Novartis AG (NYSE:NVS) Q4 2023 Earnings Call Transcript

Vas Narasimhan: Yes. Thanks, Simon. I think it’s early days. So I think, I don’t want to get too far ahead. But so far, we’ve heard positive feedback overall from clinicians. I mean, Cosentyx has an outstanding long-term safety profile. I think that’s been well established now over many, many years. It doesn’t have some of the safety topics that some of our competitors may have. And so, I think that allows us to have a very strong comfort level with dermatologists for treating these patients. And as well, overall, the efficacy, I think, is solid. And with the opportunity to give these patients a safe efficacious option. And as you know, the big challenge in HS is really getting patients to come in to be treated, given that it’s been so long since there have been new medicines that have been launched since the TNFs were indicated for this condition.

So I think solid early start. And we’ll certainly see how the quarters unfold. But I think the safety profile and the overall comfort level in dermatologists gives us a very good position for this launch.

Simon Baker: Great. Thank you.

Operator: Thank you. Your next question comes from the line of Kerry Holford from Berenberg. Please go ahead.

Kerry Holford: Oh, thank you. A couple of questions for me, please. Firstly, Kisqali. When do you expect that drugs become eligible for price negotiation under IRA? And given we’re moving towards ending up having expiry 2031, can you talk to the life cycle management options available to you here? When I look at the Novartis pipeline, I see few breast cancer specific assets, but perhaps I’m wrong. And any feedback you could give there, any areas of interest would be gratefully received. And then business development, clearly you’ve been somewhat busy over the last 12 months. What’s your appetite for deals moving into 2024? Size, therapeutic category, is RLT still an area of focus? M&A, business development? Many thanks.

Vas Narasimhan: Thanks, Kerry. So first on Kisqali, as you know, it’s not a precise science to predict IRA for these patients. I’d also noticed in the early breast cancer population, these patients are younger and tend not to be in the Medicare population. So I’d say we really see this being a topic for Kisqali towards the end of the decade, but importantly, would only affect the portion of our sales that are in the Medicare population. And we’ll, of course, as we learn more and understand better how the program will unfold, we’ll keep you all updated. But we think we have a very good runway now for this medicine for the coming years, both in metastatic and assuming approval in the early breast cancer space. In terms of life cycle management and breast cancer, of course, the one opportunity is other CDK targets, which we are pursuing in-house.

And that’s something that we are looking at within our research labs, as well as potential for combinations. And that’s another topic for us as well. We also continue to advance early stage programs with RLTs in breast cancer as well, not specifically life cycle management in Kisqali, but give us the opportunity to bring forward radioligand therapies in the breast cancer space. And that’s an area of high focus for us at the moment. So I think a combination of novel targets in small molecules, as well as radioligand therapies in the breast cancer — overall in the breast cancer space. So in terms of business development, as I outlined in the slide, our strategy is very much to focus on our four core therapeutic areas and our three key technology platforms.

So those technology platforms are cell therapy/immune reset, cell and gene therapy/immune reset, RLT and RNA therapeutics. And I think that’s well known. And in terms of size of deal, no change to our overall approach of smaller than $5 billion bolt-on acquisitions, with the vast majority of those deals being sub $1 billion deals and no change to our approach there from what we’ve previously stated. So moving next.

Operator: Thank you. Your next question comes from the line of Seamus Fernandez from Guggenheim Securities. Please go ahead.

Seamus Fernandez: Thanks very much. So I just wanted to ask one particular question in terms of the, sort of business development strategy. I know, Vas, you’ve already talked about this, but I wanted to get a little bit more clarity on specifics around the sort of threshold that you’ve talked about publicly. Is that sort of $5 billion and below threshold really still kind of the target range or given the success that you are seeing in some of the other areas of development, is there the opportunity to potentially go larger in terms of the potential transactions? Just wanted to get a better sense of, if you feel there’s more flexibility given the Phase III, solid Phase III hit rate that you’ve had, or if you’re kind of sticking to your guns or to your knitting in the $5 billion and south range.

Vas Narasimhan: Yes. Thanks, Seamus. It’s really nothing I think to add beyond what I’ve already stated. We, of course, look at the full range as you would expect a company of our size, a full range of potential opportunities within business development. But what we consistently see is the opportunities we have where there’s the most significant opportunity for value creation, as well as a differentiated view versus the market, is on the lower end of the range of deal values. I think that’s why when you look at the 15 plus deals that we did last year, the vast majority are under $1 billion or even under $500 million. We did Chinook at $3.1 billion. And I think that’s where we see the best opportunities for us as a company. I will never exclude that we would do anything if it makes sense for our shareholders, it makes sense for the long-term profile of Novartis.

But our focus is very much on that bolt-on sub-five, sub-two, $1 billion range programs. And that’s where I think we’ll be. Moving to the next question. Thanks, Seamus.

Operator: Thank you. Your next question comes from the line of Emily Field, Barclays. Please go ahead.

Emily Field: Hi, thanks for taking my question. Just a question on remibrutinib. How far along are you in the recruitment of the MS trials? Just given we’ve seen another partial clinical hold in the space. And then, if you could just remind us how your molecule is differentiated given the — we did see that Phase III failure after your R&D Day?

Vas Narasimhan: Thank you. Thanks, Emily. So on remibrutinib, let me start with why we think our molecule is differentiated. When you look at the structures, and if you go back to some of our slides in R&D Day, you’ll see that our molecule has a different overall chemotype structure than some of the other peers. We believe that the liver signals that have been seen thus far in this group of medicines have to do with off-target toxicities related to the structure of the molecule. So we have a highly potent BTK inhibitor, covalent BTK inhibitor, that we think is unique. And it’s — at least so far in the clinical and preclinical work profile in terms of having any of those off-target toxicities. So we, of course, already have read out two positive Phase III studies in CSU and plan to file with the 52-week data in the second half of this year.

We continue to pursue as well remibrutinib in other immunology indications where we think there is an opportunity given it’s a safe profile. And importantly, at that dose range, 25 milligrams BID, we saw no liver signals in those dermatology studies. In terms of the MS trials, we continue to recruit on track. However, we don’t expect a filing before 2026, if I’m not mistaken. And we did have a futility analysis looking at futility for non-inferiority to our comparator, and we passed that futility analysis. So the program will continue. So we don’t see any safety signals. We’ve passed a futility analysis, which we put in place given some of the data that some of our peers have read out, and we’ll continue then to progress the study in multiple sclerosis as well.

We do believe remibrutinib has the opportunity to be a significant medicine across a range of indications, particularly as the safety profile continues to hold up because of the structure of the medicine. So thanks, Emily. Next question, operator.

Operator: Thank you. Your next question comes from the line of Peter Welford from Jefferies. Please go ahead.