2seventy bio, Inc. (NASDAQ:TSVT) Q1 2024 Earnings Call Transcript

Unidentified Analyst: Hi. This is Gina [ph] on for Yaron. Thanks for taking our questions. Two parter from me. So you’re saying that real-world efficacy and manufacturability are points of differentiation for a Abecma. Can you remind us what your current manufacturing success rate and out-of-spec rates are for Abecma, also vein-to-vein time? And then the second part is on the ODAC in March, the committee seemed a little bit concerned about PFS for Abecma not being durable. Do you think that’s going to hinder Abecma uptake in earlier line settings? Thank you.

Chip Baird: Yeah. Thanks for the question. On manufacturing success rates were north of 90% manufacturing in spec and that’s been consistent for quite some time now. So always looking to do even better for every patient. And as we move into earlier lines with cells that have seen less lines of therapy, we’re optimistic that that could get even better. And then from a turnaround time, we’ve been consistently just a little bit under 30 days turnaround time. Sorry, can you remind me of the other question? Gina, are you still there?

Unidentified Analyst: Am I unmuted? I was asking about durability of PFS and how it’s going to…

Chip Baird: Oh! Right. For the panel. Yeah. Sorry. Thank you. Yeah. From — we — I think the panel took a study that was focused on PFS and I think really dove deep on overall survival and the confounding factors of that study. But 13 months of PFS versus the standard-of-care, which demonstrated about four months, we felt that was a statistically significant difference on the pre-specified primary endpoints. So we feel good about those data, and as you get into subgroup analysis, we believe it looks even better. Anna can — I’m sorry, Anna is not in the same room with us. Could you comment further on that one?

Anna Truppel-Hartmann: Yes. Thank you so much and thank you for the good question. As it was discussed at the ODAC and also commented by the biostatistician, it is to be noted that the PFS analysis has a certain data cut with also certain data maturity and with more follow-up. Of course, there is more censoring in the curve and it was clearly noted also at the ODAC there was some censoring before the end. So it is definitely not a mature curve. That’s one. Second, we have two PFS data cuts that are in the public domain. If you look at the second PFS data cut, it seems to be really going apart a bit better. And finally, I’d like to also mention, we’re speaking about multiple myeloma patients who unfortunately still do not have a cure at this point in time. So therefore, we would expect that at some point in time, patients relapse and then need to go to the next therapy. So that’s all from my end on the PFS discussion at ODAC. C Thanks, Anna.

Operator: Thank you. Our next question comes from the line of Samantha Semenkow with Citi. Your line is now open.

Unidentified Analyst: Hey. This is Eric [ph] on for Sam. Thanks for taking our questions. Can you speak to any utilization trends you’re seeing across treatment centers where Abecma is the only BCMA CAR-T available versus those that offer CAR-BEC-T [ph] as well? And are you seeing utilization across all activated treatment centers or is it clustered in a subset? And if so, can you characterize that subset?

Chip Baird: Yeah. Thanks for the question. We track, obviously, the utilization data across all of the centers where we’re activated and those trends can vary over time. And again, we have centers that have higher rates of utilization and ones that are less so. I would say the academic centers, the major centers, tend to drive a lot of the overall utilization. But from a growth perspective, extending the overall footprint to more geographically remote places in the United States is helpful for those patients where travel time to receive their CAR-T and the follow-up involved matters. And so we think site expansion is an important part of the overall commercial strategy. And again, we’re engaging right now with every one of those centers, highlighting the KarMMa-3 data, the data that are on the label and the real-world evidence and everything else that we’re able to do compliantly in a commercial setting.

So more to come on that. But, again, as we’ve said it before, we’re excited to get back out there with a new and expanded data set.

Operator: Thank you. Our next question comes from the line of Vikram Purohit with Morgan Stanley. Your line is now open.

Morgan Gryga: Hi. This is Morgan on for Vikram. Thanks for taking our question. So I wanted to ask about your anticipation of the initial launch ramp curve in the third-line setting and how this might compare to late-line setting uptake? Thank you.

Chip Baird: Hi, Morgan. Thanks for the question. The fifth-line launch was a different dynamic in the sense that there were patients with no treatment options. There was clearly a bolus of patients who had been waiting for that approval and capacity was limited. And so that resulted in long lines in terms of wait times and just triaging the best that we could as a manufacturer and as a sponsor. Today in third-line setting, very different dynamics, more treatment options for those patients, a much larger market. We have, as Vicki highlighted earlier, based on present demand, unlimited capacity. And so that I think sets us up well to expand into that market, but it’s not the same kind of bolus effect we expected in the fifth-line.

And so, again, as we’ve said, early days here, it will be a return to growth, but we expect, given the lag time between enrollment, AFE and then revenue, kind of the revenue impact we don’t expect to be able to show until we get into second half of the year results, third quarter, fourth quarter results.

Operator: Thank you. Our next question comes from the line of John Newman with Canaccord Genuity. Your line is now open.

John Newman: Hi, guys. Thanks for the question and congrats on the really great work that was done for the FDA panel. That was a tough one, but you could tell that you were very well prepared. Just out of question, we’ve been hearing from some of the physicians at academic centers that they are devoting more resources over time to the apheresis portion of treatment and some of them have sort of suggested that maybe in the future, in conjunction with some of the companies perhaps, some of that apheresis could be done off-site and not in the academic centers. I just wanted to get your thoughts on that and whether it’s something that you’re sort of considering in conjunction with Bristol as we go forward?