Tom Klima: Sure. Hey, good morning, Luca. Yeah, we’re going to run the same process on our price for lovo-cel that we ran with ZYNTEGLO and SKYSONA, obviously different dynamics in sickle cell disease, but we’ll take into consideration clinical benefit, quality of life improvements, cost saving system, impact of society, just like we do with our other therapies. Obviously, a one-time potentially curative therapy in a chronic condition, many are seeing the values recognized by payers, is recognized recently by ICER, so clearly the models are out there. We won’t comment on our competitors’ pricing. We don’t obviously have any privy to that. We believe that we are leaders in establishing value and setting price for these therapies and we will continue to price the way that we price.
Andrew Obenshain: And then, Luca, just on the safety issues, as a reminder, there have been no cases of insertional oncogenesis with lovo-cel. However, there have been cases of cancer related to the transplant procedure involving lovo-cel. And unfortunately, two of those patients in our early clinical trials where our procedures were in the earlier phase of Generation 1 procedures since Group A did develop leukemia and AML, and those two patients did pass away. So, although they are not — those two patients are not in our efficacy data set, it is likely that we will have a mention of the safety events in the label. In what part of the label or where, is yet to be determined. But certainly, they will be in there. It’s something that we’ve known for quite a while. Again, I think the really important point is that no cases of insertional oncogenesis. These are cases that were related to the procedure.
Luca Issi: Got it. Thanks so much. Super helpful.
Operator: Thank you. Our next question or comment comes from the line of Sami Corwin from William Blair. Mr. Corwin, your line is now open.
Sami Corwin: Hi, there. Thanks for taking my questions. I was curious, is there an incremental cost to opening new QTCs? And then, thinking about your commercial manufacturing time for lovo-cel, how should we be thinking about that? Will it likely be closer to the duration of manufacturing time to produce ZYNTEGLO or will be closer to SKYSONA? And then, across all three products, do you think that it’s possible to increase efficiencies and decrease that manufacturing time in the long term?
Andrew Obenshain: Do you want to take the first one, I’ll take the second two, Tom?
Tom Klima: Yeah, sure. So, we’ve done a lot of ROI analysis on our QTC network and the only cost is really just the time and the headcount to get the Qualified Treatment Center up and running. So, in our ROI analysis, if they just treat one patient over the course of two years, then it’s a very profitable endeavor for us. So, we will likely continue to expand our Qualified Treatment Center network beyond the 40 to 50 that we said we would do this year, not hardly any incremental cost at all.
Andrew Obenshain: And then, on the commercial time for release lovo-cel will be closer to ZYNTEGLO than it will be to SKYSONA, just because the release tests are relatively similar for those products, and that’s what drives timeline. I will say, just in terms of your question about timelines overall, the biggest impact to timeline will be how many times you have to collect cells from the patients, right? And that’s going to be the biggest driver of timelines, and we do anticipate bringing that down nicely over time. We think we have a robust process that allows us to do that. And then, the second consideration is how long those release tests take. Some of those release tests are just long lead time after incubate, so you’re never going to get down below a certain threshold, but you can imagine some time being taken out of those lead times.
Sami Corwin: Great. Thank you.
Operator: Thank you. Our next question or comment comes from the line of Jeffrey Hung from Morgan Stanley. Mr. Hung, your line is now open.
Michael Riad: Hi, this is Michael Riad on for Jeff Hung. Thank you for taking our questions. On the outcomes-based agreement specifically for ZYNTEGLO with Michigan and Massachusetts state Medicaid agencies, given that there have been zero ultimate denials, is this slowly becoming a formality, or do the state agencies generally have uncertainties on outcomes and feel that they could benefit from the agreement? I guess I just want to understand the rationale given that there’s been zero denials to date. Thanks so much.
Andrew Obenshain: Go ahead, Tom.
Tom Klima: Yeah. Hi, good morning. So, I think what we’re seeing is that state Medicaid agencies obviously recognize the value of one-time therapies in a disease state like beta-thalassemia that’s very costly to the system. However, I think they also appreciate our outcomes-based agreement where we’re saying if a patient doesn’t achieve transfusion independence and maintain transfusion independence, then they should be rebated at least a percentage of the cost of the therapy. That just gives them the additional security that they’re not paying for something that doesn’t work. So, it’s an added assurance. And in this case, we feel that it’s obviously a testament to the value of ZYNTEGLO and their willingness to work with us.
Michael Riad: Okay. Thanks so much. That’s really helpful.
Operator: Thank you. I’m showing no additional questions in the queue at this time. I would like to turn the conference back over to Mr. Andrew Obenshain for any closing comments.
Andrew Obenshain: Great. And thanks, everyone, for joining our Q3 call this morning and for your thoughtful questions. It’s a very exciting time for bluebird and the patients that we aim to serve. If you have any additional questions or would like to set up a follow-up call, please reach out to Courtney. Thank you.
Operator: Ladies and gentlemen, thank you for participating in today’s conference. This concludes the program. You may now disconnect. Everyone, have a wonderful day.
