Novo Nordisk A/S (NYSE:NVO) Q4 2022 Earnings Call Transcript

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Simon Baker: Thank you for taking my questions. Two if I may, please. Firstly, and this relates to some earlier questions. In recent years, the increased spend in the U.S. on GLP-1 was offset by lower spending on insulin, which gave some easy headwinds for the category to expand. I was just wondering if you could give us an update on whether that is still the case? And then you talked about the impact of the Dicerna acquisition on 4Q R&D. I just wondered if you could give us an idea how much of the additional R&D expense incurred was one-off and how much is continuing? Thanks so much.

Lars Fruergaard Jørgensen: Thank you, Simon. I don’t know if you have those data, Doug from the top of your head.

Doug Langa: What I would say is this, that insulin, as you saw, as we just reported, continue to be under pressure, pricing pressure, so payers still continue to take value there. And as I mentioned earlier, there’s still only approximately 10% of the prescription volumes coming out of GLP-1. So we still think that there’s opportunity there.

Lars Fruergaard Jørgensen: You can add that to DPP-4, price decline and soon to come SGLT2 will also create some space to fund innovation. So yes, Karsten on Dicerna. Any one-off versus continued.

Karsten Munk Knudsen: Yes, Simon, as we’ve been communicating all along in terms of our overall strategic resource allocation, then we are highly focused on allocating additional resources towards R&D to expand and diversify our pipeline. And that you’ve seen throughout the year with a significant step-up in R&D spend ending at 29% for the full-year. You’re right that in the fourth quarter, we have an extraordinary step-up also when you do the quarterly trending. It’s not due to Dicerna because we had the Dicerna all along. So it’s basically due to two factors: one being, a, I would say, minor impairment on intangible assets and another piece being costs related to the Forma Therapeutics transaction and restructuring. And as you recall, then here at Novo, we are reporting clean numbers.

So where other companies would have been — some of the companies have been adjusting this into core earnings or adjusted earnings, then here you get what you see is what you get. As to a specific number for Q4 in round terms between the two impairments and Forma around DKK 0.5 billion.

Simon Baker: Thank you very much.

Lars Fruergaard Jørgensen: Thank you, Simon. We have time for the final question.

Operator: Thank you. We will now take the next question. It comes from the line of Mattias Häggblom from Handelsbanken. Please go ahead. Your line is open.

Mattias Häggblom: Thank you so much. Two questions, please. Firstly, with regards to the decision in January to double down and initiate the high dose sema obesity trial. I’m curious to understand what triggered the decision and why now almost 1.5 years after the Wegovy approval and why not earlier? And then secondly, with top line data from SELECT data due mid-2023. What’s a reasonable time frame from top line results and the data can help facilitate reimbursement outside the U.S., a year or is it rather two, given the size and complexity of the study?

Lars Fruergaard Jørgensen: Thank you, Mattias. So you mentioned high-dose obesity right now.

Martin Holst Lange: So first of all, we see emerging data suggesting that it is possible to max out on GLP-1 biology. And it’s very, very clear based on some of our recent start is that we could potentially increase exposure and thereby accruing more weight loss than what we see with the current doses. There’s obviously, we had to pursue, we have to investigate because there is an opportunity to, without compromising on safety to accrue even more weight loss, specifically in obesity and potentially also improved glycemic control in diabetes. We aim to conduct these studies very, very fast, and that also means that they will be available to patients if the data supports it in an also distant future and still well within the relevant time period for semaglutide.

Lars Fruergaard Jørgensen: Then there was a question on time line from SELECT data to reimbursement. So ballpark without going into too much detail.

Martin Holst Lange: So some of you have heard about, I was breaking about being able to obviously handle our clinical data in a reasonable way. I would not be looking at a one to two year timeline. Obviously, we will close down the study. We will have the results around mid this year. We’ll do a regulatory file, and then we’ll have the regulatory interactions. And then it’s in U.S. up to Doug and his team to discuss with payers and others on how that will impact the dynamics.

Lars Fruergaard Jørgensen: Thank you, Martin, and thank you, Mattias, and thank you all for participating in our earnings call. Please reach out to our Investor Relations Officer, if you have more questions and look forward to meet you and talk to you in the near future. Thank you very much. Bye-bye.

Operator: That does conclude our conference for today. Thank you for participating. You may all disconnect.

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