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Q2 2018 · Earnings Call Transcript

Aug 8, 2018

Executives

Richard Vosser - JPMorgan Securities Plc Lars Fruergaard Jørgensen - Novo Nordisk A/S

Richard Vosser - JPMorgan Securities Plc

Welcome, everyone, to Novo Meet Management after the second quarter results. It's my great pleasure at JPMorgan to host Novo here at Victoria Embankment.

I'm Richard Vosser, European pharma analyst and I'll just hand over, at JPMorgan, I'll just hand over to Lars who will kick off the webcast section of the Meet Management Day. Lars?

Lars Fruergaard Jørgensen - Novo Nordisk A/S

Thank you. Richard, and thank you to JPMorgan for hosting us and thank you, all, for showing up.

I will give a brief presentation here and set the scene for Meet the Management. And then there's an opportunity to rotate and meet all of us in three sessions.

I'll start by talking through the sales performance in the first half year. It's well known to you that we grew sales by 4% in local currencies.

We are pleased with that development. We saw a strong 8% growth in international operations, so outside of the U.S.

that was helped a bit by the tender of NovoSeven in the first quarter. So, underlying we're seeing a growth of 7%, so this is very strong growth.

And you can see from the regions that we see good contributions coming from all regions. In Japan, we are going through a price reform that impacts NovoRapid and NovoMix this year, but we are actually growing market shares in the insulin category, so I actually think we are executing quite well also in Japan, despite the fact that we are seeing a lower growth here.

If you look at North America, it's flat growth in local currencies and this is a half year where we have a tough comparator in terms of some positive rebate adjustments in 2017 in second quarter, and also at year end. And then we have a negative $300 million rebate adjustment on Victoza that hits us in the second quarter of 2018, which is unfortunate because it destroys a bit the image of the performance in the U.S.

because we are actually executing quite well. We are growing the Tresiba market share, so in the basal category, we have grown market share by 3% and with the launch of Ozempic and the CV label for Victoza, we're also bouncing back and now growing quite strong in the GLP-1 markets.

And if you look at the launch of Ozempic, we have, during the first half, gradually built market access, so now we're at a point where we have more than 60% market access, as we exit June. And we have captured 15% of the new scripts, and I view that as very strong performance.

And we are on track to deliver more than DKK 1 billion of Ozempic sales for 2018. And as we have talked about, it's really the exit, access, and performance you should judge Ozempic performance on.

So we like what we see and believe we are on a very good trajectory. Looking across the therapy areas, flat insulin growth which is an underlying strong growth in international operations of 7% and a decline in the U.S.

linked to the rebate adjustments we talked about and price inflation in the basal category. GLP-1 growth of 14%, 13% in IO, 15% in U.S.

and again there an impact from the rebate adjustment in Q2 on Victoza. Biopharm declining by 1% because of competition to NovoSeven from Hemlibra.

And then I already mentioned that we see exit benefit from the timing of the NovoSeven tender in Brazil in first quarter this year. We didn't have that first quarter in 2017 so the underlying decline is actually 5% in biopharm.

But, again, we are pleased with the commercial execution we have seen in the first half gaining share on key products and off to a strong launch of Ozempic in the U.S. and also in Canada.

If you look at R&D, the key focus area for us entering 2018 was to execute and get good data on all semaglutides. So if you look at how we have executed on the PIONEER trial, I believe we have done a very good job and I'm also very encouraged by the data we have seen and we believe we see the emergence of a best-in-class OAD that also specs up to what some of the GLP-1 products can do.

We're still waiting for the final data throughout this year but we believe we are on a very good track here indeed. I would also highlight that we are now in full swing with the sema obesity trial, the STEP program, and we have high expectations for that also.

And then sometimes we forget to talk about biopharm, but there's also a biopharm course (05:19) in the breakout session today. And I actually think it's encouraging to see that with the portfolio we have, we have opportunities to grow both organically by getting more products to markets all around the world and we see that we have Refixia approval in Japan.

And we also believe that we're getting a good market access situation there. And then we have phase two data on somapacitan and we believe that this can turn into be potentially the best long-acting growth hormone.

And this is another area where there's unmet need for the patients and the children that needs to go on a growth hormone treatment. This is a quite meaningful improvement that we can do, weekly growth hormone treatment with the same efficacy as we see with the short-acting agents today.

If you look at the P&L, 4% growth, as I mentioned, and also 4% growth on operating profit. You can see that we are investing a bit more in S&D upfront from the beginning of the year than we have done in some years.

So, we believe we have significant opportunity and we're backing that with promotional activities. We are now live with, I believe, a very nice D2C campaign on Ozempic.

And if you haven't seen it I can highly recommend you to see it. I think it's very good.

And we believe that can help drive Ozempic even further, going forward. There's a significant change on tax.

We have managed to close some bilateral discussions between the Danish tax authorities and authorities in India and China. That has taken out some uncertainty on the tax front and that benefit we booked in second quarter of 2018.

In terms of guidance, we have kept our guidance unchanged in local currencies. And then you can see that in reported currencies, we see a benefit both on sales on 1 percentage point, and profit on 2 percentage points.

And then I would like to just comment on one thing that was key question yesterday, and that to know our contracting for 2019. So we wrote that we expect broadly unchanged access and we saw a continued price pressure, predominantly in the basal category.

So, these are, I think, encouraging directions for 2019, and in that you should also understand that we see a stable pricing environment for the portfolio outside of the basal category. So, a stable pricing environment and a broad access situation compared to also what we had this year and I think that's a strong platform for us to go out and execute commercially and continue to drive share both in the insulin and GPL-1 space.

If you then look a bit ahead on our strategy and the opportunities we haven't had at hand. We see that across all areas there are significant unmet medical needs for Novo Nordisk to address.

I believe it's well known for most that of the more than 400 million people who live with diabetes, it's only a fraction, down to 6%, who actually live lives without the risk of developing late-stage complications. So the majority of patients are not in good control and that's based on the efficacy of the products we have today, the treatment setting, the convenience, so we believe there are significant opportunities for bringing better products to people with diabetes.

And I think it's justified or it's supported by significant uptakes you see when new products are launched because physicians are in need of better medication. If you look at the obesity space, we have 650 million people who are obese and we're down to 2% who get medical treatment today.

And obesity is often talked to as one of the big issues for society. It's obviously, a leading indicator of developing diabetes but also a leading cause of a number of cancers.

So we believe it's really important that obesity, to an increasing degree, is seen as a medical condition that needs to be addressed by medical intervention. It will not do the whole trick, but it's a key part of actually addressing obesity.

In hemophilia, we see that despite a number of advancements in the new products still 50% of all patients with hemophilia live in constant pain. So another example of significant unmet need and a market that's open for better medical treatment.

And then we're looking to grow into adjacent areas, and we have defined a number of adjacencies where people who are obese or people who have diabetes actually have adjacent diseases compared to what we work on. So NASH is an example of a disease area where 80% of those who have NASH are obese and a bit more than a third also have Type 2 diabetes.

So these are patients we deal with already. Another example is atherosclerotic cardiovascular disease, there's a big overlap with diabetes and cardiovascular disease is leading cause of death for people with diabetes.

There are patients we work with already. And for both disease areas, we have technologies that work, so when you look at semaglutide, we believe semaglutide can play an important role in those disease areas.

So just like we have entered obesity based on GLP-1, we believe we have a great opportunity to expand into some of these other serious chronic diseases based on relationship with physicians, patients, and technologies we already have. You'll have an opportunity to discuss a lot of these aspects when we have the breakout sessions with management.

At the Capital Markets Day, we spoke about these six strategic priorities. They are unchanged.

So it is about growing and expanding our part of the GLP-1 segment. It's about driving insulin share both from a value and volume point of view.

It's about building the obesity market. We are the leader in the market today, so it's about broadening market access, training physicians in it.

We have an ambition to get biopharm back to growth, to avoid that it's a (12:21) drag on growth today. There's some organic and nonorganic initiatives behind that.

We're also investing in innovation and looking at for instance how digital health can help patients that live with both diabetes and obesity. And last but not least we have an opportunity to raise the innovation level in what we do both in our existing areas, but also in some of the adjacent areas, generating both new growth opportunities but also serving more new patients to avoid that we have too much cannibalization in our future growth.

So these are exciting opportunities that will generate growth for the future, and we have prepared to have sessions with all you, discussing these in the three rounds. And the way it's organized is that this great hall will be the home of the first set of discussions, and I will myself and Camilla be in this room.

In the library of course we have the professor, Mads Krogsgaard and Jesper Brandgaard. And then we have in UO2 (13:27) Karsten Munk Knudsen and Mike Doustdar.

I believe you should have all received, maybe on your name tag, I'm not sure, a flow events (13:36). So you'll have opportunity to rotate among the three groups, and the first discussions will start at 1:00.

So just to conclude, I believe we're off to a very good start for 2018. We are pleased with how we execute commercially.

We are taking market share in the U.S. in the basal category.

We are turning around our performance in GLP-1 both in the U.S. and outside the U.S., and we have very strong underlying growth in international operations.

And we are quite confident about how we can take this forward, and we see an overall stable environment as we go into 2019. So with that, thank you for your attention.

I look forward to meet you all in the breakout sessions. Thank you very much.

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