Q1 2025 Roche Holding AG Corporate Sales Call Transcript

The following is excerpted from the question-and-answer section of the transcript.

Question: Matthew Weston - UBS - Analyst : Thank you, Bruno. Can you hear me? Unidentified Company Representative Yes, we can hear you.

Question: Matthew Weston - UBS - Analyst : Okay. Understood. Can I just quickly follow up? Your answer to Sachin's question suggested that you felt that the CAF market was just winding down. But can I just check that there's no structural reason why we should assume that CAF from everybody's donations should wind down. (technical difficulty)

Question: Matthew Weston - UBS - Analyst : Understood. Many thanks for the detail.

Question: Emily Field - Barclays - Analyst : Okay, thanks for taking the question. Maybe one on NXT007. What dosing intervals will you be targeting in the Phase III studies? And then for the comparator study versus Factor VIII, will you be using a long-acting Factor VIII as one -- as a comparator? And then going back to obesity on CT-996, I was wondering if you could make any comments on the back of the high-level orforglipron data that we saw last week. If you're able to comment on any structural differences between the two molecules? And if that is sort of the framing of targeting what you think you could achieve with CT-996 in a pivotal study? Teresa Graham - Roche Holding AG - Member of the Corporate Executive Committee, Chief Executive Officer of Roche Pharmaceuticals Great. So with regards to the NXT007 trial design, both in terms of dosing and in terms of which factor we would use, those are both great questions, which when we have the Phase III trial design, I will be able to answer for you. But right now, it would be premature. In regards to your question around the [Lilly] molecule and our CT-996, that structure has not yet been disclosed. And I think as we sort of repeatedly said, reducing everything down to just structure sometimes is a little bit overly simplistic. One molecule or one atom here and there can really, really make a big difference. And so I think we are very confident in the data that we've seen thus far with our oral molecule, and we are looking forward to advancing it in other trials. And we've -- at this point, we've seen just Phase I data, just to be clear.

Question: Emily Field - Barclays - Analyst : Yes. Thank you.

Question: Justin Smith - Bernstein SociTtT GTnTrale - Analyst : Thanks very much. Just one for me. Sorry if I'm being slow. On Vabysmo, are you basically saying that the global area under the curve of the drug is the same or it's just going to come down? Teresa Graham - Roche Holding AG - Member of the Corporate Executive Committee, Chief Executive Officer of Roche Pharmaceuticals So the overall size of the -- so if you think about the US market as a pie, the size of the pie will likely remain the same. The amount of that pie that goes to the unbranded options is likely to get a bit bigger. So the slice that's left for the branded market, we would expect Vabysmo to continue to take share. And so I just want to continue to underline, we do believe that Vabysmo will continue to grow. And as Thomas mentioned, the same level of growth that we saw in Q1 is the level of growth that we're hopeful to see throughout the rest of the year.

Question: Justin Smith - Bernstein SociTtT GTnTrale - Analyst : Thank you. So just very quickly, so I get that. And then so in terms of ability of ex US to pick up any slack, does that help as well? Teresa Graham - Roche Holding AG - Member of the Corporate Executive Committee, Chief Executive Officer of Roche Pharmaceuticals I mean, remember, ex US we still have a number of markets that aren't yet approved or reimbursed, and we're still in the midst of launching the prefilled syringe ex US. So there is actually a tremendous amount of opportunity that remains. And we're still in very early days in very big markets like China, which just launched in January with NRDL coverage for all three indications. So there is still a tremendous amount of room for Vabysmo.

Question: Justin Smith - Bernstein SociTtT GTnTrale - Analyst : Thank you. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. APRIL 24, 2025 / 12:00PM, ROG.S - Q1 2025 Roche Holding AG Corporate Sales Call

Question: James Quigley - Goldman Sachs - Analyst : Great, thank you. Thank you for taking my questions. I've got two on some of the upcoming news flow for the second half of this year. So firstly, on giredestrant. Again, I know this isn't necessarily the best indicator, but primary completion dates listed on clinicaltrials.gov for persevERA and evERA have now slipped into 2026. So you've already confirmed '25 readouts, but is there any risk of slipping into '26? And also similarly on the SERD space, we've seen some data from [Astra Lilly] and Pfizer. So I was wondering what your take is on this, particularly with continued success in the ESR1 mutation population and then what your thoughts on the commercial opportunity? And secondly, on fenebrutinib, we spoke to some KOLs recently that suggested that in terms of [Biogio's] apparent overperformance in recent Phase III trials relative to the original Phase III program, patient population was the biggest the biggest change there. So from what you've seen, is there anything sort of different or novel for your trials versus what we've seen for the other two competitor trials in their populations? And when you're planning the studies, to what extent did you assume an uplift in efficacy for budget? Thank you. Teresa Graham - Roche Holding AG - Member of the Corporate Executive Committee, Chief Executive Officer of Roche Pharmaceuticals And I'm sorry, James, could you repeat the first part of your second question? I didn't catch it.

Question: James Quigley - Goldman Sachs - Analyst : Yes. So in fenebrutinib, Aubagio has done better than people thought, right? So that seems to be the reason as to why tolebrutinib and evobrutinib didn't -- weren't successful. And KOLs, we spoke to said that's because of the patient population. So have you adjusted for that patient population in your trial? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. APRIL 24, 2025 / 12:00PM, ROG.S - Q1 2025 Roche Holding AG Corporate Sales Call What were you expecting in terms of the Aubagio efficacy when you originally planned the trials and as well? Teresa Graham - Roche Holding AG - Member of the Corporate Executive Committee, Chief Executive Officer of Roche Pharmaceuticals Got it. So I would say that based on the Phase II data that we have seen from fenebrutinib, based on. (technical difficulty) The fact that it is a materially different BTK from the other BTKs that are out there. It's noncovalent. It's more -- we believe preclinically that it's more potent, that it's more selective. We've seen very strong Phase II data with fenebrutinib, virtually we are quite confident that we have a molecule that is very different from the other molecules that are out there. So from a patient population, I'm not entirely sure that there's anything materially different in the patient populations that we're looking at. But I think we do believe that we just, frankly, have a better BTK and one that we were able to bring forward into Phase IIIs at what we believe to be the most appropriate dose. And I think that's the other thing that has potentially impacted some other trials is they just weren't able to get to the level of dosing that they needed. We believe we've gotten to the level of dose that we need. But obviously, the trial is still ongoing. So we haven't been able to formally look at the baseline characteristics for all the patient populations. But there wasn't anything in how we structured the trials that we think would be materially different. Unidentified Participant Maybe, James, I can quickly add here. Your first question was this referring to giredestrant's time lines? There is no change there. And just to confirm, they both will read out in '25 with evERA expected to come in before persevERA, and you would have these -- we expect these data still to come in from midyear towards second half, one after the other. And the other question on the [Oubatio] performance, I think this was widely debated, I think, once the competitor data were out and several KOLs communicated on it. I think due to the changes in the treatment paradigm in the meantime, you can expect these effects, but it's not that we would have known the extent upfront and would have fundamentally differently designed our studies or selected the patients.

Question: Kerry Holford - Berenberg - Analyst : Thank you, Bruno. A couple of questions for me on obesity, please. So CT-388, in the context of what is now your interest in a triple approach with amylin, can I ask do you remain committed to pursuing the dual agonist alone? So can we anticipate a Phase III start for 388 next year? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. APRIL 24, 2025 / 12:00PM, ROG.S - Q1 2025 Roche Holding AG Corporate Sales Call And then secondly, in the context of your incremental US investment, I wonder if you would be willing to tell us approximately how much of the $50 billion will be allocated to obesity? And can you confirm whether you ultimately plan to manufacture 100% of the Roche obesity assets in-house or indeed whether you do intend to use CMOs for API and fill finish? Thank you. Teresa Graham - Roche Holding AG - Member of the Corporate Executive Committee, Chief Executive Officer of Roche Pharmaceuticals So for CT-388, we certainly do remain committed and that Phase III will actually start most likely this year. We are anticipating the Phase III go decision for the CT-388 Phase III this year. Thomas, do you want to take that?

Question: Kerry Holford - Berenberg - Analyst : And then your plans with manufacturing of AC assets going forward.

Question: Kerry Holford - Berenberg - Analyst : Got it. Thank you very much.

Question: Sarita Kapila - Morgan Stanley - Analyst : Thanks for taking my question. So just on the Zealand amylin, how are you viewing the upcoming competition from [Lilly's] amylin where we get data in Phase II data, sorry, in Q3? And then also, I'd be interested to get your thoughts on the [Gora] molecule and if -- or why you passed on it given 8% weight loss posted at week 6 and a much smaller upfront contribution from AbbVie? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. APRIL 24, 2025 / 12:00PM, ROG.S - Q1 2025 Roche Holding AG Corporate Sales Call And then just a follow-up question on 007, please. If the Phase IIIs are initiating in '26, how soon can we expect it to be on market? So are you targeting before the Hemlibra patent expiry in 2030? And do you expect NXT to expand on the current Hemlibra peak sales opportunity where I believe consensus is touching $5 billion? Thank you/ Teresa Graham - Roche Holding AG - Member of the Corporate Executive Committee, Chief Executive Officer of Roche Pharmaceuticals So start from the back and move up. So 007 Phase IIIs, I think when we have the announcement on the Phase III trial designs and starts, we'll be able to tell you when we expect those trials will read out. We are obviously, as we would with any molecule that we believe has this kind of transformative potential, we will be moving as quickly as possible to bring this to patients. And so it would be premature to comment at this point exactly when it will come into market and what our plans would be. But we do believe that this could potentially expand the number of patients that are on prophylactic treatment just based on what we believe it may be able to do from a clinical standpoint. From the Zealand perspective, I mean, certainly, we would expect the amylin space as every space in this market is to be competitive. That having been said, we think that the data that we've seen from the New Zealand molecule is -- has the potential to be best-in-class and certainly to be first into the market. And we don't yet have data from the follow-on compounds. And so I think we're extremely excited about the opportunity in front of us. And again, this is going to be a competitive space, but we feel like this molecule is well positioned to compete. I don't know, Thomas, do you want to take the?

Question: Sarita Kapila - Morgan Stanley - Analyst : Okay. Thank you.

Question: Simon Baker - Redman - Analyst : Thank you, Bruno. Good afternoon, [Yong]. Two questions, if I may, please. Just going back to Vabysmo. Your comment, Theresa, about being comfortable with sales expectations in light of larger slice of smaller pie would imply that you have reduced expectations for the competition in that category. Is that indeed the case that you simply see that Vabysmo market share is likely to be higher than previously thought? And then secondly, for you, Thomas, going back to the question on CapEx. You indicated that the total level of CapEx is the same, the total level of OpEx is the same. The amount being spent in the US is higher than before. I'm assuming that wasn't in the budget. So definitionally, you'll end up with a happy US government because more money is being spent in the US. Therefore, there will be less money spent ex US. I just wonder, am I thinking about that the right way? And where is that -- where is less money going to be spent going forward? And are there any political implications for doing that?

Question: Simon Baker - Redman - Analyst : Right. Thanks so much. Unidentified Participant Richard Fossa, JPMorgan.

Question: Peter Verdult - BNP Paribas Exane - Analyst : Yeah, Farina Pete BMP parba. Two questions for Teresa, please. Theresa, I'm going to be sort of on one and perhaps a little bit negative and cynical on the other to give me. But look starting on a positive note, just on Fenner ruin the conventional wisdom out there is that the trial won't work because you've seen two compestive failures. Now we've had hypotheses already put on the. All as to why that may be, but the one that we get from KOLs is that, basically the T1 GD lesion reduction was just, that efficacy waned for your competitors. So can you remind me, sorry to be gnarly, to comment whether the suppression you've seen withenne ruin it is sustained beyond the early cuts of data, and just whether you're cautiously optimistic or optimistically cautious about beating previous in PPMS. So that's the sort of positive speed of the question. And then just being a little bit cynical on 007, in your prepaid mark, you talked about, 30 times more potency. That sounds very much like the Novo pitch on Helibra. And to be fair, you got, you've got to, admit you've been talking down the advantages of me mate versus [Heliro] the past few years. I just want to better understand where differentiation is coming from. Is it just that or are there other things that you didn't mention in your preprepared marks? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. APRIL 24, 2025 / 12:00PM, ROG.S - Q1 2025 Roche Holding AG Corporate Sales Call Teresa Graham - Roche Holding AG - Member of the Corporate Executive Committee, Chief Executive Officer of Roche Pharmaceuticals Yes. No, I think -- so let's start with 007. I think fundamentally 007, yes, we believe that it is more potent, but it also has the recycling and sweeping technology built into it. And so I mean it is just fundamentally a next-generation molecule. I don't know how much we've actually disclosed on the actual composition of that molecule, maybe you can remind me -- but it is just fundamentally a different molecule from Hemlibra. So this isn't just, I think, a little bit better than. I think this is a different than. Unidentified Company Representative I think, Peter, what you should read into the announcement is also if you -- we made the comment that we benchmark versus Hemlibra. So I think this was missing in -- with competitor studies, and I think that's the ultimate test to really see whether we can establish a new standard of care. Teresa Graham - Roche Holding AG - Member of the Corporate Executive Committee, Chief Executive Officer of Roche Pharmaceuticals Absolutely. I mean I think we've been very clear that we believe that Hemlibra is the gold standard for treatment in hemophilia. And we are putting our money as we always do, where our mouth is in these trials and running our next generation up against the current standard of care. And we love nothing more than beating ourselves. So we're very excited for that possibility. Unidentified Company Representative That's something we can discuss in more detail at the June 23rd. Teresa Graham - Roche Holding AG - Member of the Corporate Executive Committee, Chief Executive Officer of Roche Pharmaceuticals And then in terms of Fenebrutinib, I mean, again, just to reiterate, I think we just fundamentally believe that we have a different molecule than the other BTKs that are out there. It is a different composition. It's a different structure. It's more potent, it's more selective. It's non-covalent. And we have, I think, more Phase II data than most of our other competitors have had. And I'm just referencing here, we have longer-term 48-week open-label extension data that really shows that we're able to suppress disease activity. So the open-label extension here will go out to 96 weeks. We'll get that later this year. And so I think we do believe that we have something different on our hands and the Phase II data is playing that out.

Question: David Evans - Kepler Capital - Analyst : Thanks very much, Bruno. So yes, two questions, please. One on petrelintide and one on brain shuttle. So on petrelintide, in your slides, you referred to looking for high-quality weight loss. I was just wondering how convinced or confident are you that amylin can be differentiated on less muscle loss and more fat loss. How much of the rationale was that for you going into amylin? And is that in practical terms how amylin you think can really differentiate? And then on brain shuttle, well, we've seen amazing proof-of-concept data from trontinemab so far. But where are we on your brain shuttle CD20 in MS? Might we see data on that anytime soon? And are there any other brain shuttle projects in the way that we should know about? Teresa Graham - Roche Holding AG - Member of the Corporate Executive Committee, Chief Executive Officer of Roche Pharmaceuticals Yes. So as you mentioned, we do have the Brainshuttle anti-CD20 in very early R&D. I don't believe we've disclosed when that first data set will come out, but it's likely not to be for some time, that's relatively early stage. And we are certainly looking at the brain shuttle technology in other diseases where we believe crossing the blood-brain barrier is going to make sense to do so. So clearly, a technology that has really proven itself in AD, and we will be bringing forward other opportunities to look at that in other diseases. In terms of petrelintide, the amylin class does work fundamentally differently, obviously, than the incretins do. And so it is, I think, very likely that we could see a different kind of weight loss with patients on these drugs. And clearly, the data are early days, but the clinical hypothesis is solid. And so I think we're very hopeful that this could be a fundamentally different kind of weight loss than what you saw with GLP GLP-1s.