Chris Boerner: Thanks for the question, Geoff. I’ll take that one. So, as we’ve discussed previously, as we think about capital allocation business development continues to be a top priority for us. Obviously, we’ve just executed a number of deals towards the end of last year, and we’ve got to stay focused on executing those deals. Having said that, we certainly are going to continue to be interested in bringing innovation into the company that makes strategic and financial sense to do so. I would characterize those a bit more as bolt-on opportunities at this point. We’re also, of course, continuing to look at partnerships and licensing deals as well. But that’s how I would characterize it. Business development is still a priority.
Tim Power: Thanks, Chris. Let’s go to the next question, please.
Operator: The next question comes from Matt Phipps of William Blair. Please go ahead.
Matt Phipps: Hi. Thanks for taking my question. Samit, I was wondering if you could give us a sense of how many SLE patients do you expect to treat with the next T — CAR-T program this year? And is the next step after this Phase 1 study straight to a pivotal? Do you have a sense yet of what that looks like?
Chris Boerner: Samit?
Samit Hirawat: Yeah. Thank you for the question, Matt. Look, we are in the dose escalation phase. As you can recall, we have to go through one patient by one patient in the beginning, but very soon we’ll be able to treat a number of patients at the same time. I can’t give you a number in terms of how many patients we intend to treat at this time, but certainly the trial will remain open as we want to certainly get a good understanding of the efficacy and safety profile at the right dose for patients with SLE, who have advanced disease. We do intend to present the data later this year, emerging from the first trial. In terms of what the next steps would be, we will be engaging with some data in hand with the regulatory agencies in terms of defining what the trial should look like.
In this particular case, would a single-arm open-label study such as has been done with immunological malignancies? Will that be the acceptable approach, or will the regulators require a randomized approach? Those are yet to come, but certainly looking forward to the emergence of this data and presenting that later in the year.
Tim Power: Let’s go to the next question, please, Andrea.
Operator: The next question comes from Steve Scala of TD Cowen. Please go ahead.
Steve Scala: Thank you very much. I believe Milvexian’s Afib trial right around now is at the point where Bayer stopped its Factor XI Afib trial. Can you reassure us that events in the Milvexian Afib trial are progressing as expected? And Samit, based on everything are you very confident in Milvexian Afib? The trial has been underway for approaching a year. So I would imagine some sort of look has already been taken. Thank you.
Chris Boerner: Samit?
Samit Hirawat: Thank you, Steve for the question. Very thoughtful as always. What we can tell you is the trial is continuously progressing — on all three trials of Af, secondary stroke prevention and ACS. Enrollment is going very well. And certainly, the DMC continues to oversee the trials, and we do not have any indication from the DMC otherwise. We will continue to look at the data from a perspective of safety, as well as the DMC will continue to look at the data. There’s nothing more to report at this time. I would say one thing, though, that assuming just because a competitor trial failed for whatever reasons and the doses that they picked, we don’t have that same philosophy. We actually did conduct two very well designed studies. We picked differential doses between atrial fibrillation versus SSP and ACS, and those are the reasons to believe. And we will certainly be looking forward to the readout of these trials in ’26 and ’27.
Tim Power: Thank you Samit. Andrea, can we go to the next question, please?
Operator: The next question comes from Terence Flynn of Morgan Stanley. Please go ahead.
Terence Flynn: Great. Thanks so much for taking the question. I was just wondering, if you could elaborate on your thoughts on Breyanzi commercial potential this year, particularly in the second-line setting and how the final OS data might impact that? And then, anything you’re seeing with respect to outpatient treatment for Breyanzi here? Thank you.
Chris Boerner: Adam and Samit?
Samit Hirawat: Yeah, certainly. Thank you. So I’ll start off and then pass it on. R&D always comes first before commercial. So I’ll start off with Breyanzi. Certainly, looking forward to these three PDUFA dates that Adam had mentioned earlier, as well as David in his remarks for Follicular Lymphoma and Mantle Cell Lymphoma and CLL. And then, of course, planning to do a little — few more trials in these lymphoma patients, because that remains a very high unmet medical need. And then, of course, there are multiple other cell therapy products that are in development. So we’ll be talking more about that. From the outer spec or the continuation of those discussions, we continue to engage with the regulatory authorities and we’ll update at a later date once we have an inkling in terms of where we are landing on that. Adam?
Adam Lenkowsky: Yeah. Thanks for the question. So we’re pleased with Breyanzi performance in the quarter. We saw a double-digit growth quarter-on-quarter. We also expect to continue to make good progress with Breyanzi in 2024, supported by strengthening of our vector supply. In fact, we will see supply materialize even further in Q2 and expand to support our new indications for Breyanzi starting with the plan CLL indication in March, where Breyanzi will be the first and only cell therapy agent to have this indication. As Samit alluded to, we’re making good progress in reducing turnaround time out of spec and drug product capacity. So now, as we move through the course of the first half of the year with this broad label and LBCL, and now with three FDA prior reviews in the first half of the year, Breyanzi has the potential to treat the broadest array of B-Cell malignancies of any CAR-T.
And these indications, we believe, will double the addressable patient population for Breyanzi. So we’re very pleased with what we’re seeing, the progress that we’re making. We are seeing increases in outpatient use because of the best-in-class safety profile that Breyanzi brings, and we expect strong demand growth this year.
Tim Power: Let’s go to the next question please, Andrea.
Operator: The next question comes from Evan Seigerman of BMO Capital Markets. Please go ahead.
Evan Seigerman: Hi, guys. Thank you so much for taking my question. So, last week you presented initial data from your androgen receptor ligand-directed degrader at ASCO GU then hosted an event for the cell side. Samit, I’d love for you to speak to why you think it’s important for investors and analysts to pay attention to a Phase 1 asset at a company as large as Bristol Myers. I know you have a lot going on in your pipeline. Why should we be focused on things like this? Thank you.
Chris Boerner: Samit will start and then I’ll turn it to Adam to get some feedback from KOLs on this product.
