Autolus Therapeutics plc (AUTL) Earnings Call Transcript & Summary

Good afternoon, everyone. Thank you for joining. My name is Rajan Sharma. I'm a European Biotech Analyst here at Goldman Sachs, including my coverage is Autolus and I'm pleased to have CEO, Christian Itin with us today. Christian, thank you for joining us. Maybe just to kind of kick off and get the -- started.

Could you just give us kind of an overview of Autolus and [Audio Gap] in the journey?

I'm happy to do that. Thanks a lot for inviting us. And thanks for those of you who managed to actually battle the rain and get in there and stay dry, which is I think is an accomplishment today. Autolus is a CAR-T company. So we're doing autologous cell therapy. Our lead program is obe-cel, a program that we have now under review with the FDA for a BLA with a target PDUFA target date for November 16. We also filed with the European agency at the end of March. So that's also in process, and we expect to file with the U.K. agency, the MHRA in the second half of this year. So in the middle of that process, we built our own capabilities. So we built our own commercial manufacturing facility, which is designed to support our lead indication for the product, which is in acute lymphoblastic leukemia, relapsed patients. And we have behind the program an ability to go into a range of [Audio Gap] malignancies, but also autoimmune diseases, which are both active developments at the company and a range of product opportunities behind that in -- with using dual targeting where we use two structures on the cell surface we go after, but also much more sophisticated programs that we're starting to work in, in solid tumor fields with a lead program being in Neuroblastoma, which is a pediatric solid tumor, kidney associated where we have actually 5 programming modules involved in that program that's right now actually starting up at the University College in London.

Perfect. Maybe we'll start on obe-cel because -- as you mentioned kind of the most advanced asset in ALL there. ASCO last week, you had some updated data there. Obviously, it's not kind of the pivotal, but could you maybe just kind of talk us through what was presented there and the extent to which the agency has access to that data, given that the filing is and the review is ongoing?

Right. So first of all, the update we provided is actually from our pivotal study, the FELIX study. We have now a follow-up of about 22 months as a median follow-up. And that actually allows us to get a very good understanding of what the long-term benefit is for the product. And what was very encouraging to see was that we're seeing event-free survival stabilized at around 40%, literally going horizontal, if you look at these curves, indicating that we have a substantial proportion of the patient that have an opportunity to get into a long-term benefit and long-term remission and hopefully cure with the product in an indication where upto now that was actually not feasible. So that's a very significant step forward. The fact that we have now this longer follow-up gives a lot of confidence that this is a real tail we're seeing in the curve, and we see it also translated in the same way into the overall survival curve where we also see a stabilization at 40%. And in fact, the overall survival curve going horizontal as well. This has been very exciting. I've been developing in this field for a long period of time, developed the standard of care in the setting with my old team, that product has been a major step forward now marketed through Amgen BLINCYTO, but we never were able to actually show long-term outcomes in these patients nor were any other program. So when the data were presented, there was a discussion after that by Lori Muffly, who's a very well-known physician in the leukemia and lymphoma field out at the University of Stanford. And she basically called the data revolutionary. Because it is a different quality in terms of outcome for these patients. What we also were able to show, which was also very encouraging and quite unusual is that normally what you have to do in patients with acute leukemia, is you induce a very profound response typically an MRD-negative complete remission. And then once you achieve that, you actually transplant the patients with a stem cell transplant. And only that second step, the stem cell transplant with any other therapy gives actually a longer-term outcome. And a small proportion of the patients also received a stem cell transplant. And in fact, what we're seeing is that these patients actually did worse. Their outcome actually was worse. Part of it was due to the fact that some of these patients actually passed away with treatment-related adverse events that are linked to the transplant. And the other portion is that most of the patients before transplant had active obe-cel in their system, so they have measurable CAR T cells. And obviously, the conditioning of these patients and then the transplant itself would actually kill all circulating immune cells, including the CAR T cells. And so you are basically taking away the active agent. And so the combination of those 2 actually led to a worse outcome. So when we look at our longer-term outcomes in event-free survival and overall survival, if we take away the patients that were transplanted, the curve actually lifts up which is the contrary of what you see with any other therapeutic modality indicative again of the fact that we have a very different type of outcome with the product. And the final part that we were observing was that patients that actually had long-term outcome also had long-term persistent CAR T cells. And so the persistence of the CAR T cells actually becomes a predictor for long-term outcome as well, which will be very helpful in terms of decision-making because you cannot only then monitor tumor burden and the recurrence of the tumor but it can record much earlier than that, actually, if the CAR T cells were actually still around, and if they're actually being lost, then obviously that's indicative of a reason or a need for potential additional therapy with the patients. So it gives you early warning and it gives you an ability as a physician to plan and to actually sort of prepare for the next steps so the patient should they be necessary.

Okay. Excuse me. So in terms of the filing -- in terms of the filing, that's underway, where are you in terms of FDA review process?

Right. So the FDA filing was done in November last year. We got the filing accepted in the middle of January. We did announce at that point in time, what was helpful to have in terms of feedback from the agency, and we referenced that also in the press release at the time is that the agency did not expect to require an advisory committee. So that's obviously a very good statement. And we're now at the point, we're sort of in the second half of the review process. Just in general terms, the first half tends to be focused on the data itself, the clinical data, but also looking at the ability to actually manufacture and supply commercially. So those are key activities that are going to be reviewed in the first half of the cycle. The second half of the cycle, it's more about the specification of the product. It is more about the label and the REMS the risk mitigation program for the -- which is sort of the key areas of focus in the second half. So we're now in the second half of that review.

And then -- sorry, I think I -- I think I'm going to -- In terms of the manufacturing piece, where are you on the review process there?

Yes. So the manufacturing, obviously, is very critical in this space. The products are very much defined by the manufacturing process. And in order to actually be able to manufacture on the one hand, reliably at scale, but also economically, it was very important to actually establish our own infrastructure that was really tailored to this particular manufacturing process. And one of the challenges that you have in this field is that you have to -- your manufacturing process has to work every time. And it is not one of those situations like we have with typical biologicals, where we can fail every fifth round or every tenth round, and that's still okay because obviously, the patients do not get impacted. It's a monetary issue. It's a financial issue, but it is not an issue from a patient access perspective. In our case, that's not true. Every patient actually -- that we manufacture for actually has to rely on our ability to deliver products. So reliability in your manufacturing is incredibly important. And that is really where we focused on, to a large extent. It's around the development, the stability of the process, the robustness of the process. We're able to actually in these very difficult population and during the height of the pandemic with all the issues that I think we all rather not prefer not to remember. We had an out-of-spec rate of about 5%, which is very low. And we managed to get 84% of all patients actually dosed. That is higher than what actually has been able and what was demonstrated, certainly for these patients prior to the pandemic. And also gives us a lot of confidence that our systems we put in place are very robust. So in terms of the facility itself, we built a facility that allows us to serve at least 2/3 of all adult ALL patients in the U.S. and in Europe. That is about 2,000 patients. The total capacity of the facility is about 3,000 patients worth per year. And we have actually set this facility up in a record time. We had groundbreaking in November 21. We filed the BLA with all the data in it, including the validation of the facility in November '23. So within 24 months, we went literally from ground breaking to fully validated facility and the entire data package worked up to go into a BLA. That is certainly way, way shorter than anyone actually had done it. And we had to do it because, frankly, we had no choice. We had to actually meet the timeline for the product and it was absolutely necessary to be actually in a position where we can also supply at a cost level that is economical. And so for us, we're actually able with this facility to operate somewhere in the range of about 15% cost of goods. And that actually allows us to have a good level of profitability for these types of products and gives us a very unique opportunity to drive this indication and actually launch in a setting where we should have no limitations on access to capacity, which is very different from pretty much any other launch that was done in this space.

Okay. And then talked about the manufacturing that just in terms of launch preparedness from a commercial perspective, because being a CAR-T therapy, there's more to it than just kind of launching the product and going to market. Could you just kind of walk us through where you are there? And then, I guess, confidence that if and when the approval comes through on the PDUFA, you can go directly to market?

So on the manufacturing side, there's 2 key licenses that we need. The first license we need is actually one from the U.K. authorities from the MHRA, which is a license to do manufacture both for clinical as well as for commercial supply and particularly for export. Most of our patients -- or all of our patients with the initial label, obviously, will be in the U.S. So that license was very important. We had the inspection from the MHRA in the very early part of the year, and we received a license in March, this year. So that facility already is licensed to do that. Subsequent obviously, we have reviewed by the FDA, which is a second step and requirement to sort of get to an ability to launch. Now in addition, what you obviously have to do is you have to actually set up the systems that actually ensure a chain of custody. And chain of custody is really important because this is truly personal. The products we manufacture can only be given to that one patient where we extracted the cells from. So you have to actually ensure that the entire journey from collecting the cells all the way through manufacturing, product release back to the patient, can be tracked and traced without any gaps. So there's a set of systems you have to set up in order to do that. But it also means that you have a very involved engagement with with the centers themselves. So when we engage with the centers, it starts out with actually identifying the patient, and there's a ping coming from the center through a platform that we developed that basically has -- is a query for access to the product. The product -- the patient gets assigned a number, and we then actually start working through the actual timing for the apheresis, get the kits there, get the cells extracted, shipped to our facility in the U.K. In the U.K., we then actually manufacture the product. We'll run through the release process. While the release process is happening, the product already gets shipped into the U.S. to a logistics center that is close to the site that is actually run by Cardinal Health, a company with whom we have a collaboration to do that. And what that allows us to do is actually cut time out of that cycle and get a quicker return. As soon as the product is formally released at that point in time, the product actually gets shipped out. And that's basically the last, whatever, 100 miles or so, 50 miles to 100 miles from that depot to the actual treating hospital. The patient gets prepared for infusion, the product gets infused and then the patient gets followed. So it's a very involved process. It also requires you to credit the centers. So the centers actually need to be accredited in order to deliver these types of therapies which means that there is an adequate level of training, there has to be sort of run through with the treating physicians, the nurses, the pharmacy at the hospital, the apheresis team that initially collects the cells. But there is also additional support. It's on support on reimbursement as well as support on the patient, might be logistics and otherwise. And then all of these products have a long-term obligation to follow from a safety perspective, a REMS program. And so when you think about that, this is a very involved process. And what you have to make sure and you want to make sure is that the workload for the center is minimized. The access is minimized. It is as simple as possible from a center perspective. And that's really where we spent an enormous amount of time developing that with a fantastic team that, frankly, we recruited from kind of the best places within the industry with a lot of experience in CAR-T launches. And understanding a very good hands-on understanding of what worked, what didn't work and where there were issues at the centers that we actually can overcome by changing the process or providing technology to do that. So It's a very involved process. So the centers are now being prepared for the activation. The activation can only occur when the label is actually granted by the FDA. We're going to have at that point between 30 and 36 centers ready. We're going to go from there to 60 centers and 60 centers in the U.S. will give you more than 90% of all patients treated with relapsed/refractory ALL in the country. So we're going to go very quickly to a relatively large number. And even the starting number of centers is substantially bigger than most launches that actually have been done in our space. And the only reason why we think we can do that is that we actually have the ability to supply from a manufacturing perspective.

Okay. And then just in terms of that process, how different is it relative to the process with Kymriah, for example, just because -- obviously, you've gone to the effort of trying to simplify it, but then the risk is that centers and positions are kind of used to another process and there's some resistance there.

I think you want to keep the process identical or similar where you can and only deviate from that where the product requires you to do [Audio Gap] simplify. So that's really kind of what you want to do because in the end, when you think about these centers, they have multiple products they're going to be managing. They're in different IT platforms, there's different interfaces, they're different policies. And the more bespoke, you actually create your process, the more difference you have and the more of a hurdle you actually create for the center to actually run with that. Now imagine on top an indication like in acute leukemia, where you might have a situation that per month, a center may have between 0 and maybe 10 patients. And so what that does, when you think about the normal proceedings in the center, it means that pretty much every time that you have a patient, it's probably a different person. It's a different shift. And that person needs to actually have a very easy way to engage and actually get that order in. So one of the key things that we've done is we made sure there's literally a single access point for each one of the centers that, for any query can be called up. And it's that access point, that coordinator, that actually then actually provides the necessary services that are required to address whatever the issue is at that particular site. So those are very practical, very simple things, but they're very important because they do actually reduce the hurdle for adoption. And that obviously is one of the key things that we need to make sure we address.

Okay. And then in terms of kind of the competitor set in ALL, obviously, kind of you're not the first CAR T to market. There's more to come. What is the key differentiation in your view on obe-cel?

Well, there are two areas that are fundamentally differentiated. The first one is, this is the only product that on its own gives a long-term outcome. That's a huge differentiator because these patients are all dying. And to have an ability to get that converted, is important. We also were able to show -- and this is data we showed at ASH that if we managed to actually get the patient's tumor burden down to less than 5% before dosing, we have an event-free survival that's between 70% and 80%. So it tells you actually how to manage the patient. It also tells you that you want to go early in the relapse and really get as many of these patients in that state, so they actually can translate that into long-term outcomes for the most of those patients. So that's the first thing. That's a fundamental difference. The second thing is we actually get there with a safety profile that actually from an immunological toxicity perspective is better than BLINCYTO and a different league from everyone else. And that is important because we're looking at high-grade CRS in about 2% of the patients. We're looking in high-grade neurological toxicity in 7% of the patients, the time to resolution being shorter than with competing products. So that's a fraction. You look at -- the competitor data is anywhere from high-grade CRS rate in the range of 25%, high-grade ICANS between 25% and 38%. So this is a totally different ballpark in terms of intensity of patient management. And also, we can predict pretty much based on the tumor burden at lympho-depletion before we dose, actually what the level of risk is that a patient will develop any form of immunological toxicity. So predictability, plan-ability much less resource use with that an ability, an onset of adverse events, which is delayed, which actually allows you to from a reimbursement perspective, to actually have the vast majority of these patients in the "hospital outpatient segment" from a reimbursement perspective and for patients with low disease burden actually in a hospital outpatient setting. And that has a huge benefit in terms of the actual way that these patients can get -- the hospitals can get reimbursed for the work they're doing. They get reimbursed at a higher level and a higher rate. There is also an opportunity for a new technology access payment, which is something we're certainly going to be applying for, which will be unique for the product. There's not enough of the other products have that at this point. And that actually is a very substantial added amount of revenue per patient for the treatment center, which also actually drives, obviously, the interest there. So it's less resources. It's a higher level of reimbursement, a higher number of patients you can manage. It's a better patient experience, and it's a chance for long-term outcome. So it is a very differentiated product.

Okay. [Audio Gap] in terms of guidelines, what are the expectations there in terms of a guideline update once obe-cel is approved?

We would expect that there's going to be a fairly quick update or a pickup into the NCCN guidelines. That's the expectation and certainly would be consistent with conversations that we had.

Okay. We've talked a lot about the U.S. process, just I guess, also when you talk about kind of autoimmune and some of the other things in the time. So quickly on the European side of things, where are you in terms of regulatory process?

Right. So we did file the MAA with EMA at the end of March. So that point went [ FIRE ] early, but at that point, it was accepted. So the product actually is now in formal review. We're getting up to the review cycle. In Europe, a bit different from the FDA. The FDA is has pretty much a rolling process of generating information requests and basically works with the data on a continuous basis, and you get actually on an ongoing basis, you engage with the agency on whatever question that the agency may have. In Europe, it's a bit different. Basically, the question gets accumulated. First time that you basically get a sharing of questions at 80 days after your filing has been accepted. And then that gives you pretty much a good lead on where the key questions are, the key areas of focus are. And then the formal questions actually are going to come back at 120 days. And then you have to take a certain amount of time to answer that. This is basically one bolus of question. So that takes a little bit of time to go through. Once you've done that, you go back, that's actually when you then get into sort of whatever [indiscernible] cycle that you might actually get into and eventually towards the CHMP opinion.

Okay. And then just on pricing, how should we think about that both in the U.S. and in Europe when we get there?

Right. So from a U.S. perspective, I think we have two very good benchmarks to look at. We have, on the one side, the pediatric patients. So our age group, by the way, is -- in the trial, it's been from 18 years to no limit on the upside, on the upper end of the range. The age range for Kymriah is up to 25 years. In fact, patients up to 40 can actually receive in real life Kymriah, with Tecartus the program from Kite, Gilead, actually, it's 26 years and older. So we're actually crossing both of those products. Now the pediatric side, the current price is $582 per patient. And on the adult side with Tecartus is $462. So that's the bracket. And we're going to be somewhere in between those 2 in terms of the price that we're going to pick. In Europe, that's more variable. The list prices originally were very close between the U.S. and Europe. But we then usually have in Europe is an element of a discount depending on the healthcare system and the way they value therapeutics. And it's going to be very interesting to see what the development is. There is a lot of movements in Europe. In an odd way, Europe has become a consumer of healthcare, with the majority of pharmaceutical activities being outside of the EU, being in the U.K. and in Switzerland, which is a really odd thing. And you see some change in behavior with that. And the other aspect, I think, from a U.S. perspective is -- it's very different in Europe is that there are different buckets of capital and budgets that are being used to actually pay for healthcare. One of the big ones in the U.S., obviously, would actually cover in the -- if we get your bill would be actually related to infrastructure. Most of the infrastructure piece in Europe actually is carried by taxes. So infrastructure, this includes also people, base salaries, all of those good things. that's actually covered through taxes. And because it's covered through taxes, it doesn't actually get properly allocated or considered in the overall cost of health care. On the other hand, you have been a much more focus on actual specific treatment and drugs and therapeutics. And that's also where there is quite a different view in thinking about where value is, what the benefit to a particular system is and they're different way of measuring that in an interesting way in the U.K. where there's a nationalized system, there's actually full transparency on the cost because of that. And there is actually a very good way of understanding the value to the healthcare system overall. That is very beneficial, actually. And actually, for therapies like ours, which have just a profound impact on patients and cost. Actually gives you a better way of actually articulating the value and frankly, have a reasonable conversation around that. So it will be very interesting. It will be interesting to see what the developments in Europe are. And typically, the launch process in Europe would be on a country-by-country basis because the approval is -- the regulatory approval is central, but then the reimbursements are really on the national level and tailored to the respective differences in the national healthcare systems.

Okay. That's clear. And on the safety side of things, and obviously, it would be good to get your perspective. There's been a lot of kind of noise around the broader CAR T space. How do you think kind of obe-cel may or may not be impacted by any kind of broader safety warnings that the FDA put in place?

Well, I think the first observation is that I think whenever you have -- whenever there is a sense that there might be a broader potential risk with a drug or therapeutics category. That tends to get reflected in the labels across. And we've seen that happen in lots of different types of therapeutic approaches. And we certainly see that happen also on the CAR T space. One of the things that you have with most of these agents is a risk for secondary malignancy. Now we need to understand though that secondary malignancies are primarily driven of the genotoxic nature of the high-dose chemotherapies that these patients get exposed to. That's where actually the mutations get triggered. There is a particular risk that was articulated by the agency, but is not substantiated by data today, is that you could actually have a pre-exposed or predisposed T Cells in those patients, that could also then be transduced with a chimeric antigen receptor, and that cell could actually have gained a benefit or an improved ability to survive. That is a certain theoretical risk. We haven't really seen it play out in the numbers. We don't see it. There were 22 cases overall reported. There is 1 case that I'm aware of that had shown presence of CAR T in a T cell that was actually removed. However, the actual lesions that drove the malignancy and the transformation preexisted in the apheresis. In other words, it is actually a consequence of the prior lines of therapy, get an accumulation and then you might actually also have a transduction of that cell. Overall, we don't see a change in the actual benefit risk profile, and we haven't seen any evidence of an elevated level of those events. I think that's, I think, important to remember. And when we think about the autoimmune side, it's worthwhile remembering that when you look at all the biologicals in the autoimmune space is you get a -- in each one of the labels a reference of a risk of malignancy. The risk of malignancy there is not primarily driven by exposure to genotoxic agents, but the risk of malignancy is driven by the fact that you have long-term immune suppression. And it is the actual reduction in immune surveillance, which increases the risk for malignancy. So those are kind of the areas that we're looking at. And I think from where we're sitting today and what we know about the products and particular about our own products, we don't see any change in the benefit risk profiles that we're projecting or that we have demonstrated.

Okay. Makes sense. You mentioned autoimmune that -- so maybe we'll spend some time there for a moment. The advantages of obe-cel that you see in the ALL population, for example, do you think that those hold true in the autoimmune indication? And I mean, conscious that in ALL, you're probably competing with the first generation of CAR T products, whereas in autoimmune is kind of the next advancements from various companies across the sector. So how confident are you in that kind of profile and those characteristics holding true?

It's a really good question. So the fundamental difference is that we actually have data, okay? We don't need to predict. We actually have data we could compare. And the interesting thing about the data is that when we started out, we developed obe-cel initially for the treatment of children, with acute leukemia. And obviously, that allows us to compare to Kymriah, which is, frankly, where we have most of the data from in the autoimmune field, a derivative from Kymriah. What we're able to show is that Kymriah like any of the other first generation programs, has a tendency of actually after delivering the kill to a target cell to linger on that target cell and actually staying bound to it. The problem with that is biologically is that you get an over-activation of the T cells or the CAR T cells, and that drives a lot of the adverse events we're seeing. obe-cel was designed to actually not to do that and in fact, has a property that allows the cells to disengage rapidly with about 100-fold faster disengagement rate, and that actually allows us to deliver the kill without having overactivation in the product and the T cell. That's fundamental to the design of the product. And what we were able to show is in a direct comparison with the same way of managing the patients between Kymriah and with obe-cel in pediatric patients. that while you had 47% of the kids with Kymriah experienced high-grade CRS, none of the children had experienced that with obe-cel. The only difference was the way the cells would engage and actually be able to sort of deliver the kill without getting overactivated. That fundamental principle is unique to obe-cel. Any of the other programs that actually will be taken forward by Novartis as well as by the MS share the same receptor that Kymriah had, identical receptor. So that change doesn't change their properties. Their fundamental properties is still differentiated, and we see that actually in the data from the team in [ Arion ] that originally actually worked in pediatric ALL with their product. That's where it comes from. That has allowed us to compare our data. And what we were showing is -- what we're seeing is the exact same thing that we've seen with Kymriah prior which is that we had very, very similar high grades and high levels of activity, long-term persistence in case very long-term outcomes and about 35% to 40% of the children, but no high-grade CRS, where they are still seeing it with their product. So we see that actually preserve that feature and differentiation in the features. And that's obviously something that we can build on because we can actually build on data in very, very challenging patients with a very significant amount of tumor burdens or target cell burdens.

Okay. And so you have the [ CARLILE ] trial ongoing in SLE. Firstly, could you just kind of remind us timelines there and then what you'd be looking for from that data set to justify progression both in SLE and in other autoimmune disorders?

So the nice thing, obviously, is that today, we have probably the strongest data set that shows we can create a complete reset of the B-cell compartment in patients. The only way you get to long-term outcomes in ALL, this is beyond MRD testing. So this is the only program that has ever shown that. So that's point number one. The second is the dosing that was used in the original work that was done in Germany was based on the pediatric ALL dosing. It was 1 million cells per kilogram. We use the exact same dosing in pediatric patients as well with obe-cel. So what this allows us to do is actually pick that dose, but rather than actually do weight-based dosing in adult patients, which doesn't make much sense to go to a fixed dose. And so we're basically converted that weight-based dosing into a fixed dose of 50 million cells. We know we could have gone lower than that, but 50 million is a good volume to work with practically in the clinic, it's a volume you can actually manage and are now confirming that those in literally 6 patients. And from there, we're going to go into a Phase II directly. So that's sort of the plan and gives us -- and it's really only possible because we do have a large data set that we can build on. And that allows us directly to extrapolate without having to do a dose escalation type of series.

Okay. And I'm guessing kind of relatively small numbers in the initial trial. So that doesn't impact your capacity from an ALL perspective and ability to serve the market there?

Not at all. In fact, the clinical supply, we're still actually supplying from a second facility. So it doesn't impinge at all into the commercial capacity.

Okay. And just ahead of the launch, just thinking about profitability of obe-cel and the initial indication, how should we think about that? Obviously, you kind of have a huge amount of manufacturing capacity, but you're not going to necessarily need that from [Audio Gap]

[Audio Gap] look at the program is that, first of all, the program on its own with the basic infrastructure, et cetera, allows us to get profitable. dependent on the level of additional investment we're going to do in additional indications, obviously, that made the timing of profitability varies quite a bit. And so that is actually the key determinant there. But the product itself is definitely a profitable product with a very nice margin. And we expect that as we're going through the launch period that we should be able to reach that within the ramp of the launch.

And then briefly just to finish on capital and financing. Where are you in terms of liquidity? And where does that take you?

Yes. So we did add $600 million at the beginning of February this year, part through a collaboration with BioNTech, which brought in $250 million, and then we raised the $350 million on the top of that. So it gives us a cash position at the end of Q1 of about just shy of $760 million. And that allows us to actually drive the launch, drive the product forward into at least one additional indication all the way through developed. And gives us a very appropriate runway of 3-plus years. So we're in a very good spot to really drive the launch and really get to the next stage of the company.

Okay. Perfect. We're right on time. I think we got 3/10 of my questions. So let's try and do a longer session next time. Thank you, Christian. Thank you for that.

Thank you very much. Appreciate it. Thanks, everybody. Thanks for the opportunity.