Q4 2021 Novo Nordisk A/S Earnings Call
Speaker 1: Hello and welcome to the Q4 2021 Novanova Disc AS Earnings Conference Call.
Hello, and welcome to the Q4 2021 Novo Nordisk <unk> earnings conference call throughout.
Speaker 1: Throughout the call, all participants will be in a listen only mode. And afterwards, there will be a question and a session.
Throughout the call all participants will be in a listen only mode and afterwards, there will be a question answer session.
Speaker 1: Today I'm pleased to be able to go ahead with your meeting.
Today I'm pleased to present loss will go Johnson. Please go ahead with your meeting.
Okay.
Speaker 2: Thank you very much. Welcome to this No Noise Earnings Call for the full year of 2021 and our look for 2022. I'm Lars Rohgard Dawgmsen, the CEO of the COS.
Thank you very much welcome to this earnings call for the full year of 2021 and outlook for 2022.
Industrial got Jorgensen, the CEO of Novo Nordisk.
With me today I have executive Vice President head of commercial strategy and corporate affairs commuters from this executive Vice President and head of product supply.
Speaker 2: With me today I have Executive Vice President and Head of Commercial Strategy and Corporate Affairs Camille Svalvesse. Executive Vice President and Head of ProxyPlay Henrik Wul.
Extensive vice President head of North America operations, Dr. Langer, Executive Vice President and head of development margin hugs.
Speaker 2: Activative vice president and head of North America, operations, dark lange. Activative vice president and head of development, Martin Holst, lange. And finally chief financial officer, Karsten Mung Knuthen. All presented as would be available.
And finally, Chief Financial Officer, Karsten Munk Knudsen.
All per centers will be available for the Q&A session.
Today's earnings release and the slides for this call are made available on our website new Nordstrom Com. Please note. This call. This call is being webcast live and a recording will be made available unknown risks website.
Speaker 2: Today's earnings release and the flights for this call are made available on our website Noon Norse.
Speaker 2: Please note this call is being webcasted live and a recording will be made available on no-no-no-risks.
The call is scheduled to last one hour. Please turn to the next slide.
Speaker 2: The call is scheduled to last one hour. Please turn to the next...
Patient is structured as outlined on slide two please note that all sales and operating profit statements will be at constant exchange rates unless otherwise specified.
Speaker 2: The presentation is structured as outlined on slide two. Please note that all failed and operating profitable statements will be at confirmed exchange rates unless otherwise specified.
The Q&A session will begin in about 25 minutes, please turn to slide three.
Speaker 2: The Q&A session will begin in about 25 minutes. Please turn to slide three.
As always I need to advise you that this conference call will contain forward looking statements such forward looking statements are subject to risks and uncertainty that could cause actual results to differ materially from expectations.
Speaker 2: As always, I need to advise you that this conference call will contain forward-looking statements. Such forward-looking statements are subject to risk and uncertainty that could cause actual results to differ mutually from expectations.
Speaker 2: For further information on the risk factors, please see the company announcement for the full year of 2022 and the slide prepared for this presentation. Please turn to the next slide.
For further information on the risk factors. Please see the company announcements for the full year of 2021 and the slides prepared for this presentation.
Please turn to the next slide.
In 2021 in order to deliver double digit sales growth and progressed on all four dimensions of our strategic aspirations I would like to highlight a few today.
Speaker 2: In 2021, we're always delivered double-gita sales growth and progress on all four dimensions of our strategic aspirations. I would like to highlight a few today.
Within purpose and sustainability, we continue to take action on our social responsibility strategy defeat diabetes with a focus on excess and prevention.
Speaker 2: Within purpose and sustainability, we continue to take action on our social responsibility strategy, defeat diabetes, with a focus on access and prevention.
In 2021, we reached almost 35 million people living with diabetes with our treatments.
Speaker 2: In 2021 we reached almost 35 million people living with diabetes with our treatment.
More than $5 million of these receive treatment through our access and affordability programs.
Speaker 2: More than 5 million of these received treatment through our access and affordability programs. Promoting environmental impacts.
From an environmental impact perspective, we have also progressed in 2021 or two emissions across operations and transportation decreased by 43% compared to 2019.
Speaker 2: In 2021, our CO2 emissions across operations and transportation decreased by 43% compared to 2019.
Finally to underline our commitment to offer an inclusive and diverse working environment, we launched a global gender diversity exploration. The purpose of this is to achieve a balanced gender representation across all material levels by the end of 2025.
Speaker 2: Finally, to underline our commitment to offer an inclusive and diverse working environment, we launched the Global Gender Diversity Aspiration. The purpose of this is to achieve a balanced gender representation across all MNGL levels by the end of 2025.
Speaker 2: Martin will come back to the specific key milestones within R&D, but I would like to briefly share my overall perspective.
Marketing will come back to the specific key milestones within R&D, but I would like to briefly share my overall perspectives.
Speaker 2: By the end of 2021, we had ongoing phase three clinical trials within all of their periods.
By the end of 2021, we had ongoing phase III clinical trials within all of our therapy areas.
2022 will be an exciting year with multiple interesting readouts from our R&D pipeline.
Speaker 2: 2022 will be an exciting year with multiple interesting readouts from our R&D pipeline.
Following a productive partisans partnership since 2019, we acquired Boston based on certain pharmaceuticals, anti innovative RNA interference platform from 'twenty to 'twenty one.
Speaker 2: Following a productive partnership since 2019, we acquired Boston-based by Surnafar Masoodikos and the innovative RNA Interference Platform 2021.
As soon as an interferon technology platform is complementary with <unk>.
Speaker 2: Barcelona's RNA-interference technology platform is complementary with no existing technology platforms. The acquisition supports Australia using a broad range of technology platforms across all our fairytales.
Existing technology platforms the.
<unk> supports our strategy of using a broad range of technology platforms across all of our therapy areas. We expect to start clinical development with the first target in 2022.
Speaker 2: We expect to start clinical development with the first target in 2022.
In 2021, we delivered double digit sales growth, reflecting solid commercial execution across geographies as well as across diabetes obesity and biopharm.
Speaker 2: In 2021, we delivered double the self-growth, reflecting salt, commercial exclusion across geographies, as well as across diabetes, obesity and biofarm.
Adding the supply situation for the Gobi tenant will provide an update later.
Speaker 2: Press Leave Click on next Video in turn to receive a lot of increasing notifications on Login Virtual confer summoner. Thanks for watching.
The commercial progress across all therapy areas would be covered by Camilla and talk.
Speaker 2: The commercial progress across all therapy areas will be covered by Camilla and Doc. Lastly, leaving financial to pass, we are pleased with the sales growth of 14% and operating profit growth of 13% in 2021, both measured at constant exchange rates. With that, I give all the words to Camilla on our stage on commercial.
Lastly, leaving financial to cotton, we are pleased with the sales growth of 14% and operating profit growth of 13% in 2021, both Miss it at constant exchange rates with that.
Hello.
Commercial execution.
Speaker 3: Thank you, Lars, and please turn to slide five. In 2021, our total sales increased by 14%. This sales increase was driven by both operating units with international operations growing 14% and North America operations also growing by 14%.
Please turn to slide five.
In 2021, our total sales increased by 14% sales increase was driven by both.
Operating units with international operations growing 13% and North America operations also growing by 14.
<unk>, one sales increased 32% driven by North America, growing 25% and international operations growing 52%.
Speaker 3: GLP-1 sales increased 32 percent, driven by North America growing 25 percent, and international operations growing 52 percent.
Speaker 3: Insulin sales increased by 1 percent, driven by 6 percent growth in international operations, partially offset by a 9 percent sales decline in North America.
Insulin sales increased by 1% driven by 6% growth in international operations, partially offset by a 9% sales decline in North America operations.
Instrument sales declined by 9% driven by lower realized prices and the decline in volumes.
Speaker 3: The U.S. insulin sales declined by 9% even by lower realized prices and a decline in
Obesity care sales grew 5% overall and in international operations sales grew 52% and in North America operations obesity care sales grew 57% in.
Speaker 3: Obesity care sales grew 55% overall. In international operations, Saksenda sales grew 52%. And in North America operations, obesity care sales grew 57%.
Speaker 3: In the U.S., obesity care sales grew 58% driven by both Saksenda and
In the U S obesity care sales grew 58% driven by both fixed into MP Colby.
<unk> sales increased by 4% driven by North America operations, growing 6% and international operations growing by 3%.
Speaker 3: Biofarm says increased by 4% through and by North and Air Club where since growing 6% and international of where since growing by 3%.
Thank you.
Speaker 3: In line with our strategic aspirations of reaching one-third of the diabetes value market by 2025, our state's growth within diabetes care of 13 percent is faster than the overall diabetes rate.
Sure.
In line with our strategic aspirations of reaching one third of the diabetes value market by 2025.
In diabetes care of 13% is faster than the overall diabetes market.
Thereby we have improved our market share by two eight points to now 81.
Speaker 3: Thereby, we have improved our market share by 0.8 points to now 30.1.
Perfect.
The increase in flex GMP, one growth of 32% and market share gains in both operating units.
Speaker 3: The increase inflects GLP-1 growth of 32% and market share gains in both operating units.
Speaker 3: Currently, Eusebio has now been launched in 72 countries, and we built it in 29 countries.
Be it with some big has now been launched in 72 countries and we felt with 29 countries.
Please turn to slide seven.
Speaker 3: In international operations, diabetes care sales increased by 14% for the full year of 2021, driven by all geographies and their...
International operations diabetes care sales increased by 14% for the full year of 2021, driven by all geographies and therapy areas.
Speaker 3: GLP-1 sales increased by 52% in 2021 and Uber Nordisk remains the market leader in international operations with a GLP-1 market share of 58.9%.
Yes, the one sei has increased by 52% in 2021.
<unk> remains the market leader in international operations, where the <unk> one market share of 58, 9%, reflecting an increase of five two percentage points compared to just one year ago.
Speaker 3: reflecting an increase of 5.2 percentage points compared to just one.
Speaker 3: This is driven by share gains across geographies and overall 0-1 share of growth in international operations of 74%.
This is driven by share gains across geographies and overall in Q1.
And international operations of 74%.
Please turn to the next slide.
Biopharm sales grew by 4% in 2021, this was driven by 6% sales growth in North America operations and 3%.
Speaker 3: Biopharm sales grew by 4% in 2021. This was driven by 6% sales growth in North America operations, and 3% sales growth in international.
International operations.
Rare blood disorders grew by 9% driven by uptake of launch products, <unk> and <unk> as well as number seven and Hawaii.
Speaker 3: Rare blood disorders grew by 9% driven by uptake of launched products S-Provox and Refixia as well as No.7 and No.8.
Specifically hemophilia a products grew by 25% hemophilia b sales by 25% and 75, 4%.
Speaker 3: Specifically, hemophilia A product group by 25%, hemophilia B sales by 25% and number 7 by 5.
Speaker 3: Where endocrine disorders saves decline by 2%. The declining saves with reduced increase in by 5% offset by North America abrasions decrease.
We're endocrine disorders.
Declined by 2% the declining sales.
Increasing by 5% offset by North America operations decreasing by 12%.
Speaker 3: And now over to Henrik for an update on the supply situation.
I will now to him I find update on the supply situation.
Thank you Camilla please turn to the next slide.
Following up on the conference call in December 22021, I would like to provide you with an update on the global supply situation and our latest capacity expectations.
Speaker 4: Following up on the conference call in December 2021, I would like to provide you with an update on the Vigovie Supply situation and our latest capacity expectations.
Speaker 4: I would like to start by recapping the situation. Put simply...
I would like to start by recapping the situation could simply.
Now in order to produce the.
Speaker 4: No notice produces the active pharmaceutical ingredients and does the assembly and packaging in-house for the COVID. Wild formulation and filling is now for now done by a large contract manufacturing organization.
Pharmaceutical ingredients and thus the assembly and packaging in house will be Colby wireless formulation and feeling is now four now done by a large contract manufacturing organization.
In close collaboration with the CMO, we were on track to ramp up capacity and meet demand for <unk> in the U S.
Speaker 4: In close collaboration with the CMO, we were on track to ramp up capacity and meet demand for Vigovi in the US.
Unfortunately, as you know the CMO received a 483 letter from the U S. FDA addressing cgmp issues at the production side, what we call. These hearings.
Speaker 4: Unfortunately, as you know, the CMO received a 483 letter from the U.S. FDA addressing CGMP issues at the production site for Wigovi syringes.
Speaker 4: Therefore, the CMO had to temporarily stop deliveries and manufacturing to correct the compliance issues.
Therefore, the CMO.
So chip I rarely stopped deliveries and manufacturing to correct the compliance issues.
Since December we have worked hard to optimize our internal capacity.
Speaker 4: Since December , we have worked hard to optimize our internal capacity. Consequently, we now expect that our internal capacity in the first half of 2022 will be close to the demand of around 20,000 really total script as seen in the US market in the end of 21.
Consequently, we now expect that our internal capacity in the first half of 'twenty two we'll be close to the demand of around 20000 weekly total script as seen in the U S market in the end of 'twenty one.
This is an improvement compared to the previous communicated 60% to 90% range.
Speaker 4: This is an improvement compared to the previous communicated 60-90% range.
While the CMO.
Speaker 4: has yet to resume production, we see good progress and have a constructive collaboration in place and still expect that we will be able to meet US demand for Vigovi in the second half of 2020.
Has yet to resume production, we see good progress and have a constructive collaboration in place place and still expect that we will be able to meet U S demand for <unk> in the second half of 'twenty two.
Outside of the U S. We have submitted the already existing PDL 290 platform for regulatory.
Speaker 4: Outside of the US, we have submitted the already existing PDS290 platform for regulatory review in the European Union and expect a decision in the second half of 22.
In the European Union and expect a decision in the second half of 'twenty two.
Speaker 4: Working with two platforms will provide additional flexibility for future launches. With that, I would like to hand over to Doug.
Working with two platforms will provide additional flexibility for future launches.
With that I would like to hand over to Doug.
Thank you Henrik for that update please go to the next slide.
Speaker 5: And globally, obesity care sales increased by 55 percent, with 57 percent growth in North America operations, and 52 percent in international operations.
Globally obesity care sales increased by 55% with 57% growth in North American operations, and 52% and international operations.
The U S launch of <unk> as illustrated the significant unmet need for people with obesity.
Speaker 5: The U.S. launch of Ogobi has illustrated the significant unmet need for people with obesity. And as Henrik mentioned, we are doing everything we can to resolve the supply issues as fast as possible.
And as Henrik mentioned, we are doing everything we can to resolve the supply issues as fast as possible.
Speaker 5: Consequently, sales and marketing activities have been put on hold until there is sufficient supply to ensure patients can escalate through each of the five doses.
Sequentially sales and marketing activities have been put on hold until there is sufficient supply to ensure patients can escalate through each of the five doses.
Since year end the launch copay cards for will go the can no longer be activated.
Speaker 5: Since year-end, the LaunchCopay cards for Wogovi can no longer be activated.
Speaker 5: and combined with pause sales and marketing activities, we do expect to have fewer weekly new patient starts compared to the fourth quarter of 2021.
And combined with Pas sales and marketing activities, we do expect to have fewer weekly new patient starts compared to the fourth quarter of 2021.
Despite the supply challenges the feedback from patients and prescribers continues to be very encouraging and we remain confident that the long term potential of <unk> is unchanged.
Speaker 5: Despite the supply challenges, the feedback from patients and prescribers continues to be very encouraging and we remain confident that the long-term potential of Vulgovi is unchanged.
Currently <unk> has around 22000 scripts per week and more than 70% of <unk> prescriptions are still new to the anti obesity medication class, thereby <unk> expanding the branded anti obesity market.
Speaker 5: Currently, Wagovii has around 22,000 scripts per week, and more than 70% of Wagovii prescriptions are still new to the anti-obesity medication class.
Speaker 5: thereby will go is expanding the branded anti-opicity mark.
Market access has progressed since the launch year of last year.
Speaker 5: Market access has progressed since the launch year of last year.
Speaker 5: And in record time, in less than six months, we have reached sexanda-like access.
And in record time and left at less than six months, we have reached that sounded like access specifically commercial formulary access for <unk> is now more than 70% and importantly includes all of the major pbms.
Speaker 5: Specifically, commercial formula access for Wagovi is now more than 70 percent. And importantly, it includes all of the major PBMs.
Please turn to the next slide.
The U S. <unk> volume market growth is around 30% comparing Q4 of 2021 to Q4 of 2020 and this is driven by once weekly injectable GOP ones as well as rebel Sis.
Speaker 5: The US GLP1 volume market growth is around 30%. Comparing Q4 of 2021 to Q4 of 2020. And this is driven by once weekly injectable GLP1s as well as rebels.
Speaker 5: Nova Nordisks, new to brand market share leadership, is now 63.9%. Driven by the continued uptake of those MPIC and rebels.
<unk> new to brand market share leadership is now 63, 9% driven by the continued uptake of those epic and rebel Sis.
Speaker 5: Importantly, OZMPIC remains the NBRX market share leader within injectable GOP1.
Accordingly, <unk> remains the <unk> market share leader within injectable GOP ones.
Measured on total scripts Novo Nordisk remains the market share leader with more than 50% market share.
Speaker 5: Measured on total scripts, Nova Nordisk remains the market share leader with more than 50% market share. Please turn to slide 12.
Turn to slide 12.
The global rollout of rebel CIS is progressing well and.
Speaker 5: The global rollout of Rebelsis is progressing well and has now been launched in 29 countries.
And it has now been launched in 29 countries.
In the U S.
Speaker 5: In the US, Rebels' total prescripts introductory continues to steadily increase.
<unk> total prescription trajectory continues to steadily increase curran.
Speaker 5: Currently at above 45,000 prescriptions per week. Despite the impact from COVID-19 since long.
Currently at above 45000 prescriptions per week, despite the impact from COVID-19 since launch.
In 2021, <unk> was the second largest contributor to growth in Novo Nordisk with its attractive clinical profile and early positioning in the type two diabetes treatment cascade.
Speaker 5: In 2021, Rebelsis was the second largest contributor to growth in Nova Nortiske with its attractive clinical profile and early positioning in the Type II diabetes treatment cascade.
We are encouraged by the weekly increases in breadth and remain confident in the potential of the product.
Speaker 5: We are encouraged by the weekly increases in breath and remain confident in the potential of the product. Outside the US.
Outside the U S. One of the key markets is Japan.
Speaker 5: Here, Rebelsis has now reached a 2.6% value share in the modern oral anti-diabetic mark.
<unk> has now reached a two 6% in value share in the modern oral anti diabetic market.
Speaker 5: In December of 2021, the 14-day prescription limitation was lifted, and we have already seen a jump in performance.
In December of 2021% to 14 day prescription limitation was lifted and we have already seen a jump in performance.
Speaker 6: Recall that in Q3 of 21, Rebellion Center, Japan had reached a .9% M O A D value market share. Now we're at a Martin Ford Update on R&D. Thank you, Doc. These turn to slide 13.
Recall that in Q3 of 'twenty, one rebel CIS in Japan, It reached a 0.9% value market share.
Now over to Martin Court update on R&D.
Thank you Doug Please turn to slide 13.
2021 ended on a high note in the R&D space within Biopharm, we reached two exciting milestones during the fourth quarter of the year.
Speaker 6: Within BioFarm, we reached two exciting milestones during the course course of the year.
Speaker 6: The first was the successful completion of the 52-week phase-free trial with Saguayah. And to one of the children suffering from growth among the
The first was the successful completion of the 52 week phase III trial with supplier and two other children suffering from growth hormone deficiency.
The climate the primary endpoint non inferiority and high velocity for once weekly Sequoia compared with once daily noted children.
Speaker 6: The prime met the primary endpoint, non-inferiority in high velocity, for once weekly segoroia compared with...
The expectation is to submit <unk> for regulatory approval for the treatment of growth hormone deficiency in children. During the first half of 'twenty two.
Speaker 6: The expectation made to submit your grower for regulatory approval for the treatment of growth hormone deficiency in children during the first half of 2020.
The second milestone was the successful completion of the first cohorts.
Speaker 6: The second milestone was the successful completion of the first cohorts, the multiple ascending dose part from the ongoing phase 1, 2 clinical concept trials and diabetes. In the trial.
Multiple ascending dose part from the ongoing phase <unk> clinical proof of concept trial might be.
In the trial.
<unk> appeared safe and well tolerated.
The pharmacokinetic and Pharmacodynamic provinces supporting once weekly as well as once monthly dosing.
Speaker 2: Will pharmacokinetic and pharmacodynamic provinces supporting once weekly, as well as once monthly dosing? For the pivot cell phase.
For the pivotal phase III trial.
<unk> was initiated in the fourth quarter of 'twenty one.
Speaker 6: and we expect initiation of active mind treatment in the second half of
And we expect initiation of exit mindset treatment in the second half of 'twenty two.
Speaker 6: You plan to share further details on both the Phase 1, 2, so as well as the Phase 3 program at an upcoming...
We plan to share further details on both the phase <unk> as well as the phase III program at an upcoming event.
Speaker 6: Finally, and in line with our strategic aspiration of further raising the innovation bar for diabetes treatment.
Finally, and in line with our strategic aspiration of further raising the innovation plan for diabetes treatment.
We have initiated the first of free trials and the global Phase III, a combined program for <unk> and.
Speaker 6: We have initiated the first of free trials in the Global Phase 3A Combined Program for Icosemma.
And once weekly combination of <unk>, one milligram and insulin I predict.
Program is expected to enroll 2650 people in total.
<unk> type two diabetes.
The first trial.
To be initiated combined fee, which is a 52 week trial investigating the efficacy and safety of once weekly <unk>.
As insulin basal bolus treatment in approximately 680 people with type two diabetes.
The combined program is expected to complete during 2024.
In physically it is expected that <unk> will show superior efficacy versus mono components as well as attractive data on weight and hypoglycemia profile combined with similar placebo control.
Speaker 6: as well as a interactive data on weight and hypoglycemia profiles combined with similar glycemia.
Furthermore, it will also have dramatically improved opinions verses insulin basal bolus treatment in patients with type two diabetes.
Speaker 6: Furthermore, it will offer dramatically improved convenience versus insulin basal bolus treatment in patients with type 2 diabetes.
Now please turn to the next slide.
Turning to the high level of R&D milestones 2022 is a year with many exciting trial readouts across all therapy areas.
Speaker 6: Turning to the high level R&D milestones. 2022 is a year with many exciting trial readouts across our tab.
Speaker 6: However, before I get to that, I would like to touch upon milestones from the 4th quarter of 2021 that I did not cover in
However.
To that I would like to touch upon milestone from the fourth quarter of 'twenty, one that I did not cover.
Speaker 6: Within diabetes, assembly 2.0 milligram was approved in the EU for the treatment of addouts with high-toly diabetes based on results.
Within diabetes simply Coupla Churro milligram was approved in the EU for the treatment of adults with type two diabetes based on results from the sustained forward to trial.
Speaker 6: In the trial, the CIS-2.0-militraim achieved a statistically significant antipereal reduction in A1.
In the trial.
<unk> had two milligram achieved a statistically significant and superior reduction in <unk>.
At 40 weeks as compared to two magnet type one two milligram.
A decision in the U S is expected during the first half of 'twenty two.
In addition, we initiated a 34 week phase III.
Comparing the effects on glycemic control and body weight of a fixed dose combination of some mix type and a once weekly CIP analogue compared to placebo as well as the megawatts at one milligram and people with type two diabetes.
Now turning to 2022.
We also reached an important.
Obesity milestone with the approval of <unk> in the EU based on the phase III clinical trial program, thus addressing the significant unmet need for people.
With obesity also in the EU.
We look forward to making we go available to many people living with obesity in Europe .
And to prioritize short term internal production capacity for <unk> initiation.
The initiation of <unk> phase <unk>.
<unk> program will be postponed to the second half of 'twenty two.
I would like to end by highlighting a few additional expected R&D milestone for us to win.
Within diabetes, we expect results from the ongoing phase III trials.
Insulin <unk> and phase II trial with <unk> in type two diabetes.
Within Biopharm, we expect results from the ongoing phase III trial with <unk> in the first half of 'twenty two.
And finally, we expect to initiate a phase II trial during the first half of 'twenty two.
<unk> our.
<unk> for.
<unk> for the treatment of <unk> cardiomyopathy.
This was the asset that we acquire.
That from Pessina during 'twenty one.
With that over to you.
Thank you Martin.
These types of the next slide.
In 2021 sales grew by 11% in Danish kroner and by 14% at constant exchange rates.
The cross margin declined to 83, 2% compared to 83, 5% in 2020, the decline reflects a negative currency impact of <unk> two percentage points lower realized prices in the U S and amortization of intangible assets related to the acquisition of atmosphere technologies.
In 2020.
These are countered by a positive product mix driven by increased tier one sales and productivity improvements in line with our strategic aspiration of driving operational efficiencies.
Distribution cost increased by 12% in Danish krone, and 15% at constant exchange rates.
The increase was driven by investments in our key strategic projects, most notably launch activities and promotional spend for <unk> and <unk>.
As market development activities for obesity.
This was partially offset by lower promotional spend related to insulin.
Research and development costs increased by 15% in Danish kroner, and 16% at constant exchange rates.
The increase is driven by pipeline expansion and diversification, including progression of the pipeline.
Cardiovascular disease and Nash.
Administration costs increased by 2% in Danish kroner, and 4% at constant exchange rates impacted by low spend in 2020 due to COVID-19.
Operating profit increased by 8% in Danish krone, and 13% at constant exchange rates.
Net financial items for 'twenty, one showed a gain of 436 million Danish kroner compared to a loss of around $1 billion in 2020.
The gains on the hits currencies, primarily related to the U S dollar.
The effective tax rate was 19, 2% compared with an effective.
Tax rate in 2020.
27%.
This mainly reflects a nonrecurring impact from acquisitions and towards 'twenty and 2021 .
Net profit increased by 13% and diluted earnings per share increased by 15% to 20 krone and 74.
Free cash flow was $29 3 billion Danish kroner compared to $28 6 billion Danish kroner towards <unk>.
The increase was driven by higher net profit and higher provisions for rebates in the U S. Partially driven by a change distribution policy for 340 <unk> program.
The increase is partially offset by unfavorable impact from changes in working capital next slide please.
In 2021, Northern returned approximately 41 billion Danish kroner in the form of dividends and share buybacks to shareholders.
The annual General meeting on 24th of March 22, the board of Directors will propose a final dividend of six Kona and nine two for a total 2021 dividend of 10 kroner in 40 years.
A 14, 3% increase from 2020.
In addition to the dividend 20 billion Danish kroner shoes for the repurchase of shares.
<unk> consistently returns, it's free cash flow to investors through share buybacks and dividends with dividends per share increasing for 26 consecutive years.
For 2022, the board of directors.
It has improved a new share repurchase program of up to 22 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 2022.
Please go to slide 17.
We enter 2022 with a solid growth momentum and expect sales growth to be between 6% and 10% at constant exchange rates.
The guidance reflects expectations for sales growth in both international operations, and North America operations and across therapy areas.
It's mainly driven by diabetes and obesity care.
Within obesity the guidance reflects an expectation of meeting demand for recovery in the U S. In the second half of 2022.
It also reflects intensifying competition within both diabetes care and biopharm as well as the negative impact from volume based procurement of China.
We have previously called out the PPP in China would impact group sales negatively by three percentage points in transparency.
Finally continued pricing pressure within diabetes care, especially in the U S is expected to negatively impact the sales development.
Operating profit is expected to grow between 4% to 8%, reflecting the sales growth outlook and continued investments in current and future growth drivers.
This include.
The continued rollout of simply can't robustness philosophy globally.
And associated market development investments.
Furthermore, additional resources being allocated to both early and late stage R&D pipeline activities.
Specifically the acquisition of <unk> Pharmaceuticals is negatively impacting operating profit growth.
Around three percentage points.
Given the current exchange rates, most notably the strengthening of the U S. Dollar we expect a positive currency impact for 2022.
Consequently, our reported sales and operating profit growth is now expected to be five seven percentage points higher.
Cost of exchange rates, respectively.
The positive currency impact on operating profit is partially offset by a net loss on financial items for 2022 financial slides I expect it to be a net loss of around two 8 billion Danish kroner.
Reflecting losses associated with foreign exchange hedging contracts.
Sure.
Capital expenditure.
<unk> now expected to be around 12 billion Danish kroner in 2002, the expected to increase mainly relates to investments in additional exit pumps vertical ingredient capacity at existing manufacturing sites, reflecting increasing demand and pipeline progress.
Lastly, free cash flow, excluding potential major business development activities is expected to be between $50 and 55 billion Danish kroner, the increase compared to 21 reflects the impact from the acquisition of <unk> pharmaceuticals and towards 'twenty one.
They promised the updated outlook for 2002 <unk> for final remarks.
Thank you Carsten just turn to the final slide.
We are very pleased with the double digit sales growth in 2021.
Sales growth was driven by all geographical areas within international operations as well as North America operations and by all therapy areas in particular sales quarter was driven by an accelerated growth of our portfolio of <unk> treatments for diabetes and obesity care and we continue to reach even more patients.
Finally, I would like to remind you of the upcoming capital markets day that will be held on March 3rd at our headquarters in Copenhagen.
At this full day event, except to management and other senior executives will be present.
<unk> will focus on our growth outlook with <unk> and our 2025 strategic aspirations, we hope to see many of you in person, but as usual.
We will also be webcast at life with that we're now ready for the Q&A, where I kindly ask all participants to limit our himself to one or maximum two questions. Operator, we're now ready to take the first set of questions.
Thank you and the first question comes from the line of remote.
Bernstein. Please go ahead.
Oh, great. Thank you very much for taking my questions. We'll have completed some benzene. So can I just ask on the global supply located being some positive movement for <unk>.
<unk> hedged both from internal capacity and some additional batches released from the CMO.
So my question really is on your internal supply capacity.
Potential additional CMO that may be brought onboard and the possible new EU device as you've used would be changed on what that means from a supply perspective ex.
The largest cattle supply do you have conviction that you can increase supply in <unk> H, regardless of catch that and if so to what extent are you able to quantify and just tied to that.
Any potential to flex touch painful obviously filed in the U S I'll use more broadly internationally.
My second question is just on the supply impact on reimbursement.
We'll go now.
<unk> has a similar accident just like center.
Curious if these discussions have been impacted by your inability to supply greater volumes you would coverage has been superior at this point if you had to supply all the negotiations on the opt ins unaffected. Thank you.
Okay. Thank you remodel.
<unk> managed to sneak into three questions there, but we're trying to cover it anyhow. So.
Semi first talks a bit through the supply situation.
As we have done internally.
And how will be ramping up and has that really changed much.
And then <unk> you can maybe talk a bit to the flex touch flexibility rebuilding and then Doug you can talk to.
There has been any impact on reimbursement because of da Vinci proteins like first on on how we look at ramping up.
Sure. Thank you very much thank you for the questions.
So first of all an.
On our internal capacity, we have reshuffled shuffled, our our internal capacity, so that we're able to to hold the demand out of 'twenty, one as I stated.
And that is the limitation of debt capacity.
We'll be back.
Following the the demand in U S. In the second half of 'twenty two.
With the restart in the CMO facility and then from there on we will continue building discipline change so it will be as mature.
In the stable.
Our supply chains, so it's basically unchanged plan compared to what we communicated in December .
Okay. Thank you.
Confident there.
Camilla on the flex touch.
Optionality, we're building, yes, so the flagstone.
Thanks touch us in LC rebuilding is for international operations is just to make sure that we have increased flexibility on the rollout of <unk> and then right now our launch plans are being developed.
To initiate the first launches.
In the second half of 2022.
So of course, we very much look forward to that Pat.
So I think that that's where we are now.
Okay.
And I think it was also a question on us. So so we believe we have the right set up for U S and we'll push on with that and we think we'll have robust supply situations. So no no reason to change course, and then Doug on the reimbursement impact if any yes. Thanks Paul.
We're certainly dealing with any concerns that are pairing may have.
That has not impacted access and just to reiterate we have more than 70% access with all major pbms and to put that in the context that was access that was achieved faster than our commercial business than if we compare it to Olympic or rebel. So so we're very pleased with the level of access right now.
Thank you. Thank you.
Thank you.
Next question please.
Next question comes from the line of Michael Larsen from UBS. Please go ahead.
Thanks, So much two questions. Please I think both for Carsten.
In the.
The width of the guidance you've left a little bit lighter again this time round.
You would have gotten in the past I'm guessing the biggest style. It's just weak ob timing, but just wondering if there is something else that would have driven that lighter than maybe in the past.
And then second question about longer term margin trajectory looking at your guidance for 2022, it looks like you're pointing towards a high single digit billion Danish increase in opex, excluding cost of sales.
Given it's a year, where the Gobi comes in the second half.
Can you help us understand how that fits with your longer term margin aspirations.
A flattish trajectory I would've thought sort of high single digit billion Opex increments. We go we could really make up for quite easily once it gets going so does that still hold.
<unk> margin trajectory and sort of what are the components that will keep it flattish. Thank you.
Thank you Michael so two questions on the risk.
England perspectives on market margins linked to Opex.
Thank you Michael.
That set of questions. So first on guidance.
I'd say our guidance range, it's not unusual compared to what you've seen from known or skin in the previous year.
If you go back in time, and and yes of course.
There's still some some uncertainty but as you can see on him I gave we are confident in our plants, but.
But of course, we need to need some.
Some flexibility in our guidance range say issue did not pan out exactly as it is.
Painful so apart from that.
It is.
It's business as usual, but.
But of course, we also learned from from 'twenty to 'twenty one.
<unk>.
There's more volatility in the demand outlook, we are facing.
Upgrading three times.
Less last year, and I think we want to be more accurate.
But it also reflects that.
That volatility is higher than it was in the old days.
As to your question on the on the Opex and margin said and the short answer is yes, we stick to our broccoli on change the operating margin that that I'll onset at the capital markets day in.
In late 19th and the way you should reconcile out our 'twenty two numbers is basically that the.
First of all that we are continuing to invest in driving top line with <unk>.
Joan.
I Hope you agree we've shown in 'twenty, one that our aggressive topline investments have paid off with the results.
Living.
And then we're building future growth platforms in R&D, so so really expanding and diversifying our R&D pipeline.
So.
So the dip in 'twenty two.
Related to di Serena and Thats without saying, 3% negative impact on the op from China and as you can see in our guidance actually we've already mitigated 1% of the three in our guidance.
So thats something that were working diligently on.
Thank you Kirsten and thank you Michael.
First set of questions. Please.
The next question comes from the line of Sachin Jain from Bank of America. Please go ahead.
Hi, Matt touched Jane Thanks for taking my questions. Two please first just a follow up the constantly guidance and then secondly for Henrik <unk> III. That's just to clarify the comments on the guidance costly GOP one growth scenario is included in the guide.
Do you still expect normalization in that growth rate, which is not necessarily physical as yet and I was just.
Wanted to clarify your commentary on we gave the supply so just to be clear to the bottom end of guide.
Include a scenario, where there's no supply resumption.
Not a scenario I just want to be clear as to what's included in the bolstering that guide on <unk>.
And then for Henrik and does the Q <unk> supply to meet demand and time on the way you would allow for timelines for assembly packaging freight and then whatever assumptions you've got on demand curves with production expected to regime for two H I'm just trying to get a sense of how close you watch production resuming and what visibility you have on that.
Be as confident and as you are facing today.
Thank you Sachin.
Constant first on.
On the guidance.
And <unk> growth scenarios.
How much clarity you can bring on that.
Yes, absolutely so.
So forecasting market growth.
It's more in Austin than a science I would say looking at that market growth data historically, but but.
As you can see in the data available externally also the tier one market growth on a global scale is to the tune of 30% and we're taking market share. So really really rapid growth of our tier one franchise and of course weak we expect very attractive tier four market growth to continue into 2022.
Normalization comment six months ago was small related to the step up we saw in Q2 in the U S warehouse I'll say, a more kind of.
Nonrecurring step up in <unk> or a few months.
But I will say since early Q3, we've seen a more stable pattern in total scripts. So that was basically the normalization of our African talking too and then guidance versus <unk>.
<unk>.
The guidance is.
Built on epic Colby.
Re launching in the U S. In the second half of 2000.
Switch to <unk>.
Thank you.
<unk>.
Let's see reached out of manufacturing and when we expect Cogs will be in the market and.
To mention that.
Yes so.
Spectrum My slide presented it.
It's clear that we of course want a certain level of operational stock and we also need time to simply and <unk> devices in our <unk>.
Internal capacities, so and as we are planning to follow the demand in U S. In the second half of 'twenty two than it would be quite logical that we need to output from the CMO in second quarter of this year.
Good.
Thank you Henrik Thank you Sachin.
Thanks for the questions. Please.
The next question comes from the line of Richard <unk> from Jpmorgan. Please go ahead.
Hi, Thanks for taking my questions.
On a GBP in China, it looks like from your numbers it may be some destocking in.
And insulin 11 novolog.
In the fourth quarter can you talk to what.
There was any inventory movements ahead of the BP, whether we should anticipate in Q1 and how we should think about the shape of implementation of EVP in in throughout this year and then the second question just on the casualty segment delays.
Prioritizing manufacturing is important for the commercial launch, but could you talk about I think there were some issues with the with the pen with Calgary semi has always been self say that as soon as you have manufacturing we can think about those trials ramping up.
Should we now think about our launch of <unk>, maybe in 'twenty five to just some thoughts on categories.
Thanks very much.
Thank you Richard.
First on <unk>, China any stocking.
So so on.
On the China numbers that I'm sure you allude to with the 5% growth in the quarter.
Sure.
You look at the Chinese numbers, you should be used to having some volatility on a quarterly basis that that number of confounding factors say beats.
Between different products.
That import licenses.
Whatever shipments to distributors and and so on so there's no no destocking to wholesalers and we continue to supply wholesale us with our instant process as we've done all along.
Thank you.
On <unk> and your comment about a small delay in initiation of that true prototypes to play we are really really pleased with our portfolio of.
Products in pipeline and obesity and think Thats a tremendous opportunity. So we don't really regard. This delay is something thats significant but Martin can you talk a bit to the device and while I don't think the guide on when we launch products a bit.
Our perspective on the clinical trial program absolutely.
Reflecting well asset.
We obviously still see a CAGR.
It's a very important product in our pipeline.
With great potential.
Specifically on the device, obviously, it's a new device.
But yes.
We are ready with that device and it will be supplied for the clinical trials.
It is.
The current wait until second half of 'twenty two is basically prioritizing.
Production that being said obviously.
And my team are now test with the secured debt that we will still look towards no delay.
Italy, and therefore, we maintain that our overall timelines will sort of be.
We kept.
Thank you Martin Thank you Richard next set of questions. Please.
Next question comes from the line of Simon Baker from Redburn. Please go ahead.
Thank you for taking my questions two if I may firstly on the <unk>.
The contract manufacturer issue.
<unk>.
Sure. Good question before about any potential compensation that you have already received so far.
Tension in China, two should there be any further delays I wonder if you could just give us.
Some color on the situation there.
And then secondly on shelf.
Sales and distribution costs in the fourth quarter.
I assume there was some offset from July .
A delayed launch activity related to <unk>.
And yet the sales and distribution.
Cost.
Hi, the move we expect just hoping you could just give us a little bit of color on if that wasn't offset that.
That means the levels of <unk>.
Distribution in 2020, thanks, so much.
Thank you Simon so on the recovery CMO issue.
We have a good collaboration with the CMO, we think they are very confident.
And competent in what they do is despite the unfortunate situation and we are not making a bid on any.
Significant compensation or the like so we have a good strategic partnership that we are investing in order for the long term.
Constant on an F&D in Q4, all linked to the delay.
Yeah. So.
So it was really bad timing with the delay because we've just been training our reps and then being ready to be registered Russo. So in reality. We spent what we plan to spend in Q4, we didn't really have any offsets vis vis the FICO relaunch.
Since it was a lot of launch preparations where we're trending so so I'd say the Q4 spending was what's not.
In any significant form impacted.
Before we supply situation, which we also learned about very late in December . So our Q4 spending is just a continuation of investing in.
Diabetes tier one and RBC franchise on a global scale too.
Right.
Thank you karsten. Thanks, so much thank.
Thank you next question please.
The next question comes from the line of Peter <unk> from Citi. Please go ahead.
Thank you Pete <unk> Citi two questions for Martin.
All R&D.
Just on the HBV Alpha one.
And alcohol use disorder.
Programs.
Should we think about these fitting into your R&D portfolio and strategy going forward.
And then secondly.
Hearing from our payroll checks that sold and flow could actually read out at the very end of this year. Early next just wanted to sort of check with you on that because that surprised us to the upside and then just perhaps select can you remind us when you expect to see an interim readout. This year based on the event rates youre seeing in that trial. Thank you.
Thank you Pete two exciting questions Martin two very interesting questions. Thanks, a lot Pete.
On your alcohol abuse and specifically.
Pipeline.
Obviously early days in <unk>.
What you'll see is that we are still booking at the individual assets and evaluating how to progress them, specifically, we know that we're going to progress.
She went towards.
With regulatory submission later this year.
But beyond that.
Probably too early to go into details.
With regard to our three outcomes trials.
We're obviously monitoring the situation.
We all hope for upside of early Readouts.
I have to disappoint you.
To the extent that as per plan sold and flow will not read out this.
This year.
We have not seen either higher or lower.
The event rate than what we anticipated and that basically means that we had to run the two facilities.
And.
Select we are still monitoring the situation and.
Cause if and when an interim will take place.
Thanks, so much and thanks.
Next question please.
Next question comes from the line of Simon Nathan from BNP Paribas. Please go ahead.
Thank you for taking my questions first one just a clarification actually on Richard's question cost and I mean can you maybe comment.
Respect to bvd has advocates off yet.
If not when should we expect that to kick off and is that one of the obviously the driving factors between the wide range of the guidance. It is much much went to India. Therefore, you're more likely to hit the top end of the guide and then secondly, one for Maarten just on your <unk>.
Phase III trial can you, maybe just discuss a bit more of that.
With respect to the doses that you're exploring.
Is it just wont make some change in the dentist get component just thinking clearly cognizant.
A few a little bit of delays in the importance of this product to fend off.
Right.
Arguably increases in importance. Thank you.
Thank you Simon first on timing of EVP.
So.
So timing of EVP, we've been informed that we should expect an implementation from from me and.
So that's that's our working assumption.
I wouldn't say it impacts guidance substantially if it's plus or minus a month.
So so far apart of course.
The guidance is impacted off that.
We don't know the exact implementation of Pvp in terms of how volumes are allocated and how the different hospitals.
We'll use some of that free volumes in the marketplace between manufacturers so.
So that of course entails some uncertainty in terms of the specific impact from from BP.
Thank you Scott and marching on <unk>.
Trying to assign doses.
Maybe taking a step back because I don't necessarily see <unk> as a result, we estimated at one milligram, we have some maintenance at two milligram and looking at the totality of efficacy and safety.
In and of itself tomato side is a very attractive offering bringing more than 80% to target in a safe and tolerable way.
That being said.
Obviously, once <unk>, but in the sense of being a superior offering with the superior tier one component, but also the superior VIP component, we're exploring different doses and different.
Strengths combinations.
Our phase II trial.
Too early to go into detail.
Thank you imagine we clearly believe we have a strong position there. Thank you Simon next set of questions. Please.
The next question comes from the line of Michael <unk> from Nordea. Please go ahead.
Yes.
Two questions. So first of all maybe you can talk a bit about the UBC the dynamics for the third quarter because of course, we don't have the split up between Gogo and extend that to just trying to understand obviously you had strong growth, but it was still below sort of what the street had expected so understanding the impacts on <unk> potential volatility also in international operations.
Secondly regarding the launch of.
With the continued launch of <unk> in China, China and also listening on the audio so maybe you could give a bit more color on your sort of strategy in China and when do you expect sort of a true lift off for some big in China.
Thank you Michael.
So clearly a strong performance in 2021.
One should get hung up in quarterly deviations, we really pleased with what we see in international operations. The fact that we can grow above 50% based on succentor.
Of course in the U S.
We had a very exciting launch of the Kobe.
And that opens peoples minds for what is a potential to grow.
And.
Although we will be prioritizing section.
Everybody is waiting.
So I don't think we can say much more about.
There.
And then Camilla on answer for simply in China, Yes.
Most of it.
Something in China, adding we now.
And that basically means that they are very.
Stay on dice guidance E&P one market now also has.
To drive further growth and there is of course in a big opportunity to have more patients with type two diabetes exposed to it once we get to everyone.
Thank you.
So as far as secondary exciting Ana and goodbye. Thank you Camilla <unk>.
All markets have been really embracing.
Embracing Olympics, so far so we have high expectation for China like any other markets. Thank you Michael next set of questions. Please.
Next question comes from the line of Kerry Holford from Baird. Please go ahead.
Thanks.
Please actually.
The event.
Okay.
Please.
And next thing you highlight tool companies.
Chinese patents.
Shannon.
Thanks, Sean.
The FTAA orientations.
And I would say what's next.
Thank you have a nice findings.
Subsequent person.
Okay.
It could be about the potential read across to the person is tight.
And secondly, a question for you on M&A you mentioned this in the call.
Tax cash payback.
Thanks.
And then fair to conclude that for you.
Hello.
What are your thoughts on next.
Energy loans.
Yes.
Matt.
Fine.
And then you may have.
Steve Thank you.
Thank you Carrie and if I start out on the <unk>.
<unk>.
This is basically exactly after the textbook.
There's a certain window after launch where you can attack patents and there is a defined route for doing that.
So we were kind of waiting to see who would be the first.
We have been notified.
The ones I mentioned in the annual report I think.
We have visibility on the remaining.
Up to the number of seven which I understand has disclosed.
So this is this is standard process and we are very confident in our patents.
On <unk> and that goes for the use of that molecule across indications.
Constant on M&A.
Advertise yes so.
So I will say, we have always advertise for attractive assets into our R&D pipeline.
I would say internally, whether I'd say its from external sources. So.
Thats of course, the premise assuming if it fits our strategy and our focus we have the capacity and you can see our balance sheet. So we have fair.
We have.
Leverage rate of zero, if you take net debt to EBITDA. So we have plenty of capacity to pursue.
<unk> said that could be out there and.
And vis vis our commentary on the potential of scaling back our share buyback program.
What you have seen the order.
Over the last couple of years has been given.
Attractive level of cost of financing that.
We are out funding in the market more so than the.
Rolling down our share buyback program. So that's our capital allocation approach to continue.
To provide attractive capital allocation tool to our shareholders.
As to the targets we're looking at.
I'd say, we continue to of course.
Relevant technology platform.
In the very early space.
Could supplement the disease areas in which we compete.
And then we're looking at early and mid stage assets across therapeutic categories.
Where we compete again and of course the assets.
We'll have to fit a set of criteria.
Whether it's.
It was a commercial attractiveness innovation height.
Safety parameters financial attractiveness.
So we have the classic.
Relevant funnel and a lot of targets. We're looking at all along and then from time to time, we succeed and get some some assets in the door, which we like.
Thank you Carsten. Thank you Kerry next set of questions. Please.
The next question comes from the line of Mark Purcell from Morgan Stanley . Please go ahead.
Yeah. Thank you very much two questions first on the.
Flattish operating margins out to 2025 is that conditional going back to a couple of earlier questions on on BT, adding R&D platforms.
Listing group and.
Context with you okay great.
R&D spend is in the high teens to low twenties, how high should we expect R&D spend as a percentage of sales to Guy and then the second question on categories.
But if a competitor is in December talked about how the signals around sort of calcitonin activation antidrug antibodies injection site reactions and things like that so.
When should we see more with respect to those those safety aspects when should we get the 40 week data for example should we assume that you are now put more positive on <unk> as opposed to Calgary Shannon. Thank you.
Yeah.
Thank you Mark.
On operating profit.
Martin.
PD impact and what do we think about R&D.
Rachel.
So.
Thanks for that set of questions Mark yes.
Our common shares to answer.
Broadly unchanged operating margin since our last capital market day towards 2025 of cost can we end up in a situation, where we're that's a specific BD opportunity that that has.
More sites for the impact on our margins than that then we'll deal with that at that point in time. It is impossible to cater for every possible scenario and into the future.
And should such an opportunity to come up we would not be stopped by.
Kind of a.
Sure.
One off type of margin impact if the opportunity is the right one.
But for now.
We stick to our bronchial unchanged operating margin as to R&D ratio, you should expect that to increase over time.
Youll see you already see a decent increase in the.
In 'twenty, one you will see even further increase.
Come 2022, and the Doctor and the impact, but I think more importantly than looking at the margin. Then you should look at how much we actually able to increase our investments in R&D.
Both the development side and on the research side, given the fact that our top line is growing at the pace. It is so so kind of the main funding mechanism to our R&D organization and expanding and diversifying our pipeline currently isn't ready to topline growth.
Thank you Carsten a powerful model.
Margin on <unk> clearly, we were moving ahead from a position of strength and we have two two is not.
A defensive play, but what can you say about so so so on <unk> I think it's fair to state that we are very very confident on <unk>, including on the safety of <unk>.
I'll remind you that we have.
Two clinical trials based on that.
Being in monotherapy 26 weeks of exposure in doses exceeding dose.
We intend to take into phase III.
And second in combination with <unk> 20 weeks also in doses exceeding those we tend to take it.
In both trials in monotherapy and combination therapy.
A briefly all amylin analogue.
To be very safe.
In that exposure.
Timeframe, which is again up to 26 weeks.
<unk>.
When we combined it.
It did look at a safety profile that was similar to that of <unk> and modal.
So from our perspective, what we've seen so far is the safety profile that is very very robust.
And as you evolve obviously seen before so an efficacy profile that is more than robust.
It's super competitive and therefore, our confidence in the categories in the molecule is very very high.
Good to hear margin very encouraging thank you.
Thank you Mark for the questions and we have time for a final set of questions.
Our final question comes from the line of Martin <unk> from Danske Bank. Please go ahead.
Absolutely excellent Matson packet Danske bank.
A couple of questions and I think I will.
Part of them all towards Dark and then North America first of all talk when I remember when I look back at the capital markets day in 2019.
The one thing that the.
That.
The stance is the highlight for me was quite muted outlook for North America.
And not willing willingness to guide towards 25%.
On <unk> why you did that on international operations now.
The muted outlook was not really panning out before 10%. This year what are you actually seeing for the outlook for North America.
After.
For the next couple of years.
And in that context, maybe you.
You can maybe also address what kind of dynamics you think we will we will see in the <unk>.
<unk> you have one market after the loss of two sabotage we've always seen that that a new launch will will will push the market all parts, but we are at a very high rate already and follow a much larger base. So will this be much more about market share. Then then further market expansion.
I'll keep it to that okay. Thanks. Thank you. Thank you Martin.
Dr Perspectives on growth in the U S. While we don't guide on the future market, but clearly a step up in growth compared to what we.
Perhaps looked at 19.
Yes, Martin and I don't want to disappoint, you again, but we're not going to guide on U S. Then or today, but I would say this I mean, we talked about the transformation of the U S business back at capital markets day, and we talked about our ability to transform the business from what was some legacy products and reinvest into what we were considering novel products for newer products from 2015 on.
The aim of our ambition was to was to transform 70% of the business and we're at about 60% and our goal is to do that by 'twenty two.
We're very encouraged to believe that we can hit that goal by the end of this year.
See in the short term is continued growth around some appetite, which will come in the form of both obesity and diabetes, we feel very good about how we're progressing with our <unk> our ability to take share. There is consistent volume gross growth across the portfolio and again, we're very pleased with how things are progressing there and we expect them to continue.
New this year as far as Giuseppettite like we mentioned back of capital markets. In 2019 when products are getting introduced into this space, which still is roughly 10% of prescriptions, maybe 30% of the value. There is still plenty of room for patients to get on <unk>. So we do believe that the introduction of additional product can bring.
Further expansion of the category it'll.
It'll be a competitive product and I'm sure, they're going to be competitive bring competitive muscle and marketing muscle but.
We believe we have great momentum with those epic the potential further products being offered and we also have a portfolio approach. So we feel pretty good about where we are.
Thank you, Doug clearly assembly as a molecule you can go to under deliver fall so lumpy.
Must be the easiest product to compete against thank you Martin.
With this we'll close our earnings call today, we look forward to meet you again sometime in the future have a great day. Thank you.
This concludes our conference call. Thank you all for attending you may now disconnect your lines.
Okay.
Okay.
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