is still down 41% over the past year, so today's reaction reads as validation of Legend Biotech's CARVYKTI ramp. Legend Biotech disclosed the results in an SEC filing before the open and hosted its earnings call at 8:00 a.m. ET. The commercial trajectory of CARVYKTI, the CAR-T multiple myeloma therapy Legend co-develops with Johnson & Johnson (NYSE:JNJ) through its Janssen unit, continues to anchor the investment case here. The setup entering the report was heavy for Legend Biotech. LEGN stock had drifted lower through July, and short-dated positioning had grown cautious around the ongoing CEO transition, leaving room for a squeeze on any clean numbers. Legend Biotech posted total revenue of $387.5 million, up 52% year over year, topping the $362.81 million estimate. Legend Biotech's adjusted EPS came in at $0.16, more than double the roughly $0.07 analyst consensus. The revenue beat headlined the report, though the bigger surprise sat further down the income statement. Act now: the analyst who called NVIDIA in 2010 just named his top 10 AI stocks — and Legend Biotech didn't make the cut. Grab the names FREE today. Legend Biotech booked net income of $33.2 million versus a net loss of $125.4 million a year earlier, adjusted net income of $63.1 million, and operating income of $57.7 million. That marks the company's first quarter of company-wide profitability on both an IFRS and adjusted basis. A meaningful piece of the swing reflects foreign exchange dynamics for Legend Biotech. Unrealized FX losses fell to $0.6 million in Q2 2026 from $110.9 million a year earlier, cushioning the bottom line even as operating gains did most of the work. The balance sheet also strengthened. Legend Biotech ended the quarter with approximately $965 million in cash, cash equivalents and time deposits and no long-term debt, boosted by about $212 million of net proceeds from a June public offering. Legend Biotech's CARVYKTI net trade sales reached $657 million, up 50% year over year, with U.S. sales up 32% and ex-U.S. sales up 128%. The mix highlights international momentum outpacing the more mature U.S. launch. CARVYKTI is now available across 348 treatment sites and 19 markets, with Ireland the most recent launch for Legend Biotech. Management reiterated peak annual sales potential above $5 billion, keeping CARVYKTI the central pillar of the LEGN investment case. In the multiple myeloma CAR-T space, Bristol Myers Squibb (NYSE:BMY) markets Abecma, the other approved BCMA CAR-T therapy. Competitive positioning against Bristol Myers Squibb remains a key debate, since Legend Biotech is still a single-product commercial story tied largely to CARVYKTI. Legend Biotech reported first clinical proof-of-concept for LB2501, an investigational in vivo CD19/CD20 dual-targeting CAR-T therapy, showing a 100% overall response rate and 83.3% complete response rate at the higher dose level in relapsed or refractory B-cell non-Hodgkin lymphoma. A U.S. IND filing is planned by year-end. The LB2102 DLL3-targeted CAR-T program is licensed to Novartis (NYSE:NVS), giving Legend Biotech a partnered second shot on goal beyond the Johnson & Johnson collaboration. Novartis funding for LB2102 lets Legend Biotech concentrate spend on wholly-owned candidates like LB2501. Sector conditions remain supportive. The iShares Biotechnology ETF (NASDAQ:IBB) is up 18.5% year to date, keeping the backdrop friendly for biotech beats. The IBB ETF is a large-cap-concentrated biotechnology fund and unleveraged, so sector-concentration caution applies here. The leadership context matters with Legend Biotech. Alan Bash is the company's interim CEO following the departure of former CEO Ying Huang last month, and some analysts trimmed their Legend Biotech stock price targets around the transition even while maintaining confidence in CARVYKTI's growth curve. Bash stated in the release, "With meaningful commercial and clinical momentum and a strengthened balance sheet, we remain confident in our ability to advance innovation and progress toward company-wide profitability." The tone from Legend Biotech's management underscored a focus on continuity through the search for a permanent chief executive. Meanwhile, the Wall Street setup still leans constructive. The consensus analyst target on LEGN stock sits at $52.10, well above where shares trade today, with 5 strong buys, 6 buys, and 4 holds. That distribution can compress if analysts lower their ratings and/or price targets around Legend Biotech's CEO search. Traders can watch for whether LEGN stock holds today's gains into the close, and they can check for refreshed analyst notes on Wednesday as well as follow-up commentary from Johnson & Johnson on CARVYKTI's trajectory. This marks a first quarter of profitability, so investors may want to size their positions with Legend Biotech's single-product concentration and early-stage pipeline profile in mind. Act now: the analyst who called NVIDIA in 2010 just named his top 10 AI stocks — and Legend Biotech didn't make the cut. Grab the names FREE today. Contact [email protected] for any questions or corrections.

Legend Biotech Corp. (NASDAQ:LEGN) is one of the 10 Stocks Delivering Massive Returns. Legend Biotech snapped a four-day losing streak on Tuesday, jumping 42.22 percent to close at $36.28 apiece following the strong first phase results of its cancer treatment candidate, which saw as much as a 100 percent response rate in enrolled patients. In an updated report, Legend Biotech Corp. (NASDAQ:LEGN) said that all six patients enrolled in the study to test the efficacy of LB2501 in patients with relapsed/refractory B-cell non-Hodgkin lymphoma fully responded to the higher dose level of the treatment, while five achieved a complete response, which means that no detectable signs of cancer remained. For illustration purposes only. Photo by Pavel Danilyuk on Pexels LB2501 is designed to infuse CAR-T cells directly into the patient’s body via a single IV. It is expected to treat faster and be less expensive than the traditional CAR-T therapies, which require a patient’s cells to be collected first and engineered in laboratories and infused back weeks later. Legend Biotech Corp. (NASDAQ:LEGN) also said that the therapy candidate showed no serious adverse effects or deaths. The company is scheduled to present additional data at the European Hematology Association (EHA) 2026 Congress in Stockholm, Sweden, on June 11 to 14. “The upcoming presentation of Phase 1 LB2501 data in patients with B-cell malignancies represents an important step in advancing in vivo CAR-T approaches,” Legend Biotech Corp. (NASDAQ:LEGN) CEO Ying Huang said. “By generating CAR-T cells directly within the patient, this approach has the potential to simplify treatment delivery and expand access for patients who may not be able to receive traditional CAR-T cell therapies. LB2501 is built on the TaVec platform, which is a proprietary lentiviral vector engineered to enhance T-cell specificity, transduction efficiency, and safety, while restricting transduction of non-T cells.” While we acknowledge the potential of LEGN as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: 33 Stocks That Should Double in 3 Years and Cathie Wood 2026 Portfolio: 10 Best Stocks to Buy. Disclosure: None. Follow Insider Monkey on Google News.

LB2102 demonstrated a manageable safety profile and encouraging clinical activity in solid tumors among heavily pretreated patients Responses observed at higher dose levels of LB2102 with an ORR of 28.6% and a DCR of 78.6%, with durable responses seen in some patients New CARVYKTI® data continue to support durable efficacy and a consistent safety profile in multiple myeloma BRIDGEWATER, N.J., June 01, 2026 (GLOBE NEWSWIRE) --  Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech or the Company), a global leader in cell therapy, today announced first-in-human clinical data for LB2102, its investigational DLL3-targeted CAR-T cell therapy for patients with relapsed or refractory small cell lung cancer (SCLC) or large-cell neuroendocrine carcinoma (LCNEC). The data demonstrate early evidence of clinical activity and a manageable safety profile. At higher dose levels, an objective response rate (ORR) of 28.6% and disease control rate (DCR) of 78.6% were observed, including durable responses in some heavily pretreated patients. The data, presented in a rapid oral presentation (Abstract #8012) at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, support the clinical potential of CAR-T cell therapy in solid tumors. Additionally, new analyses from the CARTITUDE program were presented, further highlighting sustained clinical benefit and a consistent safety profile for CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) in multiple myeloma. “The data presented at ASCO underscores the progress of our next-generation pipeline and the meaningful impact that CARVYKTI continues to deliver to patients,” said Ying Huang, Ph.D., Chief Executive Officer of Legend Biotech. “LB2102 marks an early step in expanding CAR-T cell therapy into solid tumors, addressing the unique challenges where current treatment options are limited and early data show promising clinical activity in difficult-to-treat cancers. At the same time, CARVYKTI continues to demonstrate durable efficacy and a consistent safety profile, reinforcing its role as a transformative therapy for multiple myeloma and supporting our leadership in cell therapy.” LB2102: Early Evidence of Clinical Activity Observed in Solid Tumors Early Phase 1 results from the ongoing study of LB2102 demonstrate encouraging anti-tumor activity and a manageable safety profile in patients with relapsed or refractory (R/R) SCLC or LCNEC, a population characterized by advanced disease and limited treatment options. LB2102 is an investigational DLL3-targeted autologous CAR-T cell therapy with dnTGFBR2 Armor engineered to enhance activity by overcoming immunosuppressive signaling within the tumor microenvironment. Efficacy Results Objective response rate (ORR): 20% (4/20) Disease control rate (DCR): 70% (14/20) At dose level ≥3: Median duration of response: 6.5 months Ongoing responses were observed in 2 patients at data cutoff Safety Results No dose-limiting toxicities or treatment-related deaths Cytokine release syndrome (CRS) occurred in 30% of patients (all Grade ≤2) Immune effector cell-associated neurotoxicity syndrome (ICANS) occurred in 15% of patients (two Grade 1 and one Grade 3) Most Grade ≥3 adverse events were hematologic and co-attributed to lymphodepletion “Patients with relapsed or refractory SCLC or LCNEC have historically had very limited treatment options and poor outcomes,” said Zhonglin Hao, M.D., Ph.D., Professor of Medicine and Cancer Biology, Director, Thoracic Oncology Program, University of Kentucky Markey Cancer Center. “Durable disease control and responses at higher dose levels with LB2102 are encouraging, particularly alongside a manageable safety profile. These findings support continued evaluation of CAR-T approaches in solid tumors, where effective therapies remain limited.”‡ LB2102 represents part of the Company’s broader strategy to expand CAR-T therapies beyond hematologic malignancies and into solid tumors. In November 2023, Legend Biotech’s subsidiary, Legend Biotech Ireland Limited, entered into a license agreement with Novartis Pharma AG (the Novartis Agreement), granting Novartis an exclusive worldwide license to develop, manufacture, and commercialize certain Legend Biotech CAR-T cell therapies targeting DLL3. Under the Novartis Agreement, Legend Biotech is responsible for conducting the current Phase 1 clinical trial of LB2102 in the United States, while Novartis is responsible for conducting all other development, manufacturing, and commercialization for the licensed products, including LB2102. CARVYKTI®: Ongoing Clinical Data in Multiple Myeloma New analyses from the CARTITUDE program continue to demonstrate sustained clinical benefit and consistent safety profile of CARVYKTI® in patients with multiple myeloma. In the CARTITUDE-4 subgroup analysis (Abstract #7536), progression-free survival and overall survival benefits were observed across both high-risk and standard-risk cytogenetic populations among patients who responded to bridging therapy, with 30-month OS rates greaterthan 85%.No cases of immune effector cell (IEC)–associated Parkinsonism were reported. In a separate multi-study analysis (Abstract #7533), a low incidence (1.2%) of IEC-associated enterocolitis (IEC-EC) was observed, further characterizing this uncommon adverse event and reinforcing the overall favorable benefit-risk profile of CARVYKTI®. CARVYKTI® is the first and only BCMA-targeted CAR-T cell therapy approved for the treatment of patients with multiple myeloma who have had at least one prior line of therapy. Globally, CARVYKTI® is now commercially available in 18 countries and has been used to treat more than 10,000 patients to date. CARVYKTI® IMPORTANT SAFETY INFORMATION WARNINGS AND PRECAUTIONS INCREASED EARLY MORTALITY - In CARTITUDE-4, a (1:1) randomized controlled trial, there was a numerically higher percentage of early deaths in patients randomized to the CARVYKTI® treatment arm compared to the control arm. Among patients with deaths occurring within the first 10 months from randomization, a greater proportion (29/208; 14%) occurred in the CARVYKTI® arm compared to (25/211; 12%) in the control arm. Of the 29 deaths that occurred in the CARVYKTI® arm within the first 10 months of randomization, 10 deaths occurred prior to CARVYKTI® infusion, and 19 deaths occurred after CARVYKTI® infusion. Of the 10 deaths that occurred prior to CARVYKTI® infusion, all occurred due to disease progression, and none occurred due to adverse events. Of the 19 deaths that occurred after CARVYKTI® infusion, 3 occurred due to disease progression, and 16 occurred due to adverse events. The most common adverse events were due to infection (n=12). CYTOKINE RELEASE SYNDROME (CRS), including fatal or life-threatening reactions, occurred following treatment with CARVYKTI®. Among patients receiving CARVYKTI® for RRMM in the CARTITUDE-1 & -4 studies (N=285), CRS occurred in 84% (238/285), including ≥ Grade 3 CRS (ASTCT 2019) in 4% (11/285) of patients. Median time to onset of CRS, any grade, was 7 days (range: 1 to 23 days). CRS resolved in 82% with a median duration of 4 days (range: 1 to 97 days). The most common manifestations of CRS in all patients combined (≥10%) included fever (84%), hypotension (29%) and aspartate aminotransferase increased (11%). Serious events that may be associated with CRS include pyrexia, hemophagocytic lymphohistiocytosis, respiratory failure, disseminated intravascular coagulation, capillary leak syndrome, and supraventricular and ventricular tachycardia. CRS occurred in 78% of patients in CARTITUDE-4 (3% Grade 3 to 4) and in 95% of patients in CARTITUDE-1 (4% Grade 3 to 4). Identify CRS based on clinical presentation. Evaluate for and treat other causes of fever, hypoxia, and hypotension. CRS has been reported to be associated with findings of HLH/MAS, and the physiology of the syndromes may overlap. HLH/MAS is a potentially life-threatening condition. In patients with progressive symptoms of CRS or refractory CRS despite treatment, evaluate for evidence of HLH/MAS. Confirm that a minimum of 2 doses of tocilizumab are available prior to infusion of CARVYKTI®. Of the 285 patients who received CARVYKTI® in clinical trials, 53% (150/285) patients received tocilizumab; 35% (100/285) received a single dose, while 18% (50/285) received more than 1 dose of tocilizumab. Overall, 14% (39/285) of patients received at least 1 dose of corticosteroids for treatment of CRS. Monitor patients at least daily for 7 days following CARVYKTI® infusion for signs and symptoms of CRS. Monitor patients for signs or symptoms of CRS for at least 2 weeks after infusion. At the first sign of CRS, immediately institute treatment with supportive care, tocilizumab, or tocilizumab and corticosteroids. Counsel patients to seek immediate medical attention should signs or symptoms of CRS occur at any time. NEUROLOGIC TOXICITIES, which may be severe, life-threatening, or fatal, occurred following treatment with CARVYKTI®. Neurologic toxicities included ICANS, neurologic toxicity with signs and symptoms of Parkinsonism, GBS, immune mediated myelitis, peripheral neuropathies, and cranial nerve palsies. Counsel patients on the signs and symptoms of these neurologic toxicities, and on the delayed nature of onset of some of these toxicities. Instruct patients to seek immediate medical attention for further assessment and management if signs or symptoms of any of these neurologic toxicities occur at any time. Among patients receiving CARVYKTI® in the CARTITUDE-1 & 4 studies for RRMM, one or more neurologic toxicities occurred in 24% (69/285), including ≥ Grade 3 cases in 7% (19/285) of patients. Median time to onset was 10 days (range: 1 to 101) with 63/69 (91%) of cases developing by 30 days. Neurologic toxicities resolved in 72% (50/69) of patients with a median duration to resolution of 23 days (range: 1 to 544). Of patients developing neurotoxicity, 96% (66/69) also developed CRS. Subtypes of neurologic toxicities included ICANS in 13%, peripheral neuropathy in 7%, cranial nerve palsy in 7%, parkinsonism in 3%, and immune mediated myelitis in 0.4% of the patients. Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS): Patients receiving CARVYKTI® may experience fatal or life-threatening ICANS following treatment with CARVYKTI®, including before CRS onset, concurrently with CRS, after CRS resolution, or in the absence of CRS. Among patients receiving CARVYKTI® in the CARTITUDE-1 & -4 studies, ICANS occurred in 13% (36/285), including Grade ≥3 in 2% (6/285) of the patients. Median time to onset of ICANS was 8 days (range: 1 to 28 days). ICANS resolved in 30 of 36 (83%) of patients, with a median time to resolution of 3 days (range: 1 to 143 days). Median duration of ICANS was 6 days (range: 1 to 1229 days) in all patients, including those with ongoing neurologic events at the time of death or data cutoff. Of patients with ICANS, 97% (35/36) had CRS. The onset of ICANS occurred during CRS in 69% of patients, before and after the onset of CRS in 14% of patients, respectively. Immune Effector Cell-associated Neurotoxicity Syndrome occurred in 7% of patients in CARTITUDE-4 (0.5% Grade 3) and in 23% of patients in CARTITUDE-1 (3% Grade 3). The most frequent (≥2%) manifestations of ICANS included encephalopathy (12%), aphasia (4%), headache (3%), motor dysfunction (3%), ataxia (2%), and sleep disorder (2%). Monitor patients at least daily for 7 days following CARVYKTI® infusion for signs and symptoms of ICANS. Rule out other causes of ICANS symptoms. Monitor patients for signs or symptoms of ICANS for at least 2 weeks after infusion and treat promptly. Neurologic toxicity should be managed with supportive care and/or corticosteroids as needed. Advise patients to avoid driving for at least 2 weeks following infusion. Parkinsonism: Neurologic toxicity with parkinsonism has been reported in clinical trials of CARVYKTI®. Among patients receiving CARVYKTI® in the CARTITUDE-1 & -4 studies, parkinsonism occurred in 3% (8/285), including Grade ≥3 in 2% (5/285) of the patients. Median time to onset of parkinsonism was 56 days (range: 14 to 914 days). Parkinsonism resolved in 1 of 8 (13%) of patients with a median time to resolution of 523 days. Median duration of parkinsonism was 243.5 days (range: 62 to 720 days) in all patients, including those with ongoing neurologic events at the time of death or data cutoff. The onset of parkinsonism occurred after CRS for all patients and after ICANS for 6 patients. Parkinsonism occurred in 1% of patients in CARTITUDE-4 (no Grade 3 to 4) and in 6% of patients in CARTITUDE-1 (4% Grade 3 to 4). Manifestations of parkinsonism included movement disorders, cognitive impairment, and personality changes. Monitor patients for signs and symptoms of parkinsonism that may be delayed in onset and managed with supportive care measures. There is limited efficacy information with medications used for the treatment of Parkinson’s disease for the improvement or resolution of parkinsonism symptoms following CARVYKTI® treatment. Guillain-Barré Syndrome: A fatal outcome following GBS occurred following treatment with CARVYKTI® despite treatment with intravenous immunoglobulins. Symptoms reported include those consistent with Miller-Fisher variant of GBS, encephalopathy, motor weakness, speech disturbances, and polyradiculoneuritis. Monitor for GBS. Evaluate patients presenting with peripheral neuropathy for GBS. Consider treatment of GBS with supportive care measures and in conjunction with immunoglobulins and plasma exchange, depending on severity of GBS. Immune Mediated Myelitis: Grade 3 myelitis occurred 25 days following treatment with CARVYKTI® in CARTITUDE-4 in a patient who received CARVYKTI® as subsequent therapy. Symptoms reported included hypoesthesia of the lower extremities and the lower abdomen with impaired sphincter control. Symptoms improved with the use of corticosteroids and intravenous immune globulin. Myelitis was ongoing at the time of death from other cause. Peripheral Neuropathy occurred following treatment with CARVYKTI®. Among patients receiving CARVYKTI® in the CARTITUDE-1 & -4 studies, peripheral neuropathy occurred in 7% (21/285), including Grade ≥3 in 1% (3/285) of the patients. Median time to onset of peripheral neuropathy was 57 days (range: 1 to 914 days). Peripheral neuropathy resolved in 11 of 21 (52%) of patients with a median time to resolution of 58 days (range: 1 to 215 days). Median duration of peripheral neuropathy was 149.5 days (range: 1 to 692 days) in all patients, including those with ongoing neurologic events at the time of death or data cutoff. Peripheral neuropathies occurred in 7% of patients in CARTITUDE-4 (0.5% Grade 3 to 4) and in 7% of patients in CARTITUDE-1 (2% Grade 3 to 4). Monitor patients for signs and symptoms of peripheral neuropathies. Patients who experience peripheral neuropathy may also experience cranial nerve palsies or GBS. Cranial Nerve Palsies occurred following treatment with CARVYKTI®. Among patients receiving CARVYKTI® in the CARTITUDE-1 & -4 studies, cranial nerve palsies occurred in 7% (19/285), including Grade ≥3 in 1% (1/285) of the patients. Median time to onset of cranial nerve palsies was 21 days (range: 17 to 101 days). Cranial nerve palsies resolved in 17 of 19 (89%) of patients with a median time to resolution of 66 days (range: 1 to 209 days). Median duration of cranial nerve palsies was 70 days (range: 1 to 262 days) in all patients, including those with ongoing neurologic events at the time of death or data cutoff. Cranial nerve palsies occurred in 9% of patients in CARTITUDE-4 (1% Grade 3 to 4) and in 3% of patients in CARTITUDE-1 (1% Grade 3 to 4). The most frequent cranial nerve affected was the 7th cranial nerve. Additionally, cranial nerves III, V, and VI have been reported to be affected. Monitor patients for signs and symptoms of cranial nerve palsies. Consider management with systemic corticosteroids, depending on the severity and progression of signs and symptoms. HEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS (HLH)/MACROPHAGE ACTIVATION SYNDROME (MAS): Among patients receiving CARVYKTI® in the CARTITUDE-1 & -4 studies, HLH/MAS occurred in 1% (3/285) of patients. All events of HLH/MAS had onset within 99 days of receiving CARVYKTI®, with a median onset of 10 days (range: 8 to 99 days), and all occurred in the setting of ongoing or worsening CRS. The manifestations of HLH/MAS included hyperferritinemia, hypotension, hypoxia with diffuse alveolar damage, coagulopathy and hemorrhage, cytopenia, and multi-organ dysfunction, including renal dysfunction and respiratory failure. Patients who develop HLH/MAS have an increased risk of severe bleeding. Monitor hematologic parameters in patients with HLH/MAS and transfuse per institutional guidelines. Fatal cases of HLH/MAS occurred following treatment with CARVYKTI®. HLH is a life-threatening condition with a high mortality rate if not recognized and treated early. Treatment of HLH/MAS should be administered per institutional standards.PROLONGED AND RECURRENT CYTOPENIAS: Patients may exhibit prolonged and recurrent cytopenias following lymphodepleting chemotherapy and CARVYKTI® infusion. Among patients receiving CARVYKTI® in the CARTITUDE-1 & -4 studies, Grade 3 or higher cytopenias not resolved by Day 30 following CARVYKTI® infusion occurred in 62% (176/285) of the patients and included thrombocytopenia 33% (94/285), neutropenia 27% (76/285), lymphopenia 24% (67/285), and anemia 2% (6/285). After Day 60 following CARVYKTI® infusion, 22%, 20%, 5%, and 6% of patients had a recurrence of Grade 3 or 4 lymphopenia, neutropenia, thrombocytopenia, and anemia, respectively, after initial recovery of their Grade 3 or 4 cytopenia. Seventy-seven percent (219/285) of patients had one, two, or three or more recurrences of Grade 3 or 4 cytopenias after initial recovery of Grade 3 or 4 cytopenia. Sixteen and 25 patients had Grade 3 or 4 neutropenia and thrombocytopenia, respectively, at the time of death. Monitor blood counts prior to and after CARVYKTI® infusion. Manage cytopenias with growth factors and blood product transfusion support according to local institutional guidelines. INFECTIONS: CARVYKTI® should not be administered to patients with active infection or inflammatory disorders. Severe, life-threatening, or fatal infections occurred in patients after CARVYKTI® infusion. Among patients receiving CARVYKTI® in the CARTITUDE-1 & -4 studies, infections occurred in 57% (163/285), including Grade ≥3 in 24% (69/285) of patients. Grade 3 or 4 infections with an unspecified pathogen occurred in 12%, viral infections in 6%, bacterial infections in 5%, and fungal infections in 1% of patients. Overall, 5% (13/285) of patients had Grade 5 infections, 2.5% of which were due to COVID-19. Patients treated with CARVYKTI® had an increased rate of fatal COVID-19 infections compared to the standard therapy arm. Monitor patients for signs and symptoms of infection before and after CARVYKTI® infusion and treat patients appropriately. Administer prophylactic, pre-emptive, and/or therapeutic antimicrobials according to the standard institutional guidelines. Febrile neutropenia was observed in 5% of patients after CARVYKTI® infusion and may be concurrent with CRS. In the event of febrile neutropenia, evaluate for infection and manage with broad-spectrum antibiotics, fluids, and other supportive care, as medically indicated. Counsel patients on the importance of prevention measures. Follow institutional guidelines for the vaccination and management of immunocompromised patients with COVID-19. Viral Reactivation: Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients with hypogammaglobulinemia. Perform screening for Cytomegalovirus (CMV), HBV, hepatitis C virus (HCV), and human immunodeficiency virus (HIV) or any other infectious agents if clinically indicated in accordance with clinical guidelines before collection of cells for manufacturing. Consider antiviral therapy to prevent viral reactivation per local institutional guidelines/clinical practice. Reactivation of John Cunningham (JC) virus, leading to progressive multifocal leukoencephalopathy (PML), including cases with fatal outcomes, have been reported following treatment. Perform appropriate diagnostic evaluations in patients with neurological adverse events. HYPOGAMMAGLOBULINEMIA: can occur in patients receiving treatment with CARVYKTI®. Among patients receiving CARVYKTI® in the CARTITUDE-1 & -4 studies, hypogammaglobulinemia adverse event was reported in 36% (102/285) of patients; laboratory IgG levels fell below 500 mg/dL after infusion in 93% (265/285) of patients. Hypogammaglobulinemia either as an adverse reaction or laboratory IgG level below 500 mg/dL after infusion occurred in 94% (267/285) of patients treated. Fifty-six percent (161/285) of patients received intravenous immunoglobulin (IVIG) post CARVYKTI® for either an adverse reaction or prophylaxis. Monitor immunoglobulin levels after treatment with CARVYKTI® and administer IVIG for IgG Use of Live Vaccines: The safety of immunization with live viral vaccines during or following CARVYKTI® treatment has not been studied. Vaccination with live virus vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy, during CARVYKTI® treatment, and until immune recovery following treatment with CARVYKTI®. HYPERSENSITIVITY REACTIONS occurred following treatment with CARVYKTI®. Among patients receiving CARVYKTI® in the CARTITUDE-1 & -4 studies, hypersensitivity reactions occurred in 5% (13/285), all of which were ≤2 Grade. Manifestations of hypersensitivity reactions included flushing, chest discomfort, tachycardia, wheezing, tremor, burning sensation, non-cardiac chest pain, and pyrexia. Serious hypersensitivity reactions, including anaphylaxis, may be due to the dimethyl sulfoxide (DMSO) in CARVYKTI®. Patients should be carefully monitored for 2 hours after infusion for signs and symptoms of severe reaction. Treat promptly and manage patients appropriately according to the severity of the hypersensitivity reaction. IMMUNE EFFECTOR CELL-ASSOCIATED ENTERCOLITIS (IEC-EC) has occurred in patients treated with CARVYKTI®. Manifestations include severe or prolonged diarrhea, abdominal pain, and weight loss requiring parenteral nutrition. IEC-EC has been associated with fatal outcome from perforation or sepsis. Manage according to institutional guidelines, including referral to gastroenterology and infectious disease specialists. In cases of refractory IEC-EC, consider additional workup to exclude alternative etiologies, including T-cell lymphoma of the GI tract, which has been reported in the post marketing setting. SECONDARY MALIGNANCIES: Patients treated with CARVYKTI® may develop secondary malignancies. Among patients receiving CARVYKTI® in the CARTITUDE-1 & -4 studies, myeloid neoplasms occurred in 5% (13/285) of patients (9 cases of myelodysplastic syndrome, 3 cases of acute myeloid leukemia, and 1 case of myelodysplastic syndrome followed by acute myeloid leukemia). The median time to onset of myeloid neoplasms was 447 days (range: 56 to 870 days) after treatment with CARVYKTI®. Ten of these 13 patients died following the development of myeloid neoplasms; 2 of the 13 cases of myeloid neoplasm occurred after initiation of subsequent antimyeloma therapy. Cases of myelodysplastic syndrome and acute myeloid leukemia have also been reported in the post marketing setting. T-cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T-cell immunotherapies, including CARVYKTI®. Mature T-cell malignancies, including CAR-positive tumors, may present as soon as weeks following infusions, and may include fatal outcomes. Monitor lifelong for secondary malignancies. In the event that a secondary malignancy occurs, contact Janssen Biotech, Inc., at 1-800-526-7736 for reporting and to obtain instructions on collection of patient samples.ADVERSE REACTIONSThe most common nonlaboratory adverse reactions (incidence greater than 20%) are pyrexia, cytokine release syndrome, hypogammaglobulinemia, hypotension, musculoskeletal pain, fatigue, infections-pathogen unspecified, cough, chills, diarrhea, nausea, encephalopathy, decreased appetite, upper respiratory tract infection, headache, tachycardia, dizziness, dyspnea, edema, viral infections, coagulopathy, constipation, and vomiting. The most common Grade 3 or 4 laboratory adverse reactions (incidence greater than or equal to 50%) include lymphopenia, neutropenia, white blood cell decreased, thrombocytopenia, and anemia. Please read full Prescribing Information, including Boxed Warning, for CARVYKTI®. ABOUT CARVYKTI® (CILTACABTAGENE AUTOLEUCEL; CILTA-CEL)Ciltacabtagene autoleucel is a BCMA-directed, genetically modified autologous T-cell immunotherapy, which involves reprogramming a patient’s own T-cells with a transgene encoding a chimeric antigen receptor (CAR) that identifies and eliminates cells that express BCMA. The cilta-cel CAR protein features two BCMA-targeting single-domain antibodies designed to confer high avidity against human BCMA. Upon binding to BCMA-expressing cells, the CAR promotes T-cell activation, expansion, and elimination of target cells.i In December 2017, Legend Biotech entered into an exclusive worldwide license and collaboration agreement with Janssen Biotech, Inc., a Johnson & Johnson company, to develop and commercialize cilta-cel. In February 2022, cilta-cel was approved by the U.S. Food and Drug Administration (FDA) under the brand name CARVYKTI® for the treatment of adults with relapsed or refractory multiple myeloma. In April 2024, cilta-cel was approved for the second-line treatment of patients with relapsed/refractory myeloma who have received at least one prior line of therapy, including a proteasome inhibitor, an immunomodulatory agent, and are refractory to lenalidomide. In May 2022, the European Commission (EC) granted conditional marketing authorization of CARVYKTI® for the treatment of adults with relapsed and refractory multiple myeloma. In September 2022, Japan’s Ministry of Health, Labour and Welfare (MHLW) approved CARVYKTI®. Cilta-cel was granted Breakthrough Therapy Designation in the U.S. in December 2019 and in China in August 2020. In addition, cilta-cel received a PRIority MEdicines (PRIME) designation from the European Commission in April 2019. Cilta-cel also received Orphan Drug Designation from the U.S. FDA in February 2019, from the European Commission in February 2020, and from the Pharmaceuticals and Medicinal Devices Agency (PMDA) in Japan in June 2020. In March 2022, the European Medicines Agency’s Committee for Orphan Medicinal Products recommended by consensus that the orphan designation for cilta-cel be maintained on the basis of clinical data demonstrating improved and sustained complete response rates following treatment. ABOUT MULTIPLE MYELOMAMultiple myeloma is an incurable blood cancer that starts in the bone marrow and is characterized by an excessive proliferation of plasma cells.ii In 2024, it is estimated that more than 35,000 people will be diagnosed with multiple myeloma, and more than 12,000 people will die from the disease in the U.S.iii While some patients with multiple myeloma initially have no symptoms, most patients are diagnosed due to symptoms that can include bone problems, low blood counts, calcium elevation, kidney problems, or infections.iv ABOUT CARTITUDE-4CARTITUDE-4 (NCT04181827) is an ongoing, international, randomized, open-label Phase 3 study evaluating the efficacy and safety of cilta-cel versus pomalidomide, bortezomib, and dexamethasone (PVd) or daratumumab, pomalidomide, and dexamethasone (DPd) in adult patients with relapsed and lenalidomide-refractory multiple myeloma who received one to three prior lines of therapy, including a PI and an IMiD.v ABOUT LB2102NCT05680922 is a Phase 1, first-in-human, open-label, multicenter, dose escalation and expansion study of DLL3-targeted chimeric antigen receptor T-cells (LB2102) in patients with extensive stage small cell lung cancer or large cell neuroendocrine lung cancer.vi ABOUT SMALL-CELL LUNG CANCERLung cancer is a leading cause of cancer deaths, contributing to 25 percent of all cancer-related fatalities annually in the United States.vii Small cell lung cancer (SCLC) is the most aggressive, and accounts for roughly 10-15 percent of lung cancer cases in the United States.viii,ix An estimated 30,000 to 35,000 people are newly diagnosed with the disease each year. This cancer becomes more difficult to treat once it has spread and becomes extensive stage SCLC. Approximately 60 to 70 percent of SCLC patients are diagnosed with metastatic SCLC.,x ABOUT LEGEND BIOTECHWith over 3,000 employees, Legend Biotech is the largest standalone cell therapy company and a pioneer in treatments that change cancer care forever. Legend Biotech is at the forefront of the CAR-T cell therapy revolution with CARVYKTI®, a one-time treatment for relapsed or refractory multiple myeloma, which it develops and markets with collaborator Johnson & Johnson. Centered in the United States, Legend Biotech is building an end-to-end cell therapy company by expanding its leadership to maximize CARVYKTI’s patient access and therapeutic potential. From this platform, Legend Biotech plans to drive future innovation across its pipeline of cutting-edge cell therapy modalities. Learn more at https://legendbiotech.com and follow us on X, Instagram, and LinkedIn. CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTSStatements in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, constitute “forward-looking statements” within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to: Legend Biotech’s strategies and objectives; the benefits of CARVYKTI, including its emerging curative potential; and the potential of LB2102, including the reproducibility and durability of any favorable results initially seen in patients dosed to date in clinical trials. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Legend Biotech’s expectations could be affected by, among other things, uncertainties involved in the development of new pharmaceutical products; unexpected clinical trial results, including as a result of additional analysis of existing clinical data or unexpected new clinical data; unexpected regulatory actions or delays, including requests for additional safety and/or efficacy data or analysis of data, or government regulation generally; unexpected delays as a result of actions undertaken, or failures to act, by our third-party partners; uncertainties arising from challenges to Legend Biotech’s patent or other proprietary intellectual property protection, including the uncertainties involved in the U.S. litigation process; government, industry, and general product pricing and other political pressures; as well as the other factors discussed in the “Risk Factors” section of Legend Biotech’s Annual Report on Form 20-F filed with the Securities and Exchange Commission on March 10, 2026. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described in this press release as anticipated, believed, estimated, or expected. Any forward-looking statements contained in this press release speak only as of the date of this press release. Legend Biotech specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise. ‡ Zhonglin Hao, M.D., Ph.D., Professor of Medicine and Cancer Biology, Director, Thoracic Oncology Program, University of Kentucky Markey Cancer Center, has provided consulting and advisory services to Legend Biotech; he has not been paid for any media work. INVESTOR CONTACT:Jessie YeungTel: (732) [email protected] PRESS CONTACT:Kim FoxTel: (848) [email protected] i CARVYKTI™ Prescribing Information. Horsham, PA: Janssen Biotech, Inc.ii American Cancer Society. “What is Multiple Myeloma?”. Available at: https://www.cancer.org/cancer/types/multiple-myeloma/about/what-is-multiple-myeloma.html.Accessed March 2024.iii American Cancer Society. “Key Statistics About Multiple Myeloma.” Available at: https://www.cancer.org/cancer/types/multiple-myeloma/about/key-statistics.html.Accessed March 2024.iv American Cancer Society. Multiple myeloma: early detection, diagnosis, and staging. Available at: https://www.cancer.org/content/dam/CRC/PDF/Public/8740.00.pdf. Accessed March 2023.v ClinicalTrials.Gov. A Study Comparing JNJ-68284528, a CAR-T Therapy Directed Against B-cell Maturation Antigen (BCMA), Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Participants With Relapsed and Lenalidomide-Refractory Multiple Myeloma (CARTITUDE-4). https://www.clinicaltrials.gov/study/NCT04181827. Accessed March 2024.vi ClinicalTrials.gov. DLL3-Directed Chimeric Antigen Receptor T-cells in Subjects With Extensive Stage Small Cell Lung Cancer. Available at: https://www.clinicaltrials.gov/study/NCT05680922. Accessed May 2025vii American Cancer Society. “Key Statistics for Lung Cancer.” https://www.cancer.org/cancer/lung-cancer/about/key-statistics.html. Accessed November 2022.viii Byers LA, Rudin CM. Small cell lung cancer: where do we go from here? Cancer. 2015;121(5):664-72.ix Rare Diseases. “Rare Disease Database.” https://rarediseases.org/rare-diseases/small-cell-lung-cancer. Accessed November 2022.x Gong J, Salgia R. Managing patients with relapsed small-cell lung cancer. J Oncol Pract. 2018;14(6):359-66.