We're gonna get going here. The last presenter for me at least, the BofA Annual Healthcare Conference. I'm pleased to be introducing bluebird bio and Tom Klima, Chief Commercial and Operating Officer, and, again, my name is Jason Gerberry. I'm one of the SMID cap biotech analysts here, and Tom, thanks for joining us. Good afternoon, Jason. Thank you for having us as we wrap up another successful Bank of America Healthcare Conference. Looking forward to many more in the future. So I imagine most of the questions that you're getting from investors these days are commercial in nature. You've got three gene therapy launches. We've seen, I guess, varying degrees of performance for different gene therapies across the gamut, depending upon, I guess, quote, unquote, "perceived elective nature" and the ability to potentially wait versus the urgency to treat dynamic. Seems like it's maybe an important variable, but maybe just your early observations now you're in your third gene therapy launch, how it's going, you know, what are the unique challenges and where the company is? Yeah, it's an exciting time at bluebird, and not to underplay the incredible journey that it's been to get here after more than a decade of battling to be in a situation where we have, as you mentioned, three approved gene therapies. We sit here also on the heels of announcing our first commercial LYFGENIA start last week, so that was very exciting and an important milestone at bluebird. But we talked a lot about over the last few years, the head start that we believed we had with Zynteglo and Skysona, as we thought about building out our QTC network and some of the synergies that we thought we would have with QTCs and with payers, and as we approached a unique patient population with people living with sickle cell disease, and we're seeing a lot of that come to fruition now. We continue to see great momentum with Zynteglo and Skysona, and we're pleased with where we are now with LYFGENIA. We have 64 Qualified Treatment Centers right now for LYFGENIA and Zynteglo, and we reported last week that more than half of those QTCs have reported to us that they are going through the process of evaluating patients for gene therapy, and about 25% have reported to us that they're going through the prior authorization process and getting patients approved for gene therapy through their insurances. So it's just an exciting time. We had said previously that we are on track to start between 85 and 105 patients this year across our three gene therapies, and we're excited to say that we're still on track to accomplish that. Great. And maybe you mentioned the 85-100 patient starts for the year. I think you disclosed that maybe through four or five months you were around mid-teens, like 16 starts for the year to date, and so maybe just what underpins the confidence in terms of some of those metrics you talked about, top of the funnel, to get you confident around that, that start number. Yeah, exactly. We, we've started 15 patients across three gene therapies, including the one LYFGENIA start that we reported through our last report. And it's really the momentum that we have with our QTCs. You know, again, we have 64 qualified treatment centers. We've heard that many of our centers are evaluating multiple patients for LYFGENIA, and it's really some of the leading indicators that we watch that give us confidence in our ability to get to 85-105. As I mentioned, with Zynteglo and Skysona, we're seeing continued momentum there, and we had previously announced that we are going through the process of expanding our manufacturing capacity for both drug product manufacturing capacity at Lonza, but also evaluating our strategy for adherent vector, and that's based on the strong demand that we're seeing. With LYFGENIA, again, it's a lot of these leading indicators that we're seeing in discussions with QTCs and excitement we're seeing from the patient community. And we've always said that we expected kind of a strong build in the second half of the year, and that's exactly what we believe we're gonna see. Got it. And as we think about sort of the Zynteglo and Skysona U.S. launches, do you feel like when we look, kind of, you know, in six-month or quarterly increments, how the new starts have progressed? Do you feel like you're hitting a steady cadence? Do you feel like those spaces, you know, still can step up in terms of what that kind of annual contribution you could expect from those programs, and then thinking about LYFGENIA as incremental to that? Yeah, it's a good question. So as we look at LYFGENIA, or if we look at Zynteglo specifically, we've always said that we expected strong linear growth, and that's because, number one, you know, we were bringing QTCs on board. So last year, mid-year, we were at about 15 QTCs. Starting with 64 right now is a good place to be for LYFGENIA. We've actually doubled that size of our QTC network since just approval back in December, so QTCs continue to be excited about treating patients for with LYFGENIA for sickle cell disease. And we've also obviously announced that we're expanding manufacturing, so that gives us a lot of confidence in what we're seeing with Zynteglo and Skysona. But again, you won't see a huge bolus in most cases with gene therapy. It's more of a steady linear growth over time. Mm-hmm. Where do you think you're at, where healthcare providers are at with just the learning curve of using these gene therapies, getting patients through the process and going from collection to infusion? How much optimization do you think that there still will be as, you know, you're building out something that's novel? It's a great point. As you think about our synergies, I would say that we absolutely have synergies with our QTC network, and a lot of those synergies are, you know, especially how they deal with gene therapy and how they get patients through the process. And we've actually partnered quite closely with a lot of our QTCs and learned a lot through the Zynteglo process that we've applied for LYFGENIA. There are some differences. When you look at patients who are living with beta thalassemia, they are more known to the system, meaning they were already in hospitals, in most cases, being treated with regular red blood cell transfusions. They're you know pretty medically ready, if you want to look at it from that point of view. Whereas when you look at people living with sickle cell disease, they're often not necessarily medically ready. They have to go through a process where they go through an initial consultation with a QTC. At that same time, they start to look at the patient's insurance, and then they start to think about medical readiness, and that includes things like a two-month washout period for their current hydroxyurea, and then two exchange transfusions that are each one month. So you have a couple of months in there that add a little bit of time when you look at people living with sickle cell disease. Great. Maybe we'll shift gears to LYFGENIA. Obviously, you know, I think one patient so far, so it's a little early for feedback. But maybe just in terms of laying the groundwork, infrastructure, payer coverage, I know that Medicaid's an important, you know, component of the mix, and that's probably the one piece of the payer coverage that, you know, you're still working to get that online. So you know, how do you feel like the payer element comes online over the course of this year and next? Yeah, we've made a lot of progress over the last two or three years with payers. Again, going back to the start of launching LYFGENIA, we were already working on thinking about how to bring LYFGENIA to market. And part of that was thinking through the value that LYFGENIA brings and then, you know, relating that to an outcomes-based agreement. We announced early on that we achieved greater than 200 million lives in the U.S. who were covered either under a coverage policy or through an outcomes-based agreement. So we made a lot of, I think, fantastic progress early on in the launch of LYFGENIA. We've also announced that at least one state has agreed to an outcomes-based agreement for LYFGENIA, so we continue to focus on Medicaid in our state-by-state strategy. To date, it's important to note that we haven't seen any ultimate denials with Zynteglo and Skysona, and so far, we're seeing payers cover LYFGENIA at parity with our competitors. So we're very pleased with the progress that we're seeing. It just takes a little time to get through the first patient or two and establish that flow between the QTC and the payer. Mm-hmm. How do you see the net pricing evolving for LYFGENIA, given the difference in the gross list price differential of about $1 million? Like, do you think that there's... I'll leave that open-ended for you to answer. I don't want to bias you anymore. Yeah. You know, so we take a very strict approach when we think about pricing, and it's based on value. If you look at the burden of disease, especially in sickle cell disease, in this case, it's obviously very hard for patients, but it's also incredibly expensive for the system. We recently just published a value article in April that's available for reference now, that showed cost effectiveness up to $3.9 million. When we looked at the value that a one-time potentially curative therapy can bring in a devastating disease like sickle cell disease, we took our approach without considering competitive dynamics or their approach. So we feel confident in our ability to, you know, not only convey the value, but also it's tied to an outcomes-based agreement that basically says if our therapy doesn't work like it's supposed to, then payers should not have to pay full price for the therapy. So we really are focused on our own strategy. Our strategy is not to discount beyond the outcomes-based agreement, and we feel good about the coverage that we're seeing so far. So maybe said a little differently, like the gross to net reductions off of that list, is it fair to look at kinda how we think about Skysona and Zynteglo as decent proxies and that there's not a substantial kinda cost leakage, if you will, off that list price? Yeah, that's exactly how to think about it. We haven't given a lot of details or specifics around the LYFGENIA contract or the LYFGENIA outcomes-based agreement. It is tied to a meaningful clinical outcome, but, you know, if you look at Zynteglo, we tied that to transfusion independence, and we said that if a patient didn't achieve or maintain transfusion independence, then we would rebate up to 80% of the cost of the therapy. Mm-hmm. In that case, 90% of patients in clinical trials achieve transfusion independence, and if they achieve transfusion independence, 100% maintain. So to your point, you know, the risk for the company is not that great, given the relief that it gives to payers. You can think of those same percentages when you think about LYFGENIA. So maybe think talking about the addressable market, I think, you know, you, your competitors have talked about roughly 20,000 severe SCD patients out of a roughly 100,000 U.S. prevalence. How those 20,000 or so patients, you know, what their symptom profile looks like, you know, how at risk of stroke and other organ dysfunction and such that, like, the risk-benefit trade-offs are such that there's a high motivation level to do this and do this now versus more elective, "I'm gonna wait. I'm gonna go to oral therapies and, and see." And I guess that those patients, you know, what proportion, to the extent you can speak to this, are engaged with a healthcare provider, one of these QTCs, such that, you know, there's the potential right, to, as you build market awareness, that these patients might get treated in the next couple of years? ... Yeah, it's important because I think people living with sickle cell disease have been, you know, treated poorly, frankly, over the past many decades, and there are a lot of inequities still in the system. Patients with sickle cell disease, as a result of that, lack trust in the system, and they really lean on experts who understand sickle cell disease. So there are certainly some barriers there where we need to grow the advocacy for sickle cell disease going forward. But when you look at patients who have sickle cell disease, a lot of the main factors come down to something as simple as, I would say, their relationship with their disease. If a patient is in a situation in life where they wanna get on with life and stop, you know, being controlled by sickle cell disease, they really might wanna be going on to a new job or back to school or something and getting out from, in some cases, you know, living with their parents and where their parents are making decisions for them. They just are fed up with sickle cell disease. In other cases, maybe they are, you know, adequately managed in their mind, and they wanna wait and see what the first patients that gets treated with gene therapy what happens to them and what their experience is like. So we've always said that there's a huge interest from the roughly 20,000 that we think are eligible for gene therapy. You know, there are gonna be the early adopters that wanna get treated first, and then there are gonna be, I think, some that might wanna see how those patients do and what their experience is like. Can you just paint a picture of what the process is gonna be like for a patient? How long are they gonna be spending in the hospital, out of work, you know, the sort of costs that may be borne upon them or the system, beyond just the medication or the gene therapy costs? Yeah, I'll start with the process because I think that's an important point, and for us, it's an important differentiator. But once a patient goes through the consultation process and they're ready to start therapy, they will come in for their mobilization and their first cell collection. That's an important point in the journey for gene therapy, and we've always guided to, you know, watch patient starts as kind of the proxy for how the launch is going. But with sickle cell disease, unfortunately, cell collection can be quite difficult, and some patients have to go through multiple collections. If you look at what we published at ASH last year, 85% of the time, patients treated with LYFGENIA were collected in one or two collections. That's important because if you need to come back for a second collection, you can usually do that in a matter of weeks, two to four weeks. If you have to come back for a third collection, that's usually many months because you have to wait for the bone marrow to recover. So, you know, trying to get it done in one or two collections is an important part of the journey. And again, we feel that we have an important differentiator there. They then go home, the patient goes home and lives their life while the manufacturing takes place. It takes a few days for manufacturing and then about 100 days for the testing and release assays that we have to do. So a patient is at home living their life. When the drug is ready to be shipped back to the QTC, patient comes back to the Qualified Treatment Center or the hospital. They're admitted, they go through a short period of busulfan conditioning, they get, then get their infusion of LYFGENIA, and then they're still in the hospital until they engraft. And that back end can be about 20 days on average for engraftment, so that time can be 20 to, let's call it 30 days on average. Great. Well, we're out of time, but thank you so much for joining us at the conference. Thanks, Jason. Appreciate it. All right.