Legend Biotech Q1 2025 Earnings Call Transcript

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Provided by Quartr
May 13, 2025
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Operator

Good day, and thank you for standing by. Welcome to the Legend Biotech First Quarter twenty twenty five Earnings Call. At this time, all participants are in listen only mode. After the speakers' presentation, there will be a question and answer session. To ask a question during the session, you'll need to press 11 on your telephone.

Operator

You will then hear automated message by when your hand is raised. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker today, Caroline Paul, Associate Director of Investor Relations. Please go ahead.

Caroline Paul
Caroline Paul
Associate Director - IR at Legend Biotech

Good morning. This is Caroline Paul, Associate Director of Investor Relations at Legend Biotech. Thank you for joining our conference call today to review our first quarter of twenty twenty five performance. Prior to this call, we issued a press release announcing our financial results for the quarter. You can find the press release on our IR website at legendbiotech.com.

Caroline Paul
Caroline Paul
Associate Director - IR at Legend Biotech

Joining me on today's call are Ying Huang, the company's Chief Executive Officer Alan Bash, the company's President of Carvecti and Jesse Young, the company's Interim Chief Financial Officer. Following the prepared remarks, we will open up the call for Q and A. We have our President of R and D, Gouwei Fang and Chief Medical Officer, Mythili Kanaru, joining the Q and 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.

Caroline Paul
Caroline Paul
Associate Director - IR at Legend Biotech

In addition, adjusted net loss is a non IFRS metric. This non IFRS financial measure is in addition to and not a substitute for or superior to measures of financial performance prepared in accordance with IFRS. There are a number of limitations related to the use of these non IFRS financial measures versus their closest IFRS equivalents. However, we believe that providing information concerning adjusted net loss and adjusted net loss per share enhances an investor's understanding of our financial performance. We use adjusted net loss as a performance metric that guides management in its operation of and planning for the future of the business.

Caroline Paul
Caroline Paul
Associate Director - IR at Legend Biotech

We believe that adjusted net 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. Our press release includes IFRS to non IFRS reconciliations for these measures. With that, I will now turn the call over to Yang.

Ying Huang
Ying Huang
CEO at Legend Biotech

Hello, everyone. Thank you for joining us today. During the first quarter, we continued executing on our strategic priorities by increasing the number of global ATCs and patients treated with Carvicti in partnership with J and J, delivering operational efficiency and making continued investment. We continue to anticipate achieving operational breakeven for CarVictee by the end of twenty twenty five and the company wide profitability in 2026, excluding unrealized foreign exchange gains or losses. Regarding CARVICTI performance during the first quarter, net trade sales were approximately $369,000,000 which is a 135% increase year over year.

Ying Huang
Ying Huang
CEO at Legend Biotech

We have now treated over six thousand patients with CARVICTI and our CARVICTI launch remains the strongest CAR T launch to date. In The US, more than half of our utilization is now in the earlier line setting. In a recent 50 respondent survey, after presenting CAR T4 data to eighty six percent of physicians from the community setting, preference for Carvictin in early line multiple myeloma rose from thirty four percent to fifty five percent. On this note, we're very pleased that overall survival was added to Carvictin EMA label based on the CHMP positive opinion of data from CARTITUDE IV. We're also pleased that Australia's regulator has now approved CARVICTI in the second line plus setting.

Ying Huang
Ying Huang
CEO at Legend Biotech

We're looking forward to bring CARVICTI to more patients outside The US who might benefit from its differentiated efficacy. Parvictus unique profile continues to be demonstrated through extensive data and we continue to facilitate best practice sharing as we treat more and more patients and generate additional safety data. For example, we've already incorporated additional safety measures in our ongoing CARDITUDE programs. And new data is constantly being generated about CARDITUDE's benefit versus risk profile. As a result of the posters presented at ten the meeting and given that patients are already doing routine blood work, the majority of centers administrate CarVictus have implement monitoring for absolute lymphocyte count followed by dexamethasone intervention as needed.

Ying Huang
Ying Huang
CEO at Legend Biotech

We'll continue highlighting new safety data to the oncology community as it is reported. On the clinical front for CARVICT, we continue to expect to complete enrollment for CAR TU-six this year. We believe the CARDICTIUS five and six trials are key to moving CARDICTI into the frontline setting. Looking at long term growth for Legend, in addition to moving CARDICTI into the frontline, we remain focused on building out our pipeline programs. As part of our mission to serve more patients around the world through innovative cell therapies, we're investing in research and development where we can bring to bear our industry leading expertise to drive the advancement of innovative new assets.

Ying Huang
Ying Huang
CEO at Legend Biotech

This includes in vivo CAR T delivery, which we believe represents an important opportunity to strengthen our cell therapy leadership. We are excited about the new research facility currently being built in Philadelphia, where in vivo delivery will be one of its key focuses, positioning us well to pursue this area of innovation with the right infrastructure and resources. We believe this next generation approach to off the shelf therapy holds a lot of promise for incurable diseases. By reprogramming immune cells directly in the body through direct infusion, the need for ex vivo cell engineering and manufacturing is eliminated. No lymphodepletion apheresis are necessary for in vivo delivery, enabling even more scalable manufacturing.

Ying Huang
Ying Huang
CEO at Legend Biotech

We're excited to be embarking on this next frontier of cell therapy innovation, and we look forward to providing additional updates as we make progress on this front. Turning to our upcoming anticipated company milestones, we anticipate growth to be driven by capacity expansion in Belgium and in New Jersey, which Alan will detail in just a moment. In addition to increasing our manufacturing capacity, we continue to work towards the overall survival benefit being included in The U. S. Label, now that it's already in the European label.

Ying Huang
Ying Huang
CEO at Legend Biotech

To sum up, regardless of the current macroeconomic uncertainties, Legend injures as the largest standalone cell therapy company with over 6,000 patients treated by CarVicti as we forged the path to cure. With a cash position of approximately $1,000,000,000 we are investing in our core differentiators and remain focused on delivering operational efficiency in order to ensure durable long term growth. With that, I'll pass it over to Alan to provide an update on CarVictee.

Alan Bash
Alan Bash
President - CARVYKTI at Legend Biotech

Thanks, Ying. Moving on to Carvictee's performance, as Ying mentioned, net trade sales of Carvictee were approximately $369,000,000 which is a 135% increase year over year and a 10% increase from the fourth quarter. Our global growth was driven by continued share gains and capacity expansion. US net trade sales of three eighteen million dollars grew 127% year over year and 5% quarter over quarter. In The US, we continue to certify more hospitals as authorized treatment centers and the total number of US hospitals that are certified to treat with the CRBIC D is now 114.

Alan Bash
Alan Bash
President - CARVYKTI at Legend Biotech

We remain pleased with the progress we have made in the outpatient setting and continue to anticipate that a majority of our volume will be coming from outpatient use by the end of this year. Regarding OUS performance, which was notably strong, we had sales of $51,000,000 which is more than double compared to the same period a year ago and represents a 65% increase quarter over quarter. Our OUS performance was driven by expansion in Germany, Switzerland, Austria and Brazil, and we are pleased to be bringing Carvictee to more eligible patients in Spain, The UK, Denmark, Belgium and Israel, where we recently launched. To this end, we're excited to share that TechLane initiated clinical production in Ghent during the first quarter and remains on track to initiate commercial production there later this year. This is another critical component of our plans for serving patients in Europe to meet the increasing demand.

Alan Bash
Alan Bash
President - CARVYKTI at Legend Biotech

And to meet additional demand in The United States, we expect to receive approval for our physical expansion in Raritan in the second half of the year. The progress we've made in executing our manufacturing plan and investments has enabled us to be among the best in class. We now have a 97% manufacturing success rate, which we believe is the highest in the CAR T industry. 95% of the time, we deliver CarVictee on or before the promised delivery date and our median turnaround time has been consistently declining and now stands at thirty days. We believe this turnaround time is more than sufficient based on our conversations with physicians.

Alan Bash
Alan Bash
President - CARVYKTI at Legend Biotech

As physicians place their orders, they are mindful that bridging therapy alone takes multiple weeks for a number of patients. Going forward, we expect to continue to reduce out of spec rates and increase our efficiency and expect further declines in our turnaround time. Now it's time to take a closer look at the financials, so I will turn the call over to Jesse.

Jessie Yeung
Jessie Yeung
Interim CFO at Legend Biotech

Thank you, Alan, and good morning, everyone. During the first quarter, we delivered solid financial results with CAFD net sales up 135% year over year. Total revenues were $195,000,000 driven by collaboration revenue growth of 137% year over year. Q1 delivered a 101,000,000 net loss and a EUR 27,000,000 adjusted net loss after excluding items that are not representative of the company's core business, such as a 52,000,000 unrealized foreign exchange loss due to our treasury center based in Ireland. Importantly, our operating loss of EUR 118,000,000 in the same period one year ago was reduced by over half to an operating loss of EUR 51,000,000.

Jessie Yeung
Jessie Yeung
Interim CFO at Legend Biotech

The meaningful improvement in operating results was driven by our operational efficiency and disciplined expense management. Even though we continue to invest in our robust pipeline and supporting the second line indication launch as well as our manufacturing capacity, Our first quarter gross margin on net product sales was 63%, improving from 59% in Q4. As expected, R and D expense on an IFRS basis grew only one percent year over year and SG and A on an IFRS basis only grew 29% from the prior year to 72,000,000. Overall, we believe we have been making strides towards positive operating cash flow generation and profitability. Our adjusted diluted earnings per share were negative 0 7 dollars compared to negative $0.23 for the same period last year.

Jessie Yeung
Jessie Yeung
Interim CFO at Legend Biotech

Now turning to capital allocation. We continue to have a strong balance sheet with JPY 1,000,000,000 in cash and equivalents and time deposits. We believe this is a competitive advantage for us in our industry, and we will continue to prioritize disciplined expense management as we fund our operating and capital expenditures, including future innovation until we achieve profitability, which we anticipate in 2026, excluding unrealized foreign exchange gains or losses. In summary, our first quarter results demonstrate the durability of our stand alone cell therapy platform. We are pleased with our performance and the advancements of many impactful initiatives along with increasing operational efficiency in 2025.

Jessie Yeung
Jessie Yeung
Interim CFO at Legend Biotech

And now it's time to take your questions. Operator, we are ready for the first question please.

Operator

Thank you. At this time, we'll conduct a question and answer session. And our first question comes from the line of Gena Wang of Barclays. Your line is now open.

Gena Huidong Wang
Gena Huidong Wang
Managing Director, Biotech Equity Research at Barclays

Thank you for taking my questions. I have three quick questions. First one is regarding the CARVITY price differences between U. S. And ex U.

Gena Huidong Wang
Gena Huidong Wang
Managing Director, Biotech Equity Research at Barclays

S, if you can give any color there. And the second is regarding the new Rarrington section approval in second half twenty twenty five. Would you be able to walk us through the steps you need FDA sign off and any concern on FDA on time execution? And then lastly, quickly, I know you have a multiple pipeline assets. Just give us a rough idea when should we see which program first in the coming years or 2025, we will see additional data.

Alan Bash
Alan Bash
President - CARVYKTI at Legend Biotech

Hi, Gina. It's Alan. The price differential between The US and Ex US is approximately 30 percent. Obviously, it varies country to country. In terms of the Raradin approval in the second half, we're confident that we will be able to achieve the approval from FDA in terms of capacity expansion.

Alan Bash
Alan Bash
President - CARVYKTI at Legend Biotech

And that is based on the filings with them and the CB30 with that process.

Guowei Fang
Guowei Fang
President - Research & Development at Legend Biotech

So in terms of pipeline, our focus on two different technology platform, in vivo cell therapy platform for oncology indication, and allogeneic cell platform for autoimmune disease. We are looking forward to multiple clinical results later this year. For in vivo CAR T platform, we expect to have first patient dose in our investigator initiated study in June or July, and expect to have preliminary clinical results towards the end of this year. On the allele platform side, we expect to have clinical results in the second half of this year against investigating in this study. Autoimmune currently, are running some IIT trial in China using triple targeting autologous cell therapy product, targeting CD19, CD20, CD22, trying to drive a deeper response.

Guowei Fang
Guowei Fang
President - Research & Development at Legend Biotech

And we also expect to have clinical results in the later part of the year. Lastly, on US side, we have two ongoing phase one program targeting CARD18.2 for gastric cancer and the small cell lung cancer. Again, we are reading out of the phase one dose escalation data for both programs.

Mythili Koneru
Mythili Koneru
Chief Medical Officer at Legend Biotech

Yeah, I can expand on that a little bit. For the DLL3 program, we have an oral presentation at ASGCT next week, and both the DLL3 programs and the Quadrant 18.2 programs have ASCO posters that you may have seen from the titles that were released back in April.

Ying Huang
Ying Huang
CEO at Legend Biotech

Hi, Gina, this is Dean. Maybe I'll supplement the answers by pointing out two things. First of all, I know you guys are looking at the price difference, so you're pretty much aware that in The United States, there are three types of customers that we pay the mandatory federal required rebates, so it's Medicaid, 340B hospitals, and also VA hospitals. We provide a 23.1% rebate to those customers from the list price, and this is why we don't see a really significant difference between the Euro price and those types of customers in The US, so we don't see a big impact regarding some of the proposals from the administration here. And then on FDA approval, I know people are concerned that you're seeing some staff reduction agency, but based on our current interaction with FDA on expansion at Raritan, like Anna mentioned, FDA agreed that we'll use the so called CB30 pathway, that is once we and J and J file the application in writing, within thirty days, if we don't hear from the agency a steam approval, or if there's any request during that thirty day we can answer, then again, we don't expect any delays here.

Ying Huang
Ying Huang
CEO at Legend Biotech

So we fully expect the on time approval from FDA for the physical expansion for Riotin, and right now we're still on track to achieve that by end of this year.

Gena Huidong Wang
Gena Huidong Wang
Managing Director, Biotech Equity Research at Barclays

Thank you.

Operator

Thank you. One moment for our next question. Our next question comes from the line of Jessica Fye of JPMorgan. Your line is now open.

Jessica Fye
Jessica Fye
Managing Director & Equity Research Analyst - Biotechnology at JP Morgan

Hey, guys. Good morning. Thanks for taking my question. I was wondering if you could just take a minute to kind of make the case to investors that Carvictee will successfully penetrate the community. The reason I ask is, one pushback we hear from investors is that when they do KOL calls, so, you know, with key centers, the physicians indicate they don't have a backlog, and thus, I think some investors come away thinking that demand is largely satisfied and there's limited growth ahead.

Jessica Fye
Jessica Fye
Managing Director & Equity Research Analyst - Biotechnology at JP Morgan

So, just hoping you can spend a minute on kind of making the case about why you have conviction this product can get into the community. Thank you.

Alan Bash
Alan Bash
President - CARVYKTI at Legend Biotech

Based on many of the discussions we've had, both with the KOLs in the authorized treatment centers, as well as physicians out in the community, there is a high demand for providing Carbivta as an option for patients in earlier lines. And what we hear is that the benefit based on the profile of extending survival, extending long term remission to these patients is very attractive. And there are obviously, as you know, the majority, eighty percent of the patients out there in the community. What we have done is, and based on the feedback we've received, is we've increased our investment and efforts along with J and J in terms of educating the community, going out and reaching all the major community sites, we're in the process of doing that. And not only raising awareness, there's already high awareness of Carbixia as an option, but actually where we see more opportunity is to raise awareness and increase that call to action in terms of referring patients into the authorized treatment centers.

Alan Bash
Alan Bash
President - CARVYKTI at Legend Biotech

The second thing we're doing is we are connecting the experts in the authorized treatment centers with the experts out in the community. And this is getting a lot of great traction, a lot of increased dialogue, a lot of really good opportunities for those referrals to happen. And then thirdly, we are explaining to the community that those patients are going to be coming back to them and we are building a platform around transition of support, so that those patients actually will need to get back to their community physician for ongoing monitoring, other health checks, and so that the community understands that they will not be losing those patients. So the profile of the product, the outpatient administration, the overall survival benefit, the unique differentiated benefit, these are all things that we see gaining traction in the community.

Ying Huang
Ying Huang
CEO at Legend Biotech

Jess, this is Dean. Maybe I'll just add one more point to Alan's comments. So we will present some long term data at ASCO. In fact, you'll see the abstract coming out next week, And we at J and J are extremely pleased with the results, and we think this will be actually another impetus for the community to take up CARBIC in a second line, given the unprecedented benefits. Also, I'm happy to report that our overall survival result was just added officially into the label in Europe, following the positive CHMP opinion already.

Ying Huang
Ying Huang
CEO at Legend Biotech

So again, in both The US market and European markets, we will be able to promote on the merit of overall survival, and also the significant results from CAR4 that demonstrates both clinically meaningful and also statistically significant superiority in survival over standard of care. So that will help the community uptake.

Jessica Fye
Jessica Fye
Managing Director & Equity Research Analyst - Biotechnology at JP Morgan

Thank you.

Operator

Thank you. One moment for our next question. Our next question comes from the line of Yaron Werber of TD Cowen. Your line is now open.

Yaron Werber
Managing Director, Senior Biotechnology Analyst at Cowen and Company

Great. Thanks so much. I have two quick questions. Number one, in terms of capacity for Q2, now that Obelisk is online and continuing to sort of you're pushing volume through it, should we expect can you give us a sense sort of we're expecting obviously a step up in terms of quarter over quarter growth over Q1, but is that going to be more European centric than U. S?

Yaron Werber
Managing Director, Senior Biotechnology Analyst at Cowen and Company

And then secondly, it sounds like you do not need to get the new Raritan facility inspected, the new expansion. Can you just confirm that? Thank you.

Alan Bash
Alan Bash
President - CARVYKTI at Legend Biotech

Yeah. So, in terms of Obelisk, you're absolutely right. It came online, in September, last year, and, it is now, delivering for Europe. So we do expect that that will continue to, improve our ability to supply Europe, And we do expect modest growth in Q2 with more sequential growth and acceleration in the back half of the year supported by not only Oboelesque, but also The US capacity expansions as we've outlined previously with Raritan, as well as Novartis coming online in the first half of this year. In terms of the, in terms of the Raritan physical plant expansion, as Ying described, at this point, we do not expect that there will be required any inspections relative to that CB 30 process and the approval there.

Operator

Thank you. One moment for our next question. And our next question comes from the line of Costas Beloris of BMO Capital Markets. Your line is now open.

Kostas Biliouris
Kostas Biliouris
Director - Biotech Equity Analyst at BMO Capital Markets

Good morning, everyone. Thanks for taking our question. Can you remind us, please, what is the difference between high risk patients and functional high risk patients? What is the percentage of functional high risk patients in multiple myeloma? And what percentage of the patients treated with Carvictin early lines correspond to functional high risk patients?

Kostas Biliouris
Kostas Biliouris
Director - Biotech Equity Analyst at BMO Capital Markets

Thank you.

Mythili Koneru
Mythili Koneru
Chief Medical Officer at Legend Biotech

Sure. When we refer to high risk patients, we are referring to patients with certain cytogenetic factors, whereas the definition of functional high risk is more related to the concept that they progress quickly after a frontline setting. So, it's more related to how the patients respond to a particular therapy. In terms of the CARTITUDE IV study, as the abstract titles show for ASCO, we will be having data coming out on the subgroup analysis on these various patients in CARTITUDE IV. But in general, CARTITUDE IV has shown very strong, both PFS and OS in the population in these early lines of patients.

Mythili Koneru
Mythili Koneru
Chief Medical Officer at Legend Biotech

So we feel confident that both of these populations, both high risk and functional high risk, do very well with cell to cell administration.

Kostas Biliouris
Kostas Biliouris
Director - Biotech Equity Analyst at BMO Capital Markets

And in terms of CARBICTI uptake in early lines, what dynamics do you see there with function on Far East patients? Is this a high percentage of such patients in the uptake that you see in early lines?

Alan Bash
Alan Bash
President - CARVYKTI at Legend Biotech

Yeah, I think in the early lines, namely the second through fourth line, we do see that where physicians tend to start are in these categories that Maja just described, the functional high risk and the high risk patients. That's a natural place for them to begin to think about PRVICTI as an option. But we've also, in our conversations, heard that, many physicians, once they've gotten comfortable there and they have started to use it in that population, will then expand. So I think, to your point, this is a progression from utilizing Carbixi in the early lines for the patients who are either fast progressors or have the high size of genetic risk, and then moving on from there.

Kostas Biliouris
Kostas Biliouris
Director - Biotech Equity Analyst at BMO Capital Markets

Thank you.

Operator

Thank you. One moment for our next question. Our next question comes from the line of Kelly Shai of Jefferies. Your line is now open.

Clara Dong
Clara Dong
Vice President - Biotechnology Equity Research at Jefferies

Hi, good morning. This is Clara on for Kelly. Thanks for taking our questions. So, just initiated a chronic preclinical production that's tackling facilities. So, just wondering if you can give us a little bit more color about the manufacturing expansion moving forward.

Clara Dong
Clara Dong
Vice President - Biotechnology Equity Research at Jefferies

And also, just want to quickly touch upon the in vivo CAR T initiative you mentioned. Wondering where do you see the differentiations might land in this novel space? Thank you.

Alan Bash
Alan Bash
President - CARVYKTI at Legend Biotech

Yes, as you mentioned, we achieved approval for the clinical production and began that in TechLane, and that sets us up well for the ability to start commercial production in TechLane by the end of this year, and we're on track for that. So, between Techlane and the Ovalesque facility, which is already approved in commercial, we are, quite significantly ramping there to support the European launches. And just to remind you, the European launches are across Germany, Switzerland, Austria, Denmark, and then throughout the world, we have The UK in private market, Israel in private market, and Brazil as well. And as you saw from the release, Australia is now achieving approval, reimbursement and launch will come later. Just to add to the two facilities again, as we've already mentioned, we've talked about the rear end expansion and, the Novartis commercial production, which started, the first part of this year in January, is also starting to meaningfully contribute, in q two here and then q three and beyond.

Alan Bash
Alan Bash
President - CARVYKTI at Legend Biotech

In addition, let me just mention because we have talked about the fact that there is an investment in TechLane that the companies have jointly approved. And so that speaks to the additional capacity that we plan to build in TechLane to the tune of $150,000,000 jointly by the collaboration.

Guowei Fang
Guowei Fang
President - Research & Development at Legend Biotech

So in terms of in vivo CAR T approach, this is a platform where we use molecular engineering the nanovirus that can specially recognize immune cell. In this case, T cell in the body of the patient. At the same time, we also engineer a virus to reduce the generic or nonspecific transduction to normal tissue. And we are expecting first patient dosing in June and July this year. In terms of advantage of in vivo CAR T compared to conventional ex vivo manufactured cell therapy, There are a few key areas.

Guowei Fang
Guowei Fang
President - Research & Development at Legend Biotech

One is those T cell engineered, recognized engineered in the body of patient, and therefore in general, it has better cell phenotype based on our preclinical data calculation. Second is completely off shop without the lymphodepletion. So, there's no delay in terms of administrating therapy. No lymphodepletion also provide additional safety benefit to the patient. Lastly, it's a scalable manufacturer due to the nature of anti virus being the drug product.

Guowei Fang
Guowei Fang
President - Research & Development at Legend Biotech

So those are the few key areas.

Operator

Thank you. One moment for our next question. Our next question comes from the line of John Miller of Evercore ISI. Your line is now open.

Jonathan Miller
Managing Director at Evercore ISI

Hi guys. Thanks so much for taking the question. A couple of clarifications, if I may start with those. I know you already spoke about the general price difference U. S.

Jonathan Miller
Managing Director at Evercore ISI

Versus ex U. S. But what's the price delta between The U. S. And the lowest cost anywhere else in the world, not just the average difference A?

Jonathan Miller
Managing Director at Evercore ISI

And secondly B, you talked a little bit about penetrating the community Ying, but most of the stuff that you were talking about is how to get referrals into academic centers. I know you've also talked about getting actual CAR T infusion into select community centers this year. Can you give us an update on how that process is going and how rapidly you expect to be able to deliver CAR T in the community itself? And then maybe lastly on those in vivo CAR T differentiators that you just spoke of that makes sense relative to an ex vivo CAR T, but how do you feel differentiated for your approach in vivo space relative to other in vivo players who are also working on similar lenti based approaches? Thank you.

Alan Bash
Alan Bash
President - CARVYKTI at Legend Biotech

This is Alan. I I don't think we'll be commenting on the specific lowest price, but I do I do wanna just, remind you that we have a band a a pricing band that J and J, given their pricing policy, does, adhere to. So, we don't go below that price. And that's that's supported basically based on, the costs, and other factors, obviously, speaking to the value of CarVictee in the marketplace as well. So, there is a price band there.

Alan Bash
Alan Bash
President - CARVYKTI at Legend Biotech

You're absolutely right that, I was speaking to the penetrating of the community in terms of referral base, but to add to that, we are also in active discussions around having, CarVictee closer to the patient and administered in the community setting. We have, several, I would say, sort of demonstration projects and initial, plans with, certain community centers this year in the works. Nothing to announce as of yet, but we do expect that this year we'll have, at least one, if not two or more, community, large community networks starting to administer ParvikT, in some of their centers. And then the third leg of that journey, if you will, is actually bringing it to even more sites around the country and having CARBICT adopted in the community setting as well. So we are on that journey, starting with some centers this year.

Guowei Fang
Guowei Fang
President - Research & Development at Legend Biotech

Yeah. Getting to your second question in terms of differentiation of our in vivo approach versus our peer groups approach across the industry. This is a novel platform and rapidly evolving. We began to invest in this platform two years ago. We think that there are probably four or five areas of key differentiation that we actually set up from the get go.

Guowei Fang
Guowei Fang
President - Research & Development at Legend Biotech

One is the T cell recognition mechanism. So, there are many different ways to recognize T cell and then induce the transduction. We are testing multiple mechanism of T cell recognition to drive the transduction efficiency, as well as to control the safety signal. Those approach we invested will play out in the clinical setting. The second area of differentiation is really about the engineering of the virus, reducing generic transduction capacity of virus.

Guowei Fang
Guowei Fang
President - Research & Development at Legend Biotech

We have specific point mutations with our own IP position to really reduce the generic transduction and therefore expand the potential therapeutic window between the T cell recognition and non specific recognition. The third area is the CAR design. We have large experience and expertise in optimizing the CAR design combined with armor mechanisms. So, I think that's a key area that can drive the differentiation and the activity of the in vivo CAR T. The fourth area is another area we have a tremendous expertise coming from Kapiti's experience, that is the CMC, the process development, the process robustness, and ability to scale up.

Guowei Fang
Guowei Fang
President - Research & Development at Legend Biotech

From the get go, our goal is to optimize the CMC process so that we can not only support the initial IIT trial, but also have ability to further develop down the road. And then last area, the fifth area of differentiation we focus on is really the execution of clinical validation for those platform. We have end to end capacity in clinical development on the ground in China. We can execute IIT trial very efficiently. Our first development candidate for in vivo platform was selected last December, and six months later, we are looking forward to first patient dosing.

Guowei Fang
Guowei Fang
President - Research & Development at Legend Biotech

So, let's speak to the speed and efficiency of our clinical development process. All those I think will bring value to our in vivo platform.

Operator

Thank you. One moment for our next question. Our next question comes from the line of Leonid Timmagev of RBC. Your line is now open.

Leonid Timashev
Leonid Timashev
Biotechnology Analyst at RBC Capital Markets

Hey, thanks guys. Thanks for taking my question. I wondered if you could talk a bit more about the community referral process. I guess I'm wondering how much brand awareness and stickiness actually is there in the community for CarVictee specifically versus that decision being made at other centers? I guess, effectively, are you laying the groundwork for CarVictee or for all CAR Ts, including, I guess, future and current competitors?

Leonid Timashev
Leonid Timashev
Biotechnology Analyst at RBC Capital Markets

And then related to that, I guess, what's the messaging from you and your partner in the community, given that your commercialization partner also has bispecific offerings, which are pretty popular in the community? Thanks.

Alan Bash
Alan Bash
President - CARVYKTI at Legend Biotech

Yeah, there's growing awareness of CAR T and specifically CAR VICT in the community. We estimate, we do some surveys, that about 70% of community oncologists are aware of CAR VICT. Where we see more opportunity is actually to get them to go from awareness to action based on the earlier line approval of the CARTITUDE IV population. But we are certainly laying the groundwork for that in the ways that I described earlier in terms of strong education through our field teams, through medical education, through connecting the experts at the treatment centers to the community, and making sure that the community understands that they will be getting their patients back for a transition of support and monitoring and ongoing care. In terms of I think that was the answer on that.

Alan Bash
Alan Bash
President - CARVYKTI at Legend Biotech

Oh, the messaging with the partner, yeah. So we and our partners are very committed to the fact that cell therapy, specifically BCMA CAR T, is the very best option for patients, in terms of earlier lines. We have the overall survival data. We have the durability. And the IMWG recommendations are very clear that for patients who are eligible for both bispecifics and CAR T should really be evaluated for CAR T first.

Alan Bash
Alan Bash
President - CARVYKTI at Legend Biotech

And that's based on the clinical profile. J and J is committed to this. And I should just remind you that we have our own teams out in the field. Our own sales teams dedicated to CarVictee, both on the J and J side and on the Legend side, making this case.

Operator

Thank you. One moment for our next question. And our next question comes from the line of Vikram Parolay of Morgan Stanley. Your line is now open.

Vikram Purohit
Vikram Purohit
Executive Director, Equity Analyst at Morgan Stanley

Hi. Good morning.

Vikram Purohit
Vikram Purohit
Executive Director, Equity Analyst at Morgan Stanley

Thank you for taking our questions. We had two. So first, could you just kind of walk us through your initial thoughts on the recently appointed leadership at CBER and what you see as the potential implications and key considerations here that we should keep in mind for the CARD VICT development program. And then secondly, related to an earlier question, could you remind us what portion of CardiCity use is currently in the CARTISUDE IV population, and where do you see that trending over, say, the course of the next year? Thank you.

Alan Bash
Alan Bash
President - CARVYKTI at Legend Biotech

Just to answer your second question first, we see that nearly sixty percent of our patients and this is based on our ordering system nearly sixty percent are coming from that CAR T2-four population. We expect that to continue to evolve in that direction and get to about three quarters, either by the end of this year or certainly before, our competitor in this space is launched. So again, as they get into the market in a later line population, we will have significantly evolved, our business into the earlier lines.

Ying Huang
Ying Huang
CEO at Legend Biotech

Hey Vikram, so I'll answer the question about the new CBER leadership at FDA. So we're happy to see that Doctor. Prasad has been appointed the director of CBER, which regulates all the cell and gene therapy approvals. First of all, we agree with Doctor. Persaud's point that in any cancer trial, you should use gold standard of survival benefit.

Ying Huang
Ying Huang
CEO at Legend Biotech

And to that end, we're happy to report that, first of all, we will report long term minimum five year follow-up from CAR T1. You guys will see the data at ASCO, and in fact, the abstracts coming out next week. So you will see the unprecedented benefit we bring to this population, and that is survival, which is a hard endpoint. Secondly, I think if you look at the history of CARBICT approval, we did secure FDA approval back in February of twenty twenty two based on the primary endpoint of overall response rate. However, when we started this trial back in twenty eighteen, twenty nineteen, these patients have exhausted all the available therapy to them, so it represents a very significant unmet medical need by then.

Ying Huang
Ying Huang
CEO at Legend Biotech

Today, of course, you can argue things are different because you have two BCMA targeting CAR T available as commercial therapy, and three soon to be four five-three antibodies, again, indicated for myeloma. So it's very different. But since we conducted that HER2-one trial, we have demonstrated the survival benefit, we have demonstrated the PFS, which is nearly three years from historically about four to five months in this patient population. So that is the hard evidence we demonstrated. And then thirdly, we also secured both FDA and also EMA approval based on PFS endpoint.

Ying Huang
Ying Huang
CEO at Legend Biotech

However, in September of last year, we demonstrated again clinically meaningful and also statistically significant benefit in survival with a hazard ratio of 0.55, which means forty five percent improvement in survival from standard of care. So we think CARBICTI comes with a very, very strong benefit in terms of clinical outcome, which is survival. And then that's also accompanied by the target endpoints such as PFS and overall response rates. That is why Legend and also JNJ stands by the best in class profile CARBICTI. So we welcome Doctor.

Ying Huang
Ying Huang
CEO at Legend Biotech

Prasad as the CBERT leadership because we have clearly demonstrated the survival benefit here. Now, I know there are questions from investors about MRD inactivity. So we think that given the support from ODAC last year using MRD as a starting endpoint, we plan to sit down with the FDA to explore the possibility of using MRD activity as a potential endpoint for accelerated approval. We think this is a good setting in the first line setting because, as you know, today, if the newly diagnosed multiple myeloma patient is treated, the expected survival is probably over five to seven years. Therefore, in this setting, a surrogate endpoint makes perfect sense.

Ying Huang
Ying Huang
CEO at Legend Biotech

Now, in last line or even second line, if you look at our data from CAR-four, the standard of care op had a PFS of shorter than one year. So in that setting, we're not sure whether a surrogate endpoint makes sense or not under the leadership of Doctor. Prasad. As I mentioned, again, we agree that the oncology settings of ours should be the goal standard, and we're happy to report that Carbixi does bring that lifesaving benefit to patients.

Vikram Purohit
Vikram Purohit
Executive Director, Equity Analyst at Morgan Stanley

Great, thanks so much.

Operator

Thank you. One moment for our next question. And our next question comes from the line of James Shen of DB. Your line is now open.

James Shin
James Shin
Director of Biopharma Equity Research at Deutsche Bank

Hey, good morning guys. Thank you for taking our question. I want to kind of piggyback on the Doctor. Prasad question. I know base case for CAR T2six is to lean on PFS and it sounds like you have engaged on possibly exploring MRD.

James Shin
James Shin
Director of Biopharma Equity Research at Deutsche Bank

But any thoughts on like competitors or the utilization of percentage of patients completing twelve month of follow-up? And then for Alan, what is the status on like, believe there was an industry coalition for lowering community based CAR T accreditation. Is that, I guess, it a bottleneck for community adoption right now? Thank you.

Mythili Koneru
Mythili Koneru
Chief Medical Officer at Legend Biotech

Regarding your first question, unfortunately, since we do not comment on competitors, I can't say what they are doing. We're confident about our approach and discussions that we will be having with the FDA on our part six study.

Alan Bash
Alan Bash
President - CARVYKTI at Legend Biotech

Yeah. The industry discussions around providing some sort of fact light accreditation are ongoing. There are, some, centers we are in discussions with that, and they're affiliated with the larger academic centers, around the country. So that that I would say is in process, and, that should potentially unlock some of the opportunity in the community as well.

Mythili Koneru
Mythili Koneru
Chief Medical Officer at Legend Biotech

In addition, just to add to the CARTitude six, as I mentioned, we have a clear plan to have conversations with the FDA, and we intend on meeting with them in about a two month timeframe.

Operator

Thank you. One moment for our next question. And our next question comes from the line of Mitchell Kapoor of eighteen Wainwright. Your line is now open.

Mitchell Kapoor
Director, Senior Biotechnology Analyst at H.C. Wainwright & Co., LLC

Hey, everyone. Thanks for taking the questions. I wanted to ask one about outpatient volume. I think last quarter you had mentioned that it comprised over half of all volume for CarVictee. Can you quantify that trend now and just give us a little bit of the direction of where that is heading?

Mitchell Kapoor
Director, Senior Biotechnology Analyst at H.C. Wainwright & Co., LLC

And then secondly, can you talk through your assumptions and pipeline efforts for cash runway through second quarter of twenty twenty six? Would you need to seek some avenues of non dilutive capital to bridge yourself like well into profitability? Or do you think that maybe there's some other opportunities you might see?

Alan Bash
Alan Bash
President - CARVYKTI at Legend Biotech

In terms of outpatient volume, we see that growing steadily, but slowly also because as new centers come on, sometimes they start in the inpatient. So our latest claims data continues to show that it's a little over half. We do see growth each quarter, but it's in single digit percentage points. I expect that over time, we will continue to see continued move to the outpatient setting. Again, this might be center specific or it might be patient specific, depending on the patient characteristics.

Alan Bash
Alan Bash
President - CARVYKTI at Legend Biotech

But I would say we'd probably get into kind of the two thirds, one third outpatient versus inpatient over time with the treatment centers that we have now and the ones that will be coming on board in the future.

Jessie Yeung
Jessie Yeung
Interim CFO at Legend Biotech

And Mitchell, as you know, we have many reasons to be optimistic about Legend's future, and we are the market leader with the fastest launch in the CAR T space. And we continue to expect CAR FICT will break even operationally by the end of 'twenty five, And we anticipate profitability in 2026, excluding FX fluctuations. We have $1,000,000,000 of cash on hand and that will reach profitability we that will last to 2026. So we don't have any present needs to raise capital. And we have a joint investment with J and J on CapEx for $150,000,000 that will last through 2028 for the tech length phase two expansion.

Jessie Yeung
Jessie Yeung
Interim CFO at Legend Biotech

And that is included in our cash runway. Thank you.

Mitchell Kapoor
Director, Senior Biotechnology Analyst at H.C. Wainwright & Co., LLC

Great. Thank you, guys.

Operator

Thank you. One moment for our next question. Our next question comes from the line of G. Mukherjee of BTIG. Your line is now open.

Jeet Mukherjee
Vice President & Biotechnology Analyst at BTIG

Great. Thanks for taking my questions. Just two from me. First, coming back to integrating CAR T therapy into the community setting, when it comes to the tertiary and regional centers, what are the biggest infrastructure hurdles for them currently, and what are you doing to facilitate this? And second, on the DLL3 and Claudine eighteen point two data sets we're expecting, will the data be as part of the conference abstracts, or will they perhaps be saved for the conference presentations themselves?

Jeet Mukherjee
Vice President & Biotechnology Analyst at BTIG

Thank you.

Alan Bash
Alan Bash
President - CARVYKTI at Legend Biotech

In terms of infrastructure, certainly capacity and share space and staff are some of the factors that we look at. But again, speaking to the prior question around outpatient, we do see that over half of our patients are getting Corvikti in the outpatient setting. And that's based on a couple of factors, one of which importantly is our profile around the time of onset for CRS. And that gives the centers confidence to safely infuse it in the community and then monitor patients. And that opportunity for outpatient is one of the ways that we overcome some of the infrastructure hurdles there.

Alan Bash
Alan Bash
President - CARVYKTI at Legend Biotech

One of the other infrastructure hurdles that we are monitoring and we keep a close conversation on with our centers is any capacity limits in terms of pickups in apheresis and cryopreservation. Again, there are multiple ways that centers around the country are addressing this, including use of third party suppliers for apheresis pickup, as well as cryopreservation. And we're engaging those companies to help make sure that those infrastructure hurdles are not a limit to patients getting apheresis.

Mythili Koneru
Mythili Koneru
Chief Medical Officer at Legend Biotech

Regarding DLL3 and claudin eighteen point two, as I mentioned, DLL3 will have an oral presentation at ASGCT next week regarding the ASCO abstracts. There will be key data from the dose escalation in both studies that will be available next week when the abstracts are released. We look forward to providing more details at the conference itself.

Operator

Thank you. One moment for our next question. And our next question comes from the line of Ash Birma of UBS. Your line is now open.

Ashwani Verma
Ashwani Verma
Executive Director - SMID Biotech & Biopharma at UBS Group

Hi. Yes. Thanks for taking our questions. So maybe just on Kartikti, so I know you've talked about second quarter as a step up since the Novartis supply comes online. Is that a step up more of the magnitude what we saw in the third quarter of last year, which was a pretty robust sequential growth quarter for you?

Ashwani Verma
Ashwani Verma
Executive Director - SMID Biotech & Biopharma at UBS Group

And then secondly, any thoughts you can share on the potential upcoming clinical data from our selects? We saw 98 patients of data at ASH conference and presumably now getting 19 additional patients with more than two months of follow-up. Do you think that there can be any non I can snare talks that can show up in the upcoming update? Thanks.

Alan Bash
Alan Bash
President - CARVYKTI at Legend Biotech

The step up for Novartis is now starting to contribute to our capacity expansion towards our goal of ten thousand doses by the end of this year. And we feel very confident with that target of providing the ability to supply 10,000 annualized patient doses. In terms of size of the step ups and size of growth, think we're projecting that Q2 will be another modest step up in terms of our growth based on demand and supply with sequential growth and then further acceleration in the back half of the year. Just in terms of some of the dynamics for Q1, I think one of the reasons why we saw a solid 10% growth, not only because of European markets coming online, but also based on some of the improvements we saw in out of spec with turnaround time and our Obelisk facility ramping a little bit faster than we expected. This is just great execution from our team in Europe to supply the European launches, and that helped pull in some of the revenue from what we were projecting for Q2 into Q1 for a solid Q1 performance.

Mythili Koneru
Mythili Koneru
Chief Medical Officer at Legend Biotech

Regarding your second question on the clinical data from ArcelorX, I can't comment on what's going to be presented besides just the title aspect that we are aware of at ASCO. And what I can say is that or whether they'll have any evidence of neurotoxin in their studies. They are obviously starting a Phase III randomized study, and so I think that will be very telling about more of their safety profile. What I can say is regarding our study, we're very excited about the ASCO presentation of a PRTITUDE-one long term data set. I think you'll be pleasantly excited as well when you see the data being presented.

Mythili Koneru
Mythili Koneru
Chief Medical Officer at Legend Biotech

In addition, I can also say monitoring of the absolute lymphocyte count, or ALC, and use of prophylactic steroids with ALC counts of greater than 3,000 is being further incorporated into major academic centers, as well as in our Cartitude studies, and we're seeing good response from the KOLs who are implementing this, and we expect additional data to come out later this year. Will report on that in the near future.

Operator

Thank you. One moment for our next question. And our next question comes from the line of George Farmer of Scotiabank. Your line is now open.

Analyst

Hi, good morning. This is Chloe on for George. Thank you for squeezing us in, a couple from us. So I wanted to double click on the survey number that you mentioned earlier about the preference from heme oncs in second line, prescribing private key in the second line rising from 34% to 55%. I was wondering if you could provide a little bit more color here on the diversity or the geographical location or volume of the centers where these hemangs are operating at and what they need to see to keep pushing beyond that 55%.

Analyst

And if you could also comment on uptake in this earlier line setting in the EU, if you expect the updated label to have a significant impact there on earlier line use. Also wanted to ask about outpatient administration. You did say it's a little over fifty percent now. And could you maybe break that down for us between the earlier and the end stage disease? Like in your second to fourth line patients, what proportion of those are being treated in outpatient versus inpatient?

Analyst

And how does that compare to the end stage patients? And a last question, if I may, just to clarify, when you specify the median turnaround time is around thirty days for CAR VT, are you using that kind of interchangeably with vein to vein time here? Thanks.

Alan Bash
Alan Bash
President - CARVYKTI at Legend Biotech

Yeah. So, first of all, in terms of the, EU, we do expect that, the updated label will support, the use in the earlier lines, and that's the feedback we've been getting from, the centers in Germany that are now online and, in the other European markets, as we mentioned. So we do expect that it's the overall survival data that is very compelling, and this will enable, patients, much like it has in The US, to, sort of move into the earlier treatment settings, with Carbixi. In terms of outpatient, we don't have a specific breakdown between how much of the outpatient use is in the earlier line versus the end stage. But qualitatively, I will tell you that as we get into more patients receiving Carbatec in the earlier lines, that does correlate somewhat with the ability and the comfort level with physicians to administer in the outpatient setting.

Alan Bash
Alan Bash
President - CARVYKTI at Legend Biotech

Although the outpatient setting is more a factor of safety monitoring. And we do see, again, the earlier lines, lower rates of CRS and lower rates of MNTs. And so these are the things that physicians do gain comfort with as they move to earlier lines. In terms of turnaround time, our median thirty days, you know, everyone uses a bit of a different definition in terms of what vein to vein is, but we think this is the most relevant way to think about our ability to deliver to physicians, because this is the point at which they, apheresis the patient, and then when is the product available for them to take it back and infuse patients. And as we discussed on the presentation, because of bridging therapy, this is a very acceptable, I wouldn't say even acceptable, I would say comfortable place for physicians to be by the time they get through the bridging therapy that most patients are going to receive, whether that's in later lines or in earlier lines, we're really at the thirty day mark.

Alan Bash
Alan Bash
President - CARVYKTI at Legend Biotech

And so turnaround time is quite competitive to physicians need it to be at this point. But we do expect that we'll continue to be able to reduce that over time.

Ying Huang
Ying Huang
CEO at Legend Biotech

Yeah, you heard from Adam how much improvement we have seen in our manufacturing process. In fact, the latest data from RADM suggests that the median efficiency to delivery time is about twenty seven days now. And then, Chloe, I want to answer a question about the publication. So it's a paper published actually from Cardinal Health with collaboration with Vanderbilt University Medical Center, and it was based on the response from 50 hematologists and oncologists. In terms of the breakdown of the survey physicians, it's about 86% in the community practice, and then 14% in the academic setting.

Ying Huang
Ying Huang
CEO at Legend Biotech

It's also very well distributed in terms of geographic distribution of these doctors, so it's 28% from the South, 20 8 Percent from the Western Area, 20 4 Percent Midwest, 20 Percent Northeast. So if you want to know more about this paper on the survey of 50 physicians on CARD4 data, we're happy to send you the paper, but it's a very well representative sample set here.

Analyst

Okay, thanks, Ying. I'm wondering if you could maybe comment on what feedback you got from them on what, well I guess, what are you hearing, and what is needed to further improve kind of their approval ratings in the second line prescriber setting.

Ying Huang
Ying Huang
CEO at Legend Biotech

So what we're hearing anecdotally from the field is that obviously the community based hematologists and oncologists are really excited about survival. When we survey them on the three most important decision factors when they choose a mess gene for second line, they rank in such an order, survival followed by PFS, and then followed by response rate, including complete response rate. So that shows you there's a divergence here, because in the academic setting, the physicians in tertiary also tend to put PFS on par with OS, but in the community setting, clearly there's a very strong preference on survival here. That's what we're finding out in the community setting. And like I said, we fully expect the FDA to approve our survival data in the label in the fall this year.

Ying Huang
Ying Huang
CEO at Legend Biotech

We have a PDUFA date here, and this survival benefit will also be augmented by our ASCO presentation in the next month, so you will see that once we have the detailed data, and physicians, I'm sure, will be excited about by the long term follow-up data in terms of the long term remission.

Analyst

Got it. Thank you so much.

Operator

Thank you. One moment for our next question. And our next question comes from the line of Sean McCutcheon of Raymond James. Your line is now open.

Sean McCutcheon
Sean McCutcheon
Vice President - Biotechnology Equity Research at Raymond James Financial

Hi, Thanks for squeezing me in. Can you speak to the bar to take the Cloudin 18.2 program forward? We've seen some decent results from CARSgen with some intriguing frontline signals in sequence with chemo. And the durability for the second line setting looks like it could be more of a question. And maybe it's restricted to the cloud and 18.2 high expressers.

Sean McCutcheon
Sean McCutcheon
Vice President - Biotechnology Equity Research at Raymond James Financial

And secondarily, should we expect a similar approach on the development compared to the DLL3 program? Meaning, you want to take it forward with a partner? Thanks.

Mythili Koneru
Mythili Koneru
Chief Medical Officer at Legend Biotech

Thank you for your question. So, the CLOUDIN 18.2 study, we are, as discussed earlier, going to be presenting some data at ASCO. We anticipate the dose escalation to be complete later at the end of summer, and then we anticipate the expansions to begin at that time. Obviously, Cloudant eighteen point two is important both in gastric cancer, but also pancreatic cancer. I think it's also, while there is an antibody approved zolotuximab in the frontline setting in gastric cancer, the Cloudin expression is quite high in order for people to use that antibody.

Mythili Koneru
Mythili Koneru
Chief Medical Officer at Legend Biotech

I think in general, we've seen that CAR T cells tend to have more sensitivity for lower expressing cells. So, there's an opportunity to pursue CAR T in this space, both in gastric cancer and pancreatic cancer. We'll have to wait and see how the completion of the safety dose escalation is, but we are excited for the opportunity to explore this further in the expansion.

Operator

Thank you. This concludes the question and answer session. Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.

Executives
    • Caroline Paul
      Caroline Paul
      Associate Director - IR
    • Ying Huang
      Ying Huang
      CEO
    • Alan Bash
      Alan Bash
      President - CARVYKTI
    • Jessie Yeung
      Jessie Yeung
      Interim CFO
    • Guowei Fang
      Guowei Fang
      President - Research & Development
    • Mythili Koneru
      Mythili Koneru
      Chief Medical Officer
Analysts
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Key Takeaways

  • Legend’s CAR T therapy (Carvictee) net trade sales hit ~$369 M in Q1, up 135% YoY and 10% QoQ, with over 6,000 patients treated and more than half of US usage now in earlier‐line multiple myeloma.
  • Key label expansions include overall survival added to the EMA label based on CARTITUDE IV data, second‐line+ approval in Australia, and ongoing efforts to secure US OS labeling by year-end.
  • Manufacturing execution remains best‐in‐class with a 97% success rate, 95% on‐time deliveries, a 30-day median turnaround, and capacity expansions in Belgium (Techlane), US (Raritan) and Obelisk targeting 10,000 annual doses by year-end.
  • Pipelining and R&D investments focus on frontline CAR T trials (CARTITUDE-5/6), an in vivo CAR T delivery platform set for first patient dosing mid-2025, and allogeneic programs for autoimmune and oncology indications.
  • Financially, Q1 revenues of $195 M grew 137% on collaboration and product sales, adjusted net loss narrowed to €27 M, gross margin rose to 63%, and cash of ~$1 B positions the company for Carvictee breakeven by end-2025 and profitability in 2026.
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Earnings Conference Call
Legend Biotech Q1 2025
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