Participants

Amanda Cray; Investor Relations; Autolus Therapeutics PLC

Christian Itin; Chief Executive Officer, Executive Director; Autolus Therapeutics PLC

Rob Dolski; Chief Financial Officer; Autolus Therapeutics PLC

James Shin; Analyst; Deutsche Bank

Rajan Scharma; Analyst; Goldman Sachs

Asthika Goonewardene; Analyst; Truist

Matthew Phipps; Analyst; William Blair

Gil Blum; Analyst; Needham & Company

Kelly Shi; Analyst; Jefferies

Yanan Zhu; Analyst; Wells Fargo

Jacob Mekhael; Analyst; KBC Securities

Simon Baker; Analyst; Redburn Atlantic

Presentation

Operator

Hello ladies and gentlemen and welcome to the Autolus Therapeutics call to discuss its 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

Thank you, Latonya. 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 1,995.
These may include, but are not limited to statements regarding status of the ongoing commercial launch of a castle in the US, Autolus manufacturing, sales and marketing plans for AUCATZYL. The market potential for AUCATZYL and the status of clinical trials and development and or 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

Thank you very much, Amanda, and welcome everybody to our fourth quarter 2024 financial results update. So first off, obviously, we had a very successful 2024 which sets us up well for the 2025 that we're already in, a few months now. First of all, I'd like to just highlight kind of the key objectives that we have for the year.
So the primary objective clearly is to execute a successful commercial launch for AUCATZYL, and we're doing really well and advancing well on that. We'll provide a bit of an update as we go through the presentation.
But also we see a lot of opportunity for obe-cel to actually expand its utility, the excellent profile that we've seen in our prior in our current experience with the product, and explore the opportunity and additional indications as well as look at the opportunity for moving some of our other product candidates forward and at the same time, obviously we'll be, I think, very selective and very careful in how we're going to place our investments.
Now one of the things that you'll hear us also briefly mention is the fact that we're planning for an R&D event on April 23rd in New York that will actually outline in more detail kind of the plans on how we want to move forward in sort of creating additional opportunities for future growth. So with that on slide on the next slide. I'm briefly going to summarize kind of the key opportunities that we have seen and sort of achieved during the course of 2024.
As I mentioned, this has been a remarkably successful year and we had a very strong start of the year in the first quarter when we were able to add about $600 million to our balance sheet through our collaboration with BioNTech as well as a public financing that we conducted in the first quarter. This set us up very well to really be able to focus fully on making sure that we get obe-cel already and to get through the approval process in the US, but also to set us up well for the commercial launch of the product.
As we're going through the year, I would say we have continuous activities on the commercial side to actually get the sites ready so that they actually would be in a position once the product was approved to actually start onboarding the product and and be in a position to move forward and actually use the product in the commercial space.
Now when we look at the approval itself, we achieved the approval in the US on November 8th. And I think what was very encouraging was that it not only did we actually achieve the approval slightly ahead of schedule, but also actually had a label which gives us a broad opportunity in the relapsory factory ALL space for adult patients and not and actually having the first product getting through the approval process that actually did not require a REMS program.
So very nice setup in terms of the approval itself, the timing of the approval itself, not having a delay, recognizing that the product had an attractive safety profile and therefore no obligation for collecting additional information around CRS and ICANS going forward and that actually is, I think, a very strong foundation.
What was then very helpful is that we were able to actually get the clinical results published in the New England Journal of Medicine in the early part of December, and shortly thereafter, the product was included in the NCCN guidelines. This is very important as you start launching a product because it gives us a lot of confidence and indeed this is a recommended therapy and also will support the decisions that payers have to obviously go through to get the patients signed off for commercial use.
Now when we look at the track that we had as we went through the first three months of the launch, we see a very good development in terms of the number of centers that are actually authorized and are able to deliver the product. We're currently showing 33 centers that are authorized as of March 19th, and we expect that that group of centers allows us to reach approximately 60% of the target patient population in the US.
We are continued to move forward, adding additional centers as we go through this year. By the end of the year, expect to have approximately 60 centers that'll be, ready and, in a position to deliver, or cancel to patients. We believe that those 60 centers, actually reached the vast majority of the patients, in the US and will give us a very strong foundation, for a successful delivery of the product to, the, patient, patients across the US.
Already mentioned that we obviously have the publication of the of the study of the FELIX study in the New England Journal, but we're also in addition to obviously getting ready for launch in the US We're also moving through the regulatory steps in the UK and in Europe and had filed in the early part of 2024 with the image with EMA and then by the middle of the year with the MHRA, and we expect actually regulatory decisions in the second half of 2025.
We also started the process to actually establish ultimately the utility of the product in the UK and we're going through the assessment by the National Institute for Health and Care Excellence or NICE, which is one of the key processes that you have to run through, to get to a position, to actually get a product adequately reimbursed, in the UK.
As we went through the year, there were several data presentations at key conferences that really focused on the properties that we have observed with a capsule or obe-cel in the relapsed refractory adult population as we were going through and sort of actually gained more and more data from the FELIX study.
We could report on the durability of the product, highlighted the safety profile, the impact of having deep molecular responses and persistence as indicators and likely requirements to get to long term outcomes with the patients.
And we're also actually were able to show the impact of tumor burden-guided dosing as well as the safety profile's impact on reducing health economic cost when we look at the cost of treating the patients. So quite a comprehensive data set that we actually were able to share across a range of conferences during the course of last year, including the Tandem meeting in February this year.
Moving to the next slide, we're looking briefly here at some of the key outcomes that were actually presented and published in the New England Journal publication, and what we're seeing is that the product has a very high level of clinical activity reaching deep molecular responses in the majority of the patients.
And that type of activity obviously has come with an attractive safety profile and we can see that overall the level of high grade cytokine release syndrome and the level of high grade neurological toxicity or ICANS are low. In fact, when we look at patients that have low levels of disease burden at the time of dosing, those patients did not experience high grade events either CRS or ICANS, which I think gives us a good understanding of patient profile and also kind of from a safety perspective.
And as we're looking at the next slide, we also see that the tumor burden also actually gives us important information about the impact of the therapy it can have in terms of longer term outcome. In this slide, we're looking at event free survival. As you can see in the top part of the panel, event free survival stabilizes at around between 45% and 50%.
And we see that the line actually is starting to go horizontal, indicating that there is a proportion of patients that do not actually seem to progress or actually have, events that are occurring. When we look at, what the impact is of the disease burden prior to dosing, we can see that patients that have low disease burden, less than 5%, do remarkably well, whereas most patients with a wide range of disease burden, up to 75% actually continued to do very well and only the patients that had extremely high levels of disease burden of more than 75% of two of blasts in the bone marrow at the time of dosing obviously have a lower outcome.
So overall I think gives us a lot of information about the properties of the product. We have just talked about the safety that we've seen across the Board, the obviously the efficacy from an event free survival across the Board, which looks very attractive. And also there are the impact of actually treating patients when the disease burden is still at a lower level, which gives us a very good, prognosis for these patients.
When we look in the next slide, we see that translating into overall survival, and we see the same overall picture again stabilization of overall survival in the overall population and as well an impact that we see in terms of tumor burden where patients again with lower tumor burden and lymphodepletion and also patients with extremely high levels of tumor burden actually have a poorer outlook.
Overall remarkable set of data and I think sets us up, for a very attractive proposition for patients in this field.
Moving to the next slide as we're sort of thinking about sort of the early momentum, of the launch in the US, indicators here is the centers that can actually actively deliver products to patients. As I mentioned, we reached 33 centers on the 19th of March, which gives us obviously a very good reach and distribution already across the US and obviously a presence in a lot of the more densely parts of the populated parts of the US, which is also the reason why we're already reaching more than 60% or around 60% of the patient population.
What's also important is we're making good progress in terms of patient access, in terms of lives covered, and we see actually very good momentum there as well as we go through the have been going through the last three months. So that is very encouraging and also actually is a good sign that indeed patients do have really an opportunity here to get access to this therapeutic option.
Finally, on the next slide on the update, you have heard us actually talk quite a bit about the actual manufacturing facility for commercial supply, which is the nuclear facility. I think one of the remarkable things about this field is obviously as you have the first commercial patient coming, that's when you literally start the operation at that facility.
And I think at this point we can say that we had, we're off to a really good start and the facility came to life and is humming well and I think will be a very strong, give us a very strong foundation in our ability to reliably deliver product to the centers.
So with that, on the next slide, which is really focusing on the expansion of the obe-cel opportunity, a key area that obviously we're going to be focusing on in 2025. First off, on the autoimmune side, we've been running obviously the CARLYSLE study. We have, the initial cohort that we, of six patients that are all dosed. We're running through the data [cut], for the upcoming R&D event on April 23rd, and we're looking forward to updating you on that initial experience, with the first six patients.
And we're also are planning to present the data with long term follow up, across the patients at a later point in the second half of the year. On the Oncology side, obviously we're also have been moving forward with our pediatric study, the PY01 study, and we expect to provide an update also second half of the year that study is also has been envolving very nicely.
In terms of the early pipeline, we obviously have a set of activities ongoing, with our partners at the University College London, and we are, moving forward or have been active in, AUTO1/22, AUTO6NG and AUTO8, and we continue to progress, the activities around those programs, collecting more information around the programs and are planning tools to give a short update at the R&D day, at the, end of, towards the end of April.
So with that, I'd like to actually hand over to Rob and give us a summary of the financial results.

Rob Dolski

Thanks, Christian, and good morning or good afternoon everyone. It's my pleasure to review our financial results for the full year 2024.
Cash equivalents and marketable securities at year end 2024 totaled $588 million as compared to $239 million at the December 31st, 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 US 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 end in 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 8th, 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 some 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 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 ending December 31, 2024 compared to $208.4 million for the same period in 2023. With the recent approval of AUCATZYL in the US, 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 equivalents, and marketable securities, we are well capitalized to drive the full launch and commercialization of obe-cel and 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 the 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

Thank you very much, and moving to the upcoming milestones, so when we look into, 2025, we are starting the year with, also the update on the SLE1 CARLYSLE study, which we are planning to provide on April 23rd at the R&D company R&D event in New York. We then, when we look at the pediatric study, expect to provide the update on the pediatric study second half of the year, as well as obviously longer term follow up on the CARLYSLE study as well second half of the year.
And we do expect also during the second half that we received the notifications around the regulatory process for the UK as well as for the EU regarding potential approvals in those two jurisdictions for obe-cel.
So I think a very interesting year for us in terms of the progression of opportunity that we're actually starting to execute on. We're outlined at the company R&D day, but then also obviously we'll be able to provide more and more evidence and projections as well with regards to the the launch progress that we're making for a castle in the US. So with that, we're happy to take questions and we'll take over I hand over to the operator.

Question and Answer Session

Operator

(Operator Instructions)
James Shin, Deutsche Bank.

James Shin

Hey, good morning, guys. Thank you for the question.
On AUCATZYL launch, and I know it's a progressively evolving situation. 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 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

Yeah, well, first of all, thanks a lot for joining, James. On the launch, I think what we can say is that we have also 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 and enthusiasm by the centers to actually do that work and actually and 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 in that process. So I think that gives you gives us a very good level of confidence in terms of the 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 obviously 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 is 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 to actually explore 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 on the commercial setting and the confidence physicians are building up and I think we'll see that evolve over the upcoming of 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.

Operator

Rajan Scharma, Goldman Sachs.

Rajan Scharma

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

Christian Itin

Yeah, thanks a lot for joining. So the question, the first question is related to, the ramp up of the centers getting online. I think we've seen in the first 30 centers, I think a pretty steady, sort of trajectory of these centers actually getting online, which I think has been, expected because we do have a, we didn't have the 30 centers prepared for onboarding by the time of approval and then it's the activation step that they were running through and you could see that basically that we had early January as we had reported around 20 centers that were active and then that obviously built then through the quarter to, now middle of March to about 33.
So there's a pretty continuous kind of flow and and movement that we've seen with the next 30 centers, I think we, we'll see that, I think build gradually as we go through the year. It's obviously very much, a lot of that is really driven by the individual centers and the time, and the speed at which the onboarding process is sort of conducted. A lot of that has to do with legal reviews and so on.
And frankly the capacity at the respective hospitals to sort of manage that workload. So there is an element of variability, but we would assume that we have sort of a reasonably steady process as we go through the year, and we obviously, we'll be able to keep updating you on a quarter by quarter basis and also the actual centers obviously are visible for physicians and patients on the website. So it is something that actually is, can actually be followed and, but as, in terms of projection, we would expect that to go relatively steady as we go through the course of the year.
With regards to tariffs, I think, very much an open question at this point in time whether there will be tariffs, what it might be, what type of products might be impacted, etc. I think very hard to speculate, in most other, I think in the past, if we look at tariffs that sort of imposed on pharmaceutical products. They tend to actually, be very, well thought through and typically minimal, because nobody wants to actually have an impact on the supply of medication for a population that's not a good thing to do from a health perspective, but also overall perspective, clearly not the, I think something that is really attractive, to impose.
And typically blocked products have been excluded from tariffs if you look at, historically at the development of tariffs. I think at this point, I think way too early to actually have a have a real view. I don't think we have visibility in the space and so at this point in time I don't think there's more that we can really comment on that.

Rajan Scharma

Thank you

Operator

Asthika Goonewardene, Truist.

Asthika Goonewardene

Hey, good morning and good afternoon guys. Thanks for taking my questions.
Among the centers that have treated patients in the commercial setting with their CAR T-cell, 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 have a quick follow up.

Christian Itin

Yeah, so, thanks for joining, 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, the, a lot of the activation process and the speed at which the activation process kind of went through has to do with the patient actually, being suitable for the therapy and considered to be 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 to other therapy and then there might be somewhat of a a bit of a lag until the next patient might actually come along. I think the short answer is it's variable.
I don't think it's it's, 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 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 you 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

And then, I know it's very early age of the launch right now, but one of the intriguing things about our CAR T-cell was that, perhaps patients, do better by not having, but not, being bred 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 to feel comfortable saying I don't want to take this patient to transplant after our CAR T-cell?

Christian Itin

Yeah, I think that 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 transplants, 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, etc.t hat 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 have seen a relatively limited use of transplant. We'll need to see kind of how that develops. I don't think at this point we have, we can even tell because it's just too early. But we also 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 need to see where that, where that's headed.
But overall, obviously very encouraging and also an option for, patients that currently, you would have, very limited treatment options for. And I think gives us 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's a significant appeal for this product because this, it is actually 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, and, 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 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

Matthew Phipps, William Blair.

Matthew Phipps

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 in as far as opting in. Is there a timeline for when that might occur?

Christian Itin

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 study. 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 an option on our [solitu program 0.6NG], and that's an option that actually is still running, and I think it's 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 that the path is clear for, 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

Gil Blum, Needham & Company.

Gil Blum

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 and your upcoming R&D day and maybe you maybe you can put that data in context. I mean six patients, what kind of data are we're going to see here safety B-cell aplasia?
And my second question is where would you say most of your resources as it relates to the launch are being invested just site roll out or is there more to it?

Christian Itin

Yeah, thanks a lot, much appreciated, Gil. So with regards to the SLE data as I indicated, this is a cohort of six patients dosed of 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. So the persistence that there 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 the, and compare back to as an example, the experience that the, [A Jets team] had 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 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 a 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, actually significant impact on the kidney, and so it is a population that has, a, an actual 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 airline, 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 what we're pointing to the second half of the year for longer term follow up, full reconstitution of the 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 expected, that we expect to see in these patients.
And then in terms of so the resources going into the launch, I think what's important about from a commercial perspective that, what we're delivering at 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 it's 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 been 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.

Operator

Kelly Shi, Jefferies.

Kelly Shi

Congrats on the progress and thank you for taking my questions.
I have to first, for the adult ALL program curious if the first wave of treatment, adoption included the centers had no prior [triages] experience and, for the centers have some hesitation to make a switch from triages to what would be the top reasons you're here?

Christian Itin

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 with obe-cel and in their view, apparently felt that that was the appropriate treatment for these patients. 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, sort of 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 pivotal study.

Kelly Shi

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 do higher than $50 million or 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 the goal of CAR-T for lupus at this moment?

Christian Itin

Yeah, so, obviously the way we set up the study is to, go in with a fixed dose, which is a translation of the pediatric ALL dose, use that as the basis for the fixed dose. That's how we arrived at the 50 million cell dose. We then had an opportunity or designed the trial in a way that would allow us to actually step up or step down. And, we also have an opportunity to expand the cohort. We'll provide more information obviously at the R&D day and we'll sort of give you a sense of kind of how we're moving forward and what the next steps are and where we're going to go, in that space.
And I think that will sort of answer actually I think the question in much more deeply. Fundamentally, we're obviously, I think we're at a good place. In terms of, the experience that we had and also the safety data we already had, with the product at that dose level as well as the efficacy level and it's the ability to really remove B-cells very deeply, in patients based on the pediatric ALL as well as the adult ALL experience.
So we think we're in a good spot there. We have a good understanding of what our product does and how it behaves. And we're looking forward to giving you the update in terms of where we're going to go next, at the, April 23rd R&D day.
And then I think you had a question related to SLE and the positioning of [CAR T-cell]. Did I hear that right?

Kelly Shi

Yes, okay

Christian Itin

So I think with our review actually in terms of the positioning of CAR T-cell, I don't think has really changed. Obviously when you look at SLE in the US, 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 the at a reasonably sensible level.
But you 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 had indicated that this is somewhere between 10,000 and 20,000 patients out of the 400,000.
So it's a much smaller population in the true high medical needs 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 a therapy.

Operator

Yanan Zhu, Wells Fargo.

Yanan Zhu

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

Christian Itin

Thanks a lot, and I do understand your questions, so let me go through first of all, have the top 10 centers being included, when you go on to the, this website, you can actually see the centers that are on there. You do see that, many of the top institutions in the US are already in a position to actively, deliver or cancel. So I think that's something, that's actually publicly visible. You see the key centers there, that have very significant catchment area and very consistent, high levels of patient flows.
So, we do believe that within those, first 33 centers that we have, many, of the very high volume centers, there are probably only a few additional high volume centers that may not yet be active at this point.
And this is why we're guiding to, already within that population to cover a very substantial proportion of the, of, provided, a large proportion of access to the US patients already. And that also coincides when you look at the distribution also with the big, the areas in the states with a lot of, with high levels of population, across as well, which is a way to look at this and sort of get a feel for that.
With regards to apheresis, we do not guide on apheresis. And I think there's been some companies that have tried to do that. We don't think it's going to be helpful to do that because there's obviously a time difference between aphes collection and actually dosing of the patients which actually then gets, I think, a very complex way of reporting and sort of following the story.
So we're going to report actually on the patients that were dosed. Which we think is the cleanest way of doing that because that is also the time point when in fact you re you recognize revenue. So that's important. So we're going to have a very consistent way of reporting that and we're not going to give a leading edge sort of view based on the number of states.
And then the last point was around sales guidance. We certainly for this year we will not give any, sales guidance, and we don't believe that that's actually a very sensible thing for us to do, to give guidance, simply because you basically have multiple.
Developments that you're actually going to go through that each one of them will be on a trajectory and a and a curve of its own. So you have obviously the number of centers that are active and you'll see that report on that and this is publicly visible. So that is also the basis to even have an ability to deliver therapy. So that momentum and the onboarding and the addition of centers obviously will sort of increase your footprint and your ability to sort of, drive sales.
The second aspect is that obviously within each one of the centers, there are multiple physicians that typically do deliver therapies. They have different backgrounds and you often start with an individual physician starting to use the product and over time and experience gain more of the physicians, we expect to start using the product. That's another kind of ramp that you're going through. And the third has a lot to do with obviously the experience made with the program per se.
And with that, the ability to actually, get access, and provide access to a larger proportion of patients who today may not actually have, considered access to as well. So you have several, developments that each of those are in an in curve. Trying to actually overlay that and project is actually very challenging, and we're not planning to do that. So we're going to actually stick with reality, which is patience dost and revenue recognizable. And I think that gives us a very clear, very clean communication. I think we'll allow everybody to follow exactly where we are.

Yanan Zhu

Great. That 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, date, new data, at that update?

Christian Itin

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, remove 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 all the 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

Great, thank you.

Operator

Jacob Mekhael, KBC Securities.

Jacob Mekhael

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

Yeah, so, thanks for joining Jacob. So what we see actually In the during 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 on within our expectations that we had for for and 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 little the patient number one coming through the door, basically that's when you actually, turned the engine on and you start to actually have every aspect of the process. From, supporting the centers to with information to support actually and secure reimbursement all the way through to the the actual handling of the product, the handling of the reset, the whole logistics chain, the manufacturing process itself, and then obviously the additional support of the center in terms of training, etc.
So you have actually all of those items that actually start to actually run and also 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 of 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 center just to make sure that this is a 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 the 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 to 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

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 US in terms of center on boarding?

Christian Itin

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, etc.w ell-defined process, to go through, so that's we're on, that's running. We started the process in, the end of March last year, so we're kind of getting to the latter later 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 sort of 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 a date that, wouldn't be a sensible thing for the 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 US in terms of preparation, working with the clinical centers, in the UK and we're working with, clinical centers.
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 who start to do the preparatory work as we've done in the US, very similar process that we're running through, and a lot of the learnings that we have made in the US, obviously very applicable also for the UK as well as is applicable for 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 US launch and, they, require typically on the 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

Okay, thank you. That's very clear.

Operator

Simon Baker, Redburn Atlantic.

Simon Baker

Thank you very much for taking my question too, if I may please. Firstly, just continuing on or cancel and the UK, typically we see the importance of a NICE, assessment as having relevance far beyond the borders of the UK. So I just wondering if you could give us an idea on the expected timeline of the decision, by NICE on or [CAR-T cell].
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 want you to give us some flavor of how much follow up there will be across those initial sic patients?

Christian Itin

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 are somewhere between one and three months of follow up.
So that's sort of the. 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 visa compartment.
With regards to the, to the UK, as you point out, this sort of two processes that you run in the UK you have on the one hand, the regulatory process which is run through the MHRA and has its run through its its own timeline.
It's the second set of engagements which is really to sort of actually demonstrate the health economic benefit of your product as part of the as part of the assessment that ultimately will lead them to a determination of what the price in the UK is.
Both processes take, not insignificant amount of time, and both are processes that are ongoing and, obviously not entirely under our control in terms of the timing. But I think it, both are, well on where they need to be, relative to each other, and so we're looking forward to updating you once we're sort of actually cleared the regulatory hurdle and then obviously we can talk about the final steps that you have to go through before you can actually deliver product in the UK.

Simon Baker

Great, thanks so much.

Operator

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

Christian Itin

Yeah, first off, 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

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