Sanofi (NASDAQ:SNY) Q1 2024 Earnings Call Transcript

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Paul Hudson: François, do you want to take a stab at those?

François-Xavier Roger: Yeah. I can. On the R&D flexibility, I mean this is good news if we can generate additional resources. I think that we will need to decide in due time on each and every single case on their merits. If we have good cases for good return on investment on R&D, I think we will not hesitate to do it. But that being said, I mean, we should not discount the fact that we let some of it flow to the bottom line. And I think that it’s extremely important that one that we reward our shareholders in an attractive way, which is the reason why I’m coming back to what I said earlier as well on our total confidence on the significant rebound in EPS, for example, in 2025. I think on capital allocation, I think that we have a very clear policy.

So first of all, we want to invest in our business, both organically and inorganically as well. I think Paul touched on it earlier, and we need to be very disciplined on that, so which is — which means that we are rather thinking today of bolt-on cases within the €2 billion to €5 billion. Clearly, with a view to get some return and generate value for shareholders as well. Paul said it, we don’t want to discount either larger opportunities if they themselves and they’re attractive, obviously. In terms of capital allocation, we don’t want to discount share buybacks. That’s a possibility, especially in the context of the separation of CHC. So this is part of the option that we keep on reviewing. Let us work further into the year to decide exactly on, which route we get.

But we heard the message that there is an appetite as well from shareholders to get some share of the cash that we could generate from that transaction.

Paul Hudson: Thank you, François. We have time for another question.

Operator: Yes. The last one will be from Peter Verdult from Citi.

Peter Verdult: Thank you. Peter Verdult from Citi. Two questions, Peter. I think everyone on the call realizes in your comments that pipeline perception is the missing piece of the puzzle to get the shares flying again and above €100. So with that in mind, I’ve got two follow-up questions for Houman, please, on rilza and tolebrutinib. I totally get you can’t disclose too much ahead of data presentation, but Houman, can I push you as best I can to give us a sense of how competitive you think that rilza dataset in ITP is from an efficacy safety perspective to incumbent molecules such as Promacta, especially given Promacta is facing generic risks and I try to be as ambitious best I can without getting you to disclose the data?

And then on tole ahead of the late summer Phase III readouts, just how you’re thinking about the relative opportunity across readouts remitting and progressive, because on relapse remitting, the KOL feedback we’re receiving and the data that’s being presented at ACTRIMS and ECTRIMS seems to be showing a waning effect for both EVO and tole over time as it relates to gadolinium lesion reduction. So the message we’re getting is be wary of a positive result in relapsed remitting, progressive is clearly where the biggest unmet need is. But we don’t yet have any randomized Phase II data we can bank on. So is it just the brain penetration angle and the NFL data that you spoke about earlier, Houman that it is what gives you confidence in the progressive trials?

Or would you bring any other points to the table? Thank you.

Houman Ashrafian: Okay. Thank you so much for those questions. As always, deeply thoughtful, let me just take very quickly. I think the existing standard of care leave — they’ve been incredibly important medicines by the way. I don’t want any level people not to appreciate how important they’ve been to the treatment of ITP. But they don’t get to the heart of the disorder, as I said, mechanistically, suppression of the B cells and the reduction of Fc-gamma-based macrophage platelet destruction has been really important and just building up a number of platelets doesn’t ameliorate the severe fatigue, et cetera. So I really do think rilza is a deeply important new add to that space. And as Brian beautifully said, beyond ITP, its future role potentially in rare blood is really very significant.

And the tolebrutinib profile is — as you said, I can’t disclose, but to my mind, very pleasing. So the ITP answer, bullish on rilza. On tolebrutinib from time to time, I find it frustrating that people try and change the goal post. And let me be super clear, I think in progressive disease, there is almost nothing out there of any significant value in secondary progressive MS. It’s a horrible disorder with ventricular dilatation and substantially unmet medical need. Today, many of those patients are either undertreated or labeled as a different condition in order to access therapy, right? So for progressive disease, I think the risk benefit should the tolebrutinib readout play to our favor is unequivocal. And I’m prepared to be confident that if there is efficacy with the level of safety we’ve now seen with monitoring that in progressive disease, there is significant value over here.

With respect to relapsing/remitting when my frustration comes in, to take at this stage in GEMINI’s development to argue that even if the molecule works in a Phase III and passes the goalpost that we now have another discussion about whether this is going to be sustained. I think difficult question to answer. My view is, in a few months, we will see the results of GEMINI I and II. I think that the regulatory path is really well established, both with respect to ARR, but also with respect to disability. This isn’t something we’ve invented. And I think the onus will be on us and the regulator to get this through and benefit patients with relapsing disease, if we hit ARR and/or disability. I think as simple as that.

Paul Hudson: Yes. Thank you, I mean we – I’m with you, I think rilza has a really competitive profile irrespective of Promacta and its challenges with diet and everything else. I think once we get beyond as well to asthma and to CSU, I think you took in advanced orals in these spaces, and I think the question is the right question about earlier was asked about tolerability. If you can thread that needle, which I believe we can, you really unlock huge patient potential, that’s why we put it in the two. On tole, I think Houman summed it up beautifully. Let’s not forget that an advanced oral with potentially disease-modifying could be the profile. And it’s — there’s a real space for it. So I think that if we can get it done the right way and we’ll get the study soon enough, so it’s sort of not even worth speculating anymore.

I think if we take progression in any form, even if we have to have conversations with regulators about what is understood and what is not, actually, it’s very hard to resist something that could do that. We will find out we’ll see how good the data is.

Paul Hudson: So thanks, everyone, for your time today. We’ve had an excellent start in 2024. Sales advanced by 7% growth was driven by launches, including new indications for Dupixent. Our transformation is gathering pace, and I thought that a bit today during the call questions weighted towards the future and what we’re trying to do. If you have any follow-up questions, feel free to contact the IR team, they never rest. And have a great rest of your day. Thank you.

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