Earnings Labs

Novo Nordisk A/S (NVO)

Q1 2017 Earnings Call· Wed, May 3, 2017

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Transcript

Keyur Parekh - Goldman Sachs International

Management

Good afternoon, and thank you, all, for joining us. My name is Keyur Parekh, and I cover Novo for Goldman Sachs. It's a pleasure to have the management team from Novo here post Q1. I'm not going to waste a lot of time. So, Jesper, straight over to you for making opening remarks, and then we can go to Q&A from there. Jesper Brandgaard - Novo Nordisk A/S: Yes, we're basically on the road with our first quarter results, and a good first quarter, probably better than what we anticipated, but partly marked by some one-time effects that makes it looks probably slightly better than the underlying trends. What we are going to go through here is basically highlights and key events, I'll handle that. And I will do a few comments on the sales and hand over to Christian, our Head of Global Marketing, who will review the performance of our brands. Mads will give an update on R&D; and our Head of Corporate Finance, Karsten Munk Knudsen, who will cover financials and outlook. Of course, making predictions about the future is inherently difficult, including making predictions about what happens to U.S. healthcare politics, which is changing by the day. So do read this with some caution to note the difficulty herein in making predictions about our future. The first two months of the year came out quite positively. Do bear in mind that the first quarter is marked also by significant currency tailwind. The full year is expected to have modest currency tailwind and the prime part of that currency tailwind we have actually realized in this first quarter, if currencies stay where they are. So, sales realized a 5% growth, 3% local currency and driven by North America, with a 5% growth in Danish kroner, but 2%…

Keyur Parekh - Goldman Sachs International

Management

Keyur Parekh, Goldman Sachs. I'll let Peter ask his customary access question for 2018, but I'll focus on the two separate issues. One, Jesper, you guys sound a lot more confident about the obesity approach than you historically have. Is that reading too much into it? Can you just talk about how you see that market developing? And then secondly on China and Victoza kind of on the cusp of potentially being on the reimbursement list, just help us think about that opportunity. And then, Mads, from your perspective, what's going to be the big highlight at ADA? What do you think we will learn new, what will change our perceptions from ADA? Jesper Brandgaard - Novo Nordisk A/S: Thanks, Keyur. First on obesity, I think it's apparent to us in our annual strategy update that we will present to our board of directors here in June, that you will see us place a significant more emphasis on the opportunity within obesity. And it's really coming from realizing steady growth in the markets we go into and we are realizing steady growth both in markets where we have reimbursement and in markets where it's privately paid. We're also seeing that patients are staying on product in a reasonable period, so it's not very volatile sales, it's relatively stable. I think some of the flexibility we have achieved in our cost structure by the cost initiatives we've taken over the last nine months, we would utilize that in investing in building understanding of the opportunities for medical treatment of obesity. And I think Christian can probably comment a little bit on that. And then, Christian, if you also want to comment on the opportunity of getting reimbursement in China, you were our former President of China and the expert there. Christian…

Michael Leuchten - UBS Ltd.

Management

It's Michael Leuchten from UBS. Two questions, please. One, there was quite a bit of discussion yesterday on the Tresiba prescription trends in the U.S. after the UnitedHealth exclusion that's kicked in. You've mentioned the NBRx share in your opening remark, could you talk about the changes you see in NBRx versus TRx weeklies and what that may mean – you've obviously stated your confidence in the 10% market share? And then a second question on R&D, could you talk a little bit about how you've gone about pruning the early part of the portfolio towards the end of last year? How those decisions were taken and why? Jesper Brandgaard - Novo Nordisk A/S: If I first comment on the Tresiba and then, Christian, if you want to add, you're welcome. And then, Mads, you will talk about the pruning of the research portfolio. In terms of the trends for Tresiba, of course, it is pretty difficult to read anything conclusive out of NBRx trends whenever you have changes in formulary as these kind of tend to overstate the movements. However, what we can see when we approach the CVS conversion is that we are back at the level of capturing 12% to 13% of new patients. We are not largely impacted on Tresiba from the UnitedHealthcare conversion as that is mainly a conversion between Lantus and Basaglar with a slight spillover to Levemir. What we're seeing now is a trend that make us confident in our ability to reach the 10% which we set out as our objective as the ending market share for the year, but it's not an NBRx level that enables an acceleration of that level. And that's not fully satisfying for Novo Nordisk. So, we're continuing to work hard on that, including slight changes to…

Sachin Jain - Bank of America Merrill Lynch

Management

I'm Sachin Jain, Bank of America. Mads, you touched on SUSTAIN 7. I'm wondering if you just talk about in a little bit more detail what delta is needed for superiority (41:46). Is that a must-have study or is it a nice to have given the timing versus the approval at the end of the year? And then probably as we talked about the Xultophy sort of re-launch or launch in the second quarter, could you just talk a little bit more about commercial positioning? I think we've all been at ADAs, and the physician feedback on this has been very strong. Some of that isn't reflected in the label and you've a very different price point to SOLIQUA. Maybe just touch on how you plan to position versus your existing portfolio and more importantly versus the competitors? Thanks. Jesper Brandgaard - Novo Nordisk A/S: Okay. First, Mads on SUSTAIN 7 trial and the positioning of that trial. Mads Krogsgaard Thomsen - Novo Nordisk A/S: Well, the SUSTAIN 7 is a relatively big trial. In many ways, you could say just another phase 3b trial. That being said, we expect to have in the packet insert ND SmPC (42:40) very strong data up against Bydureon, Lantus, Januvia and so on, but we all have to admit that Trulicity is the first very, very competitive once-weekly GLP-1 agonist. So almost by inference, this is a very important trial and the way it's done is in a way two trials in one trial because we are going head to head 1 mg versus 1.5. We're going head to head 0.5 mg versus 0.75 (43:05). That means that the statistical independence between those analysis and the statistical hierarchy is made in such a way where we start of course by showing we're not…

Unknown Speaker

Management

Just two follow-ups, one for Jasper, one for Mads. Just on Xultophy, when you speak to the (52:56) they lament the fact that the label is not allowed to use in OAD failures. So that's where the best data is. So could you remind us why the FDA decided that they weren't going to give you a broader label? And whether Nova will be willing do any more in terms of further clinical development to get that down the line? Or whether (53:15) why pay for two drugs to get 80% to go, when I just pay for one to get 60%. And then, Jasper, when you talk about 2% to 3% global price pressure that you baked into your forecast, I mean it'd be unfair to ask you at this stage, but does that accommodate Sanofi being extremely aggressive, and trying to fight back in this round of contracting? Is there the belief in the market that you might be quite conservative? Or do you believe you will be overly conservative on your price expectations? I realized it's early but trying to kick the tires there. Thanks. Jesper Brandgaard - Novo Nordisk A/S: All right, Mads, if you start on Xultophy, then I'll try to once again giving comment on ongoing negotiations with the inherent limitation (54:01). Mads Krogsgaard Thomsen - Novo Nordisk A/S: So, Peter (54:04) already when we in European discussions with Xultophy, some of the European member states had the opinion that to start on two different biological entities at the point in time where you are still injection naïve was to be considered an overkill, because you still had some opportunities either in the oral space or single agent use such as the GLP-1. So personally, I was not taken by surprise by the FDA…

Richard Vosser - JPMorgan Securities Plc

Management

Thanks. Richard Vosser with JPMorgan. I have just two follow-ups. Just on the Xultophy extra clinical development, just – you started a Tresiba versus Toujeo study. There is an obvious potential of doing Xultophy versus SOLIQUA, so just a thought there. And clearly, your products – I think your comments were prioritizing semaglutide anyway, but just a thought whether you would do that trial. Then, secondly, just whether this guidance this year leaves any remainder of – for this year's guidance, whether there's any U.S. pricing reform from Trump in there? I think not, but if there is, then should we just be thinking about rolling that as a pressure into 2018? Thanks. Jesper Brandgaard - Novo Nordisk A/S: Okay. I think I'll deal with the guidance question first. And then I'll give to Mads the head-to-head on Xultophy after. In terms of the guidance, we have not anticipated in the narrowing of our range in terms of both sales and operating profit that there will be any significant impact this year. It didn't look likely to us that the U.S. regulatory process would be competed with an impact on 2017, when we had the discussion with our Board of Directors on Wednesday. But I must admit that it seems to be a changing environment every day. So it is hard to make prediction on, but no significant impact. And I think we would have to make explicit – once you had a legislation through, then actually accounting for this specific items, and it would be highly speculative to be there. It may come up for voting in the Congress today, but my understanding is that the Senate is looking at it, and let's see how it plays out. Mads, on Xultophy, should be do a head to head? Mads…