Q2 2022 Novo Nordisk A/S Earnings Call

August 3, 2022

Got it.

Okay.

Phil.

Okay.

No worries.

Perfect.

Got it.

Right.

Okay.

Yes.

Okay.

And let me try to address the we go, we supply.

This concludes our earnings call.

Bob.

Scott.

Good evening. This is the conference operator.

Welcome and thank you for joining the second quarter of 'twenty to 'twenty, two Novo Nordisk earnings Conference call.

As a reminder, all participants are in listen only mode.

After the presentation, there will be an opportunity to ask questions should anyone need assistance. During the conference call that may signal, an operator by pressing star and zero on the telephone.

At this time, I would like to turn the conference over to Mr. Lars Jorgensen, CEO of Novo Nordisk.

As you recall, during our Q1 release, we communicated our expectation of making all those strengths available in the U.S. during the second half of the year, and also, as Doug also just mentioned, that the CMO had reinitiated manufacturing.

Thank you for participating, and please feel free to reach out to our congratulations colleagues regarding any follow-up questions you might have.

I would like to turn the conference over to Mr. Lasse forgot your against them.

Of Melbourne Office. Please go ahead Sir.

Thank you, and have a great day.

Thank you operator.

Please go ahead, sir.

And we also mentioned that we had stopped supplying the two low starter doses as we experienced really, really strong demand that was hard to control.

When it comes to there's no notice earnings call for the first six months of 'twenty to 'twenty, two and the outlook for the year.

Thank you, Operator.

This follows the early announcement and rise raise guidance published today.

This is Daniel Securities regulation.

The release that was originally scheduled for tomorrow morning.

Welcome to this call for the first six months of 2022 and the outlook for the year. This call follows the early announcement and race guidance published today.

And we wanted to ensure that patients starting treatment where we go, we could stay on treatment.

My name is Josh Wolk, our geography, and I'm the CEO of Novartis with me today, I have executive Vice President and head of commercial strategy and corporate Affairs, Camilla Sylvest Executive Vice President and head of North America operations talk Lana.

Due to Danish security's regulation, we advance the release that was originally scheduled for tomorrow morning.

So, what is new now is that we have experienced a bit lower ramp up versus plan, and hence volumes coming from the CMO.

My name is Lars Jorgensen, and I'm the CEO of Novo Nordisk.

And that's why we now explain that we expect all those things to be available towards the end of the year, hence the couple of months delay you alluded to. And this is really because we want to make sure that we have sufficient inventory levels, not to disappoint patients and physicians again, you can say.

With me today, I have Executive Vice President and Head of Commercial Strategy and Corporate Affairs, Camilla Sylvester, Executive Vice President and Head of North America Operations, Doc Lange, Executive Vice President and Head of Development, Martin Holst Lange, and finally, Chief Financial Officer, Karsten Munknudsen.

I'd also like to underline that in parallel with this, we are tracking well on establishing the second and the third manufacturing sites where we go, which will result in a significant step up in supply availability already in 2023.

Executive Vice President and head of development marching towards London, and finally, Chief Financial Officer, Karsten Munk Knudsen.

All of us will be available for the Q&A session.

Today's announcement and the slides for this call are available on our website, novonordisk.com. Please note that this call is being webcast live and the recording will be made available on our website as well.

Today's announcement and the slides for this call are available on our website north-northeast Dot com. Please note that this call is being webcast live and a recording will be made available on our website as well.

This call is scheduled to last for one hour.

The call is scheduled to last for one hour.

Please turn to the next slide.

The presentation is structured as outlined on slide two.

The presentation is structured as outlined on slide two please note that all sales and operating profit growth statements would be.

Please note that all sales and operating profit growth statements will be at constant exchange rates unless otherwise specified.

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.

Please turn to slide three.

As always, I need to advise you that this call will contain forward-looking statements.

As always I need to advise you that this call will contain forward looking statements such subject to risks and uncertainties that could cause actual results to differ materially from expectations.

Such are subject to risk and uncertainty that could cause actual results to differ materially from expectations.

For further information on the risk factors, please see the company announcement for the first six months of 2022, as well as the slides prepared for this presentation.

For further information on the risk factors. Please see the company announcement for the first six months of 2022 as well as the slides prepared for this presentation.

Please turn to the next slide.

In the first six months of 2022, we delivered double-digit sales and operating profit growth, which has enabled us to raise our outlook for the full year.

In the first six months of 'twenty to 'twenty, two we delivered double digit sales and operating profit growth, which has enabled us to raise our outlook for the full year.

I would like to start this call by going through the performance highlights across our strategic aspirations before handing over the work to my colleagues. Within Purpose and Sustainability, we continue to make progress across all dimensions. Under, our Defeat Diabetes Strategy, we reached even more diabetes patients compared to the same period last year.

And as such, we remain really confident in the potential of where we go with being a game changer in a very significant obesity market currently opening up and we have a lot of focus on the U.S.

I would like to start this call by going through the performance highlights across our strategic aspirations before handing over to the word to my colleagues.

But if you look at the IO data, you can really see that obesity is taking up.

Within purpose and sustainability, we continue to make progress across all dimensions.

Onto our defeat our BD strategy reached even more diabetes patients compared to the same period last year.

In line with our aspiration to be a sustainable employer, we expanded the number of women in senior leadership positions to 38% compared to 35% by the end of the second quarter of 2021.

Aligned with our aspiration to be a sustainable Empire, we expanded the number of women in senior leadership positions to 38% compared to 35% by the end of the second quarter of 2021.

Concerning Russia's invasion of Ukraine, our priorities remain to safeguard employees and continue the supply of essential medicines. The most medicines are available in more than 90% of Ukraine, and we are collaborating with humanitarian organizations to make products available in the remaining areas.

Concerning Russia invasion of Ukraine approaches remain to safeguard employees and continue the supply of essential medicines.

Our newest medicines available in more than 90% of Ukraine, and we are collaborating with humanitarian organizations to make products available in the remaining areas.

Within R&D, we are encouraged by the completion of five of the six phase III trials with one with once weekly insulin I could take you off.

Within R&D, we are encouraged by the completion of five of the six Phase 3 trials with once weekly insulin IcoDeck. The ONWARDS trial has shown that IcoDeck has the potential to improve glycemic control with greater convenience and reduce treatment burden for people needing insulin treatment.

<unk> trial show that <unk> has the potential to improve glycemic control with greater convenience and reduce treatment burden for people needing insulin treatment.

The full ONWARDS program is an important step in support of our aspiration of further raising the innovation bar for diabetes treatment and our commitment to insulin innovation.

The full onboard program is an important steps in support of our exploration of further raising the innovation bar for diabetes treatment and our commitment to engineering innovation.

Martin will come back to this and our overall R&D milestones later in this call.

Marketing will come back to this and are all R&D milestone stones later in this call.

In the first six months of 2022, we delivered double digit sales growth, reflecting solid commercial execution across geographies and all therapy areas.

In the first six months of 2022, we delivered double-digit sales growth, reflecting solid, commercial execution across geographies and our therapy areas. While both operating units contributed to sales growth, we saw particularly strong sales growth in North America, driven by accelerated demand for our GP1 treatments, which has enabled us to increase the outlook for the year.

So, strong confidence in our ability to build capacities and also drive that into to patients and to healing patient demands in the coming period.

Thank you.

Both operating units contributed to the sales growth. We saw particular strong sales growth in North America, driven by accelerated demand for RG, one treatments, which has enabled us to increase the outlook for the year.

Next question, please.

Camilla and Doug will go through the details per therapy area later.

Doug will go through the details per therapy area later.

Last customer will go through the financial details, but I'm very pleased with our sales growth of 616% and operating profit growth of 14% in the first six months of 2022.

Last, Carsten will go through the financial details, but I'm very pleased with the sales growth, of 16% and operating profit growth of 14% in the first six months of 2022.

Is that a good way to Camilla for an update on commercial execution.

With that, I give the word to Camilla for an update on commercial execution.

Thank you, Lars, and please turn to the next slide.

The next question is from Simon Mather of BNP Paribas Exxon.

Thank you Lasse and please turn to the next slide.

In the first six months of 2022, our total sales increased by 16%.

In the first six months of 2022, our, total sales increased by 16%. The sales increase was driven by both operating units, with international operations growing 10% and North America operations growing by 24%.

Please go ahead.

This increase was driven by both have already finished with international operations growing 10% and North America operations growing by 24%.

Thank you for taking my question.

<unk>, one sales increased 5% driven by North America, growing 41% and international operations growing 53%.

Our GFP1 sales increased 45%, driven by North America growing 41%, and international operations growing 53%.

I've got two.

Insulin sales decreased by 8% driven by a 5% decline in international operations, and an 18% sales decline in North America operations.

Insulin sales decreased by 8%, driven by a 5% decline in international operations and an 18% sales decline in North America operations. The U.S. insulin sales declined by 19%, driven by lower realized, prices and a decline in volume.

Firstly, the last few days, there's been increased noise over U.S. pricing reform, Biden trying to push something through the 11th hour.

I'm just wondering if you could give Novo's perspective on that, obviously short term potential upside for you guys.

The U S, including sales declined by 19% driven by lower realized prices and a decline in volume.

In line with expectations, insulin sales in international operations were impacted by the implementation of volume-based procurement in China as of May 2022.

In line with expectations instrumentation International operations were impacted by the implementation of volume based procurement in China and took me.

Obesity care sales grew 84% overall in international operations, sex sender sales, grew 60%, and in North America operations, obesity care sales grew 102%.

Two.

Obesity care sales grew 80.

12% overall.

As operations extend this age group, 50% North America operations obesity care sales grew 102%.

In the U S obesity care sales grew 110% driven by <unk>.

In the U.S., obesity care sales grew 110%, driven by legal.

So the rare disease sales were flat-streamed by a 1% sales increase in international operations offset by a 1% decline in North American operations.

Total <unk> sales were flat to down 1% sales increase and international operations offset by a 1% decline in North America.

Please turn to slide 6.

So I'm thinking more when the direct negotiations come in 2027, your thoughts on the potential inclusion of ENTIC to that part, please.

Please turn to slide six.

Our 15% sales growth within diabetes care is faster than the overall diabetes market. That means we have improved our market share by 1.5% to now 31% and that we continue to be on track to reach one-third of the diabetes value market by 2025. The increase reflects GLP-1 growth of 45% and market share gains in both operating units.

And then secondly, it's on select and it might be a crazy question, but I appreciate the double blind study.

But obviously, if you're on placebo, you're not going to lose weight. So there's potential for quite a high dropout rate in the placebo arm.

Our 15% sales growth within diabetes care is faster than the overall diabetes market.

We have improved our market share by one five percentage points to now 31% and that can continue to be on track to reach one third of the diabetes value market by 2025.

The increase was next year, if one goes to 45% and market share gains in both operating go ahead. Please.

Please turn to the next slide.

In international operations, diabetes care sales increased by 10% in the first six months of 2022, driven by GLP-1 sales that grew by 53% and especially by Osempic. Novo Nordisk remains the market leader in international operations with a GLP-1 value market share of 61.3%. This is driven by share gains across geographies, and I'm happy to share that Osempic has become the GLP-1 market leader in international operations with a 39% market share.

And international operations diabetes care sales increased by 10% in the first six months of 2022, driven by tier two one sales grew by 53% and specialty Biocentric.

<unk> remains the market leader in international operations with a tier one value market share of 61, 3%.

It's driven by share gains across geographies.

I'm happy to share that <unk> has become the tier one market and international operations with a 39% market share.

In region China, the 83% sales growth of the GLP-1 products was driven by the uptake of Osempic following the launch in June 2021, and the inclusion on the national reimbursement list as of January 1st, 2022.

And we can China, the 83% sales growth.

One products was driven by the uptake of authentic following the launch in June 2021, and the inclusion on the National reimbursement is as of January 1st 2022.

And with that, I will hand over the word to Doug.

And with that I will hand over to Thomas.

Thank you for that update, Camilla.

I'm just wondering if, you know, over a large scale dropouts within that placebo arm could have actually, in fact, led to reduce the power of the trial to be stopped interim.

Thank you for that update Camilla, Please turn to the next slide.

Please turn to the next slide.

Thank you.

The U.S. GLP-1 market volume grew by more than 35%, comparing Q2 of 2022 to Q2 of 2021, with once-weekly injectable GLP-1s and rebelsis as the main drivers.

Thank you, Simon.

The U S. <unk>, one market volume grew by more than 35% comparing Q2 of 2022 Q2 of 2021.

So let me try to talk to the U.S. health care reform.

With once weekly injectable GOP ones and rebel Sis as the main drivers.

From an NBRX perspective, we have seen a step up in volume growth in 2021 that has accelerated further since the beginning of 2022.

Obviously, we don't have a lot of details around it.

From an enemy Rx perspective, we have seen a step up in volume growth in 2021 that has accelerated further since the beginning of 2022.

We know some of the elements we support elements that would all improve, say, affordability for patients.

So so reforms, perhaps like what could be coming out of a medical party redesign that could help patients.

Measured on total prescriptions, Novo Nordisk has expanded its market leadership to 56.4% market share. In other words, we continue to take share in a fast-growing market.

Measured on total prescriptions Novo Nordisk has expanded its market leadership to 56, 4% market share.

We we we think are welcome.

In other words, we continued to take share in a fast growing market.

In terms of, say, what is being labeled as renegotiation or ability to directly negotiate with the industry, we're more worried about that because it sounds more like, say, government pricing mandates.

It's too early for us to speculate when it would and how it would impact us.

Additionally, we are thrilled that Osempic has now surpassed Dual AdvoTide, taking the lead in the TRX market with a 40.7 market share.

Additionally, we are thrilled that <unk> has now surpassed two advertise taking the lead in the <unk> market with a 47 market share.

The global rollout of rebelsis is progressing, having now been launched in 39 countries.

The global rollout of rebel CIS is progressing having now been launched in 39 countries.

It remains one of the key contributors to growth in Novo Nordisk.

Please go to the next slide.

Obesity care sales increased by 84%.

Obesity care sales increased by 84%, with 102% growth in North American operations and 60% growth in international operations.

With 102% growth in North America operations, and 60% growth in international operations.

Furthermore, the obesity market expansion continues with a volume growth of the global branded obesity market of more than 60%.

We are encouraged by the performance of Sexenda in international operations that was especially driven by the EMEA region that grew 78% in the first half of 2022. The growth was especially strong in countries that had some level of reimbursement, such as the U.K. and Norway.

We are encouraged by the performance of <unk> in international operations that was especially driven by the EMEA region that grew 78% in the first half of 2022.

The growth was especially strong in countries that had some level of reimbursement such as the U K and Norway.

In the U.S. alone, obesity care sales grew 110%.

In the U S alone obesity care sales grew 110%.

Chairman.

But I would say that overall, we believe that there would be rather limited impact short term.

Following the previously announced will go will be supply issues in the U S. Our focus remains to ensure continuity of care and the patients that have already initiated treatment.

Following the previously announced Wigovi supply issues in the U.S., our focus, remains to ensure continuity of care in the patients that have already initiated treatment. In line with expectations, this has negatively impacted Wigovi prescription trends.

In line with expectations. This has negatively impacted Dolby prescription trends.

Positively sex and the trends have picked up and are now at all time high levels.

Positively, sex ender trends have picked up and are now at all-time high levels.

Regarding with Dolby supply commercial production at the CMO was re initiated in the second quarter of 2022 and inventory building is ongoing we.

Regarding Wigovi supply, commercial production at the CMO was reinitiated in the second quarter of 2022, and inventory building is ongoing.

We expect to make all doses of Wigovi available in the, U.S. toward the end of the year.

We expect to make all doses that will go will be available in the U S towards the end of the year.

Now, Camilla, back over to you for an update on rare disease.

And I can remember back over to you for an update on rare disease.

Thank you, Doug and rare disease faithful unchanged in the first six months of 2022. This was driven by a 1% since close international operations offset by a 1% decline in North America.

Thank you, Doug.

So it's more in the medium, longer term impact that we could be expecting.

And our rare disease sales were unchanged in the first six months of, 2022. This was driven by 1% sales growth in international operations, offset by 1% decline in North America operations.

But it's a bit difficult for us to be very precise and quantify what impact it would be.

Rare blood disorders grew by 3%, driven by NOVA 7, as well as launched products Esporop and Refixia. Specifically, hemophilia A products grew by 1%, hemophilia B sales by 6%, and NOVA 7 by 3%.

Latin <unk> grew by 3% driven by an over seven as well as launch products <unk> and <unk>.

Specifically <unk> grew by 1% and we will see that these sales by 6% and notwithstanding by 3%.

Rare endocrine disorders sales declined by 5%. The declining sales were driven by international operations, decreasing by 1%, and by North America operations, decreasing by 14%. The sales decline was negatively impacted by lower realized prices in the U.S, and timing of shipments.

Endocrine disorder space declined by 5% the declining sales were driven by international operations decreasing by 1% and by North America operations, increasing by 14%.

The sales decline was negatively impacted by lower realized prices in the U S and timing of shipments.

And now over to you, Martin, for an update on R&D.

Now over to you Martin update on R&D.

Thank you, Camilla.

And then, Martin, again, again, on select, could there be anything about dropout rates that impacts this?

Thank you Camilla pizza in to the next slide.

Past months it has been exciting to share the results from the 500 fives and youngest program for once weekly insulin in aggregate.

It's actually a super important question, and it's something that we've been focusing on for many years.

Please turn to the next slide.

Patient dropout, missing data is a scientific and regulatory headache.

I would like to spend some time just summarizing the results that we've seen so far.

So therefore, we've spent the last 10 years refining our approach to outcomes trials. And one of the success parameters in doing these trials is actually to secure that we don't have dropout in either treatment arm. So we predefined a very, very small single-digit percentage number that is allowed to, so to speak, drop out from trials.

Now on what's wanted to establish that insulin I think appears to have.

Some of the best instrument data that we've seen this superiority on HBA HBA once you control as compared to both incident larger magnitude of <unk>, respectively.

And so far, both in select and soul and flow and our other outcomes trials, we are very, very happy with the retention rate, including on the placebo arm.

And just to give you an example that I can actually share, for example, for the entire IQTAC program, we are looking at retention rate in excess of 90, 95%.

And that's something similar that you had to imagine for this next one.

This with no significant risk of hypoglycemia and at the same time and improved quality of life.

For the past months, it has been exciting, to share the results from the five trials in the ONGODS program for once-weekly insulin Iglotec. I would like to spend some time just summarizing the results that we've seen so, far.

Thank you, Martin.

Very excited to see the results from almost wanted to confront enormously.

Now, ONGODS 1 and 2 established that insulin Iglotec appears to have some of the best insulin data that we've seen with superiority on HbA1c control, as compared to both insulin Glartin and insulin Deglutec, respectively. This with no significant risk of hypoglycemia, and at the same time, an improved quality of life.

We're very excited to see the results from ONGODS 1 and 2 confront in ONGODS 3.

<unk> was a double blind double dummy 26 week trial, comparing once weekly insulin architect once weekly implement equity sorry, once daily insulin <unk>.

ONGODS 3 was a double-blind, double-dominant, 26-week trial comparing once-weekly insulin Iglotec with once-daily insulin Deglutec. The objective of the trial was to assess the efficacy and safety of insulin Iglotec in, 588 insulin-naïve people with type 2 diabetes. The trial achieved its primary endpoint of demonstrating noninferiority in reducing HbA1c at week 26 with insulin Iglotec, as compared with insulin Deglutec. From an overall baseline HbA1c of 8.5 percentage points, once-weekly insulin Iglotec achieved a superior reduction in estimated HbA1c of 1.57 percentage points compared to 1.36 percentage points for insulin Deglutec, thus again demonstrating superiority with an estimated treatment difference of 0.21 percentage points. Also in this trial, there was no statistically significant difference in estimated rates of severe or clinically significant hypoglycemia, and once-weekly insulin Iglotec appeared to have a safe and well-tolerated profile.

The objective of the trial was to assess the efficacy and safety of insulin <unk> and 588 insulin naive people with type two diabetes.

The trial achieved its primary endpoint of demonstrating non inferiority introducing able chi at week 26, with the instruments I would think is competitive within some indicative.

But when the overall baseline <unk> of eight five percentage point once weekly insulin <unk> achieved a superior reduction in estimated <unk> of 157 percentage points compared to 130.

Six percentage point points of impact.

Thus again, demonstrating superiority with an estimated treatment difference of <unk> <unk>.

Two one.

<unk> points.

Also at this time there was no statistically significant difference in estimated rates of <unk>.

Severe or clinically significant hyperglycemia and once weekly insulin I could take appear to have a safe and well tolerated too.

With the ONWARDS program being a truly global program, I am also excited that ONWARDS 3 will, cater for a potential Chinese approval.

Thank you, Simon.

With the onward program being a truly global program I'm also excited that onward, we will cater for a potential Chinese approval.

As already discussed in almost six we met the primary endpoint of demonstrating non inferiority in reducing agency with insulin <unk> compared to insulin <unk> in people with type one diabetes.

As already discussed in ONWARDS 6, we met the primary end point of demonstrating non-inferiority, in reducing A1c with insulin ibuprofen compared to insulin dexeprofen in people with type, 1 diabetes. We do, however, also recognize that managing type 1 diabetes is complex and that we still, have work to do on the hypoglycemia risk.

But I also recognize that managing type one diabetes is complex and that we still have to work.

We still have work to do on behalf of placing the risk.

Finally, as also shown at this year's ADA, it's important to call out that the risk of, hypoglycemia was similar for once weekly insulin icodec and daily insulin largent in people with type 2 diabetes as shown in a dedicated hypoglycemia trial, thus underlining the safety profile of insulin icodec.

Finally.

As also shown at this year's 88.

It is important to call out that the risk of hypoglycemia was similar for once weekly insulin <unk>.

And daily insulin <unk> in people with type two diabetes as shown in a dedicated hyperglycemia trial, thus underlining the safety profile of into their life.

Now let's take a closer look at ONWARDS 4.

Next question, please.

Now, let's take a closer look at almost full next slide please.

Next slide, please.

The next question is from Martin Parcoy of SEB.

On what's fall was a 26 week efficacy and safety trial, comparing once weekly insulin and I could take two once daily incident lodging both in combination with <unk> to the NASDAQ.

ONWARDS 4 was a 26-week efficacy and safety trial comparing once weekly insulin icodec, to once daily insulin largent, both in combination with insulin aspart. The trial included 582 people with type 2 diabetes on a basal bonus regimen. The primary objective of the trial was to demonstrate a non-inferiority of insulin icodec, versus insulin largent in reducing A1C at week 26. This treat-to-target trial achieved its primary endpoint by demonstrating non-inferiority, in reducing A1C at week 26 with insulin icodec as compared to insulin largent.

Please go ahead.

Mr. Parcoy, your line is open.

You might be muted, Martin.

The trial included 582 people with type two diabetes on a basal bolus regimen.

Can you hear me?

The primary objective of the trial was to demonstrate non inferiority of incident I could take versus interest in locking in reducing <unk> at week 26.

Yeah, now we hear you.

Hi, Martin.

Just try to tie the trial achieved its primary endpoint by demonstrating non inferiority and reducing agency I think 26 within sort of in aggregate as compared to insulin <unk>.

Okay, Pablo here.

But from an overall baseline A1C of 8.3 percentage points, once weekly insulin icodec achieved, a reduction in estimated A1C of 1.16 percentage points compared to 1.18 for insulin largent with an overall estimated treatment difference of 0.02. In addition, we observed similar rates of severe and clinically significant hypoglycemia. And in the trial, once weekly insulin icodec appeared to have a safe and well-tolerated, profile.

Thank you very much.

From an overall baseline <unk> of eight three.

Three percentage points.

Once weekly insulin in aggregate achieved a reduction in estimated <unk> of 116 percentage points compared to $1 one eight points from the blood.

The overall estimated treatment difference of <unk> <unk>.

In addition, we observed similar rates of severe and clinically significant efficacy and in the trial once weekly insulin <unk> appear to have a safe and well tolerated profile.

Two questions.

Firstly, on the GOVI, I know it's only one year ago that you make the initial launch, but that has happened a bit since then.

In conclusion, we remain very excited about the attractive profile of a once weekly insulin and I could take based on the results from the trials that have read outs to date.

In conclusion, we remain very excited about the attractive profile of once weekly insulin, icodec based on the results from the ONWARDS trials that have read out to date.

I think that the goal of the GOVI, I think that the perception in the U.S. has really strengthened that Usimping and the GOVI is the same molecule.

And maybe you could speculate that many of the patients which have gone on the drug this year is maybe for obesity and maybe the same on Mojave.

Do you think that there's actually some change dynamics already now for the obesity potential compared to one year ago, looking at the GOVI, since maybe some of the upside are captured by the so-called GLD1 diabetes model?

These have underlined <unk> potential as an ideal starter insulin for people with type two diabetes.

These have underlined the icodec's potential as an ideal starter insulin for people with, type 2 diabetes. Further, also as an attractive option in combination with mealtime insulin as shown in ONWARDS, 4, thus covering the full spectrum of type 2 diabetes.

And then second question, just on manufacturing, again, supply, Lars.

If you look at sales this quarter, the growth on an absolute basis from Usimping from Q1 to Q2 is more than the total sales of Barbelsus this quarter.

So firstly, are you making long-term changes where you actually now can use some of the previous planned production capacity for Barbelsus that is now used for subcutaneous?

And maybe Martin can share some light on the trial which has recently been put on clinicalguides.gov, where you're looking at a new production or manufacturing method for Usimping.

Further also as an attractive option in combination with new time incident as shown in our watchful, thus covering the full spectrum of type two diabetes.

We look forward to sharing the results from the final trial ONWARDS 5 during the second, half of 2022.

We look forward to sharing the results from the final trial almost five during the second half of 2022.

Next slide, please.

Is that something that you could elaborate on?

Next slide please.

Now turning to the select trial and the interim analysis as a reminder, connect is a double blinded randomized placebo controlled trial in patients with overweight and obesity and established cardiovascular disease.

Now turning to the SELECT trial and the interim analysis.

Thank you, Martin.

As a reminder, SELECT is a double-blinded, randomized placebo-controlled trial in patients, with overweight and obesity and established cardiovascular disease.

Camilla, can you maybe talk a bit through what has, you know, if anything happened over the year we've been in the market, both products with the same molecule and how this is looked at?

Having said that, it's, of course, also important for us to just underline that we promote in each segment the benefits of Vigovi and, of course, USMPIC in the diabetes segment and hope to cater for each of those two groups of patients.

But, basically, the understanding and the perception of TRK1 in general has really taken off, and that was just talking to the significant growth rates that we have seen underlying the profile of methamphetamine.

Yeah, and maybe picking up on that and trying to address supply, you can say we see really, really strong dynamics now with USMPIC.

We have Repulsus as well.

Previously stated, the Independent Data Monitoring Committee will be evaluating an interim analysis, of the trial during Q3 of this year with the potential for terminating the trial earlier than planned. The interim analysis has now been conducted and based on that... As the recommendation received from the Independent Data Monitoring Committee, we have decided, to continue the SELECT trial.

We have Vigovi, and we have further combinations and all formulations as well.

Obviously stayed with the independent data monitoring committee will be evaluating an interim analysis of the trial during.

Q3 of this year with the potential for terminated with file earlier than planned.

The interim analysis has now been conducted and based on that.

The recommendation received from the independent data monitoring committee, we have decided to continue to see.

Now, it's important to remind you that Novo Nordisk has not seen the data.

So it's important for us to build a medium, long-term, flexible manufacturing setup that can produce all products, so to say, because, to be honest, our ability to precisely forecast which presentation and which administration of a molecule like semaglutide is delivered in can be hard.

Okay.

So, to your point, it's a priority for us to build flexibility both in our API but also, you can say, in our, say, filling setup.

It's important to remind you that novo nordisk has not seen the data.

And you're well aware that we have for years been investing in a significant API facility in the US, which is now coming in line.

So we have a huge capability there, and obviously also out of Denmark, where we have an ongoing significant investment in building more API.

And then you can say it's relatively easier and faster to scale up with different types of filling lines, be that for different types of devices. So, yes, flexibility across presentations and dosing forms is important.

As an additional reminder, the select trial is powered for 17%.

As an additional reminder, the SELECT trial is powered for 17%.

And then finally, Martin, on a new trial.

This is the trial design, and given the cardiovascular reduction seen in Pioneer 6, as well as Sustained, 6, both trials in type 2 diabetic populations, we remain confident about the somatotype and what somatotype can do for people in obesity.

This is the time to time and given the cardiovascular reduction seen in pioneer six as well as sustained six both trials in type two diabetic populations. We remain confident about this amazing type and what I.

I can do for people in obesity.

The SELECT trial is now expected to complete in the middle of 2023.

The select trial is now expected to complete in the middle of 2020.

Next slide, please.

Next slide please.

Let's turn to the high-level R&D milestones. We've already touched upon the ONWARD program and SELECT, so now I would like to highlight, some of the other trial readouts and initiations across our therapy areas during the course of 2022.

Yeah, without going into too much detail, we are continuously upgrading our formulations, of not only Ocempic, but also Rubellsis and other drugs.

Let's turn to the high level R&D milestones, we've already touched upon the almost five.

And obviously, we had to generate clinical data to support that.

Along with program and today, so now I'd like to highlight some of the other trial readouts and indicate initiations across our therapy areas. During the course of 2022.

Thank you, Martin.

Within diabetes, we expect results from the exploratory phase 2 trials with caclosema for people with type 2 diabetes, during the third quarter of 2022.

And Martin, next question, please.

Within diabetes, we expect results from the exploratory phase II trials of <unk> for people with type two diabetes during the third quarter of 2022.

The next question is from Michael Novod of Nordea.

In addition, we also expect to start a phase 2 trial in the same quarter to explore the potential of higher doses of, injectable somatotype for the treatment of type 2 diabetes.

Please go ahead.

In addition, we also expect to stop.

Two trial in the same quarter to explore the potential of higher doses of injectable <unk> for the treatment of type two diabetes.

Yeah, thanks a lot.

Within obesity, we have initiated a phase 1 trial with once-daily oral amicretin, a combination of amylin, and TRT1 analogs, and expect to start phase 3 with caclosema during the fourth quarter of 2022.

Just one question.

Within obesity, we have initiated a phase one trial once daily all in accretion a combination of amylin and get one analogues and expect to start phase three with Microsemi two in the fourth quarter of 2022.

Sorry about sort of digging down into supply again.

I was just wondering, is there any risk that the supply constraints on the bulk side could, also lead to sort of a delayed launch in IO of the GOVI, i.e., will you be significantly ramped up on the production side to also ensure that the GOVI is broadly launched throughout, 2023, as it seems like you're expecting also significant demand there?

Within rare disease, we've initiated a phase 2 trial with ENDEC, previously known as Eclipse, in 84 adults with, sickle cell disease.

Yeah, thank you, Michael.

Within rare disease, we've initiated a phase II trial with index previously known as <unk> in <unk>.

Paul.

With sickle cell disease.

We're also very excited about the recent U.S, approval of once-weekly Repinine prophylaxis for people with hemophilia B.

I spoke to our investments in API capacity, some kicking in shorter term, some kicking in, medium term. And even within the API capacity we have now, we have extra, say, capacity available for, next year.

So we believe we have capacity to start rolling out the GOVI in the outside of US countries, starting significantly next year.

We're also very excited about the recent U S approval of once weekly Webinars prophylaxis for people with hemophilia B.

Furthermore, the results from the primary analysis of SPROS-7 with concitumat were presented at the ISTH, conference in London recently, and we expect to submit concitumat for regulatory approval in the inhibitor segment during the third quarter of 2022.

Furthermore, the results from the primary analysis of the four seven with consistent met represented.

Th Congress in London recently, and we expect to submit completed.

We estimate for regulatory approval.

Segment during the third quarter of 2022.

Finally, within other serious chronic diseases, we have initiated a phase 2 trial with the anti-amyloid, immunotherapy acid we acquired from Prostina in 2021. The trial includes 99 people with a rare heart disease, trans-thyroidism, and amyloid cardiomyopathy.

Finally.

Within other serious chronic diseases, we have initiated a phase two trial with the anti amyloid immunotherapy asset we acquired from a partner in 2021.

The trial includes 99, Peter with array of heart disease.

Thanks Scott.

MLR cardiomyopathy.

With that, over to you, Carsten.

With that over to you.

Thank you, Martin.

Thank you Martin.

Please turn to the next slide.

In terms of the next slide.

In the first six months of 2022, our sales grew by 25% in Danish kroner and 16% at constant exchange rates, driven by both operating units.

We're already active in France, and we expect to have a couple launches later this year.

So 2023, we'll see a broader launch planned for the GOVI in international relations.

And the first six months of 2022, our sales grew by 25% and things krone and 16% at constant exchange rates driven by both operating units.

And of course, with the dynamics we see for SecSender, that is also based on that we believe, there will be significant volumes there.

We have built flexibility on, say, device platform, which gives some optionality.

So back to also the question from before, it is a lot about with the dynamics we see now, which are, you know, it's massive volumes we are expanding year over year.

So the more we build flexibility, the more we can cater for these demands.

The gross margin increased to 84.4% compared to 83% in 2021 driven by a positive product mix due to, increased year-to-month sales, a positive currency impact of 1.4 percentage points, and productivity improvements.

The gross margin increased to 84, 4% compared to 83% in 2021, driven by a positive product mix due to increased just one sales a positive currency impact of one four percentage points and productivity improvements.

These effects are countered by lower realized prices in the U.S. Sales and distribution costs increased by 29% in Danish kroner and 22% at constant exchange rates. The increase is driven by launch activities and promotional spend for Rebeltus and Olympic, as well as market development activities for BCT.

Facts are countered by lower realized prices in the U S.

Sales and distribution costs increased by 10, 9% in Danish krone, and 22% at constant exchange rates.

The increase is driven by loss activities.

<unk> spent for resources and centric.

As well as market development activities for obesity.

The cost increase is also reflecting low activity levels in 2021 due to COVID-19, as well as, higher distribution costs.

The cost increase is also reflecting lower activity levels in 2021, due to COVID-19, as well as higher distribution costs.

Research and development costs increased by 31% in Danish krone, and 26% at constant exchange rates.

Research and development costs increased by 31% in Danish kroner and 26% at constant exchange, rates. The increase is driven by higher clinical activity levels within other serious chronic, diseases and GILT1, as well as the operating costs and amortizations related to the acquisition of Dicerna pharmaceuticals in the fourth quarter of 2021.

The increase is driven by higher clinical activity.

Officers current diseases, and Q1 as well as the operating costs and amortization related to the acquisition of <unk> pharmaceuticals in the fourth quarter of 2021.

Administration costs increased by 7% in Danish kroner, and 3% at constant exchange rates.

Administration costs increased by 7% in Danish kroner and 3% at constant exchange rates.

Operating profit increased by 26% in Danish kroner and by 14% at constant exchange rates.

Net financial items for 2022 showed a loss of around 2.8 billion Danish kroner compared, to a gain of around 1.1 billion in 2021. This mainly relates to losses following the appreciation of the US dollar, which is also, reflected in the variable currency impact on operating profits.

Net financial items for transparency two showed a loss of around <unk>.

Two 8 billion Danish kroner compared to a gain of around $1 1 billion in 2021.

This mainly relates to losses following the appreciation of the U S. Dollar, which is also reflected in the favorable currency impact on operating profits.

The effective tax rate for the first six months of transparency to what.

The effective tax rate for the first six months of 2022 was 20.7% compared to 19.8% in 2021. Net profit increased by 11% and diluted earnings per share increased by 13% to 12 kroner and, 8 øre.

27% compared to 19, 8% in 2021.

Net profit increased by 11% and diluted earnings per share increased by 13% to trough Corona and <unk> yeah.

Free cash flow was $42 7 billion Danish kroner compared to $232 7 billion Danish kroner in 2021.

Pre-cash flow was 42.7 billion Danish kroner compared to 32.7 billion Danish kroner in, 2021. Cash conversion in the first half of 2022 is positively impacted by timing of rebate, payments in the US, including provisions related to the revised 340B distribution policy in the US.

The cash conversion in the first half of 2022 is positively impacted by timing of rebate payments in the U S.

Including provisions related to the revised $3 40 beat distribution policy in the U S.

Income under the 340 <unk> program has been partially recognized.

Income under the 340B program has been partially recognized.

Yeah.

Next slide please.

Next slide, please.

A key priority for Nurnorsk is to ensure attractive allocation of capital to shareholders. In line with our strategy, we have returned 28 billion Danish kroner to shareholders through, dividends and the ongoing 24 billion kroner share buyback program.

A key priority for <unk> is to ensure attractive allocation of capital to shareholders.

In line with our strategy, we have returned 28 billion Danish kroner to shareholders through dividends.

The ongoing 24 billion kroner share buyback program.

For 2022, the Board of Directors has decided to pay out an interim dividend of 4 kroner, and 25 øre per share, which will be paid out in August this year. This is an increase of 21% compared to the 2021 interim dividends.

For transferring that to the board of directors has decided to pay out an interim dividend for.

<unk> and 'twenty five.

Per share.

Which will be paid out in August of this year.

This is an increase of 21% compared with 2000.

'twenty one interim dividends.

Please turn to the next slide.

Next slide.

Yeah.

We continue to transfer to institute with a solid growth momentum and now expect sales growth to be between 12% and 16% at constant exchange rates. This is based on a number of assumptions as described in the company announcements.

We continue 2022 with a solid growth momentum and now expect the sales growth to be between, 12 and 16% at constant exchange rates. This is based on a number of assumptions as described in the company announcements. The raised guidance reflects expectations for sales growth in both international operations, and North America operations and across therapy areas, but it's mainly driven by diabetes and obesity care. The guidance update incorporates an accelerated NBRX volume trend within injectable GF1 in, the US, favorable obesity market expansion, and the expectation of making all the Go-V-Dose drinks available in the US towards the end of the year.

But that's a pleasure to do when you see the demand we are experiencing now.

So we have a lot of happy colleagues in the product supply working really hard, and doing a great job.

Thank you, Michael.

Next question, please.

The raised guidance reflects expectations for sales growth in both international operators.

The next question is from Richard Vosser of JP Morgan.

International operations, and North America operations and across therapy areas, but it's mainly driven by diabetes and obesity care.

Please go ahead.

Hi, thanks for taking my questions.

The guidance update incorporates an accelerated <unk> volume trends within injectable just one in the U S.

Favorable obesity market expansion and the expectation of making all the comito strengths available in the U S towards the end of the year.

Following our continued higher than expected volume growth of just one based products, including <unk>.

Following a continued higher-than-expected volume growth of GF1-based products, including, NOSYMPIC, the outlook also reflects expected periodic supply constraints.

<unk> also reflects expected periodic supply constraints.

We now expect that operating profit will grow between 11% and 15% at constant exchange rates.

We now expect that operating profit will grow between 11 and 15 percent at constant exchange, rates. This primarily reflects the sales growth outlook and continued investments in current and future, growth drivers.

This primarily reflects the sales growth outlook and continued investments in current and future growth drivers.

We are also allocating additional resources to both early and late-stage R&D pipeline, activities.

We are also allocating additional resources to both early and late stage R&D pipeline activities.

As mentioned before our acquisition of <unk> Pharmaceuticals is negatively impacting operating profit growth by around three percentage points due to higher operating costs and amortization of intangible assets.

As mentioned before, our excession of discernible pharmaceuticals is negatively impacting operating, profit growth by around 3 percentage points due to higher operating costs and amortizations of injectable assets.

Given the current exchange rates, most notably strengthening of the U S dollar.

Given the current exchange rates, most notably strengthening of the US dollar, we now expect, a positive currency impact for 2022. Our reported sales are now expected to be 9 percentage points higher than at constant, exchange rates, and operating profit growth is now expected to be 14 percentage points higher than at constant exchange rates. The positive currency impact on operating profits of 14 percentage points is partly, offset by a net loss on financial items. For 2022, we now expect that financial items will amount to a net loss of around 5.5 billion, Danish kroner, mainly reflected losses associated with foreign exchange hedging contracts.

Now expect a positive currency impact for 2022.

Our reported sales are now expected to be nine percentage points higher than at constant exchange rates and operating profit growth is now expected to be 14 percentage points higher than at constant exchange rates.

The positive currency impact on operating profit of 14.

It's partly offset by a net loss on financial items for <unk>, We now expect financial items.

Mount to a net loss of around five 5% in Danish krone, mainly reflects losses associated with foreign exchange hedging contracts.

Capital expenditure is still expected to be around 12% in Danish krone, and <unk> 22, which mainly related to investments in additional API production capacity at existing manufacturing sites.

Capital expenditure is still expected to be around 12 billion Danish kroner in 2022, which, mainly relates to investments in additional API production capacity at existing manufacturing sites.

Our free cash flow is now expected to be between 57% and 62 billion Danish kroner.

Our free cash flow is now expected to be between 57 and 62 billion Danish kroner.

That covers the updated outlook for 2022 now back to you for final remarks.

That covers the updated outlook for 2022.

Now back to you, Lars, for final remarks.

Thank you <unk>, please turn to the final slide.

Thank you, Carsten.

First question, can you hear me?

Please turn to the final slide.

We are very pleased with the double digit sales growth in the first half of 2022. In particular, the sales growth was driven by an increasing demand for a portfolio of, GLB-1 treatments for diabetes and obesity care, and we continue to reach even more patients.

Sorry.

We are very pleased with double digit sales growth in the first half of 2022 in particular, the sales growth was driven by an increasing demand for our portfolio of tier one treatments for diabetes and obesity care and we continue to reach even more patients.

Yeah, yeah, go ahead.

Excellent.

While both operating units continued continue to drive growth, we did see a very strong sales growth in North America. The strong financial performance in the first six months of 2022 has enabled us to raise our outlook for the full year.

While both operating units continue to drive growth, we did see a very strong sales growth, in North America.

Awesome.

The strong financial performance in the first six months of 2022 has enabled us to raise, our outlook for the full year.

From an R&D perspective, we have now successfully completed five phase III trials for once weekly insulin <unk> I believe the results underlying that we are still committed to further raising the innovation bar and thought leaders. We look forward to share results from the final trials in the <unk> program in the second half of 2022 with that.

From an R&D perspective, we have now successfully completed five phase three trials with one, squeaky insulin icodate. I believe the results underline that we are still committed to further raising the innovation, bar in diabetes.

We look forward to share results from the final trials in the Unbots program in the, second half of 2022.

With that, we are now ready for the Q&A, where I kindly ask all participants to limit her, or himself to one or maximum two questions.

Brilliant.

We're now ready for the Q&A, but I kind of ask all participants to limit her or himself to one or maximum two questions. Operator, we're now ready to take the first question.

Operator, we are now ready to take the first question.

This is the conference operator.

So when I have a look at other obesity trials, one of the challenges, apart from keeping, patients on them, has been maintaining weight loss over such a long period of time.

This is the conference operator, we will now begin the question and answer session anyone who wishes to ask a question May press star and one on that Touchtone telephone.

We will now begin the question and answer session.

So just from what you can see, how well have you been able to achieve, the maintenance of weight loss in select?

Anyone who has a question.

Anyone who wishes to ask a question may press a star and one on their touchtone telephone.

And then just one thought on the prevention of diabetes.

The press Star one now the first question is from Peter.

Anyone who has a question may press star and one now.

It was a discussion at ADA.

Of Citi. Please go ahead.

Thank you people don't city two quick questions Martin Firstly, the market seems to have taken a very binary view, so let's not being stopped to the instruments and negative I thought you'd been at pains to point out since the CMT that you had pre agreed with the SMB.

Trial would be allowed to continue.

The Permian point would be met.

Some key secondary endpoints were shown curve separation, but not quite reaching Scott sick. So I realize you're blinded to the data. My question is though what is the working assumption there though is that the primary endpoint was not met at the first interim although you come from the primary endpoint was met.

Are you excited that potentially you also hitting on some of the secondaries.

And second question much much quicker and cleaner.

When you look at the litigation section of the report.

Appeal to the <unk> would it be discount moving is the only single site potential.

Potentially being impactful from a financial perspective, just in terms of being transparent can you ballpark quantify what the percentage impact would be if you were to lose that appeal and forced to offset food 340 piece, obviously discuss thank you.

The first question is from Peter, Verdalt of Citi.

And with the new timelines or full timelines, I should say, on select, at what point do, you think you can use it to gain a prevention of diabetes claim for Wegovy?

Thank you Pete first marching on.

Interim thanks very much.

Please go ahead.

Thanks very much.

I very much agree we're not disappointed with having to continue the trial because as you also alluded to the <unk>.

Since the outcome.

Two two at the finalized date, having a power of showing 17 percentage point difference between.

<unk> and placebo.

The primary endpoint on base if.

If we were to stop at the interim analysis of 70% would actually be statistically significant thus meeting the primary endpoint, but as any sponsor we want to be very very certain that is stopping at an interim analysis is basically a bearish secured debt and therefore, we have agreed with the DMT.

Obviously too.

Look at a primary endpoint.

The estimate substantially above that of 17.

And obviously.

That was an upside to our base has always been to continue the study to date.

I think it's also important to call out if we see 17% differential between <unk> and placebo at the end of 17.

17% cardiovascular reduction that would from a clinical perspective, the medical perspective also from a commercial perspective.

Very attractive.

Thank you Martin very clear.

Thank you, Peter Verdalt of Citi.

Thank you, Richard.

<unk>.

The 340 B.

Two quick questions.

Related litigation and potential impact.

So this is kind of a comp.

A complicated issue but.

But as you know we changed our distribution policy on the 340 <unk> program beginning in January 2021, and.

And part of that policy change has meant that the.

We are paying less rebates.

For the three B program. So we had a positive cash flow impact compared to what we had previously on the other hand.

Benefit we have in our P&L in 'twenty, one as well as in 'twenty. Two is limited and recall last year, we said that we havent benefit which is less than 3% of that.

Fewer sales.

And that still holds for this year.

So a number of scenarios.

Play out, but I would say in terms of revenue recognition as we also described in our company announcement on page 14 on the cash flow.

We are recognizing income under the program, partially and and income. According to the accounting rules is that just has to be highly probable.

I would say.

In terms of an adverse ruling I would expect limited impact on our P&L.

That would be a one off impact impact in terms of financial resources or cash flow linked linked to the delta between the income recognition and cash flow benefits the exact magnitude.

Yeah.

I would not want to go into at this point in time.

I think those were two questions to you, Martin.

Thank you Kirsten and thank you Pete.

Set of questions. Please.

Yeah, I think if I'm maybe sorry about not seeing an interim analysis on select, it could, be because I'm not allowed to see the data.

Question is from the amount of capacity out of Bernstein. Please go ahead.

And obviously, I am, as you, curious to not only cardiovascular outcomes, but also other, aspects of the trial, and specifically on the weight loss.

Great. Thank you that's all my question.

Martin, firstly, the market seems to have taken a very binary view that selects not being stopped at the interim as a negative.

Again, I'm not privy to any data, including the weight loss.

So can I just spoke to.

What we do know, obviously, is that we've conducted a two-year trial where we've seen, a sustained weight loss over those two years with a similar weight loss as we've seen in our previous trials. So based on what we know so far, at least a two-year semaglutide is able to maintain, the weight loss accrued.

On the prevention of diabetes, basically this doesn't delay anything in the sense that the, regulatory requirement and potentially also the payer requirement is to observe patients off treatment for a specific period of time and still see a differential to the comparative treatment in terms of risk of developing diabetes.

Touching on your comment Martin just now.

Based on what we've seen so far, somatoglutide might have that potential.

And what we obviously intend to do with the extension of the SELECT trial is after termination of the original trial, we'll continue to follow up and we'll do that after one and two and so on years up to 10 years.

What is your view on the perception of the extent of the mace benefit.

With payers and physicians, so what I'm really asking is does it actually matter if the main benefit is 17% or 20% or 25%.

The key that the trial succeed both with respect to reimbursement and uptake. So does any feedback you could share would be much appreciated and then my second question is just on the phase III Cagny. Some obesity start I. Appreciate you mentioned for Q1, I'll stop but it will go the supply timeline change actually have any impact.

As soon as we have the first readout, we will be able to engage in dialogue with not only regulators, but also payers on the potential, should the data support us in that.

Thank you, Martin.

On that phase III study and what is your confidence in starting that study on time, maybe I'm asking because thinking about timeline chicken will go we relaunch is potentially becoming a few months ahead of us that the Italian obesity. So the cagny extend the timelines are becoming increasingly important thank you.

Thank you, Richard.

Next question, please.

Thank you every month, so Martin first one on level of mace benefits and they go to talk to the many other benefits.

Treatments.

Absolutely and obviously its on the clinical from a medical perspective goes without saying any reduction in mace mace being obviously myocardial infarction stroke and cardiovascular death is a positive.

10% as previously been shown to be <unk>.

15% has been shown to be positive anything beyond.

<unk> hundred 13, and obviously beyond that.

<unk> as a positive.

From a clinical perspective.

And I think also from a payer perspective that being said.

And obviously Camilla industrial maybe speak to that but given the takeoff.

I think it's very very clear that we see a very nice reception, even without cardiovascular data, but goes without saying with the cardiovascular data.

That will not be <unk>.

To put elected thing it's important to also call out beyond cardiovascular we built at other comorbidities of obesity in this elektron, obviously, we look at quality of life with Nook.

At risk of developing dementia, so we had a debenture score.

We look at Ulster also.

Right. So so a number of other obesity related comorbidities.

In this elektron.

I may have.

Building on the dimensions glass, you think thats the silicon so I apologize for that but overall ratios with Duke.

For dementia.

In this specific trial.

As an adverse event.

On the calculus.

As we alluded to.

In first quarter of this year, we took a sort of time hit in terms of initiating AK consider because we wanted to prioritize U S supply for <unk> that has already been accrued and we are still confident that we will initiate a shipment in Q4 this year.

So as we kind of wrap up we see a very strong demand for introducing medicine.

And the market is opening up now at a time, where there's no.

Cardiovascular data.

And so we are very bullish on the market itself and we also I would say bolt on until the prospects of the <unk> trial.

And.

I think that's the first question alluded to and I think we've been quite clear about.

All along that case, where we have to continue the trial.

A very good outcome for us.

Thank you Raimo next.

Next question please.

The next question is from Matthew Weston of Credit Suisse. Please go ahead.

The next question is from Carrie Holford of Durenberg.

Thank you very much two questions. Please first Martin can I just ask for a clarification on your answer to Pete's question.

I thought you'd been at pains to point out since the CMD that you had pre-agreed with DSMB that the trial would be allowed to continue even in the event the primary endpoint had been met, if certain key secondary endpoints were showing curve separation but not quite reaching stat sig.

Cause Pete's question implied that you knew that you have to hit the primary endpoint.

That you are waiting for secondary endpoints.

And I just want to be absolutely clear do you have any data I realize that's a possible reason for continuing.

It Didnt hit the <unk>.

Interim stopping criteria.

Can you just please clarify what you know and what you don't while we all acknowledge that there is still a positive reason for select to continue.

And then secondly, a question regarding this you keep caveats in guidance with the risk of supply shortages.

L P. One.

<unk>.

And I'd be very interested to understand what progress you've made because clearly we can see the prescription data we can see the sales of <unk> walnuts. It looks like there is absolutely hamed the capital to your current ability to grow.

So can you please tell us whether or not you've managed to improve yield whether you anticipate in the second half that we will see an impact of these potential supply shortages or whether you are working very hard and hopefully therefore were able to mitigate it.

So I realize you're blinded to the data.

Please go ahead.

Thank you Matthew So first on what we know and I think that's quite easy to answer most of that the easiest question, but it's also an important question because as we also said in the presentation basically we know nothing in terms of the data.

Yeah.

I received a phone call, saying the DMC recommended that you continue the trial and that's basically all the interaction and all the data that I have received in response to <unk> questions. We simply wanted to clarify.

For us.

Having designed a started to be looking at a 17% differential.

It's absolutely a positive seem to continue.

Because.

If we should have stopped for the interim.

Data on the primary inputs should have been substantially beyond 17%.

Again.

There were speaking in hypotheticals, because we haven't seen the data.

My question is, though, what is the working assumption at Novo?

Thank you.

Thank you Martin.

On supply.

Just the one.

Not by saying if you look at our tier one business.

Today with <unk> is the best selling that this medicine in the world.

A couple of questions, please.

Firstly, on Kagrasema, you're on track for that Phase 2 diabetes data later this quarter.

The first six months of 'twenty two it grew by 7% to 3%.

Can you remind us what you really need to see from that study in order to proceed to Phase 3 in diabetes?

Are you looking for superior HbA1c lowering as well as weight loss, superior weight loss versus Ozempic?

I think we all know that we're not we're not getting price increase price increases we're actually seeing a.

Modest price decreases so the volume growth is higher.

So.

That speaks it's clear language that from a high base, we are significantly increasing manufacturing as we go and we have.

Plans.

We are on track to further expand.

<unk> produced in our facilities, we have major new facilities coming in line as we speak.

The state of that approved facilities. So we are on a journey of driving growth and we're ramping up manufacturing capacity to cater for that but it is clear that we are in a position now where there is very very strong demand for four four.

Oh medicines, so we guided after Q1 that we would see periodic.

Supplier.

Here and there and now we raised our guidance third further while also increasing capacity. So that's also what we're facing now.

But it's not that we don't have supply.

We keep growing supply to meet demand that that also keeps growing so from time to time, we'll have issues in certain markets, but the op products coming.

In a continuous manner and we tried to tremendous this the best we can.

And we have.

Capacity expansions coming in line. So we will eventually get to a state where we believe we have also excess capacity.

It's a.

It's a changing situation, but it's from a very very positive starting point of a.

Very strong and notch platform, that's showing tremendous growth.

So just an idea that your hurdle is there in order to proceed.

Next question please.

And then just a quick check on SELECT.

Are there any further interim analysis planned or are we now moving straight towards the final data?

The next question is from Sachin Jain of Bank of America. Please go ahead.

Thank you.

Thank you, Carrie.

Thanks for taking my questions and Maarten apologies I'm going to try a round three on select.

Again, Martin, to you.

Yeah.

I think Pete question, just because it was not really around the 2017 or above or below it so I'm going to rephrase. It. It just is there a scenario where the primary endpoint was substantially above 17, let's say 'twenty two 'twenty three and beyond.

So thank you very much for the question on Kagrasema.

Is it that the primary endpoint was not met at the first interim?

Shrimp and the study is still didn't stop but whatever discussions you'd have promising to date with the SMB on secondaries.

The reason that investors are asking this question is to gauge the probability of select hitting at final analysis.

If you're in the 17% to 20% range now entering people feel differently. If you well north of 20 on the studies only not stopped because of secondaries.

Apologies again, but I'm just trying to really clarify.

On secondary is that the second question is on the weekend, we supply a couple of months delay just if you could provide any color behind that is it utilization of the plants is at a different level of inventory you've decided to bill's and just want to confirm there are no regulatory issues in the background.

Thank you Sachin so interesting number of interpretations of what Pete said, maybe we have to get people back on the line.

Not much.

<unk>.

I guess on a limited number of times you cannot under the same but yes. So so again first of all.

Or are you confident the primary endpoint was met?

I'm not privy to the data monitoring committee's integrations, obviously, we have a data monitoring charter and in that we specifically stated that.

And are you excited that potentially you were also hitting on some of the secondaries?

From a regulatory perspective, in diabetes, we are obviously primarily looking at glycemic control.

We are also looking at weight loss.

Carsten, second question, much quicker and cleaner.

When I look at the litigation section of the report, the appeal of the 340B discount ruling is the only thing you cite as potentially being impactful from a financial perspective.

In order to stop for the interim analysis.

Without going into numbers. It was important that we hit safeguard it ourselves and therefore, specifically on the primary endpoint, we needed to be substantially beyond 17%.

Just in terms of being transparent, can you ballpark or quantify what the potential impact would be if you were to lose that appeal and forced to offer full 340B pharmacy discounts?

Based on the fact that we are being recommended to continue the trial.

Not prudent to speculate what the DMC has.

<unk> seen what kind of data they have seen.

And that also means that.

Yeah as confident as we have ever been in terms of reaching the primary.

But the primary sort of purpose is to look at glycemic control.

And the purpose of this elektron because basically all of our assumptions still holds true.

And in that space, we need to be able to show a differential between the combination therapy and the individual monocomponents.

Now, the important comparison here is obviously semaglutide, and that basically means that we need to have a statistically significant but also clinically relevant differential to semaglutide on HbA1c.

And our base case has always been to continue the trial.

During the interim analysis was an interesting upside.

But again.

I really don't like to speculate on the data that the DMC is because I'm simply not privy to that.

Thank you.

So that's basically what we're looking at.

And given that we have virtually no data in this space, it's also obviously important to call out that the study is exploratory, and this is specifically why we do it before we potentially initiate Phase 3.

Thank you Martin let me try to address we've always supply.

As you recall during our Q1 release, we communicated our expectation of making all dose strength available in the U S. During the second half of the year and also as Taco Taco as you just mentioned that the CMO had re initiated manufacturing.

Thank you, Pete.

On the SELECT, the answer is easy.

And we also mentioned that we had stopped supplying the two low started doses as we experienced very strong demand that was hard to control and we wanted to ensure that patients starting treatment with recovery could stay on treatment.

First, Martin, on the select interim.

We are now looking towards the planned finalization of the trial, and no more intramenalysis will be conducted.

So what has what is new now is that we have experienced a bit lower ramp up versus plan and hence volumes coming from the CMO.

And that's why we now.

<unk>.

Explained that we expect all those things to be available towards the end of the year, hence the couple of months delay.

You too.

Thanks very much, Pete.

Thank you, Martin.

And this is really.

Because we want to make sure that we.

We have sufficient inventory levels not to disappoint patients and physicians again, you can say.

I would also like to underline that in parallel with this we are tracking well on establishing the second and the third manufacturing site.

Which will result in a significant step up in supply availability already in 2023.

I very much agree.

Thank you, Carrie.

And as such we remain really confident in the potential of where we go.

Being a game changer in the very significant.

<unk> markets currently opening up.

And we have a lot of focus on the U S. But if you look at the Io data you can read it to you that obesity is picking up so strong confidence in our ability to build capacities.

And also drive that into two patients and fulfilling patient demands.

In the coming period.

We have time for the last question, please.

Thank you next question please.

The last question is from Mark Purcell of Morgan Sunday.

Our next question is from Simon mother.

On third party Roxanne. Please go ahead.

Well. Thank you for taking my questions I've got two.

Firstly.

The last few days, there's been increased noise over U S pricing reform volume trying to push something through.

I'm just wondering if you could give novo's perspective on that obviously the shorts on potential upside for you guys.

More weapons at the direct negotiations come 2027, your thoughts on the potential inclusion of pulp.

We're not disappointed with having to continue, the trial because, as you also alluded to, you designed the outcome trial to, at the finalized date, having a power of showing 17 percentage point difference between semaglutide and placebo on the primary endpoint on maize.

And then secondly, it comes to light and it might be a crazy question, but I appreciate the double blind study.

But obviously, if you're on placebo, you're not going to lose weight. So there's potential for quite a high dropout rates.

In the placebo arm I'm, just wondering if you know of a.

Large scale drop out.

Zero production being fought led to reduce power of the trial can be stopped for interim thank you.

Please go ahead.

Thank you Simon So let me try to talk to the U S.

Okay reform.

Yeah, thank you for taking my questions.

Obviously, we don't have.

Lot of details around it we know some of the elements.

We support elements that would all improve.

Portability for patients so so reforms.

What could be coming out of <unk>.

Medicare part D redesign that could help patients.

<unk>.

We think.

Welcome.

In terms of.

What is being labeled us renegotiations.

Our ability to directly negotiate with the industry.

Okay.

Worried about that because it's it sounds more like say government pricing mandates.

It's too early for us to speculate.

When it works.

When it works and how it would impact us, but I would say that overall, we believe that there would be great.

A limited impact short term.

If we were to stop at the interim analysis, 17 percent would actually be statistically significant as meeting the primary endpoint.

So it's more in the medium longer term.

But as any sponsor, we want to be very, very certain that stopping at an interim analysis, is basically a very secure bet. And therefore, we had agreed with the DMT obviously to look at a primary endpoint estimate substantially above that of 17. And obviously, that was an upside.

Our base has always been to continue the study to the end.

I think it's also important to call out, if we see 17 percent differential between semaglutide and placebo at the end, or 17 percent cardiovascular reduction, that would, from a clinical perspective, a medical perspective, also from a commercial perspective, be very, very attractive.

Impact.

It could be expected, but it's a bit difficult for us to be.

The size precise.

Quantify what impact.

And then matching again again on select or could there be anything about dropout rates that impacts discovered Brian .

It's actually a super important question and it's something that we'd be focusing on for many years patient dropouts missing data as a scientific and regulatory headache. So therefore, we have spent the last 10 years refining our approach to an outcome for clients.

And one of the success parameters in doing these clients has asthma to secure that we don't have dropped out in either treatment arm.

So we predefined.

A very very small.

Single digit percentage number that is now two to two <unk>.

Peak drop out from.

Compliance.

And so far.

His intellect and Joan inflow in our Dol compliance.

We're very very happy with it.

Right, including on the placebo arm and just to give you. An example that I can actually share exam.

For the entire program, we're looking at retention rates in excess of 19, 95%.

And Thats something similar that you have to imagine for this unique time.

Thank you, Martin.

First question, going back to the WGOVI resupply.

Thank you very much thank.

Thank you Simon next question please.

Very clear.

Should we think about this as a resupply, Lars, or will this be a relaunch in the latter part of this year?

Next question is from Martin <unk> of S. E. B. Please go ahead.

Yeah.

Mr. <unk> your line is open.

Carsten, the 340B-related litigation potential impact?

I'm thinking about going back to Martin's question, DTC promotion.

Yeah.

Will we see this kick in?

It might be muted.

So this is kind of a complicated issue.

But as you know, we changed our distribution, policy under the 340B program beginning in January 2021.

And part of that policy change has meant that we are paying less rebates under the 340B program. So we have a positive cash flow impact compared to what we had previously.

What should we think about the shape of the relaunch?

Okay.

On the other hand, the benefit we have is our P&L in 21, as well as in 22, is limited.

Will it be a hockey stick or will it be more gradual?

Can you hear me.

I am not sure Okay Pablo Thank you very much.

Two questions Firstly on the on the go and I know, it's only one year ago that you make the initial.

But the that's happened a bit since then.

That the.

Prescription.

<unk>.

Has really strengthened that there that the that they were simply going to go is the same molecule.

Maybe you could speculate that that many of the patients which have gone on the drug this year.

Just maybe for obesity and David the scene on mobile do you think that there's actually some change dynamics already know purdue pieces of potential compared to one year ago looking at the peak over since maybe some of the upside all captured by the so called shield one therapeutic market and then second question just on.

Shang again L supply.

And are you, making long term if you look at the.

Sales this quarter.

On an absolute basis from there is simply from too once you could choose is more than the total sales of ultra.

So firstly are you are you, making long term changes where you actually can do some of the.

Previous plant production.

Could I ask what you called up elsewhere, but is now huge PA, putting should continuous and maybe Martin can can shed some light on the trials, which have recently been put on on clinic drives cutoff, but youre looking at.

The auction on manufacturing method for fault, we ship because it's not something that you could elaborate on.

And recall last year we said that we have a benefit which is less than 3 percent of US sales.

Thank you Martin.

<unk> can you maybe talk a bit through what.

If anything happens.

Given.

Okay.

Products with the same molecule in houses.

Yes.

There is no doubt that.

If you take the big picture.

The overlap between the number.

And the number of people, leaving.

And of course a hat.

And <unk> on the market criteria has under 19.

As of June <unk>.

Treating people with obesity.

It's also clear that.

Leaving the country.

It sounds like kind of overweight and obesity.

Okay.

The percent of people, leaving with Barclays.

Suffering from DCC.

Costs with the benefits of authentic the proven cardiovascular profile Avon CFO .

And also the weight loss profile, it's clear that this will benefit.

And of course also people living with PBC. So we've seen that whole connotation around how important it is to also treat.

PCT and also treat overweight in people with diabetes testing to get increased and this of course has been underlying thing and we see that effectively try and buy the growth posted in the diabetes segment and the strong on.

Unmet need in <unk> and <unk>, having said that is of course also important for us to win to just underline that we promote in segments with benefits and <unk> and of course SMT came to diabetes and.

And hope to cater for each of those two groups of patients, but basically the understanding and the protection that's yet to run in general we've been taken off and that was just talking to a significant growth rates that we are seeing underlying our profile also into Mexico.

So is it a relaunch or is it resupply effectively?

And maybe picking up on that and trying to address supply.

You can say and we said we'd reduce strong.

Dynamics now with Olympic.

Proposals as well we have we Colby.

And we have further combinations and all formulations as well so it's important for us to build.

I would say.

Long term flexible manufacturing setup that can.

Produce.

All products, so to say because.

To be honest, our ability to precisely forecast which presentation.

Which.

Administration of <unk>.

Of molecule like some flu type is delivered and can be hot so to your point it's a.

Priority for us to build flexibility both in our API.

But also you can say in our.

Feeling sit up and you are well aware that we have been investing in a significant API facility in the U S, which is now coming in line.

So we have a huge.

Capability, there and obviously also out of Denmark, where we have an ongoing significant investment in building more ipi and then.

You can say, it's relative easier and faster to scale up with different types of filling lines.

But that for different types of devices. So yes.

Flexibility across presentations.

<unk>.

And dosing forms is important.

And then the second question, I was intrigued by the Phase 2 trial.

And then finally marching on the one.

The new trial without going into too much detail will continue.

You're starting with a higher dose of injectable sema.

Upgrading our formulations.

Notable new samples, but also the doses and other drugs and obviously, we have to generate clinical data to support them.

Thank you Martin and Martin next question. Please.

And that still holds for this year.

I would have thought you would have gone straight into Phase 3.

So a number of scenarios to play out.

So what is there about this trial, which means you have to do a proof of concept trial versus going straight into Phase 3?

The next question is from Michael <unk> of Nordea.

But I would say, in terms of revenue recognition, as you also described in our company announcement on page 14 on the cash flow, we are recognizing income under the program partially.

What's the target product profile and what does it mean when it comes to fighting back versus incoming competition?

Please go ahead.

And income, according to the accounting rules, is that it has to be highly probable.

Will you use this higher dose in combination with Cagri Sema and potentially in combination with a GIP, which could give you a wider therapy window?

So I would say, in terms of an adverse ruling, I would expect limited impact on our P&L, whereas there would be a one-off impact in terms of financial resources or cash flow linked to the delta between income recognition and cash flow benefits.

Yeah, Thanks, a lot.

The exact magnitude, I would not want to go into at this point in time.

Thank you, Karsten.

Thank you very much.

Thank you, Pete.

Thank you, Mark.

Just one question.

Next set of questions, please.

So on resupply, you can rest assured that we are eagerly awaiting driving with Govee when we can make all those things available.

Sorry about sort of digging down into where to supply again I was just wondering is there any risk that the.

The next question is from Vimal Kapadia of Bernstein.

I would like to refrain from getting into the specific tactics.

So supply constraints on the bulk side.

Syed could also lead to sort of a delayed launch in Io of Gobi will.

Will you be significantly ramped up on the production side to also ensure that the Cove is broadly launched throughout 2023.

As it seems like you're expecting also significant demand the demand there.

Please go ahead.

I think we have entered into a situation where we are talking a lot to the details about how we run our business, and it's a very competitive space.

Yeah. Thank you Michael.

I spoke to our investments in ATI capacity.

Great.

So I hope you respect that we would prefer not to get into all the details of that.

Some kicking in shorter term some kicking in.

The medium term.

And even within the Pike API capacity, we have now.

We have.

Extra capacity.

Capacity.

Available for for next year. So we believe we have.

Capacity too.

Stops rolling out <unk> in.

In the outside of U S countries.

Starting.

We can do next year.

Having said that, we are very confident in the product.

It is active in <unk> in France, and we expect to have a couple launches later this year.

So 'twenty three we will see.

Broader launch plan for recovery in central operations and of course.

With the dynamics received for center that is also based on that we believe there'll be significant volumes there.

We have.

Bill flexibility on on Se device platform, which gives us some optionality. So so back towards the question from before it is a lot about with the dynamics, we see now.

It's massive volumes.

Spending year over year. So the more we build flexibility is the more we can cater for these.

Instruments.

It's a pleasure to do when you received the domain extension now so we have a lot of heavy.

Colleagues and <unk> been working really hard.

During the question.

Thank you very much for taking my question.

Thank you Michael next question please.

The next question is from <unk> <unk> of Jpmorgan. Please go ahead.

So can I just first, just touching on your comment, Martin, just now, what is your view on the perception of the extent of the MACE benefit with payers and physicians?

Hi, Thanks for taking my questions first question.

So what I'm really asking is, does it actually matter if the MACE benefit is 17% or 20% or 25%?

Can you hear me sorry, Yeah. Yeah go ahead excellent awesome brilliant.

And is it really the key that the trial succeeds, both with respect to reimbursement and uptake?

And when I have looked at other at HD, Charles one of the challenges apart from keeping patients on them has been maintaining weight loss.

Over such a long period of time say just from what you can see how well have you been able to achieve.

So just any feedback you could share would be much appreciated.

The maintenance of weight loss.

In select and then just one on the prevention that diabetes is a discussion.

And then my second question is just on the Phase 3 Cagri-Sema obesity start.

At Adi and with the new timelines or full timelines I should say on select at what point do you think you can gain.

I appreciate you mentioned, you know, 4Q start.

But did the Wgovi supply timeline change actually have any impact on that Phase 3 study?

Dana prevention of diabetes claims.

Thanks, so much thank.

Thank you Richard I think those are the two questions to you mentioned I think if I may be sorry about not seeing an interim analysis on connect it could be because I am not allowed to see the data and obviously I am as you curious to not only be cardiovascular outcomes, but also all the aspects of the trial and specifically on the weight loss again I am not.

And, you know, what is your confidence in starting that study on time?

Really, I'm asking because thinking about timelines, Wgovi relaunches, it's potentially only coming a few months ahead of placebo trial in obesity.

Privy to any data, including the weight loss, but we do know obviously is that we have conducted a two year trial, where we've seen a sustained weight loss over those two years with a similar weight loss.

We have seen in our previous plants. So based on what we know so far at least two years. So magnetite is able to maintain the weight loss of crude.

Yeah.

Okay.

Yes.

On the prevention and diabetes.

Basically this doesn't delay anything in the sense that the regulatory requirement.

And potentially also the payer requirement is to observe patients of treatment for a specific period of time and still see a differential to <unk>.

Two the compares to treatment in terms of risk of developing diabetes.

First of all we see shown so far magnified might have that potential.

And while we obviously intend to do with the extension of the select trial is after.

Mission of the original trial will continue to follow up and we'll do that after one and two until one gets up to 10 years.

As soon as we have the first readout, we will be able to engage in dialogue with not only regulators, but also appears on the potential should the data support us in that.

Thank you so much and thank you. Richard next question. Please. The next question is from Kerry Holford of buying them back. Please go ahead.

So the Cagri-Sema timelines are becoming increasingly important.

Thank you.

Hi, Thank you.

Thank you, Vimal.

Okay.

Hum.

Hey, John She states makes this quarter can you remind us for it.

Is there any need to change a lot of studying.

Page three.

Three in diabetes.

Hey, Nicole.

Go ahead Mike.

While a slight loss.

And going back.

Thank you and I could go back.

Yeah.

And then just a quick check.

Any interim analyses.

As planned.

And now we're moving towards.

And so.

So, Martin, first on the level of MACE benefits and maybe also talk to the many other benefits of these treatments.

Again margin too.

So absolutely, and obviously from a clinical, from a medical perspective, it goes without saying any reduction in MACE. MACE being obviously myocardial infarction, stroke, and cardiovascular death is a positive.

So so thank you very much for the question on <unk> from a regulatory perspective.

In diabetes, we obviously, primarily looking at Leslie under control. We are also looking at weight loss, but the primary.

10% has previously been shown to be okay-ish.

12%, 15% has been shown to be positive.

Sort of purpose is to look at placebo control and in debt.

Space, we need to be able to show a differential between the combination therapy and then individual mono components now the important comparator here is obviously magnified and that basically means that we need to have a statistically significant but also clinically relevant differential to <unk>.

Anything beyond 12%, 15%, and obviously beyond that is seen as a positive from a clinical perspective, and I think also from a payer perspective.

That being said, and obviously Camilla and Dr, will maybe speak to that, but given the takeoff of Wgovi, I think it's very, very clear that we see a very nice reception even without the cardiovascular data, but goes without saying with the cardiovascular data, that will not be a downside, to put it like that.

<unk> on its be able see so thats basically what were looking at and given that we had virtually no data in this space. It's also obviously important to call out there.

I think it's important to also call out beyond cardiovascular, we look at other comorbidities of obesity in the select trial.

Study is historically and this is specifically why we do it before we potentially initiate phase III.

On the select the answer is easy.

All working towards the <unk>.

Plant Finalization of the trial in no more interim analysis will be conducted.

Obviously, we look at quality of life.

Thank you Terry we have time for the last question. Please.

We look at risk of developing dementia, so we have a dementia score.

And last question is from Mark Purcell of Morgan Stanley . Please go ahead.

We look at osteoarthritis.

Yeah. Thank you for taking my questions first question going back to what Kathy resupply should we think about this as a resupply and also will this be a relaunch.

That's a part of this year I'm thinking about getting back to the sort of margins.

His question.

DTC promotion, where we see this kicking what should we think about the shape of the relaunch will it be a hockey stick or will it be more gradual as it re launches of resupply effectively and then the second question.

So a number of other obesity-related comorbidities are in the select trial.

I may have misspoken on the dementia score.

I actually think that's the sole trial, so I apologize for that.

But overall, we actually also look for dementia in this specific trial as an adverse event.

<unk> the phase II trial, starting with a higher doses and checks for semi I would assume.

You didn't come in straight into phase III. So what is the.

This trial, which means you have to do a proof of concept trials professors going straight into phase III, what's the target product profile and what does it mean when it comes to fighting back versus incoming competition.

Will you use this higher dose in combination with Calgary semi Sn.

Essentially in combination with its CIP, which could give you a wider therapeutic window.

Thank you very much.

On the caricocema, as we alluded to in first quarter of this year, we took a sort of time hit in terms of initiating caricocema because we wanted to prioritize U.S. supply for Wgovi. That has already been approved, and we are still confident that we'll initiate caricocema in Q4 this year.

So to kind of wrap up, we see a very, very strong demand for anti-obesity medicine, and the market is opening up now at a time where there's no cardiovascular data.

Thank you Mark so on.

And so we are very bold on the market itself, and we are also, I would say, bold on still the prospects of the select trial.

On resupply.

We you can rest assure that we are eagerly awaiting.

Driving we go we when we can make all the.

It was strength available I would like to refrain from getting into the specific tactics.

We are into the integration wherever you are talking about to the details about how we run our business and it's a very competitive space. So I hope you respect that we would we would prefer not to get into all the details of that having said that we are very confident in the product.

We know that it does a trick for both physicians and patients, and we expect that we can get back strongly when we have the products in the market.

We know that it does the trick for both physicians and patients.

And we expect that we can get back strongly.

When we have the products in the market.

Margin on the high dose sema.

And I think the first question alluded to, and I think we have been quite clear about that all along, that a case where we have to continue the trial is still a very good outcome for us.

Martin, on the high-dose CIMA trial.

Thank you, Emmanuel.

Next question, please.

The next question is from Matthew Weston of Credit Suisse.

So in this space with diabetes again, the purpose has to be showing.

Please go ahead.

So in the space of diabetes, again, the purpose has to be showing primarily a differential on glycemic control and subsequently on weight loss.

Thank you very much.

Two questions, please.

First, Martin, can I just ask for a clarification in your answer to Pete's question?

Because Pete's question implied that you knew that you had hit the primary endpoint and that you were waiting for secondary endpoints that were close.

And I just want to be absolutely clear.

Do you have any data?

Primarily.

For NGL.

Placebo control and subsequently on weight loss.

Increasing doses of <unk> that is something that is interesting for us because.

Based on data that we've seen also from the outside growth.

I realize that's a possible reason for continuing, as is it didn't hit the interim stopping criteria.

Increasing the doses of semaglutide is something that is interesting for us because based on data that we've seen also from the outside world, it appears that we have not, with semaglutide, reached sort of the maximum potential in glycemic control, potentially also on weight loss. And we've seen other data from the outside where the ceiling appears to have been sort of breached, and therefore it's relevant for us to see if we can achieve more with semaglutide.

So can you just please clarify what you know and what you don't, while we all acknowledge that there is still a positive reason for select to continue?

Yeah.

And then secondly, it's a question regarding this.

It appears that that we have not with the magnetite.

You keep caveating guidance with the risk of supply shortages to GLP-1.

And I'd be very interested to understand what progress you've made, because clearly we can see the prescription data, we can see the sales of GLP-1, and it looks like there is absolutely no handicap at all to your current ability to grow.

So can you please tell us whether or not you've managed to improve yield, whether you anticipate in the second half that we will see an impact of these potential supply shortages, or whether you're working very hard and hopefully therefore able to mitigate it?

Reached sort of the maximum effect potentially.

Second control potentially also on weight loss.

Thank you.

Doing a Phase II trial, looking at both obviously safety and efficacy vis-a-vis the different doses is a proven approach and can potentially save us time and effort in the other end.

And we've seen all the data from the outside where the ceiling appears to have been sort of reached and therefore its relevant for us to see if we can.

Thank you, Matthew.

First on what we know, and I think that's quite easy to answer.

That's the easiest question, but it's also an important question because, as we also said in the presentation, basically we know nothing in terms of the data.

I received a phone call saying the DMC recommends that you continue the trial, and that's basically all the interaction and all the data that I have received.

In response to Pete's question, we simply wanted to clarify, for us having designed a study to be looking at a 17% differential, it's absolutely a positive thing to continue, because if we should have stopped for the interim, the data on the primary input should have been substantially beyond 17%.

Again, there we are speaking in hypotheticals because we haven't seen the data.

Thank you, Matthew.

On supply of GFP1, I'll start by saying if you look at our GFP1 business, today Osempic is the best selling diabetes medicine in the world. In the first six months of 2022, it grew by 73%.

T mobile is magnified.

I think we all know that we're not getting price increases.

We're actually seeing modest price decreases, so the volume growth is higher.

So, I think that speaks its clear language that from a high base, we are significantly increasing manufacturing as we go, and we have plans that are on track to further expand volumes produced in our facilities.

<unk>.

We have major new facilities coming in line as we speak, state of the art approved facilities.

Phase II trial.

So we are on a journey of driving growth and we're ramping up manufacturing capacity to, cater for that. But it's clear that we are in a situation now where there is a very, very strong demand, for our medicines. So we guided after Q1 that we would see periodic supply shortages here and there. And now we raise our guidance further while also increasing capacity.

Looking at both obviously safety and efficacy vis vis different doses as a prudent approach and can potentially save both time and efforts.

So that's also what we're facing now.

But it's not that we don't have supply. We keep growing supply to meet a demand that also keeps growing.

So from time to time, we'll have issues in certain markets.

But there are products coming in a continuous manner. And we try to manage this the best we can.

And we have capacity expansions coming in line. So we will eventually get to a state where we believe we have also excess capacity.

So it's a challenging situation, but it's from a very, very positive starting point, of a very strong and large platform that's showing tremendous growth.

Thank you, Matthew.

Next question, please.

The next question is from Sachin Jain of Bank of America.

Please go ahead.

And.

Thanks for taking my questions.

Thank you, Martin.

Thank you, Martin, and thank you, Mark.

Thank you so much and thank you Mark. This concludes our earnings call. Thank you for participating and please feel free to reach out to our Investor Relations.

And Martin, apologies, I'm going to try round three on select.

So I think Pete's question, just to be clear, was not really around the 17 or above or below.

So I'm going to rephrase it.

Is there a scenario where the primary endpoint was substantially above 17, let's say 22, 23 at the interim, and the study still didn't stop for whatever discussions you'd had prior to the date of the BSMB on secondaries?

And I guess the reason investors are asking this question is to gauge the probability, of select hitting at final analysis, i.e., if you're in the 17 to 22 range now at interim, people feel differently to if you're well north of 20 and the study's only not stopped because of secondaries.

So apologies again, but I'm just trying to really clarify the point on secondaries there.

The second question is on where do we supply a couple months perceived delay, just if you could provide any color behind that.

Is it utilization of the plants?

Is it a different level of inventory you decided to build?

I just want to confirm there are no regulatory issues in the background.

Colleagues.

Thank you.

Regarding any follow up questions you might have thank you and have a great day.

Thank you, Sachin.

So interesting number of interpretations of what Pete said.

Maybe we have to get Pete back on the line.

Martin, I guess there are a limited number of times you can answer the same, but...

So, again, first of all, I'm not privy to the data monitoring committee's deliberations.

Obviously, we have a data monitoring charter, and in that we specifically stated, that in order to stop for the interim analysis and without going into numbers, it was important that we had safeguarded ourselves, and therefore specifically on the primary endpoint, we needed to be substantially beyond 17%.

Based on the fact that we are being recommended to continue the trial, I'm not privy to speculate what the DMC has seen, what kind of data they have seen.

Ladies and gentlemen, thank you for joining the conference is now over you may disconnect. Your telephones. Thank you.

And that also means that we are as confident as we have ever been, in terms of reaching the primary endpoint and the purpose of the select trial, because basically all of our assumptions still hold true, and our base case has always been to continue the trial until the end.

Doing the interim analysis was an interesting upside, but, again, I really don't like to speculate on the data that the DMC has seen because I'm simply not privy to it.

[noise].

Yes.

[music].

Yeah.

Okay.

[music].

Yes.

[music].

Yes.

[music].

Okay.

[music].

Sure.

Yes.

[music].

Okay.

[music].

Okay.

[music].

Okay.

[music].

Okay.

[music].

Yes.

[music].

Okay.

[music].

Okay.

[music].

Yes.

[music].

Yes.

Okay.

[music].

Yes.

Okay.

[music].

Okay.

Yes.

Sure.

Yes.

[music].

Yes.

Okay.

Yes.

Okay.

[music].

Thank you.

[music].

Thank you.

Okay.

Yes.

Okay.

Thanks.

Yes.

Okay.

Sure.

Yes.

Sure.

[music].

Okay.

Yes.

[music].

Yes.

Okay.

Yes.

Okay.

Yes.

Okay.

[music].

Okay.

[music].

Yes.

Okay.

[music].

Yes.

Okay.

[music].

Okay.

Thank you.

Okay.

Thanks.

Yes.

Okay.

Yes.

[music].

Okay.

[music].

Okay.

Yes.

Okay.

Yes.

Okay.

<unk>.

Sure.

Yes.

[music].

Yes.

[music].

Okay.

[music].

Yes.

Okay.

Yes.

Okay.

Yes.

Okay.

[music].

Okay.

Yes.

Yeah.

Okay.

Sure.

Yes.

Sure.

[music].

Yes.

[music].

Okay.

Yes.

Okay.

[music].

Thanks.

Okay.

[music].

Okay.

Yes.

Okay.

Sure.

Okay.

Yes.

Okay.

Yes.

Okay.

Yes.

Okay.

Yes.

Okay.

Yes.

Okay.

Yes.

Okay.

Sure.

Thanks.

Okay.

Hi.

Okay.

Sure.

Okay.

Yes.

Okay.

[music].

Yes.

[music].

Okay.

Yes.

Okay.

Sure.

Yes.

Okay.

Thank you.

[music].

Yes.

Sure.

Yes.

Okay.

Yes.

Yeah.

[music].

Yes.

Okay.

[music].

Okay.

Yes.

Okay.

Yes.

Okay.

[music].

Yes.

Okay.

[music].

Q2 2022 Novo Nordisk A/S Earnings Call

Request a DemoDemo

NVO

Novo Nordisk

Earnings