Q3 2021 Novo Nordisk A/S Earnings Call

November 3, 2021

Operator: Welcome to the Q3 2021 Novo Nordisk AS Earnings Conference call. During the call, all participants will be in listen-only mode, and afterwards, there'll be a question and answer session. Today, I'm pleased to present Lars Jorgensen, CEO. Please go ahead with your meeting.

Welcome to the Q3, 2021 Novo Nordisk <unk> earnings conference call.

During the call all participants will be in listen only mode and afterwards, there will be a question and answer session. Today I'm pleased to present last forgot yoga and said see yet. Please go ahead with your meeting.

Thank you very much.

Lars Fruergaard Jorgensen: Welcome to this Novo Nordisk call regarding our earnings for the first nine months of 2021 and outlook for the year. This call follows the early announcement of the high-level results and raised guidance published on Friday last week. I'm Lars Jorgensen, the CEO of Novo Nordisk. With me today I have Chief Financial Officer Karsten Knudsen and Executive Vice President and Head of Commercial Strategy and Corporate Affairs, Camilla Sylvest. Executive Vice President and Head of North America Operations, Doug Lange, and finally, Executive Vice President and Head of Development, Martin Holst Lange.

When it comes to this one what is called regard like guarding our earnings for the first nine months of 2021 and outlook for the year.

This called photos of your announcement of the high level results and raised guidance published on Friday last week.

I'm not sure what got Jorgensen CEO of Nordisk.

With me today, I have chief Financial Officer, Karsten Munk Knudsen.

Executive Vice President and head of commercial strategy and cover a fish commuter serviced.

Fenty, Vice President and head of North American operations took longer and finally executive Vice President and head of development marketing host Diana.

Lars Fruergaard Jorgensen: All presenters will be available for the Q&A session. Today's earnings release and the slides for this call are made available on our website, novo-nordisk.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 sales and operating profit growth statements will be at constant exchange rates unless otherwise specified.

All percentages would be available for the Q&A session.

Today's earnings release and the slides for this call are made available on our website north-northeast dot com.

Please note that this call is being webcast at life and a recording will be made available on <unk> website.

The call is scheduled to last for one hour. Please turn to the next slide.

Yeah.

The presentation is structured as outlined on slide two please note that all sales and operating profit growth statements would it be at constant exchange rates unless otherwise specified.

Lars Fruergaard Jorgensen: The Q&A session will begin in about 25 minutes. Please turn to slide three. 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 nine months of 2021 and the slides prepared for this presentation. Please turn to the next slide.

The Q&A session will begin.

In about 25 minutes, please turn to slide three.

As always I need to advise you that this conference call will contain forward looking statements such forward looking statements are subject to risks 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 nine months of 2021 and the slides prepared for this presentation. Please turn to the next slide.

Lars Fruergaard Jorgensen: In the first nine months of 2021, Novo Nordisk has progressed on all four dimensions of our strategic aspiration, and I would like to highlight a few today. Within Purpose and Sustainability, we have expanded the Changing Diabetes in Children Programme so that it now includes three additional countries. Indonesia, Pakistan, and Peru to reach a total of 18 countries included in the program. This will support our aspiration of reaching 100,000 children and young people living with type 1 diabetes in low resource settings by 2030.

In the first nine months of 2021, no noise because progress on all four dimensions of our strategic aspirations I would like to highlight a few today.

Within purpose and sustainability, we have expanded the changing diabetes and children program. It now includes three additional countries, Indonesia, Pakistan and Peru treats.

To reach a total of 18 countries included in the program.

This will support our exploration of reaching 100000 children and young people living with type one diabetes in low resource settings by 2030.

Lars Fruergaard Jorgensen: Today the program is providing free care to 30,000 children and adolescents in low- and middle-income countries. Within our Circular for Zero strategy, we are excited that Novo Nordisk has received an award at Climate Week in New York City. The award was given for our work in accelerating the global transition to 100% renewable energy.

Today, the program is providing free care too.

30000 children.

Essence in low and middle income countries.

Yeah.

Within our circular for Cero strategy. We are excited that noise because received an award at the climate week in New York City.

What was given for our work in accelerating the global transition to 100% renewable energy.

Lars Fruergaard Jorgensen: Martin will come back to key milestones in R&D, but I would like to briefly share my perspective. With the initiation of two phase 3 programs in obesity and other serious chronic diseases, we now have ongoing late stage clinical trials in all of our therapy areas. The Phase 3 initiation with Ciltivecumab demonstrated our ability to successfully integrate the late stage acids we acquired from Covidia Therapeutics in 2020 into our internal clinical development program.

Martin will come back to key milestones within R&D.

To briefly share my perspectives.

With the initiation of two phase III programs within obesity and other serious chronic diseases. We now have ongoing late stage clinical trials within all of our therapy areas. They phase III initiation into whether they come at demonstrated our ability to successfully integrate the late stage assets, we acquired from Cavite if they appear.

In 2020 into our internal clinical development programs.

Lars Fruergaard Jorgensen: For commercial execution, we have progressed on all three strategic aspirations; specifically, for obesity care, the initial U.S. demand for Vigovi has significantly exceeded our expectations and underscored the high unmet need for people living with obesity. Camilla and Doug will elaborate further on obesity and provide details on our other therapeutic areas later. Lastly, leaving the financials to Karsten, we are pleased with a sales growth of 13% and operating profit growth of 12% in the first nine months of 2021, both measured at constant exchange rates. With that, I'll give the word to Camilla for an update on commercial execution. Thank you, Lars, and please turn to slide five. In the first nine months of 2021, our

For commercial execution, we have progressed on all three strategic aspirations, specifically for obesity care. The initial U S demand for V. Go has significantly exceeded our expectations and underscore the high unmet need for people living with obesity.

Camilla and Doug will elaborate further on obesity and provide details on our other therapeutic areas later.

Lastly, leaving financials to caution we are pleased with the sales growth of 13% and operating profit growth of 12% in the first nine months of 'twenty to 'twenty one both measured in constant exchange rates with that I'll give the word to Camilla for an update on commercial execution.

Thank you Lasse and please turn to slide five.

In the first nine months of 2021 our total sales increased by 13%.

The sales increase was driven by both operating units with international operations growing 13% and North America operations also growing by 13%.

Yeah. If you Wanna say has increased 30% driven by North America, growing 24% and international operations growing 47%.

Unknown Speaker: Our total sales increased by 13%.

Insulin sales increased by 2% driven by 6% growth in international operations, partially offset by an 8% sales decline in North America operations.

Unknown Speaker: The sales increase was driven by both operating units, with international operations growing 13%.

The U S.

Unknown Speaker: growing 13% and North America operations also growing by 13%. GLP-1 sales increased 30%, driven by North America growing 24% and international operations growing 47%.

Client by 9% driven by a decline in volume and realized prices, the latter driven by channel and payer mix as well as rebate enhancements.

Well PC cafes grew 49% overall in international operations to extend our sales grew 51% and in North America operations obesity care sales grew 48%.

Unknown Speaker: Insulin sales increased by 2%, 3%, and by 6% due to growth in international operations, partially offset by an 8% sale.

In the U S obesity care sales grew 49% driven by both <unk> and <unk>.

Biopharm sales increased by 4% driven by North America operations, growing 6% and international operations growing by 3%.

Unknown Speaker: University. Thank you. Thank you.

Please turn to slide six.

In line with our strategic aspiration of reaching reaching one third of the diabetes value market by 2025, our sales growth of 13% is faster than the overall diabetes market.

Unknown Speaker: U.S. insulin sales declined by 9 percent, driven by a decline in

Unknown Speaker: [inaudible]

Unknown Speaker: as well as rebate enhancements.

Unknown Speaker: Obesity care sales grew 49% overall. In international operations, Accenture sales grew 51%. And in North America operations, obesity care sales grew 48% in the U.S.

We have improved our market share by <unk> seven percentage points to 29.9%. This increase reflects GMT, one growth of 30% and market share gains in both operating units.

Currently it with Sandvik has been lowest in 67 countries and with else's in 23 countries.

Please turn to slide seven.

Unknown Speaker: University Care Sales Group 49%, driven by BOSAC Center and WeGoVision. Biofarm sales increased by 4%, driven by North America operations growing 6%, and international operations growing by...

In international operations diabetes cafes increased by 14% in the first nine months of 2021 driven by all golf courses and therapy areas.

Q1 sales increased by 47% in the first nine months of 2021.

Novo Nordisk remains the market leader in international operations with a T. S. P. One market share of 57, 5%.

Afflicting, an increase of 4.7 percentage points compared to one year ago.

Unknown Speaker: Please turn to slide 6. In line with our strategic aspiration of reaching one-third of the diabetes value market by 2025, our sales growth of 13% is faster than the overall diabetes market.

This is driven by share gains across geographies and overall tier two once you have growth in international operations of 73, 6%.

Please turn to the next slide.

Biopharm sales grew by 4% in the first nine months of 2021.

This was driven by 6% sales growth in North America operations, and 3% sales growth in international operations.

Unknown Speaker: , Peter Welford, Simon Baker, Emmanuel Papadakis, Eric Berrigaud, Benjamin Yeoh, Rajesh Kumar, Harry Sephton, Lars Jorgensen, Michael Novod, Thomas Bowers, Harry Sephton, Lars Joergensen, Martin Lange, Douglas Langa, Daniel Bohsen, Matthew Weston, Martin Haggad, Daniel Bohsen, Andres Jensen, Douglas Langa, Andres Jensen, Daniel Bohsen, Andreas Hugglund, Andreas Hugglund, Currently USEMPIC has been launched in 67 countries and REBELSUS in 23 countries.

Web blood disorders grew by 7% driven by uptake of our launch products <unk> fixture as well as number seven and number eight specifically in VA products grew by 23% hemophilia B sales by 26% and it was 75, 2%.

Endocrine disorder stays with flat unchanged sales reflect international operations, increasing five 6% offset by North America operations decreasing by 10%.

And now to docs on update on U S. P. One and obesity care. Thank you Camilla Please turn to the next slide.

The U S. G O P. One volume markets market growth is around 30% comparing Q3 of 2021 to Q3 of 2020, driven by once weekly injectable GOP ones as well as for Bell says Novo Nordisk new to brand market share leadership is now 63, 7% driven by continued uptake of <unk>.

Unknown Speaker: Please turn to slide 7. In international operations, diabetes care sales increased by 14% in the first nine months of 2021, driven by all geographies and therapy areas. GLP-1 sales increased by 47% in the first nine months of 2021. Novo Nordisk remains the market leader in international operations with a GLP-1 market share of 57.5%, reflecting an increase of 4.9%.

And rebel Sis. Additionally, xanthic remains the N b Rx market share leader within the injectable GOP ones and measured on total scripts nobody noticed remains the market leader with more than 50% market share. Please turn to the next slide.

In the U S rebel.

<unk> total prescription trajectory continues to steadily increase now above 40000 prescriptions per week.

Since mid May our sales force has been fully back out in the field and rebel CIS was the second largest contributor to growth for Novo Nordisk in the first nine months of 2021 and.

Unknown Speaker: 0.7 percentage points compared to one year ago. This is driven by share gains across geographies and an overall GLP-1 share of growth in international operations of 73.6%.

And if you look at the U S. Specifically rebelliousness accounted for 36% of the growth in the first nine months of 2021.

Furthermore, leading indicators such as prescriber breadth HCP awareness and sourcing from outside the GOP one class remain encouraging.

Importantly, we are confident in the product and its long term potential.

Unknown Speaker: Please turn to the next slide.

Don't forget that the partner within the pioneer program rebel CIS demonstrated itself as the most efficacious OID on the market as measured on a one C N weight.

Unknown Speaker: Biofarm sales grew by 4% in the first nine months of 2021.

Unknown Speaker: This was driven by 6% sales growth in North America operations and 3% sales growth in international operations.

Now outside the U S. Rebel says now has been launched in 22 countries with one key market being Japan, where <unk> has reached a 0.9% modern OAD value market share.

Unknown Speaker: Where blood disorders grew by 7% driven by the uptake of our launch products Espiroc

While underlying parameters are on track it should still be noted that Japan was in a third COVID-19, lockdown until the end of September which has made it difficult for patients and sales forces or like to reach doctors.

Unknown Speaker: and Refixia, as well as Novo 7 and Novo 8. Specifically, Hemophilia A products grew by 23%, Hemophilia B sales by 26%, and Novo 7 by 9%.

Please go to the next slide.

Unknown Speaker: 1, 3, 2, 5, 5, 6, 7, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 40, 41, 42, 44, 44, 45, 46, 47, 48, 48, 49, 50, 50, 51, 52, 53, 54, 55, 56, 57, 56, 57, 56, 57, 58, 59, 57, 59, 60, 60, 67, 60.

Globally obesity care sales increased by 49% with 48% growth in North American operations, and 51% and international operations.

As long as I mentioned earlier the U S launch it goes he has significantly exceeded our expectations expectations.

Underlying the high unmet need for people with obesity.

This has put the supply chain under pressure and patients may temporarily experienced a delay in getting prescriptions filled throughout 2021.

We continue gradual increase in supply and.

And expect to be able to meet demand in early 2022 of course, depending upon demand.

The initial feedback from patients and prescribers continues to be encouraging.

19 weeks after launch will go he has already surpassed extend the weekly script levels, reaching around 17000 scripts per week.

More than 70% of it will go with your prescriptions are new to the anti obesity medication class.

Thereby will go these expanding the branded anti obesity market.

Market access has progressed since launch and three national payers have now unblocked will go V from the National formulary.

We are excited to share the commercial formulary access is now around 60% for will go V compared to around 80% for sex Center.

Outside the U S will go with you has been submitted for regulatory review in Japan, and we expect a decision from EU authorities before year's end.

Unknown Speaker: Where endocrine disorder sales were flat, the unchanged sales reflect international operations increasing by 6%, offset by North American operations decreasing by 10%.

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

Your dog.

Aligned with our corporate strategy to strengthen treatment options into pieces here.

Unknown Speaker: Presenter Transcription by Transcription Outsourcing, LLC. Realtor, LLC. www.realtor.com.

And addressing an identified unmet need we have initiated the first of free trials and the global phase three a oasis program, which has been to enroll approximately 1000 patients into.

The 68 week Oasis, one trial will investigate the efficacy and safety of once daily automatically slide 50, milligram and 660 people with obesity or overweight together with cobalt businesses.

Our expectation is to.

To achieve an efficacy and safety profile similar to that of we go.

Doug Langa: Please turn to the next slide. The US GLP-1 volume market growth is around 30%, comparing Q3 of 2021 to Q3 of 2020, driven by once-weekly injectable GLP-1s, as well as for Bell. Novo Nordisk, new to brand, market share leadership is now 63.7%, driven by continued uptake of Ozempic and Rebels. Additionally, Ozempic remains the MBRX market share leader within the injectable GLP-1s. And, measured on total scripts, Novo Nordisk remains the market leader with more than 50% market share. Please turn to the next slide.

Within other serious chronic diseases with rigor and important step to establish standalone presence within cardiovascular disease.

Specifically within atherosclerotic cardiovascular disease, or CVD are significant residual unmet need remains despite the availability for many treatments.

Therefore in September 21, we initiated the phase III cardiovascular outcomes trial called shoes.

With the CBD is it that we have named <unk>, which we acquired from <unk>.

Back in 2020.

We've since debate is a monoclonal antibody directed against IL six.

And as into address the residual inflammation in patients with <unk> as well as chronic kidney kidney disease.

The trial will assess the efficacy and safety of subcutaneous sits vacant with 15 milligram in around 6200 patients with established <unk> chronic kidney disease and systemic inflammation.

Doug Langa: In the U.S., Rebelsis' total prescription trajectory continues to steadily increase, now above 40,000 prescriptions per week. Since mid-May, our sales force has been fully back out in the field, and Rebelsys was the second largest contributor to growth for Novo Nordisk in the first nine months of 2021. And if you look at the U.S. specifically, Rebelsys accounted for 36% of the growth in the first nine months of 2021.

This will be an event driven trial, which is expected to complete in 2025.

As we've previously discussed and there's lots of old so alluded to with the initiation of these two phase III programs in the third quarter.

We now have ongoing phase III clinical programs within all of our therapy areas. This judge to the next slide.

Now turning to the high level R&D milestones, we start with the third quarter of 'twenty one.

Within diabetes, we completed a phase one trial with glucose sensitive insulin called and then one eight volt five.

In the trial as it appear to have a safe and well tolerated profile.

And demonstrated proof of principle of glucose sensitive provinces.

We're currently evaluating further development of glucose sensitive insulin is to optimize the pharmacokinetic properties of this asset.

Doug Langa: Furthermore, leading indicators such as prescriber breath, HCP awareness, and sourcing from outside the GLP-1 class remain encouraging. Importantly, we are confident in the product and its long-term potential. Don't forget that within the Pioneer Program, Robelsis demonstrated itself as the most efficacious OAD on the market as measured by A1C and Moy. Now outside of the US, Rebelsys has been launched in 22 countries, with one key market being Japan, where it has reached a 0.9% modern OAD value market share.

It goes without saying that this is an area that requires multiple shots on goal and we are actively exploring these in our research area.

Yeah.

Within other serious chronic diseases as we've just discussed.

We initiated phase III cardiovascular outcome trial for seem to bake them in.

Within this we completed a phase II trial in Q3 investigating the efficacy and safety of the American to a two four milligram in people with Nash if full cirrhosis.

While the trial demonstrated significant and clinically relevant reduction in the level of their choices. It did not meant to demonstrate an effect of some magnitude and the primary endpoint of fibrosis in this population.

She magnetite appear to have a safe and well tolerated profile.

Doug Langa: While the underlying parameters are on track, it should still be noted that Japan was in a third COVID-19 lockdown until the end of September, which made it difficult for patients and sales forces alike to reach doctors. Please go to the next slide.

The consequence of these results we've decided the tomato side will be further develop for if possible assist patients as part of combination therapy.

To this effect two combination trials have been initiated with within Nash if so why.

As previously mentioned in collaborations with Gilead and one in combination with our internal lasers.

It's important to mention that and as previously discussed in Q2.

Doug Langa: Globally, obesity care sales increased by 49%, with 48% growth in North American operations and 51% in international operations. As Lars mentioned earlier, the U.S. launch of Ogovi has significantly exceeded our expectations, highlighting the high unmet needs for people with obesity. This has put the supply chain under pressure, and patients may temporarily experience a delay in getting prescriptions filled throughout 2021.

Meg retired in monotherapy appears to be a very effective and potentially interest in treatment for patients with Nash if to win a free.

And this is currently being investigated in phase III under an FDA breakthrough designation.

Towards the turn of the year, we expect an opinion from the EU on Tomatoes at two four milligrams in obesity and <unk>.

Simply to ensure milligram in diabetes.

Within Biopharm, we expect results from the phase III program for somewhat hesitant in children.

As well as results from cohorts of the ongoing combined phase one two trials with <unk>.

As planned we will initiate baseline even for the phase III program.

With my made in Q4 and at risk while still awaiting the full results from the phase one two trial.

Doug Langa: We continue to gradually increase supply and expect to be able to meet demand in early 2022, of course, depending upon demand. The initial feedback from patients and prescribers continues to be encouraging. 19 weeks after launch, Wlgovy has already surpassed 670 weekly script levels, reaching around 17,000 scripts per week.

It aligns with the innovative and fast as well as ambitious clinical development program that we have previously talked about it for me.

In the first half of 'twenty, two we expect phase III results for Insulet I could dig in diabetes.

As well as will confuse them up.

The full results for my made in Biopharma, where.

I also expect to see the initiation of the phase III program, Okay, because it may not be.

But with you guys.

Thank you Martin please turn to slide 14.

Doug Langa: More than 70% of Wlgovie prescriptions are new to the anti-obesity medication class. Therefore, Wegovy is expanding the branded anti-obesity market. Market access has progressed since launch, and three national payers have now unblocked Wlodkowicz from their national formularies. We are excited to share that commercial formulary access is now around 60% for Wlgovy compared to around 80% for Sexenda. Outside the US, WGOVI has been submitted for regulatory review in Japan, and we expect a decision from EU authorities before year's end.

In the first nine months of 20th century, one sales grew by 8% in Danish kroner and by 13% at constant exchange rates.

The gross margin declined to 83.0% compared to 83, 8% in 2020, the decline reflects a negative currency impact of <unk> five percentage points lower realized prices in the U S and amortization of intangible assets related to the acquisition of atmospheric technologies in 2020.

These are countered by a positive product mix driven by increased year, one sales and productivity improvements.

In line with the strategy.

In line with our strategic aspiration of driving operational efficiencies.

Sales and distribution costs increased by 10% in Danish kroner, and 14% at constant exchange rates.

Martin Holst Lange: Now over to you, Martin, for an update on R&D. Thank you, Doc. Aligning with our corporate strategy to strengthen treatment options and address an identified unmet need, we have initiated the first of three trials in the Global Phase III-A OASIS program, which is planned to enroll approximately 1,000 patients. The 68-week OASIS-1 trial will investigate the efficacy and safety of once-daily, all-tamaglutide 50mg in 660 people with obesity or overweight together with co-pombition.

The increase was driven by investments in our key strategic projects, most notably launch activities and promotional spent on fault rebelliousness Anderson.

As well as market development activities for obesity and investments in the U S launch of <unk>.

Goby.

Research and development costs increased by 11% in Danish krone, and 13% at constant exchange rates. The increase is driven by pipeline expansion and diversification, including progression of the pipeline within cardiovascular disease and Nash.

Administration costs increased by 4% in Danish kroner, and 6% at constant exchange rates.

<unk> low spent in the first nine months of 2020 due to COVID-19.

Martin Holst Lange: Our expectation is...to achieve an efficacy and safety profile similar to that of Wigo, within other serious chronic diseases; we're taking an important step to establish a standard loan presence within cardiovascular, specifically within atherosclerotic cardiovascular disease or AACVD. A significant residual unmet need remains, despite the availability of many treatments. Therefore, in September 21, we initiated the phase 3 cardiovascular outcomes trial called SUCE with the CVD asset that we have named Celso Vergemap, which we acquired from Convidia back in 2020.

Operating profit increased by 5% in Danish kroner and by 12% at constant exchange rates. It was positively impacted by the amortization of the prior to review voucher for Veeco V. In the U S. In the third quarter of 2020.

The negative currency impact on operating profit is partly offset by around 1 billion Danish krone and hedging gains on our net financial items. This compares to a loss of around one 8 billion Danish kroner in the first nine months of 2020.

The gains on hits conscious primarily relate to the U S dollar.

Net profit increased by 12% and diluted earnings per share increased by 14% to 15 Corona and 98.

Free cash flow was $52 3 billion Danish kroner compared to $41 6 billion Danish kroner in 2020.

The increase reflects the higher net profit timing of rebates in the U S and favorable impact from changes in working capital.

Martin Holst Lange: In brief, Shiltevegemab is a monoclonal antibody directed against IL-6 and is aimed to address the residual inflammation in patients with ASCVD as well as chronic kidney disease. The trial will assess the efficacy and safety of subcutaneous sylcevicumab 15 mg in around 6,200 patients with established ASCVD, chronic kidney disease, and systemic inflammation.

Further it is positively impacted by lower intangible investments.

Related to the ecosystem of Covid, yet therapeutics impact in 2020.

Next slide please.

We now expect 'twenty to 'twenty, one sales growth to be between 12 and 15% at constant exchange rates the.

The raised guidance is based on the performance in the first nine months of the year and reflects expectations for continued sales growth in both international operations and North America operations.

Martin Holst Lange: This will be an event-driven trial that is expected to complete in 2025. As we previously discussed, and as Lars also alluded to, with the initiation of these two phase three programs in the third quarter, we now have ongoing phase 3A clinical programs within all of our therapy areas. Please turn to the next slide.

The updated outlook reflects reflects higher than expected.

Market share gains just one market growth and obesity care sales.

All mainly in the U S.

It also reflects intensifying competition within both diabetes care and biopharm.

Finally continued pricing pressure within diabetes care, especially in the U S is expected to negatively impact sales development.

Martin Holst Lange: Now turning to the high-level R&D milestones, we start with the third quarter of 2021. With End Diabetes, we completed a phase 1 trial with a glucose-sensitive insulin called NN1845. In the trial, the asset appeared to have a safe and well-tolerated profile, and it demonstrated Proof of Principle of Glucose Sensitive Problems. We are currently evaluating further development of glucose-sensitive insulins to optimize the pharmacokinetic properties of this anti-inflammatory. It goes without saying that this is an area that requires multiple shots on goal, and we are actively exploring this in our research area.

Operating profit is now expected to grow between 12, and 15%, reflecting the sales growth outlook and continued investments in current and future growth drivers.

This includes the continued rollout of simply can't repurchase there'll also be Kobe and associated market development activities.

Furthermore.

Additional resources being allocated to both early and late stage R&D pipeline activities.

Given the current exchange rates, most notably a strengthening of the U S. Dollar, we expect 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 <unk>.

Three and four percentage points lower than at constant exchange rates respectively.

For transfer switch one financial items I know now expect it to be a gain of around <unk> 3 billion Danish krone, mainly reflecting gains associated with foreign exchange hedging contracts.

Martin Holst Lange: Within other serious chronic diseases, as we've just discussed, we initiated phase 3 cardiovascular outcome trials for the CLT-V. With NASH, we completed a phase 2 trial in Q3, investigating the efficacy and safety of semaglutide 2.4 mg in people with NASH F4 serose. While the trial demonstrated significant and clinically relevant reductions in the level of steatosis, it did not manage to demonstrate an effect of semaglutide on the primary endpoint of fibrosis in this population.

Capital expenditures are now expected to be around 7 billion kroner and try and stretch one.

Lastly, free cash flow has increased by 5% in Kona and now expected to be between <unk>.

44, and 49 billion Danish kroner. This reflect the favorable impact from higher sales and net profit expectations timing of rebates in the U S and lower capital expenditure.

Based on the increased expectations for cash flow generation in 'twenty. One the board of directors has approved an expansion of the 2021 share repurchase program by 2 billion Danish kroner to 20 billion Danish kroner.

That concludes the outlook for two inch one now back to you lost for final remarks.

Thank you Carsten, please turn to the final slide.

We are very pleased with the sales growth in the first nine months of 'twenty or 'twenty one.

Martin Holst Lange: The Magnetite appears to be safe and well-tolerated. As a consequence of these results, we have decided that semaglutide will be further developed for F4 cirrhosis patients as part of combination therapy. To this effect, two combination trials have been initiated within NASH F4.

Sales growth was driven by all.

They are a critical areas within international operations as well as North America operations, then by all therapy areas in particular, the sales growth was driven by an accelerated growth of our portfolio of tier one treatments for diabetes and obesity care.

The strong financial performance in the first nine months of 'twenty or 'twenty, one has enabled us to raise our outlook for the full year.

Martin Holst Lange: One, as previously mentioned, in collaboration with Gilead and one in combination with our internal layers. It's important to mention, and as previously discussed in Q2, A semaglutide monotherapy appears to be a very effective and potentially interesting treatment for patients with NASH F2 and F3, and this is currently being investigated in phase 3 under an FDA breakthrough decision. Towards the turn of the year, we expect an opinion from the EU on Tamagotchi 2.4mg for obesity and Osempic 2.0mg for diabetes.

From an R&D perspective, the two phase III program initiations within obesity and all this years Qantas uses highlights that we continue to expand our light late stage clinical pipeline.

We are now ready for the Q&A.

I ask all participants to limit her or himself to one or maximum two questions. Operator, we're now ready to take the first set of questions. Please.

Thank you.

We wish to ask a question. Please press <unk> one on your telephone keypad. If you wish to mature. Your question you May do so my question is zero.

Our first question is from Lasalle Carpathia.

Martin Holst Lange: Within BioPharm, we expect results from the Phase 3 program for some of the patients and children, as well as results from cohorts of the ongoing combined Phase 1-2 trial with Vimy. As planned, we will initiate baselining for the Phase 3 program with MiMed in Q4 and at risk, while still awaiting the full results from the Phase 1 test. This aligns with the innovative and fast, as well as ambitious, clinical development program that we have previously talked about for MyMate.

<unk>.

Great. Thank you very much for taking my questions are will mark a body of phone from Bernstein.

Can I just wanted to ask a little bit more about 'twenty, one guidance and the implications heading into 'twenty. Two so the top end of the sales range for 'twenty. One suggests the potential <unk> sales growth of over 20%. So can you just got the dynamics.

Could potentially get us to that level of sales growth in the quarter and then tied to that what are the implications for this level of growth heading into 'twenty two outside of the $3 40 benefit which annualized is possibly BBT are there any other reasons why underlying growth should not be stronger next year, given there will be supply constraints will be resolved.

Martin Holst Lange: In the first half of 2022, we expect Phase 3A results for Insulin Icodec and Diphenyl, as well as for ConsensusMap and the full resource for MyMateEnvironment. We also expect to see the initiation of the Phase III program for Capri-Seminole. With that, over to you, Karsten.

You bet.

Yeah.

Thank you.

Constant while not guiding for 'twenty two yet can you talk a bit to lending this year and some of the building blocks for how to look at growth for next year.

Yeah, absolutely yeah. Thank you my mouth.

And that set of questions. So firstly looking at the French one.

As you saw then we delivered 13%.

Sales growth in the first nine months and mathematically of course, it's hard to move the needle with the only one quarter to go so so as a starting point to I think you should ask yourself in the 13% and then look at the run rate we delivered in the third quarter benefiting from the <unk> one exploration well.

S S UPC performance, so so for 'twenty one.

Karsten Munk Knudsen: Thank you, Martin. Please turn to slide 14. In the first nine months of 2021, sales grew by 8% in Danish kroner and by 13% at council exchange rates. However, the gross margin declined to 83.0% compared to 83.8% in 2020. The decline reflects a negative currency impact of 0.5 percentage points, lower realized prices in the US, and amortization of intangible assets related to the acquisition of image sphere technologies in 2020. These are offset by a positive product mix driven by increased GLP-1 sales and productivity improvement, in line with the strategic aspiration of driving operational efficiencies.

I think the starting point is more around the midpoint of our guidance range are being.

Being around 13, 5%.

Reason why would choose to go with the with a slightly.

Broader than the normal guidance range is basically it's the volatility we've seen in our business over the past few years.

Well.

Also the volatility linked to it I think to the UPC business. So so that's basically the reason for the guidance range, but the starting point would be the midpoint of the range.

Then moving into into 2022 then.

From from a strategic point of view we have.

Pursuing.

Growth focused strategy and and when you look at the growth rate for for Nynorsk as a company. We're clearly outpacing the industry you know potentially close to to double up in terms of top line growth compared to the industry at large so so clearly growth is a top priority.

Karsten Munk Knudsen: Sales and distribution costs increased by 10% in Danish kroner and 14% at constant exchange rates. The increase is driven by investments in our key strategic priorities, most notably launch activities and promotional spend for Rebelsis and Osympic, as well as market development activities for Beastly and investments in the U.S. launch of Vigovy. Research and development costs increased by 11% in Danish kroner and 13% at concert exchange rates. The increase is driven by pipeline expansion and diversification, including progression of the pipeline within cardiovascular disease and NASH.

For us as a company.

Try to stretch one was an exceptional year.

For us in terms of growth rates everything is pretty much gone well. So so so really you know a highly successful year to start on and we do continue to pursue growth into 'twenty two at a very attractive level driven by our tier one business as well as all Vista franchise.

In terms of puts and takes I would caution you are in terms of off a couple of specific aspects.

First of all.

We are currently you know getting closer to to a conclusion on the volume based procurement a tender situation in China, we have not yet received the final bidding documents, but we expect to Rajiv.

Shortly and.

And with insulin in China constituting to the tune of 9% of group sales.

Karsten Munk Knudsen: Administration costs increased by 4% in Danish kroner and 6% at constant exchange rates, impacted by a low spend in the first nine months of 2020 due to COVID-19. Operating profit increased by 5% in Danish kroner and by 12% at currency exchange rates. It was positively impacted by the amortization of the priority review voucher for Vigovi in the US in the third quarter of 2020. The negative currency impact on operating profit is partly offset by around 1 billion Danish Kroner in hedging gains under net financial items. This compares to a loss of around 1.8 billion Danish Kroner in the first nine months of 2020. The gains on hedged currencies primarily relate to the US dollar.

Then this tender situations, we do expect to have a significant negative impact on the on our group sales in 2022 is one piece secondly, what we do benefit from in 'twenty one is the.

The 340 P distribution policy change.

In the U S markets.

Where we basically restricted the distributions under the 340 B program to covered entities that we are getting a benefit.

And as we've said in prior quarters and there are no changes to that this quarter than the than we're getting a benefit it's less than 3% of your sales, but I'm just reminding you that even 3% of yourselves as one 5% of group sales. So so with that in the pace, we would not get that growth.

Benefit in 2022.

And then finally.

What we're benefiting from now is also an exploration in the tier one market in diabetes in the U S. But also outside the U S. We've seen in Q3 as you heard to the tune of 30% volume market growth.

In the <unk>, one segment that exploration and looking at some of the more weekly trends, we do expect that exploration to slow down and getting back to a more normalized.

Karsten Munk Knudsen: Net profit increased by 12%, and diluted earnings per share increased by 14% to DKK 15.98. Free cash flow was DKK 52.3 billion Danish kroner compared to DKK 41.6 billion Danish kroner in 2020. The increase reflects higher net profits, timing of rebates in the U.S., and a favorable impact from changes in working capital. Additionally, it is positively impacted by lower international investments as related to the acquisition of Covidia Therapeutics Impact in 2020. Next slide, please.

Growth level in the <unk>, one market when we get into 2022.

So you'd have to adjust for those factors, but there, but needless to say, we do continue to push for FY <unk> growth for our shareholders.

Thank you Carsten.

Okay Awesome. Thank you Remo strong a strong growth for a couple of factors to affect traffic in for the short term.

Next set of questions. Please.

Thank you. Our next question is from Pizza hut.

Citigroup. Please go ahead your line is open.

Thank you Pete <unk> Citi two questions. Firstly, just camilo, Doug I appreciate the update and comments on reimbursement access just one clarification patients should we still be thinking that when it comes to we go the prescriptions 50% are reimbursed.

Karsten Munk Knudsen: We now expect 2021 sales growth to be between 12 and 15% at consular exchange rates. The raised guidance is based on the performance seen in the first nine months of the year and reflects expectations for continued sales growth in both international operations and North America operations. The updated outlook reflects higher-than-expected Pacific market share gains, GFP1 market growth, and obesity care sales, all mainly in the U.S. It also reflects intensifying competition within both diabetes care and biopharm. Finally, continued pricing pressure within diabetes care, especially in the US, is expected to negatively impact sales development.

Versus a 50% or effectively giving away that's Paul Novo assistance programs. We wanted to make sure that has the right way of thinking about it going forward.

And then secondly.

For laws and Carsten.

Just any comments you're willing to give realizing that things are subject to change, but on the drug pricing amendments announced overnight in the U S.

Got it.

The donut hole discounts removed that looks like a big win for Novo.

But more problematic long term would be mandatory price cuts for some put somebody beside before VIP expires. So realize nothing's set in stone I realize you're not going to speculate.

I don't think you'll be remiss of me not to ask you for some initial thoughts on those developments.

Yeah.

Thanks, Peter for all for those questions.

Talk initially on say the book of business.

Karsten Munk Knudsen: Operating profit is now expected to grow between 12% and 15%, reflecting the sales growth outlook and continued investments in current and future growth drivers. This includes the continued rollout of Fosempic and Repelsis, the launch of Vigovi, and associated market development activities. Furthermore, additional resources are being allocated to both early and late stage R&D pipeline activities.

And in the U S on recovery and then I'll cover the drug price reform afterwards.

Yeah. Thanks, Peter for the question. So overall progress has been made and we're happy with the progress with the overall commercial formulary access for will go the.

And broadly speaking, we're looking at 40 to 60, 40% cover 60% not covered.

Good and.

You alluded a bit to Peter yourself that it's difficult to speculate about the U S health care reform, just noting over the past couple of weeks I think retro because has been going for some back. So we would like to have say the final text before we start assessing the impact on us.

Karsten Munk Knudsen: 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 three and four percentage points lower than at cost exchange rates, respectively. For 2021, financial items are now expected to be a gain of around 0.3 billion Danish kroner, mainly reflecting gains associated with foreign exchange hedging contracts.

Having said that though we strongly welcome anything that help.

The patient out of pocket situation, because the complexity of the system ends up with a lot of patients struggling as you should know.

Couple of years back put some affordability programs in play too.

It takes some of that pain away and there was also a cost to that so anything that can.

Smoothing out the system.

Patients better it's absolutely good for the patient, but I think it's also going to be good for our business, but we need to see the final six before we come to that so hopefully when we talk a quarter from now there's more clarity on that.

Karsten Munk Knudsen: Capital expenditure is now expected to be around 7 billion Danish Kroner in 2021. Lastly, free cash flow has been increased by 5 billion Danish Kroner and is now expected to be between 44 and 49 billion Danish Kroner. This reflects a favorable impact from higher sales and net profit expectations, timing of US rebates in the US, and lower capital expenditure. Based on the increased expectations for cash flow generation in 2021, the Board of Directors has approved an expansion of the 2021 share repurchase program by 2 billion Danish kroner to 20 billion Danish kroner. That concludes the Outlook for 2021. Now, back to you Lars, for final remarks. Thank you, Karsten. Please turn to the final slide.

Thank you Peter next set of questions. Please.

Our next question is from Simon Baker of Redburn. Please go ahead. Your line is open.

Thanks for taking my questions two for me please.

Asleep on Biopharma.

The quarter did look a little weaker.

Than consensus was expecting.

Did allude to Chinese destocking.

Packaging hemophilia I just wanted to draw any of that fact.

The factors you would highlight maybe given the exposure to the 10 day marketing biopharm any any timing tend to supply different to what you're expecting.

And then secondly on Capex.

Trend.

Capex guidance for 'twenty, one and I just wonder if you could give us any color on that and any implications for the capex outlook going forward into 'twenty, two and beyond so much.

Thank you Simon so two questions for your costs and firstly on the Biopharma performance in the third quarter.

Lars Fruergaard Jorgensen: We are very pleased with the sales growth in the first nine months of 2021. Sales growth was driven by all geographical areas within its national operations, as well as North America operations, and by all therapy areas. In particular, the sales growth was driven by an accelerated growth of our portfolio of GLP-1 treatments for diabetes and obesity care. The strong financial performance in the first nine months of 2021 has enabled us to raise our outlook for the full year.

And that's lower than what we saw in the beginning of the year and then Capex also a bit lower compared to what we've seen before.

Any perspectives on that.

Yeah.

Thank you Simon for a set.

Set of questions.

And starting out with the Biopharma I'd, just like to remind you that the that the biopharma business is a more volatile business than the rest of our businesses in diabetes. So so kind of interrupting on the course is dangerous.

On Biopharm, so you should more be looking at five five on a year to date basis growing some 4%, which we are which we are actually very very satisfied with.

To give you a little bit of flavor on the.

Lars Fruergaard Jorgensen: From an R&D perspective, the two phase three program initiations within obesity and other serious chronic diseases highlight that we continue to expand our late stage clinical pipeline. With that, we are now ready for the Q&A, where I kindly ask all participants to limit themselves to one or, at most, two questions. Operator, we are now ready to take the first set of questions.

On the quarter I'd say, we did have some some changes in shipment timing on the hemophilia Society.

In this collaboration to impacting the quarter and in the U S. We did have some.

The minor adjustments to rebate and this estimate say that impacted our growth hormone franchise. So so again, the more kind of informative measure would be a year to date performance, which we're very satisfied with.

Operator: Thank you. If you do wish to ask a question, please press 01 on your telephone keypad. If you wish to withdraw your question, you may do so by pressing 02 to cancel. Our first question is from Romuald Capadia of Bernstein.

As to Capex.

It's a slight fine tuning that's nothing substantive.

Around it.

The adjustment is basically linked to link to facing off of the execution of our cash burn on our ongoing Capex program. Sir there are no no delays or anything in our programs, it's purely I would say it.

Romuald Capadia: Well, great. Thank you very much for taking my questions, Wilmar Kapadia from Bernstein. So, can I just first ask a little bit more about 21 guidance and the implications heading into 22? So, the top end of the sales range for 21 suggests potential 4Q sales growth of over 20%. So, can you just first discuss the dynamics that could potentially get us to that level of sales growth in the quarter? And then, tied to that, what are the implications of this level of growth heading into 22?

Timing on on on cash flow nothing more than that.

Alright, thanks, Thank you Cosmos.

And on Capex.

It is clear that with the momentum you see right now we are probably going to spend more money compared to less money on capex, because it's really really strong growth.

We need to make sure we have the capacity to support that.

Thank you Simon next question please.

Thank you. Our next question is from Michael <unk> of UBS. Please go ahead. Your line is open.

Thanks, very much it's Michael license from UBS two questions. Please one cost to just going back to the guidance.

Implied opex growth in the fourth quarter.

Is pretty punchy.

Certainly as the year has progressed SKU.

Steve just sort of have walked up the opex saving into the business as the topline outlook has improved as well.

Romuald Capadia: You know, outside of the 340 benefit, which annualizes and possibly VBP, are there any other reasons why underlying growth should not be stronger next year, given the Wigobi supply constraints that will be resolved? And I'll leave it there.

In the fourth quarter.

There was that incremental investment going.

And what implications does that have as a run rate as we think about 2022, if you could.

A question for Doug looking at the value of the volume of threat analysis. It looks like that stepped up I presume that's the copay card rolling off it if that's the case timing is interesting here is for our balances really is the product that that longer term is sort of meant to carry the torch why would you.

Karsten Munk Knudsen: Thank you, Vimal and Karsten. While not guiding for 22 yet, can you talk a bit about landing this year and some of the building blocks for how to look at growth for next year? Yeah, absolutely. Thank you, Emmanuel, for that set of questions.

The co pay program at this point in time, if that's indeed, what is driving the value of the volume. Thank you.

Karsten Munk Knudsen: So first, looking at 2021, as you saw, we delivered 13% sales growth in the first nine months. And mathematically, of course, it's hard to move the needle with only one quarter to go. So as a starting point, I think you should anchor yourself in the 13% and then look at the run rate we delivered in the third quarter benefiting from the business linked to the obesity business. So that's basically the reason for the guidance range. But the starting point would be the midpoint of that range.

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Karsten Munk Knudsen: Then moving into 2022, then from a strategic point of view, we are pursuing a growth-focused strategy, and when you look at the growth rate for Novo Nordisk as a company, we are clearly outpacing the industry, potentially close to double-doing in terms of top-line growth compared to the industry at large. So clearly, growth is a top priority for us as a company. 2021 was an exceptional year for us in terms of growth rates.

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Karsten Munk Knudsen: Everything has pretty much gone well. So, really, you know, a highly successful year to start on. And we do continue to pursue growth into 2022 at a very attractive level, driven by our GP1 business, as well as our obesity franchise. In terms of puts and takes, I would, though, caution you in terms of a couple of specific aspects.

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Karsten Munk Knudsen: First of all, we are currently, you know, getting closer to a conclusion on the volume-based procurement tender situation in China. We have not yet received the final bidding documents, but we expect to receive them shortly. And with the influence in China constituting to the tune of 9 percent of group sales, then this tender situation does expect to have a significant negative impact on our group sales in 2022 as a whole.

Question from Michael <unk> of UBS.

Oh.

So Michael I'm not sure when the technology went down so did you hear Constance answer did you hear talks answer.

No sorry, it cutoffs entirely to fill it up.

Okay. So that's it.

Try again so the first question was on when guidance for Opex growth in fourth quarter.

So cost me if you can talk to that and then secondly talk we'll talk to how receivables was launched and also how we look at co pays et cetera.

Karsten Munk Knudsen: Secondly, what we do benefit from in 2021 is the 340B distribution policy change we did in the U.S. market, where we basically restricted the distribution under the 340B program to covered entities. There, we are getting a benefit.

Absolutely thanks for that.

It's a set of questions and apologize for our technical glitch. So when you look at the Opex into the fourth quarter. It's of course at the same principles. We are applying for a resource allocation and just the main nuts and bolts as basically we continue to invest in R&D.

We're now exceeding 35000 annualized to patients on clinical trials. So so all time high in the in our global development.

Karsten Munk Knudsen: And as we've said in prior quarters, and there are no changes to that this quarter, then we're getting a benefit. It's less than 3% of US sales. But I'm just reminding you that even 3% of US sales is 1.5% of group sales. So with that in the base, we would not get that growth benefit in 2022. And then finally, what we're benefiting from now is also an acceleration in the GH1 market for diabetes in the U.S., but also outside the U.S. We saw this in Q3, as you heard, to the tune of 30 percent volume market growth in the GH1 segment.

So continued increasing investments in R&D, which of course, you should expect into 2022 also and in our in our commercial investments in SMT.

We are continuing to invest in growing and expanding our th one business in diabetes as well as our market development.

As well as we can we'll also have activities in obesity. So at the same principle supplies and and in terms of run rate into the fourth quarter.

I don't see it as too dissimilar from the run rate we've seen thus far this year and then of course, you know you shouldn't it technically do you forecast S. S. I know you know.

Based on one quarter and into next year, but it's the same principle say that we're rolling it into next year, so aggressive growth.

Karsten Munk Knudsen: That acceleration, and looking at some of the more weekly trends, we do expect that acceleration to slow down and get back to a more normalized growth level in the old GH1 market when we get into 2022. So you have to adjust for those factors, but needless to say, we do continue to push for attractive growth for our shareholders. Thank you. Thank you, guys. Thank you, Karsten, and Emmanuel, strong growth for a couple of factors to begin in the short term. Next set of questions, please.

<unk> and commercial and expansion into it.

Our broader and more diverse fab five pipeline and R&D.

Doug on the business performance in the U S.

Again, Michael Thank you again for that question overall, we do consider it is still a very successful launch for rebel Sis overall.

And despite some of the Lockdowns that we've experienced with COVID-19 last year into this year as I had mentioned the field forces back in since mid May.

We still consider it a successful launch are we where we want to be.

Well again based on what I said earlier, we can't forget the through the pioneer program rebel CIS demonstrated itself as the most efficacious OID in the market. So we're still very bullish on the long term aspect of what <unk> can do and we have a lot of leading indicators, which help us be a encouraged with this whether that's again if you look at the growth overall as we said it was the second.

Operator: Thank you. Our next question is from Peter Verdult of Citigroup. Please go ahead. Your line is open.

Peter Verdult: Thank you, people at Old City. Two questions: firstly, just Camilla or Doug, I appreciate the update and comments on reimbursement access. Just one clarification, should we still be thinking that when it comes to Wicovi prescriptions, 50% are reimbursed, and 50% are effectively given away as part of the Novo assistance programs? Wanted to make sure that that's the right way of thinking about it going forward. And then secondly, for Lars and Karsten, just the any comments you're willing to give, realizing that things are subject to change, but on the drug pricing amendments announced overnight in the US, if enacted and the donut hole discount is removed, that looks like a big win for Novo.

Growth driver for the company.

36% of the growth in the U S. We delivered over 180% growth, but more importantly, other leading indicators such as breadth and depth brand awareness brand preference.

We're still seeing over 80% of the business come out of the GOP one category outside of the GOP one category.

Things like we're doing 40000 prescriptions per week and again, we have a significant number of writers over 45000 and so these are all indicators that we're still very bullish on what we can do over the long haul.

Thank you Darko. Thank you Michael mixed set of questions. Please.

Thank you. Our next question is from Emmanuel Papadakis from Deutsche Bank. Please go ahead. Your line is open.

Thank you for taking the question maybe I could just come back on we'll go with the 40 60, it sounds like kits.

I guess, you could say deteriorated if anything he Q2 I think there was more subsidized products out there how is that evolving through Q4 win.

Peter Verdult: But more problematic long-term would be mandatory price cuts for some for somagnoside before the IP expires. So realize nothing is set in stone. I realize you're not gonna speculate, but I think it would be remiss of me not to ask you for some initial thoughts on those developments. Thank you.

Beta stage.

Co pay support is fully rolled off obviously blind funds into Q1.

What kind of impact are you expecting that to have on.

The launch once you normalize the supply situation and then just a question on the commercial access you disclosed that some 60%.

You talked to us a little bit about the levels of utilization management within that or are they similar.

Doug Langa: Thanks, Peter, for those questions. Doug, initially on, say, the book of business in the U.S. for Rigovi, and then I'll cover the drug price reform after that. Yeah, thanks, Peter, for the question. So overall, progress has been made, and we're happy with the progress with the overall commercial formulary access for Wlgovy.

Are you seeing any significant differences in how do you expect those to go into 'twenty two as well. Thank you.

Thank you.

Let me try to address that that would go away.

So so.

Strategic approaches have been too to really mobilize patients to seek care to get physicians to prescribe and obesity medicine and get pay us to to reimburse.

Would go away and.

Lars Fruergaard Jorgensen: And broadly speaking, we're looking at 40 to 60, 40% coverage, 60% not. Good. And you alluded a bit to that, Peter, yourself, that it's difficult to speculate about US healthcare reform. Just noting that over the past couple of weeks, I think, rhetoric has been going forth and back.

You shouldn't.

Get too deep into short term commercial tactics in how we do that and make that a proxy for the future because the fact that we have had this bridging program hasnt did hurt us to mobilize patients and get physicians to prescribe it.

And the clinical profile of <unk> has.

Attracted a lot of attention from the payers. So now we have the three big Pbms supporting it and then you can say as launch progresses, we can gradually start considering a different promotional mix. After six months you can for instance, do DTC in the U S.

Lars Fruergaard Jorgensen: So we would like to have, say, the final text before we start assessing the impact on us. Having said that, though, we strongly welcome anything that helps the patient's out-of-pocket situation because the complexity of the system ends up with a lot of patients struggling. As you know, we put some affordability programs in place a couple of years ago to take some of that pain away. But there was also a cost to that.

You cannot do it beginning in the beginning so there you need to use a copay or the British program to gain patient experience. So so we are quite agile in how we look at this promotional mix.

And short term.

Book of business, whether it's on.

On commercial covered patients.

It's free patients.

Doesn't really matter for us it's about getting this.

Lars Fruergaard Jorgensen: So anything that can smoothen out the system and help patients better is obviously good for the patient. But I think it's also going to be good for our business. But we need to see the final text before we can comment on that. So hopefully, when we talk a quarter from now, there will be more clarity on that. Thank you, Peter. Next set of questions, please.

Margaret and Brian Cowen.

From everything we can see we are succeeding.

In doing that.

So talk.

A few more perspectives on how the commercial access works.

Yeah. So just to answer the very specific question you had it it is very similar to utilization management two shacks enter and importantly, there is no step through so that's important and then overall again as I mentioned earlier, we have 60% overall formulary access and Thats progressing nicely. The team is also doing a really nice job in terms of the opt in.

Operator: Thank you. Our next question is from Simon Baker of Redfern. Please go ahead; your line is open.

Simon Baker: Thanks for taking my questions, two, if I may please.

Component with employers I can't get any specifics there, but again that's progressing nicely remember this is still not considered a standard listed product formulary products. So we have some work to do there, but the team is working hard and as Lars mentioned, we have all three major pbms onboard that's a really good sign and we have partnerships with several of them.

Simon Baker: Two FMAs, please, firstly on biopharma

Simon Baker: The quarter did look a little weird.

Simon Baker: , Peter Welford, Simon Baker, Emmanuel Papadakis, Eric Berrigaud, Emmanuel Papadakis, Mark Purcell

Simon Baker: and then secondly on CAPEX. I see you've just trimmed the Thank you very much. Thank you, Simon. So, two questions to you, Karsten.

Weight management programs, which is also another very good sign so overall I think progress is being made.

Karsten Munk Knudsen: Firstly, on the biofarm performance in the third quarter, a notch lower than what we saw at the beginning of the year. And then Capex is also a bit lower compared to what we've seen before. Any thoughts on that? Yeah, thank you, Simon, for that set of questions.

Thank you Doug. Thank you Manuel next set of questions. Please.

Our next question is from Steve Scala of Cowen. Please go ahead. Your line is open.

Thank you you noted that you expect we go the supply to meet demand in early 2022, what level of demand does this imply based on your expected supply. So for instance is it closer to two times more 10 times more or 25 times more.

Karsten Munk Knudsen: And starting out with the biofarm, I just like to remind you that the biofarm business is a more volatile business than the rest of our businesses in diabetes. So kind of over-interpreting the quarterly results is dangerous for the biofarm business. So you should be more looking at biofarm on a year-to-date basis growing by some 4%, which we're actually very, very satisfied with. As to CAPEX, it's a slight fine-tuning. There's nothing substantive around it. The adjustment is basically linked to the phasing of the execution of our cash burn on our ongoing CAPEX programs.

And then secondly.

Similar question to ones that have already been asked but a little different version what percent of the U S population cannot access full coverage of <unk> today.

And what might that percent b at the beginning of 2022. Thank you.

So thank you Steve so.

We have our own forecast and how we module demand.

If you're not in a position to be able to share that.

Karsten Munk Knudsen: So there are no delays or anything in our programs. It's purely, you could say, exact timing on cash flow, nothing more than that. Great, thanks so much. And on CapEx, it's clear that with the momentum we see right now, we are probably going to spend more money compared to less money on CapEx because it's really, really strong growth. And obviously, we need to make sure we have the capacity to support that. Thank you, Simon. Next set of questions.

But we believe that based on how we understand the market.

<unk> of patients that we can match that demand.

But of course, we have been surprised initially here so.

We do not know much more.

Than you do in terms of what the real demand will be but we feel comfortable that we can we can.

To help the patients in need of <unk> medicine.

And Doug on the second question is in terms of which percentage of the U S population.

Operator: Thank you. Our next question is from Michael Leuchten of UBS. Please go ahead, your line is open.

Rich.

Yeah. Thank you for the questions David.

It's important to note that we still don't have Medicare coverage. So that takes out a significant portion of the population we're working really hard.

Michael Leuchten: Thanks very much. It's Michael Leuchten from UBS. Two questions, please.

Michael Leuchten: and just going back to the guidance.

Michael Leuchten: The implied OPEC growth in the fourth quarter is pretty punchy; certainly, as the year has progressed, you seem to have walked up the OPEC curve.

And we hope to at some point, whether its through the treat and reduce obesity act or at some policy change and other policy change to open up that because as a company, we certainly think that.

Michael Leuchten: [inaudible]

Michael Leuchten: Where's that incremental investment going?

Seniors in the U S should have access to anti obesity medications I mean, that's that's.

Michael Leuchten: And what implications does that have?

Michael Leuchten: have as a run rate as we think about 2022, if you could.

That's clear.

Today again, so if you just take a look at the commercial access and where we are we think around 16 million to $20 million.

Michael Leuchten: I have a question for Doug. Looking at the value of Riddell's volume, it looks like I've stepped up.

Michael Leuchten: I presume that's the co-pay card rolling off. If that's the case... Timing is interesting here. If Rubellsis really is the product that, longer term, is sort of meant to carry the torch, why would you, Holder, use the copay program at this point in time, if that's the case?

People patients living with obesity have access and again, our aim is to get that much more like other products standard listed products. So.

Our aim is to get much higher and that's going to take some work, but today around 16 to 20 million people today. Thank you Doug just perfect timing.

Michael Leuchten: Interesting here, if Ribelis really is the product that, in the longer term, is sort of meant to carry the torch, why would you All the COPE program at this point in time, if that's indeed what is driving the value of the volume. Thank you.

Thank you Steve next set of questions. Please.

Thank you. Our next question is from cost and lumber of Seb. Please go ahead.

Thank you very much.

I have a couple of questions here to Matson I guess.

Yeah Oasis program for SMA.

Operator: Ladies and gentlemen, please hold on, we're experiencing some technical difficulties.

Do you have the three trials in this program in total.

Operator: [inaudible] Theme Music Theme Music Theme Music Theme Music Theme Music [inaudible]...

China faces, one Japanese patients and one with the European and North American placements combined.

Operator: So Michael, I'm not sure when the technology went down. So did you hear Karsten's answer, and did you hear Doug's answer? No, sorry, it cut off entirely. Okay, so let's try again.

Is this a sign that you only need one.

While too to get this product approved in the U S with the.

North American places all can do.

It's something else until all of this.

Karsten Munk Knudsen: So the first question was on guidance for opex growth in the fourth quarter. So, Karsten, if you can talk about that, and then, secondly, Doug will talk about how we see rebels was launched and also how we look at copays. Yeah, absolutely. Thanks, Michael, for that set of questions and apologies for the technical glitch.

And then for semi and also as I know, it's not so long ago. Since you had to initiate the phase III trial, but could you maybe share some of the.

Feedback you have had in terms of appetite to get enrolled on this trial in the Alzheimer's community.

Thanks.

Thank you Carsten <unk> marching firsthand what it is.

Trying to sign a number of trials music et cetera.

Karsten Munk Knudsen: So when you look at OPEX into the fourth quarter, it's, of course, the same principle we're applying for our resource allocation. And just the main nuts and bolts, basically, we continue to invest in R&D. We're now exceeding 35,000 annualized patients in clinical trials, so an all-time high in terms of run rate into the fourth quarter. I don't see it as too dissimilar from the run rate we've seen thus far this year.

So as you mentioned.

On Oasis program in 1000 patients in total, which obviously also indicates that we've agreed with regulatory authorities that we need to bridge.

Just on.

The data that we already have an American side, we are in.

The good position.

We both on subcutaneous on oral and also on the different doses now ozone or have had a lot of data.

We can best to satisfy the regulatory requirements.

On the all comers trial, it's still early days.

Karsten Munk Knudsen: And then, of course, you know, you shouldn't technically do your forecast, as I know you know, based on one quarter into next year. But it's the same principles that we're rolling into next year. So aggressive growth investments in commercial and expansion into a broader and more diversified pipeline in R&D. Thank you, Karsten. Doug, on Rebels' performance in the U.S. Again, Michael, thank you again for your

As you can probably imagine we are.

We are screening a great number of patients, but the screening period in and of itself is three months.

So so so at this point in time, what we see.

Is that the sites that are opening up and running actually screening and recruiting to the level, where we would expect them to be a little bit above.

Thank you marching very encouraging and thank you for those questions next set of questions. Please.

Our next question is from Martin <unk> of Danske Bank. Please go ahead.

Doug Langa: [inaudible]

Doug Langa: , Peter Welford, Simon Baker, Emmanuel Papadakis, Eric Berrigaud, Benjamin Yeoh, Rajesh Kumar, Harry Sephton, Lars Jorgensen, Michael Novod, Thomas Bowers, Harry Sephton, Lars Jorgensen, Martin Lange, Ludovic Helfgott, Rajesh Kumar, Andres Jensen, Matthew Weston, Douglas Langa, So these are all indicators that we're still very bullish on what we can do over the long haul. Thank you, Doug. Thank you, Michael. Next set of questions, please.

I'm also part of Pennsylvania also two questions first a follow up for loss.

Quarter on on virus.

China that you would expect this to be a one time effect with Genesis significant caught too surprising, but how do you.

How do you.

State now that is what would it be a one time effect flex that will go into the right youre, saying, 35% growth in your insulin and long acting insulin franchise in China.

Do you feel comfortable that after a peak price card. Then you then you can continue on this.

Operator: Thank you. Our next question is from Emmanuel Papadakis from Deutsche Bank. Please go ahead. Your line is open.

Journey with Tresiba in China, all isn't the risk that this could be controlled.

Emmanuel Papadakis: Thank you for taking the question. Maybe I could just come back on. We'll go over the 40-60, sounds like it.

The market and then the second question I think it will be for stock.

Just on again on the on the go.

Emmanuel Papadakis: I guess you could say deteriorated of anything Q2, as in there is more subsidized product out there. How is that evolving through Q4 when you expect we'll be at a stage that the code pay support is fully rolled off, that might be via the front end of Q1, and what kind of impact are you expecting that to have on the launch once you have normalized the supply situation? And then just a question on the commercial access you disclosed the first time 60% You talked to us a little bit about the levels of utilisation management within that. Are they similar to the sex vendor? Are you seeing any significant differences, and how do you feel

And in college and stuff like that.

You say, you say, 60% on it for free.

But you also call. It of course, it's called the Brits talk because you were making a breech onto these patients hopefully good coverage.

But I also know that some are able to get.

You know the drug even though that people don't fit into that category, but how many of the 60% will actually have college when the six month period.

Items.

Thank you Martin for those two questions and let me start on China, Obviously, I don't know for sure what will happen to China, because I'm not.

In charge of that but if you look at the whole intention about the V. P that was to bring the pricing of our structure in China down to the international level and a number of product trials.

Emmanuel Papadakis: How do you expect those to evolve into 2022 as well? Thank you.

Lars Fruergaard Jorgensen: Good. Thank you, Emmanuel.

What categories.

So I feel that.

Lars Fruergaard Jorgensen: Let me try to address the WGOI. So our strategic priorities have been to really mobilize patients to seek care, to get physicians to prescribe anti-obesity medicine, and to get payers to reimburse it. And you shouldn't get too deep into short-term commercial tactics in how we do that and make that a proxy for the future. Because the fact that we have had this bridging program has indeed helped us to mobilize patients and get physicians to prescribe it.

It's irrational it Tim.

But the floaters in China to get to the right price level.

And then there is a keen interest in bringing innovation to China.

<unk> accelerated to.

Regulatory revenue et cetera, and of course, if it turns into a very hostile pricing environment I don't think the approaches.

Creating attractive market for innovation. So so at least for now we feel comfortable about that.

And dark once again on <unk>.

Yeah. Thanks, Martin for the question so.

The intent of any of these early initiations are British programs is to build awareness get initiation of use we can.

Lars Fruergaard Jorgensen: And, and the clinical profiler we go with has attracted a lot of attention from the payers, so now we have the three big PBMs supporting it. And then you can say, as the launch progresses, we can gradually start considering a different promotional mix. After six months, you can, for instance, do DTC in the U.S., which you could not do in the beginning. So there you need to use a co-pay or the bridging program to gain patient experience.

Physicians can see the results and again for US. The bridge program was designed to be screened for people that had coverage now again, it's not a perfect system based on the demand. It was probably one of our most successful programs that we've launched.

But.

I don't have we don't have the exact specificity you know how many coming off that program what exactly have coverage, but again. The intent was you start them and then they would have coverage when they come off of it.

Thank you Doug. Thank you Martin next set of questions. Please.

Doug Langa: So we are quite agile in how we look at this promotional mix and short-term book of business; whether it's on commercially covered patients or it's free patients doesn't really matter for us. It's about getting this market and the brand going. And from everything we can see, we are succeeding in doing that. So Doug... A few more perspectives on how commercial access works. Yes, so just to answer the very specific question you had, it is very similar to utilization management in SACSENDA, and importantly, there's no step through.

Thank you. Our next question is from Jo Walton of Credit Suisse. Please go ahead.

Thank you.

Two questions. If we could go back to your confidence in the lack of Oh.

In the fact that the DLP market growth of 30% will ease off next year just wonder why that is is it just the lower of large numbers or is it perhaps that particularly for your products, you'll seeing some extra obesity use with Zen take which will presumably disappear next year.

When we go to as he comes in and say, we don't need to be where we need to be sure the window of double counting.

And secondly, I wonder if you could tell us a little bit about how long people are staying on these days.

Doug Langa: So that's important. And overall, again, as I mentioned earlier, we have 60% overall formulary access, and that's progressing nicely. The team is also doing a really nice job in terms of the opt-in component with employers, but I can't give you any specifics there. But again, that's progressing nicely. Remember, this is still not considered a standard listed product. So, you know, we have some work to do there, but the team is working hard. And, as Lars mentioned, we have all three major PBMs on board.

Data that we have is that the day rates on all of the G. L piece is still pretty pretty pool, you're less than six months or so for many patients have you been able to make some progress there. Thank you.

Thank you Joe constant first obviously difficult to predict the future tier one mile growth.

So can you put a bit more color on your comments that we are right now seeing a higher level than than we've seen in the past and then can we look and talk to stay time on or simply.

Yep. Thanks, Joe for that question and of course, it's a forward looking statement.

The reason why I pulled it forward was when you look at.

Actual.

<unk> scripts on a weekly basis, we saw a significant step up I'd say in June or so if you take the U S market data absolute number of indirect in the <unk> segment.

Doug Langa: That's a really good sign. And we have partnerships with several of them in weight management programs, which is also another very good sign. So overall, I think progress is being made. Thank you, Doug. Thank you, Emmanuel. Next set of questions, please.

Most notably on an Olympic.

After that step up actually the trend has been fairly similar to what you saw what we saw before the step up so we don't see a continuous step up but more like a normalized growth rate.

During our during the third quarter and into the fourth quarter as well.

Thank you Karsten Camilla stay time, yeah, so unsafe time, and we actually do have a stay tuned.

Operator: Thank you. Our next question is from Steve Scala of Cowen. Please go ahead; your line is open. Oh, thank you.

The latest data we have.

It's close to around roughly speaking more than 15 months on in an authentic.

Steve Scala: Thank you. You noted that you expect Wigovi's supply to meet demand in early 2022. What level of demand does this imply based on your expected supply? So, for instance, is it closer to two times more, 10 times more, or 25 times more? And then secondly, a similar question to ones that have already been asked, but a slightly different version. What percent of the US population can access full coverage of Wi-Fi today? And what might that percent be at the beginning of 2022?

We don't think that this is a this is in general just a quite significant.

You can stay tuned and pizza.

We know that we can get 80% of people in good controls on all clinical trials.

So I think that covers that.

Thank you Camilla. Thank you Joe our next set of questions. Please I think we are homing in on the last set of questions, perhaps two depending on the length of the answers.

Thank you. Our next question is from Telehealth that of Bernbach. Please go ahead.

A couple for me.

And back to the table.

Hum.

What proportion of that.

Lars Fruergaard Jorgensen: 2022. Thank you. So, thank you, Steve.

Got it.

Oh, Oh Oh.

Well, that's a good point.

Lars Fruergaard Jorgensen: We have our own forecast for how we model demand, and unfortunately, we're not in a position to be able to share that. But we believe that based on how we understand the market, and the flow of patients, we can match that demand. But, of course, we were surprised initially here, so we do not know much more than you do in terms of what the real demand will be, but we feel comfortable that we can help patients in need of anti-obesity medicine.

Okay.

Maybe a little debate.

Thanks.

We'll go slow.

April.

Hey, Chad.

Got it.

We can experiment.

Yeah.

Okay.

And then just quick one.

Hi, good morning.

Forward to stop he study next quarter.

We had to pay warranty.

Lars Fruergaard Jorgensen: And Doug, on the second question, in terms of which percentage of the U.S. population is within reach... Yeah, thanks for the question, Steve. In the end, it's important to note that we still don't have Medicare coverage, so that takes out a significant portion of the population. We're working really hard, and we hope, at some point, whether it's through the Treat and Reduce Obesity Act or some other policy change, another policy change, to open that up.

Okay.

Thank you Kerry so.

I'll talk first a perspective on.

Yeah.

As I understood it.

How many employers.

<unk>.

Yeah. So so we don't disclose that but generally speaking we do have I would say a large number of employers that have opted in to where we have coverage today.

And our aim is to continue to work we have a regional account team that's out there every day working hard as well as an employer team and again, it's an important component to building the overall access and affordability quite frankly over the long haul.

Lars Fruergaard Jorgensen: Because, as a company, we certainly think that seniors in the U.S. should have access to anti-obesity medications. I mean, that's clear. Today, again, so if you just take a look at commercial access and where we are, we think about 16 million to 20 million people have access. People, patients living with obesity, have access, and again, our aim is to get that much more like other products, standard listed products, so you know, our aim is to get much higher, and that's going to take some work, but today, around 16 to 20 million people. Thank you. Steve, next set of questions, please.

And you want to pursue our plane. Thanks.

Thank you margin. Thank you carry and we'll take one final set of questions. Please.

Operator: Thank you. Our next question is from Karsten Lomberg of SEB. Please go ahead.

E. A final question will be from such an Jane of Bank of America. Please go ahead.

Karsten Lomberg: Thank you very much. I have a couple of questions for Martin, I guess.

Hi, Thanks for switching me in just a couple of clarification questions. Please.

First of all I want to write Bolsa's sequential growth in the U S to traffickers to Michael's question. It grew sales, 40% versus prescription volumes 15 sequentially just to clarify would you expect sales to grow ahead of scripts going forward.

Martin Holst Lange: The OASIS program for Alzheimer's and Obesity, you have three trials in this program in total: one Chinese patient, one Japanese patient, one with European and North American patients combined. Is this a sign that you only need one trial to get this product approved in the US with North American patients, or can you leverage something else on top of this? And then for Sima, in Alzheimer's, I know it's not so long ago since you actually initiated the phase three trial, but could you maybe share some of the feedback you have had in terms of appetite to get enrolled in this trial in the Alzheimer's community? Thank you, Karsten. Now, over to you, Martin, first on the OASIS trial design, the number of trials needed, etc. Yep, absolutely.

Co pay programs come off.

Secondly, fall upon the G. L P. One growth outlook for next year.

<unk> you have a competitor launch does that petard, which you can start when you said would accelerate in the market. So just to clarify how we think about 22 G. L. P. One growth.

Given that new launches normalized most direct Michelle off so competitive.

What would you think that pulled up term accelerates the markets. Thank you.

Thank you for such an costume cause you try to put some call on both questions <unk> value prescript on proposals and then what more you can give on just one Margaret.

Martin Holst Lange: So as you mentioned, on OASIS, it's a fairly slim program, a thousand patients in total, which obviously also indicates that we've agreed with regulatory authorities that we need to bridge based on the data that we already have on semaglutide. I mean, we are in a good position that we both on subcutaneous and oral and also on different doses, now also on oral, have a lot of data with which we can bridge to satisfy regulatory requirements. On the Alzheimer's trial, it's still early days. As you can probably imagine, we are screening a great number of patients, but the screening period, in and of itself, is three months.

Yeah. So thank you searching for that set of questions.

First of all on rebels as in the U S and.

And.

Delta between the scripts and X factory and realized AFP.

Inc.

The key point is way.

We showed in the earliest slide then we actually have a very stable cherish uptake curve in the U S and darkness was talking to that so so I think the more meaningful measure on rebellious is basically to look at the stupidity of that your ex curve and then individual quotas are impacted by it could.

Be mine inventory movements, either this year or last year et cetera. So so I think I would feel that away and say look look at the T Rex trending and look at all yesterday.

Martin Holst Lange: So at this point in time, what we see is that the sites that are open and up and running are actually screening and recruiting at the level where we would expect them to be or a little bit above. Thank you, Martin. Very encouraging. And thank you, Karsten, for those questions. Next set of questions, please.

That's a more reflective.

Looking at doses.

As to what you had one Margaret growth.

Then.

Then, yes, what we've seen historically is that the launch it's beneficial church with the market, but you can say the market has also been benefiting from from the rebellious launch.

Over the past.

Wanted to have yes up to two years. So so so that's what I mean with a with a normalized Margaret growth so assuming it to sabotage launch next year that.

Operator: Thank you. Our next question is from Martin Parkhoi of Danske Bank. Please go ahead.

Martin Parkhoi: Martin Parker, Danske Bank, also has two questions. First

Of course, what we've seen until one is that it has been the market expansion strategy on our site and also on the decided to I don't know their strategy, but.

Martin Parkhoi: also two questions, first for Lars, you quoted on various news media about China that you expect this to be a one-time effect with a potentially significant haircut to pricing, but how do you state now that it will only be a one-time effect, for example going into right now you're seeing 35% growth in your long-acting insulin franchise in China, do you feel comfortable that after a big price cut then you can continue on this journey with Traceeba in China or isn't there the risk that this could be a controlled tender market? And then the second question I think will be for Doug, just again on Vigovy and coverage and stuff like that in US, you say 60% are on it for free, but you also call it of course it's called the bridge card because you're making a bridge onto this patient hopefully should get coverage, but I also know that some are able to get the drug even though they don't fit into that category, but how many of these 60% will actually have Thank you, Martin, for those two questions.

But.

Presumably it would help extent the markets.

[noise], thanks crossed and lifts sneak in one final episode final question a set of questions.

A final question will be fun.

J P. Morgan. Please go ahead.

Thanks for taking my questions I will just need one and it's just looking at the obesity franchise in a bit more.

How should we think about the development with that franchise, you think you could already see the franchise double relative to for four quarters.

Give them increasingly gave me supply given what we can put you in the display.

We go to the.

Probably doubling in the U S and strong continued guys and sex and directs you that you feel so thank you so much.

Thank you Richard so so I can unfortunately go into guidance guiding on obesity, but of course, you raise a good point that we see a very very strong uptake of Ah. We go in the U S better than anyone I would say you have anticipated it's not on on on Ah based on cannibalization of six in there which is holding up.

Nice and yours, and we see that six into is accelerating his position outside of.

You were so very strong growth.

Exit to the same degree as we've seen in the U S.

International Relations and we see a number of markets, where obesity is moving in being.

Lars Fruergaard Jorgensen: And let me start on China. And obviously, I don't know for sure what will happen in China because I'm not in charge of that. But if you look at the whole intention of the VVP, that was to bring the pricing of drugs in China down to the international level, and for a number of drug categories. So I feel that it's a rational attempt by the authorities in China to get to the right price level, and then there's a keen interest in bringing innovation to China, accelerated regulatory review, etc. And, of course, if it turns into a very hostile pricing environment, I don't think the authorities are creating an attractive market for innovation.

Being repaired.

Burst because health care systems acknowledged the need for having introduced medicine, not least coming out of a pandemic, where it's can you establish that living with obesity is is.

There is a risk factor.

If you catch a cold and 19. So we are very encouraged in terms of the three poets as I mentioned mobilizing physicians to prescribe mobilized in patients where she care and also increasingly having pay us to acknowledge the need for <unk> medicine. So I think that holds well for the future growth and in due time.

<unk> we will.

Clarify with you what our aspirations are or Phonologist at least two governments by 2025, and we feel comfortable we can we can do that.

So with that thank you all for your participation. This concludes our earnings call and if you have more questions feel free to reach out to our Investor relations and looking forward to to meet you sometime soon in the future. Thank you very much bye bye.

Doug Langa: So at least for now, we feel comfortable about that, and Doug once again on WeGoWe. Yeah, thanks, Martin, for the question. So, the intent of any of these early initiations or bridge programs is to build awareness, get initiation of use, so we can, you know, physicians can see results. And again, for us, the bridge program was designed to be screened for people that had coverage. Now, again, it's not a perfect system. However, based on the demand, it was probably one of our most successful programs that we've launched.

[music].

Doug Langa: So, but it would, I don't have, we don't have the exact specificity to know how many coming off that program would exactly have coverage. But again, the intent was, you start them, and then they would have coverage when they come off.

Doug Langa: Thank you, Doug. Thank you, Martin. Next set of questions.

Operator: Thank you. Our next question is from Jo Walton of Credit Suisse. Please go ahead. Thank you. I've got two questions.

Jo Walton: If we could go back to your confidence in the lack of, in the fact that the GLP market growth of 30% will ease off next year, I just wonder why that is. Is it just the law of large numbers? Or is it perhaps that, particularly for your products, you're seeing some extra obesity use with Ozempic, which will presumably disappear next year when Wegovy comes in? So we don't need to be; we just need to be sure that we're not double counting.

Jo Walton: And secondly, I wonder if you could tell us a little bit about how long people are staying on Ozempic these days. I think the data that we have is that the stay rate on all of the GLPs is still pretty, pretty poor, you know, less than six months or so for many patients. Have you been able to make some progress there? Thank you.

Lars Fruergaard Jorgensen: Thank you, Joe. Karsten, first, it's obviously difficult to predict the future of DLV-1 market growth, so can you put a bit more color on your comments that we are right now seeing a higher level than we have seen in the past? And then Camilla can talk about staying time on OCEMPIC.

Karsten Munk Knudsen: Yeah, thanks, Joe, for that question. And, of course, it's a forward-looking statement. The reason why I pulled it forward was when you look at actual NBRX scripts on a weekly basis, we saw a significant step up, I'd say in June or so, if you take the US market data, the absolute number of NBRX scripts in the GF1 market segment, most notably on USMPIC. After that step up, actually, the trend has been fairly similar to what we saw before the step up. So we don't see a continuous step up, but more like a normalized growth rate during the third quarter and into the fourth quarter as well. Thank you, Karsten. Camilla, stay tight.

[music].

Camilla Sylvest: Yeah, so on stay time, we actually do have a stay time that, from the latest data we have, is close to around, roughly speaking, more than 50 months on OCEMPIC. We do think that, in general, this is just a quite significant stay time and people are, you know, we know that we can get 80% of people in good control from our clinical trials. So I think that covers that.

Camilla Sylvest: Thank you, Camilla. Thank you, Joe. Next set of questions, please. I think we are homing in on the last set of questions, perhaps two, depending on the length of the answers.

Operator: Thank you. Our next question is from Kerry Holford of Berenberg. Please go ahead. Thank you.

Kerry Holford: Thank you. Yes, coming from me, please.

Kerry Holford: Firstly, just going back to COVID, I would be interested to see what proportion of the 60% of covered loads have the employer opt-in effectively granted. Can you say the end of the panel? Whether you're finding any debate in your pricing and access negotiations for that obesity outcomes data, you know, how much further do you think you can expand or go access essentially ahead of that readout? I think at the back end of 23. And then just quickly on MIM 8, what is giving you the confidence to move forward to start Phase 3 this quarter and see that read out into Phase 1 too?

Doug Langa: Thank you, Kerry. So, so, Doug, first a perspective on, as I understand it in the commercial sector, how many employers are opting in? Yep, so we don't disclose that, but generally speaking, we do have, I would say, a large number of employers that have opted in to where we have coverage today. And our aim is to continue to work. We have a regional account team that's out there every day working hard, as well as an employer team.

Doug Langa: And again, it's an important component to building overall access and affordability, quite frankly, over the long haul, and if I just should give a very quick answer to the question about outcome data and health technology assessments, etc. So, we actually see that payers today with what we go, we can deliver, see that there's value in the product, so I don't think we have a situation where we need to see COT data for the case to Yes, so as you know, we designed a fairly ambitious development program where we try to go from first human dose to basically submission in a matter of four years. That requires some assumptions, and it requires a little bit of initiating things, including our phase three trial at risk.

Doug Langa: We do obviously continuously monitor the different cohorts that read out in the ongoing phase one to two study. That basically means that we know about the safety of Thank you, Martin. Thank you, Kerry. And we'll take one final set of questions, please.

Operator: Thank you. Our final question will be from Sachin Jain of Bank of America. Please go ahead.

Sachin Jain: Hi there, thanks for fitting me in. Just a couple of clarification questions, please. So first, we go back to Rye Beltus' sequential growth in the US. For clarification on Michael's question, it grew sales 40% versus prescription volumes 15% sequentially. So just to clarify, do you expect sales to grow ahead of scripts going forward as co-pay programs come off? And secondly, a follow-up on the GLP-1 growth outlook for next year, noting you have a competitor launch to Zephyrtide, which you've historically said would accelerate the market. So just to clarify how we think about 22 GLP-1 growth, given that new launch, is that normalized market growth with share loss to a competitor, or do you think that product accelerates the market? Thank you.

Karsten Munk Knudsen: Thank you, Sachin. Karsten, can you try to put some color on both questions, both, say, value per script on rebeltious, and then what more you can give on the JLPT-1 market outlook? Yeah, so thank you, Svetlana, for that set of questions. First of all, on rebalancing in the U.S. and the delta between Scripps and X-Factory and realized ARP, I think the key point is, as we showed in the earlier slide, we actually have a very, very stable TRX uptake curve in the U.S., and Doug was talking about that.

[music].

Karsten Munk Knudsen: So I think the more meaningful measure on rebalances is basically to look at the stability of the TRX curve, and individual quarters are impacted by – it could be minor inventory movements either this year or last year, et cetera. So I think I would peel that away and say look at the TRX trending and look at our year-to-date numbers. That's the more reflective way of looking at rebalancing. As to GLP-1 market growth, then yes, what we've seen historically is that a launch is beneficial to the market, but you can say the market has also been benefiting from the rebels' launch over the past one and a half years, up to two years or so.

Karsten Munk Knudsen: So that's what I mean by normalized market growth. So assuming it's a sabotage launch next year, you know, of course, what we've seen in GLP-1 is that it has been a market expansion strategy on our side and also on the Lilly side. I don't know their strategy, but presumably it would help expand the market.

Operator: Thank you, Karsten. Let's sneak in one final, absolute final question, or set of questions.

Operator: Thank you. Our final question will be from Richard Butser of J.P. Morgan.

Richard Vosser: Thanks for taking my questions. I'll just do one.

Richard Vosser: And it's just looking at the obesity franchise in a bit bigger picture, the fourth quarter. So how should we think about the development of that franchise? Do you think you could already see the franchise double relative to fourth quarter 20?

Lars Fruergaard Jorgensen: Given improving Wegovy supply, given what we can see in the script of Wegovy, probably doubling in the US and strong continued growth of sex, please direct us if your thoughts there. Thanks so much. Thank you, Richard. So, I can unfortunately not go into guidance on obesity, but of course, you raise a good point that we see a very, very strong uptake of Obesity in the U.S., better than anyone, I would say, has anticipated.

Lars Fruergaard Jorgensen: And we see a number of markets where obesity is moving in, and being reimbursed because healthcare systems acknowledge the need for having anti-obesity medicine, not least coming out of a pandemic where it's clearly established that living with obesity is a risk factor if you catch COVID-19.

Lars Fruergaard Jorgensen: Thank you very much. So I think that holds well for future growth, and in due time, we will clarify with you what our aspirations are, but for now, it is at least to double it by 2025, and we feel comfortable that we can do that. So with that, thank you all for your participation. This concludes our earnings call. And if you have more questions, feel free to reach out to our investor relations team. I look forward to meeting you sometime soon in the future. Thank you very much. Bye bye. Thank you for watching!

[music].

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