Hello, and welcome to the Q3 2020 Novo Nordisk A/S Earnings Conference Call. [Operator Instructions] Today, I'm pleased to present Lars Fruergaard Jorgensen. Please go ahead with your meeting..

purpose and sustainability, innovation and therapeutic focus, commercial execution and financials. In 2020, Novo Nordisk has progressed on both adding value to society and on our environmental footprint.

During the course of 2020, Novo Nordisk has launched of a new social responsibility strategy, Defeat Diabetes and as part of our access to instant commitment, we have lowered the ceiling price of our human insulin in 76 low and middle income countries.

In the third quarter of 2020, Novo Nordisk set a target to ensure that all direct suppliers supply the company using 100% renewable power by 2030. In the third quarter we made progressed within our innovation and therapeutic focus aspiration in particular the Phase 2b trial investigating, ziltivekimab in cardiovascular disease successfully completed.

Mads, will share more on R&D a little later. Moving to commercial execution, Diabetes care sales increased by 8% and we increased our diabetes value market share leadership by 0.8 percentage points to 29.2%. GLP-1 sales continue to perform well at 29% sales growth while Obesity care and biopharm sales increased by 6% and 4% respectively.

Within financials, total sales increased by 7% with International Operations growing by 12% and North America Operations growing by 2%. Operating profit increased by 7% to DKK22.9 billion. As we disclosed on 8th of October, we now expect both sales and operating profit growth of 5% to 8% mentioned at constant exchange rates for the full year 2020.

Please turn to Slide 5, Novo Nordisk like the rest of the world continues to be impacted by COVID-19 pandemic. And like many other organizations our commitment to employees, patients and communities remain unchanged.

For production, Novo Nordisk manufacturing sites continue to operate and products are being made available to patients throughout the world. Within research and development trial recruitment is still below the pre-COVID-19 levels with some new trials being initiated. Commercially fewer new patients-initiated treatment during the lockdowns.

This has specifically impacted launched products and products with a short stay time. A gradual recovery of patient initiations took place in the third quarter. The COVID-19 pandemic continues to evolve differently across geographies and operations are running accordingly. In many markets, sales representatives are partially back in the field.

As alluded to the pandemic has increased a number of new patients using our products. For the US GLP-1 class as seen on the right-hand side of this slide new-to-brand prescriptions were substantially impacted by lockdown measures in Q2 of this year, what has since gradually recovered.

However total GLP-1 prescription growth has been relatively stable throughout this period. Please turn to Slide 6, for first nine months of the year total sales increased by 7% which was driven by 12% sales growth in international operations and 29% sales growth for our global GLP-1 franchise.

In International Operations all geographies and all therapies continue to contribute to growth. Sales growth was negatively impacted by COVID-19 as fewer patients-initiated treatment partially offset by COVID-19 related stocking and timing of shipments.

Sales in North America operations increased by 2% in both Danish kroner and comparable exchange rates. Sales growth was negatively impacted by COVID-19 as fewer patients-initiated treatment and increasing unemployment in the US. Partially offset by COVID-19 related stocking in the first [ph] quarter.

Sales growth was primarily driven by GLP-1 although we did see growth across our diabetes, biopharm and obesity franchises. Global insulin sales decreased by 3% which is a result of 22% sales reduction in the US partially offset by 10% sales growth in International Operations.

The US sales decline was driven by lower realized prices following rebate enhancements, unfavorable channel mix, changes in coverage gap legislation and the launch of affordability programs. In International Operations sales growth was driven by all insulin segments.

GLP-1 sales increased by 29% driven by 37% sales growth in International Operations and 27% sales growth in North America operations. Obesity care sales grew by 6% with both operating units contributing to growth. Sales growth was negatively impacted by fewer patients initiating treatment due to COVID-19.

Biopharm sales increased by 4% driven by Norditropin. Please turn to Slide 7, as part of our strategic aspirations 2025 we aim to reach one-third of the global diabetes market. As previously mentioned, we have now reached 29.2%. This increase is a reflection of both the GLP-1 and insulin market share gains.

For GLP-1 since 2019 we have increased our value market share by 3 percentage points to nearly 50%. A global rollout of Ozempic in its national operations and the uptake of Ozempic and Rybelsus in North America have been key to this. For insulin since 2019, we have steadily increased our market share by 0.8 percentage points.

This can be attributed to the launch of new generation insulins in international operations facilitated by our markets bid approach. Please turn to Slide 8, as US GLP-1 market continues to grow around 30% in volume when measured quarter-over-quarter driven by one, weekly Tier one products. With uptake of Ozempic and launch of Rybelsus.

Novo Nordisk has neutral brand market share leadership of over 60% in this GLP-1 and is the GLP-1 market leader measured in total prescriptions with around 50% market share.

Despite facing difficult launch conditions due to COVID-19 Rybelsus continues to take market share both for new-to-brand prescriptions and total prescriptions which are around 14% and 4% respectively. Please turn to Slide 9; Rybelsus has had a promising start in the US.

You can see in the graph on the left that in the 20 weeks after launch new-to-brand prescription numbers were matching that of SGL-2 class. Once the COVID-19 related lockdowns were implemented in March. We saw substantial decrease in new-to-brand prescriptions. However as lockdowns were lifted Rybelsus uptake has picked up.

This launch uptake development reflects the improved market access of Rybelsus which is now around 85% across commercial and Medicare. Furthermore more than 80% of new prescriptions are new to the GLP-1 class and direct-to-consumer advertisement has begun. Outside of the US, Rybelsus has now been launched in eight countries. Please turn to Slide 10.

In International Operations, diabetes sales increased by double-digit presented across all geographical areas. This growth has been driven by both Insulin and GLP-1 across all geographical areas. The sales performance reflects our increased diabetes value market share in International Operations as indicated by the 30% share of growth.

Business driven 0.5 percentage point increase in our market share which is now at 22.7%. Please turn to Slide 11, obesity care sales increased by 6% to DKK4.2 billion. Growth was driven by both International Operations and North America Operations. Sales growth was negatively impacted by COVID-19 as fewer patients-initiated treatment.

We have now launched Saxenda in 54 countries and just yesterday the US National Institute for Health and Care Excellence recommended the reimbursement of Saxenda. All of this report our strategic aspiration of more than doubling obesity sales by 2025. Please turn to Slide 12.

Biopharm sales grew by 4% in the first nine months of 2020 driven by 8% sales growth in International Operations. Sales growth was driven by Norditropin. While Haemophilia is declining sales of 2% where a result of sudden sales decline by offset by Esperoct and Refixia launches.

Norditropin sales increased by 13% reflecting commercial execution as well as changes in inventories, COVID-19 related stocking and additional demand driven by supply challenges for competing products in selected countries. With this over to Mads for an update on R&D..

Thanks Lars. Please turn to Slide 13. In the next couple of slides I'll first share the results from the recently completely phase 2b RESCUE trial for ziltivekimab and thereafter maybe some recent and imminent R&D milestones.

Ziltivekimab to be referred to as zilti is the first fully human anti IL-6 ligand and monoclonal antibody that we obtained as part of the Corvidia Therapeutics acquisition back in June of this year. At the time of the acquisition the phase 2b RESCUE trial was well underway. Now it's completed and we're happy to share the results.

To start with a big of context, our Head of Global Drug Discovery, Dr. Marcus Schindler described Novo Nordisk ambition to enter the cardiovascular disease space at our R&D investor event held in June.

Within this therapeutic area zilti seeks to address the residual inflammation related risk that exists despite today's state-of-the-art management of Atherosclerotic cardiovascular disease also known as ASCVD.

In ASCVD refused inflammation within the heart and blood vessels typically assist clinically by measuring CRP has been shown to correlate with a robust production in major adverse cardiovascular events in the follow-up analysis to the CANTOS trial with anti IL-1 antibody Canakinumab.

Thus, in the CANTOS trial patients in whom Canakinumab treatment resulted in an end of treatment reduction in CRP and into looking six levels below 1.65 nanograms per liter had an amazing risk reduction of no less than 36%.

Patients who did not receive their IL-6 levels below this level at end of treatment correspondingly had no reduction in [indiscernible]. Encouraged by this as well as the documented robust human genetic association between high IL-6 expression and ASCVD risk.

We measured CRP and other surrogate markers of anti-inflammatory cardiovascular action in the RESCUE trial. We found immediate dose dependent and sustained CRP reduction at all levels of zilti. In fact by 93% at the highest dose.

Additionally we saw reductions in a number of other cardiovascular inflammation biomarkers such as fibrinogen, serum amyloid A and Haptoglobin as well as a decrease in the heart failure biomarker in terminal pro BMP.

The very encouraging data set we have the zilti molecule is ASCVD should be seen in the light of zilti's ability to reduce inflation in Atherosclerotic patients at a very low dose levels that is expectedly clinically safe.

Thus and unlike any other proof into looking six blockers, we did not observe any clinically meaningful impactful on neutrophils, platelets, live enzymes or cholesterol in the RESCUE trial.

Currently a Japanese phase 2 trial is ongoing and a major pivotal phase 3 cardiovascular OUTCOME trial is being planned for initiation in the second half of next year following in the phase 2 meetings with regulators. Please turn to the next slide.

In the third quarter of 2020 several R&D milestones were reached including the notion that we now have for the first time ever more than 40,000 patients active in clinical trials. Starting with our Semaglutide franchise.

We've initiated a phase 3b trial investigating 1 milligram Ozempic in around 800 people with type 2 diabetes with peripheral artery disease also called PAD. The background for the trial is the finding of a significant 35% risk reduction in both peripheral and coronary vascularisation events in SUSTAIN 6.

The PAD indication represents yet another example of how we seek continuous Semaglutide label expansions based on demonstration of efficacy and safety in areas of high unmet medical needs. Intriguingly, the first clinical trial has now been initiated for our first in class glucose sensitive insulin.

The trial investigates the safety, thoroughability [ph], pharmacokinetics and dynamics of subcutaneously administered once daily glucose sensitive insulin. The target product profile for this molecule includes improved glucose control as well as the virtual elimination of hypoglycmeic and other side effects seen with today's therapies.

Another phase 1 trial that has just started investigates higher doses of oral Semaglutide with type 2 diabetes. Aiming for oral Semaglutide to ultimately match the full efficacy level associated with even high dose administration of injectable Semaglutide.

Within biopharm, we've received approval of Somapacitan now also known as Sogroya in the US for adults with adult growth hormone deficiency.

Also noteworthy within biopharm is the reinitiation of phase 3 clinical developmental activities for Concizumab which is the subcutaneous prophylactic TFPI antibody treatment in hemophilia A/B patients regardless of inhibitor steps. This follows pausing of Explorer trials in March of this year related to the occurrence of non-fatal thrombotic events.

A revised dosing regimen is now being deployed in the Explorer trials. Regarding the FVIII-mimicking antibody project Mim8. We have despite a COVID-19 related fear of delaying phase 1 caught up with the timelines and are now in phase 2 in hemophilia patients.

Within other serious chronic diseases, the NASH trial investigating Semaglutide in loose combination with Gilead ACC inhibitor and FXR agonist has completed results will be communicated at scientific conferences during this call. Importantly within NASH, Semaglutide has recently being granted breakthrough therapy designation by the FDA.

Breakthrough designation implies amongst other things that the FDA will work closely with Novo Nordisk to develop and hopefully approve Semaglutide expeditiously for the treatment of NASH. Looking towards the rest of the year and into 2021, we will soon initiate the phase 3 onwards program for once weekly Icodec.

Furthermore there will be a number of exciting readouts including sustained order which is the investigation of Semaglutide 2.0 milligrams in type 2 diabetes. And obesity will be submitting Semaglutide 2.4 milligrams in both the US and EU.

We accordingly expect the decision on the US submission by mid-2021 since we decided to use our priority review voucher for this application.

So within obesity in 2021 we'll seek to have phase 3 initiation for our once weekly combination product consisting of amylin 833 and Semaglutide along with reporting of phase 1 results for long-acting GDF-15 project.

Lastly within other serious chronic diseases, well during 2021 initiate phase 3 trials for both Semaglutide in NASH as well as the cardiovascular outcome trial for zilti. With that over to Karsten for an update on the financials..

For the first nine months of 2020 sales increased by 6% in Danisk kroner and by 7% at constant exchange rates. The gross margin was 83.8% compared to 83.6% in the first nine months of 2019. The increased gross margin reflects a positive product mix driven by increased GLP-1 sales and productivity improvements.

This is partly counted by a negative impact from lower realized prices in the US. Sales and distribution cost increased by 4% in Danish kroner and by 5% at constant exchange rate. The increase in cost was driven by North America operations reflecting launch activities for Rybelsus and continued promotional activities for Ozempic.

This is partly offset by lower promotional spend related to insulin. In International Operations, promotional spend is related to launch activities for Ozempic and Rybelsus and the continued rollout of Saxenda. The spend was impacted by COVID-19, resulting in a lower activity and delays in promotional activities.

Research and development costs increased by 12% both in Danish kroner and at constant exchange rates. The cost increase is driven by amortization of the product in review for semaglutide and obesity in the third quarter of 2020.

Increased activities within other serious chronic diseases are driving the cost increase following progression of the early pipeline within cardiovascular disease and stem cell projects.

This is partly offset by lower spend within obesity care, driven by finalization of the semaglutide obesity Pivotal phase 3a program and COVID-19 impact on clinical trial activity. Administration costs remained unchanged at Danish kroner and increased by 1% at constant exchange rates, reflecting broadly unchanged spend across administrative areas.

Operating profit increased by 6% in Danish kroner and by 7% at constant exchange rates. Net financial items showed a loss of around DKK1.8 billion compared to a loss of around DKK3.1 billion in 2019. Diluted earnings per share increased by 10% to DKK14. Free cash flow DKK41.6 billion compared to DKK32.7 billion in 2019.

The increase was driven by higher net profit and favorable timing of rebate payments in the US. Please turn to Slide 16, as Lars mentioned our growth outlook for 2020 was updated on 8th of October. Sales growth is expected to be between 5% and 8% at constant exchange rates.

The guidance reflected expectations for continued global sales performance for the GLP-1 franchise, Ozempic, Victoza and Rybelsus. The portfolio of new generation insulin and the biopharm products. The guidance also reflects intensified competition within diabetes and biopharm especially within the hemophilia inhibitor segments.

Furthermore, continued pricing pressure within Diabetes care as well as expansion of affordability initiatives especially in the US are expected to impact sales development.

Given the current exchange rates versus Danish kroner reported growth is now expected to be around 3 and 4 percentage points lower than at constant exchange rates respected to sales and operating profit.

The current COVID-19 pandemic causes uncertainty to the outlook regarding new patient initiations and societal impacts such as the unemployment rate in the US which is impacting health care insurance coverage. The estimated annualized impact is now around 2% of US sales. Operating profit growth is expected to be between 5% to 8%.

The updated outlook reflects savings due to COVID-19. The expectations for operating profit growth primarily reflects the sales growth outlook and continued investments in current and future growth drivers. Financial guidance is now expected to be a loss of around DKK1.4 billion compared to a loss of DKK1.2 billion in August 2020.

This development mainly reflects losses from non-hedge currencies due to depreciations across several emerging market currencies. Lastly, we now expect free cash flow to be between DKK34 billion and DKK39 billion reflecting higher net profits. And now over to Lars for his final remarks..

Thank you, Karsten. Please turn to Slide 17. We are very satisfied with the performance in the first nine month of 2020 despite the negative impact from COVID-19. More patients use our GLP-1 treatments and our diabetes market leadership continues to expand.

Within R&D an important milestone was reached with encouraging results from the phase 2 trial in cardiovascular disease with ziltivekimab. The lead candidate from Corvidia Therapeutics acquisition earlier this year. With that, thank you and we're now ready for the Q&A, where I kindly ask all participant to limit him or herself to two questions.

Operator, we're now ready to take the first set of questions..

[Operator Instructions] Wimal Kapadia from Bernstein. Please go ahead..

So just a few for Mads, please.

Can I ask about the balance, how do you think about the balance Hba1c control and tolerability for the GLP-1? So firstly, what in your mind what Hba1c level do you see incremental increase is less relevant given the impacts on vascular complications start to slow down and you know the majority of patients under glycemic control? And then secondly what level of nausea, diarrhea, vomiting levels do you believe tolerability consensus outweigh incremental Hba1c control? So what I'm really trying to get is a sense of balance between these two prescribing drivers and both from the patient and the physician side whilst taking to account the compliance adherence.

And then my second question, you now started glucose sensitive trial which complements the weekly and insulin 965 which targets micro and macro vascular complications. But how should we think about these three novel incidents in the context of what we're seeing in the base market today.

What gives you confidence that these products will actually raise the bar enough to make a difference in what is a very challenging market. How should we think about return on investment of these products? And then just a very quick one, tied to that what is Insulin 147, I've never of that one before. Thank you..

Well Wimal the last one, first. It was a hybrid molecule that had dual activities but you shouldn't concern yourself about that one anymore for the time being. But more focused on the GSI insulin and the cardio protective insulin and the not the least of course the Icodec insulin entering phase 3.

But it's a longstanding debate the kind of correlation between a1c control and cardiovascular risk and what level is okay. And I think it's suffice to say that the most ambitious a1c guidelines namely the American Academy of Clinical Endocrinology, ACE.

They have 6.5% in a1c target and they have derived that from the notion that when you go much beyond or below 6.5 in a1c, there is very little contribution of glycemia or hypoglycemia to the expected advent of major adverse cardiovascular events or macroangiopathy.

Likewise for micro vascular complications, so I would argue that in a patient who's anywhere in a range of 6.5%, you would have to weigh up against the tolerability profile any glucose decrement below that level.

That being said, of course if you can achieve normal glycemia such as for instance with glucose sensitive insulin without any risk of GI tolerability or hypoglycemic issues then that is decide state - then you're basically having a diabetes normalizing molecule.

I would say that the balance between if you're talking about GLP-1 therapies and tolerability vis-à-vis the efficacy. I think we feel that at the tolerability levels we're seeing for our semaglutide molecule including what we're seeing at the 2.4 milligram dose in obesity in the STEP program.

We've seen single-digit level drop outs because GI tolerability concern and very high satisfaction with the therapy.

Health related quality of life where that was estimated by acolyte or SF-36 where that was estimated psychologically or physically was increased at 2.4 milligram hence, I can say here we have a good balance between GI tolerability and efficacy. If you go much beyond that.

I'm afraid it starts to be a different situation because then the patients like Mike [ph] too often be a bit troubled by nausea and the likes. But that's not what we've seen. So I think that more or less covers in. In terms of the selling glucose sensitive insulin.

If you can achieve better glycemic control that will be put into the core and other models of health economic outcomes and actually drive greater efficacy and more bang for the buck, for the payers and if you're on top of that reduce the risk of side effects. You actually have a pretty interesting molecule also from a payer perspective..

Thank you very much..

Thank you, Mads. Thank you, Wimal. Next set of questions please..

The next question comes from the line of Peter Sehested from Handelsbanken. Please go ahead..

Thank you for taking my question. I've one on obesity and just a follow-up question. I mean now that you spend review onset.

You're very close to launch so Camilla there, if whether you could provide some further comments on how many physicians actually prescribing obesity drugs in the USA today and what is your target for year one post launch and also year three post launch and where you're in your preparations in order to - how have you prepared authorities in terms of reimbursement etc.? Just for us the gage how fast the uptake could be, so that is the first question.

If I have to select a second one, it would be respect to the glucose sensitive insulin you are saying that you have phase 1 data next year. Typically you'll be in phase 1 quite some time from your previous molecule.

Could you confirm that you're planning to start phase 2 relatively shortly after that? Should we expect that to think a little bit longer? Thank you very much..

Thank you, Peter. So first, Camilla on obesity and the level of disclosure we can and also, we can give targets about numbers of prescribers after one or two years. But any comments on that? And Mads then on glucose sensitive insulin speed of going to next phases..

Thank you, Lars. So what we can share is that as progression for the launch and for obesity in general. We're looking at the number of prescribers and it is very clear that for obesity of course to be realizing the significant potential that it has for the future.

We need to be looking at more prescribers than we have today, so that's a clear focus of ours and we can support with a lot of education in the area. Another focus area of ours is of course the number of people seeking treatment. So here we know that with 650 million people suffering from obesity only a fragment of those actually do seek treatment.

We estimate around 10%. So in both of these areas the significant potential is basically now when we will be launching some semaglutide 2.4 that has twice the benefits in terms of weight loss as Saxenda..

And I think it's also encouraging to see that we actually now have this new nice endorsement of Saxenda in the UK. So I think we're making progress and actually being able to articulate the value of treating obesity and obviously this is based on Saxenda then one can only believe Semaglutide can do. Mads over to you on glucose insulin..

Yes, so what you do Peter the usual story.

You start with single ascending doses and then you move onto multiple ascending doses and you typically in an insulin trial will always meet a comparator and that comparator, if it's a glucose insulin intervention what you want to document that is truly glucose sensitive, you have to go up against the comparison with least documented hypoglycemia risk to prove even further benefits and that in this case is insulin deguldec.

And the way that you can assess for instance the risk of hypoglycemia is by forcing the patients with for instance tripling the insulin dose into what could be a severe hypoglycemic conditions had they not been in a hypoglycemic clam [ph] situation where you can save them at any pre-defined glucose level and then you can simply measure, do they go down there or do they level off at a safe level without risk your therapy.

This is the kind of trials we're doing, they're ongoing as we speak and of course moving into phase 2 from thereon, we'll do as fast as possible..

Thank you, Camilla. Thank you, Mads and thank you, Peter. Next set of questions please..

The next question comes from the line of Martin Parkhoi from Danske Bank. Please go ahead..

Two questions, first on IO. One of your competitors mentioned yesterday that there was some weakness in out of pockets markets in outside North America. Is that really visible in your IO numbers on the safe.

But they - are you seeing small sign of that and this is something that we should expect to escalate going into 2021? And then just on GLP-1 pricing US economy standard you will not give any hard numbers on where the pricing are this year, next year.

But just conceptually if we look at the what Lilly said earlier this week and if I look at, I guess that your net pricing if you adjust for a bit closer true up, then its maybe down 10% in the third quarter, that is slightly more than Lilly.

Can you maybe discuss conceptually why is that given that it appears that your segment mix change are much more favorable than Lilly? And should we conceptually look at you compared to Lilly with fairly old tier one now going into the coming years..

Thank you, Martin, for those two questions and let me try to give it a shot. In IO we're not really seeing anything that is a measurable impact of lower out of pocket pay. You know we have a good momentum both with the insulin and GLP-1 and we have the market set strategy that's still pulling through. So we incurred by the growth levels we see in IO.

To the US GLP-1 pricing. What we see in Q3 is a continuation of what we have seen in the first and second quarter of this year, so we don't really much change. It's a market with very, very attractive volume growth. We're down to 8% of patients using GLP-1. We see differentiation in the market.

So it's really a market that's driven by launch of new products which is fueling growth and preference. And the pricing impact from year-over-year enhancing rebates level a bit to stay on open formula [ph] there's legislative impact we see in Medicare now and then getting to your point about channel mix and maybe portfolio is unchanged for us.

As a function of say the differentiation of products in the market. You of course have dynamics where brands as they grow older in the categories, they have broad and broader access and get into low and lower price points. And as new products are launched typically starting in the high end of the market.

You of course have the different players will have different say quality of book of business overtime and that dynamics will probably change a bit between the competitors but we don't see any significant over the quarters. So what we communicate here is a stable situation compared to what we've seen in prior quarters.

Thank you, Martin and next set of questions, please..

The next question comes from the line of Simon [indiscernible] from Exane. Please go ahead..

I've got two, I think they're mainly for Mads.

But you didn't discuss it in the presentation but I'm just wondering if you could maybe give us an update with respect to your intention or otherwise whether or not you learn back on the phase 3 program for semaglutide in Alzheimer's and with that, with the data it's set to be published next Friday I believe would you like urge caution to over interpret that what we should see and just what your view is around that would be very helpful.

Thanks. And then the second one is, just a broader discussion on obesity. Obviously, you got the recommendation from Nice [ph] which is positive. But still in the US it remains somewhat elusive. I'm just wondering if you could help us understand.

You know how negotiations are going there with the authorities and if it does remain elusive the rationale really can use your product to review voucher for semaglutide obesity. Thank you..

Simon, first Mads on potential start of phase 3 in Alzheimer's..

Yes, well I'll essentially repeat I think what I also may be answered last time being Novo Nordisk is looking at the aggregated burden of evidence of lack of such in terms of favoring entry with Semaglutide into a phase 3 trial in Alzheimer Disease/Mild Cognitive Impairment and in that regard, one has to look at whatever exists out there including the lab study.

But by no means the lab study I don't think is the solution to all questions in that field for one of the reasons. But it will be of course be interesting to see those data I believe next weekend.

One also has to look at the aggregated data sets that exist from meta [ph] analysis as you know we have done from registry base studies and from pre-clinical studies and then make up once mind about such a decision. It is of course a big decision to go phase 3.

But that also meets that one has to have all the pertinent considerations ahead of that decisions..

Thanks Mads and Camilla on obesity..

In the US in general there 70% access in the commercial segment to obesity care. But what we're really focusing on is to make sure that also employers opt into this because in reality the real access is only 20% when we take this into account. So this is of course where we're putting our focus.

For the longer term we will also be focusing on the TROA, Treat and Reduce Obesity Act of course that potential will give access to Medicare overtime. But this small related on political decisions. Right now of course with semaglutide having as we talked about before twice the effect of Saxenda.

There is also sustained potential for longer stay time as we see that the weight loss continues up until 60 weeks while we see from our STEP program. So in terms of that, the earlier we can get Semaglutide 2.4 to the market, the earlier we can realize the potential of the obesity franchise..

Thank you, Camilla. Thank you, Simon. Next questions please..

The next question comes from the line of Simon Baker from Redburn. Please go ahead..

Two for Mads, from me. Firstly on zilti, the lipid profile or lack of negative effect is impressive on unusual Mads. So I just wondered if you had any thoughts on why you're not seeing a negative effect where others have.

And secondly, there was an interesting case report in the New England Journal a couple of weeks ago about the use of ruxolitinib for essentially reversing type 1 diabetes.

I'm interested in your thoughts generally about the potential for jak inhibition in type 1, is this something that you looked up before whether you think there's any mileage in this? Thanks so much..

So I think in regards to zilti and the benign adverse in profile or by chemical profile that we've seen in the RESCUE trial. I think there are two factors that come into play here.

One of them is the notion that it is a IL-6 ligand and it doesn't interfere with the IL-6 receptor signaling complex that as you know also mediates other cytokine signaling. So we're not interfering with that.

At the same time, we've apparently found a dose down to the level of 50 milligrams that actually corresponds to a daily dose of 0.5 milligrams since the monthly dosing regimen is deployed that is solo and so potent, that I think what we're seeing is essentially intravascular and cardiovascular anti-inflammatory action without enough of these antibodies actually permeating into more peripheral target tissues and compartments of the body including the immune system and maybe therefore having much less of an impact than we've seen for other IL-6 blockers.

So I hope I cannot prove this will hold true in phase 3. But based on the data we have, we think we actually have the emergence of the very encouraging benefit risk profile for this particular compound. So we're very happy with the acquisition and with the progress of the project. As regards jak inhibitors and other remedies for type 1 diabetes.

I have to say and we've been as you know working a lot in the field included with antibodies anti IL-21 antibodies with a very nice dataset from phase 2 but that we have decided not to progress as you aware.

That any remedy that will seek to reverse the autoimmune process to the extent, that you're void the immune attack and the killing of the beta cells in the pancreas will have to be so relatively powerful that it is unlikely to not have untoward side effects i.e.

the benefits will go along with the risks and I think the next major breakthrough is in the field of type 1 diabetes. If you want to go down that alley, a more likely to relate to retentive medicine such beta cell replacement when [indiscernible] is very active with a late stage research project is also a couple of other companies..

Great, thanks very much..

Thank you, Mads. Thank you, Simon. Next question please..

The next question comes from the line of Steve Scala from Cowen. Please go ahead..

Two questions probably both for Mads. Mads when you see the first Lilly for [indiscernible] phase 3 data later this quarter. what will be most interested to look for and please enlighten us to any statistical methods Lilly may employee to portray the data in the most positive light, so that's the first question.

Second question is that, we've tracked clinical trial activity during the pandemic and it shows Novo trials that are recruiting are down 20% year-to-date that is two times worse than the next closest companies and 10 times worse than the average company.

What do you think accounts for this? Is it a function of the therapeutic areas in which you traffic? Is it geographies or is it something else? Thank you..

Well first of all I can't really comment on how Eli Lilly does their physical analysis of PI [ph] side of things and related conditions. I think that will be up to regulators and other bodies to really discuss that with the company. What I will look at as a clinician. Is what is as we discussed in an earlier question during this session.

What is the balance between efficacy and side effects because there is no doubt you can achieve almost anything with a molecule, if you put people into a situation where they're constantly vomiting of course because that corresponds to a fasting situation and that can actually almost make you undergo diabetes remission but it's not a nice way to achieve that.

So you have to have the overall benefit risk profile define and we discussed that in earlier point in time and I think we've hit that spot both with a semaglutide in the injectible and in the oral versions at the doses that you've heard us talk about earlier today and previously.

But we'll have to see the [indiscernible] data as they come out into bid only to speculate and in particular for us. In regards to clinical trial, I'm not quite sure I agree with your statement because we follow the different TA areas including the diabetes area and today, we've exceeded 40,000 patients in active trials.

The greatest reduction we have in any or delayed, we have in any trial even the mid outcome trails that we're waiting for today is max three months till termination based on current analysis.

We have adopted a number of tools allowing remote contact between precision investigator and patient arrival of medicine at the postal address of the person involved in the trial and a lot of other things that can make source data verification possible remotely using newly developed apps and alike.

So I would say that the Nordisk is a bit proud that we're able to say that we have managed to basically enhance the portfolio and grow the portfolio and the amount of patients during a time of COVID-19.

So I think one of the reasons is that, we have our own clinical research associates 2,000 of them all over the world and they're very dedicated colleagues and they work closely with headquarter to adopt these new, you can say remote tools that will allow us to do virtual trials almost possibly next year, even in a COVID-19 situation allowing us to progress the pipeline..

Thank you Mads. Thank you, Steve, for those questions. Next questions please..

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

Three questions, Lars just on potential US, drug price reform. We all know net pricing is every day off the table, which is very shame to know clearly health committee have we done our whole exposure. The one bypass and bill that nearly made it this year was Copay caps.

Now regardless of who wins next week? I'm interested to here Novo's view on copay caps rather solutions that you think propose to deal with the fundamental problem of lowering antibody cost. And Camilla, I'm sorry to come to these [indiscernible] commercial strategy. Don't worry I'm not going to ask you for year one same forecast internally.

But I do want to just understand how you're thinking about the opportunity. We all know the numbers that are large and the data is good and the prescriber base and the reimbursement is terrible. What we haven't talked about is Saxenda's day list price is way excess of $50 per day which clearly is not conducive.

So I'm just wondering you have a drug that's clearly got significant efficacy.

But are you thinking about being able to price to create this market or given the fact that you have a single dose device, does that give you an opportunity to really rapidly expand prescriber base and reimbursement by going out in lower prices? Your general thoughts about how you can maximize the commercial opportunity in obesity. Thank you..

Thank you, Pete. So I'll refrain from going into much detail about the US elections and what could happen. I can only observe that a lot of ideas has been on the table. But it's quite difficult to make significant intervention in a rather complex and gridlocked US healthcare system. We are launching a portfolio of competitive products.

We have an inhibition of converting incentive in our business to innovative products and as such conduct business based on clinical differentiation and real need and demand in the market. I think that's the strongest precision to have in any market and I'm not say we'll be immune for all kind of interventions.

But that means that there'll be an underlying way to use our innovative products and I feel comfortable that we can compete and also be successful from financial point of view in most of these potential interventions.

So we have to wait and see what the political system can agree on, in a market that's largely a private market and hence not that prone for regulation.

Camilla on back to obesity strategy?.

Yes so just to we have on the general market expansions we're working on four dimensions, so one is about having obesity recognized as a disease and this of course will be extremely important for also reimbursement down the road and we're also working on the number of patients seeking treatments and just before I mentioned that.

Right now, only 10% of patients living with obesity seek treatment. But when they then go to the physician to get treatment actually the big majority of those are sent back without any treatment other than exercise and eating suggestions.

So both on these dimensions we can work on with education and with that hopefully also get some more you can persistent prescribers of obesity medication.

It's clearly that many of the people suffering from obesity also have a number of co-morbidities that from a health economic point of view gives rise to us discussing with payers like we've just done with Nice [ph] in terms of the cost effectiveness of better treatment and it is in this perspective that semaglutide 2.4 of course has an even bigger impact that what we've been used to with Saxenda.

So these are the dimensions that we are working on to realize our long-term strategic aspiration that we've communicated at our last Capital Market's Day. Of course reimbursement is important, but it is also very patient-driven disease that we're talking about here. So it is not a pre-reconceived for us to realize our ambition.

But of course it is something that we keep working on. When it comes to the price, as you know from other launches we've done. We will only communicate around the price by the time that we launch. Thank you..

Thank you..

And the next question comes from the line of Michael Lofton [ph] from UBS. Please go ahead..

Two questions, please. One just bigger picture patient footfall. Lars I assume the last couple of quarters you given us some steer on what your underlying assumption was for normalization of patient footfall. I guess we all thought we were going to get back to normal this year. But we had lockdowns coming again.

So what's your assumption on the shape of the footfall, the patient footfall recovery as we head into the end of the year and then early next? And then my second question is, on Rybelsus sequentially third quarter the product was light relative to where consensus was, I guess we've all been sitting here trying to use the prescription data and assume realized price and it came in a little bit light.

So as we look at Q3 over Q2 other than the COVID impact and the area under the core, is there anything else we should keep in mind as we think about the fourth quarter and trajectory into 2021? Thank you..

So first Karsten on what to expect in terms of or what we have assumed in terms of patient flow or patient normalization..

Yes, thanks for that question Michael. And as you know predicting a pandemic and how it rolls across the globe has proven to be difficult around first, second, third wave.

I think what has been encouraging for us to see is the resilience of our total script based and I would say the slightly smaller impact from a lower indirect space and lower indirect impact and you saw from the initial slide that last showed on COVID that we see a direct trend improving over the past quarters.

What will build into a modeling is that we see a continuation of our direct transfer but needless to say there is uncertainty around how COVID will impact our business over the coming quarters until a vaccine is generally available. So that's why we're also operating with a broader range at this point than we normally do..

Thank you Karsten and just initially on Rybelsus performance. We're very pleased with the launch we're making. The reception of the product. The trend we see in terms of scripts. So let me just make that comment upfront and then Camilla, maybe a bit more caveat on that..

Yes, so today we have over 33,080 [indiscernible] in Rybelsus and we're actually back to the number of new 80-piece prescribing Rybelsus as we were before COVID-19 impacted us all. So we have more than 900 new prescribers per week on Rybelsus. We also have all districts in strike mode and as you know our access is around 85%.

So also our expansion of the classes working as we had planned for meaning that more than 80% of the new scripts is coming from outside the GLP-1 class. And then you would also notice that the most recent numbers on our Rybelsus scripts are - where we estimate that approximately half of those are still impacted like our co-pay or voucher offering.

So just to keep that in mind when you do the numbers. And then on the 21st of September we launched our new [indiscernible] wake up to the possibilities with Rybelsus and we saw that there was an immediate increase to business on our rybelsus.com website following this. So at last we are very encouraged by the launch of Rybelsus..

Thank you, Camilla. Thank you, Karsten and thank you, Michael. So next set of questions please..

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

It's actually Mark [ph] [indiscernible] thanks for taking my questions. Just kick off for Karsten and thinking about 2021. [Indiscernible] official outlook next year. But wondering on a high level if you could just discuss some fishes and pools to sales growth rate versus the existing 67% run rate.

And you previously talked about coverage affordability initiatives run rate of the existing IO 12%, so any update or perspectives there? And any directional margin commentary for next year how do we think about an SG&A cost rebound following the COVID savings this year and R&D growth given the number of phase 3 starts with obviously a number of outcomes that is? Second question is on semi-national breakthrough any early regulation conversations that changed your perspective on the ability to use surrogate to speed up the file.

And if you're able to use file for the furthest and when could the earliest file be? And just a clarification on Elad on your earlier commentary regarding about decisions progress to phase 3.

Have you actually convened an advisory board yet to discuss options and when do you expect to make a decision by and how will you communicate to the market? And working on the assumptions that we'll hear nothing from you next week. Thank you..

Thank you, Sachin. First Karsten, while we do not guide for next year some high-level comments..

Thanks Sachin for this question. So as Lars was saying then we'll issue our 2021 guidance in connection with our full year results in February. Our starting point is and what you see in our numbers currently and underlying run rate to the tune up to 6% to 7% in our base business. The key drivers you should expect to remain the same.

So a continued solid tier 1 performance across the globe and solid growth from IO while US will still be in the process of transforming the business to more recently launched products. So IO as we talked to at our Capital Markets Day, we're working this 6% to 10% range over the five-year period. We've had very good traction there.

This year performing even above that range. So of course we hope to continue to have solid traction in IO in the 6% to 10% range also come next year. As to US and some of the puts and takes, yes, it's great we will not have some [indiscernible] impact and some of the affordability impacts we have this year.

On the other hand then we have the unemployment where we only have a modest impact on channel mix this year and we have this annualized 2% impact on US sales pulling in the other direction.

And finally with the puts and takes we also some sale went this year in our growth [indiscernible] business from a supply issues with the competitor and of course we don't expect that to continue into next year.

And then layer on top of those puts and takes, which should be no surprise to the market then of course COVID-19 and potential segment just puts an additional layoff of uncertainty to the outlook, we're looking into. In terms of margins and P&L.

If I take the different lines then with more than 40,000 patients on clinical trials currently and expanding and moving towards closer to the 50,000 mark then of course we'll be investing more in R&D or you should though note that we're running a number of efficiency in this and R&D also in terms of running our clinical trial.

So it's not a linear approach you should stick to it. But clearly, we will be expanding our investments in R&D which was also what we communicated 12 months ago at our Capital Markets Day. In terms of S&D, we will continue to have a number of launches both with Ozempic where we're only in some 50 markets now.

And then Rybelsus we're some 10 markets at this point. So quite a number of launches to come for the new products. In terms of the savings, this year and into next year. Yes, you're great - we've some savings.

We do expect also some savings come next year in terms of some of the learnings we have and also given the fact that COVID-19 is not overcome 2021. And then finally on gross margin and cost of goods as we also communicated Capitals Markets Day then we're ramping up our facility in Clayton, North Carolina manufacturing for all Semaglutide.

So with the early volumes of 100 [indiscernible] then you should expect a negative mix impact from Rybelsus compared to what you see this year..

Good, thank you, Karsten. Then you can do all the modeling, all of you. Mads, quickly on Sema NASH..

First the last question is quietly yes we've had advisory board meetings. We have discussed the potential profile of GLP-1 [indiscernible] semaglutide in that disease and no we're not connecting any kind of potential communication in the area to the presentation as we have described previously.

It's a multitude of data gatherings that will form the basis of such a potential decision. In regards to surrogates for NASH. I'm a strong believer in a combination of using for instance FibroScan on this four one of the other of the biomarkers.

In conjunction to actually diagnose and follow the prognosis of NASH treatment however as it stands today with the FDA and with the EMA with whom we've had meetings otherwise you cannot be granted a breakthrough designation. There we have actually agreed that, it will be biopsy based in phase 3.

However it may not be in the trial that the entirety of the population has to have reported 72-week biopsy results at the time of the NDA submission. So there are some gives and takes there.

But we think are on the way to a very robust trial design with a single pivotal trial and a 72-week readout followed by an extension where you seek together [indiscernible] benefits of the drug, post marketing..

Thank you Sachin. This concludes our conference call. Thank you for participating and the interest in Novo Nordisk and do feel free to contact our Investor Relations officer should you have more questions. Thank you and have a great day..

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