And then I had a follow-up to this Times article featuring your first patient collection with LYFGENIA. The article notes that Children’s National has a capacity of about 10 — capacity to do about 10 gene therapy treatments a year. Can you talk about how representative that capacity is across your QTC network? Do you anticipate any efforts to kind of expand that in a way that would support uptake?
Andrew Obenshain: Go ahead, Tom.
Thomas Klima: Eric, 2 great questions. The first question, probably I can answer that 2 different ways. I think if you consider the dynamics of when we brought on the QTCs. We really focused on the first 10 to 15 for the most — the first half of last year, and then we rapidly accelerated into the end of last year and the start of this year. If you look at those initial 10 to 15, now you’re seeing roughly 11 or treating at least 1 patient or going on to treat their second and third patient.
The second component is just time. If you look at the sickle cell, the patient journey for sickle cell disease, it just takes time from the initial consultation going back and discussing it with their family going through the process of getting the prior authorization and then being medically ready, making sure they’re stopping their hydroxyurea for 2 months and going through transfusions. I would say the early adopters kind of saw this in advance, and we’re thinking about patients and patients were already calling in prior to approval, and that’s why you’re seeing some QTCs get off to a faster start.
And the second part of your question around the New York Times article, very inspiring to see the [indiscernible] go through the start of the process. I would say if you’ve seen one qualified treatment center, you’ve seen one qualified treatment center. So I wouldn’t say that, that’s necessarily representative, but I would say that most of the large QTCs are building out large capacities for cell and gene therapy.
Eric Joseph: Okay. Maybe just a quick follow-up to that. Did Children’s National or has Children’s National treated any patients with ZYNTEGLO?
Andrew Obenshain: We are not going to comment individually by QTC by QTC on that information, but I think they are obviously 1 of the 11 that’s treated patients. So in many of those QTCs have now come on to their second and third, so I’ll just say it that way.
Operator: Your next question comes from the line of Eric Schmidt from Cantor Fitzgerald.
Eric Schmidt: In terms of the new start guidance for 2024, I just want to maybe put a finer point on how you’re quantifying a new start or qualifying a new start. Is it from the time of patients first collection has been completed. Does that make them a new start?
Andrew Obenshain: Go ahead, Tom.
Thomas Klima: Eric, so we’ve been pretty consistent in how we’ve defined new patient starts since the beginning. We really believe that the metric to watch is the first unique cell collection when the cell collection is complete, we believe that once a patient goes through that process, that it’s highly likely that they’ll go through the entire journey and ultimately get treated and infused at the end of the day. So we define it by that unique first cell collection being completed.
Eric Schmidt: Maybe for Chris, we’re kind of flying into uncharted waters with regard to restatement. Is there anything you can say on how COGS are trending, OpEx, cash burn in Q1? I guess, I’m struggling with being able to understand your financial state right now.
Andrew Obenshain: Go ahead, Chris.
Christopher Krawtschuk: First, I’ll say that the restatement will not have an impact on cash will have an impact on the key metrics of the company, such as patient starts, et cetera. And that’s why we continue to make that message. I’m not going to comment on the other elements of the lines of the P&L associated with where we’re trending. Just because we’re in the process of the restatement, and it’s not fair or appropriate to [indiscernible].
Eric Schmidt: Do you have a better sense on when we’ll see those numbers?
Christopher Krawtschuk: We have the sales that we’re working expeditiously to complete the restatement. We’re not providing a time line associated with when that will occur.
Operator: Your next question comes from the line of Mani Foroohar from Leerink.
Unknown Analyst: This is Ryan on for Mani. Kind of a 2-parter one. We were just wondering how should we think about the pace of cell collections for LYFGENIA as we go through the year? Are we going to start to reach a steady state at some point, do we see this accelerating into the end of the year?
And then kind of to dovetail off of that, can you guys talk about what specific actions your field team is taking to kind of help accelerate the LYFGENIA launch, whether it’s the QTC support, engaging with physicians, et cetera.
Andrew Obenshain: Go ahead, Tom.
Thomas Klima: Yes. Ryan, we really have — we’ve said all along, we expect the trajectory of our starts to really accelerate and ramp into the end of the year in Q4 — Q3 and Q4. And the field team has shifted their focus completely from bringing new qualified treatment centers on board to now focusing on supporting qualified treatment centers in pulling through patients and making sure that they’re ready to pull through patients. So we’re completely shifting gears. Our field team is — has built great relationships with the qualified treatment centers over the last 1.5 years. A lot of credibility and report, but now completely focused on supporting patient pull-through.
Operator: Your next question comes from the line of Yanan Zhu from Wells Fargo.
Unknown Analyst: This is Kwan on for Yanan. So first, a quick question on LYFGENIA. So any colors on how many patients have started their high [indiscernible]?
Andrew Obenshain: So I think the question was how many patients have started the hydroxyurea wash out.
Thomas Klima: Yes. So it varies. We aren’t going to really give guidance on that. It varies by not only patients, but by qualified treatment center. Some patients are on hydroxyurea, some patients have not, some qualify — qualified treatment centers have different SOPs in terms of when they start that washout period. Obviously, they want to start some of the medical readiness concurrently with some of the prior authorization work that they need to do. And that’s pretty consistent. But we aren’t giving guidance on kind of some of the precursors before the cell collection.
Unknown Analyst: Got it. And one quick question on manufacturing. So what’s your current capacity a CDMO for LYFGENIA? Is there any additional investment needed if you want to increase the capacity in the future?
Andrew Obenshain: Yes. So the — I think the question about capacity for LYFGENIA, and I think probably talking about drug product capacity. So we do have a separate supply chain for LYFGENIA then ZYNTEGLO, SKYSONA that we do have more robust supply on the LYFGENIA side in anticipation of higher volume. We also have the ability to increase that supply as we see demand come in. So we’ve always — we’re going to match how we bring on new capacity with how we see the demand come in. So there is close to lockstep as possible.
Operator: Your next question comes from the line of Luca Issi from RBC.
Lisa Walter: This is Lisa on for Luca. Just wondering if you can talk about whether you are reconsidering launching in ex U.S. geographies. For instance, your competitor seems really excited about the Middle Eastern market, stating there are potentially 23,000 eligible patients in that region. So wondering if you are reconsidering an ex U.S. launch, either solo with a partner or utilizing a distributor. Any thoughts there much appreciated and congrats on all the progress.
Andrew Obenshain: Yes. Thanks very much. So right now, we are entirely focused on the U.S. and that’s — and we will remain focused on the U.S. for the very — at least near and probably midterm future. The — we are watching the ex U.S. geographies. If we go there, we’d most likely go with a partner and not do it alone.
Operator: Your next question comes from the line of Sami Corwin from William Blair.
Brooke Schuster Gray: This is Brooke Schuster on for Sami. So with a total of 64 QTC centers activated, I guess what would you say is the biggest bottleneck to the initiation of patient starts. And we are also wondering in some of the ZYNTEGLO patients that had cells collected in Q4 or if all of them have been treated already?
Andrew Obenshain: Go ahead, Tom.
Thomas Klima: So it’s — I wouldn’t call it a bottleneck. I would just characterize it as time. It just takes time for patients to go through the process. If you look at sickle cell disease, one big difference in — from sickle cell to beta thalassemia, with beta-thalassemia, patients are already basically medically writing. They’re going through regular blood cell transfusions in are identifiable and mostly ready to go for treatment.
When it comes to sickle cell disease, many of these patients are not already in a QTC. Many of them are not doing transfusions currently and some of them are on hydroxyurea. So from a medical readiness perspective, it just takes a little longer for a patient to be ready to go through the treatment process for LYFGENIA. The insurance process obviously takes a little bit of time as well. And that starts with the first patient in the first patient, it usually takes a little bit longer, until the QTCs get into a cadence and the payers start to understand more about the cadence of QTCs. So it’s really not a bottleneck per se. It just takes time.
Operator: And your next question comes from the line of Salveen Richter from Goldman Sachs.
Unknown Analyst: This is Lydia on for Salveen. Could you just discuss your confidence in achieving the patient start guidance this year? And do you still intend for roughly half of these patients to come from LYFGENIA?
Andrew Obenshain: Go ahead, Tom.
Thomas Klima: Yes. We’re pleased with how the launches are going. Obviously, a lot of momentum building with ZYNTEGLO, we feel that there is consistency with what we’re seeing with SKYSONA, and then with 64 qualified treatment centers, we’re hearing a lot of positive experience in terms of patients excited about gene therapy and patients ready for gene therapy.
So based on not only what we did kind of prelaunch and the numbers that we’re running, but also based on what we’re hearing in the field today, we remain confident in the 85 to 105 starts this year. And obviously, that will ramp in the second half of the year as the treatment centers get through the process.
Operator: And this does conclude our Q&A session for today. I would like to hand the call back over to Andrew for closing remarks.
Andrew Obenshain: Thank you. Thanks, everyone, for joining our call this morning and for your questions. Our management team is available for follow-up calls today, and please reach out Courtney, if you would like to connect. Thank you.
Operator: This concludes today’s conference call. Enjoy the rest of your day. You may now disconnect.
