This morning to enable continued investment in the launch activities where we have seen the greatest ROI over our 2+ years of commercial experience, most notably QTC engagement and manufacturing optimization and scale. We have the capacity today to achieve our cash flow breakeven point, and we have plans to double capacity for Lyfgenia in 2026. This follows a similar launch dynamic as Zynteglo, where we scaled capacity to commensurate to demand. I will now turn the call over to James to discuss some of the details of the restructuring and our financial position. Thank you, Tom, and good morning. As outlined in the press release this morning, the restructuring is expected to result in a 20% reduction in cash operating expenses when fully realized in Q3 of 2025, compared to the prior reporting period. Initial reductions are already underway, and as part of these actions, we are reducing our workforce by approximately 25%. The reductions to our workforce and external spend are being made across the entire organization, with the greatest impacts on our G&A and R&D functions. With three gene therapies now in the market commercially, this enables us to focus our spending on imperative commercial activities. To reiterate, we announced this morning that with these cost reductions, we estimate we can reach quarterly cash flow breakeven in the second half of 2025, assuming the approximately 40 patient starts projected in Q4 of this year translate to deliveries and infusions as expected. Based on current operating plans, our cash runway remains into Q2 of 2025. As a reminder, this runway does not account for the cash minimums required by our covenants with Hercules. Our runway, taking into account the cash minimum, is into Q1 of 2025, and we are evaluating a range of options to bridge this gap and reach the breakeven point. Now, I'd like to hand it back to Andrew to provide some closing remarks. Thank you, James. Making this decision to restructure our business was not easy, and I want to personally thank every Bluebird who helped realize our founding mission of bringing potentially curative gene therapies and more Bluebird days to patients and their families. Each new patient start represents the first step towards a new life for someone living with a devastating genetic illness, and we expect that the actions announced this morning put us in a much stronger position to continue to execute on this vital work. After more than a decade of pioneering the gene therapy industry, we stand here today with the potential for cash flow breakeven in our sights and a sustainable gene therapy business on the horizon, and with that, we'll pause and ask James and Tom to join me and open up for Q&A. Operator? Thank you. As a reminder, to ask a question, please press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. And the first question will come from Sami Corwin with William Blair. Your line is now open. Hi, guys. Thanks for taking my question. I was curious if you envision the breakdown going beyond 2024 between products being similar to what you project in Q4, and if you have any limits in terms of the manufacturing capacity per product. Also, I noticed that with the restatement, the gross margins were negative, so I was wondering if you could provide a bit of guidance on that as well. Yeah. Morning, Sami. Thanks for the questions. I'll take the first one on manufacturing capacity, then hand it to Tom to talk about the product mix for 2025 and to James for the, gross margin question. So in terms of manufacturing capacity, the way we think about capacity is that we, ramp capacity commensurate with demand. So this is what we did for Zynteglo. We reached our limit of capacity with Zynteglo and had already put in plans in place to expand capacity, with a small waiting list before that capacity, before that new, capacity came online, mid this year, where we'll take the same approach with Lyfgenia. So we have enough capacity overall in the business to get to cash flow breakeven, and we do anticipate ramping capacity for Lyfgenia in mid-2026 as demand comes in. But a little bit different than other, maybe other, biotech businesses, we don't ramp capacity in advance of demand. We ramp it commensurate with demand just because of the cost of building capacity. So let me pass it to Tom to talk about the product breakdown in 2025. Yeah. Hi, good morning, Sami. We're not going to give specific guidance on the breakdown, but we feel comfortable going forward that we will start between five and ten patients for Skysona each year going forward. With Zynteglo, as Andrew mentioned, we completed an expansion this year for Zynteglo, and we expect to see strong linear growth with Zynteglo going forward. But we expect over time that the largest portion of our collections and deliveries will be Lyfgenia, and that's just because of the size of the patient population. Keep in mind that there are about 20,000 patients in the U.S., we feel, that are living with sickle cell disease and also could be eligible for gene therapy versus the roughly one thousand patients with beta-thalassemia. Over time, you will see Lyfgenia become much larger than the other two. Go ahead, James. So, regarding gross margin, our cost of sales include a good bit of fixed costs in our suites and personnel in the manufacturing side that when applied against smaller volumes in these early quarters result in a negative gross margin, and we do expect to see that change in the years ahead. We've guided before that we see 70% gross margin within five years. One dynamic you're seeing in the restatement or just the financials in general for last year in Q4, when Lyfgenia got approved, expenses or costs associated with Lyfgenia were up to that point expensed under R&D, and then they became part of cost of sales after approval. So that's factoring into the math as well now. Gotcha. Thank you, guys. And the next question comes from Mani Foroohar with Leerink. Your line is open. Hi, thank you for taking our question. This is Lillian Shang for Mani. So I guess one question would be, I know you've talked about the patient start that need to happen, for to reach the guidance of breakeven. But I was wondering, what are your assumption in terms of time, to revenue recognition? Is there any room there for compression of the timeline? And, additionally, any color you could potentially, give us on the cash bolstering strategies? And lastly, so thinking a little bit more long term, you mentioned the doubling of capacity in 2026. How would that translate into, the expected patient starts and the expected revenues for 2026? Thank you. Let me just address the last part first. We're not gonna go into any kind of projections for 2026 at this point. But Tom, if you could talk about the delivery timelines and the cash flow, sorry, the revenue recognition, and then we'll pass it to James to talk about our cash flow strategy. Yeah, that sounds good. Good morning, Lillian. Right now, what we've shared is that from the time that we do cell collection to the time of drug product delivery is roughly five months on average, and then that's when we collect cash. We then recognize revenue when the drug product is infused, which is usually about a month later, so around month six. In the short term, we feel we could shorten that timeline minimally by getting more efficient and as we learn, you know, through our launches. The reality is that we won't be able to shorten that timeline significantly in the foreseeable future. There are things that we could do in the future that could potentially reduce that timeline, but not over the next one to two years. Lillian, apologies, I didn't quite make out your question regarding cash flow strategy. What did you ask there? Yeah, if you could just give us any additional color on the potential options for raises until now and the expected cash flow breakeven. As far as the getting to breakeven or additional opportunities to- Yes, yes. And so I guess maybe, you know, is there any flexibility with Hercules? Would you have to go.. Oh, I see. For other cash sources? I see, as far as extending the runway. Yeah So we're exploring all options there. I think what we announced today provide a pretty compelling picture with regards to accelerating starts and our path to breakeven in the second half of next year. So we think there'll be options available to us. And so can't get into specifics as to what we're looking at for additional capital to extend the runway and get to the breakeven point. But you can imagine it's top of mind for us, and we're actively working on it. Thank you. The next question comes from Eric Joseph with JPM organ. Your line is open. Hi, good morning. I guess, you know, thanks for the visibility that you're providing here on patient starts for the remainder of the year and partially next year. I just wonder sort of how you should be thinking about the cadence of patient infusions or treatments. And part of the reason for asking is really just picking up from that Times feature last week, where it seems to suggest that cost outlays by QTCs might be a gating factor here. Is that, in fact, the case? And I guess maybe how should we be thinking about sort of financial capacity at QTCs, perhaps being a gating item to patient treatments going forward? Thank you. Go ahead, Tom. Yeah, good morning, Eric. Thank you for the question. You know, we've grown and now have reported that we have 71 activated qualified treatment centers or QTCs. This is above the roughly 40- 50 QTC goal that we had at the end of last year, which puts us in a pretty good position with a lot of upside ahead. If you look at, you know, the 31 that we have announced that have either started a patient or will treat a patient this year, that leaves over half of the qualified treatment centers that still have potential upside to start their first patient. We, we have heard from some QTCs that they have different capacity constraints, whether that be, you know, a financial worry, just to make sure that they're gonna get through the process or maybe apheresis beds, but there are other hospitals where they have less capacity constraints. And so we feel that as we get the cadence going with both launches, you know, QTCs are figuring out how to get patients through the funnel. And if you look at just what's happened with Zynteglo, it's really accelerated, and we've started to see even stronger linear growth than before. So we have a strategy that will continue to expand and work with our QTCs and don't see capacity at the QTCs becoming a barrier to us achieving our goals... Got it. Thanks for taking the question. Thanks, sir. And our next question comes from Eric Schmidt with Cantor Fitzgerald. Your line is open. Thanks for the call and taking my questions. Maybe first on just the visibility you have once you schedule a slot, what sort of follow-through or success do you have in actually treating patients once that treatment slot has been scheduled? Go ahead, Tom. Yeah. Hey, good morning, Eric. So, you know, we don't want to give a definite number here, but we can say with high confidence, just based on our 2+ years of experience, that once a patient schedules for treatment, they generally go through with that treatment. What we have seen is some variability in the timeline. We haven't seen a lot of patients fall out of the funnel, so to speak, but what they do is they might move the date based on an event, especially when you're dealing with people living with sickle cell disease who have, you know, they're trying to get off their current medicines and going through transfusions often might have a vaso-occlusive event. In some cases, you see the timeline shift a little bit, but we have a pretty high degree of confidence that once they schedule, they're going to go through with the treatment. Thank you. And in terms of getting to break even in the second half of 2025, how much cash do you think you'll need to raise to get to break even? And, you know, given that cash could be substantial relative to your market valuation today, can you rule out that you won't use equity to get there? Go ahead, James. We're not guiding to the specific target for additional capital that we'd be seeking. I will remind figures that are in the Hercules agreement that unlock tranches two and three indicate raising the range of $75 million-$125 million, but that's not necessarily the cash we're seeking, nor do we necessarily feel we need those tranches to get there. That's as far as we'll go on the cash plan. It's a full range of options for obtaining that additional capital. It could be equity, it could be different types of debt, unlocking restricted cash, other options like that could all help do the trick. Are you guiding that you believe the Hercules tranches will be available to you based on your progress? We indicated in the August call that we did, and that's still the case, yes. Thank you. The next question comes from Yanan Zhu with Wells Fargo Securities. Your line is now open. Oh, great. Thanks for taking our questions, and thanks for the clarity on patient starts to date and providing the guidance. So just wondering, it feels like Lyfgenia growth quarter- over- quarter is pretty substantial to date. But you know obviously you're guiding for more than 20 for the fourth quarter from 10 this quarter. However, the overall patient start guidance was 40 per quarter going into next year. How do we reconcile the seemingly very rapid growth for the quarters to date and for the next quarter, yet the overall patient start numbers are projected to be flat throughout 2025? Also, if I may, another question on how much of that is constrained by manufacturing capacity for Lyfgenia? Thanks. Yep. So we're not guiding on patient starts for 2025. At what we've discussed is patient starts for 2024 in Q4. So targeting about 40, and then that translates to deliveries, is what we've talked about for 2025, which is 40 deliveries by the second half of the year, which gets us to cash flow break even. So we are not commenting on the collections for 2025. We have the capacity we need to get to a cash flow break even. As we said before, we will expand that capacity commensurate with demand. We don't put capacity in place in advance of demand. Got it. Can you... Thanks for clarifying. Can you talk about the dynamics you're seeing in the marketplace for Lyfgenia? What is the interest level, and are there any common concerns expressed by patients or treaters, and at centers that offer both Lyfgenia and competitor products, Casgevy? Any color on how doctors and patients are choosing between the products? Thanks. Go ahead. Yeah. Good morning again, so first of all, I would just say that we're really pleased with our progress with qualified treatment centers. We have seventy-one qualified treatment centers ready to give either Lyfgenia or Zynteglo, so we've made a lot of progress there. Those qualified treatment centers decided to become qualified treatment centers because they have patients they want to treat, and so we anticipate a lot of upside when the second half of our treatment network starts to treat their first patient. We've heard a lot of exciting demand from both the patient community and people living with sickle cell disease, but also from the KOLs at our qualified treatment centers. This continues to be true everywhere we go. We also recently, I think we talked about this on our last call, conducted a market research study where 38 of our qualified treatment centers showed preference towards Lyfgenia, which, you know, really goes along with what we've been hearing in the field. So demand continues to be strong. I would just say it's an element of time. When you think about what might be a quote-unquote "barrier," the process to getting a sickle cell patient treated is just a little bit longer. That's in part because of the disease, but that's also in part that we're building a new market with gene therapy for sickle cell disease. But we're extremely pleased with our progress, and we're really excited with the demand that we're seeing. Got it. Thanks for the call. As a reminder, to ask a question, please press star one one on your telephone. I am showing no further questions at this time. I would now like to turn the call back over to Andrew Obenshain for closing remarks. Thank you, everyone, for joining our call this morning and for your questions. Our management team is available for follow-up calls today. Please reach out to Courtney if you would like to connect. Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect.
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