Novartis AG (NYSE:NVS) Q1 2023 Earnings Call Transcript

Mark Purcell: Thank you.

Vas Narasimhan: Next question, operator?

Operator: Thank you. Your next question comes from the line of Richard Vosser from JPMorgan. Please, go ahead. Your line is open.

Richard Vosser: Hi. Thanks for taking my question. I just wanted to follow up on Pluvicto as well. And just thinking about your supply into the second half as you ramp up the Millburn facility. So just some thoughts on the proportion of the 2024 target you might be — for doses you might be able to have in available in Q3 and by the end of the year, just to give us some idea of how that supply is going to phase as we go forward, thanks, in the second half? Thanks.

Vas Narasimhan: Yes. Thanks, Richard. I’d say, broadly, we believe we’re comfortable that Pluvicto exceed $1 billion in sales over the course of this year. And by how much will largely be dependent on when the additional lines are operational in Millburn, which we’re working very hard on to file those lines with FDA. And because this is an approved facility, that review is a relatively short review. And then ultimately, the Indianapolis facility, which we’re also raising now to file as well, which would lead to a further unlock. So, difficult at this moment to dimensionalize the scale above that $1 billion mark. And I think as we get those lines operational, I think by Q2, we can provide some better color on the scale of the supply increase.

Richard Vosser: Thanks.

Vas Narasimhan: Next question, operator?

Operator: Thank you. Your next question comes from the line of Emmanuel Papadakis from DB. Please go ahead, your line is open.

Emmanuel Papadakis: Thank you for taking the question. Perhaps I would take one on the longer-term implications of NATALEE the financial outlook. So, on the one hand, your previous margin guidance or getting above 40% from 2027. Does this reaffirm that outlook, or does it actually potentially tip the probabilities to the upside of that. And then on the other hand, your best system at the timing of potential IRA inclusion, price negotiation if the commercial opportunity proceeds as we hope it may. Thank you.

Vas Narasimhan: Yes, thanks, Emmanuel. So, first on the margin, I’ll give it to Harry. Harry?

Harry Kirsch: Yes. Manuel, thank you for your question. I mean, overall, of course, as we do our five to 10 to 15-year forecast on which we base our guidance to you all. There’s, of course, a portfolio with certain probabilities and all of that. We had, I would say, the NATALEE trial as an appropriate Phase 3 high probability. I would say, as we always mentioned, that was one of the disconnects of the consensus to our 4% CAGR. As I think when I looked at the consensus, there was almost nothing in the consensus for NATALEE, which I always find a bit strange, but in the end, everybody makes the estimates. So, that is certainly — we increased our own, of course, modeling now from a Phase 3, call it, 70%, 80% probability, to 100%, right, if you will, of course, approval still have to happen.

But we are close to that. So, it’s positive. It’s certainly supporting our case and I think that the confidence levels go up. Now, on the other hand, the 40%, I mean we always had very strong plans for the 40% to hit that margin in 2027. Again, when the topline is great on high-margin products, that is always helpful. Often I get the question and what’s beyond the 40%? I think let’s first get through 40%. And recall that 40% is for the new Novartis after Sandoz spin. So, it also includes roughly 1.3 points of corporate costs, right, which was back then when we gave guidance basically in the inherent upgrade. And then beyond that really depends on the product mix. But let’s first get to the 40%. Once we get closer, we will have more visibility on the mix beyond.

But I think it’s anyway important that we and you are confident in our topline growth, right, which is always the most important, the pipeline. Thank you.

Vas Narasimhan: And then I think, Emmanuel, on IRA, the Kisqali today roughly about a third of the patients are Medicare patients. So, I think it’s early days for us to forecast when exactly it would fall within the IRA. I think that we’ve previously stated we would expect it to be at the end of the decade, given that Kisqali’s LOE would be in the early 2030s. We think it would roughly coincide. But obviously, with the NATALEE data, now we’d have to obviously observe that over the coming years to get a better estimate of when we might qualify in our Medicare sales and also depending on how CMS ultimately measures the sales. As you know, that’s an ongoing topic. And when — certainly, the industry is planning to provide a full opposition to maybe some of the unfair approaches that are currently being taken by CMS, at least in our view. Thanks, Emmanuel.

Emmanuel Papadakis: Very helpful. Thank you.

Vas Narasimhan: Next question, operator?

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

Stephen Scala: Thank you. As noted earlier, when describing NATALEE results, Novartis refers to the benefit as consistent. When using the word consistent, we assume Novartis is referring to a consistent hazard ratio across and among all the relevant groups depicted on slide eight. Is that the expectation you want investors to have heading into the readout, or should that expectation be modified? Thank you.

Vas Narasimhan: Yes. Thanks, Stephen. Thanks, Steve. So we don’t want to provide excess data here, given that we have committed to present the data at upcoming medical congress. We want to preserve that and also preserve our ability to publish the data in a major medical journal. But certainly, when we say consistent benefit in a — when we say consistent benefit in a broad population of patients with stage II and III early breast cancer at risk of recurrence, we’re referring to the primary endpoint in the study. And I think that is always what we’re referring to when we look at that data. And I think then you can interpret that as you will, it will be hopefully soon that you’ll be able to see the full data set and understand better the specifics, both from the primary endpoint, but also the trends in OS as well. Next question, operator. Thanks, Steve.

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