Okay, great. Good morning. I'm Eric Joseph, Senior Biotech Analyst with J.P. Morgan. Our next presenting company is bluebird bio, and to take us through the story is company CEO, Andrew Obenshain. There is a Q&A session after the presentation. Just raise your hand, and we'll bring a mic over to you for those who have questions. Then for those who are tuning in via webcast, feel free to submit questions as well. We'll bring them up in Q&A. With that, Andrew, thanks for joining us. Good morning. Thank you, Eric. Welcome to everyone in the room, and welcome to everyone on the webcasts as well. bluebird bio is in a class of its own. We're the only company with three FDA-approved gene therapies. Most recently, we added Lyfgenia to that mix with an approval in December for sickle cell disease, and which is one of the most underserved populations in the U.S. And importantly, all of this puts us on a solid path to profitability in the near future. Today's presentation contains forward-looking statements. Please refer to our SEC documents, as well as this statement, which is both in this presentation and available on our website as well. Now, Bluebird has been pursuing curative gene therapies for over a decade in research and in the clinic, and then now commercially. We took the latest step in December with an approval of a gene therapy for sickle cell that delivers on the promise to patients with, and families who are living with sickle cell disease. Patients like Charlotte, who is pictured here, who lives in D.C. and is a sickle cell warrior, 36 years old, and also serves on Bluebird's Insight Council. Now, the approval of Lyfgenia for sickle cell disease means that we now have three approved commercial gene therapies, you know, on the market in the U.S. We are the only company that can say that. We have designed each of our three therapies. They're custom-tailored to the patient population that they treat. Overall, they can address 22,000 patients in the U.S. We can really do have a transformative therapy for three different indications across 22,000 patients. We started last year with the launch of Skysona and the launch of Zynteglo. Skysona is for cerebral adrenoleukodystrophy, a very rare disease. Zynteglo is for beta thalassemia, about 1,500 patients in the U.S. And then most recently, we've added Lyfgenia for sickle cell disease, which has the potential to address 20,000 severe sickle cell patients in the U.S. Now, this is an incredibly devastating disease for the patients that have it. The outward manifestation, what we hear about a lot, is vaso-occlusive events or pain events. These are pain events so severe that they send the patient to the hospital, or to the emergency room multiple times. But there's a lot of hidden effects of this disease as well. A full 60% of adult patients have end organ damage. 1 in 4 patients will suffer a stroke, and their lifespans are shortened. The average patient dies by the age of 45. So it impacts them, it impacts their families, it impacts their caregivers, and there's a lot of hidden morbidity with this terrible, terrible disease. Now, we are deploying a validated commercial strategy to bring Lyfgenia for sickle cell disease to patients in the U.S., and it's informed by our experience with Zynteglo and with Skysona. I'm gonna focus in on three different aspects of the delivery that we are doing. The first is the QTC network or Qualified Treatment Center network. These are transplant centers in the U.S. that actually deliver the therapy and need to be onboarded. The second is access and reimbursement. These are one-time therapies with transformative benefit, and, it brings significant value to the healthcare system. We've pioneered the ability to get access and reimbursement for gene therapy, in the U.S. And the third is the patient and provider experience, the overall treatment experience. How can we deliver these therapies in a way that is the least burdensome to patients and the least burdensome, to the centers? So I'd like to focus on all three in turn, but Zynteglo is really setting the stage for this. We were able to collect cells from 20 patients last year for Zynteglo, and we are prepared actually to collect cells from our first patient for sickle cell disease in the first quarter of this year. So let me talk about the treatment centers first. In order to treat a patient with gene therapy, you can't distribute this therapy through a wholesaler like a normal therapeutic. You have to establish relationships and quality agreements and contracts with transplant centers in the U.S. In short, if you don't have this network set up, if you don't have these treatment centers set up, you can't treat patients. Bluebird leads the way right now with a network far larger than anyone else in this field. We have nearly 50 treatment centers activated for Zynteglo, and we're quickly onboarding these centers for Lyfgenia. We have all of our Zynteglo centers will eventually become Lyfgenia centers in very short order. About 35 of them are already ready to receive sickle cell patients, and by the end of Q1, we expect all of these 48 will be ready to accept Lyfgenia patients. Now, we're not gonna stop there. We plan to continue to expand this QTC network through the course of 2024 for both Zynteglo and for Lyfgenia. Now, as we've designed this network, we've really thought about optimizing the access for patients with sickle cell disease, and we know that there's a very strong demand for gene therapy among the sickle cell population. Our market research has consistently shown that about 70% of sickle cell patients would consider a gene therapy if it was offered by their physicians. And importantly, 80% of providers want Lyfgenia and its competitor to be available at their institution, so this is likely to be widely available across the U.S. And we're poised to actually meet the patients where they are. We've designed these centers so that 95% of the patients, 19 out of every 20 patients, are within 200 miles of a QTC, and a large majority of them are actually within 50 miles of a planned treatment center. There's, I think, a stereotype that these patients aren't in the healthcare system. That's not supported by data. 9 out of 10 of these patients are already within the healthcare system and being treated by physicians. I want to turn to access and reimbursement. Gene therapies have a transformative impact on both the healthcare system and on the patients. They have tremendous value, and that value is reflected in a $ multimillion price. bluebird has built its market access strategy around demonstrating, you know, two things: demonstrating the value of these therapies to payers, we publish all of our data, and the second thing is pairing them with an outcomes-based agreement. So payers will only pay the full price if the therapy works. And that strategy has worked for Zynteglo. We've demonstrated that this can work for both Zynteglo and Skysona, where patients with beta thalassemia are achieving access. So if we look how we did in 2023, 200 million lives are covered under a contract or coverage policy for Zynteglo. 90% of the published coverage policies are positive for Zynteglo, and we've had zero ultimate denials, zero denials for Zynteglo in 2023. Now, what we've actually seen is after the approval of Lyfgenia, there's been an acceleration in contracts for Zynteglo as well, as payers begin to recognize the value of gene therapy. Now, we are employing this same approach for Lyfgenia and having success already. So the price of Lyfgenia is $3.1 million, and it's tied to the value of the therapy. So in addition to the clinical benefit that we bring to the patient, there's a lifetime of costs that are being defrayed. So if we look, you know, on average, a sickle cell patient, even though the average age of death is 45 years old, the healthcare system spends $4 million-$6 million caring for that patient throughout the course of their life. Now, that doesn't include caregiver cost, that doesn't include out-of-pocket costs, that doesn't include $1.3 million in lost employment opportunities to either do the different education or job opportunities for these patients. And then because of being taken, you know, they're in the hospital, they don't have the same opportunities as other patients. And what we've done is we've taken that price, and we've tied it to an outcomes-based agreement, where we say we share the risk with payers. And this is across, importantly, we offer this to both Medicaid plans and to commercial plans. We tie it to hospitalization, something that the plans can easily measure. And we follow those patients for three years. And if a patient, or actually, the plan, the plans easily look at the claim data. If a patient has a vaso-occlusive event during that time or pain crises that lands them in the hospital, the plan does not pay full price. The result of this, a value-based price, combined with an outcomes-based agreement, has meant that we've had very early success in coverage. We have, in fact, already 200 million lives covered under, in the US. Every six out of every 10 patients in the US are now covered for Lyfgenia, one month and one day after approval. We're also in advanced discussions with about 15 Medicaid agencies, and I say we're in advanced discussions, these are discussions that have been going on for over a year, and that covers about 80% of the individuals, in the US with sickle cell disease. Very early, good traction with reimbursement, for Lyfgenia. Now, I also want—I want to turn to the third pillar, which is treatment experience. Now, this is something we don't talk about a lot, but gene therapy, as a reminder, is delivered in a way that requires a big commitment from the patient, it requires a big commitment from the hospital, it is a multi-month process. And the treatment selection for gene therapies will be as dependent upon the treatment experience as it will be upon the safety or efficacy of the therapy. Now, the foundation of the treatment choice is the depth of the clinical data, and Lyfgenia is supported by the most robust and longest follow-up of any gene therapy program for sickle cell. This data is data that we presented at ASH. It represents the 32 patients that were in our Group C trial, and I want to just orient the—everyone to this slide. So on the left, every bar that goes horizontal is a patient. On the left, in the gray parts of those bars, below the before the zero time point, is the two years before treatment. And every single red dot means that patient went to the hospital or went to the emergency room multiple times for a vaso-occlusive event, for a pain crisis, pain so severe that they had to be hospitalized. Time point zero is the treatment, and afterwards, those light blue lines, if I'm not color blind here, represent the follow-up, and it's out to five years, so over 60 months. Now, our endpoint measured between month 6 and 18, and of that, 30 of the 32 patients had complete resolution of severe VOEs in that 6-18 months post infusion. I want to call your attention to two subpopulations in this group. First of all, there was the adolescent group, 8 adolescent patients, and 8 out of 8 of those patients remained VOE free. And also, importantly, unique to Lyfgenia, were strokes. 5 of the patients had had stroke prior to treatment, and they remained free of recurrent stroke post-treatment. Now, the label for Lyfgenia includes a boxed warning for hematological malignancy. This is based on 2 cases of AML that occurred in a previous version of manufacturing for Lyfgenia. And this is really an important tool to educate physicians and educate patients, and bluebird has always remained very transparent with, with all of our data. In fact, these events were published in New England Journal of Medicine as well. Now, I want to talk briefly about what a patient goes through, and the four-stage process that a patient goes through to get a bluebird gene therapy. Now, initially, it's a consultation with the physician and the preparation. Stage two is the collection of cells from that patient. Those cells are then sent fresh to our manufacturing plant in either New Jersey for sickle cell or in Texas for beta thalassemia, where the drug product is manufactured, tested, and then released. The cells are then sent back to the hospital, where the patient returns to the hospital, receives conditioning regimen to create space in the bone marrow for the new cells. The new cells are then infused into that patient, and the patient recovers. So a very involved process for a very profound clinical effect in the future. Now, Lyfgenia has some differentiated attributes that we believe are going to provide advantage in the treatment experience for both patients and for physicians. As I mentioned before, this treatment decision is likely to be made not only on safety, not only on efficacy, but on these differentiated attributes of treatment delivery. So the first one is cell collections. Now, a patient comes in for cell collection. Those cells are sent to the manufacturing plant and manufactured. If you don't meet dose, the patient has to come in again to get collected again and sent to the hospital to be remanufactured. In our clinical trials, patients came in, one or two times, 85% of the time. This is important because a second collection can happen within weeks after the first collection, on the order of two, four, six weeks. However, if you need to go to a third collection or a fourth collection, the bone marrow needs to recover, and that patient has to wait months, not weeks. So the metric of getting those patients in and being able to collect them within one or two cycles is very, very important. It impacts not only the patient experience, it also impacts COGS as well. The second aspect is drug delivery. So our process is designed to take between 70-105 days from cell collection to drug product delivery to the QTC. And meeting those timelines and delivering back to the QTC on time, so both the QTC and the patient can plan their schedule and their lives, is incredibly important. We've learned through the Zynteglo launch how to do this and how to optimize this as well. And the third is actually a clinically specific item, which is engraftment time. So the median time to neutrophil engraftment is 20 days, and this is a really important metric. This is a key step to enable the patient to be discharged from the hospital when the immune system has recovered enough to prevent infection. And taken together, we believe that all three of these; we are going to focus on all three of these to optimize the patient experience, and we believe that we could have the shortest treatment time possible given Lyfgenia. Now, I just want to recap. We have an experienced commercial team that's well-positioned to lead in Lyfgenia launch based on our Zynteglo experience. We have the QTCs network set up, we have payer coverage, and we're focused on the treatment experience. This is what an 18-month commercial head start looks like. This is what it means to be a recognized gene therapy leader. Our third product is Skysona for cerebral adrenoleukodystrophy. Now, this is a very rare disease that has a devastating impact on the boys, which it affects often before the age of 5. And we have been indicated with Skysona to slow the progression of this disease and the neurological dysfunction, in particular, in boys 4 to 17 years old with early active cerebral adrenoleukodystrophy. Untreated boys with, if they're not treated, are about half of those boys will die within 5 years. So we've been very pleased to be able to treat 6 patients commercially, or try to collect cells from 6 patients commercially in 2023. We've done-- we've activated 4 QTCs that are entirely overlapping with our Zynteglo network. And again, we've had zero ultimate denials, meaning that patients have had access to this therapy both across government and commercial programs. Now, we've talked about our portfolio, we've talked about the importance of our products. We're now going to turn to the financials of bluebird bio. bluebird bio is on a path to profitability in the near term. We have $275 million in cash equivalents, restricted cash to marketable securities. That was as of the end of last year, and that gives us cash runway into the first quarter of 2025. We are evaluating additional non-dilutive funding options to bridge to near-term profitability. And then part of what's included in our cash runway is our revenue, and we've actually guided to 85-105 patient starts combined across the portfolio. Just to put that, say what that means, a patient start has a one-to-one correlation with revenue. The revenue comes later, but as soon as that patient is collected, almost universally, that leads to revenue later on. So that 85-105 patient starts will translate into gross revenue around $300 million. Not all of that will come in in 2024, but some will come in later, but that value creation moment will be in 2024. Yes, 2024. So Bluebird has a leadership position in gene therapy. We have clinical leadership with over 200 patients treated across eight clinical trials. We've commercial impact. We have the transplant and cell therapy infrastructure set up with proven reimbursement, and we lead on the regulatory front with 3 approvals, unlike any other company in this industry. Now, we have hard-won experience and hard-won investments over time that allowed us to build up a gene therapy expertise in manufacturing, a gene expertise, gene therapy expertise in R&D, and a gene therapy expertise in the commercial infrastructure. This is going to form a platform for future growth for bluebird bio. I want to thank all of the patients, all the investigators, and the investors that have been with us on this journey and stayed with us on this journey. Thank you. You want to invite Tom up here? Yeah. Yeah, I'd like to invite Tom Klima up to answer questions with me as well. Okay, great. And, I'm sure there are a lot of questions in the room. If you have, just wait for a microphone. But, by way of starting out, Andrew, just kind of picking up on the last point around your guidance for expected therapy starts in 2024, I guess. Can you talk a little bit about some of the assumptions underlying that outlook in terms of, you know, the QTCs perhaps feeding into that funnel, that patient funnel? Okay. Go ahead, Tom. I'm going to pass that to Tom. Sure. So we haven't given specific breakdowns on by product, which products will drive the 85-105 starts, but keep three things in mind. As Andrew said with Skysona, this year we predict, or in 2023, we had said that we would start between 5 and 10 patients. We started 6 patients. So for Skysona, we are predicting that we will start between 5 and 10 patients on an annual basis going forward. With Zynteglo, we have a lot of exciting momentum. Keep in mind that we started 2023 with very few QTCs. We now have 48 QTCs. The newer QTCs are starting to enroll patients, while some of the more seasoned centers are starting to enroll their fifth and sixth patients, so the momentum is building with Zynteglo. In fact, we're already scheduling 2-3 months out for Zynteglo. With Lyfgenia, we're starting with a much higher base. Not only is it 20,000 patients that we believe are eligible for gene therapy, but we have 48 centers, 35 of which are ready to go to receive a patient referral for Lyfgenia. By the end of Q1, all 48 will be ready to go. The base is much higher, so as Lyfgenia catches up, that's the much larger opportunity. Okay. And should we expect a similar pattern of disclosures in terms of how you, you are sort of proceeding along to that, to that goal in terms of, you know, updating the street in terms of patient numbers that have started collections? Yeah, as Andrew said early on, the value-creating moment is the cell collection, which we believe leads to revenue, so we will keep everyone updated on the number of collections, as we progress towards our goal in 2024. Is it sort of reasonable to think that you might have a bolus of sickle cell patients seeking to start with Lyfgenia, sort of as the product is available this quarter? I think it's. I'm gonna pass to Tom. I think it's safe to say there's gonna be a bolus of interest, but that the demand is probably gonna come in a more linear fashion. Tom, you can comment why. Yeah, we're very excited about the build-up and the excitement from the sickle cell community and patients living with sickle cell and their interest in gene therapy. That is very clear. The demand is out there. However, through our Zynteglo experience, we have found that qualified treatment centers will likely put one patient on, see how the experience goes before they get comfortable putting a second patient on or multiple patients. So we, we believe there's a bolus of demand out there, but we also have learned through our experience that this is more of a steady, linear growth and not a bolus effect. I see. Can you just talk a little bit about sort of the profile of patient, I guess, demographically speaking, that's sort of is probably likely to, you know, lead the way in seeking treatment with Lyfgenia? Go ahead, Tom. Sure, yeah. Yeah, we sat here a year ago trying to predict which Zynteglo patients might be the ideal patient or the most appropriate patient, and what we found is that the range of patient interest was all over the place, in a good way. You know, age, health status, inside the U.S., outside the U.S., we saw a pretty wide variety of interest coming from patients for Zynteglo. So I'm gonna tell you, we believe the patients that will come forward first for Lyfgenia are 18 to maybe 30 or 35 when they're transitioning out of their house. They're starting to take care of their own healthcare. They're maybe trying to get involved with a job or in school, and they're really fed up with their management of their sickle cell disease. It's just too much for them. I'm saying that today. We might sit here next year, and it might be all over the map again, but we believe that there are many motivated patients, and we're excited about the opportunity to, to serve them. You highlighted... Let me back up a second. Certainly, time between collection and administration is a key factor here, for the success of the product, and a key component to that is the number of collections that a patient would have to undergo. You highlighted the experience from clinical trials with 85% of patients achieving a successfully manufactured product with two mobilizations or two collections or less. Can you just sort of relate that to that profile in the clinical setting to what you might expect in the commercial setting, whether you would anticipate a similarly efficient rate of collection? Yeah. So our initial anticipation is, yes, we will be in that range for the commercial, but we are actually working on ways to actually increase to improve that as well. We have, over the years, been working on cell processing, and so our yield rates in cell processing have gone up over time. One of the advantages of a viral transduction process is that it's a fairly gentle process on the cells. It doesn't kill cells, so you're able to get a better yield. But this is something that we believe that we can focus on and have an advantage in this area. You note that cell collections or patient starts is really what's tied to revenue recognition, right? That being said, I have to think that, you know, administration, successful engraftment also has to be part of the outcomes-based agreement to fully recognize a revenue, right, or to mitigate rebates. I guess, can you just talk a little bit about how you'll be, I guess, so updating investors along that metric as well, right? The number of collections that ultimately matriculate to engraftments. Yeah, absolutely. So just to orient us, the collection is the-- we call it the value-creating moment, because once we have the cells, almost certainly they'll be manufactured and given back to the patient, and infused. It's about, it's from the time to collection to the time and infusions on the order of three months plus, depending on the therapy, depending on how the hospital schedules that infusion. So what happens is we manufacture the product, we send it back to the hospital, we send the hospital actually an invoice at that point, right? So the receivable's generated, but we don't recognize revenue until we infuse the patient. Now, in many cases, that patient will be under an outcomes-based agreement. So depending on the contract, depending on the therapeutic area, we might follow that patient for one, two, or three years. So we'll create a reserve in our financials and, you know, we'll go into gross-to-net in the financials to make a reserve against the potential that that patient will either have a hospitalization for a VOE or have to undergo a transfusion for beta thalassemia. And then after that, after that patient passes the time point where that might have happened, that reserve will be reversed. So we'll recognize the majority of the revenue upon that infusion, but not all of it, due to the outcomes-based agreement. Okay. Question in the back. Can we get a microphone here? Hi there. Is there a sliding scale to the outcomes-based reimbursement based upon the number of VOEs or the events that could occur? Go ahead, Tom. Yeah, good question. We are not giving a lot of specifics around our outcomes-based agreement for Lyfgenia. We feel that we're leading the way with this type of outcomes-based agreement, and obviously, we want to protect the competitive landscape. But also, you know, we feel that we work with payers to identify what was meaningful to a payer, and it was the hospitalization tied to a VOE. And as Andrew said in his opening remarks, if a patient doesn't achieve and/or maintain a response, or if the therapy doesn't work, then a payer should not have to pay full price. Thank you. Of course, you're launching Lyfgenia alongside a competitor, Casgevy. Can you just talk a little bit about sort of the feedback you're getting from QTCs and their likelihood to, you know, offer either both products or carry one exclusively? And what factors do you expect to sort of influence physician or QTC preference, product preferences, you know, either in the beginning or over time? Yeah, so I just want to start with patients who have been living with Sickle Cell Disease have been void of innovation for quite some time. And so we believe strongly that having two options available or new options available is good for patients, good for families, and good for physicians to have a choice, so that there's room for multiple players in this space. Having said that, we believe that our head start with Zynteglo, our number of QTCs being 48, so we simply have more treatment places to treat patients right now. And then the treatment process and other things that Andrew outlined earlier are gonna make a big difference as we go forward. We believe that physicians have been familiar with bluebird and familiar with our transparency around our data for quite some time. And so we're just excited about the opportunity to have new treatment options for patients living with sickle cell disease. Okay. What role, if any, has list price played in your, you know, contracting work recently here into launch? Yeah, I'm gonna hand that to Tom in a second, but I just I wanna back up one month and one day ago when we got approval, and I think there was a lot of concern that our list price on face value was different from our competitors. I think there's a couple of things to really consider there. Number one, we chose a price for Lyfgenia that was based on value. We'll publish that value in Q1 of this year. Second, is paired with an outcomes-based agreement. And so a month ago, we had to get up and say: "Listen, these payers will value this therapy," right? "We bring a lot of value to the healthcare system with this." Today, you know, just one month later, we have 200 million lives covered. So a lot of that question has been kind of asked and answered about whether the payers will value these therapies. But, Tom, maybe you can talk about how in some of the conversations payers are reacting as well. Yeah, we have, we see the launch of Lyfgenia as multiple years long, and it started years ago when we started working with payers to not only recognize the unmet medical need in sickle cell disease, but also the burden on the system and the overall cost of patients living with sickle cell disease to the system. And so we really, I think, defined value through our payers and through partnerships with payers to come up with the list price of $3.1 million. And I would say that most payers were not surprised by that because they'd done some of their own modeling in some cases and believed it was gonna be around $3 million. And so they recognized the value that a potentially curative type of therapy has on the lifetime impact on a patient, their families, and the healthcare system. And so I think tying that to a meaningful outcomes-based agreement that basically says if it doesn't work, you shouldn't pay full price, is obviously a very important part of it. Any additional color you mentioned towards the end in talking about the balance sheet, you know, non-dilutive financing, timing, anything else you can comment there? I guess I'll let you flesh that out. Yeah. Well, you know, on such and such a date, we'll raise such and such amount. No, the... So I can't comment on specifics, obviously. Yeah. But I think it remains a really high priority for the company. I mean, we recognize that we have cash into Q1 of next year. We're nearing profitability, right? So it's a hop, skip, and a jump away, and it's relatively near term. So the amounts that we're talking about are very, very doable. We would much prefer to take something like a debt or a royalty or a business development deal, obviously, because I think that that's something that's, you know, I think that those types of financing options are available to us. And that type of thing is what we'll be exploring. I can't give you any, you know, the... I all options are open. We will pursue all avenues. It remains, I think, a big focus for me personally, and for our board. It's a top priority. On that path to operating profitability, can you just talk a little bit about really cost of goods here, right? Just, you know, gross margins, I guess one can think about early in launch, but also, you know, for fast-forwarding a year from now, having treated, you know, 95 plus patients, I guess, should gross margin sort of improve with scale? So the answer is yes. But I think the question behind the question there, which we get is, you know, can gene therapy be profitable, right? Mm-hmm. Can this be a profitable business? The answer is absolutely yes. So we've come out, and we said that, you know, we gave a 5-year vision where we said that the gross margins would be at least 70%. But in fact, right now, on an incremental basis, every patient we treat, we're at that 70%. What's weighing us down is the fact that you have to buy capacity out in advance. You have to build capacity and contract for capacity out 18 months, 24 months in advance. And so that weighs down on the gross margin, and as we treat more patients, as we fill up that capacity, you'll see a linear increase in gross margin as we go forward. Okay. All right. Any planning with respect to, you know, life cycle behind, you know, Lyfgenia 1.1, or perhaps, you know, beyond that sort of pipeline expansion? Maybe to answer that, I'll talk about how I think about this market overall, especially for sickle cell disease, for beta thalassemia, as well, and then what could possibly come next. So I think there's 2 players right now in the curative options for sickle cell disease. There'll probably be a third entrant at some point, maybe in 5 years. I think it will look a lot like maybe some of the lysosomal storage disease markets, where there was a third entrant after having 2 players for a while, where it takes some share, but overall, the market keeps growing. I think the major changes in this sickle cell market will likely be reduced toxicity conditioning, maybe 5-6 years out, and that's guesswork. That should be accessible to all players in the field. And then the really what's going to change the market more dramatically is in vivo, where you can have an injection, but we don't see that coming for at least a decade, or probably much more than that. So overall, I think this is a you know, we could see ourselves investing in these markets quite robustly over the next decade. Now, we have built, through these three therapies, a very, very unique platform. We have hard-won both experience and a lot of investments into manufacturing, into clinical development and regulatory expertise, into commercial expertise. There's a lot of players behind us in the cell and gene therapy space that need that expertise and are facing having to build it in a capital environment that really is not that friendly to build infrastructure. So we do see an opportunity to be a platform, to put other cell and gene therapies onto this platform, and provide the expertise and the infrastructure that we have to them. Or alternatively, you could imagine that a larger player would want this platform to do the exact same thing. Okay. All right. Maybe just coming back to the balance sheet question that came from the audience. You know, I wonder whether into the approval decision, there was some expectation of a PRV- Mm-hmm ... being awarded alongside it. It didn't happen. Is there any expectation that FDA may revisit that decision? Have you kind of gone back to the agency to get clarity on that potential? Well, we're certainly planning to discuss this with the FDA. I can't give any timelines or probability of success with that. The way I think about this right now, we're going to put that off to the side. That's a potential upside in the future, but we have to plan our business as if we're not going to get that PRV. Yeah. That's how we're thinking about it. Okay, great. I think I'll just see if there are any more questions from the audience. All right, I think we'll leave it there for time then. Well, thanks very much, Andrew. Yeah. Thank you, Eric. Thank you.