The time to join us today for another session at the Baird Healthcare Conference. My name is Jack Allen, I cover biotech here, and today I'm joined by the bluebird bio team, Andrew Obenshain, the CEO, and Tom Klima, the COO. Thank you both so much for taking the time to join us. Maybe to kick things off, I'd like to send it over to you for a couple minutes, just briefly on bluebird bio and top-level overview of the story for those that might not be as familiar. Yeah, absolutely. bluebird, I think, for those of you who are not familiar, is a company with three gene therapy products. Two of them are on the market. They were launched late last year, and one is coming up for an FDA approval, hopefully here on December 20th, the PDUFA date. Just to describe them briefly, we call them, you know, there's an orphan disease, one of ultra-rare disease, one, SKYSONA, for a disease called adrenoleukodystrophy. We anticipate treating 5-10 patients a year with that therapy. We have actually collected cells now from 5 patients already this year. The second one is ZYNTEGLO, which is for beta thalassemia. Beta thalassemia is about 1,500 patients in the U.S. It is a disease where the patients require blood transfusions to stay alive every 2-6 weeks. We have a therapy that reduces the need to have those transfusions and lets them live transfusion-free, in many cases. We've collected cells from about 11 of those 11 patients this year. And then we have a third, lovo-cel, for sickle cell disease, which is the largest opportunity, and we have a PDUFA date for that therapy on December 20th. So the launch of these first two is actually building the platform, the treatment centers, and the reimbursement network to actually enable the launch of the third lovo-cel, which is the largest opportunity. Great. Thank you so much for that context. Maybe we can kick things off with the two approved products and how those launches have been going. I know you mentioned that you pulled cells from 11 patients with ZYNTEGLO, and you know, cell pull to dosing can be a number of months. How are you seeing pull-through there, and, you know, what are you thinking about as we move into the second half of this year as it relates to the demand for ZYNTEGLO after launching the therapy earlier this year? Yeah, sure. So we're extremely pleased with how the launch is going. It's going exactly according to our plan. We were hyper-focused on our Qualified Treatment Center network, or QTCs, we refer to them as QTCs, and also on patient pull-through, as you mentioned. We're also telling people to watch the starts because we believe that although it's an extended period of time before the infusion happens, once they start happening, it's almost certain, not guaranteed, but almost certain that it will lead to an infusion and ultimately revenue. And we did say at our Q2 earnings result that we had started 16 patients, which ultimately created, we believe, about $45 million in potential revenue. The pull-through is a little bit dependent on patient scheduling and qualified treatment center scheduling. The part that we can control, as you mentioned, is the 70-90 days that's designed for the manufacturing and the testing. Beyond that, we believe the Qualified Treatment Centers will infuse patients pretty quickly, but that part is out of our control. Got it. And it sounds like you have about 15 or so qualified treatment centers for ZYNTEGLO up and running in the U.S. Can you talk a little bit about how that's ramped and what you're expecting as we move through the course of 2023? I think the guidance had been 40-50 or so ahead of that lovo-cel launch, but I'd love to hear how that's progressing. Absolutely. So the first 15 were really designed to be maximized for... The first launch was ZYNTEGLO in beta thalassemia. Obviously, we're looking at the overlap between beta thalassemia and sickle cell disease. In the second half of the year, we're bringing on centers that are both focused on ZYNTEGLO, but also for lovo-cel. We started, obviously, right after FDA approval back last year with ZYNTEGLO. We've continued to build efficiencies into our process, but also strategically backloaded the second half of the year. So although we're at 15 right now, we feel confident that we'll get to the 40 between now and the end of the year. Have you prioritized, I guess, high volume QTCs, or do you see all 40-50 of these as similar volume? How do you think about that? Are there any waitlists to gauge patient demand before you move into a QTC? Yeah, so it's a good question. We look at the number of patients that we believe that might either be in a QTC or in close proximity to a QTC. We look at things like commercial adoption of the QTC, because in some cases, clinical trial sites don't want to be huge commercial sites. We take that into consideration, and then we looked at a geographical spread, at least initially, so that we could provide access to as many patients as possible. Our ultimate design with QTCs is designed so that we put a QTC within close proximity to the vast majority of patients, so that ultimately, patients don't have to travel very far for treatment. Got it. Got it. And then, as it relates to developing the starts around ZYNTEGLO and the conversion of a start to a dosing of a patient and revenue, can you just walk us through? I know there's a mix of payment methods that are, you know, surrounding these patients with ZYNTEGLO. You have commercial patients and public payer patients as well, and then you have these, I guess, outcomes-based agreements with ZYNTEGLO, and that affects how you recognize revenue. Can you talk a little bit about that revenue recognition on the back end? Yeah, so we. I'm sorry, maybe you could add, but we start, obviously, again, we want investors and people to focus on the starts because we believe that's gonna lead to revenue recognition. Obviously, we collect cells. We're ready to ship the cells back to the hospital. Once the hospital receives the cells, that's when we invoice for the product, and then we recognize revenue upon infusion. And so you might start to see some of the numbers we're talking about as far as collections, not necessarily equal what you're seeing quarter by quarter in on the balance sheet. And some of that is just the variability that we're seeing on the timing on the back end. I'll just layer on to the, in terms of the outcomes-based agreement. We do have an outcomes-based agreement for beta thalassemia, and, you know, that involves a rebate if the patients do not reach transfusion independence. As a reminder, the vast majority of our patients, about nine out of ten reach transfusion independence, and once they reach it, they stay there. And so, but there's a rebate that would come back to some payers if they opt to sign it, the agreement for the transfusion or potentially therapy failure, if that happens. Do you recognize the revenue at the time of infusion and then rebate if transfusion dependence isn't achieved, or do you risk adjust? We recognize the revenue, we recognize the revenue, but then we hold, we hold some, a reserve back that hits the gross to net. Okay. So there's a small reserve that we hit back that would then be either utilized, if we have to use the rebate or returned to the P&L later on. Got it. And what, what's your expectation as it relates to that withholding of the revenue? I guess the majority of patients in the clinical study hit the metrics... Yeah. Based on this outcome phase. It's a combination of the fact that the majority hit it, so it'd be a very small number that actually qualify for it. Okay. Plus, not every payer is going to sign up for it, so we do anticipate that adjustment to gross net to be pretty small. Got it. Great, and then as you mentioned, the revenue recognition on the patient dosing, and that can be, you know, subject to a number of different factors, be it the site, the patient's lifestyle and life events they have. I guess generally as you've moved through these launches, what are you seeing as it relates to, you know, patient appetite for dosing and how proximally you expect that after you're, you know, completed the manufacturing release of the cell therapy products? Yeah, so you know, it's, that's why we're not giving a lot of consistent, we're not giving guidance on that part of it because we haven't seen a lot of consistency. Our belief is that patients are going to want to get, get treated as quickly as they can. But the benefit in a, in a condition like beta thalassemia is we, we can do a cell collection, the patient can go home and live their lives and not be impacted, and then they come back for the, the therapy. That part of it really depends on some, you know, the, what's going on at the Qualified Treatment Center. It can depend on what's going on in a patient's life. So they will schedule some of those things around life events. But generally, we've seen from patients, they're excited to get treated. Once they start the process, they have hope, and they want to get through the process. Do the centers also have an appetite to kind of close the loop as quickly as possible? How do we think about it from the provider perspective? Yeah, from a provider perspective, the same thing. Of course, they're going to schedule around capacity for beds or whatever the case might be at that Qualified Treatment Center. But because they're invoiced when we deliver the drug and they're not usually reimbursed until later in the process, usually when a patient is discharged from the hospital, they're also incentivized to try and treat the patient as soon as possible. Got it. And do you have a sense for the number of beds or number of slots at each of these Qualified Treatment Centers as you... Or do you look to have any metrics that someone would have to meet to become a Qualified Treatment Center? It's certainly one of the criteria that we look as we prioritize Qualified Treatment enters. We haven't seen capacity be a huge issue. In many cases, especially with the high-volume cell and gene therapy centers, they've built, you know, huge wings to you know account for expanded cell and gene therapies. And because this is not a chronic condition, they can schedule around if they're seeing a capacity issue, they can schedule around that. Got it. Then just shifting gears to SKYSONA, I know we've talked a lot about ZYNTEGLO. SKYSONA is a more progressive disease that you're treating with CALD. Are you seeing more rapid pull-through because of the progression of CALD in light of, you know, no therapy approved for this indication? Yeah, absolutely. It's a, it's a situation where, patients' families are watching very closely, qualified treatment centers. And keep in mind, backing up a little bit, we have 4 Qualified Treatment Centers that are highly specialized, soon to be 5, and that'll probably be about... We won't go too much higher than that. They're highly specialized. They understand adrenoleukodystrophy, and they understand that these boys have to be treated, pretty quickly. So that's a, a sense of urgency on the patient and family, sense of urgency on the QTCs. Then, Andrew, I know the guidance for this year is 5-10 patients with SKYSONA. How do you think about it evolving in the long term? What do you view as the incidence of that disease or prevalence? I mean, what's the metric to look towards as it relates to the long-term opportunity for SKYSONA? Yeah, absolutely. There's 40 patients per year diagnosed with the disease, and then they move through, and from the time of diagnosis, they need to be treated pretty rapidly. So it's an incidence number, that 40. Now, some of them may be diagnosed too late to be treated, some of them might go on to allo transplant, and some of them might use SKYSONA. I think for the foreseeable future in the U.S., that 5-10 is around the right number, and it will just bounce up in between those numbers. So that's a pretty steady state number for now. I know you have a lot going on, but is there anything you could do to try to expand into a greater percentage of the SKYSONA population by, you know, aiding in awareness of the disease or anything? So I think the awareness is pretty much 100% among the treaters. The treaters are very concentrated. Yeah. No, I think that 5-10 is really a steady state that would, that would continue. The one element that's changing is that Bluebird has been working on newborns, newborn screening for ALD, and we now have very good coverage in the U.S. for newborn screening, and that has really come in in the last couple of years. So the majority of the states in the U.S. have newborn screening now, so we could see an increase in the, the diagnoses. But at the same time, the increase in diagnoses does not necessarily translate into the number that are transforming to the cerebral form of the disease, because you might, what you might be discovering is that more people have the genetic mutation, they don't progress. Okay. And... I'm not as familiar with CALD, but if you don't have the cerebral form, is there significant detriment, or is there any opportunity for ZYNTEGLO in that form of the disease as well? So they have something called AMN, which is a milder form of the disease. I use the word mild. Patients who have it don't. I don't necessarily think it's mild, right? But it's more in the forties, fifties, sixties, that you start to get some detriment. But it's, you know, that is not an area that we're studying to use SKYSONA. Got it. Maybe shifting gears to lovo-cel, as you mentioned at the beginning, the really significant commercial opportunity here. I guess maybe for those less familiar, could you just shape up the, the history of the program and, and how you think about the clinical trial data relative to the field for lovo-cel? Yeah, absolutely. So this was. We now have data, you know, patients have been followed out for over 5 years from the first patients treated. So we initially started a trial for sickle cell disease. We called it Group A, and it was quite and we were collecting slightly fewer cells and having very good results. We had the first patient, we had great results, and we relieved all the VOEs going forward. Second and third, not so much. We had to tinker with the trial to figure out what the parameters were we needed to change. We actually did a number of changes, including the collections, the reinfusions, the number of copies of the vector that we got in, that really improved the product profile. That's when we started our, really our pivotal trial, Group C, in the 206 trial, and we've treated 36 patients in that trial. We have an average of 32 months follow-up in those patients. That is forming the efficacy package. We have a safety package of about 50 that were submitted to the FDA. So we have really a long history here with this therapy, and really a robust data package that was submitted to the FDA. And along the way, too, we've changed our manufacturing, which was a to actually move from a clinical plant to a commercial scale plant, that we got to really meet the commercial demand for this therapy at commercial quality. And so we and we've actually submitted the comparability of data for those two plants to the FDA as well. It's a program that's evolved quite a bit over time, but we've ended up, I think, with a very robust, both clinical and CMC package. Yeah, maybe starting with the clinical profile, can you talk a little about some of the market research you're doing? I know there's a competing program that's on a similar timeline as well, with a maybe shorter data package as it relates to follow-up. But how are docs... You know, what attributes are docs looking to as they make a decision between the two products, based on your market research, I guess? Yeah, sure. So we've done market research for over seven years now in, obviously, sickle cell disease. The first thing I will say is that this is a huge area of unmet need, and I will say that the more therapeutic options that patients and doctors have, the better off everyone is going to be. So you could, I could just start by saying if we just split the market, it's good for patients, and we would both do just fine. Let me move on then to say that we believe that our launch for ZYNTEGLO is going to give us a huge advantage because we're building our QTC network today. We're out there treating patients today, and we're getting a lot of valuable feedback on how to make things more efficient and improve going forward. When you look at the clinical profile of the two gene therapies and just the methodology, we've shown target product profiles now for seven years and asked which one they would prefer to use. Things like long-term follow-up come to the top of the list in decision making. Things like exactly what you said early on, the experience needs to be smooth, and they want consistent delivery and a consistent manufacturing process. Those are very important. Things that fall to the bottom of the list and just don't matter are mechanism and kind of how the each therapeutic option works. We hear a lot of that, especially at investor conferences, but we just don't hear that from doctors. Yeah. And I guess to that end, the safety of lovo-cel has been reviewed by the FDA and shown to be very clean because it was reviewed with ZYNTEGLO. Maybe you could talk a little about your regulatory interactions around lovo-cel to date and what gives you confidence as we move towards this December 20th PDUFA, which is going to be, in my view, a very pivotal event for the company. Yeah, absolutely. So you referenced the two adcoms that we had for SKYSONA and ZYNTEGLO last year, where they were reviewing the, both the products, but also the LVV platform in general. And you're right, during that review, they actually pulled in the safety events with lovo-cel. There was 2 cases of AML with patients who were treated with lovo-cel. Because our therapy is traceable, because we can trace the vector, we were able to show that the vector was not implicated in that, that the AML was likely caused actually by a poor quality transplant. I referenced that Group A set of patients there that we had where we hadn't perfected the transplant yet, and that it was likely that either the chemotherapy or the transplant itself and the underlying disease caused the cases of AML, not the vector. So that was all re-reviewed by the FDA during those ADCOMS. On top of that, we actually, the FDA asked to review our manufacturing data, the comparability data, before we submitted it. So they pre-reviewed that and said it was good enough to submit, and then if you think about a BLA package, you have a, you have a clinical package we just talked about, that they reviewed, you have a CMC package that they pre-reviewed, and then you have a preclinical package. The preclinical package is the same one we used for ZYNTEGLO. So many elements of almost the entire package has been pre-seen by the FDA here. Furthermore, we learned a lot, and the FDA learned a lot from our first two reviews about how to review and how to write a label for and how to follow up a post-market, a gene therapy. We took all of those learnings, and we included it in our lovo-cel BLA. So, I would say that this review is going much smoother than our first two, as a result of all those learnings, both by the FDA and us, about how to do gene therapy. Yeah, and I don't think we've formally touched on it yet, but there's not going to be an adcom for your product, or at least that's what the FDA has indicated to you to date, and seems like you're pretty confident in that based on your disclosures. Yes, I would not have said we would not have an adcom unless they had definitively said it, and they definitively said it in writing. Now, I'm going to say right now that they can always change their mind, right? Yeah. But as a... You know, they have put in writing that there is no adcom. I guess as we look ahead, your competitor does have an adcom. Mm-hmm. Is there anything you're looking to keep an eye on ahead of that adcom or at that adcom? Uh, well- Yeah. ... I think we'll certainly be watching. Yeah. And I think we would like to see some more data, as they haven't released a lot of data. I think there's going to be interesting conversation about both fetal hemoglobin and the role of fetal hemoglobin in the body. And of course, there'll be the conversations about the mechanism and CRISPR and double-strand breaks. So I think they'll... I think all of those topics will. I mean, I don't know what they're going to cover, but that's what I would imagine would be covered. You know, I think we are planning, as bluebird, to be on the market at a relatively similar time to exa-cel, and we're preparing, as I said, we'll come to market with relatively similar labels at the same time, and we feel very confident in our preparations for that. As it relates to that, I've had some investors ask about the idea that you not having an adcom could lead to an accelerated review. Is that something that you've seen in your past experience in any way, shape, or form? Any experience with that? So we have experience of two... Yeah. So far, and then we got approved on the day, on our PDUFA date, and a couple days before. So our experience, a set of two, suggests that they'll go right up to the deadline. Got it. Great, and then shifting gears back to the commercial opportunity for lovo-cel and sickle cell disease, 100,000 patients with sickle cell disease in the U.S., about 20 or so severe patients. Of the 20, I mean, how many of them are directly, you know, have a strong appetite today if it was approved to go seek these gene cell therapies? It's an interesting question. We've actually asked over time, not only, you know, through our market research, which therapy they would prefer, but also, would you seek therapy in the next less than 12 months if it were approved? And about a third of patients are excitingly saying they're ready for gene therapy. And so we believe that the initial demand is quite high, and we're seeing that also pan out as we're working with qualified treatment centers. A middle third, a slightly bigger than a third, are telling us that they would likely seek treatment, but they'd like to see a few patients get treated first and see how their experience goes, and then they would potentially be excited for treatment. And then there's a smaller subgroup that sees the profile and says, "Probably not for me. So that's a substantial bolus. Do you expect a really robust early launch? Or how do you think about the launch? Is it gonna take time for these QTCs to ramp, maybe a couple of years before you can really get, you know, family members who've had experience with the cell therapy? Or do you think there's gonna be a substantial number of patients in the first couple of years that seek treatment immediately? Yeah, it's a good question. We hear the word bolus a lot- Yeah. I think if you're used to, like, an oncology launch or a different launch, you see boluses happen. In gene therapy, I don't believe that the trend is gonna be a bolus. I think that it's gonna be steady and linear growth over time. And the reason I say that, I think there's a bolus of patients out there and a big group of patients that are ready to be treated, and they're going to be treated, but the process takes time. And then secondly, Qualified Treatment Centers are usually not gonna rush out and put 20 or 30 patients on at the same time. They're gonna put a few patients on, see how the process goes, and then start thinking about treating the next group of patients. So I think the growth trajectory you're seeing with ZYNTEGLO will continue to accelerate. You'll see us start much higher with lovo-cel because we'll start warm, and we'll start with 40 QTCs, but I would expect kind of the same linear growth over time. Got it. And how about manufacturing capacity? I know that's been something that gates some of these CAR T launches and leads to a linear launch in CAR T. How are you guys thinking about building out manufacturing capacity to meet this high need at launch? Regardless of manufacturing capacity, we do anticipate a linear launch, which actually then answers the question about manufacturing capacity. Okay. Because unlike a CAR T, where there's an urgency to treat right away, and you have to build up capacity in advance, we believe this will be a linear launch. We'll be able to look at the capacity demands as, you know, as we measure up that curve. So we have enough capacity for at least the first year of launch, and then we have plans in place to trigger more capacity. And that's some of those plans that would only take a month or two to put into place, or three months, and that would be hiring more staff to more cycles. Mm. Some take a little bit longer, from 6 months to 2 years, to either build out an existing clean room or start to de novo in a new clean room. But we'll just trigger those as we go, and we'll have a... Because we believe this is a linear launch, that we'll be able to trigger them as we watch the ramp. And is it the clean rooms that would be the great limiting step as it relates to building out the capacity? I know you're using a suspension. Yeah. Method of ma.... So we have... Manufacturing. We have, we believe that we have plenty of vector inventory. We have, because it's a suspension method, that's quite high volume. Mm. For the vector for lovo-cel, so really, it is the clean rooms that limit capacity. You don't want to overbuild capacity. Capacity is very expensive, right? So you want to be careful about, especially as a small biotech, really overbuilding that capacity too soon. How do you think about profit margin for the business kind of evolving over time? These are really, you know, high upfront revenues that you can get from these cell therapies if you infuse a product, a patient and have them have a positive outcome. How are you thinking about the evolution of the profit margin- Well... For these therapies? So five years from now, I mean, we've been on a five-year vision. We think this is a multi-billion dollar portfolio across all three, with about a 70% or more gross margin, right? And then a pretty thin commercial infrastructure, given that it's rare disease. It's gonna take us some time to get there, right? We do have some high fixed costs, you know, especially with manufacturing, so it's not gonna be immediate that we get to that 70%, but we will track there nicely over time. Maybe stepping back to lovo-cel specifically, I know you have this outcomes-based agreement for ZYNTEGLO, and you've hinted that you may look at a similar dynamic with lovo-cel. Any further comments as it relates to your experience with ZYNTEGLO and what translates to lovo-cel? Yeah, so I think that's another great example of where our leadership position and our head start is gonna pay dividends in the long run. We've been working with payers for a few years now, and what it could look like for sickle cell disease, an outcomes-type-based agreement. It can't be the same as ZYNTEGLO because of the patient population is different, the endpoint is a little bit different, the clinical profile is a little bit different. But we're really excited about the approach that we're finalizing right now, and we'll be talking to payers very soon about, and we believe that that will ultimately achieve rapid access for patients with sickle cell disease. Is there anything you can key on from a competitive dynamic as you design that outcomes-based agreement? I know ZYNTEGLO has been on the market as the only beta thal program to date, but is there anything you can do to kind of reassure payers of a, you know, substantial outcome that they're looking to achieve that maybe your competitor can't achieve with some of the other products? Yeah, we've kept all options as we designed this, and we really wanted to make sure that it was, you know, directly tied to something meaningful, put us in a good position so that we achieved access and was easy to implement. So we'll talk more about it as we get closer to approval. Okay, and then we'd expect that at approval, with the pricing, is similar at the same time? I would say, like with ZYNTEGLO and SKYSONA, somewhere around approval. Yeah. And maybe could you talk a little bit about fetal hemoglobin versus your, your engineered hemoglobin? Sorry, forgive me, I don't remember the exact... Yeah.. Combination of letters and numbers. But, can you talk about the difference as it relates to biologic implications of those? Yes. So HbAT87Q, it just rolls right off the tongue. Yeah. So it is adult hemoglobin. There's a single amino acid change in it, and that same, that same, that amino acid change, single acid change, is the same one that's in fetal hemoglobin, has the anti-sickling properties. The difference with the fetal hemoglobin versus the adult hemoglobin is the oxygen affinity. Fetal hemoglobin has a higher oxygen affinity. It's because the baby needs to pull oxygen away from the mother. And so there are patients out there, there are people that have high levels of fetal hemoglobin naturally. I'm not sure they have as high levels as being put in, but through an editing mechanism. So if you have basically a different type of hemoglobin circulating into the body with a high oxygen affinity, I think, you know, what physiological effects does it have, especially under stress, I think is something that it will be interesting to see. I think it's. I mean, I think the, these are... Again, I think we say that they will both be on the market. I think we'll both be, we both get approved around the same time with relatively similar labels, and I think our head start with the QTCs and with the payers is really what's gonna make the difference. The thought would be, though, if you had a hemoglobin that bound oxygen too tightly, it wouldn't be able to deliver that throughout the body effectively. Yeah. Is that... I'm gonna leave that... Yeah. To the Q&As. Okay. To debate. Yeah. Great. Maybe we'll shift it back to commercial. Yeah. You know, you're on the doorstep of a lovo-cel approval. You've got these two approved products in the US. How are you thinking about going about commercialization in the US? What's your appetite for a partner? I know there's a cash runway component to this as well, but... Yeah, absolutely. So we wanna get these therapies to the patients, right? We have always said that we're open to partnership if at the right time, if that involves—if that means getting the product to patients in the right way. Right now, we have the capability of going it alone. We've made it this far, right? Yeah. We do have a need to. You know, we do have capital needs, but I'm confident in our ability to fill that gap, and we have a lot of different options. Yeah. Maybe you could speak to that capital needs just briefly as well. Yeah, absolutely. So we have—we've said publicly that we have cash into Q2 that's excluding our restricted cash. And if you think about just a menu of options that we have in front of us as a company at this stage with revenue growing, with a potential blockbuster product coming on soon, we could think we have a potential PRV that comes with the approval that we could sell, we could raise debt, we could do a royalty financing, that's all on the non-dilutive side. On the dilutive side, we could—we have an ATM that we could utilize. We do a straight raise, we could do some sort of PIPE. But there's a host of things that we can do, and some combination of those things is, you know, what's the most likely outcome that would be able to extend our cash runway quite meaningfully. I guess to that end, any thoughts on the restricted cash as well? I believe there's a lease tied to that. Yeah. You mentioned on the last quarterly call. I'd love to hear any update as it relates to that. Yeah, there's really no update. Okay. It's, yeah, we know we continue to try to free up that restricted cash. We have no timeline that we can predict associated with that. Great. Well, that cleans up all the questions I have. Amaya, any closing remarks? Thank you again for taking the time. No, thank you for the time. Thanks for having us, Jack. I think it's a really... You know, I have to say it's a very exciting time for bluebird bio. We're fully commercial now. We have a big event coming up in Q4, and we look forward to talking to you at this podium next year about the success of our launch. Great. Thank you both. All right. Thanks, Jack. Thank you. Awesome. Thank you.