Q3 2020 Novo Nordisk A/S Earnings Call (London-Based Investors)

Karsten Munk Knudsen: We've previously talked about U.S. affordability offerings. And in the third quarter, we have adjusted our affordability offering across international operations, so we have lowered the ceiling price for human insulin in 76 low- and middle-income countries. On the environmental agenda, we continue to drive our Circle for Zero strategy, reducing our CO2 footprint and generally reducing our impact on the environment. We are at 100% renewable power across production already.

Hello, and welcome to the Q3 2020 Novo Nordisk <unk> earnings presentation.

Throughout the call all participants will be in a listen only mode. Afterwards, there will be a question that the session.

Today I'm pleased to present cost smokers. Please go ahead with your meeting.

[laughter]. Thank you and welcome to the known always good third quarter results meeting, it's a pleasure to watch a host of this meeting and that.

Karsten Munk Knudsen: And in the third quarter, we launched a target for our suppliers also to reach 100% renewable power, but only by 2030. In relation to therapeutic focus, I will leave that to my co-worker Scott Thompson to go through that in a few slides. But clearly, you see the progress both in our insulin business, our GF1 business, in diabetes as well as solid readouts in obesity, especially in the second quarter of this year. And finally, we had a Phase 2b readout for Cilicivecumab in the third trial that Max will come back to later. On commercial execution, we increased our diabetes care sales by 8% on a year-to-date basis, and our diabetes value market share has now reached 29.2%, which is 80 basis points higher compared to 12 months ago.

And the big banks to Richard Palestine, Chip Moore, and Paul for helping set setting up this meeting [laughter]. So for the meeting today, we have an update on our strategic aspirations.

A follow up by a couple of nights in commercial execution innovation and therapeutic focus and the and financial so organised. The in line with our strategic aspiration say a framework we have a plan that they in a way. So are the presentations will be followed by black Q and a session in Indiana.

[noise] as you. All know then the then as Tayfun said around the future inherently yeah, I caught by a certain level of telephone certainty at that and say we remind you about this this circumstance.

[laughter] moving onto our strategic aspirations said then there.

More or less 12 months ago, where we replaced our previous long term financial targets, which were focused.

Karsten Munk Knudsen: This is predominantly driven by our GF1 business, which grew 29% during the first nine months. Obesity grew by 6%, impacted by COVID-19, and biopharm sales increased by 4%, driven by IO. All of this led to a group sales growth of 7% and operating profit growth of 7% and a free cash flow that increased 27% to $41.6 billion, and $31 billion of cash returned to shareholders during the first nine months.

On the growth in operating profit and and and the <unk> called financial performance, we replace that with the our strategic aspiration said, which provides a more holistic view on that on the progress and and performance of the company.

Mm Hmm, the first quadrant or with the point your attention to as a percent and sustainability, where we are.

Driving our new defeat diabetes, social responsibility strategy.

We work a lot with affordability.

We've previously talked around the U.S. affordability offerings at the end in the third quarter, we have fair or.

Karsten Munk Knudsen: COVID-19 is impacting societies across the globe, and it's also impacting Novo Nordisk, briefly covering then: our manufacturing sites are operational across the globe, and we're able to supply medicines to all markets globally. In R&D, we have all our trials running. Recruitment is impacted, albeit running at, I'd say, index 70 or so compared to pre-COVID. And we are now also able to initiate new trials. In this commercial, we've seen a recovery on new patient starts. You see that on the right side of the slide.

Adjusted affordability offering across international operations said, well, we have to know what the ceiling price for human insulin in their 76, low and middle income countries.

On the M. on Ensco agenda, we continue to drive all Sherpa zero strategy of reducing our Oh, Soo Choo footprint and a generally introduced now.

The impact on the on the environment today, we.

We added 200% knew about power across production already and in the third quarter, we launched a target fossil plants also to reach 600.

100% renewable power, but that but only at bite by 20 to 30.

Karsten Munk Knudsen: And we have sales representatives in the market in many of our geographies. Furthermore, we are more and more using digital tools to communicate and interact with our stakeholders in the field and in the market. Our sales growth, when we look at it on the key dimensions, you see that our sales growth is driven by, from a geographic point of view, 12% sales growth in international operations. And within international operations, we see very solid sales growth across both EMEA, China, and the rest of the world, all at double-digit sales growth. The sources of growth are slightly different, but the key growth is coming from insulin and GF1 in aggregate across international operations, and you should note that 12% compares to the 6 to 10% that was set out in our strategic aspirations last year. And talking about strategic aspirations, in North America, operations are growing 2%.

In the innovation therapeutic focus I would leave that to show too much color Scott Thompson to go go through that day in a few slides time, but but clearly you see the progress at both in <unk> and now it's gonna business out you've won business.

In in diabetes as well that's a that's a solid reduction abused she is especially in the second quarter of.

Of this year and finally, we had to face to be re read out for since you've actually my opinion in to try that that mats will come back come back to later.

Commercial execution.

We increased our diabetes care sales by 8% on a good state basis, and our diabetes said remarks, yet has now reached 29.2%.

An 80 basis point increase compared to 12 months ago. This.

This is predominantly driven by biologists one business, which grew 29% during the first nine months.

Well basically grew by 6% impacted by Cobot, 19, and biopharm sales increased by 4%.

Driven by by Io.

All of this led to a group sales growth of 7% and operating profit growth of 7% and the air and the free cash flow that increased 27% or 41.6 billion and 31 billion.

Camilla Sylvest: And as we've been communicating, we're transforming our portfolio from insulin to GLP-1, which is what you see in the stacked bars, with the red bar now, significantly bigger than the dark blue insulin bar. And that's also visible in terms of growth, where you see that in terms of therapy areas, you see GF1 driving 29% growth and solid growth both in IO and North America operations. So GF1 truly was the growth driver of the company in the first nine months, obesity impacted by COVID-19, and a solid 4% growth in biopharm, mainly driven by our human growth hormone franchise, and with that, I'll hand it over to Camilla Sylvest to give an update on the market performance. Thank you, Karsten.

Cash returned to shareholders during the first nine months.

[laughter] co not seen that it's a it's impacting side to say across the globe and it's also impacting no one orders at.

At the end that briefly covering than Oh manufacturing sites operational across the globe and and we're able to supply medicine said to all markets globally.

R&D, we have all arthritis running.

Recruitment its impact that that albeit a running at I'd say, the 70, s., so compared to a pretty cool with and we are now also able to initiate a new trials.

In commercial we would see net recovery on their on their new patient starts you see that on the right hand off the side, there and we have fair yeah.

Camilla Sylvest: And if we look at our diabetes value market leadership, market share leadership, it continues to expand. It is now at 29.2% and has increased 0.8 percentage points since the same time last year. This is driven both by GLP-1 market share that has increased around three percentage points versus 2019, and primarily driven by the rollout of USMPIC, which is now available in 48 countries. The uptake of the GenPIC and loan-to-be-built-as-in-North-America operations, of course, also significantly contribute to the growth in market share. Also, in insulin, we have increased our market share to now 44.5% from 44.3% at the same time last year. This is mainly driven by a market feed approach in international operations and the launch of our new generation insulin. If we look at the details of our GLP-1 market shares, we see on the left-hand side here the U.S. GLP-1 NBRX market share, where we now see Rebeltus at 13.5 percentage points and a total GLP-1 Novo Nordisk market share of 60.2. On the right-hand side, we see the total TRX market share, where we now have 49.6% market share, and Rebeltus has increased to 3. The uptake of Ribeltus we have here in this slide compared to the uptake of SDLC-2s in the U.S. exemplifies the difference between canically frozen and impactly frozen.

Same strip back.

In the market in a in many of our geographies and.

Furthermore, we have more and more are you seeing it is suitable satchel to communicate and an intact with all stakeholders sitting there in the field and in the markets.

[laughter].

Oh sales growth as well when we look at it on that on the key domains and say you see that on sales growth. This is driven by say on a geographic point of view is driven by 12% sales growth in international operations.

And within this that's cup races, we see very solid sales growth.

Across both EMEA, China and rest of world all be being at that double digit sales growth the source of growth I slightly different but there, but the key growth is coming from Matt from insulin and tier one.

In aggregate across international operations, and that you should note that 12% compared with the 6% to 10%.

That was set out in our strategic aspirations say last year.

And talking about strategic aspirations, and North America operations growing 2%.

And as we've been communicating then we're transforming our portfolio.

From insulin towards tier one which is what you see.

In the stack boss with it with the Red bar now significantly bigger than that and the Doctor who are insulin Bob.

And that's also visible in terms of a of a growth wave she that they're on the intensive therapy areas.

You'll see that units, one driving 29% growth.

And the solid growth both in the Io and North America operations. There. So just one a truly being the growth driver of the company in the first nine months.

Camilla Sylvest: And here you see that the uptake of Ribeltus is now at least on par with a small dip in the COVID-19 period, but we now have 85% access across commercial and Medicare, and we have more than 80% of new prescriptions are new to the GLP-1 class. We've also initiated our new Rebels Who Seek to Seek campaign a little more than a month ago. And this is also picking up nicely, and we are seeing a continued flow of patients going into rebelswhos.com. Outside of the U.S., Rebeltus has now been launched in eight countries with market access.

The Beast impacted by COVID-19, and and the solid 4% growth in the international operations, I, sorry, and biopharm, mainly driven by our human growth hormone franchise.

And with that I'll hand, it all to come it's the best to give an update on there on the market performance.

Thank you Catherine if we look at our athletes all your markets and leadership market share leadership continues to expand it is now at 29.2%. It has increased 2.8 percentage point.

Time, and that's yeah. This is David though by GLP, one and I could see how that has increased about three percentage points. This is 2019 and primarily driven by the rollout of the campaign that is now available in 48 countries and.

Camilla Sylvest: In international operations, we see continued growth across all the regions and geographical areas, as well as both in insulin and GLP-1. Especially in the EMEA region, GLP-1 is of significant size, and it's also having a relatively big growth rate in China and the rest of the world. In total, IO is growing 13%. On the right-hand side, we see the diabetes value market share in I.O. specified by 22.7%.

I'll take over 10 pick and no one should be dealt with in North America operations of course also significantly contribute to the growth in their market share.

Oh, sorry, the insulin we have increased our markets you have to now 44.5% air from 44.3% at same time last year. This is mainly driven by a mcafee to approach in a in international operations and the launch of our new generation insulin.

Camilla Sylvest: That is an increase of 0.7% versus last year, but we also see the Novo Nordisk share of growth that has now increased to 30%. In the obesity area, we see sex tender sales growing 6% impacted by COVID-19 due to fewer patients being initiated. SACSANTA is now launched in 54 countries with a market share of Novo Nordisk of 63%. Here we have an IEO 40% market share and in North America 78% market share, and the uptake of the reported sales is relatively two-thirds in North America and one-third in I.O. in the last quarter.

If we look at the details of our tier one markets, yet and we see on the left hand side. He had the U.S. and yet they want MPLX markets, yet where we now see the same thing at 13.5, it's Harvey boxes at 13.5 percentage points.

And I told her GLP, one over Nordic markets, Yes, 60 point to MPLX.

On the right hand side, we see the total trx market share, where we now have 49.6% at market share and we built the sales increase to 3.7%.

With that peak to almost 27%.

The uptake of the of the boxes and be.

Be happy I dislike of pass through the uptake of the FDIC too in the U.S. exemplified by Kennedy Wilson cannot actually it fills in an impact. These proceeds and you see that the uptake of they have with US which is now at least on par. If we had a small dip in the call. The 19 period, but we now have 85%.

Ludovic Helfgott: And now I will hand over to Ludovic for the update on FireFarm. Thank you very much, Camilla. So biofarm growth for the first nine months of the year was 4%, driven by norethrophin and the launches of the new hemophilia product. If you look at these cells more precisely, the growth of eight percent in the internal operation fueled the overall four percent growth in the first three quarters of the year with a strong impact of norethrophin. The hemophilia cells decreased by two percent as the successful launches of Asperox and Refixia are countering the Novo7 cells decline driven by fewer procedures and elective surgeries across the world. Nordic Rappin sales increased by 13% on the basis of higher sales driven by logistic and supply issues from competitors as well as increased efficacy from a commercial perspective.

Access across commercial and Medicare and we have more than 80% of new prescription you took at TRP one class.

We've also initiated our new assay thoughts with TCC campaign ads.

A little more than a month ago and this is also picking up nicely and we are seeing a continued fill us and pacing it going into retail so stock comp.

And outside of the U.S.. We built this has not been noticed in eight countries and with market access.

[noise] aiming for National operations, we see continued growth across all the regions and graphical areas as well as both an insulin and GLP, one, especially in a EMEA region. The GLP one at least at significant size and is also having a relatively big both ways in.

Mads Krogsgaard Thomsen: Novo Nordisk is now the leading company in the global human growth disorder market with a value market share of 35.3%. Let's move now to science and fuzzy math. We will actually move directly into the product that became part of the acquisition of Covidia Therapeutics Company, namely the fully human monoclonal antibody against the interleukin 6 ligand. We believe that this holds great potential within atherosclerotic cardiovascular disease, where there is a residual risk that is unrelated to lipids and blood pressure and platelets and so on but is rather related to the inflammation that occurs in the cardiovascular system in ASCV So we here have an enriched population with a presumably high event rate of major adverse cardiovascular events.

China and the rest of the world.

In total I O is growing at 13%.

On the right hand side, we see to diabetes Sandy markets, yet in the Io S. basis, I thought it to 22.7% that is an increase of 2.7% and this is last year, but we also see the noise Schaffel that has now increased to 30%.

Indeed at obesity as area, we see if they send assays going 6% impacted by COVID-19 at due to fewer patients being initiated and.

And the second is now launching in 54 countries with a market share of Novo Nordisk to 63% and he'll also and we have an io, 40% market share and in North America, 78% market yet.

Mads Krogsgaard Thomsen: And what we targeted in the Rescue Phase 2B trial was to investigate CILTIS action on markers of inflammation, biomarkers of inflammation, such as high-sensitive CRP, serum amyloid A, fibrinogen, and haptoglobin. And in each of the cases, you can, as evidenced on this slide, see that there was a fast and sustained and dose-dependent reduction in the biomarkers of inflammation, as evidenced by CRP Whilst we at the same time did not see the typical IL-6 blockade side effects or adverse events, such as clinically meaningful neutropenias, thrombocytopenias, transaminase elevations, or, for that matter, LDL cholesterol elevations.

And and the uptake of fire TV policies is say well it is relative to that in North America and one third in I O in the last quarter and I would hand over to due to weak all at the update on Uh Huh.

Thank you very much cumulative biopharm gross for the first nine months of the year well, 4%.

Driven by Norditropin and the launching of the new and if your product is if we look at the sales more precisely the growth of 8% and indeed in sound operation fueled the overall, 4% growth in that three quarters of that you have with Ics.

Strong impact us and Norditropin hemophilia sales decreased by 2%.

Mads Krogsgaard Thomsen: So overall, a very nice benefit-risk assessment based on this Phase 2B trial, and we are now happy to announce that, during the course of the second half of next year, we will initiate in the same target population a big Phase 3A cardiovascular outcome trial with CILTIS. So many things have actually happened over the last quarter or so and will happen in the next quarter, and regarding Osempic, we're awaiting the Sustane 40 2 milligram results that will lead to a submission in major markets as soon as possible thereafter. I would also like to mention glucose-sensitive insulin, the holy grail of insulin therapy, that we have now entered into clinical trials with the first of these molecules and maybe also just highlight that ultramaglutide rebelsis has now initiated a clinical program with higher doses compared to the 7 and 14 that we today have on the market. When it comes to BT, we're looking very much forward to using the PRV voucher in the US submission, which will take place very imminently, followed by the European submission and, hopefully, launch in the US as the first market already around mid next year or immediately thereafter.

Well has a successful launch of the best are optimistic show are countering. The note seven sales declined driven by less procedures and then if you surgeries across the world.

No the tripping sales increased by 13%.

On the basis of a higher sales the driven by logistic and supply issues from competitors as well as an increase from a commercial perspective, no but all these good now the leading company in the global human growth to go to market with the value market share of 35.3%.

Let's move now to science and guilty Matt.

Thank you.

We will actually move directly into the product that became part of the acquisition of Covidien Therapeutics company, namely be fully human monoclonal antibody against the interleukin six like and.

We believe that this whole suffering potential within atherosclerotic cardiovascular disease, where there is a residual risk that is unrelated to liquids and blood pressure on take rates and so on but its bother related to the information that occurs in the cardiovascular system in A's CBD or any particular, if you also have.

Mads Krogsgaard Thomsen: We also hope to initiate a Phase 3 program for the joint combo of the AMLIN 833 and the CEMA 2.4 towards the end of next year. Within BioPharm, we are happy that Ludo has gotten Sugroya and Sumapastan, the ones we could go through and approved in the U.S., and we are awaiting action with the European regulators in the near future. And also, we are happy that we were able to come up with a revised dosing regimen for the pan-segment antibody against hemophilia known as Concisumab, and that has been re-introduced in Phase 3. I would also just highlight that we actually started sub-chronic dosing with MyMate in Phase 2 in patients with hemophilia A, with or without inhibitors, and finally, We're extremely happy that Symmacrotide in the Nash indication was awarded breakthrough designation by the U.S. regulator and will be followed by phase 3 initiation as soon as possible next year and CILTI, which we've already spoken about. So without further ado, over to an update on the financials. Thank you, Matt.

Comics and chronic kidney disease. So we hear happen enriched population with the presumably high event rate of major adverse cardiovascular events.

The what we targeted in the rescue piece to be trial was to investigate shelties.

Action on markers of inflammation biomarkers of inflammation, such as high sensitive CRP serum amyloid eight fibrinogen and have to globally and in each of the cases, you kinda dividend. Some thislife. She thought that was a CPA and sustained and dose dependent reduction in the biomarkers.

Okay inflammation as evidenced by CRP on this one.

Watch we at the same time did not see the typical six blockade.

Hi to fix or adverse events, such as clinically meaningful and utopian, yes, compost cytopenias and seventies innovations or for that matter LDL cholesterol innovation. So overall, a very nice benefit risk assessment based on this phase Twob trial, and we're now happy to announce that we will during the course of the second half of next year finish.

Karsten Munk Knudsen: So, as I started out mentioning 7% sales growth and 7% profit growth on the year-to-date basis and also for the quarter in isolation, we are continuing to invest in our business in terms of sales distribution costs with a 5% constant exchange rate growth versus 12% growth in R&D costs. The 12% is impacted by the amortization of a priority review voucher that we have informed the FDA that we'll be using in conjunction with the regulatory review of Semacrocyte 2.4 in the US. As to outlook, as stated in early October, we have raised our outlook to 5-8% top line growth and 5-8% operating profit growth. Currency impact is a 3% negative impact on sales linked to the lower US dollar and around 4% negative impact on operating profit, while financial, Free cash flow is now at between $34 and $39 billion, up $1 billion compared to our Q2 guidance linked to the upgraded profit outlook I just went through.

The same target population a big piece.

He talked about the outcome trial with CL King.

So many things that actually happened over the last.

Core also and will happen in the next quarter and regarding or some big we're awaiting the sustain for two milligram results that will lead to a submission in major markets as soon as possible thereafter I.

I would also like to mention the glucose into the pension and the Holy Grail of gene therapy that we have now entered into clinical trials with the first of these molecules and maybe also just highlight that all to macro type results. This has now initiated a clinical program with higher doses compared to the seven at 14.

We today have on the market when it comes to BT, we're looking very much for choosing the PRB Boucher in the U.S. mission that will take place at very imminently qualified European submission and hopefully don't watch in the U.S. as depressed market already around the mid next year or immediately thereafter.

We also hope to initiate phase three program for the joint combo.

Combo off and then we had the same at 2.4 towards the end of the next year within the Biopharm, we're happy that the new two has gotten so glass from a cost on the once we could go from an approved in the U.S. and we are awaiting action with European regulators in the near future and also we are happy that we were able to come up with a revised.

Dosing regimen for the past six months antibody against you known us consumer and that has been renegotiated piece. We are also just highlight that actually have started.

Operator: So this concludes our presentation on the third quarter performance and this slide just to remind you of our strategic aspirations and what we're pursuing against 2025. And with that, I will hand it over to the operator to initiate the Q&A. If you do wish to ask a question, please press 01 on your telephone keypad, and if you wish to withdraw your question, you may do so by pressing 02. Our first question comes from the line of Richard Bosser from J.B. Morgan. Please go ahead. Hi, thanks for taking my questions. Maybe I could do three, please, if that's okay with you.

Dosing, so chronic dosing with my make feed phase two in patients with certain chemotherapy with or without inhibitors and finally on other serious chronic diseases. We are extremely happy that some appetite in the Nash indication was awarded breakthrough designation by the U.S. regulator and will be followed by phase three initiation.

As possible next year and so you'll see we've already spoken about so without further ado over to an update on the financials and that's you can thank you Matt.

So as a as I started out a man's thing seven cents EPS growth and 7% a profit growth on a year to date basis and also fall off for the quarter in isolation.

We're continuing to invest in our business in sepsis distribution cost.

Richard Vosser: So, firstly, you talked on Friday about the outlook for 2021 in broad terms, but maybe you could give us a little bit more help on the pricing pressure you anticipate across the different insulins in the U.S. and outside the U.S., and in particular, how you see the impact of Semgli on the basal insulin space, and possibly as well, how we should think about the GLP-1 pricing situation next year relative to this year. Second question, just on the COVID impact, just your latest picture on new patient starts throughout Europe as the second wave intensifies, just your view on how that impact is relative to the first wave. Is it smaller than that?

With the five cents cost exchange rate growth, but versus.

So said, 12% growth in R&D cost the 12% impacted by the amortization of a project review watch it to add that we have informed the ft that that will be using in conjunction with the with the regulatory review of some exercise to platform in the U.S.

[noise], that's where outlook a as a as stated in the in early October than the than we have raised our outlook to 5% to 8% top line growth at 520% operating profit growth.

Currency impact is a 3%.

A negative impact on sales linked with the lower us dollar and a and around 12% the negative impact on operating profit while financial items are now at a loss of 1.4 billion Danish kroner versus 1.2 in August linked to a deterioration of.

Karsten Munk Knudsen: And how do you think the lockdowns might impact you as they come through? And then third question, just on the nausea or the GI profiles in the step trials, I think Matthew mentioned the discontinuation rates were low, but if you could maybe give us an idea how the nausea and vomiting levels are in the step trials relative to what we know of the profile of Azempic and how then the titration profile in the step trials might be different to the sustained 40 trials so that we can have a bit of an idea there. Thanks very much.

Sure certain emerging market currencies.

Free cash flow is now at between 34.9 billion up one 1 billion compared to our Q2 guidance linked to a link to the upgrade it.

Profit outlook I just went through.

So this concludes our presentation for for the third quarter performance and the and this slide just to remind you.

Mads Krogsgaard Thomsen: Thank you, Richard. So I'll start out with the first two questions, and then Matt is on Norcia. So Richard, talking about 2021, we're not providing this level of granularity on our guidance at this point in time. So you will have to wait until February to get more detailed commentary. That, I will say, as we talked about before, that we see rapid growth in DLT1. However, the competitive situation is stable between us and one competitor.

You around our strategic aspirations and worked with assuring against.

20 to 25 at the end with this I will hand, it over to the operator to initiate the acuity.

Thank you if you do wish to ask a question. Please press zero one on your telephone keypad.

[laughter] withdraw your question you may do so by pressing zero two to cancel.

Our first question comes from the line of Richard Vosser from JP Morgan. Please go ahead.

Hi, Thanks for taking my questions, maybe I could do three.

Three please.

As possible.

Karsten Munk Knudsen: So our focus is to continue to drive growth in the DLT1 segment and have open access in that segment. As to COVID-19's impact in Europe, it's kind of something that evolves day by day or week by week. We don't have very detailed data in terms of impact on the diabetes market in Europe compared to what we have, for instance, in the US. But anecdotally, what we hear is, for instance, in Sweden, where they have more data granularity, as of last week, we heard that diabetes patient visits to Swedish clinics were down some 30% or so compared to pre-COVID.

So firstly you too.

On Friday about the outlook for 2021 in broad terms, but maybe you could give us a little bit more help on pricing pressure you anticipate to crossing.

Across the different in ceilings in the U.S. and.

And outside the U.S.

And in particular, how you see the impact just separately on the basal insulin space and possibly as well how you how we should think about the GLP one pricing situation next year.

Relative to this year second question just on the type of impact I'm just still do.

His picture on new patient starts throughout year at as the second wife Intensifies. Just your view on how will that impact is relative to the first why visit smaller and how are you.

You think the lockdowns might that might impact you as they come through and then second question just on the news the LNG price falls in the step trials I think Matt you mentioned.

Karsten Munk Knudsen: We do believe that compared to Q2, although we have a lockdown, societies have learned better how to manage through a lockdown and keep certain wheels running at the same time. But, of course, tough lockdowns will impact patient flows to some extent. And then I would furthermore add that when you look at our prescription trends and sales trends across geographies, then we've seen a high level of resilience in our TRX curves and our sales performance. So, of course, an impact from fewer new patient initiations, but very high resilience on the continued patient performance, and then over to UMass on Norcia. Yes, well, first of all... Speakers, we can't hear you, are you on mute?

The discontinuation rates are low, but if you could maybe give us an idea how the nausea and vomiting levels are in the step trials.

Relative to what we now ill probably follow that same pick and how then the.

Hi, trace and probably fall in the set top might might be different to that sustained towards a trial. So that we can have a bit of a thought that thanks very much.

So so rich are talking about a 2021.

Then that when we're not providing that said this level of granularity on our guidance at this point in time. So you won't have to it would have to wait until February to a tour to get more detail or commentary.

With that I will say is as we talked about before that day that we see rapid growth and deal with one however, what they can.

Competitive situation is stable between the us and one one compared to <unk>. So our focus is to to continue to drive growth in the just one segment and I'm happy to have open access in the in that segments.

Mads Krogsgaard Thomsen: Sorry, I was. So I'll just repeat, vis-a-vis the titration within diabetes and obesity for obesity sema 2.4 is done via titration over 0.25 to 5, 0.5 to 1.0 via 1.7 milligrams to 2.4. But for diabetes and sustained 40, we go directly from 1.0 to 2.0 milligrams without an intermediate dose. So that's on the titration regimen. And it is based on prior evidence of high and consistent tolerability of GI side effects with this dosing regimen and titration regimen. Vis-a-vis the absolute numbers, you are aware that you see mild to moderate occurrences of nausea, typically within the realm during the titration phase of up to, let's say, 15%, 15, 20% reporting in any given week on a mild to moderate basis.

As to a COVID-19, the impact in <unk> and Europe its.

Kind of something that evolves a day by day a week by week, we don't have varied.

Very detailed data in terms of the impact said Oh.

On the diabetes market in Europe compared to what with what we have for instance in the US I would say anecdotally.

What we do is said, France, France, and Sweden, where they have to have more data granularity data as of last week, we heard that the that the diabetes patients visits into a Swedish clinics, where it went down some 30% or so compared to compared to pre Corbett said.

Mads Krogsgaard Thomsen: And then that wanes over time as we hit the target dose, such that when you're in steady state after, let's say, a year or so, you have a total of one out of 10 patients reporting mild to moderate nausea in a given week. And for the other GI tolerability issues, diarrhea, constipation, so on, the numbers are much lower, much lower, actually. So that's what it looks like.

We.

We do believe that yeah that compared to Q2 than albeit albeit we have locked on than that then societies have affluent better how to manage through a locked down and keep certain wheels thread running at the same time, but of course tough tough luck lockdowns will impact the pace of growth too.

Michael Leuchten: And we believe, hence, we have found a very tolerable dosing regimen for semaglutide, whether it is in diabetes, obesity, or, for that matter, NASH. And we don't really comment on the other products from other companies. Time and data will, of course, show how they stack up. Thank you very much. And the next question comes from the line of Michael Leuchten from UBS. Please go ahead. Thanks very much

To some extent and then out Furthermore, at that day, when when you look at our prescription trends.

At the end sales trends both across geographies then there we've seen a high level of residents in our trx curves and the and I'll say performance, so and so of course, an impact from fewer new patient the initiations, but but but very high resilience on on the continued patient performance.

Yeah.

Camilla Sylvest: Three questions, please. One, Camilla, I was just wondering if you could go back to your commentary around Rai Belsa's. I think you said 50% of patients are still benefiting from the $10 access program. How do we think about this phasing out over the next couple of quarters? Is there a firm deadline? Can you extend it?

And then also you mess on our no show.

Yes, well first of all.

Speakers, we can't hear you are you on mute.

Camilla Sylvest: And as that rolls into a co-pay assistance program, what does that do to dynamics, if anything? Second question, just interested in your reduction of the ceiling price for human insolence. Just how do you benchmark it?

Sorry, I was so I'll just repeat vis-a-vis the tightrail within diabetes and obesity for obesity Summit 2.4 is done via titration over 4.25 to 5.5 to one point not be a 1.7 million gram to 2.4, but for diabetes and speak for.

Camilla Sylvest: Why did you decide to do that now? It's obviously very applaudable, but just interested in your thinking on timing here. And then thirdly, just Matt's on ConchitzaMap, I think you said you changed the dosing to be allowed to restart the trial. I just wondered if you could give us a bit of color on what you had to change.

We go directly from one point not to 2.9 milligrams without any intermediate dose. So that's under tight treatment regimen and it's based on prior evidence of a high and consistent Tolerability a choice I try to fix with this dosing regimen and titration regimen vis a vis the absolute numbers you are aware.

Camilla Sylvest: Great. Thank you, Michael. So the first two for you, Camilla: Rebelsis access and more use of co-pay programs at 50%, the ceiling price benchmark, and then Consisimap for mass. Thank you, Karsten.

That you see.

Mild to moderate occurrence of nausea.

Typically then the rounds during the type patient phase of up to lets say, 15% 15, 20% reporting in any given week on a mild to moderate basis mid that wins over time as we hit the target those such that when you are in steady state after let's say a year or so you have a total of one out of 10 patients reporting.

Camilla Sylvest: On rebels with access, we talked about the other day that there is, of course, a movement over time in terms of what we call clean scripts and what co-pay or voucher scripts. And this development, in principle, takes place with the access that we gain over the years. So we have seen, and I mentioned the other day that we are now at around 50% of what is the clean scripts and what is the voucher co-pay scripts. Earlier in the year, of course, we were at a different starting point.

In a given week mild to moderate and knows yet and for the other Gi tolerability issues Styria constipation, Sean the numbers a much lower much.

Fluctuate. So so that's what it looks and we believe hence we power the very tolerable dosing regimen for Semaglutide, whether it is in diabetes with BCG or for that matter Nash and we don't really comment on what the other products from the other companies to time at data will of course show how the cycle.

Camilla Sylvest: So as we gradually gain access, you should expect that we will get up to the level of the access that we have now, so approximately around 85%. This is the movement that is taking place at the moment. Then on the ceiling price for human insulin, this was really one of the first initiatives that we launched as part of our new social responsibility strategy that we launched at the end of May called Defeat Diabetes. Defeat Diabetes has innovation as the core contribution to society, but we also realized that not every patient gets access to our innovation. So access and affordability are a big part of our Defeat Diabetes strategy, and the ceiling price for the low and middle-income countries, the 76 countries where we have lowered the price, is really being benchmarked against where we are and what would make meaningful access to those patients. And we are talking about approximately 2.9 million patients that, in principle, would benefit. This, of course, also means that local governments need to apply this in their tenders, but So that's the background for that.

Right.

Thanks very much.

And the next question comes from the line of Michael Larsen from Yes. Please go ahead.

Oh, thanks, so much two questions. Please one Camilla I was just wondering if you could go back to.

Your commentary around black belts is.

Access into U.S., I think you said, 50%.

Patients are still benefiting from the the 10 dollar access program, how do we think about this phasing out over the next couple of quarters is there a firm deadline can you extend that and that's that rolls into a co pay assistance program, what does that do to dynamics if anything.

Second question just interested on your reduction of the ceiling crisis human insulin I'm, just how do you benchmark. It why why did you decide to do that now it's obviously very affordable it's interesting and you think interested in your thinking on on timing here.

Camilla Sylvest: The last element in our strategy to defeat diabetes is prevention, but we can talk about that another time. Great, and over to you, Mads. Yeah, so what happened was we saw three cases of non-fatal thrombotic events early this year that led us to the clinical hold in March of this year that was then followed up by interactions with regulators very diligently such that the FDA and other regulators allowed us to resume with a revised dosing regimen, both actually for consistomab but also for the on-demand treatment of bleeding episodes in a way that, based on our investigation of So we think we are in a good situation, and not all, but almost all of the patients have resumed in the Explorer Phase III program. Next question, please. And the next question comes from the line of Peter Welford from Jeffreys. Please go ahead. Hi, thanks so much for taking my question. I've got two.

And then thirdly, just mattson from kit sum up I think you said you've changed the dosing to be allowed to restart the trial and just wondered if you could give us a bit of color of what you had to change. Thank you.

Yes.

Right. Thank thank you Michael So the first two for you Camilo rebel society axis, and and more use of co pay programs of 50% ceiling price benchmark and then consistent message from us.

Yes.

Thank you Catherine.

Every thats with excess we talk about the other day that there is of course, a movement over time in sense of what we call clean it's based on what their co pay a voucher script.

When did this development in principle takes place with the access that we gain over the year. So we have seen and I mentioned the other day that we are now at about 50% what do you say cleans cliffs and what do you say about your co pay scripts.

Any idea of course, we were at a different starting point so as we gradually gain access what you should expect that we get up to the level of excess that we have sold approximately about 85%.

So this is the movement that is taking place at the moment.

And then on exceeding price for human insulin. This was really at one of the first initiative that we launched as part of our new social responsibility strategy, we launched in May call defeat diabetes.

Peter Welford: Firstly, for Mads, I wonder if you could comment at all on the NASH late-breaking abstract ASLD with the Gilead combination molecules. We can see data there with regard to some of the biomarker data. I wonder any comment on that relative to the Phase II NASH data that you've obviously already presented for SEMA, and particularly as well about the tolerability as well of somaglutide together with the Gilead small molecules and how you think about going forward for the NASH indication if possible. And secondly, another one I think for Mads, just on MIM-8; I didn't catch quite what you said just with regard to Phase II. Are we yet at therapeutic doses, and will we use therapeutic doses, or is this initial study just looking at sort of PKBD at sub-therapeutic doses, and there'll be another study looking at therapeutic doses before we move forward? Thank you, Peter. So Matt, first question on the combo versus mono therapy, Semenash, and the second one on my mate, Doustdar.

Diabetes said has innovation is the core contribution to society, but we also realize that not every patient get access to our innovation. So access and affordability is a big part of our defeat diabetes JV entity.

Defeating price for them and for the low and middle income countries 76 countries, where we have lowered the price is really being benchmarked against and where will be and what would make a meaningful access to those patients and we're talking about approximately 2.9 million patients that includes.

Good.

Dan will benefit from this.

At this of course also means that the local government needs to apply this in depth into us but that is what we are working with them on at the moment. So that's the background for that the last element in our defeat that BD strategies prevention, and where we can talk about that's another test.

Right I know CMS, yes, no so.

What happened was we saw three cases, often nonfatal thrombotic events.

Mads Krogsgaard Thomsen: Well, first of all, I can first of all confirm that semaglutide, both in our own biopsy-based phase 2B trial but also in the one that you will see announced in the combination of the FXR agonist and the ACC inhibitor alone and together in conjunction with semaglutide, proved a point that semaglutide has a high level of efficacy based on either biopsies or, in this case, on biomark With the addition of one or both of the Gilead compounds, there is, of course, data coming out very, very soon, and I don't think it would be too pertinent of me to comment specifically on that because we're in a partnership with Gilead. We will have those data announced very, very soon at the conference, as you mentioned, and then we will discuss the path forward with our strategic partner, Gilead, in that regard.

Early this year that led us to the clinical hold in March of this year that was then followed up by interactions with the regulators very diligently so that the FDA and other regulators allowed us to resume with a revised dosing regimen.

Both actually pull consumer but also for the on demand treatment of bleeding episodes in a way that based off our investigation of the individual patients allows us to do so we believe safely going forward and also we are able to we can see a monitor the catlin status all of these patients. So we think we had a good teacher.

And not all but almost all of the patients have to reissue explore phase three program.

Okay.

Mads Krogsgaard Thomsen: But overall, I think it's nice to see the confirmation of semaglutide's efficacy based on different readouts in the NASH condition. Also, tolerability-wise, I can just say that there were no big issues in these trials, but you will hear more about that soon. With regard to my mate... We actually have the situation that the single ascending dose study in healthy volunteers has shown us what we believe to be an expected efficacious dosing range that we are now investigating. So these are clinically therapeutic dosages. It's a classic dose range finding subchronic study that will guide us towards the phase three trial that we hope we'll be able to run during the latter part of next year. So we believe we have a next generation mimicking antibody and, of course, we will look forward to sharing data as they emerge.

Next question please.

And the next question comes from the line of Peter Welford from Jefferies. Please go ahead.

Hi, Thanks, so much for taking my question I'd like to first be for Mads I Wonder if you could comment at all on the match late breaking abstract stays healthy with the caveat accommodation molecules we can see.

Data that are all nobody doubts due to some of the biomarker data.

Any comment on that relative to the the phase two Nash data that you've obviously already presented sense December and particularly as well about the the tolerability as well all semaglutide together with the give me at small molecules and how you think about going forward and so the Nash indication if possible.

Second the end of the one I think the match just till midnight didn't catch probably you said just regards to the phase two are we repeated doses, where we use therapeutic doses or is this initial study and just looking at sort of PK PD, we supported piecyk doses and there'll be another study.

Mads Krogsgaard Thomsen: Sorry, can I just follow up briefly on NASH. Can you make any comments at all on the choice of oral? Because I noticed that Gilead, I think, is using a weekly Zempik-like regimen, whereas on the other hand, I think your own study used the daily oral. Any thoughts there on, with regard to the optimal choice for NASH going forward?

Doses before we move forward. Thank you.

Okay.

Right. Thank you Peter So CMS, a first question on the combo versus versus mono monotherapy seminars and the second one on on that my made the doses.

Mads Krogsgaard Thomsen: Well, Semacrotide will always be a once-weekly application via the injectable version. I am aware of what we did in Phase 2B for historic reasons, but in Phase 3, we're moving with a classic dosing regimen that will help people reduce both the inflammatory status and the steatosis status, I hope, in the liver with a therapeutic dose of once-weekly Semacrotide. I won't comment on the other combination partners until and if it comes to that.

So first of all.

I can first of all confirm that semaglutide, both in our own biopsy based fees to be trial, but also in the one that you will see announced in the combination between if excitement has been the senior pizza.

Alone and together in conjunction with some appetite.

Proves the point that you make the tide has a high level of efficacy based on either biopsies and in this case on on Biomarkers with the the.

Operator: Next question, please. Next question comes from the line of Sachin Jain from Bank of America. Hi, thanks for taking my question, Stats and Jane, Bank of America. Two, if I may.

Addition of one or both of the Gilead compounds there are of course.

Data coming out very very soon and I don't think it would be to put an end to have me to comment specifically on that because when the partnership gilliatt.

Sachin Jain: One for Camilla. You very kindly discussed the SEMA obesity sort of commercial program on Friday and outlined your sort of four objectives. My question was, what really unlocks the payer and patient market? Is the weight loss you see with SEMA, which roughly doubles AXN, enough for that conversion?

We will have those data on out very very soon at the conference as you mentioned and then we will discuss at the path forward with a strategic partner give yet in that regard, but overall I think it's nice to see the confirmation of some appetite. If you can see based on different read out in the Nash condition.

Camilla Sylvest: Or do you need to select an AM833 type weight loss to really unlock this market? The reason for the question is, you know, CMD a couple of years back when you were asked about your aspirational heat sales, one of the things that came out at that time was that selection was really required to unlock this market. So I wondered if that is still the case, or has the thought process evolved a little bit since then.

Also tolerability wise I can just say that there were no big issues in these trials part, but you will hear more about that soon with regard to my mate we.

We actually have the situation that the.

Single ascending dose study in healthy volunteers has shown us what we believe to be a expected.

Mads Krogsgaard Thomsen: Second question for Mads on the SEMA, sorry, the Ribelis higher doses phase one. Can you just remind us of the regulatory pathway there and what exactly is required to get these higher doses on the label? That'd be great.

If acacias dosing range that we are now investigating so these are clinically therapeutic dosages, it's a cash dose range finding some chronic study that will guide us towards the phase three trial that we hope will be able to run in during the latter part of the next year. So we believe we have a next generation.

Sachin Jain: Thank you very much. Thanks, Sajan. So first, for Camilla, on reimbursement for similar obesity and what triggers that, and for MERS, the high dose and the regulatory process forward. Yeah, thank you. So on reimbursement and what really triggers that, what we have seen now is, of course, the weight loss has a big impact, but already now with the Saxenda, which has half of the weight loss that we have seen now with the Magnesite 2.4, we have obtained reimbursement in selected countries and, most recently, as you know, with NICE, which has recommended Saxenda for use in a specific patient population. So what has been important in that type of process is the health economics and modeling of the long-term outcomes related to weight loss, and it's very clear that a big part of the patients living with obesity have severe comorbidities like cardiovascular risk, or cardiovascular problems like diabetes, and some types of cancer, and when you model all of that into a health economic model, you're able to show the benefits of keeping the weight down to a level And so that has been what we have used as part of our health economic modeling. We have a new model that actually takes all of this into account. Having said that, of course, the SELECT study will also prove very valuable to show in real life what some of these modeling assumptions that we're applying now, and how we can verify those.

Basically mimicking antibody and of course, we will look forward to sharing data as they emerge.

Can I just follow up briefly on the Nash just can you make any comments still on the choices or because I know that the give me out I think using the weekly then bake like regimen, whereas on the latter your rights to use the the Davy oral any thoughts there on with regards to the optimal choice for Nash going forward.

[noise] Semaglutide will always be a once weekly application via the injectable version I am aware of what we didnt say to be.

For for historic reasons, but the in faced we were moving with a classic dosing regimen that will make people reduce both the excess inventory status and the this dsos is that as I hope in the LIBOR with a therapeutic dose of once we get some equity I won't comment on on the other combination partners until and if the.

Yes to that.

Next question please.

Next question comes from the line of Sachin Jain from Bank of America. Please go ahead.

Hi, Thanks for taking my question Sachin Jain Bank of America, I'm sure if I make long sure I'm Camilla.

You very kindly on Friday discussed some a b C sort of commercial program and online just four objectives. My question was was really unlocks the pay a inpatient market is the weight loss.

You see with semi stuffy double Saxon enough on that conversion.

Camilla Sylvest: So SELECT will still be important, but we can now model most of the implications, and we know from Canadian studies that obesity-related complications and costs can take up to 10% of healthcare spending. So it's really something that payers and policymakers are interested in seeing how they can lower. Thanks.

Would you need to select and the and 833 tight weight loss ratio this market.

The question is.

MD a couple of years back when you were asked about your inspirational keep sales one of the things that came out of that time was to select was ready requests on maintenance markets I Wonder if that's still the case, what's the thought process evolved a little bit since then second.

Mads Krogsgaard Thomsen: And then, Sachin, when it comes to high dose reversals, I'll just remind you of a discussion we had with you maybe at ADA last year, where we stated that we had been in a good and constructive regulatory dialogue with, among others, the FDA, following which we could conclude that we would increasingly be able to bridge between all and injectable versions of the semaglutide molecule, if and when we could show that exposure was And the reason why I mention that is that with high dose rebels... We will be operating in a range of exposure that we either have done or are doing also with the injectable counterpart of Somatricide, which actually enables us to have a slim program toward approval of higher doses.

Second question mounts on the semi sorry, the rebelliousness higher dosing phase one can you just remind us of the regulatory pathway. Then what exactly is your quantify these higher doses on label that'd be great. Thank you very much.

Thanks, so much and so for Camilla on reimbursement and therefore, CMO PCM and what the trigger.

Trigger set and to and from us at the high dose and the regulatory process forward.

Yes. Thank you.

So on the reimbursement and what really triggers that what we have seen now you see and of course, the wait list has a big impact but already now with this xcenda every test at half the weight loss that we have seen now we have to make a tied to planful. We have obtained reimbursement in selected countries and most recently as you know we have to wait.

Mads Krogsgaard Thomsen: This is a known molecular entity. It's a known level of exposure. It has a known safety and tolerability profile. So, what you typically can do is one kind of pivotal trial, not necessarily a huge one, but one that can provide the indication for the new and higher dose. And if for some reason you were to have a formulation that has different characteristics compared to the original repulsive formulation, one would do a clinical pharmacological bridging study to show that the equivalent dose corresponding to a given dose of the old formulation that is present in the new formulation is modified, and you then show that they are bioequivalent.

I said its recommended to make it takes into for you.

In a specific patient population the what has been important in that type of process is the health economic and modeling up a long term outcomes related to weight loss and it's very clear that a big part of the patients, leaving little PCT would have severe co morbidities like at cardiovascular.

At risk like cardiovascular problems like diabetes. Unlike some types of cancer and when you model all of that into a health economic model you were able to show the benefits of keeping to break it down to a level below my authority and so that it's been what we have used in add of our health economic modeling we have a new.

Mads Krogsgaard Thomsen: Thank you, so if I could just push you for filing, rough filing time, does that sound sort of like 23, 24ish then, or is it potentially earlier than that? I think we will not comment on the filing at this point in time, only that we started this phase one, which we were happy to announce. Great. Thank you, Matt. Thank you, Sachin.

I believe that that actually takes all of this into account having said that of course. The select study will also prove their vertical to show in real life, let's somewhat this modeling at these modeling assumptions that we apply now how how we can verify those so as to make will still be in Poland, but we already now can most of most of the implications and we know from.

Operator: Next question, please. The next question comes from the line of Tijor Parikh from Goldman Sachs. Please go ahead. Good afternoon.

Canadian studies that obesity related company.

Keyur Parikh: And thank you for taking my questions. Karsten, two clarifications on your comments on Friday and then one from Mads. The first one is, as you talk about the transformation of the US from the older products you had to the newer products like the kind of your GLP-1 franchise, logically, that should translate to the growth rate moving higher. So just wondering if there was anything I was logically missing in that assumption. If so, it would be great to hear your perspectives on it.

Complications and costs can take up to 10% of the healthcare and so its really something that pay us and policymakers interested in seeing how they can and lower.

Thanks.

And then setting when it comes to Heico's rebuilds us.

Just to remind you of the discussion we had with you maybe at 88 last year, where we stated that we had been in a good and constructive regulatory dialogue with among others. The following.

Following which we could conclude that we will increasingly be able to reach between all an injectable versions of this back inside molecule.

Karsten Munk Knudsen: Secondly, I think you laid down multiple kinds of details on how you see the cost lines growing into next year, which was helpful. But again, in the context of the growth outlook, I wonder if you might be able to comment whether you expect 2021 operating margins to be broadly similar to 2020, meaningfully lower than 2020, or anything that would be helpful. And then secondly, Mads, as you look at initiating multiple kind of large phase three studies kind of into next year, is there anything we can do from a platform perspective or kind of from an R&D recruitment perspective that can either help you think about scaling up and lowering the cost of those recruitments or quickening the enrollment for those? Thank you. Great

If and when we procure that exposure was at the same level for each time, we had this discussion about one of the other products and the reason why I mentioned that is that with high dose for Bill says, we will be operating in a range of exposure that we either have done or are doing also with injectable counterpart, some appetite, which actually in Naples.

To have a limb program towards approval upon those as the new molecular entity, it's a new level of exposure. It's unknown Seacon Tolerability profile. So what you typically can do is.

One kind of pivotal trial not necessarily a huge one but one that that can.

Provide the indication for than UN and higher dose and for some reason you were to have a formulation that has different characteristics compared to the original recourses formulation, one would do a clinical pump could logical bridging study to show that the equivalent dose corresponding to it given dose of the old formulation.

That is present in the new formulation is modified by some sort so and that you then show that they are bio equivalent so to speak.

Thank you so if I could just push you for finding refining some of that sounds sort of like 23, 24 extent or is it potentially earlier than that.

Karsten Munk Knudsen: Thank you, Keyur. I'll take the first 2021-related questions and then transfer you to the R&D, and clinical trial recruitment. So, Keyur, in terms of the US transformation, then the 70% we've set out to transform, to launch products launched after 2015. So, from that point of view, you can say future impact on US pricing, everything else equal, would be less.

I think we will not comment on filing a at this point in time only that we started this phase one, which we will have to sort out right.

Okay. Thank you Matt.

Thank you Sachin and next question please.

Next question comes from the line of Keyur Parekh from Goldman Sachs. Please go ahead.

Good afternoon, and thanks for taking my questions.

Austin two clarifications from your comments on right and then one for Mark.

The flow through as you about one's formation or do you.

Karsten Munk Knudsen: I have to remind you, as you know, that we are providing our guidance come February. So these are just the building blocks that I provided last week. And the transformation is nothing new to that. And actually, the same goes for the cost lines.

From the older products you hired the newer products like kind of GLP, one franchise logically that should translate to the growth rate moving higher. So just wondering if there was anything that would logically missing in that assumption, if so would be great.

Yes Duane.

Secondly, I think you laid down multiple kind of begins on how you see the cost lines growing into next year will be towards health.

Karsten Munk Knudsen: And it's important to note that we are pursuing a growth-based strategy, and we are investing in driving growth for our franchise, both in the short-medium term, but also investing in future growth platforms in R&D. So that's the strategic backdrop for my comments on Friday.

But again in the context of the growth outlook I Wonder if you might be able to comment whether you expect kind of 2020, one operating margins to be broadly similar krwtwenty, two Andy meaningfully lower than Twentytwenty anything that would be helpful.

Karsten Munk Knudsen: So I think at this point in time, we have a unique opportunity between the top-line growth we have and thereby being able to invest both in realizing that top-line growth through launches, while at the same time ensuring that we have future product platforms and technology platforms that will yield growth in the long term for investors. So I think strategically, this is a perfectly sensible way of running our business at this point in time. And in reality, nothing new in the direction of communication from the company compared to what we've said, at least since Capital Markets Day, and then over to you, Mads, on the clinical trial recruitment. Yes, well, first of all, a couple of more generic statements surrounding the way that Dr. Martin Lange and his crew at the Global Development Organization are conducting our trials. You are aware that, unlike most companies, we do not use a lot of CROs.

And then secondly, Mads you look at initiating multiple kind of large increase studies into next year.

Is there anything you can do from a platform perspective or kind of from an R&D perspective can you think about scaling up and lowering cost of those improvements to becoming the enrollment for those thank you.

Okay.

Great. Thank you for your I'll take the first tranche tranche, one or two questions and then mess for you on on the R&D.

Clinical trial recruitment. So so could you D in terms of the U.S. <unk> transformation. There then the.

The seven just presented we've set out to transform the air.

To launch products products launched after 2015 by 2022 were roughly at the at the 50% now and to and what you can see is that the that a U.S. insulin business is is less or.

Mads Krogsgaard Thomsen: We predominantly have our own clinical research associates all over the world in close dialogue with investigators and knowing which sites work and which don't, and so on. So two things have prompted us to change the way we conduct global clinical trial development or clinical development. One was the notion that we had to move from around 16,000 patients in trials just a year and a half ago to today more than 40,000 and, a bit more than a year from now, more than 50,000 patients. How do we do that without crippling the cost of clinical development? Well, we've done two things. We are kind of leveraging the fact that we are an independent organization that has all the tools and the puzzle pieces to the jigsaw, so to speak, to play around with.

Oh wait compared to what it was so I'll use insulin that business is now some 13% off of.

Of group sales. So so of course continuing to be impacted by a buyer.

By pricing process, but the but the but the size of the business is smaller so so from that point of view.

I would say future impact on us pricing everything else equal what would would be less.

I have to remind us as you know that the that we are providing our guidance call come February.

So so this is just the building blocks that I provided last week.

And the transformation. This is nothing new on that and actually the same goes for the cost lines and it's important to note that the we are pursuing growth based strategy and and we are investing in driving growth of our franchise. Both in short medium to ramp up but also investing in future.

Mads Krogsgaard Thomsen: And elements in enhancing our productivity have included but are not limited to having our clinical research associates do a lot more of their work monitoring, source data verification, et cetera, et cetera, remotely. So they are no longer, they can do that electronically; they don't have to do a visit to the investigator every single time to check up on the temperature in the fridge or whatever.

Growth platforms in the in the NRG. So so that's that's a strategic becca backdrop between between my comments on on Friday. So so I think at this point in time, we have a unique opportunity between the topline growth, we have and that by being able to to invest both in realizing.

Mads Krogsgaard Thomsen: So a lot of optimization has happened and is happening on an ongoing basis there that enhances productivity. But we have also prepared for the COVID-19 situation by digitizing a lot of the work we do, including the interface between the company, the patient, and the physician, or the company, the doctor, and the patient, such that we can really do a lot of almost virtual trials as we speak, and there will be more fully virtualized over time. So we are rendering ourselves less susceptible to a second or third wave of COVID-19, whilst at the same time optimizing productivity. Something that is difficult to do if you work too much with CROs because then you are dependent on their systems playing together with your systems, but we can develop all of this ourselves.

Yeah, the topline growth through a through launches why that's at the same time, ensuring that we have.

Future product platforms, and technology platforms that will yield to growth in the long term friend asked us. So I think strategically this is a perfectly it kind of sense for way of running our business at this point in time and in reality and nothing new in directional communication trial from the company compared to what it was.

Mads Krogsgaard Thomsen: And I actually have a team in early research in Seattle that is helping out doing some of the work so that we're also ready for the phase three program, for instance, for Great. Thank you, Max. Thank you, Keyur. And next question, please? This question comes from the line of Mark Purcell from Morgan Stanley. Please go ahead.

We've set the at least since the capital markets day.

And then what you mess on the on the clinical trial improvements, yes, well first of all to you up a couple of more generic statements surrounding the way that the doctor merchandising and his accrual in the global development organizations are conducting our trials you are aware that unlike most companies we do not use a lot of euros, we predominantly have our own clinic.

Research associates, all over the world in close dialogue with investigators and knowing which sites work in which don't and so one so two things have prompted us to change the way we conduct a global clinical trial development of clinical development. One what's the notion that we had to move from around 16000 patients in trials just to your hopper.

Mark Purcell: Yeah, thank you so much for taking the questions. The first one's on the positioning of Zilchia. I guess this one's for you, Mads.

Mads Krogsgaard Thomsen: Can you help us understand the development program you're going to start here? I'm just sort of thinking that CV disease obviously remains underdiagnosed and under-treated in patients with CKD. But you could maybe start with hemodialysis where you have an event rate in terms of MACE of 20 per 100 patient years and start there as a specialist product. And then that could chime in with Ludovic in terms of his previous experience in bringing in HIIT inhibitors and other sorts of hemodialysis target agents as well. Or is this going to be more of a broad GenMed approach and therefore would probably warrant doing some prevalence trials to look at some of the biomarkers you mentioned in terms of relevance as you do your CV outcome study? So I'd be really interested in terms of positioning that.

So should stay more than 40000, and a bit more than a year from now more than 50000 patients how to do that without crippling the cost of clinical development well. We've done two things. We are we are kind of leveraging the fact that we are a independent conversation that has all the tools and the the parcels to the jig saw so to speak.

With an element in enhancing our productivity have included but are not limited to having our clinical research associates do a lot more of that work monitoring source data verification et cetera, et cetera remotely. So they are no longer they can do that electronically. They don't have to do every single time visit to the investigator to check.

Mads Krogsgaard Thomsen: The second one was in terms of SexSender in the UK. Could you just help us understand the price reduction that you offered tonight and the specific patient population that you got the recommendation for? I'm just wondering, Camilla, is that a guide to how Sema may be positioned in the future? And then third, in terms of ribosomes and pricing, and net pricing more specifically, should we just sort of broadly think that this product will be priced more or less in line with injectable GLP-1s outside the US and then at a sort of a constructive discount to injectable GLP-1s in the US when we' Thanks very much. Thank you, Mark. I counted three questions.

Cup on the Tempur trying to preach or whatever so a lot of optimization has happened and is happening on an ongoing basis. There that enhances productivity. But then also we are prepared for the Cobi 19 situation by digitizing a lot of work. We do include the interface between the companies the patient and the physician or the companies that position and the decision.

And the patients such that we can really do a lot of almost virtual trials as we speak and there will be more pretty virtualized overtime. So we rendering ourselves that's susceptible to a second third wave of COVID-19 was at the same time, having optimize the productivity something that it's difficult to do if you work too much with euros.

Because then you are dependent on das systems, bringing together with your systems and we can develop orthos ourselves and I actually have a team in early research in Seattle that is helping out doing some of the work. So that will also ready for the phase three program for instance for instant I predict to tease out the whole your benefits of the molecule with the latest estimate of digital technology.

Camilla Sylvest: So the first question to Mads on CILTI and early thoughts on phase three development programs and inclusion criteria and what patient population to go for. Then Succenta UK, price and patient population restrictions. And then finally, for you, Camilla, and then also for you, Rebelsis pricing US and ex-US on a conceptual level. Yes, thank you, Karsten.

Great. Thank you Mike. Thank you for your aunt a next question. Please.

The next question comes from the line of Mark Purcell from Morgan Stanley. Please go ahead.

Yes. Thank you so much better the taking the question.

Mads Krogsgaard Thomsen: I will start; I might pass over to Ludovic, who has experience in the cardiometabolic arena from his prior experiences, just a couple of comments on how that has fared. But overall, Siltivecumab is supposed to address the residual unmet need, i.e. The residual risk of patients who are already treated with a myriad of platelet blockers, antihypertensives, and all the usual agents, diuretics, and whatnot, that are statins that are used in this population. So we know that about 7 out of 10 people with atherosclerotic cardiovascular disease actually do have some degree of intravascular and cardiovascular inflammation.

The first one so not positioning itself I guess this one's for you Mike.

So can you help us understand the development program, you're going to just on here.

Just sort of thinking that CV disease, we'll see remains an under diagnosed and treated in patients with CKD.

Maybe start with team without assist.

Hi, the event rates in terms of basis of 20 per 100 patient years start there as especially as products and that that could chime in with a little bit conservative in his previous experience imprinted inhibitors, another sort of hemodialysis.

Probably agents as well or is this going to be more of a broad genmab hi, Jim.

Jen, Matt approach and that would probably warrant doing us and prevalence files to look at some of the bond markets. You mentioned in terms of relevance as you do your CV outcome study said you really upsets in terms of positioning.

Mads Krogsgaard Thomsen: Then, of course, over time, we can broaden Siltivecumab in that population, and basically, the trial design is going to be similar to a MACE risk reduction trial with secondary endpoints related to chronic kidney disease and other elements, as you would normally do in a CVOT. Thank you very much, Matt, for that. I have two comments on my side.

The second one was in sensor.

Thanks, Andrew in the UK could you just help us understand the price reduction the off that Tonight.

On this specific patient population that you you got the recommendation that.

Was wondering Camilla, it's not a guides how some may be positioned in the future.

And then third in terms of right Bellsystem pricing net pricing. Both this most specifically should we just sort of broadly thing that this product will be priced more or less in line with injectable GLP ones outside the U.S. and that sort.

Sort of constructive discounts injectible GLP ones in the U.S., when you're sort of thinking about modeling Miss that said its growth driver for you.

Ludovic Helfgott: The first one is that it's completely logical to look at the benefit of these drugs in the context of a wide metabolic set of diseases. If you look at the patients today that are diabetic and cardiovascular, and real, these are the same patients. It's not yet the same physicians, but it's the same patients. The risk factors are the same. The pathways are the same, and I would even say that increasingly, the drugs used to treat them are actually effective across the renal sphere, the cardiovascular sphere, and the metabolic sphere. So it's very logical to do so and to consider the patient holistically. That's the sense of science and the sense of history.

Long term going forward, thanks very much.

Thank you Mark I counted three questions. So the first question to mass on on silty and to enter early thoughts on the on a phase III development program Center, and the inclusion criteria and what pace <unk> patient population to go for the sex and the.

UK.

Price and pay a patient population restrictions and then finally a focus for you Camilla and then also for your rebelliousness pricing US X X us on a conceptual level.

Thank you Scott.

I will start I am I pass over to Ludovico, who has experience in the Cardiometabolic arena from from his prior experience is just a couple of comments on on how that has fat, but overall since you making map is supposed to address the residual unmet need either residual risk of patients will already treated with a mere yet.

Ludovic Helfgott: The second comment is that when you're addressing specifically the renal, the nephrology side, you then have a wide range of patients, ranging from the moderate EGFR decreased down to the pre-dialysis or the actual dialysis sector. And that is, of course, a very complex population, and you don't want to treat all these patients the same way. And that's why I completely support the philosophy behind phase three, which is to look at a... [inaudible] And the next question comes from the line of Peter Riddell from Citi. Please go ahead.

Of platelet blockers antihypertensive send all the usual agency direct and whatnot that settings that are used in this population. So we know that about seven out of 10 people with the ethane has got to come to us because they actually do have some degree of intramuscular and cardiovascular inflammation. That's what we are talking with since you've taken.

The reason why we only going for the five to 8 million patients initially that have come.

Conjunction with moderate to severe CKD.

Is that it is as you correctly stated mock a enrich population with event rates that are much higher than normal making the trial population.

Easier and faster to dissect out a benefit of these anti inflammatory action because the signal to noise ratio will be enhanced that population then of course over time, we can broaden out sooty in that population.

Peter Verdult: Sorry, before we get to that, maybe we should just answer the second question. So, very fast, on Sex Center UK in terms of NICE and the patient population. NICE has recommended Sex Center for use in a patient population with a BMI above 35 and patients that are also pre-diabetic with a cardiovascular risk. This is the recommendation from NICE.

And basically the trial design is going to be similar to what it's amazing risk reduction with secondary endpoints related to the chronic kidney disease and and other elements as you would normally do in.

Yes, just a relatively sick population and that also means that matson Duncan to recruit quite as many patients for quite as long as you would have done if it were more like you know.

Cross licenses, but do you have any in any comments that you historically have in that field because you're all company also now has a different drug on the market or close to the market.

Camilla Sylvest: And you asked also whether this should be sort of a general assumption that this is how it is. But actually, we see that these specifications vary slightly from country to country. So you would say that this exactly fits the UK and the NICE recommendation. However, we cannot comment on the actual price level in the NICE recommendation.

That's it thank.

Thank you very much matter that I think that the two comments on my side. The first one is that completely logic to.

Look at the benefit of these drugs in the context of the wide metabolic that up if you look at the patients today that up.

But our diabetes and cardiovascular and real these are the same patient.

Camilla Sylvest: And then on Rebelsys pricing outside the U.S. and in the U.S., what has been important for us in documenting the support for the price of Rebelsys has been that Rebelsys is an innovation, being an all-GLP-1, and it should be priced relatively to the efficacy that it can give compared to other GLP-1s. So we've seen that being supported generally in the U.S., but also in the countries where we are now launching outside the U.S. So currently, we have launched the product in eight countries outside the U.S., but we have also obtained reimbursement similar to GLP-1.

It's not kept the physicians, but at the same patient the risk factor, though the same than the pathways are the same and I wouldn't say that increasingly the drugs used to treat them actually effective across the renal fear the CAGR basket to see your estimate of what exactly is very logical too.

To do so and to consider the patient Holistically. The defense a science I think the sense of history. The second comment is that when you when you addressing specifically the Reno the need for luxury side. You then having a wide range of patients ranging from the motorists CFR decrease down to the pre dialysis or the actual daily the sector and that is.

Camilla Sylvest: Thank you. Next question. The next question is from Peter Vidal from Citi, please go ahead. I thank you people, I'm through quickly please, Camilla just came back. Peter, can you speak up tonight? It's a little bit soft.

Of course, it very complex population that you don't want to treat all these patients.

And it looks like I completely yet.

Support to the philosophy behind the phase three which is to look at it.

First assessed that bit of patients with a that enriched with high risk factor without necessarily cover the broad spectrum of effect can you patient that by the way.

Operator: Is it true? Can you hear better? Try again.

Operator: Transcribed by https://otter.ai Yeah, try it out. Okay, so three quick ones. Kayla took this from ETC. Can you remind us, typically, how long you run these for?

Very strong Comorbidities and you really want to make sure that you understand how the drug is working for them rather than just which our drug in a very complex data. So I on the on the two on this two elements I believe that the roads taken on the program a field team makes total sense.

Okay.

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And the next question comes from the line of Peter Verdult from Citi. Please go ahead.

Operator: And give us some quantification on the impact you're seeing beyond side traffic and other KPIs in the monitor? Secondly, the pattern. This is a clarification of the underlying growth. New York City and the U.S., and Aya Ho. Once you take into account COVID stocking, it's probably around season and term, and there's a lot we can add.

Before we get to that maybe we should just answer the second question for very fast on this extend the UK intensive nice to see.

Active patient population and they they are nice and recommended for funding for use in a patient population. We the PMI about 35 and patients that are also pre pre diabetic leader cardiovascular risk and this is the recommendation from nice and you you asked also whether they should be sort of a general assumption.

Operator: Just on R&D, you talked about R&D spend. What about trial integrity and trial quality? With all these big outcomes during COVID, how worried are you about the impact day-to-day? Thank you. Thanks, Pete.

But this is how it is but actually we see that the specifications very slightly from country to country. So you would say that this is what exactly 50, UK and the nice recommendation, we cannot comment on the actual price lever India into nice recommendation and then on they have with us as pricing outside the U.S. and in us.

Operator: Your reception here was not good, but I think we'll try to go top line and address your questions. So the first one was the duration of our DTC programs in the U.S. The second one was with regard to patient level inventories linked to COVID, and the third one was COVID's impact on clinical trial activity. Thank you.

What is important for us in documenting the support for the price of everything else has been that we felt this is an innovation being an all GLP, one and it should be priced relatively to the efficacy that he can keep compared to other GLP. One so we've seen that being supported in January in the us but.

Also in the countries, where we are now launching outside the U.S. So currently we have no one in eight countries outside the US where we have also obtained at save a lot to GLP one the investment.

Camilla Sylvest: So, forgive me, we didn't hear all of your questions, but regarding the duration of the DTC with Rebelsus that we started on the 21st of September, we call it "wake up to the possibilities of Rebelsus." And we've seen that it has had really nice traction on rebelsus.com after the launch of the DTC campaign. When it comes to the duration, which I believe was also part of your question, we cannot share a specific timeline.

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Next question.

The next question is from Peter Verdult from Citi. Please go ahead.

Thank you Peter.

Hey, Craig we committed to come back.

Pete.

Andy speak up a little bit soft.

Bill.

Yes.

Try again.

That's right.

Yeah, China.

Okay.

We could but.

Hello.

Well DTC.

Can you remind us typically how long you run before.

Engage with some quantification.

In fact, you'll see the on site traffic.

Camilla Sylvest: But what I can say is that USTEMPIC is still running, we're still running DTC campaigns with Rebelsus, sorry, USTEMPIC, that seems to have really good traction. So we will continue focusing, of course, both on Rebelsus and USTEMPIC when it comes to DTC in the future. Thanks, Camilla. And on COVID's impact on geographies and inventories, then on a year to date basis, our 7% growth, our estimate is that COVID, on a net basis, impacts our year to date sales growth by to the tune of 1%. And that 1% you should take as similar between North America and and and Iowa.

Well the Cape Yami monitor.

Secondly, the product.

A clarification that the underlying growth.

You will see.

Hi.

When you take into account book.

Okay, you probably around two.

Okay.

No we did not.

Just on the you talked about R&D.

What about schroedahl integrity unsure of quality.

Loan book.

During code, how worried though either.

Hey, David.

Thanks Pete.

Yeah reset.

Reception here was it was it was not good but I think let let's try topline and Ah and address your questions. So the first one was the duration without C programs in there in the us.

The second one was with regards to two at the patient level the inventory, mostly linked to Covance and the third one was a cool with impact on on clinical trial of the active Tms.

So.

Karsten Munk Knudsen: And in relative terms on on a products, etc., around 22% or so share of products on 90 day scripts, as of the latest data points at Denmask on clinical trials and COVID. Yeah, and I'll do my best. I heard most of the questions.

Yes so.

Steve I think we didn't yet one of your question, but regarding the duration of PTC was with doctors that we started on day 21st of September we call. They wake up to the possibilities of professors and we've seen that here has had really nice traction to refocus that come after the launch of the DTC campaign.

When it comes to the duration that I believe it's also part of your question.

We cannot share specific timeline, but what I can say that it was fantastic.

He was running the ferry running DTC campaigns with with our coast centric and that seems to have really good traction. So we will continue focusing of course, both on repurchases and SMP when it comes to rule so DTC in the future.

Mads Krogsgaard Thomsen: You have to bear in mind a couple of things that have happened related to the COVID pandemic. One is that the industry as such has been in really close dialogue with regulatory agencies across the globe, in particular FDA and EMA, in actually agreeing upon how to allocate or what to do with missing data and the kind of things that happen during a pandemic. And I think there's been really good solutions to that, what the company has to be able to account for and whatnot. And at the same time, in terms of reporting adverse events, which are the ones you have to report despite lockdown, serious adverse events, for instance, and whatnot. So I think that there's been really good dialogue there, but at the same time, we as a company have developed very rapidly tools to mitigate the COVID-19 situation, such that we can today say that in, for instance, the Cardiovascular Outcome Trial, which runs for many years, we are now able to actually have the investigational medicine in question shipped directly to the trial participant.

Okay.

Thanks, Camilla and on the uncoated impact on geographies and inventory.

On a year to date basis, our 7% growth.

Our estimate is that the cool with that on a net basis impacts our yesterday sales growth that by to the tune of one cents.

And that 1% to it you should take us as similar between North America and Io.

And in relative terms on on a product basis say, but needless to say that that spread and our answers. So so for instance, when you look at the at our sex and the growth rate of 6% to clearly we would have expected the m. at double digit sales growth prospects endesa. So so that certain certain barrett dipped.

Pending on.

How sensitive products are true.

The secretive incessant hemophilia on new patient day, it starts as a sin.

Yes in the PC in terms of a of Destocking.

Not a molecule or not a lot much more to add than previously we cannot the cheese out the remaining inventory impact destocking into the into the script trends between geographies.

Mads Krogsgaard Thomsen: We're able to monitor remotely what's going on at the investigator site. We're able to follow the patients very closely via an electronic patient interface system, etc., etc. And then bear in mind that the major readout in a Cardiovascular Outcome Trial is a very easy one: it's either you die or you don't, either you have a stroke or you don't. And, of course, adjudication will take place, but adjudication doesn't take place on the day of the event.

You recall the steps that we sold 2 billion a year.

Inventory hike in Q1 linked to our 14% sales growth than 500 million.

In Q2, mainly on wholesalers.

Mads Krogsgaard Thomsen: So we will be able to collect what needs to be adjudicated over time, and that will then be done in a blinded and centralized manner, as usual. But this is actually an easier readout, so to speak, and the trials are less intensive than if it's a treat-to-target, A1C-driven trial, because here the patients don't come so often to the investigator because it's basically a trial that measures how you fare in terms of major adverse cardiovascular outcomes. And now, let's take the last question. The last question comes from the line by Vimal Kapadia from Bernstein.

Then we've seen slight destocking in Q3, but it's it's impossible to tease out at this point.

We have seen.

In the U.S., we have seen that the share of 90 day scripts.

The air going up it has been a trend or time.

But we we did see an other pick up.

Or the or Q2. So we are in rough terms, we saw a step up of some two percentage points. So we are around you know depending.

Depending on products et cetera around 22% or so.

Vimal Kapadia: Please go ahead. Thank you very much for taking my questions. First, can I just ask about the obesity trend? So we're seeing an improving trend sequentially in the U.S. with smaller declines. And actually, within international markets, EMEA had nice growth, and the rest of the world was flat.

Share of products on 90 day scripts.

So the latest data points.

The mess on a clinical trials and covert yep and I'll do my best to I heard most of the question Pete.

You have to bear in mind, a couple of things that have happened related to the covert pandemic. One is that the industry as such has been in a really close dialogue with the regulatory agencies across the globe in particular ft. Yes.

Camilla Sylvest: So my question is, should we expect further sequential improvement in 4Q across all regions? So, you know, should we expect growth in totality for the fourth quarter? And could we actually see a return to growth in the U.S.?

Actually agreeing upon how to.

Mads Krogsgaard Thomsen: My second question is just a bit deeper one from Mads on the profile of the new formulation of oral stemma. I mean, I guess what gives you, you know, what is different that gives you the confidence to increase the dose so substantially? Because I was kind of anticipating improved bioavailability would drive lower doses and therefore superior tolerability, or similar doses for improved efficacy, but not such increased dosages. So just curious, you know, what is driving the higher dosage in terms of the product profile?

L. cake or what to do with missing data and the kinds of things that happen in a pandemic and I think thats been really good solutions to that what is the company has to be to account for and whatnot and at the same time in terms of reporting adverse events, which are the once you have to report despite lockdown serious adverse events for instance, and whatnot.

So I think that's been really good tied up there, but at the same time, we as a company have developed very rapidly tools to mitigate the COVID-19 situation such that we can so they can say that influenced the psychiatrist outcome trial that runs over many years. We are now able to actually have the investigational medicine in question.

Vimal Kapadia: And then, as a final, very quick one, just following up on Michael's question, I'll go through the map. You know, you know, you're continuing the product. So I'm just curious how you think about the return on investment for the asset, given the profile that you've seen so far.

Vimal Kapadia: So first question to Camilla on obesity trends and whether we see sequential improvement in growth into Q4 with the COVID uncertainties we all know about. Second one, all similar high dose mass dosages versus bioavailability and all that. And finally, I think Ludovic on ConsciousMap and return on investment given the restart. So Camilla, if you start.

Directly to the trial participants we are able to monitor remotely what's going on at the investigator site. We are able to follow the patients very closely yeah in electronic patient interface.

System et cetera, et cetera, and then bear in mind that the major readout in the cardiovascular outcome trial its a.

Very easy one it's either you dial you don't I don't have a stroke or you don't and of course adjudication will take place, but adjudication doesn't take place on the day of the event. So we will be able to collect what needs to be adjudicated over time that will that be done in a blinded and centralized may not as usual, but this is actually an easy read out so to speak.

Camilla Sylvest: Yeah, thanks a lot. So on obesity, as Karsten mentioned earlier, of course, because of the short stay time, obesity is impacted by a slowdown in patients going to visit the doctor that we saw in the second quarter of this year. But we do see improvements in the third quarter, and depending on how things are progressing, of course, we expect that improvement to continue for the remainder of the year. We are, of course, also looking into how in the future we can learn from a less contact-based situation, meaning how prescriptions can potentially be done more online in the future. And here obesity is, of course, a good place to start because it's easy to diagnose.

And the Tras less intensive than if it's a treat to target once you've driven trial because the other pieces to come so often keep investigator because its a pace you could try that measures. How you fair in terms of major adverse cardiovascular outcomes.

Thank you mess and now lets take the last question.

Last question comes from the line of Mark How do you have from Bernstein. Please go ahead.

Great. Thank you very much for taking my questions marketplace.

So can I just ask about the obesity trends that we're seeing improving trends sequentially. The U.S. with smaller declines and actually within international markets EMEA had nice growth in rest of world was flat.

Camilla Sylvest: So we have taken these factors into account when giving our guidance for the rest of the year and, And when it comes to oral semaglutide, I know, Wimal, that you are aware of ongoing trial activities with the new and upgraded formulations of oral semaglutide tablets. That has been ongoing for quite some time now. So what is happening now is that by taking these high doses in an already known formulation, we will get data on the efficacy, the safety, tolerability, and so on, based on these tablets. We can then, assuming that we were to come up with tablets with superior qualities and properties in terms of, for instance, bioavailability, then bridge to those tablets via a clinical pharmacology bridging study. And from there on, move directly into the so-called pivotal trial that can then include the go-to-market tablet formulations. So that's the thinking. So you need not necessarily believe that these are the nominal doses that will end up being there, but these are the ones you want to investigate with a known tablet formulation.

Question is should we expect further sequential improvement in full view across all regions. So.

Should we expect growth in totality for the fourth quarter could we actually see a return to growth in the us in the fourth quarter.

My second question is just the dignity depot laundromats on the profile of the new formulation of all summer and I guess, what gives you. What you know what is different that gives you the confidence to increase the dose of so substantially because noma I was kind of anticipating improved by high bioavailability will drive lower dosing and therefore superior tolerability or similar dosing.

Good efficacy, but no such increase dosage. So just curious what is driving the higher dose in terms of the product profile and this is the final very quick one.

Just following up on Michael's question on currency. The map you continue the products I'm just curious how you think about the return on investment for the asset given the profile that youve seen so far thank you.

Great. Thank you very much. So so first question took camilla on obesity trends and whether we see sequential improvement in the <unk> and growth into into Q2 for with the core with the uncertainty as we all know about taking one also.

Hi doors mess that.

Mads Krogsgaard Thomsen: What do they say? And when it comes to Consusumab, thank you for the question. I think Matt alluded to the resuming of the trial a few weeks ago, and we continue to believe that Consusumab can offer a very interesting treatment alternative for patients, for hemophilia A and D patients. From a segment perspective, especially on the B segment, which is a segment that is highly uncovered by the current product, that's one, but also because the features provided by Consusumab in terms of injection, in terms of patient friendliness, in terms of storage, in terms of all sort of features that are complementary to the low ABR that you're getting from this drug, we believe can make it a very interesting profile for a patient even beyond hemophilia B.

The dose just versus.

Well, it looks and all that and finally.

I think ludovic on consistent map and return on investment given the restart so I mean, the future. Yes. Thanks, a lot. So on obesity in aircraft mentioned earlier of course because of the short stay time PCT is impacted by a slowdown in patients going to visit the Doctor every cell in a second for that this year, but we do see improved.

In the third quarter and gay depending on how things are progressing of course, we expect that improvement to continue for the remainder of the year. We of course also looking into how and how in the future. We can then from me on my list contact based situation, meaning how prescription can become.

We have begun and mall on line in the future and he obesity is there you say of course equity place to stop so because it's easy to diagnose so as.

Ludovic Helfgott: So we still believe that there's a place for that drug in the momentum of hematologists, and that's the spirit in which we're continuing the trial right now. Thank you. Thank you so much. Thank you, Ludovic. Thank you, Vimal. This concludes our third quarter London presentation. Again, thank you to Jake Morgan and Richard Fosser for hosting and arranging this session, and we look forward to seeing you all either on Roadshow or in conjunction with our full year release come February.

We are taking these factors into account think giving out guidance for the rest of the year and it.

And based on the current situation because.

And when it comes to where oil some appetite I know we've all that you are aware off from ongoing trial activities with the new.

And upgraded formulations of or some appetite tepid. So that has been ongoing for quite some time now. So so what is happening now is that by taking these high doses in a already known formulation, we will get data on the if you could see the safety tolerability and so on.

Karsten Munk Knudsen: So stay safe and look forward to connecting soon again. Bye-bye. This now concludes the conference call. Thank you all for attending. You may now disconnect.

Based on these habits. We can then assuming that we were to come up with tepid with superior quality properties in terms of Prince's by visibility then bridge to those teapots in yet.

Clinical pharmacology bridging study and from there on move directly into the.

The so called pivotal trial that can then include the go to market. The tepid formulations. So that's the thinking so you need not necessarily believe that beside the nominal doses that will end up being there, but these are the ones who want to investigate with a known tepid formulation what do they do.

And when it comes to consider Matt. Thank you for that for the question I think not diluted to the resuming of the trial. If you weeks ago and we continue to believe that can offer a very interesting at the treatment alternative for patients for mophie on that and be patient from a segment perspective.

That should be on the B segment, which is a segment that is highly uncovered by the current product. That's one but also because the features provided by consistent in terms of injection into the.

Patients friendliness intends of storage in terms of full set of features that are complimentary to the mill.

Low hbr that youre getting from these drugs, we believe can make it a very interesting profile for for patient even beyond hemophilia B. So we still believe that there is a place for that drug in our.

Menton, rheumatology and Thats the spirit in which we're continuing to try to right now thank you.

Perfect. Thanks, so much.

Thank you Rick Thanks.

This concludes so a third quarter London presentation again, thank you to check Morgan and rich its a philosophy.

Hosting and arranging this session and we look forward to seeing you all on either on road show in conjunction with our full year release come February so stay safe and looking forward to connect soon again bye bye.

This now concludes the conference call. Thank you all for attending you may now disconnect your lines.

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