Earnings Call Transcript - AUTL Q4 2024

Operator, Operator

Hello, ladies and gentlemen, and welcome to the Autolus Therapeutics Call to Discuss the Full Year 2024 Financial Results and Business Updates. As a reminder, this conference call is being recorded. I would now like to turn the conference over to your host, Amanda Cray. Please go ahead.

Amanda Cray, Host

Thank you, Tanya. Good morning or good afternoon, everyone, and thank you for joining us on today's call. With me, our Chief Executive Officer, Dr. Christian Itin, and Chief Financial Officer, Rob Dolski. I'd like to remind you that during today's call, we will make statements related to our business that are forward-looking under federal securities laws and the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. These may include, but are not limited to, statements regarding the status of the ongoing commercial launch of AUCATZYL in the U.S., Autolus manufacturing, sales, and marketing plans for AUCATZYL, the market potential for AUCATZYL, and the status of clinical trials and development and regulatory timelines for obe-cel and our other product candidates. These statements are subject to a variety of risks and uncertainties that could cause actual results to differ materially from expectations and reflect our views only as of today. We assume no obligation to update any such forward-looking statement. For a discussion of the material risks and uncertainties that could affect our actual results, please refer to the risks identified in today's press release and in our SEC filings, both available on the investor section of our website. On Slide 3, you'll see the agenda for today's call. As usual, Christian will provide an overview of our operational highlights. Rob will then discuss the financial results, and Christian will conclude with upcoming milestones and closing remarks. We will then take your questions. With that, I'll turn it over to Christian.

Christian Itin, CEO

Thank you very much, Amanda, and welcome everyone to our fourth quarter 2024 financial results update. First, we had a very successful 2024, setting us up well for 2025, which we're already a few months into. I’d like to highlight our key objectives for the year. Our primary objective is to successfully launch AUCATZYL, and we are making good progress on that front, with updates to follow during the presentation. We also see significant opportunities for obe-cel to expand its use based on our current experience with the product, explore additional indications, and advance some of our other product candidates. While we will be selective in our investments, we are also planning an R&D event on April 23rd in New York to outline our future growth strategies in more detail. Now, I will summarize the key achievements of 2024. We started strong, adding about $600 million to our balance sheet through our collaboration with BioNTech and a public financing conducted in the first quarter. This positioned us well to focus on moving obe-cel through the U.S. approval process and prepare for its commercial launch. Throughout the year, we continuously worked to ensure that our sites were ready to onboard the product as soon as it was approved. We received U.S. approval on November 8, ahead of schedule, which included a broad label for relapsed refractory ALL in adult patients, making it the first product approved without the need for a REMS program. This strong foundation was further reinforced when we published our clinical results in the New England Journal of Medicine in early December, and the product was included in the NCCN guidelines, which supports payer decisions for commercial use. As we launched the product, we saw a solid increase in the number of centers authorized to deliver it, reaching 33 centers as of March 19, which allows us to cover approximately 60% of our target patient population in the U.S. By year’s end, we expect to have around 60 centers ready to administer AUCATZYL, giving us a robust foundation for patient access. In addition to our U.S. launch, we are moving forward with regulatory filings in the UK and Europe, with decisions expected in the second half of 2025. We're also assessing the product's utility in the UK with the National Institute for Health and Care Excellence (NICE) to ensure adequate reimbursement. Throughout the year, we shared key data presentations from the FELIX study, showcasing the safety and efficacy of AUCATZYL in the relapsed refractory adult population. We reported on the durability of the product and the significant impact of treating patients with lower disease burdens, which contributes to positive long-term outcomes. In terms of patient reach, we have made good progress in expanding access and coverage for lives, emphasizing that patients have a real chance to access this new therapy. Regarding our manufacturing facility, the Nucleus facility is operational and has been performing well, ensuring reliable product delivery. As we look toward 2025, we will focus on expanding the obe-cel opportunity, including running the CARLYSLE study for autoimmune conditions with initial patient data to be discussed at our April R&D event. We are also advancing our pediatric PY1 study and other early pipeline activities in collaboration with our partners, expecting to provide updates later this year. With that, I will hand over to Rob for a summary of our financial results.

Rob Dolski, CFO

Thanks Christian and good morning or good afternoon everyone. It's my pleasure to review our financial results for the full year 2024. Cash, cash equivalents and marketable securities at year end 2024 totaled $588 million as compared to $239 million at the December 31, 2023 time frame. This increase was primarily a result of our strategic collaboration with BioNTech and concurrent equity financing for a combined $600 million in gross proceeds to bolster the balance sheet ahead of our U.S. commercial launch for AUCATZYL. Loss from operations for the year ending December 31, 2024 was $241.4 million as compared to $179.7 million for the year ended 2023. Cost of sales totaled $11.4 million following the BLA approval for obe-cel. This amount represents the cost of commercially available plant capacity that can no longer be classified as R&D expense as of November 8, obe-cel approval date even though it was not associated with product sales in the fourth quarter. Our research and development expenses increased to $138.4 million for the year end in December 31, 2024, compared to $130.5 million in the same period 2023. This change was primarily driven by increases in employee salaries, related costs, manufacturing costs related to obe-cel, and then partly offset by some decreases in professional fees and facility costs. Our selling general and administrative expenses increased to $101.1 million for the year, compared to $46.7 million for the same period in 2023. This increase was primarily due to the salaries, other employee-related costs driven by the overall increase in headcount supporting commercialization activities. And finally, net loss was $220.7 million for the year-end, December 31, 2024, compared to $208.4 million for the same period in 2023. With the recent approval of AUCATZYL in the U.S., I'd also like to note two financial milestones that were triggered in the fourth quarter. As a result of the FDA approval, Autolus received a $30 million milestone payment from Blackstone, based on the terms of our previously announced Blackstone collaboration agreement. In addition, the company made a regulatory milestone payment of GBP10 million, in accordance with our UCLB license agreement. These are both detailed more specifically in our 10-K filing. We continue to believe that with our current cash, cash equivalents, and marketable securities, we are well capitalized to drive the full launch and commercialization of obe-cel in relapse refractory adult ALL, as well as to advance our pipeline development plans, which includes adequate runway to reaching data in the first pivotal study of obe-cel in autoimmune disease. And as Christian noted, we look forward to providing further detail on these plans at our upcoming R&D event. I'll now hand back to Christian to wrap up with a brief outlook on expected milestones.

Christian Itin, CEO

Thank you very much. Looking ahead to 2025, we will start the year with an update on the SL1 CARLYSLE study, which we plan to present on April 23 at the R&D event in New York. For the pediatric study, we anticipate providing an update in the second half of the year, along with longer-term follow-up on the CARLYSLE study during that same period. We also expect to receive notifications regarding the regulatory process for the UK and the EU concerning potential approvals for obe-cel in those regions in the second half of the year. Overall, we see a very promising year ahead as we begin to implement our opportunities. We'll outline our plans at the company R&D day and will be able to share more evidence and projections regarding the progress of our launch for AUCATZYL in the U.S. We are now ready to take questions, and I'll hand it over to the operator. Thank you.

Operator, Operator

Certainly. Our first question will come from James Shin of Deutsche Bank. Your line is open, James.

James Shin, Analyst

Hey, good morning, guys. Thank you for the question. On AUCATZYL launch, and I know it's a progressively evolving situation. But can you provide any color on the initial demand or the book of orders thus far? And then secondly, oncologists have mentioned that the split dosing and the delayed onset of CRS for AUCATZYL can be useful for outpatient administration. Can you say whether outpatient use is happening or planned thus far? And I'll just leave it there.

Christian Itin, CEO

Yeah, well, first of all, thanks a lot for joining, James. On the launch, I think what we can say is that we have obviously seen a very nice dynamic around the actual activation of the centers, which is really critical. And it's very much driven by the level of interest, enthusiasm by the centers to actually do that work and actually get the product active. That also is often driven by actually having patients that are in need of therapy, which is sort of usually actually the key driver in that process. So I think that gives us a very good level of confidence in terms of how the product is viewed, the level of interest. And I think the dynamic we've been seeing has been very encouraging. Obviously, we provide a fuller picture at the Q1 update, but I think what we can say is that we see a very good dynamic and I think a very significant level of interest and I think a recognition that the product has attractive properties for these patients. With regards to the outpatient question, I think there's an opportunity, as you've seen from the safety data that I highlighted during the presentation is that patients that have very low levels of tumor burden and lymphodepletion tend to have a very limited amount of immunological safety events. And I think that is certainly attractive and has led to a number of physicians to suggest that they might be interested in actually exploring and possibly to administer the product in a sort of a hospital outpatient setting. We'll need to see how that evolves. A lot of that has to do with the actual experience gained with the product in the commercial setting and the confidence physicians are building up. And I think we'll see that evolve over the upcoming periods. I don't think at this point in time I think we can guide you in any way at this point. I think it's too early in the launch, but it's clearly an observation that a number of the physicians certainly have made. And it will be interesting to sort of follow that as we go through the year.

James Shin, Analyst

Thank you.

Operator, Operator

Our next question will be from Rajan Sharma of Goldman Sachs. Your line is open.

Rajan Sharma, Analyst

Hi. Thanks for taking my questions. Just a couple on logistics, actually. So, obviously, you have the target to have 60 authorized centers by the end of the year. I'd be just interested in the ramp to get to that from where you are right now. Should we expect that to be linear, or could this potentially come in blocks of centers coming online? And then the second one, just on tariffs. Actually, that's obviously been a focus for investors in the sector, given the headlines we're seeing. Could you maybe just talk to how you think that could potentially impact, given that manufacturing's in the UK? Thank you.

Christian Itin, CEO

Thank you for joining us. The first question is about the ramp-up of the centers going online. We have observed a steady trajectory with the first 30 centers becoming active, which was expected since not all were ready for onboarding at the time of approval. Initially, by early January, around 20 centers were active, and this number grew through the quarter to about 33 by mid-March. We anticipate that the next group of 30 centers will also see gradual growth throughout the year. This process is heavily influenced by each individual center's onboarding timeline, which is affected by legal reviews and the capacity of the hospitals to handle the workload. While there is some variability, we expect a reasonably steady process moving forward, and we will provide updates on a quarterly basis. The centers are also listed on Autolus’ website, making it easy for physicians and patients to track their progress. Regarding tariffs, it's still uncertain how they might affect us, what products could be impacted, and it is difficult to predict at this stage. Historically, tariffs on pharmaceutical products have been carefully considered and often minimal, as there is a general consensus against hindering the supply of medication. Blood products, in particular, have usually been excluded from tariffs in the past. Currently, it's too early to have definitive insight into this issue, and we don't have visibility in this area at the moment.

Rajan Sharma, Analyst

Okay, thank you.

Operator, Operator

And one moment for our next question. Our next question comes from Asthika Goonewardene of Truist. Your line is open.

Asthika Goonewardene, Analyst

Hey, good morning. Good afternoon, guys. Thanks for taking my questions. Among the centers that have treated patients in the commercial setting with their AUCATZYL, can you give us a little bit of color on what the spread is from the spread of time from site activation to getting that first patient in? And then I have a quick follow up.

Christian Itin, CEO

Yeah, so thanks for joining us, Asthika. It's quite variable in terms of the time it takes to actually go from activation to actually having a patient on. For many of the centers, a lot of the activation process and the speed at which the activation process kind of went through had to do with a patient actually being suitable for the therapy and considerably suitable for the therapy and the momentum around that. So there's some centers where there's a relatively short period in between, but you could also have situations where if the process took a certain amount of time that maybe the patient had to move on throughout the therapy and then there might be somewhat of a bit of a lack until the next patient might actually come along. I think the short answer is it's variable. I don't think we could easily project that within X amount of time the patients are on. We're seeing in general that we see centers to actually get into sort of a repeat mode and actually get more than one patient obviously on, which is really good. Because one of the things we would like to see that over time, centers actually start using the product more regularly. And with that, obviously, it will start to see some element of momentum build over time. So early signs, I think, are very positive, but it's still early days.

Asthika Goonewardene, Analyst

Thanks, Christian. I know it's very early days of the launch right now, but one of the intriguing things about our capsule was that perhaps patients do better by not being bridged to a transplant. And you've had several opportunities to talk about the data and present the data in medical journals since approval. I'm just wondering with your initial experience right now, what seems to be the sentiment among prescribers and treating physicians? Has there been some sort of an appreciation for this or do you think you'll still need more time and to give them more hands-on experience to feel comfortable saying, I don't want to take this patient to transplant after AUCATZYL? Thanks.

Christian Itin, CEO

Yeah, I think the question with regards to, is there a need for sort of subsequent therapy? When we look at the trial experience, we had about 18% of the patients move to a subsequent stem cell transplant, a relatively low percentage of the patients. A lot of the patients, if you had a prior transplant, actually wouldn't be eligible again for a transplant, or they might have other comorbidities, et cetera, that would sort of prevent a transplant or make it unlikely to be successful. So it depends to some extent on the nature of the patients coming in, but overall, obviously, even in the trial, we had seen a relatively limited use of transplants. We'll need to see kind of how that develops. I don't think at this point we can even tell because it's just too early. But we obviously, based on the experiences that the physicians had with the product through the development, that we would see probably initially a similar picture. And then as there's more, I think, experience gained, we still need to see where that's headed. But overall obviously, very encouraging and obviously an option for patients that currently you would have very limited treatment options for. And I think this is an opportunity here to really position the product across the entire range of risk factors of age. And I think that's really where there is a significant appeal for this product because it is actually, it can actually deliver positive outcomes across the entire range of the patients that we have in the relapsed refractory setting. And obviously, what we have seen is that the patients that were receiving transplant didn't appear to actually do better than patients who did not receive transplant and that certainly has resonated with a lot of the physicians. And so we'll see how it develops. I think too early to tell, but overall, I think a lot of conviction that there is a real opportunity for the product to be a standalone therapy without the need for subsequent consolidation.

Operator, Operator

And one moment for our next question. Our next question will be coming from Matthew Phipps of William Blair. Your line is open, Matthew.

Matthew Phipps, Analyst

Hi, Christian. Thanks for taking my question. I was wondering if you could just maybe comment on any of the manufacturing success rate or turnaround time so far in the commercial launch, maybe just if it's, I guess, maybe I'm in line with some of the clinical experience. And then I assume that BioNTech has not yet made any decision on AUTO6NG as far as opting in. Is there a timeline for when that might occur?

Christian Itin, CEO

Yeah, thanks for joining, Matt. In terms of sort of the production experience that we're gaining now on the commercial side. We see that actually mirroring very nicely what the experience was during the conduct of the pivotal studies. So that's very reassuring. And obviously, we're starting to get more and more experience as we're sort of running more and more products through the facility. But we're seeing the data to track very nicely what our prior experience was. So that's the first observation. The second question was related to the options that BioNTech has. BioNTech has an option on our solid tumor program, AUTO6NG. And that's an option that actually is still running. And I think is obviously going to be an option as we had indicated before, that will be triggered prior to moving the product into a pivotal study. So we're still obviously running through the current clinical study we're conducting with UCL. And so we would expect that trial to actually deliver results. And then after we have the results in and the path forward is clear, that that sort of actually would sort of be the time point for an option exercise. So it's still a little bit ahead of us here.

Operator, Operator

And one moment for our next question. Our next question will be coming from Gil Blum of Needham & Company. Your line's open.

Gil Blum, Analyst

Good afternoon, good morning. And thanks for taking our question. Just a quick couple from us. So we're going to see some of the SLE data in your upcoming R&D day. And maybe you can put that data in context. I mean, six patients, what kind of data are we going to see here? Safety, vasal aplasia. And my second question is, where would you say most of your resources as it relates to the launch are being invested? Just side rollout or is there more to it? Thank you.

Christian Itin, CEO

Yeah, thanks a lot. Much appreciated, Gil. So with regards to the SLE data, as I indicated, this is a cohort of six patients those are 50 million cells. There's a set of parameters we're looking at. The first set of parameters are really understanding the properties of the product. We've seen quite a bit of variability across the various programs in terms of the ability of the products to actually expand in vivo and the sort of persistence that was observed with these products. So that's the first observation. Because that gives us a sense of the quality of the product and how it actually performs. And it also gives us an ability to sort of look at and compare back to, as an example, the experience that the Aerojets team have in airline, which I think is still kind of the key data point or set of data points that I think the field is comparing to. So first is product property from a behavior perspective of the product itself. The second is clearly around safety. We've seen variability in terms of the safety events. So we're going to look obviously at the CRS. We're going to look at whether there's anything that we would pick up on neurological talks. But that gives us sort of the next picture, element of the picture in terms of the behavior of the product in these autoimmune patients. The third area is around the actual expected action of the product. And that actually goes to the depletion of B-cells. So we're going to look at B cell depletion. We're also going to look at the impact on auto-reactive antibodies. We're going to look at disease scores. And in particular, we're going to also look at not just the disease score as a generic score, but also to look at the individual components of the disease score, which I think is important and has certainly led to a bit of confusion during the last year when I think different data sets were compared to each other or people were trying to do that. In general, I think the patient population we're looking at is sort of a more advanced and more real-world population that we're looking at in our CARLYSLE study. These are patients that do have significant impact on the kidney. And so it is a population that has a level of tissue damage that you actually do see an impact on kidney function. So it's a more real-world population compared to the very young and early in the disease population that we've seen in previous studies. But I think it gives us a very good view to sort of actually compare to some of those early experiences, but also gives us an understanding of the profile of the product. The follow-up obviously is limited. And that's also why we're pointing to the second half of the year for longer term follow-up, full reconstitution of the B-cell compartment post persistence stops in those patients. So that will be sort of a second data set later in the year, but I think we're going to get a very good feel for the product and the properties that we were expecting, that we expect to see in these patients. And then in terms of the resources going into the launch. I think what's important about from a commercial perspective that what we're delivering and this with these types of therapies is really a set of services to support the centers. So it's different from your conventional commercial model, and it's much more focused on delivering services and providing support. We do that through a single point of access that actually triages and supports the center, triages the needs and requests for support. And actually is directly engaging with the centers and partners with the center very closely. I think that's sort of the model that we're running, and that's obviously then supported by medical affairs, as well as obviously the support on the reimbursement side and the engagement from a market access perspective. So that's sort of the distribution we have. So it's much more on the service side than it would be sort of the more classical, sales and marketing functions that you would have with a conventional launch of a product. So maybe that could be helpful. Thank you.

Operator, Operator

Thank you. One moment for our next question. Our next question will be coming from Kelly Shi of Jeffries, your line is open, Kelly.

Kelly Shi, Analyst

Congrats on the progress, and thank you for taking my questions. I have two. First, for the adult ALL program, I'm curious if the first wave of treatment adoption included the centers had no prior Takeda's experience, and for the centers have some hesitation to make a switch from Takeda to what would be the top reasons you hear. Thank you.

Christian Itin, CEO

Yeah, thanks for the questions, Kelly. I think what's been very interesting to see is that we had both centers with prior experience with obe-cel as part of the FELIX study, as well as centers that were not part of the FELIX study that we saw actually very early on onboarding and activate and getting activated. So it's very interesting to see that we have both types of centers actually moving very quickly. And we do see that there's clearly a substantial need there in terms of patients that were considered by those physicians to be very suitable for the treatment with obe-cel, and in their view, apparently felt that that was the appropriate treatment for each patient. So it was very interesting to see the dynamic of both types of centers to get on very quickly, and I think we're seeing very good interest levels for using the product early on, and across quite a wide range of patients in terms of the conditions that the patients were in. So I think overall, I think looking very positive and sort of similar to kind of the range of experience I think that we were having in the clinical study.

Kelly Shi, Analyst

Thanks for the color, and also for SLE, you have mentioned that you could add a few more patients at the same 50 million dose or higher. Just curious, what kind of efficacy signals would drive your decision to dose higher than 50 million? Alternative question here is after several data sets dropped from last year for cell therapy and SLE, could you share your insights on the treatment goal of CAR-T for lupus at this moment? Thanks.

Christian Itin, CEO

We designed the study around a fixed dose, which is based on the pediatric ALL dosage, leading us to the 50 million cell dose. The trial is structured to allow for adjustments in dosing, and we can also expand the cohort. We will share more details at the R&D day, giving insights into our future direction and steps forward. We're pleased with the experience and safety data we've gathered at this dosage, as well as its efficacy and the ability to significantly remove B cells in patients, informed by both pediatric and adult ALL experiences. We have a solid understanding of our product's performance and are eager to update you on our next steps at the April 23rd R&D day. I believe you also had a question about the positioning of CAR-T in SLE; is that correct?

Kelly Shi, Analyst

Yes.

Christian Itin, CEO

Okay, so I think that our review actually in terms of the positioning of CAR-T in SLE, I don't think has really changed. Obviously, when you look at SLE in the U.S., you've got about 400,000 patients overall, so it's a very large population on an incidence basis. But many of these patients can be managed with standard of care at a reasonably sensible level. But we do have a small proportion of patients that do actually progress to very severe stages of the disease where the level of intensity of therapy that we're obviously having with the CAR-T therapy we believe is very well positioned, very well warranted. And that's actually a much smaller population. We have indicated that this is somewhere between 10,000 and 20,000 patients added to 400,000. It's a much smaller population in the true high medical need segment of the disease where we think that this type of a therapy is well suited to be used. And I think also where you have a compelling health economic argument to treat those patients with the CAR-T therapy.

Kelly Shi, Analyst

Thank you very much.

Christian Itin, CEO

Thank you.

Operator, Operator

One moment for our next question. Our next question will be coming from Yanan Zhu of Wells Fargo, your line is open.

Yanan Zhu, Analyst

Great, thanks for taking our questions. So first, I was wondering, could you comment on in terms of the centers onboarded, have you onboarded the top 10 centers in terms of the ALL patient volume or is there still work to be done there? And also wondering, are you in a position to comment on number of apheresis to date or how has that been evolving? And lastly, I was wondering whether you plan to provide sales guidance at some point and if so, when might be the right time to do so? Thank you.

Christian Itin, CEO

Thank you, Yanan. I appreciate your questions. Let me address them. Firstly, the top 10 centers have been included. If you visit Autolus’ website, you can see the centers listed there. Many leading institutions in the U.S. are already set up to deliver AUCATZYL, which is publicly available information. The key centers have significant catchment areas and consistently high patient flows. We believe that among the first 33 centers we have, only a few additional high-volume centers may not be active yet. This suggests that we are already providing significant access to U.S. patients. Moreover, the distribution aligns with areas in states that have high population levels. Regarding apheresis, we do not provide guidance on this matter. Some companies have attempted to do so, but we find it unhelpful due to the timing differences between apheresis collection and patient dosing, which complicates reporting. Therefore, we will report only on the patients dosed, as this aligns with when we recognize revenue. This reporting method will remain consistent, and we won’t offer projections based on apheresis numbers. On sales guidance, we will not provide any for this year. We don’t believe it is sensible to issue guidance given the multiple developments, each with its unique trajectory. We will report on the number of active centers, which is publicly available, and this forms the basis for delivering therapy. As we onboard additional centers, this will enhance our sales potential. Each center typically has multiple physicians who deliver therapies, starting with individual physicians using the product, and over time more physicians are expected to join as they gain experience. This creates another ramp-up process. Additionally, many patients today may not have considered access to CAR-T, which is another factor influencing our ability to provide access. Each of these developments follows its individual curve, making it challenging to provide an overall projection, and we do not plan to do so. We will focus on the reality of patients dosed and recognized revenue, which allows for clear communication and enables everyone to track our progress accurately.

Yanan Zhu, Analyst

Great, great. Those makes a lot of sense. If I may have a very quick follow-up on the SLE second half data update. I was wondering beyond the additional follow-up for the first six patients, what might be the incremental new data at that update? Thank you.

Christian Itin, CEO

Yeah, so I think the most important update will be obviously the follow-up because one of the key questions that you have with this type of a therapy is whether indeed you had a full reset of the compartment. So whether you were able to actually have an impact on the disease or move the auto-reactive antibodies. And then actually once the therapy stops working in the patient, you see the recurrence of the B-cells and what you want to see at that point is an absence of auto-reactive B-cells. That gives you the information that indeed you were able to do a reset in the compartment. So I think that's really important information because it gives you information about the actual clinical impact and true impact that the therapy will have. So that's the most important information. And then we're going to guide obviously at the April meeting and how we're going to plan going forward. But I think the primary and the most valuable piece of the information we'll be sharing will certainly be around the long-term follow-up.

Yanan Zhu, Analyst

Great, thank you.

Operator, Operator

Thank you, one moment for our next question. Our next question will be coming from Jacob Mekhael of KBC Securities. Your line is open, Jacob.

Jacob Mekhael, Analyst

Hi there, and thanks for taking my question. I just wanted to zoom in again on the initial experience with AUCATZYL in the commercial setting, particularly in terms of the vein-to-vein time that you have been able to achieve. Have you been able to achieve your target of 16 days with the first few batches? And perhaps more broadly, what has been going well and are there any learnings from the first few, yeah, I guess, batches that you will implement going forward?

Christian Itin, CEO

Yeah, so thanks for joining, Jacob. So what we see actually in doing the initial phase of the launch in terms of the turnaround time for the product is that we see a high degree of consistency with our prior experience and tracking within our expectations that we had for the guidance that we had out for the product itself. So we feel very confident that the consistency we're seeing actually builds very nicely and we see those processes work very well. In terms of the learnings, I think one of the interesting things, of course, is that I've mentioned that in the context of the manufacturing side, it's literally the patient's number one coming through the door. Basically, that's when you actually turn the engine on and you start actually have every aspect of the process from supporting the centers with information to support actually and secure reimbursement all the way through to the actual handling of the product, the handling of the up sale, the whole logistics chain, the manufacturing process itself, and then obviously the additional support of the center in terms of training, et cetera. So we have actually all of those items that actually start to actually run. And obviously, they have to run on time, they have to be consistent, and all of the systems also have to be robust and stable. And that's an interesting transition. So I think a lot of good input that we had working very closely with the centers to really focus on making sure that the experience for the centers are positive and that we're also taking as much of the workload off the centers. And I think that's been a key focus. And as you can imagine, each center works a bit differently. And so there's a lot of learnings that obviously we're going through with each one of the centers to make sure that this is as positive an experience as possible and that we're continuously improving our platform for the engagement, the booking, and all the way through in terms of delivery of the product. So this is an ongoing process. And I think we're seeing really good collaboration with all our centers, very valuable feedback. And we're continuously looking and strive to actually improve the experience. And that's actually the process we're in. And we're convinced we're going to be in that for the duration of the delivery of this product because we want to be as easy to use as possible for the centers, as easy to access as possible. And we're going to continue to work on that and make sure that that's going to be an experience that we can actually continuously improve over time. But great start, good level of engagement, great feedback. And I think puts us in a very strong position.

Jacob Mekhael, Analyst

Okay, thank you. I just have one more, if I may. On your conversations with the EMA on the EU approval. Based on those conversations, where in the second half do you expect the approval to come? And perhaps are you able to comment on any preparations that you're working on for the EU launch and how does that process compare to the U.S. in terms of center onboarding?

Christian Itin, CEO

Yeah, so the interaction with the European agency is going through the normal process, which is a very well-described. And also from a timeline perspective, accessible, well-defined process to go through. So that's running. We started the process in the end of March last year. So we're kind of getting to the latter part of the process, which is a series of questions, answers, additional review, final questions. Again, a review answers, a final review. And then you go into the final steps that ultimately result in an approval or no approval. So we're in that second half of the process, but I don't think it makes sense for us to actually try to pinpoint dates. That wouldn't be a sensible thing for us to do because frankly, we don't run the clock. So with regards to the preparation, I mean, very similar to what we did in the U.S. in terms of preparation, working with the clinical centers in the UK and we're working with clinical centers at an earlier stage in Germany as the first country that we're interested in to potentially be in a position to launch. So we're in conversation with the center. We start to do the preparatory work as we've done in the U.S., very similar process that we're running through. And a lot of the learnings that we have made in the U.S. obviously are very applicable also for the UK as well as is applicable for European centers. So that's ongoing and obviously gives us a very strong basis because obviously a lot of the systems have been worked out already for the U.S. launch and they require typically only minimal adaptation for the jurisdictions in Europe as well. So we think we're in a very good spot there and can do that and actually frankly, do that work in a very efficient way.

Jacob Mekhael, Analyst

Okay, thank you. That's very clear.

Christian Itin, CEO

Thank you very much.

Operator, Operator

Thank you. One moment for our last question. Our last question will be coming from Simon Baker of Redburn Atlantic. Your line's open.

Simon Baker, Analyst

Thank you very much for taking my question. Two, if I may, please. Firstly, just continuing on AUCATZYL and the UK. Typically, we see the importance of a NICE assessment as having relevance far beyond the borders of the UK. So just wondering if you could give us an idea on the expected timeline of a decision by NICE on AUCATZYL. And then moving on to the CARLYSLE study. Could you give us an idea of the duration of exposure that we will see at that interim analysis for the six patients? You started dosing in February 24. So I just wanted to give us some flavor of how much follow-up there will be across those initial six patients. Thanks so much.

Christian Itin, CEO

Thanks, Simon. So I'll start with the second question, which is sort of the follow-up time. Out of the six patients, we're going to have one patient with more than six months of follow-up, two patients with more than three months, and three patients that have somewhere between one and three months of follow-up. So that's sort of the nature of the follow-up. And that's also why I indicated the importance of going to the second half of the year for longer follow-up and understanding kind of the overall profile in terms of the reconstitution of the research department. With regards to the UK, as you pointed out, there's sort of two processes that you run in the UK. You have, on the one hand, the regulatory process, which is run through the nHLA and has it run through its own timeline. And then there's the second set of engagements, which is really to sort of actually demonstrate the health economic benefits of your product as part of the assessment that ultimately will lead into a determination of what the price in the UK is. Both processes take an insignificant amount of time. And both are processes that are ongoing. And obviously, it's not entirely under our control in terms of the timing. But I think both are well where they need to be relative to each other. And so we're looking forward to updating you once we've sort of actually cleared the regulatory hurdle. And then obviously, can talk about the final steps that you have to go through before you can actually deliver a product in the UK commercially.

Simon Baker, Analyst

Great. Thanks so much.

Christian Itin, CEO

Thank you very much.

Operator, Operator

And I would now like to hand the call back to Christian for closing remarks.

Christian Itin, CEO

Yeah, first of all, thanks a lot for joining. Exciting 2024. I think we're in a really good start for 2025. We're excited about where we are with the launch, the opportunity to broaden the utility of obe-cel in the future as well. And we're looking forward to updating you at the 23rd of April at the R&D Day in New York. And obviously, we would love to see many of you actually be able to join us in person at that event. So thank you very much. And thanks for your questions. Have a great day.

Operator, Operator

And this concludes today's conference call. Thank you for participating. You may now disconnect.