Doug Langa - Executive Vice President & Head of North America Operations Martin Holst Lange - Executive Vice President & Head of Development.

Thank you very much and welcome to this Novo Nordisk Earnings Call for the First Six Months of 2021 and the outlook for the year. I'm Lars Fruergaard Jørgensen, the CEO of Novo Nordisk.

I'd like to start by thanking you for your scheduling flexibility today as we decided to advance this earnings call as a consequence of our earlier than anticipated release of our results following an upgrade of both sales and operating profit.

With me I have our Chief Financial Officer, Karsten Munk Knudsen; Executive Vice President and Head of Commercial Strategy and Corporate Affair, Camilla Sylvest; Executive Vice President and Head of North America Operations, Doug Langa; and finally Executive Vice President and Head of Development, Martin Holst Lange.

All presenters will be available for the Q&A session. Today's earnings release and the slides for this call are available on our website novonordisk.com. Please note that this call is being webcasted live and a recording will be made available on Novo Nordisk's website. The call is scheduled to last for one hour. Please turn to the next slide.

The presentation is structured as outlined on slide 2. Please note that all share -- sales and operating profit growth statements will be at constant exchange rates unless otherwise specified. The Q&A session will begin in about 25 minutes. Please turn to slide 3.

As always I need to advise you that this conference call will contain forward-looking statements. Such forward-looking statements are subject to risk and uncertainty that could cause actual results to differ materially from expectations.

For further information on the risk factors including the uncertainties around COVID-19 please see the company announcement for the first half of 2021 and the slides prepared for this presentation. Please turn to the next slide. In the first half of 2021, Novo Nordisk has progressed on all four dimensions of our strategic aspirations.

I would like to highlight a few today. As a company, we are continuously working on being the best for the world and have progressed within purpose and sustainability.

Under our Defeat Diabetes strategy that focuses on prevention, access and affordability and innovation we have expanded the Changing Diabetes in Children program by including Ghana as the 15th country. This will support our aspiration of reaching 100,000 children and young people with type 1 diabetes in low-resource settings by 2030.

An integrated part of being a sustainable business is to offer an inclusive and diverse working environment. In Novo Nordisk a number of initiatives have been launched to achieve a balanced gender representation across all managerial levels, but the reality is that progress has been slow.

The current share of women in leadership positions defined as vice presidents and above is 35%. To underline our commitment to accelerate progress and ensure leadership accountability, we are launching a global gender diversity target.

Specifically our aspiration is to achieve a minimum of 45% women and a minimum of 45% men in leadership positions by the end of 2025. Personally I see this as an important step to create an inclusive culture with equal opportunities in Novo Nordisk. Martin will come back to key developments within R&D, but I wanted to touch upon a few.

We have reached a very important milestone with the approval of Wegovy in the US to the benefit of people living with obesity. Wegovy was made available to US patients in June 2021 and Doug will share more about the details of the launch later.

Furthermore, we expanded our pipeline within cardiovascular disease with the Heartseed collaboration and acquisition of Prothena's, ATTR amyloidosis programme. For commercial execution we have progressed on all three strategic aspirations, which Camilla and Doug will elaborate on later.

Lastly leaving the details to Karsten, we are pleased with the sales growth of 12% and operating profit growth of 9% in the first half of 2021 both measured at constant exchange rates. With that I give the word to Camilla for an update on commercial execution..

Thank you Lars and please turn to slide 5. In the first half of 2021, our total sales increased by 12%. This sales increase was driven by both operating units with international operations growing 13% and North America operations growing by 11%.

All therapy areas contributed to growth with diabetes care sales growing 11%, driven by GLP-1 sales growth; and broadly unchanged insulin sales. GLP-1 sales increased 30% driven by North America growing 24% and international operations growing 46%.

The broadly unchanged insulin sales were driven by a 6% growth in international operations, partly offset by an 11% sales decline in North America. The U.S. sales declined by -- insulin sales declined by 11% driven by a decline in volume and realized prices, the latter driven by channel and payer mix as well as rebate enhancements.

Obesity care sales grew 34% overall and now includes both, Saxenda and Wegovy in the U.S. In International Operations, Saxenda sales grew 44% and in North America Operations obesity care sales grew 27%. Biopharm sales increased by 7% driven by North America Operations growing 12% and International Operations growing by 4%. Please turn to slide 6.

In line with our strategic aspirations of reaching one-third of the diabetes value market by 2025 our growth of 11% is faster than the overall market. And hence we have improved our market share, by 0.5 percentage point to 29.6%. This increase reflects GLP-1 growth of 30% and market share gains in both operating units.

Currently, Ozempic has been launched in 62 countries and Rybelsus in 18 countries. Please turn to slide 7. In International Operations diabetes care sales increased by 13% in the first half of 2021 driven by all geographies.

The continued rollout of new generation insulins and focus on the GLP-1 product portfolio have resulted in an increased diabetes market share in international operations, which is now 23.9%, reflecting an increase of 1.4 percentage points compared to one year ago. This is driven by share gains in both, GLP-1 and insulin.

And in the last 12 months our insulin volume market share has increased from 47% to 47.3%. Please turn to the next slide. Biopharm sales grew by 7% in the first six months of 2021. This was driven by a 12% sales growth in North America Operations and 4% sales growth in International Operations.

Rare blood disorders grew by 11%, driven by uptake of launch products Esperoct and Refixia and NovoEight and NovoSeven. Specifically, Hemophilia A products grew by 39%, Hemophilia B sales by 30% and NovoSeven by 3%. Rare endocrine disorders grew by 2%, driven by new indications and global rollout of the next-generation device for Norditropin.

And now, over to Doug for an update on U.S. GLP-1 and obesity care..

Thank you, Camilla. Please turn to the next slide. The U.S. GLP-1 volume market growth is around 25%, comparing Q2 2021 to Q2 2020, driven by once-weekly injectable GLP-1 as well as Rybelsus. Novo Nordisk's, new-to-brand market share leadership is now 62.6%, driven by the continued uptake of Ozempic and Rybelsus.

Furthermore, Ozempic has regained NBRx market share leadership within injectable GLP-1 in the first half of 2021. Measured on total scripts, Novo Nordisk remains the market leader with more than 50% market share. Please turn to slide 10.

In the U.S., Rybelsus increased its volume market share both in terms of total scripts and new patient starts in the first half of 2021. This should be viewed in light of the two COVID-19-related commercial lockdowns in the U.S. with no face-to-face interaction between Novo Nordisk and the prescribers.

Since mid-May, our sales force has been fully back out in the field. Importantly, leading indicators such as prescriber breadth, HCP awareness and sourcing from outside of the GLP-1 class, remain encouraging. And we remain confident in the product and its long-term potential.

In addition, the launch trajectory is broadly progressing in line with the average performance of major SGLT2s that were all launched in a non-COVID world. Outside the U.S., Rybelsus has now been launched in 17 countries with one key market being Japan, where Rybelsus has reached a 0.7% modern OAD value market share.

While underlying parameters are on track it should be noted, that there continues to be COVID lockdowns in Japan which makes it difficult for patients and the salesforce to reach doctors. Please go to the next slide. With the US approval of Wegovy in June, obesity care is now a portfolio consisting of two products.

Globally, obesity care sales increased 34% with 27% growth in North American Operations and 44% in International Operations. As we have touched upon throughout 2020 and 2021, fewer patients have started treatment with Saxenda, due to COVID-19 lockdowns and reduced access to health care providers.

But thankfully, the situation has now started to improve. In the US, since the start of the year, we have seen positive momentum in new patient starts on Saxenda, which during the second quarter of this year were above pre-COVID levels. The US launch of Wegovy has been extraordinarily fast.

Following a six-month FDA review, Wegovy was approved on June 4, launched on June 10 and available to – or excuse me yes, available to patients and pharmacies on June 18. Market access has progressed since launch and two national payers have unblocked Wegovy from their national formulary.

The initial feedback from patients and prescribers has been encouraging. Five weeks after launch more than 8,000 Wegovy prescriptions have been filled and more than 50% of these are new to the anti-obesity medication class.

Now the overwhelming initial demand has put the supply chain under pressure, leading to temporary shortages for the starting dose which is 0.25 milligram. Novo Nordisk is committed to ensuring that any patient who has started on Wegovy will be able to continue on the product and production plans are being adjusted to satisfy the current demand.

Now over to you Martin for an update on R&D..

Thank you, Doug. Please turn to Slide 12. Now in the first half of 2021, we progressed our pipeline in diabetes, in obesity, in biopharm, as well as in other serious chronic diseases.

Based on the significant unmet need of millions of people as well as scientific evidence to the potential benefits of GLP-1-based treatment of dementia, we initiated in May, two Phase III trials evoke and evoke+, investigating the efficacy and safety of oral semaglutide 14-milligram in early Alzheimer's disease.

As discussed before, we have in real-world data as well as in post-hoc evaluations of our large-scale RCTs seen the potential of clinically very meaningful impact of GLP-1 treatment on the progress of dementia.

The mode of action is still being evaluated but based on preclinical data semaglutide is believed to work by reducing neuroinflammation as well as by impacting other pathways in the Alzheimer's pathophysiology thus reducing neurodegeneration and slow the clinical decline in Alzheimer's disease.

The duration of the two trials will be three years with a confirmatory readout after two years. There are 1,840 patients in each trial. And therefore a total of approximately 3,700 patients will be randomized the majority of whom being diagnosed with mild cognitive impairment or early dementia of the Alzheimer's type.

Our – in evoke+ however, at least 20% of patients enrolled will have small vessel pathology. The primary endpoint for both trials is the change in the clinical dementia Rating Sum of Boxes score after two years of treatment.

If successful, semaglutide has the unique potential to become the world's first oral disease-modifying treatment for Alzheimer's disease with a very well-established safety profile from across several indications. Please turn to the next slide.

Within cardiovascular disease, Novo Nordisk's strategic ambition is to have at least one dedicated compound to be launched between 2024 and 2028. This should target either atherosclerotic cardiovascular disease or heart failure with a highly innovative first-to-market product serving a significant unmet need.

In support of this ambition, we've entered into a new stem cell R&D license agreement with Heartseed and further acquired Prothena's ATTR amyloidosis program. Let us start with the Heartseed agreement.

Novo Nordisk has entered into an exclusive worldwide collaboration as well as licensed agreement for the development manufacturing and commercialization of Heartseed's lead asset HS-001.

HS-001 is an investigational cell therapy using purified cardiomyocytes derived from induced pluripotent stem cells which is currently under development by Heartseed for the treatment of heart failure. Heartseed expects to initiate a combined Phase 1/2 trial in Japan during the second half of this year.

The collaboration very nicely complements our own stem cell technology platform. Further, we've acquired Prothena's broader ATTR amyloidosis programme and the Phase 2-ready antibody PRX004 for the rare heart disease ATTR cardiomyopathy.

More specifically, this is a rare type of heart condition characterized by a buildup of amyloid deposits in the cardiac tissue. This can cause both weakening and stiffening of the heart motion. And it is an often fatal disease with a very significant unmet need.

The asset PRX004 has an innovative mode of action with the potential to remove myocardial amyloid, preventing further progression and to reverse the course of the disease in ATTR cardiomyopathy. Novo Nordisk expects to initiate a Phase 2 clinical trial in 2022 which is expected to be followed by a Phase 3 cardiovascular outcome drug.

These activities support an expansion of Novo Nordisk activities and commitment within cardiovascular disease and add to the ongoing activities within the cardiovascular space such as our clinical development program for Ziltivekimab, oral PCSK9 as well as our major cardiovascular outcomes trial such as SELECT and SOUL. Please go to the next slide.

Turning to the high-level R&D milestones. We start with the second quarter of 2021. Within diabetes, we resubmitted the label expansion application for Ozempic 2.0 milligram for the treatment of diabetes to the FDA on May 28. The standard review time by the FDA is 10 months.

This resubmission followed the refusal to file letter received by the FDA on March 22. It's already been mentioned during this call, but within obesity we reached a very important milestone with the approval of Wegovy in the US. This was based on the results from the STEP program.

And building on that in Q2, we completed the Phase 2 -- sorry the Phase 3b trials STEP 5 and STEP 8. STEP 5 demonstrated a sustained weight loss of 16.7% over a period of full two years of treatment, almost a little bit repetitive, but very consistently to the profile STEP 8 demonstrated a similar 17.1% statistically significant weight loss.

This is to be compared to the 6.7% achieved for Saxenda. In the second half of 2021, we expect Phase 1 results for our glucose-sensitive insulin as well as several trial initiations across all therapy areas such as the Phase 3 initiation of oral semaglutide in obesity and the CP outcomes trial for Ziltivekimab in other serious chronic diseases.

Towards the turn of the year, we expect a decision from the EU on semaglutide 2.4 milligram in obesity and Ozempic 2.0 milligram in diabetes. Within Biopharm, we expect results from the Phase 3 program for somapacitan in growth hormone-deficient children and results from cohorts of the ongoing combined Phase 1/2 trial with Mim8.

With that over to you Karsten..

Thank you, Martin. Please turn to slide 15. In the first six months of 2021, sales grew by 5% in Danish kroner and by 12% at constant exchange rates. The gross margin declined to 83.0% compared to 84.1% in 2020.

The decline reflects a negative currency impact of 0.7 percentage points, lower realized prices in the US and amortization of intangible assets related to the acquisition of Hemisphere Technologies in 2020. These factors were partly offset by positive product mix driven by increased GLP-1 sales and continued productivity improvements.

Sales and distribution costs increased by 8% in Danish kroner and 15% at constant exchange rates. The increase is driven by investments in our key strategic priorities, most notably launch activities and promotional spend for Rybelsus and Ozempic, market development investments for obesity as well as sales force expansion in China.

Research and development costs increased by 12% in Danish kroner and 15% at constant exchange rates.

The cost increase is driven by increased investments associated with more patients enrolled in clinical trials, as we progress the early pipeline within cardiovascular disease, and NASH as well as the ongoing cardiovascular outcome trials SOUL and SELECT. Furthermore, we increased our investments in our research platform technologies.

Administration costs increased by 5% in Danish kroner and 8% at constant exchange rates impacted by a low spend in the first half of 2020. Operating profit increased by 1% in Danish kroner and increased by 9% -- decreased by 1% in Danish kroner and increased by 9% at constant exchange rates.

The negative currency impact on operating profit is partly offset by around DKK 1 billion in hedging gains under net financial items. This compares to a loss of DKK 1.7 billion in 2020. The gains on hedge currencies, primarily relate to the US dollar. Net profit increased by 10% and diluted earnings per share increased by 12% to DKK 10.71.

Free cash flow was DKK 32.7 billion compared with DKK 30.3 billion in 2020. The increase reflects the higher net profit and a favorable impact from changes in working capital, further positively impacted by within timing of US rebate payments. Next slide please.

A key priority for Novo Nordisk is to ensure attractive capital allocation to shareholders and over the past three years our average cash to earnings ratio has been around 80%. In May, the share repurchase program for 2021 was increased by DKK 1 billion to a total of DKK 18 billion.

It should be noted that the program may be reduced in size, if significant business development opportunities arise during 2021. For 2021, the Board of Directors has decided to pay out an interim dividend of DKK 3.50 per share, which will be paid out in August this year. This is an increase of 8% compared to the 2020 interim dividend.

Novo Nordisk has consistently returned its free cash flow to investors through both share buybacks and dividends with dividends per share increasing for 25 consecutive years. Finally, in Q2, we executed a three and seven year Eurobond issuance in an aggregate amount of €1.3 billion.

The two tranches were issued with a coupon of 0% and 0.125% respectively. The Eurobonds were issued under a €5 billion EMTN program. Please turn to the next slide. We now expect 2021 sales growth to be between 10% and 13% at constant exchange rates.

This is based on the performance seen in the first half of the year across therapies and geographies, including the strong initial Wegovy uptake in the US increasing global obesity market growth, Ozempic growth, acceleration as well as a reduced likelihood of a negative impact from volume-based procurement in China in 2021.

The guidance reflects growth across therapy areas, but it's mainly driven by GLP-1 products Ozempic and Rybelsus, as well as obesity care. Also embedded is intensifying competition within both diabetes care and Biopharm and continued pricing pressure mainly within diabetes care in the US.

Operating profit is now expected to grow between 9% and 12%, reflecting the sales growth outlook and continued investments in current and future growth drivers. This includes the continued rollout of Ozempic and Rybelsus the launch of Wegovy and associated market development investments.

Furthermore, additional resources are being allocated to R&D pipeline activities such as the many Phase 3 clinical trial activities. Given the current exchange rates most notably a strengthening of the US dollar we expect a less negative currency impact for the full year compared to three months ago.

Consequently, our reported sales and operating profit growth is now expected to be 4% and 5% lower than at constant exchange rates respectively. For 2021, financial items are now expected to be a gain of around DKK 0.6 billion, mainly reflecting gains associated with foreign exchange hedging contracts.

Capital expenditure is still expected to be around DKK 7.5 billion in 2021. Lastly, free cash flow is increased by DKK 2 billion and now expected to be between DKK 39 billion and DKK 44 billion. That covers the updated outlook for 2021. Now back to you, Lars, for final remarks..

Thank you, Karsten. Please turn to slide 18. Firstly, we are proud of our progress within purpose and sustainability with the introduction of a concrete gender diversity target to continue to build an inclusive culture with equal opportunities in Novo Nordisk. We're also pleased with the sales growth in the first six months of 2021.

Sales growth was driven by all geographical areas within International Operations as well as North America Operations and by all therapy areas, in particular our portfolio of GLP-1 treatments.

The strong financial performance in the first six months of 2021 and the initial substantial demand for Wegovy has enabled us to raise our outlook range for the full year. We reached an important milestone with the approval and very fast launch of Wegovy in the US with encouraging initial feedback from both patients and prescribers.

Finally, the license agreement with Heartseed and the acquisition of Prothena's ATTR amyloidosis programme is fully aligned with our ambition within cardiovascular disease. We're now ready for the Q&A, where I kindly ask you to limit yourself to maximum of two questions. Operator, we are now ready to take the first questions..

Thank you. [Operator Instructions] Our first question is from Emmanuel Papadakis from Deutsche Bank. Please go ahead..

Thanks for taking the question. Maybe I'll take two on Wegovy please. If you could just give us a little bit of insight into what proportion of the strong initial prescription uptake is free versus paid product? And when you expect to phase out the form of that i.e.

the free product and I'm not referring to the $25 co-pay support, just literally the product you're subsidizing. And the second question would be around your anticipation based on initial discussions for coverage rates in 2022.

So we -- I think we had reasonably strong technical commercial insurance coverage rates but a lot of opt-outs so less than half of that was effective.

Are you expecting something similar on Wegovy or do your initial discussions lead you to believe that there will be more opt-ins from commercial employers? And to what extent will that also involve utilization management such as prior [indiscernible]? Thank you..

Thank you, Emmanuel. So I'll hand over to Doug, the questions on how we see the split of the initial scripts on Wegovy whether it's based on commercial access or its support programs.

And maybe Doug you can talk a bit to, how we are building access with the caveat that we're not at this call going in and giving guidance on access or the like when it comes to 2022. So, it's a bit about how we are progressing as we speak. So, over to you Doug..

Yes. Thank you, Lars, and thank you Emmanuel for the question. So for your first question, I would say it's roughly 50-50 in terms of where we're seeing coverage today and where we need to assist as an organization.

Secondly to your question on coverage, I think that we've been pleased initially with the work that the team has done the receptivity from major PBMs as well as local health plans and employers. As I stated in my opening two major PBMs did unlock the blocking of Wegovy early on almost at launch. So that's a promising sign.

And I think the receptivity and the feedback from the clinical conversations has been extremely strong. We have communicated that we believe that we'd like to see Saxenda like access in 2022 moving on. And I'd say these early indicators are a good sign that we're well on our way..

Thank you, Doug and thank you, Emmanuel. And the next set of questions please..

And our next question is from Matthew Weston from Credit Suisse. Please go ahead..

Thank you very much. Two questions for me please. The first on Rybelsus. If we look at the US prescription trends versus revenue, Doug, it would suggest a significant step down in revenue per unit.

And I'd just be very interested to understand whether that's a re-increase in rebating and patient support as the sales force comes back online? Or has there been a significant change in mix in the US market? And how would you expect us -- how do you expect that to progress over the course of the year? And then secondly a general question on guidance.

You've significantly raised revenue expectations, but you've also kept operating margin growth below sales. I realize that was the guidance in your previous setting because it was all about investing in R&D.

Now that you've added incremental sales, I'd be very interested to know what you're spending the extra money on? Is it R&D? Or is it more incremental sales support for the launches? Thank you..

Thank you, Matthew. So two questions one on Rybelsus prescription and how do you see the revenue per script, I think that looks okay, but Karsten can cover that. And also Karsten you can cover the guidance that we are keeping intact. You can say the ratio between top line and bottom line. .

Yes. Matthew, thanks for these questions. So, first of all, as to Rybelsus value prescript in the US there are basically very limited changes to what we're reporting for the first quarter. We're now at the tail-end of some of the initial launch co-pay programs. We saw them run out here in the middle of the second quarter.

So that's pretty much the only change vis-à-vis Rybelsus value prescripts. Then we have a competitive co-pay program vis-à-vis the oral competition down to $10 per scripts. And we have a GLP-1 like pricing from there. So pretty much nothing new from Q1.

In terms of investments with the increased sales outlook then, of course, that's something that we carefully consider and I would put it in rather simple buckets. So, first of all, we continue to invest in our GLP-1 portfolio between Rybelsus and Ozempic both in the US, but also on a global basis.

Then secondly our obesity franchise with the market development required clearly is a focus area of investments on a global scale. This is a market that we have to build on our own. So clearly a lot of investments going into both building internal capabilities but also working a lot on market development at large.

Thirdly, we invest in specific emerging markets based on growth opportunities and portfolio in those markets. And then finally, I would say, as I've been commenting on before, clearly we have a strategy to increase our R&D to sales ratio gradually over time thereby increasing our whole R&D pipeline and diversifying our R&D pipeline.

And that is exactly what you also see in the patient numbers and the portfolio that Martin was talking to. .

Thank you, Karsten. Thank you, Matthew.

Next set of questions please?.

And our next question is from Wimal Kapadia from Bernstein. Please go ahead. .

Great. Thanks so much for taking my question. I'm Wimal Kapadia from Bernstein. So just first on Rybelsus. I just wanted to know what's Novo's preference in terms of volumes between Rybelsus and Ozempic, given that Ozempic seems to have a higher net price, but a shorter IP duration and does not have the same level of life cycle management as Rybelsus.

So just curious given Ozempic seems to be beating market expectations, but Rybelsus seems to be coming in a little bit lower. And then my second question I just want to ask about the broader -- the growth of the broader obesity market in the US.

And if I look at volumes over the last five years in the US, we actually see flat absolute volumes in -- for AOMs.

So I'm just curious how you're thinking about market volume growth from here? Do you expect Wegovy to drive market growth? And to what extent do you think that they can do that over the majority of volumes actually come from generic products on the market? I appreciate the initial volumes to just 50-50 like you outlined in your slide but just curious how you think that will play out moving forward? Thanks..

Thank you, Wimal. So first Camilla, if you can talk to a bit whether we have a preference for one or the other Rybelsus versus Ozempic in terms of driving growth. And then Doug can talk to what we see in terms of obesity market growth in the U.S. .

Yes. Thank you, Lars. So since we had the approval of Rybelsus it has all along been our strategy to expand into the OAD market. And from the PIONEER program, we saw that the Rybelsus is the most efficacious OAD.

So our plans and strategies are to expand the use of GLP-1 being in the injectable segment and being in the OAD segment where we historically have never been present. So that's basically the strategy that we've been following and that we are executing on. .

Thank you Camilla. That's very clear. And I think we've seen some good success.

So Doug what can you say about your expectations to the obesity market growth in the US?.

Thanks. Appreciate the question. So what I would say is as I said in my opening comment that we did see in the second quarter, Saxenda coming back and then additionally and importantly Wegovy adding to the growth of the category. And importantly, we saw within that over 60% of that coming from naive patients.

So the expectation is that Wegovy will continue to add to the class and its growth..

Thanks Doug. And when we compare to IO, we can see that there's a very, very nice uptick in the obesity market in IO. And obviously we are not even close to getting Wegovy on the market there.

So I think it's a very strong sign that 44% growth in IO is a sign that the obesity market is back and you could say that it may be coming back even stronger because during the lockdown and many people have developed an even larger need for obesity medicines. So we're quite confident and bold on the future growth of the obesity market globally.

Thank you Wimal.

And next set of questions please?.

And our next question is from Steve Scala from Cowen. Please go ahead..

Thank you so much. Two on Wegovy.

First, curious if versus your expectations more physicians have prescribed Wegovy so far or among the physicians who have prescribed it, you are seeing more prescriptions per physician than expected? So the former might suggest a bigger opportunity, the latter might suggest quicker saturation? And then secondly, have commercial insurers mandated any stopping or discontinuation conditions on Wegovy use? Thank you..

Thank you Steve. So two questions on Wegovy. So the first one to rest or test in terms of this prescriber universe and then whether there are any say conditions to how commercial plans can join the Wegovy campaign.

So Doug can you talk to that please?.

Yes. Thanks Steve for the question. So for us what's critically important is both breadth and so the number of prescribers as well as depth and those prescribers prescribing more. So we're hard at work at both of those. And I'd say, it's early days to tell. We're five, six weeks into the launch.

What we have been pleased with is that we've seen 8,000 prescriptions in less than a month. If you compare that to Saxenda that took approximately four years to achieve that. So I think that it's a combination of both.

As far as your payer question right now, we're seeing the same traditional components on Saxenda in the payer community as we are with Wegovy, but we're working very hard to have this treated like a standard listed product. We think that's critically important not only for patients but the overall success of the brand.

So that's where we're hard at work. And again early indications are good there receptivity of the PBMs..

Thank you Doug. Thank you Steve. Next set of questions please..

And our next question is from Peter Verdult from Citi. Please go ahead..

Thank you. Peter Verdult, Citi. Just a quick clarification for Doug and then my two questions. Just very quickly Doug when do you expect the supply situation on the start of dose to Wegovy to resolve? Just a very quick clarification. Just on the two questions maybe for Karsten.

Can you just give us some ballpark quantification what the uplift was for guidance this year from VBP insulins in China not coming to pass in 2021? And any intel or insight you can give us about potential scope and breadth of VBP plans for 2022 in light of the recent meeting with the government and industry payers? And then for Martin just a quick update on the key outcome studies, SELECT, SOUL, FLOW, just any comment -- I realize these trials are live just can't give too much but anything you can say about event rates whether they're running in line, ahead or behind schedule? Thank you.

.

So thank you Pete. I'll deal with the supply issue because that's not really under Doug's responsibility. So it's clear we have seen a very, very strong uptake of Wegovy. And I think we have to admit it's stronger than what we had planned for. So when you launch you're obviously in a ramp-up phase for manufacturing. So we have some bottlenecks right now.

But you can rest assured that we're working hard to make sure that we can ramp up manufacturing as fast as possible. And these are standard say manufacturing processes that we know how to handle very well. So we know what needs to be done to get the supply back on track.

And as Doug mentioned our key concern is of course to make sure that those who start on treatment can continue on treatment. On VBP in China, Karsten, you could talk a bit to how it's baked into the guidance but I can just say that there was recently a consultation meeting in China with the authorities where manufacturers participated.

Based on that we now believe it's less likely that there will be an impact this year. If an insulin VBP is implemented which we believe will eventually happen it's probably not going to take place before 2022. And if you put a bit of caveat around it, had it been easy to do most likely, it would be done.

So, I think I've commented before that the experience that is already in the market is in the small molecule space. And if you want to do a VBP for a biologic and not least life-saving medicine like an insulin, this is not a trivial thing to do to secure both volumes and quality of those volumes. So, for now we think it's unlikely for this year.

And if it happens it could be next year. So, Karsten you can talk to how we have baked that into the guidance we have given. .

Yes, absolutely, and thanks for that question Pete. So, based on what Lars just explained around the status of VBP that was part of enabling us to narrow the breadth of our guidance range for our top line and lift the floor.

But of course, the key driver behind us lifting the overall range was what we have just discussed in terms of our performance within obesity care both Wegovy and the oral obesity market growth as well as the acceleration in GLP-1 and the strong Biopharma performance in the first half. .

Thanks Karsten. And since I think this was actually two questions Martin very shortly on the status on the outcome trials..

Yes, thanks very much Pete. Things are going well. We managed to secure recruitment of all three trials on time. In fact SELECT and FLOW were a little bit ahead of time. And what we see right now is despite of COVID-19 really good retention in all trials. So, more than 95% of patients still being in trial.

We can't really speak to the event rate but maybe just saying that what we see right now is very close to what we anticipated when initiating the trials..

Thank you, Martin. Good to hear that is well on track. Thank you Pete for the two questions. And on to next set of questions please..

Our next question is from Martin Parkhøi from Danske Bank. Please go ahead..

Yes. Martin Parkhøi Danske Bank. Actually also on Wegovy all the two questions. Just on the supply side Lars or Karsten whoever you say that you of course prioritize to make sure that the patients which already on the draft can continue.

Does that mean that we can -- what should we think about script count because we have tapped enormous growth in script over the last five weeks.

Can you know new scripts actually our new brand stalled because you can actually not have supplier to start new patients now? Or how should we see the dynamics? And then secondly maybe this is on to Doug I guess that a lot of the demand for the -- has been driven by patients seeing about this new wonder drugs and media and stuff like that.

Are there a risk that it's not the right patients they're not the patients that you actually like to have to make sure that this is will be a strong long-term upside of the drug? And also maybe you can talk about because we also saw many years ago that that contract actually had a quite nice start not to the magnitude like this but it died out.

So, how many -- are there risks that you're actually not getting the right patients on board?.

Thank you, Martin. I'll start on the supply. So, we have seen here initially that we were out of the start dose to low dose. But of course manufacturing is running constantly. So, yes, we can start new patients. But the initial uptake we have seen is significantly higher than what we had planned for.

And it's not -- it's always quite common that when you launch a new product you are ramping up manufacturing as you launch and we're doing that. So we will eventually be able to cover the full demand. But it's not that we cannot start new patients for the rest of the year. So don't need to worry about that. You're right that.

There's a lot of excitement around, Wegovy.

And Doug what can you talk to the type of patients we get in? Obviously, its early days, but what is your intelligence from the field?.

Thanks Lars and Martin. Thank you for the question. Let me first start by saying, we have a -- there's a -- when we think about an unmet need and the 650 million patients in the world with 100 million patients in the U.S. they need help. And they've been in a lot of ways, maybe waiting for a drug like this.

So, there's certainly a significant patient pool. I would say, it's early days, when we look at the patient level data that we see with Saxenda, typically the patients are aged between 40 and 60 with a BMI of 35 or less with Comorbidity. So I think there is a significant unmet need. And now is the right time to unlock the potential..

And who are the main prescribers? Are they primary indoors, weight loss centers?.

Yeah. So what we're seeing -- and again, this is really based on, what we've seen for Saxenda and anticipate is that, the primary care physician, the interim medicine and nurse practitioners, PAs that's going to be the bulk of the prescript -- writers that we're going to see in this space right now.

It's less about specialty as comparatively as we would see in say diabetes. But based on what we see in Saxenda what we anticipate is PCP and MPs..

Okay. Thank you..

Thank you, Doug. Thank you, Martin. It's clearly exciting times. And I think we've all been talking to that Wegovy is the first time, there's a real solution to the problem being obesity. And I think the sign received from the market is that, that's well understood. And there is a significant demand for this. So we're very encouraged with what we see.

Next set of questions please..

Our next question is from Carsten Madsen from SEB. Please go ahead..

Thank you very much. I will just jump a little bit into the GLP-1 diabetes segment. What we saw here in Q2 was that you significantly -- also your sort of market share gain trajectory in the U.S. market, and you had a very, very strong quarter in terms of market share gains.

And it came after a period where maybe Lilly has put a little bit of pressure on you with the high-dose Trulicity launch.

What have you changed? Have you changed anything in your marketing message or your go-to-market strategy for -- in particular Ozempic because it seems to me Ozempic that's the driving force? And then, secondly on -- what's your expectations for timing of U.S.

interchangeable version of NovoLog? And what do you think will happen once the product hits the market?.

Thank you, Carsten. And I think the first question on U.S. GLP-1 dynamics, clearly a very, very strong performance. I think we have all along been very excited about the Ozempic.

But Doug, can you share anything about any change in tactics or anything? Or is it just, pull through? And then secondly, I don't know timing about interchangeability for NovoLog, whether you have overview of that?.

Thanks Carsten for the question. And what I would say is if you just remember we started to phase in our sales reps in mid-February and then got them fully back in the field by May. So there was a component of us reentering into the market. I would also suggest that, semaglutide has become a well-known molecule. Ozempic itself is highly recognized.

It's excellent efficacy. If you think back to the numbers of patients in the SUSTAIN program, 80% of them reaching HbA1c of less than seven. So it's a great product. And I think that we haven't necessarily changed our strategy.

We're still deploying what we've communicated is sema's synergy which is to be effective and successful with both, Ozempic and Rybelsus in the category..

Okay..

And on the second question on interchangeability in the U.S., I think our perspective is that to a large degree we already see that the market seen from a manufacturer's point of view is a market that works like a interchangeable market in the way PBMs buy from us. It might not be fully -- the benefit of that might not fully be going to the patients.

But in terms of the contracting we do that is largely of an interchangeable nature. Thank you, Doug. And thank you Carsten. So we take our next set of questions please..

And our next question is from Michael Novod from Nordea Markets. Please go ahead..

Thanks a lot. Two questions as well. So perhaps on NovoSeven first. So how should we sort of foresee growth going forward? It seems you have been able to completely stabilize it. And if you look at the first half year you're up around 19% in the US.

So are we through this market share erosion from HEMLIBRA? And what should we expect going forward? And then secondly to Rybelsus dynamics in IO, where you see a quarter-over-quarter decline in sales.

Is that due to the aforementioned lockdowns in Japan, still going on? Or what are sort of the drivers of this? Or is it just that you don't really get the traction that you wish for with Rybelsus in IO?.

Yes. Thank you, Michael. Yes indeed Ozempic performance is very strong in a rather competitive arena. So Karsten, can you talk a bit to how we see growth there? And then Camilla, you can touch upon Rybelsus' performance in International Operations, where – yes, I think we have seen a lot of pandemic activity going on.

But first Karsten?.

Yes Michael I fully concur, we were very satisfied with the 3% growth in the first half for NovoSeven after a number of years, where the brand has been significantly under competitive pressures. I'd say there are a couple of aspects to it.

So first of all then as you know the demand for NovoSeven is somewhat stochastic in nature linked to the number of bleeds and surgeries and so on. And we did see some significant events in the second quarter in the US positively impacting US sales.

And on top of that without having a firm data on it then of course with the society and health care systems opening up, one could speculate that the increased activity levels could lead to increased bleeding episodes requiring NovoSeven treatments.

As to the commercial impact on the brand then we are not fully through the set of emerging markets that have yet to launch competition but to a large extent we are through it in some of the more developed markets. .

Thank you, Karsten.

And Camilla on Rybelsus' performance in IO?.

Yes. So on Rybelsus in IO, we are continuing to see increasing market share performance in key countries but it is of course in the light of COVID-19 that continues to impact especially EU countries and also Japan. We've launched in 17 countries and Japan being the country the biggest potential has been impacted by multiple states of emergencies.

And that of course impacts our ability with the sales force to reach our customers. And nevertheless, the underlying parameters, such as number of actively prescribing physicians and source of business and also launch uptakes does look good and encouraging.

And as in the US, we're also in the rest of the world continuing to expand the number of prescribers and of course the number of scripts what we call depth per prescriber as well..

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

Our next question is from Sachin Jain from Bank of America. Go ahead..

I'm Sachin Jain, Bank of America. Just two on Wegovy, please. I'm just trying to try and get the excitement on scripts into a numbers extent you're able to.

So firstly, is it fair to assume that the biggest single element of the sales guide raise is Wegovy of the various factors that you've listed implying Wegovy sales are sort of DKK1.5 billion to DKK2 billion for this year? And then secondly, again Doug you mentioned that scripts have matched Saxenda within eight weeks.

And if that is converted to paid drug into next year is it fair to think that you could potentially your mid-term obesity aspiration of doubling sales by 2022 itself?.

Thank you, Sachin. So we are not going into speculations about 2022 as of yet. But we have limited amount of recovery sales in the books so far.

Karsten, but what can you tell us about what we are seeing without going into guidance on individual brands?.

Yes Sachin, as I was covering before, then obesity care at large is one of the key drivers for us operating our guidance for the full year. And that is the combination of Wegovy and the overall market growth benefiting Saxenda both in the US and in International Operations. So Wegovy is part of it, but only one segment.

So the two main chunks of the upgrade is obesity care and acceleration of our GLP-1 business..

Thank you, Karsten. So we take the final set of questions. .

And our next question is from Seamus Fernandez from Guggenheim Securities. Please go ahead..

All right. Great. Thanks for the questions. So a couple of questions. First on the SELECT trial and the current obesity market uptake and opening up of access. Just hoping in the past you've generally commented that the SELECT trial would be critically important.

I think one investor earlier this week characterized it as biblically important to a real opening up of the obesity market.

Just wondering how you're feeling given the strong early launch of launch of Wegovy relative to the importance of a successful SELECT trial? And then incremental to the SELECT trial opportunity, I don't think we've had many questions on AM833 and the acceleration of your combination program there.

Just hoping you could provide a little bit of context of the pace of a switch there potentially? And how quickly you would want to drive patients to that.

Is it optimized for obesity? Or do you really view that combination as a preferred diabetes plus obesity and NASH market opportunity product?.

So thank you. If I start by giving it is a shot on how we see the importance of SELECT and then Martin you can cover the second question.

So we have -- when we have spoken to the obesity opportunity, we have spoken about the importance of mobilizing patients living with obesity the importance of getting physicians to prescribe, and the importance of getting payers to reimburse. And you can see that based on the initial signs we see here, we do see that patients are mobilized.

We do see that physicians are willing to prescribe based on what Doug mentioned in terms of two national payers having removed block. We also see that there's a willingness to pay for it. So I think it's -- I think we're off to a very exciting start.

And it seems like the profile of the product and the market build activities we have done is resonating well and I think that's quite encouraging.

Martin on AM833?.

Yes. Very briefly cagrilintide between trends to be combined with semaglutide and we've shared the data showing that with the combination of cagrilintide and semaglutide we can see an approximately 17% weight loss, but in a matter of 20 weeks. And with the safety profile that is comparable to that of semaglutide in monotherapy.

Obviously that has made us very excited and we intend to initiate Phase 3 already next year. I think the question was more about the positioning of the combination product towards semaglutide, and maybe that's too early to speculate on..

Thank you, Martin. And let's -- since we are on a good roll take one final question..

And our next question is from Keyur Parekh from Goldman Sachs. Please go ahead..

Hi. Thank you for fitting me in. Two questions if I may please. First one, Doug as we think about the launch for Wegovy ex US, if my memory is correct kind of the Saxenda launch ex US was actually more successful than the Saxenda launch in the US.

As we think about Wegovy launch ex US, is there a reason why that might be different? Or should we expect a similar enthusiasm to the Wegovy launch ex US? That's question number one. And then question number two, Karsten, you kind of made an oblique reference to the risk to the stock buyback in the event that you were to pursue a sizable transaction.

You're clearly raising your free cash flow guidance. You have done a couple of transactions, but your balance sheet capacity is still meaningful.

So I'm just wondering kind of if -- what is the size of transaction that might need you to rethink your stock buyback? And is that something we should be anticipating over the course of the next few months? Thank you..

Thank you Keyur. So on Wegovy ex US, we have plans to get European approval by turn of the year. So it's a bit early for us to start speculating on how it might look like. I think, it's a quite dynamic position that, in IO, it's typically out-of-pocket paid, whereas in the US, it's reimbursement.

And clearly now, in the US, it seems like we are now hitting a weight loss profile, where it becomes meaningful for payers to reimburse. And I can only project that individuals who are paying out of pocket today, when they see the profile of Wegovy at a similar pricing, there is a very robust demand for that also outside of the US.

So again, encouraging prospects based on the profile of the product and the price point we have set. You raised a good point, in terms of capital allocation in the context of deals. So Karsten, can you talk a bit to that? You have introduced debt financing in Novo Nordisk at a 0% coupon which obviously is an attractive rate.

So, what can you tell about that?.

Yes. Thank you, Lars. Thank you, Keyur. Yes. So first of all, it's interesting how to finance the company. It was 40 years ago, that we actually listed on the New York Stock Exchange at a PE at around 15. And now, we are issuing bonds at a zero coupon this year.

So, just to wind back, we basically have three core pieces to our toolbox in terms of capital allocations. So we have the cash we have on our balance sheet, then we have adjustments to our share buyback; and then we have debt leverage. Of course there are additional means, but that's kind of three core tools that we use.

And what you saw last year just to baseline us and that is that the Corvidia transaction we did last year with an upfront of $725 million.

That we actually able to finance through our financial reserves or the cash on balance sheet without impacting our share buyback or raising debt, whereas the Hemisphere acquisition at $1.8 billion in reality, is mainly linked and financed from the bond issuance we just did.

So, we are very focused on continuing to provide an attractive capital return to our shareholders and thereby continuing our track record on increasing dividends for now 25 years. But also, continuing our share buyback program. So, of course, it depends on the exact deal and so on how we finance it between three means and the magnitude of the deal..

Thank you, Karsten. Thank you, Keyur. With that we'll close the call. And again, thank you for your flexibility in rescheduling this earnings call. We were excited about our half year results and wanted to share the insights with you as fast as possible. So thanks a lot for dialing in, and have a great day and a great evening wherever you are.

Thank you, very much..