Mani Foroohar: Great. Thanks, guys.
Operator: Thank you. Our next question or comment comes from the line of Salveen Richter from Goldman Sachs. Mr. Richter, your line is now open.
Unidentified Analyst: Good morning. This is [Anumit] (ph) on for Salveen. Thank you for taking our question, and congratulations on the progress. I just have one question on manufacturing. What issues have you seen to date with manufacturing ZYNTEGLO? And has this been a hurdle to cell collection and treating patients to date? And then, just a follow-up on the QTCs that are being activated by the end of the year. I guess, what proportion of the sickle cell patients are these QTCs able to address? Thanks.
Andrew Obenshain: Yeah. So Tom, why don’t you start with the QTC question about how much they can address?
Tom Klima: Yeah. Hi, good morning. So, we designed our QTC network with the end goal being getting to the sickle cell community. And our goal with the 40 to 50 QTCs that we plan to have on board by the end of this year was to be within 95% — reach 95% of patients who have sickle cell disease within 200 miles of a planned QTC. So, we feel that we have excellent coverage for the sickle cell community. We will likely continue to expand QTCs in the next year, because we wouldn’t want a patient being unwilling to travel to be a barrier for treatment.
Andrew Obenshain: And regarding manufacturing, so in our clinical trials, we did show that we had recollections in manufacturing. The same remains true on commercial. This is really just part of gene therapy, specifically, gene therapy where you’re collecting stem cells, not T cells. The critical difference is, with T cells, you can expand them or re-expand them. With sickle cells — sorry, with stem cells, your only option is to collect them. We have one mobilization agent to do it. So, we do see — or two in the case of thalassemia, one in the case of sickle cell. So, we do see recollections for various reasons, and we uphold the highest quality standards for manufacturing. So that means, at times, we have steps in the process that need to be repeated, but I think this is going to be a very normal dynamic across all of the stem cell gene therapies.
Unidentified Analyst: Got it. Thank you.
Operator: Thank you. Our next question or comment comes from the line of Eric Schmidt from Cantor Fitzgerald. Mr. Schmidt, your line is open.
Eric Schmidt: [Technical Difficulty] taking my question. It’s about lovo-cel manufacturing. I think you have two different facilities that are supporting the manufacturing, one for vector and one for drug product. Maybe you could just confirm whether that’s the case and comment as to whether these facilities have been approved to support any other existing commercial products or whether they’ve been already inspected by the FDA? Thanks.
Andrew Obenshain: So, on the last one, I can’t comment whether they’re inspected by the FDA or not, because we don’t go back and forth with — we don’t do the blow-by-blow with FDA interactions. But you’re correct, we do have two facilities. We make the vector in Belgium with Thermo Fisher, and we make the drug product in New Jersey with a company called Minaris. We’ve been working with these companies for quite a long time now. So, have a really established relationship. No, those — the ones have not gone through other FDA inspections, but our team has. They’ve gone through two inspections in Europe. They’ve gone through the Abecma inspection when [indiscernible] company. They’ve gone through the SKYSONA and ZYNTEGLO inspections. So, this is their sixth time around. So, we feel very confident in our process.
Eric Schmidt: Thank you very much.
Operator: Thank you. Our next question or comment comes from the line of Yanan Zhu from Wells Fargo. Mr. Zhu, your line is open.
Yanan Zhu: [Technical Difficulty] taking our questions. If I may, I have three questions. First, could you talk about whether — for the BLA, for lovo-cel, whether you’re in a labeling discussion stage with FDA? Second question also on lovo-cel. You talked about this launch for lovo-cel is going to be at a higher scale at the starting point. I think there are 20,000 severe sickle cell patients versus perhaps 1,500 TDT patients. That’s 10x in scale, or actually a little more than 10x. If that’s how you see this launch as well, or could there be some other factors, like willingness to get treated, that could affect that scale? And lastly, a question on TDT launch. Could you give some color on adult versus pediatric patients so far? Thank you.
Andrew Obenshain: Yeah, thank you for the question. So, on a BLA, we don’t comment on ongoing interactions with the agency. So, we’ve submitted the lovo-cel for the treatment of patients with sickle cell disease aged 12 and over. So, this is the history of vaso-occlusive events, and we are confident in the robustness and maturity of our BLA package and the review process. Then, the last — next two I’m going to pass to Tom. I think it was a question about the sickle’s 10x, how should we expect to see that dynamic in the — play out in the market. And then the third is by TDT adult versus pediatric. Go ahead, Tom.
Tom Klima: Yeah. Hi, good morning, Yanan. So, the lovo-cel, obviously, a much larger opportunity. And just to remind everyone, there are about 100,000 patients in the United States who have sickle cell disease. And we believe that there are about 20,000 who have more severe sickle cell disease that could potentially be qualifying for gene therapy. With beta-thalassemia, TDT, there are about 1,500 patients in the United States. And we’re estimating that about 850 of those 1,500 would be potentially eligible for gene therapy. So, it’s actually greater than 20 times the market size. So, it’s obviously a much larger patient population — addressable patient population. And then, it’s hard to comment on individual dynamics with patients coming in for treatment with — for beta-thalassemia with ZYNTEGLO, and that’s because we haven’t seen a huge [end] (ph) yet, but we’ve seen just such a huge range.
We have both adult and pediatric centers online now. We’ve seen a lot of patients come forward that obviously meet the criteria and we’ve seen a lot of different stories. So, it’s hard to say that there’s a common theme there, but we’re just excited that the demand is there and the demand is there from a wide range of patients.
Operator: Thank you. Our next question or comment comes from the line of Luca Issi from RBC Capital. Mr. Issi, your line is now open.
Luca Issi: Thanks so much for taking my questions. Two quick ones here. Maybe the first on pricing. I believe your PDUFA date is 12 days after your competitor, which means you’ll have an opportunity to see their pricing before you make the final call. Is there a scenario where you’ll price the drug at a discount versus them to gain faster commercial adoption, or should we assume there’s a price on par with them? Any call there much appreciated. And then, maybe on safety. Any update on the two patients that developed AML in the trial for sickle cell disease? Wondering if you can comment on how they’re doing today. And maybe bigger picture, whether there is a scenario where you get a label that includes risk of secondary malignancies while your competitor does not? And in that scenario, how should we think about implications for the launch? Thanks so much.
Andrew Obenshain: Thanks, Luca, for the question. Tom, do you want to take the first bit there?
