Q4 2020 Novo Nordisk A/S Earnings Call

Hello, and welcome to the Q4 2020 in Novo Nordisk.

Operator: Hello and welcome to the Q4 2020 Novo Nordisk AS Earnings Conference Call. Throughout the call, participants will be in listen mode only, and afterwards, there will be a question and answer session. Today, I'm pleased to present Lars Fogar Jorgensen. Please go ahead with your meeting.

<unk> conference call.

Throughout the call participants will be in listen mode, Ernie and afterwards, there will be a question and answer session. Today I'm pleased to present philosopher Yogi.

Please go ahead with your meeting.

Thank you very much welcome traditional Nordisk 40, yet 2020 and outlook for 'twenty one earnings call.

Lars Fruergaard Jorgensen: Thank you very much. Welcome to this Novo Nordisk full year 2020 and Outlook for 2021 Learning School. I'm Lars Jorgensen, the CEO of Novo Nordisk. With me I have our Chief Financial Officer, Karsten Munk-Knudsen, and our Chief Science Officer, Max Krofgaard-Thomsen.

I'm, Josh Wolk, our joke wishing the CEO of Novo Nordisk.

With me I have our Chief Financial Officer, Karsten Munk Knudsen.

And our Chief Science Officer, Ms Costa assumptions.

Also present and available for the Q&A session is executive Vice President and head of commercial strategy and corporate Affairs <unk> risks.

Lars Fruergaard Jorgensen: Also present and available for the Q&A session is Executive Vice President and Head of Commercial Strategy and Corporate Affairs, Camilla Sylvest. Today's earnings release and the slides for this call are available on our website, www.nonoise.com. Please note that this call is being webcasted live and a recording will be made available on No-Noise websites. This call is scheduled to last for one hour.

Today's earnings release and the site for this call are available on our web site no noise Dot com.

Please note that this call is being webcast live and a recording will be made available on the website. This call is scheduled to last for one hour.

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

Operator: 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. The Q&A session will begin in about 25 minutes.

The Q&A session will begin in about 25 minutes, please turn to slide three.

Operator: Please turn to slide 3. As always, I need to advise you that this 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.

That's always a neutral advise you that this call will contain forward looking statements such forward looking statements are subject to risks and uncertainties that could cause actual results to differ materially from expectations.

For further information on risk factors, including the uncertainties around COVID-19, do you see the company announcements for the full year 2020, and the slides prepared for this presentation.

Lars Fruergaard Jorgensen: For further information on the risk factors, including the uncertainties around COVID-19, please see the company announcement for the full year of 2020 and the slides prepared for this presentation. Please, please turn to the next slide. Novo Nordisk has also been challenged in the last year by COVID-19. During this period, our key priorities have been to safeguard our employees, continue the supply of life-saving medicines, and support societies around the world. We believe we have successfully delivered on these priorities while also delivering on our strategic aspirations. Novo Nordisk has taken important steps towards reaching our strategic aspiration of 2025 in all four dimensions. We launched our social responsibility strategy to defeat diabetes and raised the ambition on renewable power to include our direct suppliers.

Please turn to the next slide.

No Nordisk has also been challenged in the last year from COVID-19. During this period, our key priorities have been to safeguard our employees continue the supply of life saving medicines and supports the sciences around the world.

We believe we have successfully delivered on the east for horses, while also delivering on our strategic aspirations.

And one also has taken important steps towards reaching our strategic aspiration trends through the five on all four dimensions.

Launched our social responsibility strategy defeat diabetes and rates raised the ambition on renewable power to include our direct suppliers.

Lars Fruergaard Jorgensen: Later, Mads will elaborate on the successful year within innovation and therapeutic focus. For commercial execution, we have increased our market share in diabetes and have progressed on obesity and biopharm aspirations. Lastly, on financials, both sales and operating profit grew by 7% at comparable exchange rates, and we continue to provide attractive capital allocation by returning 37 billion Danish kroner to shareholders. Please turn to slide 5. Before we move on to the particulars of this full year's performance, I would like to update you on changes to Executive Management.

Later, <unk> will elaborate on the successful year with innovation and strategic focus.

While commercial execution, we have increased our market share in <unk> and have progressed on efficiency and biopharm explorations lastly on financials, both sales and operating profit grew by 7% the comparable exchange rates and we continue to provide attractive Kevin so allocation by returning 37 billion.

Coolness for shareholders, Please turn to slide five.

Before we move onto the particulars of this full year performance I would like to update you on changes to executive management.

After more than 30 years with no notice and 20 years as Chief Science Officer, Ms. Kercher Thompson of whatever trial from his current position by the end of February 2021, and take off the position as CEO at Illinois Foundation.

Lars Fruergaard Jorgensen: After more than 30 years with Novo Nordisk, and 20 years as Chief Science Officer, Mads Kulka Thompson will retire from his current position by the end of February 2021 and take up a position as CEO at the Novo Nordisk Foundation.

Lars Fruergaard Jorgensen: This leaves the role as CO at a time when the noise pipeline is strong and the entry into new therapy areas is on track. As a consequence, and in accordance with succession planning, as of 1 March, R&D will be reorganized into two separate areas, one of which is research and early development, headed by Marcus Schindler, who is promoted to Executive Vice President and Chief Science Officer. The other area is development, headed up by Martin Lange, who has also been promoted to Executive Vice President.

This leaves the role as CEO my sorry mess leaves the role as CEO at a time when our newest pipeline is strong and the entry into new areas is on track.

As a consequence and in accordance with succession planning.

First of March R&D will be reorganized into two separate areas one of which is research and early development aided by Mark with Schindler was promoted to executive Vice President and Chief Science Officer. The other area is development headed up by much in Diana was also promoted to executive Vice President.

In a time, where we are broadening our technology platforms and expanding our research into adjacent disease areas Marcus will play a central role in bringing higher levels of innovation across all therapy areas, thereby ensuring that our business continues to be sustainable in the decades to come.

Lars Fruergaard Jorgensen: In a time when we are broadening our technology platforms and expanding our research into adjacent disease areas, Marcus will play a central role in bringing higher levels of innovation across all therapy areas, thereby ensuring that our business continues to be sustainable in the decades to come. Furthermore, with more projects and a broader strategic therapy area focus than ever before in our history, development is essential for ensuring that our portfolio of innovative drugs and devices progresses and achieves competitive levels, allowing us to bring better treatments to patients. With that, I thank Mads for his outstanding contributions and wish him all the best in his future career.

Furthermore, with more critics and a broader strategic area of focus than ever before in our history development is essential for ensuring that our portfolio of innovative drugs and devices progress and achieved compared to labels, allowing us to bring better treatments to patients.

With that I think Matt for his outstanding contributions and wish him all the best in his future career.

Lars Fruergaard Jorgensen: Moreover, I would like to welcome Marcus and Martin to executive management and congratulate them both on their promotion. Please turn to slide six. The 10% sales growth at comparable exchange rates was driven by 10% growth in staffer operations, where all areas and therapies supported growth, and North America operations growing by 3%. Sales growth was driven by growth across all therapy areas. Diabetes care grew by 8% despite insulin sales decreasing by 3%, reflecting lower realized prices in the U.S. GF1 sales increased by 29%, driven by a 32% sales growth in international operations and a 28% sales growth in North America operations.

I would like to welcome Marquess and matching and exact commencement and congratulate them both with their promotions.

Please turn to slide six.

The 7% sales growth at comparable exchange rates was driven by a 10% growth in Zephyr operations, where all areas and therapies supported growth and North America operations growing by 3%.

Sales growth was driven by growth across all therapy areas diabetes care grew by 8% despite instrument sales decreasing by 3%, reflecting lower realized prices in the U S.

Just one sales increased by 29% driven by a 32% sales growth in international operations, and a 2% to 8% sales growth in North America operations.

We used to sales will be.

Lars Fruergaard Jorgensen: Obesity Sales, Obesity care sales grew by 3%, driven by international operations, partly offset by North America operations. However, sales growth was negatively impacted by COVID-19, driven by fewer patients initiating treatment. Firefarm sales increased by 1%, driven by international operations. Please turn to slide 7.

Sales of these cafes grew by 3% driven by international operations, partly offset by North America operations sales growth was negatively impacted by COVID-19, driven by fewer patients initiating treatment.

Biopharm sales increased by 1% driven by international operations.

Please turn to slide seven.

We aim to reach one third of the global diabetes value market and we are now at 29, 3%. This increase is a reflection of tier one market share gains.

Lars Fruergaard Jorgensen: We aim to reach one-third of the global diabetes value market, and we are now at 29.3%. This increase is a reflection of GF1 market share gains. For instance, we have increased our volume market share by 0.7 percentage points in the last 12 months, which was driven by market share gains in Emir and the rest of the world. Since 2019, we have increased our GLP-1 market share by around 3 percentage points to over 50%. This is driven by market share gains in EMEA, the World Bank, and the US. Furthermore, it reflects the global uptake of the Semplic and launches of Rebelsus in nine countries. Please turn to slide 8.

In Spain, we have increased our volume market share by <unk> seven percentage points in the last 12 months.

This was driven by market share gains in EMEA and rest of world.

Since 2019, we have increased our tier one market share by around three percentage points.

50%.

This is driven by market share gains in EMEA and rest of world and the U S.

It reflects the global uptake of <unk> and launches of <unk> in nine countries.

Please turn to slide eight.

The U S. Just one volume market continues to grow around 30% driven by once weekly <unk>, one products with uptake of <unk> and the launch of our <unk>, Illinois has neutral brand market share leadership of 57, 1% and use a market leader with around 50% market share mission and total prescriptions.

Lars Fruergaard Jorgensen: The U.S. GF1 volume market continues to grow around 30%, driven by once-weekly GF1 products. With the uptake of Ocempic and the launch of Rebelsus, Novo Nordisk has new-to-brand market share leadership of 57.1% and is the market leader with around 50% market share measured in total prescriptions. Please turn to slide 9.

Please turn to slide nine.

Since the initial focused launch.

Lars Fruergaard Jorgensen: Since the initial focus launch, the Robelsus uptake has been on par with that of select STLT2 launches. In its first full financial year since its broad launch, sales of Rebelsus were 1.9 billion Danish Kroner. Despite a challenging launch environment, where on several occasions we have had to stop face-to-face interactions between our sales force and doctors, we are pleased with the Rebelsys performance. In the U.S., our market share, sorry, our market access is now around 90%.

Uptake has been on par with that of STR to two launches in its first full financials, yes since brought loans central of our barrels which was $1 9 billion Danish kroner.

Despite a changing launch environment, where on several locations, we have had to stop face to face interactions between our sales force and Dr.

We are pleased with <unk> performance in the U S for <unk> market share so sorry in the U S. <unk> market access is now around 90%.

Lars Fruergaard Jorgensen: Furthermore, 80% of new prescriptions are new to the GLP-1 class, with direct-to-consumer advertising continuing. Outside of the US, Rebelsis has been launched in 8 countries and has obtained around 5% volume market share in the modern non-insulin anti-diabetic market in select launch countries. Additionally, in the first quarter of 2021, we plan to launch Belsus in Japan, where the OAD class represents around 8% of the total diabetes market. Please turn to slide 10.

Furthermore, the 80% of new prescriptions are neutral GOP, one class with direct to consumer advertisement continuing.

Outside of the U S, where <unk> has been launched in eight countries and has obtained around 5% volume market share in the modern non insulin anti diabetic market intellect launched countries.

Additionally, in the first quarter of 'twenty, one we plan to launch <unk> in Japan, where the OE or E class represents around 8% of the total diabetes market. Please.

Please turn to slide 10.

NSS operations <unk> <unk> sales increased by 11% supported by all geographies and therapy areas.

Lars Fruergaard Jorgensen: In SNAS operations, diabetes care sales increased by 11%, supported by all geographies and therapy areas. The sales performance reflects our increased diabetes value market share, as indicated by the 37% share of growth. This has driven a one percent point increase in our market share, which is now at 23%. Please turn to slide 11.

The sales performance reflects how increased diabetes value market share as indicated by the 37% share of growth.

This is driven at 1%.

Point increase in our market share, which is now at 23%.

Please turn to slide 11.

Mads: Obesity care sales increased by 3% to 5.6 billion Danish kroner, but they were negatively impacted by COVID-19, as fewer patients initiated treatment. In international operations, sales grew by 11%; in North America, operations, sales declined by 1%, impacted by channel mix. Of note, we have submitted marketing authorization applications in both the US and EU for Semiclotide 2.4 mg for the treatment of obesity; please turn to slide 12. Wirefarm grew sales by 1% in full year 2020, driven by 5% sales growth in its national operations, as well as the launch of new hemophilia products and growth disorders.

<unk> sales increased by 3% to $5 6 billion Danish kroner negatively impacted by COVID-19, as fewer patients initiated treatment.

In International operations sales grew by 11% and North America operations sales declined by 1% impacted by channel mix.

Note, we have submitted a marketing authorization application in both the U S and EU with similar type two four milligram for.

For the treatment of obesity.

Please turn to slide 12.

Biopharm grew sales by 1% in full year 2020, driven by a 5% sales growth in international operations as well as the launch of new hemophilia products and growth disorders.

Mads: For Haemophilia, the 4% sales decline reflects declining No. 7 sales, while the Haemophilia A and B franchises grew, driven by desperate demand and reflection. Nordic tropian sales increased by 8%. Sales growth was positively impacted by additional demand following supply challenges for competing products in select countries. With that, over to Mads for an update on R&D. Thank you, Lars.

I am a failure the 4% sales decline reflects declining or Sim sales, while the hemophilia, a and b franchises grew driven by <unk> and the fixture.

Noticed hoping sales increased by 8% sales growth was positively impacted by additional demand falling supply challenges, while competing products in select countries.

Was that <unk> for an update on R&D.

Thank you Laura please turn to slide 13.

Mads: Please turn to slide 13. In the next few slides, I'll share with you our progress in both GLP-1 and insulin innovation, as well as in the rest of the pipeline. Starting with semaglutide, we were very pleased with the results from the SUSTAIN-40 2mg osempic trial, including the greater than 2% HbA1c reduction that was accompanied by a benign safety and tolerability profile, thereby establishing an attractive benefit-risk ratio in type 2 diabetes. Across the SUSTAIN program, semaglutide 1 mg has demonstrated that up to 80% of patients have achieved an HbA1c level below 7%.

In the next few slides I'll share with you our progress within both <unk>, one and insulin innovation as well as within the rest of the pipeline.

Starting with <unk>, we were very pleased with the results from the sustained 42 milligram Pacific trial, including the greater than 2% <unk> reduction that was accompanied by a benign safety and tolerability profile, thereby establishing an attractive benefit risk ratio in type two diabetes.

Across the sustain program <unk>, one milligram has demonstrated that up to 80% of patients have achieved in HB, one C level below 7%.

Mads: With a statistically significant increase in the percent of patients reaching the A1C target on semaglutide 2mg versus 1mg, the trial demonstrates the potential of 2mg weekly to further improve glycemic outcomes for patients in poor control. This is seen despite the low rate of gastrointestinal adverse events observed in Sustain40 that were actually similar between both doses of temacrotoxin. We've now submitted regulatory applications for label expansion in both the EU and the US.

With a statistically significant increase in the percent of patients, reaching the <unk> target, obviously magnetite two milligrams versus why don't you to Graham.

Trial demonstrates the potential of two milligrams weekly to further improve glycemic outcomes for patients and for control.

This is seen despite the low rate of gastrointestinal adverse events observed in sustain four days that were actually similar between both doses of <unk>.

We've now submitted regulatory applications for label expansion in both the EU and the U S.

Mads: Furthermore, we've now begun the phase 3 trial with all semaglutide 25 and 50 mg in type 2 diabetes. As you can see, the higher doses will be compared to the currently approved rubellosis dose of 414 mg. The trial has been designed to confirm superiority of the higher doses versus the 14 mg. Similar to high-dose subcutaneous semaglutide, the high doses of oral semaglutide aim at providing additional options for those needing oral treatment intensification over time. Please turn to the next slide.

Furthermore, we have now begun the phase III trial with Alstom, Exenatide 25, and 50 milligrams in type two diabetes.

You can see the higher doses will be compared to the currently approved doses dose of 414 milligrams.

The trial has been designed to confirm superiority of the higher doses versus the 14 milligram dose <unk>.

Similar to high two subcutaneous some appetite the high doses of ultimate aim at providing additional options for those needing all treatment intensification overtime.

Please turn to the next slide.

Mads: 2021 marks the 100th anniversary of the discovery of insulin in Toronto. Despite the long history, Novo Nordisk's diabetes pipeline still showcases a continued focus on delivering improved treatments, including potentially preventative ones. In the fourth quarter of 2020, we initiated the Phase 3 program for insulin IQODEC, poised to become the first-in-class, once-weekly insulin. As you can see, the program will consist of six trials, collectively known as the ONWARDS program.

2021 marks the 100 year anniversary of the discovery of introducing.

So despite.

Despite the long history.

Diabetes pipeline still showcases our continued focus on delivering improved treatments, including potentially preventative treatments.

In the fourth quarter of 2020, we initiated the phase III program for interesting iconic poised to become the first in class once weekly insulin.

As you can see the program will consist of six trials collectively known as the <unk> program. The <unk> program comprises multiple trials are bearing designs to demonstrate <unk> efficacy and safety profile in different settings, we believe that architects improve pharmacodynamic profile, along with enhanced convenience and adherence can drive improved.

Mads: The ONWARDS program comprises multiple trials of varying designs to demonstrate iCodec's efficacy and safety profile in different settings. We believe that iCodex's improved pharmacodynamic profile, along with enhanced convenience and adherence, can drive improved patient outcomes, thus providing a differentiated profile versus the currently most used one's daily interface. In this regard, one of the type 2 diabetes trials, ONWARDS V, sets out to prove the above in a pragmatic setting by sampling a real-world evidence trial while also deploying app-based dosing.

The outcomes, thus, providing a differentiated profile versus the currently most juice once the interesting.

In this regard one of the type two diabetes trials on what's five sets out to prove the above into pragmatic sitting been sampling of real world evidence trial, while also deploying at least dosing guidance.

Mads: Additionally, the first clinical trial for a first-in-class glucose-sensitive insulin has been ongoing since the third quarter. The target product profile for this insulin includes improved glucose control as well as the elimination of hyperglycemia and other side effects of today's insulin therapy. In Q4, we initiated a Phase 1 trial for the so-called Ideal Pumping. This insulin seeks to deliver better glycemic control and improve convenience in general, including its use in closed-loop insulin pumps. This is principally achieved by avoiding the lag time from instant infusion to instant action.

Additionally, the first clinical trial of our first in class glucose sensitive insulin has been ongoing since the third quarter.

Product prices.

<unk> improved glucose control is what is the elimination of hyperglycemia and other side effects of today's interesting therapies.

In Q4, we initiated a phase one trial for the so called ideal pumping fleet.

This incident seeks to deliver better glycemic control and improve convenience in general including its use in closed loop insulin pump systems.

This is principally achieve by avoidance of the neck time from insulin infusion two inch connection.

Last but not least we initiated a phase one trial investigating DNA based immunotherapy as a potentially preventative treatment for people at high risk of encountering type one diabetes.

Mads: Last but not least, we initiated a phase one trial investigating DNA plasmid-based immunotherapy as a potentially preventative treatment for people at high risk of encountering type 1 diabetes. This potentially disease-modifying treatment uses a subcutaneous tolerogenic DNA plasmid injection to prevent the onset of reverse diabetes in high-risk subgroups. Please go to the next slide.

This potentially disease modifying treatment uses a subcutaneous tolerogenic DNA plasmid injection to prevent the onset of Covid typing in high risk subjects. Please go to the next slide.

The upcoming year will prove particularly exciting as we plan to initiate new phase III programs and had been running in each of our therapeutic areas, including the new ones.

Mads: The upcoming year will prove particularly exciting, as we plan to initiate new phase 3 programs and have them running in each of our therapeutic areas, including this new one. Starting with the fourth quarter of last year, several R&D milestones were reached. Starting with macrotitin type 2 diabetes, we had both a successful completion and regulatory submission of the Phase III Sustained Forward Update. Moving to obesity, we have now submitted the new drug application in the U.S. and the marketing authorization application in the E.U.

Starting with the fourth quarter of last year. Several key milestones were reached starting with some macro tied in type two diabetes. We had both the successful completion and regulatory submission of the phase III sustained forward data.

Moving to <unk>, we have now submitted the new drug application in the U S and the marketing authorization application in the EU for some exercise two four milligrams as a once weekly treatment for people with obesity in.

In the U S. A priority review voucher was us reducing the expected review time from 10% to six months. This gives the opportunity for U S approval mid 'twenty, one and EU decision is expected around the turn of the year.

In Biopharma, we just received a positive opinion in the EU and approval.

Mads: for Cimetratide 2.4 mg as a once-weekly treatment for people with obesity. In the US, a priority review voucher was used, reducing the expected review time from 10 to 6 months. This gives the opportunity for US approval in mid-21. An EU decision is expected around the turn of the year.

Approval in Japan push to grow the once weekly treatment for adult growth hormone deficiency also known as <unk>.

<unk> is currently being investigated in the real full phase III trial for children and adolescence and these pivotal results expected around year end.

As we continue into 'twenty one there are a number of exciting clinical developments in the first half of this year, we expect to be proof of concept, we see proof of concept data for Miami, a bi specific antibody for subcutaneous prophylaxis treatment in people with hemophilia a.

Mads: In BioPharm, we just received a positive opinion in the EU and approval in Japan for Segroia, the once-weekly treatment for adult growth hormone deficiency, also known as somapatitan. GROIER is currently being investigated in the REAL-4 Phase 3 trial for children and adolescents, and these pivotal results are expected around June. As we continue into 2021, there are a number of exciting clinical developments. In the first half of this year, we expect to receive proof-of-concept data for MIME-8, a bispecific antibody for subcutaneous prophylaxis treatment in people with hemophilia A.

Obviously as chronic diseases. We also expect civil phase III initiations during this year, namely foresee macro tied to four milligrams weekly Nash and also macro site once daily in Alzheimer's disease as well as since you Vicki map in atherosclerotic inflammatory cardiovascular disease.

On a personal note I would like to round off my last roadshow out of many by mentioning that our wonderful company, including some with stakeholders like yourselves has been both my passion and my job for 30 years.

It will likely remain so in my new role as CEO of Illinois Foundation from where I expect to follow the future innovation to conclusive off Novo Nordisk very close I've treasured on many years of interactions and I will miss him going forward. Good luck stay safe and now over to you guys.

Mads: In other serious chronic diseases, we also expect several phase 3 initiations during this year, namely for semaglutide 2.4 mg weekly in NASH and oral semaglutide once daily in Alzheimer's patients, as well as Silti Vekimap in atherosclerotic inflammatory cardiovascular disease.

Thank you Ms. Please turn to slide 16.

In 2020 sales increased by 4% in Danish kroner and by 7% at constant exchange rates.

Mads: On a personal note, I would like to round off my last roadshow by mentioning that our wonderful company, including its liaisons with stakeholders like yourselves, has been both my passion and my job for 30 years. It will luckily remain so in my new role as CEO of the Novo Nordisk Foundation, from where I expect to follow the future innovation-driven growth of Novo Nordisk very closely. I have treasured our many years of interactions, and I will miss them going forward. Good luck, stay safe, and now it's over to you, Kasper.

Martin was unchanged at 83, 5%.

Sales and distribution costs increased by 3% and things Corona and by 6% at constant exchange rates the increase.

It was driven by global launch activities for <unk> and continued promotional activities for <unk> as well as rollout of <unk> in international operations.

R&D costs increased by 9% in Danish kroner, and tips and at constant exchange rates.

The increase is driven by amortization of the prior to review voucher for macro tightened obesity and the high activity level within other serious chronic diseases. Following progression of the early pipeline as well as patient recruitment for the ongoing cardiovascular outcome trials so in to that.

Karsten: Thank you, Maths. Please turn to slide 16. In 2020, sales increased by 4% in Danish kroner and by 7% at constant exchange rates. The Gross Martin was unchanged at 83.5%. Sales and distribution costs increased by 3% in Danish kroner and by 6% at constant exchange rates. The increase was driven by global launch activities for Rebelsis and continued promotional activities for Osempic, as well as the rollout of SACENDA in international operations. Priority costs increased by 9% in Danish kroner and 10% at a constant exchange rate.

Administration costs decreased by 1% in Danish kroner and increased by 1% at constant exchange rates, reflecting broadly unchanged spend across administrative areas.

Operating profit increased by 3% in Danish kroner and by 7% at constant exchange rates, resulting in an operating margin of 42, 6%.

Net financial items showed a loss of around 1 billion things kroner compared to a loss of $3 9 billion in 2019, driven by foreign exchange hedging contracts.

Come back to this in the following slides.

Net profit increased by 8% and diluted earnings per share increased by 10% to 18 cooler.

Karsten: The increase is driven by amortization of the priority review voucher for semaglutide and obesity and higher activity levels within other serious chronic diseases following progression of the early pipeline, as well as patient recruitment for the ongoing cardiovascular outcome trials, SOL and SELECT.

Free cash flow was 28, 6% to $28 6 billion Danish kroner compared to $34 5 billion contains kroner in 2019.

The decrease reflects business development investments of $16 3 billion Danish kroner from the acquisitions of <unk> and image here.

Karsten: Administration costs decreased by 1% in Danish kroner and increased by 1% at constant exchange rates, reflecting broadly unchanged spend across administrative areas. Operating profit increased by 3% in Danish kroner and by 7% at constant exchange rates, resulting in an operating margin of 42.6%. Net financial items showed a loss of around 1 billion Danish Kroner compared to a loss of 3.9 billion in 2019, driven by a foreign exchange hedging contract. I'll come back to this in the following slides.

Please turn to slide 17.

In 2020, Nynorsk returned approximately 37 billion Danish krone in the form of dividends and share buybacks to shareholders at.

At the annual General meeting on 20 <unk> of March.

2021.

Board of directors will propose a final dividend of five kroner and $85.

For total 2020 dividend of nine kroner and tenure.

And 9% increase from 2019.

In addition to the dividend 17 billion Danish kroner was used for the repurchase of shares.

Because consistently returned.

Free cash flow to investors through share buybacks and dividends with the dividends per share increasing for now 25 consecutive years.

Karsten: Net profit increased by 8%, and diluted earnings per share increased by 10% to 18 kroner. Precast flow was 28.6 billion Danish kroner compared to 34.5 billion Danish kroner in 2019. The decrease reflects business development investments of 16.3 billion Danish kroner from the acquisitions of Corvidia and Emissier. Please turn to slide 17.

For 2021, the board of Directors has approved a new share repurchase program of up to 17 billion to be executed during the coming 12 months.

The total program may be reduced in size in case of significant business development transactions during 2021.

Please go to slide 18.

Karsten: In 2020, Novo Nordisk returned approximately 37 billion Danish Kroner in the form of dividends and share buybacks to shareholders. At the Annual General Meeting on 25th March 2021, the Board of Directors will propose a final dividend of 5,85 Danish Kroner for a total 2020 dividend of 9,10 Danish Kroner, a 9% increase from 2019. In addition to the dividends, 17 billion Danish Kroner were used for the repurchase of shares. Novo Nordisk has consistently returned its free cash flow to investors through both share buybacks and dividends, with dividends per share increasing for now 25 consecutive years.

Tranche, one we continue to focus on top line growth with sales ex <unk>.

Expected to grow between five 9% at constant exchange rates.

The guidance reflects expectations for continued sales growth in international operations in line with the strategic aspiration of 6% to 10% growth.

As well as growth in North America operations.

On a therapy level. The guidance reflects continued sales growth within diabetes care, mainly driven by losses and growth within obesity care.

The guidance also reflects intensifying competition in diabetes, and biopharm and continued pricing pressure mainly within diabetes in the U S.

Operating profit is expected to grow between four and 8%, reflecting the sales growth outlook and continued investments in current growth drivers as well as pipeline assets to secure future growth.

As previously mentioned following the strengthening of the Danish kroner versus our main currencies reported sales and operating profit growth is expected to be 4% and 6% at constant exchange rates respectively.

Karsten: For 2021, the Board of Directors has approved a new CEAP repurchase program of up to $17 billion to be executed during the coming 12 months. The total program may be reduced in size in the case of significant business development transactions during 2021. Please go to slide 18.

The current COVID-19 pandemic causes uncertainty to the outlook regarding new patient initiations and societal impacts such as the unemployment rate in the U S, which is impacting health care insurance coverage.

Karsten: In 2021, we continue to focus on top line growth with sales expected to grow between 5 and 9% at constant exchange rates. This guidance reflects expectations for continued sales growth in international operations in line with the strategic aspiration of 6-10% growth, as well as growth in North American operations. On a therapy level, the guidance reflects continued sales growth within diabetes care, mainly driven by Olympic and rubella, and growth within obesity care. The guidance also reflects intensifying competition in diabetes and biopharm and continued pricing pressure, mainly in diabetics.

Financial items is now expected to be a gain of around <unk> 7 billion <unk> Corona I would get.

Back to the impact from currency movements in the next slides.

Capital expenditure is expected to be around 8 billion Danish kroner in 2021, primarily relating to investments in additional capacity for API production. Following the progression of R&D pipeline projects based on the all technology platform.

Lastly, free cash flow is expected to be between 36% and 41% in Danish kroner. Please go to the next slide.

The negative currency impact in 2020 reflects the Danish krone appreciation versus most foreign exchange rates.

This had a negative impact on operating profit, but it was partially offset by gains on foreign exchange hedging.

Karsten: Operating profit is expected to grow between 4% and 8%, reflecting the sales growth outlook and continued investments in current growth drivers as well as pipeline assets to secure future growth. As previously mentioned, following the strengthening of the Danish kroner versus our main currencies, reported sales and operating profit growth is expected to be 4 and 6% lower than at contract exchange rates, respectively. The current COVID-19 pandemic causes uncertainty regarding the outlook regarding new patient initiations and societal impacts, such as the unemployment rate in the US, which is impacting healthcare insurance coverage.

We are expecting similar developments in 2021, given the current spot rates.

And negative impact on operating profit of around 3 billion Danish kroner.

We expect hedging gains of $1 1 billion to any program mainly relates to the U S dollar with the hedging period 11 months and associated hedging costs.

And now also utilized for final remarks.

Thank you Carsten, please turn to slide 20.

We are very pleased with the progress on our strategic explorations in 2020, despite the challenges of COVID-19.

The financial results for <unk> sales growth in both international operations, and North America operations, driven by more patients using our tier one treatment.

Karsten: Financial items are now expected to be a gain of around 0.7 billion Danish Kroner. I'll get back to the impact of currency movements on the next slide. Capital expenditure is expected to be around 8 billion Danish Kroner in 2021, primarily relating to investments in additional capacity for API production following the progression of R&D pipeline projects based on the oil technology platform. Lastly, free cash flow is expected to be between 36 and 41 billion Danish Kroner. Please go to the next slide.

Within R&D key milestones in the fourth quarter, where the regulatory submission of <unk>, two four milligram, which has the potential to redefine the treatment of obesity.

In 2021, we'll continue our focus on commercial execution, while conducting more late stage clinical trial programs than ever to meet the unmet needs of people living with diabetes analysis constant thesis.

We are now ready for the Q&A kindly ask you to.

To limit yourself to two questions operator, we're now ready to take the first questions.

If you wish to ask a question. Please do so via questions. There one on your telephone keypad. If you wish to assure you question you may do so by Princeton Zero Kensal.

Karsten: The negative currency impact in 2020 reflects the Danish crown appreciation versus most foreign exchange rates. This had a negative impact on operating profit, but it was partially offset by gains on foreign exchange debt. We are expecting similar developments in 2021, given the current spot rate, and we are expecting a negative impact on operating profit of around 3 billion Danish Kroner. Additionally, we expect hedging gains of 1.1 billion Danish Kroner mainly related to the US dollar with a hedging period of 11 months and associated hedging costs. And now it is over to you, Lars, for final remarks.

Again, please press <unk>, one telephone keypad, if you wish saw similar to your question.

So can you please poll for questions to be registered.

Our first question comes from Pizza dough from Citi. Please go ahead.

Yes. Thank you.

Here from Citi, two big picture questions. So thats, given us last quarter conference call.

Lars Fruergaard Jorgensen: Thank you, Karsten. Please turn to slide 20.

Firstly can you just remind us Matt is on.

Lars Fruergaard Jorgensen: We are very pleased with the progress on our strategic aspirations in 2020, despite the challenges of COVID-19. The financial results reflect sales growth in both international operations and North America operations, driven by more patients using our GF1 treatment. Within R&D, key milestones in the fourth quarter were the regulatory submission of semiglutide 2.4 mg, which has the potential to redefine the treatment of obesity. In 2021, we will continue our focus on commercial execution while conducting more late-stage clinical trial programs than ever to meet the unmet needs of people living with diabetes and other serious chronic diseases. We are now ready for the Q&A, where I kindly ask you to limit yourself to two questions. Operator, we're now ready to take the first questions.

Broader technologies and timelines Novo is working to with respect to your stem cell therapy efforts.

He's asking the question in light of all the companies beginning to talk more about this area I just wanted to get a gauge how you're feeling with the vanguard of development, how you handicap.

Apologies you are using versus the competition.

And then secondly.

Usually when you ask your head of R&D to me the most promising part right assets.

We're very proud of the boring answer about having all of our children equally.

Youll heading off to a load of time Thats being CSO, perhaps talk more openly could you maybe just call out what you believe to be the most interesting.

An exciting early stage pipeline assets and the diverse portfolio and all the best going forward.

Yes.

Thank you Peter mess that was two questions for you.

Operator: Thank you. If you wish to ask an audio question, please do so by pressing 01 on your telephone keypad. If you wish to withdraw your question, you may do so by pressing 02 to cancel. Once again, please press 01 on your telephone keypad if you wish to ask an audio question. There will be a brief pause as we wait for questions to be registered. Our first question comes from Peter Werdorff from Citi, please go ahead.

And then Youre dialing.

Yes.

Yeah.

Yeah.

Okay.

Yeah.

Apology, there seems to be a technical issue. Please hello dwells so.

I'll start I'll start all over because that was a muted sorry Pete no.

Of course, I am still CSO for the remainder of February month. So there are limitations to how much I can't be specific on my pet projects I would say, though that our oral biologics biologics can you leadership position now that we also have made the misfit acquisition allows us to broaden out into very very exciting target areas in many different therapeutic areas and you can do.

Peter Werdorff: Yeah, thank you. Pete Biddle here from Citi. Two big picture questions for Mads, given it's his last quarterly conference call. Firstly, can you just remind us, Mads, of the sort of broader technologies and timelines Novo is working on with respect to your stem cell therapy efforts in diabetes? I'm asking the question in light of other companies beginning to talk more about this area. I just want to know, or get a gauge, how you're feeling, whether Novo is in the vanguard of developments, and how you handicap the technologies you are using versus the competition.

Things with all biologics that are not amenable to classical small molecule. So I'm very excited there without singling out one project, but you can imagine that if you take the.

The combination of Emily and sumac, the tide and I can now tell you the Emily's Coca Cola inside we are achieving WD too often impact women's light. So if you can take the greenside in semi and deploy that more or less in all of this when you're standing in a unique position. So these are kinds of the exciting things that you should be looking out for in the future, but in terms of the.

Peter Werdorff: And secondly, usually when you ask a head of R&D to name their most promising pipeline assets, you get a very bland and boring answer about loving all their children equally. Now, given that you're heading off to a well-deserved retirement from being CSO and perhaps can talk more openly, could you maybe just call out what you believe to be the most interesting and exciting early-stage pipeline assets in the Novo portfolio? Thank you, and all the best going forward.

The stem cells with the ambition that management has approved for the transformation research unit doing stem cells is one new clinical <unk> that is an investigational new drug application to every year. Starting this year. The first indication will be in Parkinson's disease and not in diabetes diabetes is going to come in the second piece of this.

It also means that you should imagine.

Towards the end of next year or thereabouts, depending on the progress I have to make the comment that the semi therapeutics company that was acquired by vertex.

Mads: Thank you, Peter. Mads, that was two questions for you, stem cell, and then your darling.

In the not too distant past they have announced that they are deploying initially a non encapsulated raw injection of stem cell derived beta cells that will call for the use of an immuno suppressive cocktail. So this kind of approach is nice for them to show proof of principle, you might argue but it is highly unlikely to deliver.

Operator: Yeah. Uh...

Operator: Apologies, there seems to be a technical issue; please hold whilst we solve the issue.

Mads: I will start all over again because I was muted. Sorry, Pete.

Mads: No, of course, I'm still CSO for the remainder of February month. So there are limitations to how much I can be specific on my pet projects. I would say, though, that our oral biologics leadership position, now that we have also made the MSphere acquisition, allows us to broaden out into very, very exciting target areas in many different therapeutic areas. And you can do things with oral biologics that are not amenable to classical small molecules.

Back to the market, which is also why the themselves are stating that the next generation product is using encapsulation and I may remind you that we did a <unk>.

Development, a research agreement with purpose the purpose and the Protium company, we're having the most elegant encapsulation device available for our beta cells and they are the ones that are now taking into toxicology trials aiming at the second indication being type one diabetes for the company.

And we hope maybe.

Mads: So I'm very excited about that without singling out one project. But you can imagine that if you could take the combination of amylin and semaglutide, and I can now tell you that amylin is called cagrilliontide. We are achieving WHO approval of the name cagrilliontide. So if you can take cagrilliontide and sema and deploy that more or less in all versions, you're standing in a unique position.

Celebrate that.

100, <unk> anniversary not of insulin in Toronto.

No it's comparable.

Got it thank you.

Thank you mentioned there was some good as their feed so next next question. Please.

Question comes from Raimo <unk> from Bernstein. Please go ahead.

Great. Thank you very much for taking my questions, we'll talk about it progressing firstly just congrats on the great success of Novo youll be missed.

Good luck in the new role at de Novo Foundation. So my first question is just on the onwards program for weekly incident.

Mads: So these are kinds of exciting things that you should be looking out for in the future. But in terms of stem cells, well, the ambition that management has approved for the Transformation Research Unit doing stem cells is one new clinical IND, which is an investigation new drug application every year starting this year. The first indication will be Parkinson's disease and not diabetes. Diabetes is going to come in the second place.

I kind of always assumed that you would want a relatively tight phase III program that was quite cost effective.

Quick speed to market. So it looks like quite a robust program as planned. So just your thoughts if anything has changed on the potential role of a weekly insulin.

And the royalty complaint in the basal market and if so was there any data that's driven that change and then my second question is just one on the guidance.

Mads: This also means that you should imagine an IND towards the end of next year or thereabouts, depending on the progress. I have to make the comment that the Sema Therapeutics Company, which was acquired by Virtex in the not-too-distant past, has announced that they are deploying initially a non-encapsulated raw injection of stem cell-derived beta cells that will call for the use of an immunosuppressive cocktail. So this kind of approach is nice for them to show proof of principle, you might argue, but it is highly unlikely to deliver a product to the market, which is also why they themselves are stating that their next generation product is using encapsulation.

And obesity.

The most impacted franchise within your portfolio from a COVID-19 perspective, given its highly discretionary so I'm just trying to get a sense of how novo think about the next six months with Tech Center and then the launch of semi in obesity should we be expecting a strong uptake in.

In the second half even in the Covid world given its significant given significantly superior to <unk>.

So just your thoughts on the launch there would also be helpful. Thank you.

Thank you reminder, mass first on the <unk> program.

So.

Originally we were anticipating a very slim program. Realizing that this was all items in an undifferentiated clinically speaking insulin pump with a attractive convenient and thereby adherence profile because it was once a week instead of once daily what we came to learn in the data that were published for instance in the inkjet of Medicine recently.

Mads: And I may remind you, Pete, that we did a development and research agreement with Professor Pappas and the Procyon Company for having the most elegant encapsulation device available for our beta cells, and they are the ones that are now being taken into toxicology trials aiming at the second indication being type 1 diabetes for the company. And we hope.

But one of the most critically important phase II trials was that we actually exceeded our own expectations for the molecule. This means that the capping of a molecule that we believe is clinically differentiated compared to for instance interesting clocking while at the same time be more convenient and the advent of new technology. If you look into the on what's five trial, we have done.

Mads: Celebrate that at the 100 year anniversary, not of Insulin Toronto, but of Novo Nordisk.

Peter Werdorff: Got it. Thank you.

Lars Fruergaard Jorgensen: Thank you, Mads, and there were some goodies there, Pete. So next question, please.

Real World evidence study with very very few clinical interventions quite few site visit it resembles very much a real world evidence trials and that means that you get an impression of how does this perform in the relapsed setting and integrating that with some new technology, where we have a electronic patient interaction device, which enables both dose guide.

Operator: Our next question comes from one more from Bernstein. Please go ahead.

Michael Bowers: Great, thank you very much for taking my questions. I'm Michael Bowers. First of all, congratulations on a great success at Novo, you'll be missed, and best of luck in the new role at the Novo Foundation. So my first question is just on the ONWARDS program for weekly insulin, iCodec. Now I kind of always assumed that you would run a relatively tight phase 3 program that was quite cost effective, ensuring quick speed to market, so it looks like quite a robust program is planned.

But also easy interaction remotely between physician patient and even the company collection of data for that matter. It has allowed us to do a slightly broader program than originally anticipated, but we are recruiting and thats high enthusiasm, we can see from the investigators and part of that of course is based on high impact publications with good data such as.

Michael Bowers: So just your thoughts, if anything has changed on the potential role of a weekly insulin and the role it could play in the basal market, and if so, was there any data that's driven that change? And then my second question is just one on guidance and obesity. You know, clearly this is the most impacted franchise within your portfolio from a COVID perspective, given it's, you know, highly discretionary. So I'm just trying to get a sense of what Novo thinks about the next six months for Saksenda and then the launch of Sema in obesity. Should we be expecting a strong uptake in the second half, even in the COVID world, given it significantly, you know, given it significantly superior to Saksenda? So just your thoughts on the launch there would also be helpful. Thank you.

So we're excited it's slightly broader program than we originally anticipated we apologize for that but it will also mean that we would get a more attractive level.

Thank you Ms Cumulus and perspectives on obesity.

Less so on obesity. There is no doubt that we will continue our efforts on developing the market as you recall from when we discussed last time, yes, 650 million people suffering from obesity, but only 10% of those actually seeking care and when they see care. It's only a fragment of dose that have been treated with <unk>.

Please proceed medication so from the 650 million down to less than a million being treated with <unk>. So there's still a lot to do on market development in the coming six months and hopefully that will also paved the way for a much more efficacious product.

Lars Fruergaard Jorgensen: Thank you very much.

Mads: Yes, Vimal, originally, we were anticipating a very slim program, realizing that this was, in all likelihood, an undifferentiated, clinically speaking, insulin but with an attractive convenience and, thereby, adherence profile because it was once a week instead of once daily. What we came to learn from the data published recently in the New England Journal of Medicine for one of the most critically important phase 2 trials was that we actually exceeded our own expectations for the molecule.

And connect with back to kind of fall with almost twice the secrecy of September so the awareness building their physician support and then of course also the peak utilization at some of the efforts that we are working on right now that hopefully will also be useful in a COVID-19 context, meaning that.

Online care for obesity.

It's something that we are also embarking on.

Thank you Camilla. Thank you of your house.

Thank you next question please.

Mads: This means that the coupling of a molecule that we believe is clinically differentiated compared to, for instance, insulin glycogene, while at the same time being more convenient, and the advent of new technology. If you look at the ONWARDS V trial, we have done a real-world evidence-like study with very few clinical interventions and quite few site visits. It resembles very much a real-world evidence trial, and that means that you get an impression of how this performs in a real-life setting, and integrating that with some new technology where we have an electronic patient interaction device, which enables both dose guidance, but also...

Next question comes from Simon Baker from Redburn. Please go ahead.

Simon Baker. Please go ahead with your question from Beckman.

Okay.

Simon it's unable to answer at this moment since we will proceed to our next question from Martin <unk> from Danske Bank. Please go ahead.

Hello, Martin Parka Danske bank two questions.

First one maybe just lastly.

Just on the market growth because you have talked a lot about your growth. This year are hurt by <unk>.

<unk> treatment starts on June one and so forth, but the reality is is that if you look at the reported growth for all of the diabetes companies in the world that has actually been quite strong growth rate I think that it's at the tune of 6% for the global diabetes market in 2020.

Unknown Executive: New Zealand

Camilla Sylvest: Thank you very much.

Camilla Sylvest: as well as Camilla from Perspectives on Obesity.

Camilla Sylvest: Yeah, thank you Lars. So on obesity, there's no doubt that we will continue our efforts in developing the market. As you recall from when we discussed last time, there are 650 million people suffering from obesity, but only 10% of those are actually seeking care. And when they do seek care, it's only a fragment of those that are being treated with anti-obesity medication. So from the 650 million down to less than a million being treated with Sexenta.

I remember back at your capital markets Day in 2019, you were looking for long term growth rate at the.

4% adjusting for the Januvia patent expiry so.

So what are you what are you.

So what's on why we have seen the strong growth is this due to higher beta compliance and.

Camilla Sylvest: So there's still a lot to do in market development in the coming six months, and hopefully, that will also pave the way for a much more efficacious product, called semaglutide 2.4, with almost twice the efficacy of Sexenta. So the awareness building, the physician support, and then, of course, also the digitalization are some of the efforts that we are working on right now that, hopefully, will also be useful in the COVID-19 context, meaning that online care for obesity is something that we are also embarking on.

How do you look into the world market going into 2021, and then the second question.

Of course have to be for fall for mass I just had a question to the <unk>.

On slide 13, and the higher doses after all some appetite.

Can you come a little bit because it's a little bit like comparing apples with oranges, because the 14 milligram are based on the old formulation and the $25 50 milligram are based on a new formulation. So.

Operator: Thank you. Thank you. Thank you. Next question, please. Our next question comes from Simon.

Operator: Our next question comes from Simon Baker from Redburn; please go ahead. Simon Baker, please go ahead with your question from Redbone. Okay, it appears Simon is unable to answer at this moment, so we'll proceed to our next question from Martin from Danske Bank. Please go ahead.

So in reality.

<unk> 50 milligram.

On the new formulation is properly correspond to more than 60 milligram on the old formulation.

Is that.

Martin Parkhoi: Hello, Martin Parkhoi, Danske Bank. Two questions. First one: maybe it's Lars or Camilla.

Correct and then.

What do you actually think this will match this is something we will.

Martin Parkhoi: Just on market growth, because you have talked a lot about your growth this year being hurt by less treatment starts on GILD 1 and so forth. But the reality is that if you look at the reported growth for all the diabetes companies in the world, then it's actually been quite a strong growth rate. I think that it's at the tune of 6% for the global diabetes market in 2020. And I remember back at your Capital Markets Day in 2019, you were looking for long-term growth rates of 4% adjusting for the January patent expiry. So, what are your thoughts on why we have seen this strong growth? Is this due to beta compliance? And how do you think the overall market will do going into 2021?

Currently approved Olympic dose or do you think that it can be all the way through the two points.

Milligram, but we have the data on the same slide.

Thanks, Thank you Martin.

There can be some perspectives on what we believe.

Our tier one growth.

It's actually for the Nokia one it's about the whole diabetes market okay.

Okay alright. Thank.

Thank you.

So on the whole diabetes market.

It's important when we talk about this treatments that is of course is we need to separate between existing treatments and also and new treatments is very.

In the light of COVID-19, so it's also important too.

I understand that as we add new and better treatments to a segment like we've seen in TLC, one that will be and we have seen increased growth rates.

Martin Parkhoi: And then the second question, of course, has to be for mass. I just had a question about the slide on slide 13, and about the higher doses of all somatotypes. Can you explain a little bit because it's a little bit like comparing apples and oranges because the 14 milligram is based on the old formulation, and the 25 and 50 milligram are based on the new formulation. So, in reality, the efficacy of 50 milligram on the new formulation is probably corresponding to more than 60 milligram on the old formulation.

S Mall and data treatment becomes available however, when we talk about less treatments staff, if they're mainly reflects on new launches.

As for existing products, we see a continuation of the existing trend and.

But the simple facts are that for new launches.

It is more difficult to get to the same atlantis level when in place. After the sales force is grounded. So I think I just think we have to separate between the two things but no.

Martin Parkhoi: Is that correct? And then what do you actually think this will match? Is this something that will match the currently approved Olympic dose, or do you think that it can be all the way to the 2.0 milligram that we have the data on on the same slide?

Better treatment options of course will drive a better underlying growth.

As we've seen.

Thank you and mass prospectus on hydro.

Zimmer.

Yeah, well the marketing, it's a very smart and crisp observation, you've made because we hate to waste too much time in R&D. So so we actually decided to embark on a very.

Camilla Sylvest: Thanks. Thank you. First, Camilla, some perspectives on what we believe about GLP-1 growth.

Rapid onset phase III trial for these high doses and it is also true that so called <unk>.

Camilla Sylvest: It's actually for the whole diabetes market.

Camilla Sylvest: Okay, hold tight, please, Mary. Yeah, thank you.

Type nine rebels as tepid, which is on the market represents the 40 milligram.

Camilla Sylvest: Thanks a lot. So, on the whole diabetes market, it's important, when we talk about less treatment stats, it's, of course, we need to separate between existing treatments and also new treatments in the light of COVID-19. So it's also important to understand that as we add new and better treatments to a segment, like we've seen in GLP-1, there will be, we have seen increased growth rates as more and better treatment becomes available.

Yes.

We are into one of the newer generations with the other ones.

These studies are rather long as you can see because we have the full 52 week.

In the maintenance period at steady state, making it a rather long trial and also a relatively big trial. So when we get data which is happening during the course of the next months on these new properties.

<unk> of these new tablet formulation.

Camilla Sylvest: However, when we talk about less treatment starts, it mainly reflects on new launches, whereas for existing products, we see a continuation of the existing trend. But the simple facts are that for new launches, it just is more difficult to get to the same awareness level when, for example, the sales force is grounded. So I think, I just think we have to separate between two things, but more and better treatment options, of course, will drive a better underlying condition, as we've seen in the video.

So of course, if you have a very bold I think the 25 milligram and the new formulation does fantastic stuff you might not need to go above that one we're just investigating a full dose response range you can argue and by the way are marching. The ambition is as you stated very correctly to go all the way to the two milligram simply sustain forte. If you could see level that is actually to talk about.

Camilla Sylvest: Thank you, and Mass. Perspectives on high-dose marijuana, all SEMA.

It just happens.

Very exciting thank you Matthew.

Mads: Yeah, well, Martin, it's a very smart and crisp observation you've made because we hate to waste too much time in R&D. So we actually decided to embark on a very rapid onset phase retrial for these high doses. And it is also true that the so-called type 9 reverses tablet, which is on the market, represents 14 milligrams, whereas we are into one of the newer generations with the other ones. These studies are rather long, as you can see, because we have a full 52-week treatment period at steady state, making it a rather long trial and also a relatively big trial.

Just follow up because I don't think that you answered my my first question, maybe I didn't.

I was just looking at the overall diabetes market and not to the point, we are seeing if you will.

Youre all debuted as Mike reported by all diabetes companies. It looks like we have had actually a quite good diabetes growth of around 6% report, which is more than the 4% that you have put into your long term aspirations. So what's happening there.

Is this driven by our high compliance rate you can see that the instrument growth in international region has been much higher than than historic growth rates.

Mads: So when we get data, which is happening during the course of the next months, on these new properties of these new tablet formulations, we are actually able to correct for that before we have, you can see, the completion of such a trial. It is actually possible, via bioequivalence and those kinds of simulations and data, to actually exchange one tablet with another. So you have the go-to-market tablet ultimately generating the pivotal data.

So have you seen the high compliance, meaning that people have been because diabetes is a risk factor due to COVID-19.

Victor by COVID-19, so people maybe after you bolt compliant and does that mean that 2020 on the Mako spectrum, maybe back to the surf is a tough comparison.

Mads: Another option is, of course, if you are very bold; I think the 25 milligram in the new formulation does fantastic stuff; you might not need to go above that one. We are just investigating a full-dose response range, you can argue. And by the way, Martin, the ambition is, as you stated very correctly, to go all the way to the 2 milligram Osempic Sustain 40 efficacy level. That is actually the target for this tablet.

Thank you Martin I know you do some detailed research in this area and I know that Cosmos details that he would like to make a comment on it.

So not so much in the first of all we talked about comparing apples and oranges. So the 4% we presented at <unk> that was in the IMS.

<unk>.

New market growth and what we have yes.

Company reported and one is kept CAGR and then other one as it is for one year. So so just to say that there are a couple of differences and data as I'm sure you understand.

Mads: Very exciting. Thank you, Mesh.

That said then.

Martin Parkhoi: Can I just follow up? Because I don't think that you answered my first question. Maybe I...

And then Youre correct.

Solid diabetes smart growth and we're growing faster than the market I should see it at 8% and despite COVID-19.

Martin Parkhoi: I was just looking at the overall diabetes market and not just one. We have seen if you look at the overall diabetes market reported by all diabetes companies, it looks like we have had quite good diabetes growth of around 6%, which is more than the 4% that you have put into your long-term aspirations. So I'm just wondering, how is this driven by a high compliance rate? You can see in the insulin insulin growth in international rates has been much higher than historic growth rates.

So we have also been surprised around how resilient, our diabetes care businesses and of <unk>.

It's a function of it.

Talking about chronic therapies so.

So patients on treatments when we look at.

At adherence data on therapy adherence data in terms of impacting the usage, we have not been able to prove statistically that the that it has increased during COVID-19.

Martin Parkhoi: So have you seen high compliance, meaning that people have been, because diabetes is a risk factor due to COVID, if you are infected by COVID-19, so people might have been better maybe have been more compliant. And does that mean that, on a market perspective, maybe actually serve as a top comparison?

And then the final comment is that.

I mean, that's it so so where we do see the main the main impact is on the Orange, France, and then you could say.

As a physician and when you are initiating treatment.

And you are not too familiar with the new brand because you have not.

Martin Parkhoi: So, Martin, I know you do some detailed research in this area, and I know that Karsten has written in detail, so he would like to make a comment on that.

I had too much education from from sales reps on on the product then you will start patients on a different.

More kind of classic product B that will simply go victoza.

And I guess in particular around 2020 total place isn't that there was some stock building in the beginning of the year and part of that.

Karsten: Yeah

Karsten: So Martin, first of all, we talked about comparing apples and oranges. So the 4% we presented at our Capital Markets Day was an IMS or IQVIA-based value market growth. And what you have here is company data, and one is CAGR, and another one is for one year. So just to say that there are a couple of differences in data, as I'm sure you understand. That said, then you're correct.

Citigroup patients.

How big a share that is but that's probably also a patient thank.

Thank you I hope that that's fine.

So I'm just thinking on Mike's question.

Thank you. Our next question comes from Sachin Jain from Bank of America. Please go ahead.

Karsten: There's solid diabetes market growth, and we're growing faster than the market, as you see, at 8% and despite COVID. So we have also been surprised by how resilient our diabetes care business is. And of course, it's a function of we're talking about chronic therapy. So patients are on treatment. When we look at the adherence data on therapy, adherence data, in terms of impacting usage, we have not been able to prove statistically that it has increased during COVID.

Hi, Sachin Jain from Bank of America. Thanks for taking my questions. Firstly, just to echo prior comments, Matt. Thanks, Willie insights ideas and best of luck with the next benches I see financial questions first if I may I'm, sorry cost and firstly one of the key Delta is within the guidance range, which is slightly wider than usual I guess investors. This morning of gravitate to the top.

And given your usual conservatism at this time I was wondering if just outlines some of the factors within that range and then related the guide seems to imply U S growth.

Karsten: And then the final comment is that, as Camilla said, where we do see the main impact is on launch brands. And then you could say, as a physician, and when you're initiating treatments, and you're not too familiar with a new brand because you haven't had too much education from sales reps on the product, then you will start the patients on a different, more kind of classic product, be that Ozempic or Victrosa.

Mid single digit range versus commentary, obviously, you won't see year and half ago excuse me around two so could you give some color on variables within that and I guess, most importantly won't be seen for 340, b and risk of that benefit being realized.

Karsten: and I guess in particular around 2020, it also plays in that there was some stock building at the beginning of the year, and part of that is still sitting with patients. I'm not sure how big a share that is, but that probably also plays in. Thank you. I hope that satisfies you, Marshal, and we'll move on to the next question.

And then just one for Matt if I may.

<unk> phase one two data this year expectations from that data set where you see differentiation and how quick could a phase III program be run that thank you.

Operator: Thank you. Our next question comes from Satyen Jain from Bank of America. Please go ahead.

Thank you for such an first constant on the guidance for 'twenty one.

Sachin Jain: Hi, Sachin Jain here from Bank of America. Thanks for taking my questions.

The range U S growth.

<unk> 33 for the year.

Sachin Jain: Firstly, just to echo prior comments, massive thanks for all the insights over the years and best of luck with the next ventures. Actually, financial questions first, if I may. So for Karsten, firstly, what are the key deltas within the guidance range, which is slightly wider than usual? And I guess investors this morning have gravitated to the top end, given your usual conservatism at this time of year.

Yep.

Thank you for that question. So so first of all on the ranges.

You can say.

Our planned rate range is wider than that than a year ago, but given COVID-19 I don't think.

That is unusual or anything like that and historically, we've also have to hit a.

Four point, so so I think you should just consider that.

Sachin Jain: So why don't you just outline some of the factors within that range? And then, related, the guide seems to imply US growth in a sort of mid single-digit range versus commentary, obviously, almost a year and a half ago for this year to be around too. So could you give some color on variables within that? And, I guess most importantly, what have you seen for 340b and the risk of that benefit being realized?

In the current environment.

That's kind of.

Range.

Given the Covid uncertainty.

As to your question on U S growth.

So with that with five to nine in our rates and <unk> seven at the midpoint.

Then the starting point.

Is that.

We have indicated in our strategic aspirations that we aim at the Io growing between six and 10% and for the last couple of years, we've been in the high end of that range or even slightly up often in 19.

Sachin Jain: And then just one for MADS, if I may, MIM-8, Phase 1, 2 data this year, expectations for that data set, where you see differentiation, and how quick could a Phase 3 program be run there? Thank you.

So if you assume.

Io somewhere in that range, then implicitly that would entail that debt.

U S growth.

For next year will be higher than West coast was in 2020. So so so we do see a step up in U S growth in 'twenty 'twenty, one compared to 2020.

Karsten: Thank you, Sachin. First, Karsten, on guidance for 2021, the range, U.S. growth, and potential clarity on 340B.

The building blocks on that on the step up step up in that growth is first of all we have.

Karsten: Yeah, so thank you for that question, Sachin. First of all, on the ranges. You could say our top-line range is one notch wider than a year ago, but given COVID, I don't think that is unusual or anything like that. And historically, we've also had four points. So I think you should just consider that, you know, in the current environment, as kind of a normal range, given COVID uncertainty. As to your question on U.S. growth...

A couple of tracks in the in our 2020 performance.

There will be in the base in 2021, being a donut hole and the step up in our affordability offerings in the U S.

As one key points then.

And then we do see.

Continuation of.

Karsten: So with 5 to 9 in our range, and you take 7 as a midpoint, then the starting point we take is that we have indicated in our strategic aspirations that we aim for IEO growth between 6 and 10%, and for the last couple of years, we've been in the high end of that range, or, for next year, will be higher than U.S. growth was in 2020. So we do see a step up in U.S. growth in 2021 compared to 2020.

Our underlying performance in tier one business and in our.

Insulin business and then specifically to 340 <unk>, yes.

Yes, we have included in our guidance.

Positive effects from 340, B, we have changed our 340 P shipping principles as of first of January 2021.

And.

As you know historically when we have been.

Being more explicit around the specific impacts to our business.

S business, we have commented specifically when we've had impacts I would say, 3% up greater you remember the historic Donut hole.

Karsten: Building blocks on the step up in that growth are, first of all, we have a couple of drags in our 2020 performance that will be in the base in 2021, being donor toll and a step up in our affordability offerings in the US, as one key point. Then, we do see a continuation of our underlying performance in TF2-1 and in our insulin business, and then specifically to 340B. Yes, we have included in our guidance a positive effect from 340B.

Mid last year U S unemployment.

At 3%, so so since we're not calling out specifically.

340 <unk> positive.

Positive impact next year, you can assume that that's because it's less than 3%.

A positive impact on growth next year.

Thank you okay. Thank.

Thank you Carsten and maybe some perspective on on Miami.

Yes, absolutely so.

Karsten: We have changed our 340B shipping principles as of the 1st of January 2021, and as you know, historically, when we have been being more explicit around specific impacts to our business, that US business. We have commented specifically when we've had impacts; I would say 3% or greater. You remember the historic donor toll or mid last year, US unemployment was at 3%. So since we're not calling out specifically 340B positive impact next year, you can assume that that's because it's less than 3% positive impact on growth next year.

Thanks for the kind words that you in a couple of comments on the technology. What we did was to license. The so called dual body technology from the Genmab company in Denmark, and then we did not own discovery efforts to come up with what we call an optimized second generation factor eight mimicking bi specific antibody of the ITT force of class and we.

We've optimized on three.

Horizon, one being potency and why its potency interesting it's interesting because while you may see some airplanes that you have to have brought the high injection volumes, calling for some injection site reactions and rather thick needles et cetera, et cetera, but with a high potency, we can deliver low volume and that will lend itself to a single use thin needle.

Karsten: Thank you, Karsten, and Mads. Some perspectives on MIME-AID.

Mads: Yes, absolutely. So, thanks for the kind words, Sachin.

Ready to use device with a very simple administration. We then also optimized for efficacy and you might have read the paper in the circulation journal, where we actually I believe that people have shown that in severe bleeds.

Mads: A couple of comments on the technology. What we did was to license the so-called dual body technology from the GenMap company in Denmark. And then we've used it in our own discovery efforts to come up with what we call an optimized second generation factor eight mimicking by specific antibodies of the IgG4 subclass. And we've optimized it on three horizons, one being protein Why is potency interesting? It's interesting because with imicizumab, for instance, you have to have rather high injection volumes, calling for some injection site reactions and rather thick needles, etc, etc.

In animals that are used to decide where you actually have a rather severe COPD.

System App show to say.

Efficacy, but this one did and it's probably because <unk> has the ability to very potently stop tissue factor induced bleeding episodes, which is a very unusual parameter.

Why is there might be an upside this might be difficult to call out the phase III trials because the.

Haven studies by the Roche company were done in a very smart way vis vis.

Mads: But with a high potency, we can deliver a low volume, and that will lend itself to a single-use, thin-needle, ready-to-use device with a very simple administration. This might be difficult to call out in a phase 3 trial because the HAVEN studies by the Roche company were done in a very smart way vis-à-vis how bleeding was registered, and so on. So that means that we are also planning to do some early real-world evidence insights into actually showing real-world differences between imicizumab and our new MyMate molecule, but more about that a couple of years from now.

How bidding.

Was registered so and so that means that we are also planning to do some early real world evidence insight into actually showing real world differences between you may see some app and you might meet molecule, but more about that a couple of years from now the final thing we've tried to optimize safety in that we have designed a molecule that can only really find when you are.

Having an <unk> service. So if you have certain leading pack the nine and 10 in the free state there will be no binding of the antibody and hence no risk of intramuscular calculation. So we actually believe that at least based on animal and that data. We have a very strong offering and we are targeting proof of concept. This all might be if that looks good.

Mads: So we actually believe that, at least based on animal and lab data, we have a very strong offering, and we are targeting proof-of-concept this summer, and if that looks good, we will then initiate phase 3 immediately.

And if that looks good we will then initiate phase III immediately.

Mads: Thank you.

Excited thank you can I just go back to the first question comes from the question on the guidance range is more what are the key factors seem top and bottom.

Sachin Jain: Can I just go back to the first question, Karsten, the question on the guidance range was more about what are the key factors between top and bottom. If you are able to comment on that, thanks.

Well to comment on that thanks.

Karsten: Yeah, okay, sorry, then I may have misunderstood your session there. So, so the key practices, I would say, are fairly the classic ones. So, IO growth is, of course, something that, you know, given potential health care reforms in different geographies, which can, if nothing happens, can, can pull it up. And, and if we have significant health care reforms, can, can, can pull it down compared to, compared to our base case.

Yeah, Okay, sorry, I misunderstood your search and so and so the key practices.

I would say is fair value the classic one Sam so so Io growth. This is of course, something that given potential health care reforms in different geographies, which can there.

If nothing happens can can pull it up and if we have significant health care reform.

Can can put down compared to compared to our base case.

Karsten: Then we have our launch products, which for this year mainly will be the global rollout of Rebelsis, which can impact our guidance. There's always an uncertainty on launch products, and and then COVID-19 you know you read kind of the same media I'm sure as we do in terms of the expectations around a vaccine and and the second third wave and and all that so so there will be some uncertainty related to to COVID-19, and I think that would be kind of the main uncertainties and 340B is perhaps the last one I'll call out since it's kind of there's some uncertainties regarding the legal situation as to 340B and some legal proceedings ongoing.

And then we have our launch products.

So far this year will be the global rollout of <unk>.

Can impact our clients is also that's always an uncertainty on our launch products.

And.

And then the COVID-19, you know you read kind of the same media I'm sure as we do in terms of the expectations around the vaccine.

In the second third wave and all that so that will be.

Some uncertainty related to COVID-19.

And.

I think that would be kind of the main uncertainties.

340 B.

As perhaps the last one I'll call out.

Since it's kind of fair.

Yes.

Uncertainties regarding the legal situation.

300, <unk> and some legal proceedings are ongoing.

Karsten: Very good, thank you.

Alright, thank you.

Operator: Thank you, guys, and thank you. Our next question comes from Chongyun.

Thank you Scott and thank you Sachin.

Next question next question comes from Trung Nguyen from Credit Suisse. Please go ahead.

Operator: from Credit Suisse, please go ahead. Hi guys, it's Trung from Credit Suisse.

Hi, guys. Its turn from credit Suisse. First question is simply on the timings of the data of that high dose or <unk> study. If we have a look at Clinicaltrials Gov.

Trung: The first question is simply on the timing of the data for that high dose oral SEMR study. If we have a look at clinicaltrials.gov, it schedules it for early 2023. But could, you know, could this come a bit earlier with some faster recruitment? Because presumably, this is pretty key to compete with things like Pfizer's oral GLP-1 and Tazepatide, which are on the horizon. My second question is on Ribelis. So could you perhaps talk about the coverage of Ribelis that you have within Europe, in terms of price and access? And then there are the US?

<unk> set for early 2023.

But could you.

Could this come a bit earlier with some faster recruitment because presumably this is pretty key to compete with things like the sizes.

One does appetite which are on the horizon.

Second question is on <unk> so can.

Can you perhaps talk about the coverage of <unk> balances that you have within Europe in terms of the price and access and then on the U S is the level of patient assistance support required coming down as you start 2021.

Trung: Is the level of patient assistance support required coming down as you start 2021? And then, finally, Mads, we wish you the best for the future. Jo, who's tied up with some other results, who's known you the longest on this team, would like me to pass on her thanks, specifically for their endless discussions on oral insulin over the last 20 years, even if you are retiring before Novo finally succeeds at that. Thanks very much.

And then finally just.

We wish you the best for the future, Joe who is tied up with some of the results whose name you. The longest on this team would like me to pause on that thanks.

Pacifically for the endless discussions on oral insulin over the last 20 years, even if you are retiring before they finally succeeds in that thanks very much.

Mads: Thank you, John. Max, first, on the timing of all the seminars without getting too excited on the way out.

Thank you John.

Mess first on.

Timing of all without getting too excited on the way out.

Mads: Yes, I promised my boss not to be too excited. By the way, say hello to Jo and remind her that my former boss, also called Lars, and I had endless discussions about what was most likely to happen, oral GFP1 or oral insulin. And one of them happened, and one of us supported that one. But do say hello to Jo from me.

Yes, I promised my boss not to be too excited and by the way I say Hello to Joe and remind her that my Boston My former boss also called loss and I, We had perpetual discussions about what was the most likely to have them all tier one oral insulin and.

And one of them happened in one of our support at that one so but to do say Hello to Joe from me.

Mads: When it says early 23 on clinicaltrials.gov, we have to remind ourselves this is a rather big trial. We want to have this as pivotal data for a new dosage indication. And we are living in COVID-19 times, even though recruitment is going quite well across our pipeline. It is, of course, hurt a little bit by COVID. And also, bear in mind that this is a long treatment study. We have a full 68-week period plus some end-of-study follow-up. So I think you should, for now, follow the guidance found on clinicaltrials.gov.

When is this early 'twenty three on clinical trials Gov, we have to remind ourselves. This is a rather big trial, we want to have these as pivotal data for a new dosage indication and we are living in COVID-19 times, even though recruitment is going quite well across our pipeline. It is of course or hurt a little bit by Covid and.

Also.

Bear in mind that it's a long treatment study we have a full six to eight week period plus some in the study follow up so I think you should for now followed the guidance seen in clinical trials Gov, and then there are pluses and minuses to that but we realize we want to be out in the marketplace. The high if you're all biologic.

Mads: And then there are pluses and minuses to that. But we realize we want to be out in the marketplace with a high-efficiency oral biologic, whatever the dose becomes, that is superior to what we could expect to see from competition. And we'd rather do it sooner than later. So it's a high-priority project.

Whatever the dose becomes that is superior to what we could expect from competition and we'd rather do it sooner than later, so it's a high priority project.

Camilla Sylvest: Thank you, Mads. And Camilla, some perspectives on the Brussels launch, the EU, and the U.S.

Thank you Miss and can be lessened perspectives on Victoza launch EU and fewer exits.

Unknown Executive: [inaudible]

Yes, so in.

Camilla Sylvest: Yes, so in the EU, the coverage is, in general, on par with the injectable GLP-1, and that means that in most of the countries where we have launched now, we do have access at a fully reimbursed level to prices on par with the GLP-1 waffle. In the U.S., we are now at a stage where the majority of the reversal scripts are reimbursed, reflecting the broad market access level we have, which is around 90% now. So that's the short status. And then, of course, we're excited to launch in Japan very soon, where we have also obtained access to and full reimbursement.

You the coverage.

Jacob.

We won and that means that the.

Most of the countries, where we have known now we do have excess ex and fully reimbursed.

Hi, this is on par with <unk>.

In the U S. We are now at a stage where the majority of it was also sweeps we impaired.

Reflecting the broad market access level, we have which is about 19, 90% now so that's.

That's the shelf status and then of course, we excited.

To launch in Japan, very soon but we have also obtained.

Access and truly investment.

Operator: Thank you, Camilla, thank you Mads, and thank you John. Next question, please.

Thank you Camilla. Thank you Ms. Thank you John next question. Please.

Operator: Our next question comes from Simon Baker from Redburn. Please go ahead. Simon Baker from Redburn, please unmute your microphone and please go ahead with your question.

Our next question comes from Simon Baker from Redburn. Please go ahead.

Yeah.

Simon Baker from Redburn. Please submit your microphone and please go ahead with your question.

Operator: We move on to our next question from Michael Novo from Nordia. Please go ahead with your question.

Okay.

Our next question from Michael <unk> from.

From Nordea. Please go ahead with your question.

Michael Novod: Thanks a lot. This is Michael Novod from Rodeo.

Thanks, a lot it's Michael Overfond idea.

Michael Novod: First of all, a question about the CAPEX expansion. So it comes rather soon after you sort of complete the expansion, the large expansion in the U.S. So how comfortable are you with the current expansion plans and what you have sort of put into your demand, your demand schedule for Somatotrite going forward? How far does this take you in terms of your projections on the demand for all SEMA across the different indications?

First of all.

Question, two is with the Capex expansion so.

It comes rather soon after you sort of complete the expansion and the largest banks in the U S. So.

How.

Comfortable are you with the with the current expansion plans and what you sort of put into your demand.

The demand schedule for willful some appetite going forward.

How far does this take you in terms of your projections on the demand for <unk> across the different indications.

Michael Novod: and then secondly on iCodec and also circling back to the previous question regarding market growth, how do you see iCodec going forward and also bearing in mind the larger Phase 3 program? Is this more a market share game globally? Or is it also a market volume growth game with the world? Is it even a potential market expansion game in the US and, also on the value side, whether it can drive additional value to the US insulin market?

And then secondly on Iclusig and also circling back to previous question regarding market growth. How do you see I could take going forward and also bearing in mind the larger.

Phase III program is this more a market share game globally is it also a.

Market volume.

Gross game rest of World is it even a potential market expansion game in the U S. And then also on the value side, whether you can drive additional value to the U S market.

Karsten: Thank you, Michael. First, Karsten, on CapEx, all SEME, and how far that will get us.

Thank you Michael first cost on.

No capex, all summer and how far that will get us.

Karsten: Yeah, thanks, Michael, for this question. As we said, historically, then, if we had to upgrade our CAPEX from, I would say, around 6 billion DKK per year, as we discussed at Capital Markets Day, if we had to up it from there, then it would be based on a positive pipeline progression. And that's in relative terms what we're seeing here.

Yeah.

Thanks, Michael for.

This question so as we've said historically.

Then the.

If we had to upgrade.

Our capex from the from the I would say around $6 6 billion DKK per yes, we discussed that the caps remarks day, if we had to operate from that and then it would be based on a poll.

Positive pipeline progression and that's in relative to what we're seeing here. So so.

Karsten: So the current status on our CAPEX project is that we're in the final phases in term before we get moved to a regulatory site submission to the FGA of our site in the US. So all the main construction and construction companies are pretty much off the site. So it's quality approvals that are currently outstanding before we can start producing from the first parts of the factory, being purification. And then later on, we'll be able to go live with fermentation and recovery also.

The current status on our Capex projects so to say.

That we are in the in the final phases in terms before we get moved to a regulatory side submission to the FDA.

Of our site and in the U S. So so all the main construction and construction companies are pretty much off the site. So so it's a quality approvals.

I will say that that are currently outstanding before we can start producing from from the first parts of the factory being purification and then later on it.

We'll be able to go live with the <unk>.

The presentation and recovery or so so so that project is as following.

Karsten: So that project is following the plan that we laid out. What we are now contemplating and the reason why we are upping our CAPEX forecast is that with the pipeline projects that we have told about, now we just talked about high dose all summer and you heard about our Alzheimer phase 3 trial late last year that we intend to initiate, then the reason why we are upgrading our capacity is basically to meet the potential demand on some of these pipeline projects and also potential pipeline projects on the same platform which are not publicly disclosed at this point in time.

That we laid out.

What we are now contemplating and the reason why we are upping, our capex forecast is that the.

With the pipeline projects.

We have talked about and that we just talked about hydro all summer and you heard about.

Alzheimer's phase III trial.

Last year that we intend to initiate than that then the reason why we are upgrading our capacity is basically true to meet the potential demand on some of these pipeline projects and also potential pipeline projects on the same platform.

Which are not publicly disclosed at this point in time.

Lars Fruergaard Jorgensen: Thank you, Karsten. If I should give some perspectives on the iCodec. It's clear when you see the dynamics in the diabetes market today, the swing we've seen in GFP1 category going from daily to weekly, if you think about the physician setting where you have a patient that's looking for intensified treatment, it's clear that if you can develop a product that gives a clear benefit in terms of weekly profile, but also higher time and, After that, the lower need for glucose monitoring, I think we have potential to actually make a significant step up in how insulin is used.

Thank you Carsten.

Give some perspective on the <unk>.

It is clear when you see the dynamics in the diabetes market today.

The swing machine and Juniper, one category going from from weaker to I'm, sorry from daily to weekly.

If you think about the physician setting where you have a patient that.

Looking for intensified treatment.

It's clear that if you can develop a product.

Debt.

Gifts.

Benefit in terms of weaker profile, but also higher time and range. This is a significant opportunity.

To that.

Lower need for glucose monitoring I think we have potential to actually make a significant step up in how insulin is used and.

Lars Fruergaard Jorgensen: And still, insulin is the most efficacious way to treat diabetes, and there's a significant unmet need today if you ask people using insulin. So I think we have a great opportunity. Obviously, we need to see the phase three program, but I think we have an opportunity to both enlarge the market for the use of insulin and, obviously, also take share because this is, hopefully, a differentiated product, both from a convenience and a clinical profile point of view.

Still introducing notifications way too cheap to treat diabetes.

And there are significant unmet needs.

Today, if you ask people who are using insurance.

So I think we have a.

Right opportunity, obviously, we need to see the phase III program.

I think we have an opportunity in both.

In lodging.

The market for use of insulin and obviously also taking share because this is a.

Mike.

Hopefully.

Your friend traded product both from a convenience and a clinical profile point of view. So it's a project that I'm really.

Lars Fruergaard Jorgensen: So it's a project that I'm really glad we have, and I strongly believe there is a role for insulin in the future, and that we can significantly increase innovation height, redefine that market, and add to that our glucose sensitive insulin program. Thank you, Michael, and we have time for one final set of questions. Our next question.

Clearly, we have and I strongly believe there is a role for insurance in the future and that we can significantly increase innovation height, we define that market.

So that's our newco sensitive instrument program.

Thank you Michael and we have time for one final set of questions.

Next question comes from Richard <unk> from Jpmorgan. Please go ahead.

Operator: Our next question comes from Richard Vosser from J.P. Morgan. Please go ahead. Just going back to the Rybaltis launch in Japan, perhaps you... Richard, please unmute your mic.

Just getting back to the right doses launch in Japan.

Richard Please on mute you Mike.

Richard Vosser: [inaudible]

Richard Vosser: Can you hear me?

Can you hear me.

Richard Vosser: Yes, now we can.

Yes, now we can.

Okay excellent sorry about that.

Richard Vosser: Okay, excellent. Sorry about that.

So just going back to the <unk> launch and.

Richard Vosser: So just going back to the iBelsys launch and thinking about the launch in Japan, and how we should think about that launch relative to the uptake in the US. Clearly, there's not much COVID in Japan, but there is also the OAD market in Japan. Maybe give us some idea of the sizing of that relative to the GLP-1 market in the US and the opportunity you see there. And then, second question, just thinking about if we can have an update on PCSK9 and other options there to add on within the SNAC technology with semaglutide. Maybe how many things can you co-formulate and maybe an update on PCSK9? Thanks very much.

The launch in Japan.

And how we should think about that reality.

Relative to the uptake in the U S.

Clearly there is not much COVID-19 in Japan, but also.

The Lady market in Japan, maybe.

Maybe give us some idea of the sizing of that relative to the the GOP on market in the U S.

Opportunity you see there.

And then second question just thinking about.

If we could have an update on the <unk> canine.

And the other options there.

To add on with it.

In the.

The snap technology.

With similarly tight may.

How how many things can you kind of formulate and maybe an update on <unk>. Thanks very much.

Camilla Sylvest: Thank you, Richard. Camilla, first, some perspectives on Lawrence of Rebellion in Japan.

Thank you Richard.

First of all perspectives on long haul business in Japan.

Camilla Sylvest: Yeah, so we're quite excited about the launch of Rebelsis in Japan because the OAD market, as you know, is 80% of the diabetes market in Japan. The GLP-1 market in Japan is still at less than 10%, so there is a big opportunity here, of course, to expand the treatment of GLP-1 with Rebelsis.

Yes.

I'm excited about the launch of the doses in Japan, because the <unk> market as you know is 80%.

The diabetes market in Japan.

The <unk> one market in Japan.

And the size of less than 10%.

The opportunity here of course to expand.

Treatment of TLC one.

<unk> and <unk>.

Camilla Sylvest: And we are planning for, of course, launching very soon from now. And we are, of course, also building on many of the experiences we've had in other markets. But we have also co-teamed up with Merck, MSC, to make sure that they can help us co-promote with others in the primary care space, where they have a lot of experience, where we primarily have had experience in the injectable segment.

Planning Paul of course, and launching it very soon from now and be and of course also building on many of the experiences we've had in other markets, but we have also teamed.

<unk> MST.

To make sure that they can help us co promote <unk> in the primary care space, where they have a lot of experience, where we primarily up until now have had experience in the injectable.

Mads: Thank you, Camilla, very exciting, and then Mads, ending up on the speakers at 2.89.

Thank you camilo very exciting and didn't mess anything up.

Consistent yes.

Mads: Yeah, and I think maybe, Richard, I'd rather take general perspectives on the oral platform with SNAC and other enhancers we are deploying, because at this point in time, we have a great many options for peptides up to the size of approximately 10,000 Dalton, i.e., 10 KD, that seem to lend themselves to varying degrees to being bioavailable vis-à-vis the newest generations of our SNAC We are actually on to the fourth generation in that regard, and PCSK9 is one option. We have many, and we'll keep you updated as we one by one enter them into the clinic, or not we, as the company enters them into the clinic one by one over time. Thanks.

And I think maybe Richard I'd, rather take general perspective on the Oracle.

Platform with snack and other enhancements we are deploying because at this point in time, we have a great. Many options for peptides up to the size of approximately 10000 Dalton I E 10 Kt.

That seem to lend themselves to varying degrees.

Two by available vis vis the newest generation. So ill pass next technology, we are actually onto the fourth generation in that regard.

And pieces can I is one option, we have many and we'll keep you updated as we one by one into them into the clinical.

As the company interest them into the clinic, one by one over time.

and I can confirm we will update you. So this concludes our earnings call. Thank you for participating, and feel free to contact our investor relations officers should you have any follow-up questions. Thank you very much, and have a good day.

And I can confirm we will update you.

Progress. So this concludes our earnings call. Thank you for participating in context.

Contact our Investor Relations officers.

Any follow up questions. Thank you very much and have a good day.

Yeah.

Okay.

[music].