Novartis AG (NYSE:NVS) Q3 2023 Earnings Call Transcript

Vas Narasimhan: Yeah. Thanks, Mark. So first on Kisqali NBRx, obviously, it’s hard to predict, and we certainly know that the Monarch program will also read out in OS at some point in time. But nonetheless, we see very strong trends across the board on Kisqali. We think, the — given our superiority or I should say, given their strong OS data across three lines versus one competitor and the other competitors largely positioned as a second line therapy after a first CDK4/6 failure, we’re seeing very strong uptake and we continue to believe we can become the leading — consistently the leading NBRx player. And most importantly, that to start to translate consistently on TRx share, which of course is the long-term what was going to drive the sales potential.

So we don’t see any signs at the moment of a slowdown on the trajectory that we — you saw on that slide. And I would note that we see that trajectory not only in the US, but Kisqali now is achieving market leadership for NBRx in our key markets, in Europe, as well as elsewhere around the world, which I think really demonstrates that in a metastatic setting, we’re extremely well positioned for this medicine. And as I noted, we believe in the metastatic setting alone, we have a multi-billion dollar potential and then, of course, the adjuvant early breast cancer settings would come on top. I can’t comment on the details of the iDFS — of course, on the data that will be presented later this year on the full 500 iDFS events, but we’re really confident on the data set that we’ve seen.

It’s consistent, and I think only continues to support our case that this medicine should be approved in both the intermediate and high-risk settings. And that’s what we tend to file for.

Mark Purcell: Thank you.

Vas Narasimhan: Next question, operator.

Operator: Thank you. Your next question comes from the line of Stephen Scala from TD Cowen. Please go ahead.

Stephen Scala: Thank you very much. There’s a lot of momentum in the Novartis business as evidenced in the guidance raises. There’s no reason why the momentum would suddenly stall as we begin 2024, yet consensus does show a bit of a slowdown. I assume you think consensus is underestimating the outlook in 2024. So where do you think consensus is misunderstanding the outlook for next year? Thank you.

Vas Narasimhan: Yeah. Thanks, Steve. So we won’t provide, of course, any guidance at the moment on 2024. I mean, if you just go through some of our key brands, and I actually am not up to speed on any of the precise numbers for 2024 consensus. As I’ve learned, it’s better to focus on driving the medicines than to pay too much attention to where consensus is. But, look, Entresto has continued momentum. We expect it to continue to grow across our key markets as we outlined. We think Cosentyx can get back to growth on the back — globally on the back of the HS, a stronger growth than the back of the HS and IV indications. Kisqali is really on a strong growth trajectory, and we see no indications of that slowing down in the metastatic setting.

And it is our intention to use a priority review voucher, assuming that we — FDA agrees to accept it and get the early breast cancer indication moving with respect to Kisqali as soon as possible. You’ve seen Kesimpta with really strong growth, and Kesimpta, independent of the revenue adjustment item, very dynamic, 86% growth. And we see again, no reason for that not to continue as the B-cell class share grows and Kesimpta’s share of the B-cell class also grows over time. Pluvicto, given the patient growth numbers that we see and getting the supply now fully unconstrained and getting the centers back up and running, adding more centers, focusing on demand generation, I think that’s an exciting opportunity. And then we’ll see, I think, Lutathera in the frontline setting.

This all just builds our radioligand therapy portfolio for the longer term to drive growth also in next year. And then, of course, Leqvio, Scemblix, Iptacopan, all have the potential to make meaningful contributions as well. Scemblix, I think it’s going to moderate the growth given that the third line setting is starting to get tapped out, but eventually hope to be able to move it into earlier lines. Leqvio will be slow and steady but climbing that cardiovascular curve, which we’ve proven we know how to do over the years with Diovan, Entresto, Exforge, LOTREL. So we’ll keep climbing that curve. And then the opportunity to launch Iptacopan in PNH, I would say that launch will be a tougher launch initially, but we believe over time we can drive Iptacopan to be the standard of care in PNH and then hopefully get the approvals in C3G and IgAN in the later part of the year.

So I think that’s the profile on those nine key brands. And Harry, anything you wanted to add?

Harry Kirsch: Yeah, just one comment. Of course, one thing we have to watch here together for — is, of course, how the currencies are moving. I haven’t mentioned this in my prepared remarks. But as we have outlined on Page 40 of the IR deck and as you know, we update this every month on our website. In ’24, when you look at consensus at the moment, what we see on the in-house, right, is 3% on the top line roughly, and then 7% on the bottom line. The FX is at the moment seen as a minus 1% to minus 2% on the top line impact if the currencies stay where they are and minus 3% on the bottom line given that in the recent weeks and months the dollar has strengthened. So just one element as you model, right, and watch this. Of course, on top of that, we see some little increasing generic and LOE impacts and [indiscernible] divestment.

Again, don’t want to talk down 2024, but we have to carefully model these things. I do expect that we have continued excellent momentum on our growth drivers, of course.

Vas Narasimhan: Terrific. Thanks, Steve. Next question, operator. That’s it.

Operator: Thank you.

Vas Narasimhan: Go ahead. I think it’s one more question.

Operator: Thank you very much, sir. We will now take our last question for today, and the question comes from Peter Welford from Jefferies. Please go ahead.

Peter Welford: Hi. Thanks for fitting me in. A quick, more broader one on radioligand therapies given we’ve seen some big competitors potentially try and get into this area. Curious if you can remind us of the barriers to entry that you see you can build in this space, and also what your thoughts are in terms of presenting data internally from both the actinium and also potentially using antibodies together with your radioligands rather than just some of the peptides that are currently used in the portfolio. Thank you.

Vas Narasimhan: Yeah. Thanks, Peter. The first thing, of course, is building up the supply chain. And here, you’ve got to be able to source the upstream, source materials, be able to produce the lutetium, and then have the ability to do the manufacturing of a radioligand in a sterile environment. And then have the ability to run that supply chain with five days to get it — or less actually, it’s really three days. You have to get it to the physician in their office to be able to administer, or in their center to be able to administer. This is a major logistical challenge. We’ve worked on it now for many, many years. We’ve built up the global supply chain to have really unconstrained supply between our sites in Europe and our two sites in the US with plans to add additional sites in Asia and potentially add additional capacity in Europe and the US.

I would also say, on the supply side of things, we’ve invested heavily in semi-automated and automated lines, which puts us at the forefront, we believe, technologically in the industry to produce high volumes of radioligand therapy. So I think that’s one piece of the puzzle, is really solving that supply chain topic. We’ve had our bumps along the way. But I think it’s not straightforward for a biotech or pharma company that lives in the world of inventories and not — and having the luxury of having six months of inventory on hand to having a medicine that has zero inventory in which patients and physicians expect the medicine to be delivered on time every time. So really just-in-time delivery. Second is to build up the expertise to have a broad RLT pipeline.