Novo Nordisk A/S (NYSE:NVO) Q1 2024 Earnings Call Transcript

Louise Chen : Okay, thank you for taking my question. I just wanted to ask you for SELECT, has the approval actually helped you gain better coverage of some of Semaglutide with your peers? And then secondly, on your ESSENCE MASH data, we’ve received a lot of questions on that. I’m curious what you feel would be a good outcome to give you confidence that you have a commercially competitive drug. Prior, you had said it was end of the year for readout, but now it’s, we’ll you said it’s coming out in second half of 2014. I didn’t know if there was an acceleration in the timeline. Thank you.

Daniel Bohsen: Thank you, Louise. Doug, SELECT and the implications for the U.S. market?

Doug Langa : Yep. Thank you, Louise. Maybe as a starting point, it’s probably good to remind you that currently we have over 50 million people that we’re covering living with obesity. Now, there’s still room to grow, and certainly that’s our ambition, but we’re pleased with the level of access today. Again, I think it’s also important that, as you know, in March, Wegovy was – the label was expanded based on the SELECT data trial, and to become the only, I repeat the only AOM with proven CV benefit. So, we’ve already seen an impact of the label update with CMS allowing for reimbursement in Medicare Part D for AOMs with a CV indication. So we’re pleased with that. Now, there’s still some work to do with planned sponsors on the exact criteria of reimbursement, and so we think the uptake will be gradual, a couple million today. But overall, we’re pleased with the level of access, and we think we’re going to take advantage of SELECT moving forward.

Daniel Bohsen: Thank you. Doug, Martin on MASH?

Martin Holst Lange : Yeah, thank you very much. So as a reminder, the ESSENCE trial is in two parts. First, 800 patients treated for 72 weeks, which will be the regulatory trial. Here, the primary endpoint is liver biopsy assessment of steatosis and fibrosis. What we hope to see is basically what we saw in our pretty large Phase 2 trial, where we saw a significant and clinically relevant improvement in steatosis and also clinically relevant improvement in fibrosis. If we see the same level in Phase 3, we would be looking at a very attractive profile. This is also what allowed the FDA to grant us breakthrough designation based on the Phase 2 data. Then in addition, we are extending the study to an additional couple of hundred patients where we will continue treatment to look for heart outcomes. So basically, both liver-related and also cardiovascular heart outcomes, also to cater to the broader, both clinical as well as payer discussions.

Daniel Bohsen: Thank you, Martin. We are now ready for the next question.

Operator: Thank you. We will now go to the next question. Your next question comes from the line of Evan Seigerman from BMO Capital Markets. Please go ahead.

Evan Seigerman : Hi all. Thank you so much for taking my question and congrats on all the progress. Can you walk me through some of the expected pricing dynamics for Wegovy in the United States? And I’m asking this in the context of, why are you necessarily giving price given that, supply is constrained and the demand is so high? Maybe walk me through how you’re thinking about how this will evolve over the next few quarters. Thank you so much.

Daniel Bohsen: Thank you, Evan. So Lars, will you give that a go?

Lars Fruergaard Jørgensen : Yeah. So thank you for that question. So we strongly believe in the value of our GLP-1 products, and we just spoke about some of the very nice outcome data we have achieved. So we have a situation where we are gradually increasing access to more and more, say, channels of the market, which comes some of those with a lower price. It’s really a sign of us reaching more and more patients and also some of the more vulnerable patients that’s impacting the pricing dynamics. We see an overall stable competitive environment. With the volume of (inaudible) we have at hand, that significantly outweighs what we see in terms of lower price points in some of these additional channels. So strong belief in the value of our products, but also a wish to treat more and more patients, and some of those come at a slightly lower price point than what we launched at, so to say [ph]. Thank you.

Daniel Bohsen: Thank you, Lars. Thank you, Evan, for the question. We’re ready for the next question.

Operator: Thank you. We will now go to the next question. Your next question comes from the line of Sachin Jain from Bank of America. Please go ahead.

Sachin Jain: Hi there, Sachin Jain, Bank of America. Two for Martin, if I may. Firstly, back on Mim8 and the zero bleed rate you referenced Martin. I think at the CMD you referenced a 70% zero bleed rate post hoc analysis. I think Hemlibra’s got about a 50% zero bleeds on the label, but Roche quotes 80% to 90% in real life. So given the sort of various benchmarks, just what zero bleed rate for you as an absolute number confirms a superior profile versus Hemlibra for the caveat of cross trial comparisons? The second question is on Amycretin. Maybe I misunderstood and perhaps I didn’t hear your commentary correctly. You’ve referenced a Phase 2 start towards the end of this year. From the CMD, I thought you were awaiting a sub cut date early next year and the diabetes data next year before potential Phase 3 start. Did I misunderstand at the CMD or has something changed since then? Thank you.

Daniel Bohsen : So, thank you Sachin. Two for you, Martin. First on Mim8 and then on Amycretin timeline here.

Martin Holst Lange: Thank you very much, Sachin. So first of all on Mim8, obviously I can only compare the regulatory data and what is in the label. I think you are right. What we’ve seen so far in our clinical trials is slightly in excess of 70% of patients with no bleeds, which obviously if that is also confirmed in Phase 3, will be a very competitive profile. So this is what we’re looking for and then again, you have to compare like-to-like for the regulatory studies. On Amycretin, I don’t think you misunderstood anything. We for better or worse had to focus from a regulatory perspective on obesity and diabetes as two distinct entities. And for obesity we are currently in the process of finalizing the subcutaneous Phase 1 and then we’ll look at how to further progress Amycretin in obesity. For type 2 diabetes, we are currently in the process of conducting a Phase 2 study to understand the potential of Amycretin in type 2 diabetes.

Daniel Bohsen : Thank you, Martin. Thank you, Sachin. We are ready for the next question.

Operator: Thank you. We will now go to the next question. And your next question comes from the line of Peter Verdult from Citi. Please go ahead.