Novo Nordisk A/S (NVO) Q1 2020 Earnings Report, Transcript and Summary

Thank you. Welcome to the virtual Q1 Novo Nordisk London Roadshow. This is Karsten Knudsen, CFO of Novo Nordisk. With me today, I have our CSO, Mads Thomsen; and our EVP of Commercial Affairs and Commercial Strategy, Camilla Sylvest. So we have a broader presentation that we will go through briefly in the next 15 to 20 minutes, after which we will go - move over to Q&A as in our normal London Q1 roadshow launch events. So first of all, I'd like to thank Michael Leuchten and UBS for hosting this virtual call. And we hope you're all safe out there, even though it's challenging times with the COVID-19. This is the agenda for today, and as usual, then this call might include some forward-looking statements. And of course, they're surrounded by uncertainty. And I would say even - or especially in these COVID-19 times, there is a certain level of uncertainty regarding how that plays out and consequences of COVID-19. In terms of COVID-19 and our response as a company, then early on in the spread of the pandemic, we saw what was happening in China. And as a company, we initiated a corporate crisis response team. And the team, we set out earlier, a couple of top priorities for - to guide the company through this crisis. One was to safeguard the health of our employees because without the health of our employees, then we would not be able to supply life-saving medicines to patients on a global scale, which is our second priority in this context. And then thirdly, we are also - while we've been navigating through the crisis, been very focused on how we, as a company, are able to support society, getting through the crisis in the best possible way, using our capabilities and resources to support that. In the fourth quarter of 2019, we hosted the Capital Markets Day. And as part of the Capital Markets Day, we launched a set of strategic aspirations, which are basically the aspirations we are pursuing from now until 2025, fully aligned with our corporate strategy, and basically saying, what are we aspiring to reach by 2025. In the first quarter, we launched a number of affordability options in the U.S. that we've been - that are out there in the public. Part of that includes a patient assistant programs for - that is linked to the new high unemployment levels in the U.S. So as unemployed, then people have the possibility of accessing free insulin for a period of time until they find the right health care insurance. Then we supported on a number of fronts, including international aid organizations vis-à-vis the COVID-19 pandemic. And then finally, we went live with our solar power field in the U.S., thereby securing 100% renewable power across all production sites globally, which in round terms is reducing our global CO2 emissions by more than 10% on a global scale on an annual basis. On investment and therapeutic focus, Mads, will go through the pipeline later on, but worth noting Rybelsus approval in the EU and U.K., Ozempic submitted in China and then this quarter, we reported the semaglutide Phase II data readout in NASH. So we'll come back to that. In terms of commercial execution, we expanded our diabetes care leadership in terms of value market share increasing by 0.7 percentage points, thereby moving towards our strategic aspirations of 33% diabetes value market share. Our obese business increased by 30%, thereby also tracking towards our aspiration of doubling our obesity care business over the period of the strategic aspirations. And biopharm grew by 16% in the quarter with some one-off impacts that we'll get back to later on. All in all, this led to a sales growth of 14% in the quarter, of which 7% was COVID-19 stocking related. And in turn, deriving 12% operating profit growth for the quarter also COVID impacted. So with that, I will hand over to Camilla Sylvest to go through the commercial execution for the quarter.

Thank you, Karsten. And before we get into the details of the growth and sales split, maybe fortify to just mention that we have established a new reporting structure in IO, meaning that we now have the EMEA reading consisting of Europe, Middle East and Africa. And for this - and we have booked a couple of regions for this purpose reporting here. We also have China consisting of Hong Kong, Taiwan and Mainland China, and then the rest of the world. And as you can see, the sales growth is distributed across all geographical regions, meaning that they are all contributing to growth. The 14% sales growth is around 7% when adjusted for the COVID-19-related stocking. And international operations is driving sales growth of 19% by all therapy areas. And the stocking effect that we see here is mainly in the EMEA region. North America operations sales increased by 9%. And here, the stocking is mainly at the patient level. When we look at how the sales growth is distributed across therapy areas, you see here that all therapy areas are contributing to growth. In insulin, we see a plus 2% increase with a very wide variation between the U.S. and North America and IO. So U.S. minus 15%, including Canada, driven by channel mix, high rebates and coverage gap, whereas in international operations, we see a growth in insulin of 14% driven by all insulin categories. In the GLP-1 segment, we see a growth of 37%, driven by a 30% increase in North America and 55% increase in international operations. And summing all of that up, it means that, as Karsten said, we are expanding our global diabetes value market share with 0.7 percentage points to 28.7%. That is driven by an increase in both the insulin volume market share to 46.5%, but also an increase in our GLP-1 market share of 2.2 percentage points to 43.3%. Obesity grew by 30% with an equal split between international operations and North America. And biopharm grew by 16%, primarily driven by Norditropin and hemophilia products, as you can see. When we look at the details of the early results uptake, you see from this slide on the left-hand side, that Novo Nordisk has a total GLP-1 NBRx leadership of 50 - almost 58%. We have also a TRx GLP-1 leadership of 48%. We see a continued uptick of Ozempic now with NBRx leadership compared to Trulicity of 36.6%. And on the TRx and continued improvement in our total market share are now at a level of 24%. Rybelsus is - has progressed to 8.8% NBRx and 2% total scripts. And here, it's also important to say that the market access is progressing and is now above 50% unrestricted access, and we expect that to gradually increase over the year. Also in IO, we are now gaining market share in the total diabetes value market share segment, driven by growth also in both insulin and GLP-1. And you see here that our share of growth is now above our total diabetes market share. What's driving the growth in IO, you see on the right-hand side, you see that insulin sales is driving 44% of the growth. And GLP-1 is driving 35% of the growth with a distribution that makes insulin still the bigger growth driver in most of the regions so far. On obesity, we had 30% growth in the quarter. We now have launched Saxenda in 46 markets, and we are continuing to invest in market development. We have a market share of 39% in IO and 72% in North America. However, our efforts is less focused on keep gaining market share, but more on developing the market to meet our long-term aspirations of also doubling our obesity sales by 2025. In biopharm, we see growth of 16%, driven by hemophilia and growth disorder products and especially also 7% growth in NovoSeven sales and also a continued global rollout of our innovative products in the hemophilia area as well as a growth of 28% for Norditropin, driven also by some stocking and change in inventories, but also an additional demand due to the competitive landscapes in selected countries. And now I'd like to hand over to Mads for an update on our R&D.

Thank you, Camilla. And if we turn to the next slide, I'll just start by saying that ever since [indiscernible] showed the 39% NASH resolution with liraglutide 1.8 milligrams in NASH in the U.K. in the Lancet paper 5 years ago. We've been intrigued by the potential of GLP-1 in the NASH field. And we're happy to now report the outcome of a large Phase IIb biopsy-driven trial dose response for semaglutide versus placebo and what you can see here is that sema 0.1, which corresponds to a lira 1.8 milligram dose in terms of metabolic efficacy actually also provides 40% NASH resolution coinciding more or less with what we have seen before. And then growing all the way up to 59% NASH resolution as the primary endpoint versus 17% on placebo. In this study, the drug was well tolerated. There were 4 discontinuations in the high dose group as well as in the placebo group, 4 out of 80. So low discontinuation, it's good safety and tolerability. And there were numerous readouts on secondary endpoints in terms of FibroScan imaging based elastography in terms of health biomarker test panel in terms of numerous other assessments of fibrosis, that actually point to the fact that semaglutide is arresting the fibrosis progression, including also the histology assessments, arresting the progression, but not significantly reverting progression during the course of these 72 weeks. So very, very encouraging and exciting data that will be discussed with the relevant stakeholders, including regulators in the near future. On the next slide, this is to preempt what will promise to be very exciting times, I hope, for the evolution of obesity management or therapies in the industry, namely the STEP program. And the first of the STEP trials for semaglutide in obesity once-weekly 2.4 milligram is the STEP 4. And I'll just spend a few seconds on explaining the somewhat strange design of the trial. It's a trial where people essentially are escalated to 2.4 mgs of sema over a period of 20 weeks. And at this point, they're then randomized to either withdraw therapy or continue therapy. So this will draw a design in a way, mimics a little bit what happens in the real-world that people treat themselves for 5 months, then they stop and put on weight again. Here, it will be exciting to see what is the difference between whether you actually treat yourself for a full 68 weeks with semaglutide or if you withdraw the drug already after 5 months. So it's actually an interesting trial that mimics a little bit a real-world situation of chronic therapy versus abrupt therapy, and that will then be followed by a classic STEP 1 obesity trial, a STEP 2 diabesity trial and a STEP 3 combination interventional therapy trial. All of that is coming during the first half of this year and hopefully gaining for a submission during the latter part of the year and the regulatory review. We're excited by this, and the SELECT trial will, of course, continue, hopefully, to show cardio protection in the nondiabetic context, namely in obese individuals. Finally, just to wrap up, there are many exciting results, milestones and approvals throughout the rest of the year. I would just right now highlight the quarter here, what will follow is, in Phase I, the PCSK9 peptide LDL lowering readout from Phase I in Phase II, it's actually the [indiscernible], the new WHO name for the Amlin 833, once-weekly analog that reads out in monotherapy plus in Phase Ib in combo therapy for 4 months together with semaglutide. And then in Phase III, it's, of course, the STEP program. And in terms of approval, the most important thing will be the Japanese Rybelsus' approval, which is relatively imminent. I think with that, I'll hand it over to Karsten.

Yes. Thank you, Mads. Briefly on financials. So as you saw, we reported 14% sales growth and 12% operating profit growth. When we adjust for COVID-19 stocking-related effects in the first quarter, then sales growth was 7% compared to the 14%. And if we further adjust for the one-off reversal of Rybelsus preapproval inventories in Q1 last year, then our operating profit growth was 4%. And the reason for our profit growth being lower than the sales growth on an adjusted basis is basically driven by a low R&D spend in the first quarter last year, then it's more or less a flat operating margin and do note a 48% operating margin in the quarter. Net financial items, impacted by a significant deterioration or depreciation of emerging market currencies, very much linked to the oil price in countries like Russia, Brazil, et cetera, impacting net financials significantly in the quarter. All in all, diluted earnings per share up 16%. In terms of the outlook for 2020, we maintain our outlook across all the main parameters with only one exception, which is on financial items. And that - where we have a movement from DKK 1.5 billion to DKK 2.5 billion. And that movement is for all practical purposes explained by the depreciation of emerging market currencies I just spoke to before. So with that, we'll end our presentation. This is just a slide showing our key focus areas and milestones for 2020 that links to our strategic aspirations for 2025, including a news, heavy R&D news flow here in the second quarter of this year that we are all looking forward to. So with that, I would like to open up for Q&As. (Operator Instructions) And I would like to give the first set of questions to Michael Leuchten from UBS.

[Operator Instructions]. The line of Mr. Michael Leuchten from UBS is now open.

So I'd start with one question actually. We spent a lot of time on NASH yesterday. On the international business, so on the IO business, I was wondering if you could talk a little bit in more detail about the trends in Q1. We saw very strong performance in China. You did refer to some tender business or phasing there. But when we look at the corridor that you said, the 6% to 10% for your international business. Obviously, the business seems to be tending towards the upper end of that range. So as you look at the performance and strip out the phasing, is there anything else that is worth flagging that would give us confidence that we can actually see the growth range ending up in that upper end of the corridor for the rest of the year? Or is it really an extraordinary quarter in Q1, and we should see a reversal to something more moderate in the second half?

Okay. Thank you, Michael. And when you look at our business mix or geo mix, then it's clear that our operations in IO are performing extraordinarily well. You will recall that last year, IO grew 11%. And when we adjust out stocking and you say, some of the shipment phasing in IO in the first quarter, then the number would be around the 10%, 11% mark. So clearly, in the high end of the 6% to 10% range we indicated in our strategic aspirations. One should always be careful with looking at IO on a quarterly basis. But I would say that we see very solid traction going for IO last year and into the first quarter. And then you could say the balancing factor is, of course, COVID impact over the coming quarters as well as stocking impact that you would have to take into account. And then finally, there could be some periodization of product launches. But all taken together, very solid trends for IO for the quarters to come. We're not guiding specifically on where we are in the range. But I think underlying, we're trending very positively in IO.

[Operator Instructions]. Our next question comes from the line of Jaxie Liu from Billy Gifford.

And it's great to hear about your progress this quarter. And I was just wondering if you could speak to any lasting effects that you might have considered or noticed even from this COVID crisis?

Yes. That's a really good question. And when you look at how to navigate through COVID, then people are dividing it into a number of phases. So initially, it's simply about getting over and control of the entire situation then stabilize the business then prepared to get out on the other side. And as part of that, look into what can we bring with us of learnings and practices from COVID-19. I would say, as a company, when we look at it, then just talking through the value chain, then I would say, on our supply chain side, I think we're very happy with how we've managed COVID-19 thus far with all the factories running. But of course, when you put more pressure on the system, then it's also more clear where potential weaknesses are. So we have good learnings to become an even more resilient manufacturing organization in the years to come. In R&D and executing trials, I would say, one of the learnings we have is how to work even more remotely. And one example could be in executing our trials and using more digital means in terms of our trial execution. Something that we've been looking at already for a while, but a trend that we believe will be accelerated in the years to come. Commercially, I would say, the commercial approach for us and many other pharmaceuticals is based on sales reps detailing GPs and having visits and doing sales calls. And I'd say the technology and e-detailing is clearly getting turbocharged in terms of virtual interactions with our stakeholders from now on. So a lot of good learnings there. And then as a company culture and generally operating as a company, and I think this call is a good example about the need for traveling could probably go down over time and more virtual means of operating as a company. Whether it's in Investor Relations and investor insections or it's just generally company events and meetings. So we're looking at a number of cases. And currently, we are also in the process of defining what of the - how and what are the better practices to anchor going forward.

Our next question comes from the line of Michael Leuchten from UBS.

So two questions. One, just on your new geographic disclosure. I was wondering whether there's anything more to it. Is there any replumbing that is being done? And if so, what's the rationale behind it? That will be question number one. And then question number two is following up on the previous question. When we think about things like medical conferences. Obviously, the ADA this year is virtual, like our many other conferences. Do you think there's going to be a change in the way companies like Novo Nordisk who will interact with physicians on the scientific side? And what implications might that have as we think about the world going forward, if and when we come out of the pandemic?

Great. Thank you, Michael. I'll take the first one, and then I'll hand over to Mads and Camilla for the medical conferences. In terms of our geographical split, then the reason why we changed the - and I apologize for the hassle on the analyst side of redoing kind of your forecast models. But it is purely a function of an internal restructuring in our commercial organization in international operations, where we are basically looking at how do we most effectively organize that. And that is the case from time to time, and that's the fundamental driver for our external disclosure. So there's nothing more to it than that. And Mads on the conferences.

Yes. So Michael, if you consider all the many, many ADAs and ESDs and other conferences that many of us have been to, they are fantastic in terms of getting your scientific messaging across from clinical trials to the scientific community. But do bear in mind, when we mingle and walk around at the conferences, you can only attend one session at a time. And the new thing with ADA, the way it's done virtually this year, is that if the attendance is good enough and high enough, so to speak, that remains to be seen, then you actually have the opportunity because they will be able to be live streamed and downloaded each and every presentation. So one doesn't have to miss a presentation just because it's simultaneous with another one. And you can actually revisit it later on. So if people get the - the doctors get the habit of actually using this even after the event has occurred, that gives a unique opportunity to better understand data and remember them going forward. But it remains to be seen how it pans out. And to be honest, personally, I'm, of course, also looking forward to be able to meet folks again at real live conferences. But there can be ups and downs to it. Camilla, do you have something to add?

Thanks, Mads. Just wanted to add that from a commercial point of view, of course, this also gives us a good opportunity to reach out to a broader audience with the scientific data from being able to utilize some of these sessions with a broader audience that normally would not be able to travel all of them to ADA. So we're already making plans in terms of how we can do that, and that takes place in most of the countries that would have joined the ADA. And we expect the same to continue also in the future.

Our next question comes from the line of Peter Sehested from Handelsbanken.

It's Peter from Handelsbanken. And I am sorry if this question has been asked before, but I came a bit late into the call. So essentially, it's for Mads, and it's relating to the NASH data. If you look across studies, which has reported on the Phase III endpoints preferred by the FDA and EMA. I mean you clearly blow the roof here with your data with respect to this endpoint, with respect to the other endpoint, which is also important, given the correlation between fibrosis and cirrhosis. We still need to see them, but nevertheless, could you add some flavor here as to your confidence of showing a benefit. Do you have some internal studies? Can you make some kind of correlations? Just anything that can sort of add to the confidence of being able to show a positive sign here in the Phase III data. And also, as I believe, this may not be correct that EMA, actually requires both endpoints for approval.

Yes. So Peter, that's a good question. And one of the most important things for us now is to align FDA and EMA expectations for the trial design that will lead to approval. Because we would, of course, like to have something that satisfies both regulators and not just one regulator. And I think there's a path forward in that regard. When we look at all the measures of fibrosis, the ELF bio panel being one of them, the FibroScan elastography imaging being another and the histopathology data from the biopsy being 1/3, we can actually consistently see that the placebo group stays neutral and doesn't move much over 1.5 years in the trial. Whereas there's a consistent decrease in the progression or even actually less fibrosis, those dependently using the various assessments for semaglutide. The only thing we didn't hit, as you know, is the endpoint of fibrosis improvement without worsening of NASH. And that's where we had numeric around 10% increase in patients, but that was not significant. But what it tells me is that we're arresting the progression also of the fibrosis. And that means that you should imagine that a Phase III trial will hit the endpoint of NASH resolution, and that is the approval endpoint, at least according to FDA, and then you continue your F2, F3 patients into an extension, not open-label, but full extension, where you go for hard outcomes, and they will then readout, depending on how long it takes for people to progress on placebo to a fulminant outcome such as liver failure, transplantation or even mortality, then that would readout later and, of course, give a stronger health economic picture that you will then reap at that point in time. So that's how you to achieve. This is predominantly in metabolic and, to some extent, anti-inflammatory drug, but it clearly pans out in the way that it arrests progression also of fibrosis.

Should I interpret your answer as saying that as monotherapy, this is mainly a struck for the U.S., where in Europe, the combination drug studies are the way forward there? And also in terms of investments needed to sort of establish an infrastructure, some comment on that, and it is something that could impact the P&L in 2021?

Well, first of all, Peter, in terms of the finances, Karsten and I have built into the expected R&D budgets, progression of certain of the pipeline projects. So there's no news on that one. No, on the other one. I would like to see a harmonization between our colleagues and coworkers at FDA, EMA and other regulators, so that we can find one common stance on how to develop such products and get approval. And preferably, that would be meeting the FDA guidance of showing NASH resolution or in the case of a 4 trials, then fibrosis improvements. And we will see how far we get into discussions with the European regulators as well. But we'll try to harmonize the guidance here. I think that is important for the whole industry.

Our next question comes from the line of Keyur Parekh from Goldman Sachs.

Two questions, please. Karsten, Camilla, I would love to hear your thoughts on kind of what do you think this pandemic means kind of from a longer-term perspective, kind of for the biopharma industry? Kind of both as it relates to kind of what might be perceived as increased investment in health care over the next few years, but also kind of and what it means for the social contract that the industry might have on a broad basis. And if there are particular geographies that one should kind of think about, I think that would be keen to hear that. And then separately, kind of Mads, as we think about kind of this NASH data set, and obviously, we'll see that - we will see incremental data over the next few weeks. But I think yesterday, you mentioned that while the secondary endpoint of fibrosis wasn't met that you were encouraged by a lot of the other kind of secondary endpoints. So as kind of - as you look at the totality of data, are you more or less encouraged than you were kind of on sema's potential role in NASH kind of 3 months back? And how would you categorize your excitement for sema in NASH versus summer in obesity?

So we'll take the first question to Camilla on long-term industry impact from COVID-19. And then Mads, how do you see NASH versus obesity? And how encouraged are you really about these data?

Okay. Thank you, Karsten. So in terms of expectations for the longer-term for the pharma industry, it's likely that, of course, there will be an increased focus on health care in general, but also likely that there will be an increased focus on emergencies and potentially some of the severe chronic diseases that we work with, could risk getting less attention and be put under slightly more cost pressure. Of course, our opportunity in this context is to make sure vis-à-vis the digitalization discussion we just have to make sure that we can provide health care systems with easier ways of diagnosing and following up and getting patients with chronic diseases in good control. And here with both diabetes and obesity, we have an opportunity to use digitalization efforts to provide more information about each individual patient, for example, via our connected pens and follow-up with glucose measurements and getting that data set ready for the doctor, meaning that a longer distance dialogue with the patient, online dialogue with the patients would be more likely. And the same for obesity, where one could also imagine where the diagnosis is easier to make the online scripts and potentially online pickup of products and so on, would be ways to try to eliminate some of the pressure on the health care systems. So whereas, we do believe that there will be an increased pressure on the health care systems, we also expect that we, also from a social contribution point of view, would be able to also improve both the efficacy of the system and with that also, hopefully, increase our reputation in the longer term. So those are some of the dynamics that we are looking into.

Okay. Keyur, on - first of all, it's very difficult to compare swings and carousels or apples and pears. And you know, generally, I am a relatively enthusiastic CSO. And I would say my enthusiasm for the STEP program that we'll see results from in the next couple of months is - remains very, very high. I've kind of hinted that a 15% weight loss would be achievable based on Phase II. We'll see if that pans out or not. If that happens, I will remain highly enthusiastic. But I must say, Keyur, that the NASH data also, in my view, very encouraging because I had hoped for like 50% NASH resolution, we are homing in on around 60% for the high dose. And on top of that, using, as I have mentioned now a couple of times, both progression of fibrosis and the biopsies, but also fibrosis decreases on elastography on ELF biomarker panel and the other biomarkers is really encouraging because it's probably secondary to the metabolic and anti-inflammatory effects that are exerted on the liver by semaglutide and in the systemic circulation, maybe even. But it still hints that over time, you will improve fibrosis. Histologically, that may take longer time to prove, but that will then be seen in kind of the extension part of a Phase III trial. So I remain very encouraged by the biopsy data or the Phase II data.

Our next question comes from the line of Michael Luncheon from UBS.

So I was wondering if I could go to the outlook. So you've maintained your guidance for the year. You've given us the sort of tailwind in Q1 from the pandemic. But when I go back to your AGM, you did make an assumption about a normalization in the patient flow earlier than you're assuming now. So as you sit here today, obviously, the underlying performance has gone a little bit better than you had expected. This is how I would read your commentary. So how are you tracking that patient flow? Is this sort of like we would do on an NBRx basis? What are the variables that you keep an eye on? And the reason I'm asking is the AGM was not long ago, and you've changed your view on how you think the situation might go back to normal.

Good. Thank you, Michael. So in terms of our outlook and the impact from COVID-19, I think it's fair to say that none of us have seen a situation like this ever before. So in terms of modeling impact, where normally, diabetes is a very, very stable market. Then estimating impact from something as COVID-19 and basically estimating how a pandemic rolls across the globe is highly complicated. And I think we see that also with all the epidemiologists that are making comments in this space. So the way we're looking at it is and the way we're modeling it is, as you allude to, we're looking at a duration of impact. So what's our recovery assumptions and that links to what you read in the papers about the models or new models or ELF based recoveries, et cetera. And so duration and then death or impact of it, which is mainly on top [indiscernible] and the new patient starts on our front. And the new patient starts, we model based on - in a U.S. setting based on NDRx levels as we've been talking to. In other geographies, it's different data sources. We have a different data source, for instance, in Brazil. And in other places, it's purely like an APAC factory trending tool we use to estimate impact. So I say there are many uncertainties in how to model that. And I'd say, even though it seems like a short period of time between AGM and then this guidance, I think some of us feel it's actually - it's a long time in terms of COVID-19 and what has happened in just those weeks. And I think, generally speaking, also when you look at the impact across the globe, I think more and more people are being clearer on the shape of recovery and that this is not a V-shaped recovery, but a more gradual recovery, with - is also informed about what we see in the Chinese market. And when we look at the data points in China in terms of impact to the overall pharma market in China then we saw some impact to the tune of 7% down versus baseline in Q1. And our estimate is that, that is gradually improving over time, but it's not rapidly improving. So that's why we've been adjusting kind of our impact modeling in the latest guidance. Thank you.

[Operator Instructions]. Our next question comes from the line of Keyur Parekh from Goldman Sachs.

Karsten, just a follow-up to Michael's question that obviously, your kind of reiterated guidance now also includes an unquantified impact kind of from - for the channel mix pressure or kind of commercial patients going to noncommercial channels. And I realize that there are many variables. Just - but help us understand how, even within broad ranges, how we should think about what is included in your guidance for 2020 for that? And I'm presuming that the bigger impact of that is likely in 2021 compared to 2020. But if you can just confirm that?

Yes. You're perfectly right, Keyur. We have included the U.S. channel mix in our guidance. The starting point for us being able to maintain guidance, just to reiterate, is that we had a very solid progress in our business and very good commercial performance end of last year and going into the first quarter. So that we're very satisfied with. And that is what is fundamentally enabling us to maintain our guidance for this year despite the impact from COVID and U.S. channel mix. In terms of U.S. channel mix specifically, then a lot of parameters going into our modeling around that. And this is based on, I would say, many assumptions like COVID. But fundamentally, we start with the unemployment numbers in the U.S. and then clearly, there will be a negative impact from patients moving from commercial insurance to either uninsured or Medicaid insurance. So that will have a negative impact on profitability and potentially volumes on our side. That uncertainty or that modeling, of course, has uncertainty in terms of what coverage did people have [indiscernible] and the coverage they are moving to. And the duration that we're seeing this impact. So there might be a positive rebound in terms of unemployment numbers when the U.S. economy opens back up. When we look at the sectors, mostly impacted by unemployment being, for instance, hospitality business and restaurants, et cetera. So the - we have modeled a negative impact in 2020. And given the movement of channel mix, that will also negatively impact 2021.

Our next question comes from the line of Richard Vosser from JP Morgan.

Just a couple of questions about high-dose sema. When we think about high-dose sema, of course, the dose is just slightly higher than the high-dose diabetes dose. So could you give us some ideas on how you can differentiate the price of that medicine, given that Saxenda is roughly double the price of Victoza and Ozempic today? How can you work around that going forward? And maybe linked to that NASH is a very interesting area, but essentially treating the same obese patient, but with hard potential avoidance of outcomes, just like the cardiovascular claim that you hope to get from SELECT. So how should we think about that in terms of pricing and given the future potential savings that health systems can get?

Thanks, Richard. I will hand the first question regarding pricing of our Phase III project for high-dose sema to Camilla vis-à-vis obesity pricing. And then next question for you, Mads.

Yes. Thanks, Karsten. Thanks, Richard. So as you can imagine, it's early days to give details on how we will price also both the obesity business in the future and also high-dose sema and how that corresponds. But of course, over time, it's likely that as we see more and more reimbursement in the obesity channel, it's likely that there might be a conversion of the prices in the obesity and the diabetes business. But I cannot give more sort of tangible details at this point in time. We need to see the results of the trials. And of course, we're also excited to see the STEP program readout now in the second quarter. And much more on the commercial part of all of this once we have the approval of sema obesity.

And then, Richard, on the NASH issue. It is interesting, isn't it that in the case of Victoza, the harder outcomes for Victoza came in the form of the leader trial many years after the first launch. With Ozempic, it came aided by PIONEER 6 in terms of the cardiovascular indication claims only a couple of years into the launch. And I think you're right, when it comes to semaglutide in NASH, the harder outcomes that will also facilitate better reimbursement and uptake in that specific market will also come a couple of years probably after the first launch and approval. But it's coming out of the same trial, so we don't have to do additional trials, which is one good thing. I think we should watch up not only to lump even though one of the comorbidities of obesity clearly is NASH, we know that. It's also one of the commodities of type 2 diabetes. And when I look at the 60% who had diabetes in this population, they were on average less obese than the nondiabetic obese. So the things that induce NASH are both weight-related, but also nonweight-related, inflammation-related, metabolically related. And of course, as a management team, we will now look into strategically, how we'll make all of this come together. But the short version is that whether you do a mixed diabetes obesity trial or only 1 of the 2 or whatever, you will still do the same kind of trial with the same kind of endpoint where you will extend the trial. And we are speaking with the power that we can see from the Phase II, not thousands of patients, but maybe 1,500 to 2,000 patients, also a little bit depending on the safety database that the agencies want. And that's a little bit uncertain because sema is already on the market. So it's known to be a safe product, but still there are demands in new indications. So we will revert with a lot more of our strategic and operational thinking once we have met with the regulators also and ourselves.

Our next question comes from the line of Wimal Kapadia from Bernstein.

Sorry, I missed the first few minutes and it has already come up. But just in terms of the Rybelsus co-pay program, I know it was 3x the size of the Ozempic program. So I guess, I just wanted to know how far you are in giving those volumes and those co-pays away. Previously, you made a comment that by the end of 1Q, most of the volumes would have been distributed. So just to get some context there on when we think, given COVID-19, there's been a delay there. The second question, a bit of a random one, but I thought I'd ask, is this on the new remuneration policy. So I guess can you give any color on what's actually being included and what the weightings are for the long-term incentives, so whether they be R&D based or financial based? Just on weightings, some color there would be, I think, really interesting. And then the final question is just on insulin rebates. So if I look at basals now in the U.S., we're looking at 80% - close to 80% rebate levels. So I guess I want to get your thoughts on at what point do you think the biosimilar players will be unable to compete given your scale and your ability to manufacture peptides very cost effectively? Any comments there will be helpful.

Great. Thank you, Wimal. I will hand the question on the Rybelsus program - co-pay program to Camilla. And then then I'll talk to the LTI program structure. And then Mads, we can split the biosimilar comments.

Thank you, Karsten. So on Rybelsus co-pay program. As you said, we currently have a co-pay program. That means that the patient maximum co-pay $10. And this program, we are continuing with as we are developing our market access. So that will eventually replace that program. As we spoke to yesterday in our news is that we now have a 50% combined access for Rybelsus. And we expect that to continue to increase over the rest of the year. So gradually, with that, of course, the co-pay program will diminish in its importance as we sustain more and more access.

Great. Then on the LTI program and our remuneration policy. And in case you have not all read it, then I encourage to find it on our website. So it was approved in connection with the AGM. In terms of - to your question on the specific targets on LTI, Wimal, then this is something which - for management, which will roll into effect from 2021. The main targets group will be on sales less commercial, then it will be on profits, and then it will be on pipeline as the main groups that we're looking at in the LTI program going forward. Then Mads, on biosimilars and productivity and ability to get to our scale and productivity.

Yes. I think it is a fact that coming from a beer brewing country, a place called Carlsberg, we have a very long experience with yeast physiology and technology. And that also means that the way we produce our insulins, not only if we did x yield per liter fermentation broth 20 years ago, will we now be doing 10 or even 20x because of the constant technology improvements. We're also doing them in a way where it's continuous fermentation and not batch fermentation, where you have to clean up every time, you've done a batch, et cetera, in most other companies. So technology-wise, we are in a situation where even in a commoditized, biosimilarized insulin market, we can produce an extremely competitive cost. That's also why you quite often see that government tenders in countries like Latin America and so on are won by our company. So we are very competitive. But Karsten, I don't know whether you have more non-technical stuff to add?

No. I think that's sufficient for now.

Our next question comes from the line of Peter Verdult from Citi.

Peter Verdult, Citi. Apologies if this question has already been asked, but a little late on the call. Just Mads, going into the setup for STEP 4 or the obesity program. We've obviously got the Phase II data that we can look at. If we speak to some of the KOLs out there, they're saying a game changer would be if they can see up to 30% of patients losing 15% of their weight in the trial. So look, just help me understand, at least from a Novo perspective, what you would define as a minimum expectation? And what for you would be a win in terms of interpreting the upcoming data set for semaglutide in obesity?

Yes. So Pete, excellent question. First of all, you do recall from the Lancet paper with the Phase II data. That my aspiration of the 15% weight loss on average, for instance, in the STEP 1 trial, for instance, that's a classic obesity trial, hinges upon the weight loss seen in Phase II and the fact that we are having a full year on the steady state dose and there was weight loss even at week 52. This time, we're doing 6 to 8 weeks. Also, the way the FDA wants data analyzed is that if you have a lot of patient dropouts, missing data counts as placebo values, i.e., nonresponders. That's bad news in terms of the percent you can report weight loss. But since we know even on a [indiscernible] basis that the dropouts in these trials are very low and much lower than they were in the scale program for Saxenda. We will not be hit by all of these things to the same extent as we could have done if we had great [indiscernible]. So I remain optimistic about this. And if you're okay well to say that if I lose 50% or more body weight, then you could actually argue. If my theory holds true, that it's around 15% on average, then you would expect to see more than 30% above 15% weight loss. So let's see who's right, but I would agree, that number would still be a major improvement because I know what the number is for saxenda, and that's very low. So we - by the way, by the way, Pete, we have those categorical weight loss elements, 10, 15, 20 with all of them included as secondary endpoints. So you will have them coming soon, they're secondary endpoints. The weight loss, of course, per se, is the primary endpoint.

Mads, can I ask a follow-up?

Yes.

Just shifting gears Select. So we're hearing that, that's a difficult patient population to recruit for because relatively young, have to bear a price in the event, and that is unlikely to readout until '23, '24. Is that - I think you were hinting at that yesterday in your comment, I think someone else asked the question. I think it was Peter from where he had Handelsbanken. But is that fair that SELECT has, even pre-COVID, has been enrolling pretty slowly?

No, it's not quite fair, Pete. We were nervous. We were truly nervous pre-SELECT about the frequency and occurrence of these patients because of the reasons you mentioned. However, pre-COVID-19, we were actually training ahead of the recruitment curve. And I would like to say that we probably have more than 12,000 patients enrolled at this point in time, we were ahead of the anticipated recruitment curve plan for pre-COVID-19. Right now, we're still tracking on it, but that is due to us being ahead pre-COVID-19. So the longer that COVID-19 grows out, it is true that we will then end up being behind the recruitment curve. Then of course, once we have all the patients, 17,000, if we decide to go for the full 17,000, then you, of course, it's the event rate that drives when you have events enough to terminate the trial. And it's too early to speculate on the event rate, but it's lower than it is in a leader sustained 6 like population but it's higher than it is in a normal diabetic population. So we're probably speaking around a couple of percent event rate, but let's see.

I think we have just time for two rounds more of questions. So two more, and then we'll have to close out for today.

Certainly, sir. Our next question comes from the line of Sachin Jain from Bank of America.

Sachin Jain, Bank of America. And again, apologies if these have already been asked. I joined a little bit late. But one question on Rybelsus, if you just talk to 2Q trends with lower new patient visits and how we should think about 2Q sales relative to 1Q? And you haven't ever really confirmed the DKK 2 billion sort of consensus forecast, but that is basically unchanged since COVID. So just your perspectives on being able to achieve that 2H patient flows normalize? And the second one on NASH. Mads, maybe you just touch on if you, in your data or reading, see any evidence of metabolic versus cirrhotic phenotypes within NASH. There's been a little bit of a debate there. And whether you think GLP-1s can act across both or more favorable and a metabolic phenotype? And then a very quick third question, just on oral sema next-gen formulations. We haven't heard about those for quite a while. So I just wanted to check in where you were with progressing those.

Great. Thank you, Sachin. Camilla Rybelsus script trends into Q2. And how do you see Rybelsus impacted by COVID-19. And then over to Mads on NASH and fibrotic phenotypes.

Yes. Thanks, Karsten. Rybelsus, first of all, we'd like to just reconfirm that the early uptake before COVID '19 was very encouraging. And therefore, we also expect that the NBRx trend will get - will pick up again when patient dynamics are less affected by COVID-19. So our assumptions are, as our general assumptions are that when the patient flow gets back to normal, as we assume now in the second half of this year, then we will also be able to see the trend of the early uptake of Rybelsus to come back to that level. And right now, we are seeing sort of a weekly slight change in the NBRx uptake on Rybelsus that has increased slightly also over the last few weeks. So that is a little higher than the average for GLP-1 impact on NBRx. But as I said, with the early uptake we had before, we do expect this to come back to normal in the second half of the year.

And then Sachin on - yes. There's a lot of debate in the community around metabolic and cirrhotic phenotypes and so on. Based on the data we have at our hands, and we'll, of course, I mean, disclose in the conferences and in major publications. Then I would argue that the life cycle of a standard NASH or MACE patient, this is actually driven by this metabolism that causes inflammation in the liver. And then when you have ballooning of the cells, i.e. the cells are dying, that is quite often replaced by fibers tissue. So I - and the reason why I can say this, we had very nice effects on ballooning in this trial. We had very significant reductions in cell death in the biopsies. And when I then look at the fibrosis markers in the ELF biomarker pan, but also in the elastography fibroscan, we're actually seeing that those fibrosis parameters come down dose dependently. So for me, the cirrhotic phenotype is typically a consequence of the dismetabolism inflammation that drives the disease, then the fibrosis is the end outcome. You might have patients that are more prone to fibrosis even at lower levels of steatohepatitis. But I don't have much proof to the pudding from this trial. And then on the oral, yes, it is true. We are doing these new generation - new ways of formulating Rybelsus in a smarter way. And those trials are ongoing. They might be a bit delayed because they are ongoing trials. And of course, these are early stage trials, and you know that Phase I like trials are more hurt by the COVID-19 situation. But then again, we have Rybelsus on the market, and we are not desperate for having a new formulation of Rybelsus market even though we'd like to have it, of course, for obvious reasons.

Can I just take one follow-on for Camilla? Thanks for that color on NBRx and 2H. And what are you seeing in terms of real-life discontinuation rates versus what was in the label?

It's too early for us to say anything on that at this point in time. So we would have to see sort of the continuous uptake of Rybelsus before we can say that with a reasonable patient number. And we don't see any signals that there are any issues on this regard. So we don't have any qualitative sort of feedback on that.

Our last question comes from the line of Michael Leuchten from UBS.

So just talking about risk management. One of your big driver of the returns has been your ability to be extremely efficient on the manufacturing side, which obviously includes the yield improvement that Mads was referring to. As we now go through the pandemic, is there an argument that you may have to decentralize your manufacturing process to be able to stop potential disruption that a pandemic, such as we are experiencing now, might bring to a manufacturing side? Or are you able to manage this in your minds with the setup you have, maybe just segmenting the existing facilities?

Thank you, Michael. It's a very relevant question that we, of course, ask ourself as part of the learnings from COVID-19. And in reality, it's a question that we've been discussing with our Board for a number of years as part of general risk management. And we have a review of the biggest risks for the company across the value chain. And I would say, in conclusion, when you look at our manufacturing, and if I take kind of the value chain in manufacturing, then for - on our supplier base, then for our critical suppliers of the various raw materials, we are very focused on having dual sourcing from different manufacturers or from different geographies for the critical raw materials in manufacturing. If, for some reason, that is not the case, then for those few raw materials, then we set inventory policies that are very, very high. So then we could have perhaps 6 or 12 or even more months' worth of raw material on inventory. Then in terms of our in-house manufacturing, if we move through the value chain in API, this is basically a key part of our API manufacturing that now we have diabetes API facility soon to be up and running within the next year or so in Clayton, North Carolina. So actually, we have a better hedge than ever before on insulin API on top of the inventory policies we have that are between, I would say, 9 and 24 months on API. Biopharm, we also have a facility in the U.S. now in New Hampshire for some of the biopharm products, apart from the inventory levels. And then finally, on the finished goods manufacturing, we have filling factories in France, in China, in Brazil, in the U.S. and in Denmark. And then a few others. So - and there, we are securing dual approvals for our products. So for instance, when China closed down early in the year, then we had other finished goods facilities that could step in and supply markets that Tianjin could not supply. So I don't foresee any significant change to our global manufacturing network as a learning from COVID-19. But that said, of course, there are other learnings that will take into account.

So with that, thank you for attending the UBS virtual Novo Nordisk Q1 roadshow, and thank you for the interest in our company. And if you have further questions, please do not hesitate to reach out to Investor Relations, and we'll get back to you swiftly. So have a good rest of the day and stay safe out there. Thank you.