Bristol-Myers Squibb Company (BMY) Earnings Call Transcript & Summary

All righty, Ben. Let's continue here with Ben Hickey, now from Bristol, welcome. Thanks for joining us today. And so yes, before we start with the fireside chat here, yes, could you just introduce yourself and talk a bit about your role at Bristol?

Sure. First of all, good to see you. Good morning. Thanks, Michael, for hosting. Yes, Ben Hickey, I'm currently the President of RayzeBio. We are going to run RayzeBio as an independent company within the Bristol-Myers family. So that will be a first for Bristol. Prior to that, I was the Chief Commercial Officer and Head of Business Development at Mirati, which was also bought by Bristol-Myers Squibb. And then prior to that, a short stint at Halozyme. And before that, I was actually 17 years at Bristol-Myers, so a bit of a boomerang. So good to be back with Bristol.

Yes, there was calling to come back, I guess. Yes, maybe talk a bit about the acquisition of RayzeBio. And yes, why does it make sense for Bristol? And how is Bristol thinking about the opportunity in general?

Sure. Well, the team did an extensive amount of work on the whole radiotherapy space, and RayzeBio was really their top choice. So I'm sure we'll get into some of the reasons around that. But with Bristol being historically and currently one of the leaders worldwide in oncology development, it makes a ton of sense to be thinking about what's the next wave. And radiotherapy was top of the list as a modality that Bristol really wanted to get engaged with. So very happy with the outcome. A great deal of excitement around the potential, not only with our current program, but with the pipeline at Rayze. And then, obviously, the potential for combinability in the future with a number of different assets within the pipeline, both within and external to Bristol today.

Yes. So I think you mentioned Bristol's keeping the RayzeBio as independent, more or less. But can you talk a bit about how this could be integrated into Bristol's existing R&D organization?

Yes. So the structure is what we call the standalone. So there were multiple different archetypes which are similar to this. We plan to have very quick decision-making just like a biotech. So keep the team in place. I report directly to the CEO of Bristol, Chris Boerner. And the idea is that we move with the agility and speed of a biotech, but at the same time, leverage the resources know-how and worldwide footprint of Bristol-Myers Squibb. So it's worked very well to date. I sit on the leadership team at Bristol. So I bring the updates directly to the team there. The Bristol-Myers Squibb Board is very supportive of it being a stand-alone organization. It's a first for Bristol. So very excited about maintaining the speed that the team has already executed against and continue in the future. But having again the backbone of Bristol behind us is a massive benefit. And I would say even to date, it's been wonderful just to tap into some of the platforms and expertise within the company.

Okay. Maybe just one more on the deal. I guess why now? What drove the timing at this point in time?

Well, clearly, it's a very hot space. And we really view it as a key modality and next wave of cancer treatment. So again, RayzeBio was at the top of the list. The team did an extensive review of the market. As it heats up, now is the right time to strike as it were. And I think they're very happy with the outcome of bringing Rayze in-house and super excited about the future.

So I think before you got here this morning, we had a little bit of a discussion about actinium-225 as payload, perhaps relative to lutetium-177 or lead. And yes, maybe talk a bit about how you or how Bristol sees the advantages perhaps of actinium-based technology.

Sure. Yes. We see it as the preferred technology at this juncture based upon the data to date. The large particle size and having the energy release of something around 400x lutetium with that degree of increased potency. We really do see the ability of the alpha emitter to create these double DNA strand breaks, which we think over time will lead to more durable responses and hopefully, better outcomes for patients over time. So that's one aspect. The second aspect is from a half-life of having it around 10 days. From a logistical standpoint, that really gives us the opportunity to actually source worldwide markets from the U.S. today. And moving forward, that gives us a great deal of comfort that we can actually learn from things like the cell therapy organization and get to just-in-time delivery and make sure the patients in need are able to receive therapy very, very quickly. So those are 2 of the major reasons. And the third one potentially been as we've seen from the early data in GEP-NET, you can also use a different modality such as actinium post-lutetium treatment, hence, of the Phase III design. So an opportunity to go both post and maybe in the future even as the first option for an actinium-based therapy.

Right. And that's a good segue to my next question. So a few clinical questions just about RZY101 in net -- in GEP-NETs. Just reminder us of the opportunity, how do you think about it? And also sort of what went into the design of the ACTION-1 trial?

Yes. So the Phase III is designed as a post-lutetium study. So it is a PFS endpoint, which we believe is the right one to look at in the space and, more importantly, the FDA is aligned to that. It's a worldwide study. It's enrolling well currently. And we actually think that the -- potentially, the data that Novartis rolled out will actually increase the opportunity for an actinium-based therapy in second-line treatment. So we are highly supportive of that data will look very positive, and look to build on that for patients who ultimately may progress. So yes, enrolling well and excited about what that could look like.

Specific question, just as you think about the Phase III trial. And I think the guidance has been the data will be available in the 2026 time frame. Just wondering if there's perhaps an interim analysis built-in that could potentially allow for earlier unblinding.

Yes. We haven't disclosed the exact numbers around that. But as you might imagine, we have both a regulatory meaningful as well as a clinically meaningful outcome on that or power the study for the right level of benefit on that front. So we do have an interim built into the study when we're disclosing that, but I feel confident around the '26 time line that we should be able to see some positive data.

Okay. And then there will be some more Phase I data here at ASCO from this program. Any additional learnings here that folks should look forward to?

So the presentation at ASCO will be a build upon the data that we've already released earlier. So we'll see greater maturity of patients. So really focused on what that looks from a durability standpoint. So that will be the data we're disclosing. We'll also obviously be taking a look at the continued safety of the program and addressing some of the earlier concerns around the accumulation in the kidney. To date, the program has seen very little of that. So we feel, today, very comfortable with the safety profile of the drug as well as the efficacy.

Okay. And then Novartis already said they'll obviously file for first-line treatment with Lutathera soon this year. I think they already filed in Europe, which as you mentioned, obviously, may expand the opportunity for post-Lutathera treatment. But yes, is there a potential path for RYZ101 also into first line down the road? Is that part of the plan?

It's certainly a consideration. We'll obviously look at the therapeutic effect in second line and make a risk-based decision from that. But the early data, we've certainly seen responses post lutetium. And again, if the hypothesis is true about this alpha particle and just the higher level of energy being released at the tumor, then it's certainly within the possibility that we could look to move to earlier lines of therapy.

And then the drug is also being evaluated in small cell lung cancer, yes, in SSTR2-positive small cell lung cancer. Remind us of the percentage of patients that express SSTR2 perhaps relative to things like DLL3. And yes, what should investors expect here in terms of the data in small cell?

Yes. So we do have a program in small cell. It's actually building on current standard of care looking at atezolizumab plus chemotherapy. Interestingly enough, when we look at the immunohistochemistry, the tumors, the DLL3 versus the SSTR2 look quite distinct. So probably competing a bit of a new space and not directly with the DLL3s in the market. And the market is significant. Obviously, there is a high unmet need. While response rates have been relatively high in frontline in the 60-ish range, we're still not seeing great PFS. So we certainly see from a durability standpoint, the progression-free survival is a measurement that we will be certainly be following closely with the early data in small cell.

And so yes, maybe I missed it just now. But yes, this first one study is in the first-line small cell setting, right, in combination. So you said, yes, what is the bar here by standard of care?

Yes. So the response rates, again, are reasonable in the 60s, but we're just not seeing durability response over time. It's a complex disease. So we're hoping that building on standard of care, which obviously derisks, we're not trying to necessarily replace standard of care, gives us an additional opportunity with this modality to hopefully build. And could give us proof of concept about how to build on top of an IO-based therapy as well, which could give us learnings for additional tumor types.

Got you. Okay. Super helpful. Any sense of any additional details on that study sort of in terms of enrollment? How has that been going? And sort of the extent of the data update?