Yahoo Finance

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 CARVYKTI in partnership with J&J, delivering operational efficiency and making continued investment. We continue to anticipate achieving operational break even for coveted by the end of 2025 and company-wide profitability in 2026, excluding unrealized foreign exchange gains or losses.
Regarding CARVYKTI performance during the first quarter, net trade sales were approximately $369 million, which is a 135% increase year over year. We have now treated over 6,000 patients with CARVYKTI, and our CARVYKTI 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 respondents survey, after presenting (inaudible) 4 data to 86% of physicians from the community setting, preference for CARVYKTI in early line multiple myeloma rose from 34% to 55%. On this note, we're very pleased that overall survival was added to CARVYKTI's EMA label based on the CHMP positive opinion of data from CARTITUDE-4. We're also pleased that Australia's regulator has now approved CARVYKTI in the second line plus setting. We're looking forward to bringing CARVYKTIto more patients outside the US who might benefit from its differentiated efficacy.
CARVYKTI's 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 CARVYKTI programs, and new data is constantly being generated about cCARVYKTI's benefit versus risk profile. As a result of the posters presented attend the meeting and given that patients are already doing routine blood work, the majority of centers administered CARVYKTI have implemented monitoring for absolute lymphocyte count, followed by dexamethasone intervention as needed. We'll continue highlighting new safety data to the oncology community as it is reported. On the clinical front for CARVYKTI, we continue to expect to complete enrollment for (inaudible) 6 this year. We believe the (inaudible) 5 and 6 trials are key to moving CARVYKTI into the frontline setting.
Looking at long-term growth for Legend, in addition to moving CARVYKTI into the front line, 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. This includes In Vivo Party 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 as 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 lympho depletion aphesis are necessary for In Vivo Delivery, enabling even more scalable manufacturing. 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 US label now that it's already in the European label.
To sum up, regardless of the current macroeconomic uncertainties, Legend endures as the largest stand-alone cell therapy company with over 6,000 patients treated by CARVYKTI as we force the past to cure. With a cash position of approximately $1 billion, 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 CARVYKTI.

Alan Bash

Thanks, Ying. Moving on to CARVYKTI's performance, as Ying mentioned, net trade sales of CARVYKTI were approximately $369 million 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 $318 million 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 CARVYKTI is now 114. 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 million 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 CARVYKTI to more eligible patients in Spain, the UK, Denmark, Belgium, and Israel, where we recently launched.
To this end, we're excited to see that Tech Lane initiated clinical production in Gante 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. And to meet additional demand in the United States, we expect to receive approval for our physical expansion and 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 CARVYKTI on or before the promised delivery date, and our median turnaround time has been consistently declining and now stands at 30 days. We believe that turnaround time is more than sufficient based on our conversations with physicians. 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 Jessie.

Jessie Yeung

Thank you, Alan, and good morning, everyone.
During the first quarter, we delivered solid financial results with perfect net sales up 135% year over year. Total revenues were $195 million, driven by collaboration revenue growth of 137% year over year. Q1 delivered a $101 million net loss and a $27 million adjusted net loss after excluding items that are not representative of the company's core business, such as a$ 52 million unrealized foreign exchange loss due to our Treasury Center based in Ireland.
Importantly, our operating loss of $180 million in the same period one year ago was reduced by over half to an operating loss of $51 million. The meaningful improvement in operating results was driven by our operational inefficiency and discipline expense management. Even though we continue to invest in a robust pipeline and supporting the second line indication launch as well as our manufacturing capacity, our first quarter growth margin on net product sales was 63%, improving from 59% in Q4.
As expected, R&D expenses on an IFRS basis grew only 1% year over year, and SG&A on an IFRS basis only grew 29% from the prior year to $72 million. Overall, we believe we have been making strides towards positive operating cash flow generation and profitability. Our adjusted diluted earnings per share were negative $0.07 compared to negative $0.23 for the same period last year. Now, turning to capital allocation.
We continue to have a strong balance sheet with $1 billion in cash 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. And now, it's time to take your questions. Operator, we are ready for the first question, please.

Question and Answer Session

Operator

(Operator Instructions)
Gena Wang, Barclays.

Thank you for taking my questions. I have three quick questions. The first one is regarding the CARVYKTI price differences between US and the ex-US, if you can give any color there. And the second is regarding the new Warrington section approval in second half '25, 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, very quickly, I know you have a multiple pipeline assets. Just give us a a rough idea when should we see which program first in the coming years or 2025, we will see additional data.

Alan Bash

Hi, Gena. it's Alan. The price differential between the US and ex-US is approximately 30%, obviously, varies country to country. In terms of the rarity approval in the second half, we're confident that we will be able to achieve the approval from FDA in terms of capacity expansion, and that is based on the filings with them and the CB30 with that process.

So in terms of pipeline, our focus is on two different technology platforms, In Vivo cell therapy platform for oncology indication and the all genetic cell platform for autoimmune diseases. We are looking forward to our multiple clinical readout later this year. For the In Vivo CAR-T platform, we expect to have first patient dose investigator initiated the study in June or July and expect to have preliminary clinical result towards the end of this year. On the platform side, we expect to have a clinical results in the second half of this year against the investigating in this study.
Autoimmune currently, we are running some IT trial in China using the triple targeting or target cell therapy product targeting CD19, CD20, CD22, try to drive a different response. And we also expect to have a clinical result in the later part of the year.
Lastly, on the US side, we have two ongoing Phase 1 program targeting CLAUDIN 18.2 for gastric cancer and DR, small cell lung cancer. Again, we are reading out of the Phase 1 escalation data for both programs.
Yeah, I can expand on that a little bit. For the DLL 3 program, we have an oral presentation at ASGCT next week, and both the DLL 3 programs in the CLAUDIN 18 2. programs have (inaudible) posters and that you may have seen from the titles that were released back in April.

Hi, Gina. This is Ying, maybe I'll supplement the answers by pointing out two things. First of all, I know you guys are looking at the price difference, right? So you're pretty much aware that in the United States, there are three types of customers that we pay a mandatory Federal required rebate. So it's Medicaid, 340B hospitals, and also VA hospitals, right. 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 EUR 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 (inaudible). Like Alan mentioned, FDA agreed that we'll use the so-called CB30 pathway. That is once we and file the application in writing within 30 days, if we don't hear from the agency, it's deemed approval, or if there's any request during that 30 days we can answer, then again, we don't expect any delays here. So we fully expect the on-time approval from FDA for the physical expansion rather than. And right now, we're still on track to achieve that by the end of this year.

Operator

Jessica Fye, 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 CARVYKTI will successfully penetrate the community. The reason I ask is one pushback we hear from investors is that when they do KOL calls, so 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. 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

Based on many of the discussions we've had both with the KOL in the authorized treatment centers as well as physicians out in the community, there is a high demand for providing CARVYKTI as an option for patients in earlier lives. And what we hear is that the benefits 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 of nearly 80% 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&J in terms of educating the community, going out and reaching all the major community sites, and we're in the process of doing that. And not only raising awareness, there's already high awareness of CARVYKTI as an option, but actually where we see more opportunities to raise awareness and increase that call to action in terms of referring patients into the authorized treatment centers.
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.

And just -- this is Ying. 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 and Ginger are extremely pleased with the results, and we think this will be actually another impetus for the community to take up CARVYKTI in the 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 CHMP opinion already. 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 (inaudible) 4 that demonstrates both clinically meaningful and also statistically significant (inaudible) in survival over standard of care, so that will help the community uptake.

Operator

Yaron Werber, TD Cowen.

Great, thanks so much. I've got 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-to-quarter growth over Q1? But is that going to be more European centric than the US? 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

Yeah, so in terms of (inaudible), you're actually right, it came online in September of 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 of the back half of the year supported by not only (inaudible) 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 CB30 process and the approval there.

Operator

Konstantinos Biliouris, 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 CARVYKTI in early lines correspond to functional high-risk patients? Thank you.

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 sort of a frontline setting. So it's more related to how the patients respond to a particular therapy, In terms of the Cartitude 4 study, as the abstract titles show for ASCO, we will be having data coming out on the subgroup analysis of on these various patients in Cartitude 4. But in general, Cartitude 4 has shown very strong both PSS and OS in the population in these early lines of patients, so we feel confident that both of these populations, both high risk and functional high risk, do very well with still to sell administration.

And in terms of CARVYKTI uptake in early lines, what dynamics do you see there with functional high-risk patients? Is this a high percentage of such patients in the uptake that you see in early lines?

Alan Bash

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 I just described the functional high risk and the high-risk patients. That's a natural place for them to begin to think about CARVYKTI 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 CARVYKTI in the early lives for the patients who are either fast progressors or have the high side of genetic risk and then moving on from there.

Operator

Kelly Shi, Jefferies.

Hi, good morning. This is Clara on for Kelly. Thanks for taking our questions. So you just initiated (inaudible) clinical production at the tackling facility. So just wondering if you can give us a little bit more color about the manufacturing expansion moving forward. 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

Yes. As you mentioned, we achieved approval for the clinical production and began that in Tech Lane, and that sets us up well for the ability to start commercial production in Tech Lane by the end of this year, and we're on track for that. So between Tech Lane and the OLS 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, is in the 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 Raritan expansion and the Novartis commercial production, which started the first part of this year in January, is also starting to meaningfully contribute in Q2 here and then Q3 and beyond. In addition, let me just mention because we have talked about the fact that there is an investment in Tech Lane that the companies have jointly approved, and so that speaks to the additional capacity that we plan to build in Tech Lane to the tune of $150 million jointly by the collaboration.

So in terms of In Vivo CAR-T approach, this is a platform where you -- we use molecular engineering, the antivirus that can specially recognize the immune cell. In this case, T cell in the body patient. At the same time, we also engineer a virus to reduce the generic or non-specific transaction to normal tissue, and we are expecting the first station those in in June and July this year.
In terms of advantage of In Vivo CAR-T compared to convention law Ex Vivo manufactured cell therapy, there are a few key areas. One is those things are engineered -- recognized engineering in the body of patient and therefore, in general, it have better self phenotype based on our preclinical data characterization. Second is completely off shelf without the need for depletion. So there's no delay in terms of administrating the therapy and no need for deletion also provide additional safety benefit to the patient. Lastly, it's a scalable manufacture due to the nature of lentivirus being the drug product. So those are the few key areas.

Operator

John Miller, 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 US versus ex-US, but what's the price delta between the US and the lowest cost anywhere else in the world, not just the average difference?
And secondly, you talked a little bit about penetrating the community, 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 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 lenty-based approaches? Thank you.

Alan Bash

This is Alan. I don't think we'll be commenting on the specific lowest price, but I do want to just remind you that we have a band, a pricing band that J&J, given their pricing policy, does adhere to, so we don't go below that price. And that's supported basically based on the costs and other factors, obviously, speaking to the value of car safety in the marketplace as well. So there is a price there.
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 perfectly 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 CARVYKTI 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 CARVYKTI adopted in the community setting as well. So we are on that journey starting with some centers this year.

Yeah, I'm 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.
One is on the T cell recognition mechanism. So there are many different ways to recognize T cell and then induce the transaction. We are testing multiple mechanisms of T cell recognition and to drive the transaction efficiency as well as to control the safety signal. Those approach we invested will play out in the setting.
The second area of differentiation is really about the engineering venting virus, reducing the generic transduction capacity of virus. We have specific point mutations with our own IP position to really reduce the generic transaction 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 the expertise in optimizing the CAR design, com 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 committee's experience that is the CMC. The process development, process robustness and the ability to scale up. I found the get our goal is to optimize the CMC process so that we can not only support the initial (inaudible) try but also have the ability to further develop down the road.
And then last area, the fifth area of differentiation, we focus on is really the execution of validation for those platforms. We have end-to-end capacity in development on the ground in China. We can execute the (inaudible) try 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. So let's speak to the speed and efficiency of our clinic development process. All those, I think we bring value to our (inaudible).

Operator

Leonid Timashev, RBC.

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 CARVYKTI specifically versus that decision being made at other centers. I guess, effectively, are you laying the groundwork for CARVYKTI or for all CAR-Ts, including I guess, future and current competitors? 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 buy specific offerings which are pretty popular in the community. Thanks.

Alan Bash

Yeah, there's growing awareness of CAR-T and specifically CARVYKTI in the community. We estimate, we do some surveys that about 70% of community oncologists are aware of CARVYKTI. Where we see more opportunity is actually to get them to kind of go from awareness to action based on the earlier line approval of the CAR-T 4 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. 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 by specifics and CAR-T should really be evaluated for CAR-T first, and that's based on the clinical profile. J&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 CARVYKTI both on the J&J side and on the Legend side making this case.

Operator

Vikram Purohit, Morgan Stanley.

Hi, good morning. Thank you for taking our questions. We have wo. So first, can you just kind of walk us through your in your initial thoughts on the recently appointed leadership at CDER and what you see as the potential implications and key considerations here that we should keep in mind for the CDER development program. And then secondly, related to an earlier question, could you remind us what portion of CARVYKTI use is currently in the Cartitude 4 population and where do you see that trending over, say, the course of the next year? Thank you.

Alan Bash

And just to answer your second question first, we see that nearly 60% of our patients, and this is based on our ordering system, nearly 60% are coming from that Cartitude 4 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 land population, we will have significantly evolved our business into the earlier lines.

Hey, Vikram, so I'll answer the question about the new CDER leadership at FDA. So we're happy to see that Dr. Prasad has been appointed the director of CDER, which regulates all the cell and gene therapy approvals. First of all, we agree with Dr. Prasad's point that in any cancer trial, you should use gold standard of survival benefit. And to that end, we're happy to report that first of all, we will report long-term minimum five-year fallout from (inaudible)1, and you guys will see the data at ASCO. In fact, the assets coming out next week, so you'll see the unprecedented benefit we bring to this population, and that is survival, which is a hard endpoint, right?
Secondly, I think if you look at the history of CARVYKTI approval, we did secure FDA approval back in February of 2022 based on the prime endpoint of overall response rate. However, when we started the trial back in 2018, 2019, these patients have exhausted all the available therapy to them, so it represents a very significant on mathematical need by then. Today, of course, you can argue things are different because you have 2 BCMA targeting CAR-T available as commercial therapy and 3 soon to be 4 by 3 antibodies again indicated for myeloma so it's very different. But since we conducted that 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 TFS standpoint. However, in September of last year, we demonstrated, again, clinically meaningful and also specifically significant benefit in survival with has a ratio of 0.55%, which means 45% improvement in survival from standard of care. So we think CARVYKTI comes with a very strong benefit in terms of clinical outcome with survival, and then that's also accompanied by the surge endpoints such as PFS and overall response rate, right? That is why Legend and also J&J stands by the best-in-class profile. So we welcome Dr. Prasad as the CDER leadership because we have clearly demonstrated the survival benefit here.
Now, I know there are questions from investors about MRD connectivity. So we think that given the support from ODA last year using MRDA as a survey endpoint. We plan to sit down with the FDA to explore the possibility of using MRD activity as a potential end point for accelerated approval. We think this is a good study in the first line study because as you know, today, it's a newly diagnosed multiple myeloma patient is treated. Expected survival is probably over five to seven years. Therefore, in this setting, a surrogate input makes perfect sense.
Now, in the last line or even second line. If you look at our data from CAR 4, right, the standard of cure had a PFS of shorter than one year. So in that setting, we're not sure whether a surrogate end point makes sense or not under the leadership of Dr. Prasad. As I mentioned again, we agree that in oncology studies survival should be the gold standard, and we're happy to report that CARVYKTI does bring that life-saving benefit to patients.

Operator

James Shin, DB.

Hey, good morning, guys. Thank you for taking our question. I want to kind of piggyback on the Dr. Prasad question. I know base case for card 26 is to lean on PFS, and it sounds like you have engaged on possibly exploring MRD, but any thoughts on like competitors or the utilization of a percentage of patients completing 12 months of follow up. And then for Alan, what is the status on like, I believe there was an industry coalition for lowering community-based CAR-T accreditation is that, I guess, called a bottleneck for community adoption right now? Thank you.

Regarding your first question, unfortunately, if 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 on with the FDA on our on our cards base study.

Alan Bash

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 are affiliated with the larger academic centers around the country, so that I would say is in process and that should potentially unlock some of the opportunities in the community as well.

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

Operator

Mitchell Kapoor, H.C. Wainright.

Hey, everyone. Thanks for taking the questions. I wanted to ask one about outpatient volume. I think last quarter, you'd mentioned that it comprised over half of all volume for CARVYKTI. Can you quantify that trend now and just give us a little bit of the direction of where that is heading? And then secondly, can you talk through your assumptions and pipeline efforts for cash runway through second quarter of 2026? Would you need to seek some avenues of non-diluted capital to bridge yourself like well into profitability, or do you think that maybe there are some other opportunities you might seek?

Alan Bash

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 kind of in the 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, but I would say we 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

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 CARVYKTI will break even operationally by the end of '25, and we anticipate profitability in 2026, excluding FX fluctuations. We have $1 billion of cash on. And that will reach profitability when we that will last till 2026. So we don't have any pressing needs to raise capital and we have a joint investment with J&J on CapEx for $150 million that will last for 2028 for the Tech Lane Phase 2 expansion and that is included in our cash runway.

Operator

(inaudible) 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 CLAUDIN 18.2 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? Thank you.

Alan Bash

In terms of infrastructure, certainly, capacity and chair space and staff are some of the factors that we look at. But again, speaking to the prior question around outpatients, we do see that over half of our patients are getting perfectly 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 outpatients is one of the ways that we overcome some of the infrastructure hurdles there.
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 and 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 a (inaudible)

Regarding DLL3 and CLAUDIN 18.2, 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 and look forward to providing more details at the conference itself.

Operator

Ash Verma, UBS.

Hey, yeah, thanks for taking our questions. So maybe just on CARVYKTI, so I know you've talked about second quarter as a step up since the what the 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? And then secondly, any thoughts you can share on the potential upcoming clinical data from our select? We saw 98 patients of data at the at the ASH conference and presumably now getting 19 additional patients with more than two months of follow up. So do you think that there can be any non (inaudible) talks that can show up in the upcoming update? Thanks.

Alan Bash

The step up for Novartis is now starting to contribute to our capacity expansion towards our goal of 10,000 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, I 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 the European markets coming online, but also based on some of the improvements we saw in (inaudible) 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.

Regarding your second question on the clinical data from RFlex, 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 3 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 protitude one long-term data set. I think you'll be pleasantly excited as well when you see the data being presented. In addition, I can also say that our monitoring of the absolute lymphocyte count or ALC and the use of prophylactic steroids with ALC counts of greater than 3,000 is being further incorporated into major academic centers and 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 so we will report on that in the near future.

Operator

George Farmer, Scotiabank Airlines.

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 (inaudible) in the second line, prescribing 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 -- geographic location or volume of the centers where these monks are operating at and what they need to see to keep pushing beyond that 55%? And if you could also comment on uptake in this early line setting in the EU if you expect the updated label to have a significant impact there on early airline use.
Also wanted to ask about outpatient administration, you did say it's a little over 50% now. And could you maybe break that down for us between the earlier and the and the end stage disease, like in your second to fourth patients, what proportion of those are being treated in outpatient versus in patient and how does that compare to the end-stage patients?
And a last question if I may, just to clarify when you specify the turnaround time is around 30 days for CARVYKTI, are you using that kind of interchangeably with vein-to-vein time here?

Alan Bash

Yes. 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 CARVYKTI.
In terms of outpatient, we don't have a specific breakdown between how much of the outpatient uses in the earlier line versus the end stage, but I -- qualitatively, I will tell you that as we get into more patients receiving CARVYKTI in the earlier lines, that does correlate somewhat with the ability and the comfort level with additions to administer in the outpatient setting. Although the outpatient setting is more a factor of sort of safety monitoring and we do see, again, in the earlier lines, a lower rates of CRS and lower rates of MMTs. And so, these are the things that physicians do gain comfort with as they as they move to earlier lines.
In terms of turnaround time, our media 30 days, 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 (inaudible) 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 30-day mark. And so, turnaround time is quite competitive to where physicians needed to be at this point, but we do expect that we'll continue to be able to reduce that over time.

Yeah. I mean, you heard from Alan how much improvement we have seen in our manufacturing process. In fact, the latest data from Rason suggests that the median efficiency delivery time is about 27 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 the Vanderbilt University Medical Center, and it was based on the response from 50 hematologists and the 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.
It's also very well distributed in terms of geographic distribution of these doctors. So it's 28% from the South, 28% from the Western area, 24% Midwest, 20% Northeast. So if you want to know more about this paper on the survey of 50 physicians on CAR 4 data, we're happy to send you the paper, but it's a very well representative sample set here.

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.

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 surveyed them on the three most important decision factors when they choose a medicine for Second Life, they ranked in such an order, right, survival followed by TFS and then followed by a response rate including complete response rate. So that shows you there's a divergence here because in the academic setting, the physicians in (inaudible) also tend to put TFS 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, we have a date here. And you know, 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 the physicians, I'm sure will be excited about by the long-term follow up data in terms of the long-term remission.

Operator

Sean McCutcheon, Raymond James.

Hi guys, thanks for squeezing me in. Can you speak to the bar to take the CLAUDIN 18.2 program forward? We've seen some decent results from (inaudible) with some entrying frontline signals in sequence with chemo, and but the durability for the second line setting looks like it could be more of a question. And maybe it's restricted to the CLAUDIN 1.2 high expressers. And secondarily, should we expect a similar approach on the development compared to the DLL3 program, meaning would you want to take it forward with a partner? Thanks.

Thank you for your question. So regarding the CLAUDIN 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 in at that time. We have -- obviously, CLAUDIN 18.2 is important both in gastric cancer but also pancreatic cancer. I think it's also while there is an antibody approved Zotuximab in the frontline setting in gastric cancer, the expression, the CLAUDIN expression is quite high in order for people to use that antibody.
I think in general, we've seen that CAR-T cells tend to have more sensitivity for lower expressing cells, so there's, I think, an opportunity to pursue CAR-T in this space, both in gastric cancer and pancreatic cancer. So 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 has conclude the program, you may now disconnect.