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

Peter Welford: Hi. Thanks for taking my question. Just curious, I wanted to come back to Fabhalta and Iptacopan. You sort of had some more cautious commentary, perhaps, than you might expect for a new launch. I wonder if you could just talk a little bit about, does this, as you say, relate very specifically to the PNH market, and perhaps why are you perhaps more confident that you potentially can’t get into some of those currently untreated patients sooner? Or does it reflect the REMS and the initial program and perhaps impediments you’re seeing getting this in front of doctors and through the process than perhaps you envisaged? And I guess how does that and the profile of the drug, if at all, read into the potential rollout for the larger IgAN indication potentially in the future? Thank you.

Vas Narasimhan: Yes. Thanks, Peter. So first on PNH, it very much — the uptake very much has to do with the REMS, as well as some of the other elements that need to be placed, so particularly vaccinations. And so this takes time to put in place for this medicine, as well as our organization getting the infrastructure fully up and running. We estimate 7,000 to 8,000 patients with PNH in the United States, roughly 3,000 to 4,000 of them being treated today. And so, in such an ultra-rare patient population as well, you have a relatively high dispersion of physicians who are treating one or two patients. So it also takes time to reach all of these physicians. It doesn’t change our long-term belief that this can become the medicine of choice for these patients, given it’s a twice-a-day safe oral medicine with high efficacy and I think a reasonable safety profile overall.

And that will just take time as we get physicians up to speed. Either patients in the position where they need to switch because they’re uncontrolled over time, even controlled patients, we would argue would want to be switched and then new starts as well. And then we do make efforts already to try to reach that half of the — estimated half of the patient population, which is currently untreated. So we just want to set reasonable expectations for the first year, and then we hope to ramp up thereafter. We do think that given our positioning in C3G and IgAN, C3G already also being an ultra-rare disease, IgAN, we target refractory patients. Again, given that we’re targeting a very select patient population, we think we can absolutely manage the patient start process for those patients and then ensure a very strong uptake for the medicine.

And then if you look at the future indications for Fabhalta, largely also in the ultra-rare space, which will then, I think as we build that capability, we should be able to get patients on therapy sustainably over time. Thanks, Peter. Next question, operator.

Operator: Thank you. Your next question comes from the line of Richard Parkes from BNP Paribas. Please go ahead.

Richard Parkes: Hi, thank you for taking my question. Just following up on business development strategy. I mean, it’s been quite clear the last 18 months, you’re now very confident about growth through upcoming LOEs for the business overall, but you still will have to absorb LOEs in specific therapeutic categories and what we are thinking about Entresto. So when you look at your cardiovascular franchise, given that [indiscernible] maybe been a bit slower, and a [indiscernible] clinical risk, are you comfortable you’ve got enough coming through [indiscernible] maintain a healthy franchise and not have any kind of negative leverage post that? Or is that an area where you would look to maybe be more active in terms of business development to bring in later stage products? Thank you.

Vas Narasimhan: Yes, thanks, Richard. We feel very confident with what we have in-house in cardiovascular disease. When you look at it, we have Leqvio in secondary prevention and then moving to primary prevention as well. We have Pelacarsen, the LP little a program. We have a program called XXB, which we are currently moving forward in mid-stage studies in hypertension and heart failure, as well as an oral version of XXB as well, NPR1 agonist that we’re also bringing forward. And as I’ve noted, we have an extensive in-house siRNA effort targeting a range of lipid lowering and cardiovascular targets, as well as external collaborations that we’ve also now brought on board, which we think allows us to cover most of the key targets which would be of interest for siRNAs. And our goal is, one, to move to new targets, two, to move to combinations, and three, also to get to annual dosing, which we think is the right strategy in cardiovascular disease in the long run.

Of course, other companies are pursuing orals, and fully understand that, but we believe that in this space, given the compliance challenge over the long run that’s been demonstrated over decades, having infrequently administered siRNAs on validated targets is the right strategy. So given all of that and the efforts that we have ongoing, we feel very comfortable with our internal cardiovascular portfolio and pipeline. Next question, operator.

Operator: Thank you. [Operator Instructions] Your next question comes from the line of Mark Purcell from Morgan Stanley. Please go ahead.

Mark Purcell: Yes, thanks for taking my question. On Kesimpta, Vas, hopefully you can help us understand the growth dynamics here and what MBX leadership means, especially in light of the ex-US acceleration. So when you think about B-cell NBRx share, how does the ex-US share compare to the US where we get data from Roche? And then when I look to the NBRx leadership footnote in seven out of 10 markets, it just said data on file. So could you help us understand, I guess, where infusions are more of a barrier to treatment in some ex-US markets versus US, where your share stands relative to the alternative infused therapy in this space? And then just housekeeping on Kisqali and the NATALEE filing, did you include no negative patients in that filing? Thanks very much.