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Novo Nordisk (NVO) Q4 2023 Earnings Call Transcript

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Novo Nordisk

Novo Nordisk Stock Quote

NVO earnings call for the period ending December 31, 2023.

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Novo Nordisk ( NVO -1.96% ) Q4 2023 Earnings Call Jan 31, 2024 , 7:00 a.m. ET

  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:

Good day, and thank you for standing by. Welcome to the Q4 2023 Novo Nordisk earnings conference call. At this time, all participants are in a listen-only mode. After the speakers' presentation, there will be a question-and-answer session.

[Operator instructions] Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Daniel Bohsen, CVP, investor relations. Please go ahead.

Daniel Bohsen -- Head of Investor Relations

Welcome to this Novo Nordisk earnings call for the full year of 2023 and the outlook for 2024. My name is Daniel Muusmann Bohsen, and I'm the head of investor relations at Novo Nordisk. With me today, I have CEO of Novo Nordisk, Lars Fruergaard Jorgensen; executive vice president and head of commercial strategy and corporate affairs, Camilla Sylvest; executive vice president and head of North America operations, Doug Langa; executive vice president and head of development, Martin Holst Lange; and finally, chief financial officer, Karsten Munk Knudsen. All speakers 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 the call is being webcast live, and a recording will be made available on our website as well. The call is scheduled to last one hour. Please turn to the next slide.

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The presentation is structured as outlined on Slide 2. Please note that all sales and operating profit growth statements will be at constant exchange rate unless otherwise specified. Please turn to the Slide 3. We need to advise you that this call will contain forward-looking statements.

These are subject to risks 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 full year 2023 and the slides prepared for this presentation. With that, over to you, Lars, for an update on our strategic aspirations.

Lars Fruergaard Jorgensen -- President and Chief Executive Officer

Thank you, Daniel. Please turn to the next slide. In 2023, we delivered double-digit sales and operating profit growth, and we continue to make progress on our strategic aspirations. I'll walk you through the performance highlights before handing over the word to my colleagues.

We continue making progress on purpose and sustainability. On carbon emissions -- our carbon emissions decreased by 34% compared to pre-pandemic levels in 2019. And in 2023, we reached more than 40 million patients with our diabetes and obesity treatments. To uphold our commitment to being a sustainable employer, we expanded the number of women in senior leadership positions to 41% compared to 39% at the end of '22.

In the past year, we have developed and expanded our pipeline across all our therapy areas. In diabetes and obesity, we have seen several exciting trial readouts, and we have advanced novel assets into phase 3. We have also expanded our footprint in cardiovascular disease and strengthened our late-stage pipeline in rare blood disorders. Martin will come back to this and our overall R&D milestones later.

In 2023, we have achieved two major milestones within commercial execution. We have reached our obesity sales operation of more than 25 billion Danish kroner and our aspiration for diabetes, which was to achieve one-third of the global diabetes value market. Going forward, we continue to aim for treating more patients with our innovative treatments. Lastly, we're very pleased with a strong sales growth of 36% and operating profit growth of 44% in 2023, both measured at constant exchange rates.

Now, I would like to hand over the word to Camilla, who will give us the latest update on our commercial execution.

Camilla Sylvest -- Executive Vice President, Head of Commercial Strategy and Corporate Affairs

Thank you, Lars, and please turn to the next slide. In 2023, our total sales increased by 36%. The sales growth was driven by both operating units with North America operations growing 54% and international operations growing 16%. Our GLP-1 sales in diabetes increased 52%, driven by North America growing 52% and international operations growing 53%.

Insulin sales decreased by 6%, driven by declining sales in the U.S. and region China. Obesity care sales grew 154%. And international operations, sales grew 47%, driven by both Saxenda and Wegovy.

Sales of Saxenda increased by 14% and sales of Wegovy reached around 2 billion Danish kroner. Going forward, we continue to roll out Wegovy in a sustainable manner by volume cap launches to balance supply and demand. In North America operations, obesity care sales grew 212%. Total rare disease sales decreased by 15%, which was driven by a 24% decrease in international operations and by a 1% decrease in North America operations, following a reduction in supply of Norditropin.

Please turn to the next slide. With 29% sales growth in diabetes care, we are growing faster than the total diabetes market. As a result, our global diabetes value market share increased to 33.8%, which is above our strategic aspiration of reaching one-third of the global diabetes value market. This increase reflects market share gains in both North America operations and international operations.

Please turn to the next slide. In international operations, total diabetes cases increased by 20% in 2023, which was primarily driven by GLP-1 sales growing 53%. Novo Nordisk is the market leader in international operations with a GLP-1 value market share over 70%. Ozempic continues its GLP-1 market leadership with 47.5% market share.

Rybelsus has just shy of 14% value market share, driven by solid uptake across geographies. And with that, I will hand over the word to Doug.

Doug Langa -- Executive Vice President, Head of North America Operations

Thank you, Camilla. Please turn to the next slide. In the U.S., sales growth of our GLP-1 diabetes treatments are driven by a 50% expansion of the market in 2023 versus 2022. In the fourth quarter of 2023, the prescription volume growth of the GLP-1 class was more than 30% compared to the fourth quarter of 2022.

Measured on total prescriptions, Novo Nordisk continues to be the market leader with around 54% market share. Please turn to the next slide. Obesity care sales grew by 154%, driven by both operating units. The volume growth of the global branded obesity market more than doubled with a volume growth of 116%.

In international operations, obesity care sales are driven by a strong Saxenda performance and Wegovy launches in seven international operation countries. In the U.S., sales of Wegovy grew by 393%, reflecting the commercial relaunch in January of 2023. To safeguard continuity of care, we reduced the release of lower-dose strengths back in May of 2023, which continued throughout the remainder of last year. I am very pleased to state that we are now enabling more new U.S.

patients to initiate treatment by more than doubling the amount of the lower-dose strengths of Wegovy compared to the previous months. We will gradually be increasing the overall supply throughout the remainder of 2024. Please go to the next slide. Our rare disease sales decreased by 15%.

The sales decrease was driven by a 1% sales decline in North America operations and 24% sales decline in international operations. Sales of rare blood disorders increased by 3%, driven by the launch products in hemophilia A and B, and partially countered by NovoSeven. Sales of our rare endocrine disorder products decreased by 47%, reflecting a reduction in manufacturing output. Now, Martin, over to you for an update on R&D.

Martin Lange -- Executive Vice President, Head of Development

Thank you, Doug. Please turn to the next slide. First, I'm very pleased to share the exciting headline results from the COMBINE 3 trial with once-weekly IcoSema. COMBINE 3 free was a 52-week, open-label treat-to-target phase 3 trial comparing once-weekly IcoSema with once-daily insulin glargine U100 together with up to four daily injections of insulin aspart.

This is also called basal-bolus insulin treatment. The objective of COMBINE 3 was to assist the efficacy and safety of once-weekly IcoSema in people with type 2 diabetes poorly controlled on daily basal insulin. The trial achieved its primary endpoint of demonstrating noninferiority in reducing A1c at week 52 with once-weekly IcoSema compared to insulin glargine U100 together with insulin aspart. From an overall A1c baseline of 8.3%, once-weekly IcoSema achieved an estimated reduction in HbA1c of 1.47 percentage points compared with 1.40 percentage points for insulin glargine together with the insulin aspart.

People in the trial had a baseline body weight of 85.8 kilograms. Treatment with IcoSema achieved a superior reduction in body weight with a weight loss of 3.6 kilograms with IcoSema compared with a 3.2 kilogram weight gain with the basal -- with the insulin basal-bolus treatment. The estimated treatment difference was 6.7 kilograms. IcoSema also showed superiority over insulin glargine U100 together with the insulin aspart in terms of severe or clinically significant hypoglycemic events with only 0.26 events per patient year of exposure compared to 2.18 events per patient year of exposure in the basal-bolus treatment arm.

Overall, IcoSema appear to have a safe and well-tolerated profile. These phase 3 results for once-weekly IcoSema are very promising. For people with poorly controlled type 2 diabetes on basal insulin, IcoSema has the potential to streamline insulin intensification by addressing the main patient barriers. IcoSema sets a new standard for once-weekly treatment by reducing the annual injections from around 1,450 to 52 injections.

This substantial reduction in patient burden is provided together with a strong glycemic control, proper weight management, and, importantly, a factor of 10 times lower rates of hypoglycemia as compared to the current gold standard of insulin basal-bolus treatment. Please turn to the next slide. Turning to the upcoming R&D milestones. There are many exciting trial results in 2024.

However, before I get to that, I would like to highlight a few of the milestones from the fourth quarter of 2023. Within obesity, we have successfully completed two phase 3 studies with semaglutide 2.4 milligram, addressing obesity-related comorbidities, as well as the phase 1 trial for oral amycretin. First, the STEP 9 trial was a phase 3 knee osteoarthritis trial that investigated the effects of semaglutide 2.4 milligrams once-weekly on the co-primary endpoints of body weight and the Western Ontario and McMaster Universities Osteoarthritis Index, abbreviated WOMAC. This is a self-administered measurement used in assessing pain and functionality.

In the trial, 407 people with obesity and mild to moderate knee osteoarthritis were enrolled. The study achieved its co-primary endpoint by demonstrating a superior reduction in both the WOMAC pain score, as well as in-body weight with semaglutide 2.4 milligram compared to placebo. The estimated reduction in mean WOMAC pain score from baseline to week 68 was 41.7 with semaglutide 2.4 milligram and 27.5 with placebo. The estimated treatment difference was 14.1, which was not only statistically significant but also considered clinically very relevant.

The trial results will serve as a foundation for potential outcomes trials with future obesity assets. In addition, we have successfully completed the STEP HFpEF diabetes trial. The STEP HFpEF diabetes trial investigated the impact of semaglutide treatment on functionality and symptoms in patients with obesity, type 2 diabetes, and established heart failure. In total, 660 people were enrolled in the study.

The co-primary endpoints were the average change of baseline in the Kansas City clinical summary score questionnaire and body weight. In the trials, semaglutide showed a 13.7 points improvement versus 6.4 in the placebo arm at 52 weeks. The mean change was 7.3 points in favor of semaglutide, which is considered clinically very relevant and very solid results with chronic heart failure. A superior reduction in body weight was also observed for semaglutide 2.4 milligrams versus placebo.

We've submitted the results from the STEP HFpEF obesity trial, as well as the type 2 diabetes trial for regulatory review in the U.S. and Europe during the course of January of '24. This marks another milestone in our ongoing efforts to address the unmet medical needs in patients with overweight obesity and established cardiovascular disease. The last highlight for the fourth quarter of 2023 is the successful completion of oral amycretin phase 1.

This trial appeared to have a safe and well-tolerated profile for amycretin. We have decided in September of 2023 to also initiate a phase 1 trial with one-weekly subcutaneous amycretin. And further, we expect to advance amycretin into further clinical development. Moving forward to 2024, within diabetes care, we expect a decision on approval of insulin icodec in Europe, Japan, China, as well as the U.S.

during the second half of 2024. We are also anticipating the exciting results of COMBINE 1 and COMBINE 2 from the IcoSema development program during the initial half of 2024. Of note, we are expecting the phase 1 results of the once-weekly GLP-1/GIP in the first half of '24, and we have further initiated a phase 1 trial with once-monthly GLP-1/GIP during the course of January of '24. We continue to build evidence for semaglutide molecule within diabetes as well.

For subcutaneous semaglutide 1.0 milligram, we anticipate the readout of FLOW for people with type 2 diabetes and chronic kidney disease in the first half of this year. This will be followed by the functional outcomes trial, STRIDE, for people with type 2 diabetes and peripheral artery disease in the second half of 2024. As far as semaglutide, the cardiovascular outcomes study, SOUL, is expected to be completed in the second half of 2024. This is getting semaglutide in people with diabetes and cardiovascular disease.

In the obesity area, we expect an FDA decision on the approval of the SELECT data submission in the first half of '24. Furthermore, we look forward to the first phase 3 readout for CagriSema toward the turn of the year. And as a last highlight, we are very excited about the upcoming readout of Mim8 phase 3 in the first half of 2028. Mim8 is a novel, next-generation factor VIII mimetic antibody with potential for improved patient outcomes and reduced burden of treatment in people with hemophilia A.

With that, over to you, Karsten.

Karsten Munk Knudsen -- Executive Vice President, Chief Financial Officer

Thank you, Martin. Please turn to the next slide. In 2023, our sales grew by 31% in Danish kroner and 36% at constant exchange rates, driven by both operating units. The gross margin increased to 84.6% compared to 83.9% in 2022, driven by a positive product mix following increased sales of injectable GLP-1-based treatments.

Costs related to ongoing capacity expansions and negative currency impact and lower realized prices mainly in the U.S. and region China partially offset these effects. Sales and distribution costs increased by 23% in Danish kroner and by 26% at constant exchange rates. The increase is driven by both operating units.

In North America operations, cost increase is driven by the relaunch of Wegovy and promotional activities for Ozempic. While in international operations, cost increase is driven by promotional activities for Rybelsus, as well as obesity care market development activities. Furthermore, the increase in sales and distribution costs are impacted by adjustment to legal provisions. Research and development costs increased by 35% measured in Danish kroner and 37% at constant exchange rates.

The increase reflects our strategic objective to expand the pipeline across therapy areas. Specifically, we continue to increase late-stage clinical trial and early research activities. The acquisition of Forma Therapeutics in 2022 and Inversago Pharma also increased R&D spending. Administration costs increased by 9% measured in Danish kroner and by 11% at constant exchange rates.

Operating profit increased by 37% measured in Danish kroner and by 44% at constant exchange rates, reflecting the sales growth. Net financial items showed a gain of 2.1 billion Danish kroner compared to a net loss of around 5.7 billion kroner last year. The effective tax rate is 20.1% in 2023 compared to 19.6% in 2022. Consequently, net profit increased by 51%, and diluted earnings per share increased by 52% to 18.62 Danish kroner.

Free cash flow realized in 2023 was 68.3 billion Danish kroner compared with 57.4 billion in 2022. This is in line with the strategic aspiration to deliver attractive capital allocation to shareholders. The cash conversion in 2023 was positively impacted by timing of payment of rebates in the U.S. and provisions related to the revised three 340B distribution policy also in the U.S.

Capital expenditure for property, plant, and equipment was 25.8 billion Danish kroner compared with 12.1 billion in 2022. This primarily reflects investments in additional capacity for active pharmaceutical ingredient production and for finished capacity for both current and future injectable and oral products. Please go to the next slide. In 2024, we expect to increase our capital expenditure to around 45 billion Danish kroner.

The significant step-up compared to 2023 reflects the expansion of our supply chain. This includes the previously communicated expansions of manufacturing facilities in Kalundborg and Hillerod located in Denmark and Chartres based in France. The increase in capital expenditure in 2024 mainly relates to investments in additional capacity for active pharmaceutical ingredient production and for finished capacity for both current and future injectable and oral products across our strategic therapy areas. In the coming years, the capital expenditure to sales ratio is still expected to be low double digits.

Next slide, please. In line with our strategic aspiration to deliver attractive capital allocation to shareholders, we have returned more than 61.7 billion Danish kroner to shareholders via share buybacks and dividends during 2023. At the end of general meeting on March the 21st of 2024, the board of directors will propose a final dividend of 6.40 Danish kroner for a total 2023 dividend of 9.40 Danish kroner, including the interim dividend paid in August of 2023. This is over a 50% increase compared to 2022, making it the 28th consecutive year with increasing dividend per share.

In addition, to the dividend, the 30 billion Danish kroner share buyback for the past 12 months has been concluded. For 2024, the board of directors has approved a new share repurchase program of DKK 20 million to be executed during the coming 12 months. Next slide, please. We continue to -- we continued the growth momentum in 2024 and expect the sales growth to be between 18% and 26% at constant exchange rates.

This is based on several assumptions as described in the company announcements. The guidance reflects expectations for sales growth in both North America operations and international operations. The sales growth is expected to be mainly driven by volume growth of GLP-1-based treatment for obesity and diabetes care. With the expectations of continued volume growth and capacity limitations, the outlook also reflects expected continued periodic supply constraints and related drug shortage notifications across a number of products and geographies.

We expect that operating profit will grow between 21% and 29% at constant exchange rates. This primarily reflects the sales growth outlook and continued investments in future and current growth drivers within research, development, and commercial. Our reported sales are expected to be 1 percentage point lower at constant exchange rates, and operating profit is expected to be 2 percentage points lower than at constant exchange rates. For 2024, we expect net financial items to amount to a gain of around 1.3 billion Danish kroner.

This mainly reflects gains associated with foreign exchange hedging contracts, as well as interest rate gains from cash and marketable securities. The free cash flow is expected to be between 64 billion and 74 billion Danish kroner, reflecting sales growth, a favorable impact from rebates in the U.S., countered by investments in capital expenditure. That covers the outlook for 2024. Now, back to you, Lars.

Thank you, Karsten. Please turn to the final slide. We are very pleased with the strong performance in 2023, which reflects that more than 40 million people are now benefiting from our innovative diabetes and obesity treatments. We continue to make progress on our strategic aspirations.

In 2024, our focus will be on the continued significant expansion of our production capacity, reaching more patients and progressing the expanding pipeline. With that, I would like to hand the word back to Daniel.

Thank you, Lars. Next slide, please. With that, we are now ready for the Q&A. We kindly ask all participants to limit her or himself to one or maximum two questions.

This includes sub-questions. Operator, we are now ready to take the first question.

Questions & Answers:

[Operator instructions] We will now take the first question. One moment, please. And the first question comes from the line of Mike Nedelcovych from TD Cowen. Please go ahead.

Mike Nedelcovych -- TD Cowen -- Analyst

Thank you for the questions. I have two for Martin. The first is on the GLP-1/GIP dual agonist. As it relates to the clinical profile of a once-monthly injection, it seems to me that navigating GI toxicity during the titration phase with a drug that's on board for an entire month could be tricky.

Do you think that's a valid concern? And if so, might it undercut to some extent the convenience advantage? And then, my second question is on oral amycretin. Can you provide any insight into the efficacy you saw in the phase 1 trial? A reasonable ambition would be for weight loss that approaches that delivered by CagriSema but via the oral route. How close did amycretin get to that profile?

Thank you, Mike. And, Martin, over to you.

Yeah, so thank you. Thank you for those questions. First of all, on the once-monthly GLP-1/GIP, honestly speaking, we asked ourselves the same questions when we move from once-daily to once-weekly. And this is all in the focus of titration.

So, proper titration will mitigate most GI and tolerability side effects. And therefore, we're quite confident that we can manage a once-monthly in that setting. We actually didn't see an increase moving from once-daily to once-weekly, and we don't expect to see that moving from once-weekly to once-monthly. On the amycretin, we're not disclosing phase 1 data, but you should obviously read into the fact that we are stating that we are progressing further development, which also means that we believe amycretin to be properly differentiated to whatever else is out there.

Thank you, Mike. Thanks for being up early. Next question, please.

Thank you. We will now take the next question. One moment, please. And the next question comes from the line of Peter Verdult from Citigroup.

Please go ahead.

Pete Verdult -- Citi -- Analyst

Yeah, thanks. Pete Verdult, Citi. Two questions, please. For Lars or Karsten, you've mentioned many times Novo or management No.

1 priority is scaling supply. I just want to try and marry that with the comments you provided for '24 and guidance. I mean, if I just annualize your exit run rate Q4 2023, you pretty much are at the bottom end of 2024 guidance. And I realize there's FX and there's rebating to consider, but I didn't want to push my luck and try and get a handle how significantly capacity will increase in 2024, especially in light of SELECT coming on the label this year and likely increasing demand further.

And then, secondly, for Karsten, just a quickly on the revenue recognition from 340B pharmacy. I know you currently only partially revenue recognize, and that's what's baked into guidance, but I thought there was a chance that that could change in 2023, given that you had prevailed in litigation with HHS. So, is -- could there be any change in your stance in 340B in '24? And am I right that where you to fully revenue recognize that could actually have quite a meaningful uplift to Novo earnings, around 5%? Thank you.

Thank you, Pete. Karsten, two questions for you.

Yeah, so, first, as to our 2024 guidance, the important point is that we are continuing the growth trajectory we showed already in 2023. And just to remind you, 36% sales growth adding to the tune of 5 million people on Novo Nordisk products over a 12-month period. So, we do believe that that's significant scaling and in round numbers. We're talking about that magnitude when you look at our scaling into next year.

So, it's a similar type scaling we'll be doing in 2024. I don't like necessarily the logic between multiplying Q4 by four because we're in a chronic disease business, so all the ups and downs of currencies and inventories in one quarter makes it dangerous to annualize just based on three months. So -- but again, the growth platforms remain the same. It's Rybelsus, it's Ozempic, and it's Wegovy.

And we're scaling those -- all of those three platforms, which is what gives us a the guidance that we provided today. And then, as to 340B, you're right. As we state, we're only partially recognizing 340B revenue. And that's linked to the accounting standards of in order to recognize revenue, it has to be what the accountants or the authors call highly probable.

So, that's the backdrop behind that. And, yes, we prevailed in our case back in January of '23. There are still two cases outstanding in different jurisdictions around the same question. So, that would be key informative points for us to decide on how to proceed forward vis-a-vis our accounting recognition in this space.

Thank you, Pete. Thank you, Karsten. And next question, please.

Thank you. We will now take the next question. One moment, please. And the next question comes from the line of Louise Chen from Cantor.

Louise Chen -- Cantor Fitzgerald -- Analyst

Hi. Thank you for taking my questions. So, my first question is how do you think about the launch of Lilly's Zepbound in your guidance for 2024? And then, second question is, when do you expect to report data from your NASH or MASH studies, such as your ESSENCE study or your FGF21? Thank you.

Thank you, Louise. And, Karsten, I will give the first to you with guidance. And then, Martin, later to you on the MASH.

Yeah, so as always, when forecasting, we take into account the demand the market competition and supply capacity. So, those factors are what we've weighed into guidance, both in terms of the pricing environment in the U.S. to maintain a high degree of formulary access with -- at PBM basis. And then, on the volume basis, I would say, that is more a question about supply capacity since we're not competing for share, given the magnitude of the markets.

Thank you, Karsten. And over to Martin.

Yeah. Thank you very much. So, for the ESSENCE and MASH study, we expect to see a readout around the turn of this year and then progress toward regulatory filing. The FGF21 study is a phase 2 trial, actually, also investigating the effect of IcoSema in NASH, and we'll see that readout a little bit later.

Thank you, Martin. And we're ready for the next question.

Thank you. We will now take the next question. One moment, please. And the next question comes from the line of Sachin Jain from Bank of America.

Sachin Jain -- Bank of America Merrill Lynch -- Analyst

Thanks for taking my question. Sachin Jain here from Bank of America. Firstly, just on amycretin, back to you, Martin, the plans to progress your commentary is very vague, particularly for the oral formulation. So, we're going to just ask you why you're being vague at the moment and the factors that go into that decision, one would assume an oral CagriSema would be exciting so why not commit? So, just what are you waiting for? And then, the second question on supply, thank you for the color on doubling of the lower doses for Wegovy in the coming months.

Should I assume there's ability to further supply at the lower dose? Or is doubling the limit for full year '24? Thank you.

Thank you, Sachin. So, Martin, first to you. And then, Karsten, you'll take the supply question.

So, thank you very much, Sachin. I'm not sure I'm being vague. We're just saying that we're not communicating phase 1 data. I think you will hear and see -- or you will see us progress should the data confirm it, both the subcutaneous but also potentially the oral.

The reason why we are pursuing both in phase 1 is obviously providing optionality. We see a big demand, and we need to provide flexibility and optionality. Having both an oral and a subcutaneous is providing that. When it comes to the efficacy, you've heard us say a number of times, and we'll stay with that, we want to see differentiated products.

And that goes for both the subcutaneous and the oral in the marketplace. And what we have seen so far for amycretin brings us confidence that amycretin in both oral and subcutaneous, when we see the data, has that potential.

Yeah, Sachin, and thank you for the Wegovy question. So, to be a little bit more precise, with the Wegovy, what we have done is that we have increased our supply of the starter dose by more than double. So, that has taken place. And as we have also previously communicated, then we will continue to gradually expand our supply of starter doses, as well as all dose strengths.

And we'll gradually scale that as we are scaling our supply capacity so we have a sustainable supply chain in place, including the necessary inventories to avoid the stop-go pattern that we saw in the past.

Thank you, and thank you for the questions. And we're ready for the next set of questions.

Thank you. We will now take the next question. And the next question comes from the line of Martin Parkhoi from SEB. Please go ahead.

Martin Parkhoi -- Skandinaviska Enskilda Banken -- Analyst

Great, thank you very much. Two questions. Firstly, on the regional development, you know, we saw a very big imbalance this year, at least in the -- especially in fourth quarter between North America and the international relations. How should we see that going into 2024? I don't expect to get, you know, precise numbers, but just some words compared in relation to the guidance that you have.

And then, the second question, you are doing some reprioritization among other things, removing Levemir from the U.S. market. How far can you actually go and how cynical can you be to prioritize less on insulin and, of course, more of your production capacity on the GLP-1 franchise?

Thank you, Martin. Karsten, the first question related to the guidance on regional and then the last few about the portfolio participations.

Yeah, so as to the regional dynamics, I'd say these are classic dynamics when people as yourself have followed the company for an extended period of time, then there will be this type of seasonality. So then, talking into 2024, the growth drivers remain the same, again, Rybelsus, Wegovy, and Ozempic. And the real difference, what you saw in 2023 is actually that on GLP-1 and diabetes, the growth levels were similar, just north of 50%, both in IO and North America. So, the fundamental difference is the pace of Wegovy rollouts.

And, of course, the North America are rolling ahead of IO, but it is important to note that we will be launching in additional IO markets in the volume cap way for Wegovy into 2024. But you should expect North America still to be rolling at a higher pace than IO.

Thank you, Karsten. Lars, over to you.

Yeah. Thank you, Martin. On portfolio participation, I think you should see us as being committed to people living with diabetes and in need of insulin. When we look at Levemir, specifically in the U.S., we have a situation where we have, you know, Tresiba as well, we will be launching a weekly insulin.

And we also see a dynamics where we have lost a contract on Levemir. So, for us to stay committed to patients is also leading to us, then thinking carefully about what are the most, say, optimal ways of treating those patients with the most efficacious products. And on GLP-1, there's also the optimization in moving patients from daily treatment to weekly treatment, where you get higher efficacy and obviously an easier to produce presentation as you reduce the number of injections and presentations needed. So, we are going to be, say, having a social responsibility vis-a-vis the patients while still optimizing to a degree where it both benefits patients and our ability to scale.

Thank you, Lars. Thank you, Martin. So, we'll take the next question.

Thank you. One moment, please. The next question comes from Richard Vosser from JPMorgan. Please go ahead.

Richard Vosser -- JPMorgan Chase and Company -- Analyst

Hi, thanks for taking my questions. Two questions, please. First question, just could you update some of the payer discussions around SELECT and how you see rebate pressure in '24 for the obesity franchise, given it's still supply constrained, particularly in the U.S.? And the second question, also thinking about diabetes, we've seen, you know, a consistent sort of 10% to 15% rebate pressure in the U.S. around Ozempic, Rybelsus, and in the type 2 side.

Is that how we should think about the pressure going into '24? Thanks very much.

Thank you, Richard. And, Doug, I'll give the word to you for SELECT payer discussions, what you can say, and then also competitive dynamics within diabetes.

Yeah, thank you for the question, Richard. Really appreciate it. So, just to reiterate, we're super excited about the potential of SELECT data. And we do eagerly await the whole full label update in the coming months.

And, you know, we're doing our normal preparation for that. When we think about what that means, certainly for Part D access, you know, we're hopeful that SELECT can unlock some of that access. But, you know, in the end, even with the excellent data, it's likely not going to happen overnight. But, you know, in the end, we believe that SELECT can set sema 2.4 milligram apart as the first and only AOM, showing a consistent benefit across endpoints, including MACE.

So, you know, we're super excited about that.

And the second part, Doug, of the question with regards to competitive dynamics in the GLP-1 diabetes space.

Yeah, so overall, you know, we see a stable competitive environment. Obviously, as we see an increase in volume, we should expect to see also a decrease in price over time as a product gets larger in the marketplace. But again, it's a stable competitive market environment that we have.

Thank you, Doug. Thank you, Richard, for the questions. Next questions, please.

Thank you. One moment, please. The next question comes from Harry Sephton from UBS. Please go ahead.

Harry Sephton -- UBS -- Analyst

Brilliant. Thank you very much for taking my questions. Maybe just, for the first question, back to Doug. So, you mentioned that you've seen a stable competitive environment in the U.S., but just wanted to question whether you've observed any changes to formulary position for Ozempic in the U.S.

through 2023 and whether that impacted prescription growth for Ozempic in the fourth quarter. And then, my second question is on the stay time on therapy for patients. So, firstly, an update on what you're seeing for Wegovy, but also whether the observed stay time on Ozempic has changed at all over the last year and what might be driving that. Thank you.

Thank you, Harry. So, Doug, any comments to formulary status for key products. And then, the stay time, I will give to Camilla.

Yep. Thanks, Harry. So, overall, we don't see any major change to formulary status for GLP-1s. And if -- you know, again, you recall, we have more than 90% unrestricted access, so very favorable access, and we see that largely unchanged in 2024 this year.

And on stay time, what we can say is that we generally see a better stay time on Wegovy than what we've seen on previous anti-obesity treatment like Saxenda, so we basically see fewer patients dropping out. And it's still early days for Wegovy because of the interrupted supply in the countries. But it can also say that both in the U.S. but also in Denmark, we see strong indications that the stay time is longer for Wegovy.

And especially in Denmark, we see the majority of the patients who initiated treatment in the beginning of last year, they stayed on the treatment throughout the year. And on Ozempic, generally, we see a continued long stay time in the tune of four to five years. So, there's been no major changes to that.

Thank you, Camilla and Doug. And thanks for the question, Harry. So, we'll take the next question.

Thank you. One moment, please. The next question comes from the line of Emily Field from Barclays. Please go ahead.

Emily Field -- Barclays -- Analyst

Hi. Thank you. I'll ask two questions. The first is just on the guidance range for revenue growth at constant exchange rate.

It is quite a wide delta between 18 and 26. Could you just give us some color on the drivers between that? Is that primarily the cadence of Wegovy supply coming online, or is there anything else particularly at play? And then, another question just on commercial coverage in the United States, you know, you've pretty consistently indicated that in that commercial slice, about 50% of employers in the U.S. opt in. Are you expecting any major changes to that in 2024? Thank you.

Thank you, Emily. The sound was a bit bad, but I think we got your question. So, Karsten, any color on the guidance ranges. And then, later, Doug, coverage of Wegovy in the U.S.

Thank you for that question, Emily. And yes, you're correct, guidance ranges are not broader than what they had normally been at this point in time. And, of course, the plan is to narrow guidance ranges over the years as time progresses. The reason why we've chosen to broaden them is likely -- is basically the dynamics we've seen over the past quarters in '23 and even in '22, so a dynamic market and constrained supply and growth to net adjustments linked to the U.S.

growth to net model. So, fundamentally, there are no major fundamental changes to what we've seen in prior quarters. We just felt that it was prudent at the beginning of the year to start out with a much wider guidance ranges.

Thank you, Karsten. And, Doug, your comments on coverage for Wegovy in the U.S. and employer opt-in?

Yep, thanks, Emily. So, we still continue to enjoy broad market access for Wegovy. That's over 90%. And as we've communicated, that equates to around 50 million people living with obesity who are now covered.

And overall, there will be opt-ins and opt-outs, but we continue to see improvements in the net coverage. So, our focus will be continuing to secure coverage over time and to keep continuing to grow the volume market. But overall, we're pleased with the level of access that we have and looking forward to improving that over time.

Thank you so much, Doug. And thanks, Emily, for the questions. Next questions, please.

Thank you. One moment, please. The next question comes from the line of Seamus Fernandez from Guggenheim Securities. Please go ahead.

Seamus Fernandez -- Guggenheim Partners -- Analyst

Thanks so much for the question. So, just a couple here. On the GLP/GIP, can you just help us understand the technology that you are using to extend the half-life to once-monthly? Just trying to get a better understanding of the likelihood that -- and your confidence in delivering a monthly profile here, as well as the efficacy profile, given your plans to work with [Inaudible] on the oral amycretin molecule. And then, just on the WOMAC scores, can you just help us understand how those WOMAC scores kind of compare in your OA study to other treatment regimens and if drop-in on pain medication, like naproxen or other medications like that, was allowed and if that separation occurred despite that? Thanks.

Thank you, Seamus, for these questions. Martin, I'll give the word to you.

Yeah. Thank you very much. First of all, on the once-monthly, as you obviously know, this is phase 1 and this is one of a number of tracks that we are pursuing in this space. It's a technology that we cannot share at this point in time.

But broadly speaking, we are confident and happy with our research progress in this space. And obviously, we will not take assets into phase one without a level of confidence in the broad applicability and success. On the WOMAC, the sort of broad applicability is that if you see a 35-point change from baseline, you are in the very clinically relevant space. And here, we saw a 41-point improvement.

In terms of concomitant medication, this was allowed, but this is specifically why we have a control group in the study. You actually also saw improvement in the placebo arm. But the improvement seen with semaglutide was above and beyond that and in the space being statistically significant, as well as clinically relevant.

Thank you so much, Martin. And thanks, Seamus. Next question, please.

Thank you. One moment, please. The next question comes from the line of Simon Baker from Redburn Atlantic. Please go ahead.

Simon Baker -- Redburn Partners -- Analyst

Thanks for taking my questions. Two, if I may, please. Firstly, on capex, I wonder if you could give us some sort of idea of when that 45 billion of investment in '24 will start to come on stream, be it API manufacturer or film finishing. And any indication about the run rate thereafter? And then, secondly, a question on the recent EraCal collaboration that you did.

I wonder if you could just give us some more of your reasoning for choosing that. And is this about accessing their platform, or is it a specific molecule that you've licensed, namely Era-379? Thanks so much.

So, first, Karsten, capex.

Yeah, so, Simon, just reframing your question slightly because taking a point estimate and making into a time series, I don't think is necessarily the optimal way. So, I would say because a good chunk of the capex we will be spending this year will be on projects we already initiated in 2023 or earlier. So, as you've noted, then we have announced capex just in '23 to the tune of 75 billion over the lifetime of these projects. So, those are, of course, a key element of the 45 billion.

So, in terms of when coming on stream, it will be gradually over time on API with some of the bigger ticket items. We'll see API coming on stream already from -- additional API capacity coming on stream already from 2025. And then, there will be different capacities coming online pretty much every year from there on across our manufacturing footprints.

Thank you, Karsten. And thank you, Simon. With regards to the recent collaboration, then at this point in time, we don't have too much to add. But I will use the opportunity to do a bit of advertisement for our upcoming capital markets day, where we'll talk more about these early research partnerships.

And then, we will be happy to address that. Next question, please.

Thank you. The next question comes from the line of Mark Purcell from Morgan Stanley. Please go ahead.

Mark Purcell -- Morgan Stanley -- Analyst

Yeah. Thanks for taking my questions. Question number one, Wegovy U.S. fill-and-finish lines.

I think you moved from one to three lines over the course of 2023. Could you help us understand how many lines might be added to the cadence of those additions during the course of 2024? And then, secondly, as we shift from weight as a surrogate marker to outcomes becoming more important, how much are you assessing the key product attributes of CagriSema and amycretin such that you have confidence you can show an outcomes benefit over semaglutide in future clinical development?

So, Wegovy, over to you, Karsten. And, Martin, later, outcome trials for future obesity pipeline products.

Hi, Mark. So, as to Wegovy and CMO filling, what I can say is that we are on track with what we previously communicated with the three CMO lines. We don't think it's prudent to continue to specify number of lines and locations and potential CMOs just to say that we will continue to expand capacities in the years to come, given the significant unmet need we're seeing. So, unfortunately, then you will have to impute from our guidance into our scalability, how we are scaling our supply.

And specifically, on the cardiovascular benefits of our pipeline products vis-a-vis semaglutide, what we, for example, know from CagriSema, and right now, we have to rely on biomarkers, is that CagriSema is obviously superior on body weight or has the potential to be superior on glycemic control, but also will be superior on, for example, blood pressure lowering, lipid lowering, and potentially all the very relevant cardiovascular biomarkers. All of that gives us a lot of confidence in that CagriSema will be associated with a quite profound benefit in the cardiovascular space. But obviously, we have to show that in phase 3. And as you know, we are currently running the REDEFINE 3 study to that effect.

Thank you, Martin. And thank you, Mark. So, we'll have time for two more set of questions if they are kept brief, so let's try to squeeze that in.

Thank you. The next question comes from the line of Richard Parkes from BNP Paribas Exane. Please go ahead.

Richard Parkes -- Exane BNP Paribas -- Analyst

Hi. Thanks for taking my questions. I'll be quick, both on guidance capacity. I think through last year, you consistently stated that the top end of guidance wasn't necessarily a magic ceiling in terms of what you had capacity to manufacture.

I wonder if that's still the case in 2024, or whether the wider range suggests you've been more bullish with the top end. And then, just to push you a bit more on capacity expansion plans, I mean, you've been quite clear about fill-finish expansion for Wegovy. But my understanding is with FlexTouch, it's all about optimizing what you already have. So, is there any waypoints that you can give for investors around when you might be able to move from seeing more of an inflection around that rather than just optimizing the capacity you currently have? Thank you.

Karsten, over to you.

Yeah. Thanks, Richard, for those questions. So, as to the guidance range, it's important to reiterate, this is the most realistic outlook that we're providing to the markets. So, had we thought that we could grow faster than this realistically, then we wouldn't have been providing this guidance at this point in time.

So, this is what you should expect on. And as a normal distribution, expect something around the mid of the range. That's how we work on this. And then, it's important to note that being in a supply constrained environment, it's very important for us in order to manage our business in a sustainable way that we focus on our supply chain and ensure that it's resilient so we don't get into some of the bumps that we saw in the past with the stop-go type decision.

So, it's important that we have a sustainable supply chain. So, that factors in also. So, most likely range. And, of course, our job is to run the company in the best possible manner.

And that entails driving the top-line growth, as well as having a resilient supply chain setup. Then, as to scaling of FlexTouch, it, you can say, entails both the cartridge filling assembly and pack. I can only say that we're scaling all of those on an ongoing basis, so we have active projects in each of these areas. We don't want to get into details externally around the project plans and so on, but I would point you to our recently announced expansion in Chartres of some DKK 16 billion which taps directly into expanding that pipeline just as an example of a significant capex project to that extent.

Thank you, Richard, for the question. Thank you, Karsten. And we'll take one final question.

Thank you. One moment, please. The final question comes from the line of Michael Novod from Nordea. Please go ahead.

Michael Novod -- Nordea Markets -- Analyst

Thank you very much. Two brief questions. So, first of all on oral amycretin. So, you've been previously saying that the ambition was to sort of create an oral CagriSema.

Is that still the sort of the ambition given all the other questions we've had on oral amycretin? And then, secondly on the program that they did on LillyDirect for sort of direct to consumer more or less. Is that something that Novo is considering as well, given that could be sort of a significant untapped potential in the private market? Thanks.

Good. Martin, any brief comment on amycretin?

Yeah. So, very high level short answers, yes. Obviously, if we have the aspiration to have differentiated products, amycretin, oral amycretin, has to be in the range of where we see efficacy and safety with CagriSema.

Thank you, Martin. And, Doug, over to you. Any comments on our competitive commercial strategy in light of a competitor movement?

What I would say is I bring it back to us and say, you know, we believe in the foundation that we have in NovoCare, and there's lots of elements to that. So, we'll continue to stay focused on that, and appreciate the questions.

Thank you, Michael. Thank you, Doug, for the answer. This concludes the Q&A session. Thank you for participating, and Please feel free to reach out to investor relations if you have any follow-up questions.

Before we close the call, as always, I would like to hand over to you, Lars, for the final remarks.

Yeah, thank you, Daniel. And also, thank you from me for all participating today. I hope it's clear that we are very pleased with our performance in the past year and equally excited about what we can do in 2024 based on the attractive guidance range we have put forward. A lot of focus on scaling capacities with some real, tangible backing of our scaling in the form of now more than doubling the start doses in the U.S., and we look to continuously expand our capacity and, equally important, the expansion of our pipeline and really doubling down on our strongholds in diabetes obesity, but also increasingly cardiovascular disease and rare blood disorders.

So, we are excited about how the pipeline is shaping up. So, thank you all for your attention today, and we look forward to see you in the near future. Bye.

This concludes today's conference call. Thank you for participating. [Operator signoff]

Duration: 0 minutes

Call participants:

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Stock NOVO B

Novo Nordisk A/S

Dk0062498333, pharmaceuticals.

Market Closed - Nasdaq Copenhagen 11:20:00 2024-07-09 am EDT 5-day change 1st Jan Change
966 -1.89% -2.77% +38.38%
06:05pm MT
05:14pm MT
  • Novo Nordisk : Q3 Investor presentation

Novo Nordisk

-a focused healthcare company

Investor presentation

First nine months of 2023

RAFAEL VALVERDE Rafael lives with obesity Mexico

2

Investor presentation

First nine months of 2023

Progress on Strategic Aspirations 2025 Commercial execution

Innovation and therapeutic focus Financials

3

Investor presentation

First nine months of 2023

Novo Nordisk®

Forward-looking statements

Novo Nordisk's reports filed with or furnished to the US Securities and Exchange Commission (SEC), including the statutory Annual Report 2022 and Form 20-F, which both were filed with the SEC in February 2023 in continuation of the publication of this Annual Report 2022, this presentation, and written information released, or oral statements made, to the public in the future by or on behalf of Novo Nordisk, may contain forward-looking statements. Words such as 'believe', 'expect, 'may', 'will', 'plan', 'strategy', 'prospect', 'foresee', 'estimate', 'project', 'anticipate', 'can', 'intend', 'target' and other words and terms of similar meaning in connection with any discussion of future operating or financial performance identify forward-looking statements. Examples of such forward-looking statements include, but are not limited to:

  • Statements of targets, plans, objectives or goals for future operations, including those related to Novo Nordisk's products, product research, product development, product introductions and product approvals as well as cooperation in relation thereto,
  • Statements containing projections of or targets for revenues, costs, income (or loss), earnings per share, capital expenditures, dividends, capital structure, net financials and other financial measures,
  • Statements regarding future economic performance, future actions and outcome of contingencies such as legal proceedings, and
  • Statements regarding the assumptions underlying or relating to such statements.

These statements are based on current plans, estimates and projections. By their very nature, forward-looking statements involve inherent risks and uncertainties, both general and specific. Novo Nordisk cautions that a number of important factors, including those described in this presentation, could cause actual results to differ materially from those contemplated in any forward-looking statements.

Factors that may affect future results include, but are not limited to, global as well as local political and economic conditions, such as interest rate and currency exchange rate fluctuations, delay or failure of projects related to research and/or development, unplanned loss of patents, interruptions of supplies and production, including as a result of interruptions or delays affecting supply chains on which Novo Nordisk relies, shortages of supplies, including energy supplies, product recalls, unexpected contract breaches or terminations, government- mandated or market-driven price decreases for Novo Nordisk's products, introduction of competing products, reliance on information technology including the risk of cybersecurity breeches, Novo Nordisk's ability to successfully market current and new products, exposure to product liability and legal proceedings and investigations, changes in governmental laws and related interpretation thereof, including on reimbursement, intellectual property protection and regulatory controls on testing, approval, manufacturing and marketing, perceived or actual failure to adhere to ethical marketing practices, investments in and divestitures of domestic and foreign companies, unexpected growth in costs and expenses, strikes and other labour market dispute, failure to recruit and retain the right employees, failure to maintain a culture of compliance, and epidemics, pandemics or other public health crises, and the effects of domestic or international crises, civil unrest, war or other conflict.

For an overview of some, but not all, of the risks that could adversely affect Novo Nordisk's results or the accuracy of forward-looking statements in this Annual Report 2022, reference is made to the overview of risk factors in 'Risk management' of this Annual Report 2022.

Unless required by law, Novo Nordisk is under no duty and undertakes no obligation to update or revise any forward-looking statement after the distribution of this Annual Report 2022, whether as a result of new information, future events, or otherwise.

Important drug information

Victoza ® and Ozempic ® are approved for the management of type 2 diabetes only

Saxenda ® and Wegovy ® are approved for the treatment of obesity only

4

Investor presentation

First nine months of 2023

Novo Nordisk®

Strategic Aspirations 2025 | Highlights first nine months of 2023

Progress towards zero environmental impact

Carbon emissions decreased by 28% vs first 9M 20191

Adding value to society

• Medical treatment to ~40 million people with diabetes

andPurpose sustainability (ESG)

• Reached more than 46,000 children in Changing

Diabetes® in Children programme

Partnership with Aspen to produce human insulin for

Africa

Being recognised as a sustainable employer

Share of women in senior leadership positions has

increased to 41% from 38% at end of September 2022

Diabetes value market share increased by 1.8%-points

to 33.3%2

Commercial execution

Obesity care sales of DKK 30.4 billion (+174% at CER)

Rare disease sales of DKK 12.6 billion (-18%at CER)

Light blue indicates developments in Q3 2023

Further raise innovation bar for Diabetes treatment

• Regulatory submission of once-weekly insulin icodec

• Initiation of phase 3 trial with CagriSema T2D

therapeuticfocus

• FLOW stopped for efficacy based on interim analysis

Innovationand

Develop superior treatment solutions for obesity

• Regulatory submission of SELECT CVOT

Strengthen and progress Rare Disease pipeline

• Concizumab approved for HAwI/HBwI in Japan

Establish presence in other serious chronic diseases

• Acquisition of ocedurenone within CVD

Sales growth of 33% (CER) and operating profit growth

of 37% (CER)

Operational leverage reflecting sales growth

Financials

Free cash flow of DKK 75.6 billion and DKK 52.0 billion

returned to shareholders

1 Scope 1,2 and partial scope 3 limited to CO2 emissions from business flights and product distribution; 2 MAT (Moving annual total) value market share CER: Constant exchange rates; 9M: Nine months; HAwI/HBwI: Haemophilia A/B with inhibitors

Note: The strategic aspirations are not a projection of Novo Nordisk's financial outlook or expected growth

5

Investor presentation

First nine months of 2023

Novo Nordisk®

Sales growth of 33% driven by both operating units

Reported geographic sales split for first nine months of 2023

DKK

Insulin

GLP-1

Other diabetes

billion

Obesity care

Rare disease

Growth at CER

100

49%

80

17%

International Operations

60

40

19%

20

16%

12%

0

NAO

IO

EMEA

China

RoW

Reported therapy area sales and growth for first nine months of 2023

DKK

North America Operations

International Operations

billion

Growth at CER

180

33%

49%

-7%

174%

-18%

150

90

60

60%

IO

-1%

IO

52%

NAO

-24%

NAO

244%

IO

-22%

30

49%

NAO

43%

-13%

0

Total1

GLP-1

Insulin Obesity care Rare disease

1 'Other diabetes' is included in Total

IO: International Operations; EMEA: Europe, Middle East and Africa; China: Mainland China, Hong Kong and Taiwan; RoW: Rest of World; NAO: North America Operations; CER: Constant exchange rates

Note: Unless otherwise specified, sales growth rates are at CER

6

Investor presentation

First nine months of 2023

Novo Nordisk®

Diabetes value market leadership reached 33.3%

Novo Nordisk global diabetes value market shares

Diabetes GLP-1 Insulin

55.7%

54.3%

52.1%

49.9%

44.6%

44.0%

44.2%

44.1%

Diabetes value market leadership expansion

driven by the GLP-1 franchise

Diabetes care sales grew by 25% (CER) with global value market share increase driven by market share gains in both IO and NAO.

• Global diabetes value market share increased by 1.8%-

points to 33.3%

• Novo Nordisk continues to be the global market leader in

the GLP-1 segment with a 54.3% value market share

• Estimated global GLP-1 share of total diabetes

prescriptions is ~6%

29.2% 29.9%

2020

2021

2022

2023

CER: Constant exchange rates; IO: International Operations; NAO: North America Operations

Note: Sales growth rates are at CER

Source: IQVIA MAT, Aug 2023 (Spot rate); Volume growth based on Moving Annual Total (MAT); Market values are based on the list prices

7

Investor presentation

First nine months of 2023

Novo Nordisk®

International Operations diabetes care sales growth is driven by

GLP-1 performance

Reported Diabetes care sales and growth per IO geography

DKK

billion

Insulin GLP-1

Growth at CER

50

Geographical regions

40

60%

30

23%

20

50%

26%

-1%

13%

10

61%

95%

2%

0

-10%

5%

IO

EMEA

China

RoW

GLP-1 patients and value market share in IO

Number of

Value

patients (millions)

market share

Class growth >35%

8

68.7%

75%

6

60%

45.8%

45%

4

27.5%

30%

2

12.4%

15%

10.5%

0

2.3%

0%

Aug

Aug

Aug

2021

2022

2023

GLP-1 patients

Ozempic®

Victoza®

Rybelsus®

dulaglutide

tirzepatide

IO: International Operations; NN: Novo Nordisk; EMEA: Europe, Middle East and Africa; China: Mainland China, Hong Kong and Taiwan; RoW: Rest of World; CER: Constant exchange rates Note that the market share and patient numbers are based on countries with IQVIA coverage. GLP-1 class growth calculated as Jun'23-Aug'23 vs Jun'22-Aug'22 (Rolling 3-month average) Source: IQVIA MAT, Aug 2023 (Spot rate). Volume packs are converted into full-year patients based on WHO assumptions for average daily doses; Market values are based on the list prices

8

Investor presentation

First nine months of 2023

Novo Nordisk®

GLP-1 class expansion continues in the US in the first nine months of 2023

US GLP-1 weekly NBRx prescriptions

US GLP-1 TRx market share

Weekly NBRx

TRx share

Total GLP-1 scripts

scripts ('000s)

(millions)

Class growth ~50%

90

80%

7

6

60

60%

53.1%

5

40%

42.3%

4

3

30

26.6%

19.5%

2

20%

7.2%

1

3.7%

0

Oct

Oct

0%

Oct

Oct

0

2021

2023

2021

2023

Ozempic®

Rybelsus®

Victoza®

NN GLP-1

dulaglutide

tirzepatide

Total monthly GLP-1 scripts

NBRx: New-to-brand prescriptions; TRx: Total prescriptions; NN: Novo Nordisk; Scripts: Prescriptions; US: United States

Note: Class growth calculated as Q3 2023 vs Q3 2022

Source: IQVIA Xponent, NBRx data from week ending 13 Oct 2023. TRx data from week ending 13 Oct 2023. Each data points represents a rolling four-week average

9

Investor presentation

First nine months of 2023

Novo Nordisk®

Obesity care sales grew by 174% in the first nine months of 2023

mainly driven by the US

NN sales and volume BAOM market growth

Branded AOM TRx in the US2

within Obesity care

DKK billion

TRx count ('000s)

15

55%1

84%1

174%1

180

94%

95%

160

The US

12

75%

140

• Commercial relaunch in January 2023

• Broad commercial formulary access

120

109

9

55%

100

While supply capacity is gradually

98

being expanded, the supply of the

6

80

lower dose strengths will remain

35%

60

restricted to safeguard continuity of

care

3

15%

40

International Operations

20

• Wegovy® launched in Denmark,

0

-5%

0

3

Norway, Germany, UK and Iceland

• Volume capped launches in IO in

2021

2022

2023

June

October

2023, balancing supply and demand

2021

2023

IO

NAO

BAOM Market growth (RHS)

Saxenda®

Wegovy®

NN sales growth at CER

Branded AOM market

1 Annual growth at CER. Each TRx data points represents one week of data; 2 IQVIA weekly, 20 October 2023

NAO: North America operations; IO: International operations; RHS: Right-hand side axis; TRx: Total Prescriptions; AOM: Anti-Obesity Medications (includes Wegovy ® , Saxenda ® , Qsymia, Belviq and Contrave); BAOM: Branded AOM market; CER: Constant exchange rates

Note: Sales growth at constant exchange rates. 94% volume growth for Global BAOM market growth refers to moving annual total.

10

Investor presentation

First nine months of 2023

Novo Nordisk®

Rare disease sales decreased by 18% driven by temporary reduction in manufacturing output

Reported Rare disease sales

Rare disease sales driven by global commercial execution

DKK

billion

Growth at CER

Rare disease sales decrease is driven by:

15

-18%

2%

15%

44%

-5%

-54%

12

9

Rare blood disorders

6

3

0

Total1

Rare

Haem.

Haem.

Novo-

Rare

blood

A

B

Seven®

endocrine

disorders2

disorders3

  • 13% sales decline in North America Operations
  • 22% sales decline in International Operations

Rare blood disorders sales increased by 2%, driven by:

  • Launch products in haemophilia A and B, partially countered by NovoSeven®

Rare endocrine disorders sales decreased by 54% driven by:

  • Sales for Norditropin ® declined by 50% in NAO and 56% in IO, reflecting a temporary reduction in manufacturing output
  • Novo Nordisk has a value market share of 24.6% in the global human growth disorder market

1 Total includes "Other Rare disease", which consists of primarily Vagifem ® and Activelle ® ; 2 Comprises NovoSeven ® , NovoEight ® , Esperoct ® , Refixia ® and NovoThirteen ® ; 3 Primarily Norditropin ®

CER: Constant exchange rates; Haem. A: Haemophilia A; Haem. B: Haemophilia B; NAO: North America operations; IO: International operations; Unless otherwise specified, sales growth is at constant exchange rates

Note: NovoThirteen ® is not shown for Rare blood disorders breakdown, only for the total bar.

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The flow diagram shows the cohort selection for the analysis of the risk of nonarteritic anterior ischemic optic neuropathy (NAION) in patients treated with semaglutide vs a non–glucagon-like peptide 1 receptor agonist (GLP-1 RA) either for type 2 diabetes or for overweight or obesity.

a Matching criteria included propensity score matching on age, sex, hypertension, type 2 diabetes, obstructive sleep apnea, obesity, hyperlipidemia, and coronary artery disease as well as lack of chronic kidney disease, personal or family history of multiple endocrine neoplasia type 2, thyroid tumors, or pancreatitis status.

Survival probabilities are shown for NAION in patients with type 2 diabetes prescribed semaglutide vs a matched cohort of patients prescribed non–glucagon-like peptide 1 receptor agonist (GLP-1 RA) antidiabetic medications (A) and in patients who were overweight or obese and prescribed semaglutide vs a matched cohort of patients prescribed non–GLP-1 RA antiobesity medications (B). HR indicates hazard ratio.

Data Sharing Statement

  • Semaglutide and Nonarteritic Anterior Ischemic Optic Neuropathy JAMA Ophthalmology Invited Commentary July 3, 2024 Susan P. Mollan, MBcHB

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Hathaway JT , Shah MP , Hathaway DB, et al. Risk of Nonarteritic Anterior Ischemic Optic Neuropathy in Patients Prescribed Semaglutide. JAMA Ophthalmol. Published online July 03, 2024. doi:10.1001/jamaophthalmol.2024.2296

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Risk of Nonarteritic Anterior Ischemic Optic Neuropathy in Patients Prescribed Semaglutide

  • 1 Harvard T.H. Chan School of Public Health, Boston, Massachusetts
  • 2 Department of Ophthalmology, Massachusetts Eye and Ear, Harvard Medical School, Boston
  • 3 Neuro-Ophthalmology Service, Massachusetts Eye and Ear, Harvard Medical School, Boston
  • 4 Department of Psychiatry, Brigham and Women’s Hospital, Boston, Massachusetts
  • Invited Commentary Semaglutide and Nonarteritic Anterior Ischemic Optic Neuropathy Susan P. Mollan, MBcHB JAMA Ophthalmology

Question   Are prescriptions for semaglutide associated with an increased risk of nonarteritic anterior ischemic optic neuropathy (NAION) in patients with type 2 diabetes or patients who are overweight or obese?

Findings   This matched cohort study of 16 827 patients revealed higher risk of NAION in patients prescribed semaglutide compared with patients prescribed non–glucagon-like peptide receptor agonist medications for diabetes or obesity.

Meaning   The findings suggest a potential risk of NAION associated with prescriptions for semaglutide, but future study is required to assess causality.

Importance   Anecdotal experience raised the possibility that semaglutide, a glucagon-like peptide 1 receptor agonist (GLP-1 RA) with rapidly increasing use, is associated with nonarteritic anterior ischemic optic neuropathy (NAION).

Objective   To investigate whether there is an association between semaglutide and risk of NAION.

Design, Setting, and Participants   In a retrospective matched cohort study using data from a centralized data registry of patients evaluated by neuro-ophthalmologists at 1 academic institution from December 1, 2017, through November 30, 2023, a search for International Statistical Classification of Diseases and Related Health Problems, Tenth Revision code H47.01 (ischemic optic neuropathy) and text search yielded 16 827 patients with no history of NAION. Propensity matching was used to assess whether prescribed semaglutide was associated with NAION in patients with type 2 diabetes (T2D) or overweight/obesity, in each case accounting for covarying factors (sex, age, systemic hypertension, T2D, obstructive sleep apnea, obesity, hyperlipidemia, and coronary artery disease) and contraindications for use of semaglutide. The cumulative incidence of NAION was determined with the Kaplan-Meier method and a Cox proportional hazards regression model adjusted for potential confounding comorbidities. Data were analyzed from December 1, 2017, through November 30, 2023.

Exposures   Prescriptions for semaglutide vs non–GLP-1 RA medications to manage either T2D or weight.

Main Outcomes and Measures   Cumulative incidence and hazard ratio of NAION.

Results   Among 16 827 patients, 710 had T2D (194 prescribed semaglutide; 516 prescribed non–GLP-1 RA antidiabetic medications; median [IQR] age, 59 [49-68] years; 369 [52%] female) and 979 were overweight or obese (361 prescribed semaglutide; 618 prescribed non–GLP-1 RA weight-loss medications; median [IQR] age, 47 [32-59] years; 708 [72%] female). In the population with T2D, 17 NAION events occurred in patients prescribed semaglutide vs 6 in the non–GLP-1 RA antidiabetes cohort. The cumulative incidence of NAION for the semaglutide and non–GLP-1 RA cohorts over 36 months was 8.9% (95% CI, 4.5%-13.1%) and 1.8% (95% CI, 0%-3.5%), respectively. A Cox proportional hazards regression model showed higher risk of NAION for patients receiving semaglutide (hazard ratio [HR], 4.28; 95% CI, 1.62-11.29); P  < .001). In the population of patients who were overweight or obese, 20 NAION events occurred in the prescribed semaglutide cohort vs 3 in the non–GLP-1 RA cohort. The cumulative incidence of NAION for the semaglutide vs non–GLP-1 RA cohorts over 36 months was 6.7% (95% CI, 3.6%-9.7%) and 0.8% (95% CI, 0%-1.8%), respectively. A Cox proportional hazards regression model showed a higher risk of NAION for patients prescribed semaglutide (HR, 7.64; 95% CI, 2.21-26.36; P  < .001).

Conclusions and Relevance   This study’s findings suggest an association between semaglutide and NAION. As this was an observational study, future study is required to assess causality.

Nonarteritic anterior ischemic optic neuropathy (NAION) is the second most common form of optic neuropathy and a significant cause of blindness among adults. 1 - 4 Our anecdotal clinical experience motivated us to study whether semaglutide is associated with an increased risk of developing NAION.

Semaglutide (Ozempic; Novo Nordisk) was approved by the US Food and Drug Administration (FDA) in December 2017 to treat type 2 diabetes (T2D) and in December 2022 to treat obesity (typically at higher doses, as Wegovy [Novo Nordisk]). Weekly new-to-brand prescriptions in the United States of these and other glucagon-like peptide receptor agonist (GLP-1 RA) drugs increased by approximately 60% from 2021 to 2023. 5

In major medical centers, neuro-ophthalmologists are most likely to evaluate suspected cases of NAION. This study was designed to capitalize on this expertise by characterizing the risk of NAION among individuals using semaglutide within a neuro-ophthalmology practice at a single academic center.

Following approval by the Massachusetts General Brigham (MGB) Institutional Review Board, we conducted a retrospective, matched cohort study of neuro-ophthalmic patients at Massachusetts Eye and Ear, Boston. Our methods adhered to the Declaration of Helsinki for human research, the regulations of the Health Insurance Portability and Accountability Act, and the Strengthening the Reporting of Observational Studies in Epidemiology ( STROBE ) reporting guideline. 6 Informed consent was not required as this was a retrospective study.

The number of unique patients who had been referred for any presumed neuro-ophthalmology indication and evaluated in our neuro-ophthalmology clinic from December 1, 2017, through November 30, 2023, was determined from the MGB centralized clinical data registry and composed our eligible cohort. Events of NAION were identified by electronic health record query for the International Statistical Classification of Diseases and Related Health Problems, Tenth Revision ( ICD-10 ) code H47.01 (ischemic optic neuropathy) and text search (with terms “NAION” and “non-arteritic anterior ischemic optic neuropathy”). Each identified record was manually reviewed to confirm that the diagnosis of NAION had been rendered by one of our faculty members and to ascertain the time of vision loss. Our manual review confirmed that there was painless vision loss and optic nerve head edema during the acute phase, as per our prior criteria for NAION, 7 although now with more a relaxed age criterion given that our eligible cohort had a median age of 47 years. Patients with NAION prior to our start date were excluded. To mitigate risk of bias due to residual confounding effects, cohorts of T2D and overweight or obesity were analyzed separately; for each cohort, we identified comparative groups not receiving semaglutide. The categorizations of race (as American Indian or Alaska Native, Asian, Black or African American, Native Hawaiian or Other Pacific Islander, White, declined, patient does not know, race not listed, or unavailable) and sex or gender were self-reported in all cases.

To analyze the hazard ratio (HR) of NAION with respect to T2D, the study population consisted of 710 patients with T2D who were prescribed either semaglutide (n = 194) or non–GLP-1 RA antidiabetic medications (n = 516) ( Figure 1 ). Non–GLP-1 RA medications that we assessed included insulin and analogues, metformin, sulfonylureas, α-glucosidase inhibitors, thiazolidinediones, dipeptidyl peptidase-4 inhibitors, and sodium-glucose transport protein 2 inhibitors.

To analyze the HR with respect to weight, we included patients who were overweight or obese (body mass index of 25-29.9 or >30, respectively [calculated as weight in kilograms divided by height in meters squared]). This study population consisted of 979 patients prescribed either semaglutide (n = 361) or non–GLP-1 RA weight-loss medications (n = 618) ( Figure 1 ). Non–GLP-1 RA antiobesity medications that we assessed included bupropion, naltrexone, orlistat, topiramate, phentermine, and setmelanotide.

To achieve balance between cohorts (prescribed semaglutide or not) for each study population (T2D, and overweight or obese), 1:2 nearest-neighbor propensity score matching (caliper = 0.05) was used to account for demographic factors (sex, age); comorbidities related to NAION (systemic hypertension, T2D, obstructive sleep apnea); indications for use of semaglutide (T2D and obesity) and contraindications of semaglutide (personal or family history of multiple endocrine neoplasia type 2, thyroid cancer, chronic kidney disease, pancreatitis) 8 ; covarying factors related to T2D or to overweight or obesity (hyperlipidemia, coronary artery disease); and use of drugs associated with NAION (phosphodiesterase type 5 inhibitors, 9 amiodarone 10 ). No patient with NAION had received α-interferon. 11 After matching, all standardized mean differences (SMDs) for covariates were less than 0.1, and all SMDs and 2-way interactions among confounding factors were less than 0.15, which in the context of this study using propensity score matching indicates adequate balance between cohorts. Table 1 and Table 2 provide the characteristics of the T2D cohort and the obese or overweight cohort, respectively, with frequency distributions and measures of variability. The primary outcome was the first event of NAION. For all patients who experienced NAION and had been prescribed semaglutide, we confirmed by manual review that the prescribed medication had been dispensed. Although we aimed to match each treated unit with 2 control units in a 1:2 ratio, the actual matching yielded slightly lower ratios due to the relatively small sample sizes.

Patients in the eligible cohorts (T2D and overweight or obese, separately) had differing distributions of baseline characteristics ( Table 1 and Table 2 ). To further isolate and more evenly distribute these characteristics between the eligible (ie, semaglutide vs non–GLP-1) cohorts, we performed secondary analyses with 1:1 nearest-neighbor propensity score matching plus an exact match for variables that differed by 20% or more between the cohorts for each population.

Cumulative incidences of NAION in each cohort were determined with the Kaplan-Meier method to track first events of NAION during follow-up. Person-time was calculated from the first prescription of semaglutide vs non–GLP-1 antidiabetic or weight-control medications in the T2D and overweight or obese populations, respectively, until NAION, death (n = 42 across both populations), or end of the maximal 36-month follow-up period. The Cox proportional hazards regression model with adjustment for matching factors analyzed associations among covariates (described earlier) and the risk of NAION. The ability of our Cox model to discriminate between individuals who did and did not experience NAION was supported by the concordance correlation coefficient. Likelihood ratio testing outperformed a null model that did not incorporate predictors. The Wald test for semaglutide exposure assessed the statistical significance of individual predictors. The log-rank test assessed survival times between cohorts. Schoenfeld residuals and log-log plots for survival curves assessed the proportional hazards assumption and investigated its adequacy. All analyses were conducted with RStudio version 2024.04 statistical software (Posit). All P values were 2-sided and there was no adjustment for multiple analyses.

Our search identified 17 298 unique patients across 6 years. Individuals younger than 12 years (the lower limit of semaglutide exposure) were excluded, which yielded 16 827 patients for analysis ( Figure 1 ). Among the included patients, 710 had T2D (median [IQR] age, 59 [49-68] years; 369 [52%] female) and 979 were overweight or obese (median [IQR] age, 47 [32-59] years; 708 [72%] female).

The study population with T2D included 710 patients ( Figure 1 ). A 1:2 propensity score matching yielded adequate balance between the 2 groups (SMD < 0.1). NAION occurred in 17 patients in the semaglutide cohort vs 6 in the comparative cohort. The median (IQR) age was 57 (49-63) years for the semaglutide cohort and 58 (47-66) years for the nonsemaglutide cohort.

The Kaplan-Meier survival analysis at 36 months showed a cumulative incidence of NAION of 8.9% (95% CI, 4.5%-13.1%) for the semaglutide cohort vs 1.8% (95% CI, 0%-3.5%) for the nonsemaglutide cohort. The mean (SD) follow-up time was 33.3 (1.1) months for the semaglutide group and 34.5 (1.2) months for the nonsemaglutide group. The survival probability for the semaglutide cohort declined steepest over the initial 12 months, with a cumulative incidence of 6.5% (95% CI, 2.7%-10.2%) at year 1 ( Figure 2 A). The Cox proportional hazards regression model showed a higher NAION risk in the semaglutide cohort vs the nonsemaglutide cohort (HR, 4.28; 95% CI, 1.62-11.29; P  < .001; concordance coefficient = 0.84). The likelihood ratio test comparing the full model with a reduced model yielded a χ 2 18 statistic of 39.10 ( P  = .003). The Wald test for the overall significance of the model produced a χ 2 18 statistic of 25.62 ( P  = .008). The score (log-rank) test resulted in a χ 2 18 statistic of 30.08 ( P  = .009).

Secondary analyses for baseline variables that differed by 20% or more between the 2 cohorts included an exact match for overweight or obesity and obstructive sleep apnea. The 1:1 propensity and exact matches yielded 264 patients without history of NAION. The Cox proportional hazards regression model showed a higher NAION risk in the semaglutide cohort vs the nonsemaglutide cohort (HR, 4.35; 95% CI, 1.37-13.81; P  = .01; concordance coefficient = 0.79). The likelihood ratio test comparing the full model with a reduced model yielded a χ 2 18 statistic of 33.88 ( P  = .004). The Wald test for the overall significance of the model produced a χ 2 18 statistic of 23.96 ( P  = .008). The score (log-rank) test resulted in a χ 2 18 statistic of 29.10 ( P  = .01). These results are not substantially different from those obtained with the Cox analysis based on the 1:2 propensity matching analysis. Male sex also was significant in the Cox model (HR, 2.88; 95% CI, 1.03-8.03; P  = .04). Obesity did not significantly change the HR.

The study population of patients who were overweight or obese included 979 patients ( Figure 1 ). A 1:2 propensity score matching yielded adequate balance between the 2 groups (SMD < 0.1). NAION occurred in 20 patients in the semaglutide cohort vs 3 in the comparative cohort. The median (IQR) age was 46 (35-58) years for the semaglutide cohort and 44 (29-59) years for the nonsemaglutide cohort.

The Kaplan-Meier survival analysis at 36 months showed a cumulative incidence of NAION of 6.7% (95% CI, 3.6%-9.7%) for the semaglutide cohort vs 0.8% (95% CI, 0%-1.8%) for the nonsemaglutide cohort. The mean (SD) follow-up time was 34.1 (1.4) months for the semaglutide group and 35.4 (1.0) months for the nonsemaglutide group. The survival probability for the semaglutide cohort declined steepest over the initial 12 months, with a cumulative incidence of 5.5% (95% CI, 2.7%-8.3%) at year 1 ( Figure 2 B). The Cox proportional hazards regression model showed a higher NAION risk in the semaglutide cohort vs the nonsemaglutide cohort (HR, 7.64; 95% CI, 2.21-26.36; P  < .001; concordance correlation coefficient = 0.86). The likelihood ratio test comparing the full model with a reduced model yielded a χ 2 18 statistic of 56.20 ( P  < .001). The Wald test for the overall significance of the model produced a χ 2 18 statistic of 35.05 ( P  = .009). The score (log-rank) test resulted in a χ 2 18 statistic of 56.40 ( P  < .001).

Secondary analyses for baseline variables that differed by 20% or more between the 2 cohorts included an exact match for systemic hypertension, T2D, hyperlipidemia, and obstructive sleep apnea. The 1:1 propensity and exact matches yielded 442 patients without history of NAION. The Cox proportional hazards regression model showed a higher NAION risk in the semaglutide cohort vs the nonsemaglutide cohort (HR, 7.28; 95% CI, 1.59-33.34; P  = .01; concordance statistic = 0.84). The likelihood ratio test comparing the full model with a reduced model yielded a χ 2 18 statistic of 55.3 ( P  < .001). The Wald test for the overall significance of the model produced a χ 2 18 statistic of 34.13 ( P  = .04). The score (log-rank) test resulted in a χ 2 18 statistic of 55.11 ( P  < .001). These results are not substantially different from those obtained when the Cox analysis was performed using the 1:2 propensity matching analysis. For both primary and secondary analyses, hyperlipidemia in the Cox model increased the risk of NAION, but it was not significant when used independently as an interaction variable.

Our main finding is that prescribed semaglutide is associated with an increased risk of NAION. Despite extensive study, the pathogenesis of NAION has not been fully eludicated. 12 , 13 The incidence of NAION is 2 to 10 cases per 100 000 persons, 2 , 14 making it the second most common cause of blindness due to optic nerve damage (with glaucoma being the most common). The relatively high HRs (4.28 and 7.64 for our T2D and overweight or obese cohorts, respectively) identified by our Cox regression analyses reveal a substantially increased risk of NAION among individuals prescribed semaglutide relative to those prescribed other medications to treat T2D and obesity or overweight. This risk appears not to be due to differences in baseline characteristics between the cohorts.

The study has several strengths. The sample size of 629 NAION cases over 6 years, which is a substantial fraction of expected cases from the Boston area, was relatively large. All diagnoses of NAION were rendered by experienced neuro-ophthalmologists. All records coded as ischemic optic neuropathy were manually reviewed to ensure the clinician had accurately diagnosed NAION. Manual review confirmed that prescribed doses of semaglutide had been dispensed for patients who experienced NAION. Propensity score matching was used to balance cohorts to address potential confounders and reduce selection bias. Also, Cox regression was used to more precisely estimate the association of semaglutide with the risk of NAION.

Nonetheless, did confounding factors influence our estimated risk of developing NAION? Given that semaglutide was first approved to treat T2D, perhaps diabetes or related comorbidities, like obesity, were culprits. Our analyses, however, suggest that plausible confounding factors were not significant contributors to the risk of NAION, although per our Cox regression model, being male might increase the risk of NAION for patients with T2D receiving semaglutide, and having hyperlipidemia might increase the risk of NAION for patients who are overweight or obese and receiving semaglutide. We also used secondary analyses (with exact matching) to further isolate potential confounding influences of baseline variables that differed substantially (≥20%) among the eligible cohorts; however, this approach yielded similar results, supporting the notion that semaglutide, not baseline characteristics, was primarily associated with the heightened risk of NAION. Our survival analyses of both cohorts ( Figure 2 A and B) expose the greatest risk of NAION to be within the first year following prescription of semaglutide, a temporal association that supports a potential drug-induced risk of NAION.

The first 2 injectable GLP-1 RA drugs (Ozempic and Wegovy) accounted for the highest and second highest number of weekly new-to-brand prescriptions in the United States as of April 2023, and 1.7% of all patients in the United States through much of 2023 received prescriptions for semaglutide. 15 New injectable and oral GLP-1 RA formulations are FDA approved, and even more expansive use of these drugs seems likely given their medical benefits 16 - 21 and widespread popularity. If true, our data anticipate increasing numbers of NAION cases related to this class of drugs.

As with any drug, however, therapeutic benefits are inseparable from adverse effects. Related to vision, patients with diabetic retinopathy who received semaglutide incurred a higher risk of exacerbation of the retinopathy, especially with rapid reduction in hemoglobin A 1c levels, 22 and a higher rate of progression of proliferative retinopathy and risk of new-onset macular edema. 23 There has been no prior mention, to our knowledge, of an increased risk of NAION in association with semaglutide, and our study does not inform a mechanism to link semaglutide to NAION. Despite evidence of neuroprotective properties, 24 , 25 expression of the GLP-1 receptor in the human optic nerve 26 and GLP-1 RA–induced enhanced sympathetic nervous system activity might influence optic nerve head perfusion and potentially increase the risk of NAION.

There are several limitations to our study. Our tertiary care institution specializes in ophthalmology and includes a specialized neuro-ophthalmology service that evaluates a large proportion of the region’s NAION cases; therefore, our findings may not be fully generalizable to other settings. Second, our retrospective study does not allow inquiry into potential biases related to decisions about which patients were prescribed semaglutide or which of those patients were referred and evaluated in our neuro-ophthalmology clinic, although notably our hospital system and our service do not exclude any patient based on insurance coverage. Third, our study could not assess whether all patients actually took the drugs as prescribed; nonadherence is a common phenomenon, even for GLP-1 RA drugs, 27 and this may have led to an inaccurate estimation of a semaglutide-associated risk. We did, however, confirm that prescribed doses of semaglutide were dispensed for all patients with NAION. Fourth, our study also is limited in that the severity of confounding factors could not be adequately assessed, as our attempt to substratify the relatively small number of NAION cases in the semaglutide-exposed cohorts (n = 17 and 20) produced wide 95% CIs and less statistical precision. Our analyses were also hindered by laboratory data that were not retrievable from outside institutions. Although we uncovered an association between prescribed semaglutide and NAION, our study did not enable definitive inquiry into relatedness. Although we showed temporal proximity between prescribed semaglutide and NAION, the highest level of confidence to assess relatedness suggested by the FDA also requires establishing risk reduction on stopping a medication and a dose-dependent association. 28 Given that our cohorts were composed of relatively small percentages of patients of races other than White (in particular, of the 16 827 patients in our eligible cohort, 5.7% were listed in the medical record as being Black or African American vs 22.5% of individuals who in 2022 self-identified similarly in the greater Boston area), our results should be considered with caution for the general population, especially given that Black individuals generally have a lower risk of NAION. 29 , 30

This study is the first, to our knowledge, to report an association between semaglutide and NAION, although the design of our study did not enable query into a causal relationship between the two. The best approaches to confirm, refute, or refine our findings would be to conduct a much larger, retrospective, multicenter population-based cohort study; a prospective, randomized clinical study; or a postmarket analysis of all GLP-1 RA drugs. A risk inherent in larger studies, however, is the standard use of ICD-10 diagnostic codes given that there is no ICD-10 code for NAION. The most specific code relevant to NAION is the broader category of ischemic optic neuropathy. Our manual review of records for this study revealed that 40% of cases coded as ischemic optic neuropathy were not actually NAION but rather arteritic ischemic optic neuropathy from giant cell arteritis (which is commonly managed by neuro-ophthalmologists) or other forms of ischemic or nonischemic optic neuropathies. Manual review is not practical for extremely large databases, and the lack of a specific ICD-10 code for NAION (as identified by Hamedani et al 31 ) would be a severe hindrance for any large study. Emerging algorithms 32 , 33 would improve the accuracy of diagnostic coding in larger studies but would not attain the precision of a manual review and might not provide sufficient accuracy to establish a statistical association between use of a drug and occurrence of a relatively uncommon disorder like NAION.

Accepted for Publication: May 8, 2024.

Published Online: July 3, 2024. doi:10.1001/jamaophthalmol.2024.2296

Corresponding Author: Joseph F. Rizzo III, MD, Neuro-Ophthalmology Service, Massachusetts Eye and Ear, Harvard Medical School, 243 Charles St, Boston, MA 02114 ( [email protected] ).

Author Contributions: Drs J. T. Hathaway and Rizzo had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.

Concept and design: J. T. Hathaway, Shah, D. B. Hathaway, Zekavat, Cestari, Chwalisz, Estrela, Rizzo.

Acquisition, analysis, or interpretation of data: J. T. Hathaway, Shah, D. B. Hathaway, Zekavat, Krasniqi, Gittinger, Cestari, Mallery, Abbasi, Bouffard, Chwalisz, Rizzo.

Drafting of the manuscript: J. T. Hathaway, Shah, D. B. Hathaway, Zekavat, Krasniqi, Gittinger, Rizzo.

Critical review of the manuscript for important intellectual content: Shah, D. B. Hathaway, Zekavat, Krasniqi, Cestari, Mallery, Abbasi, Bouffard, Chwalisz, Estrela, Rizzo.

Statistical analysis: J. T. Hathaway, D. B. Hathaway, Zekavat.

Administrative, technical, or material support: Shah, D. B. Hathaway, Krasniqi, Gittinger, Mallery, Rizzo.

Supervision: D. B. Hathaway, Cestari, Bouffard, Chwalisz, Rizzo.

Conflict of Interest Disclosures: None reported.

Funding/Support: This work was funded in part by a grant from Research to Prevent Blindness.

Role of the Funder/Sponsor: Research to Prevent Blindness had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; or decision to submit the manuscript for publication.

Meeting Presentation: This work was presented at the annual meeting of the Association for Research in Vision and Ophthalmology; May 9, 2024; Seattle, Washington.

Data Sharing Statement: See the Supplement .

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Study suggests potential link between semaglutide and risk of non-arteritic ischemic optic neuropathy

Prescriptions with semaglutide (Wegovy, Ozempic, Novo Nordisk) are FDA approved to treat obesity and type 2 diabetes, respectively.

(Image Credit: AdobeStock/alones)

(Image Credit: AdobeStock/alones)

novo nordisk investor presentation 2023

Boston researchers led by first author Jimena Tatiana Hathaway, MD, MPH, reported that there is a potential risk of the development of non-arteritic ischemic optic neuropathy (NAION) 1 associated with prescriptions for semaglutide (Wegovy, Ozempic, Novo Nordisk). Prescriptions with semaglutide are FDA approved to treat obesity and type 2 diabetes, respectively.

Hathaway is from the Harvard T.H. Chan School of Public Health, and the Department of Ophthalmology, and Neuro-Ophthalmology Service Massachusetts Eye and Ear, Harvard Medical School, all in Boston.

The authors cited anecdotal experience that suggested that semaglutide, a glucagon-like peptide 1 receptor agonist (GLP-1 RA), the use of which has been rapidly increasing, may be associated with the development of NAION.

They recognized that this association may be important considering that the weekly new-to-brand prescriptions in the US of these and other GLP-1 RA drugs have increased by about 60% from 2021 to 2023. 2

In light of this, they conducted a retrospective matched-cohort study to determine if this association was valid. They searched a centralized data registry of patients who had undergone neuro-ophthalmologic evaluations at 1 academic institution from December 1, 2017, through November 30, 2023, for International Statistical Classification of Diseases and Related Health Problems, Tenth Revision code H47.01 (ischemic optic neuropathy) to identify patients.

They used propensity matching to determine if semaglutide was associated with NAION in patients who had type 2 diabetes or those who were overweight or obese. For each case, they accounted for covarying factors (sex, age, systemic hypertension, type 2 diabetes, obstructive sleep apnea, obesity, hyperlipidemia, and coronary artery disease) and contraindications to the use of semaglutide. All patients had been treated with semaglutide or a non–GLP-1 RA medications to manage type 2 diabetes or weight.

The main outcome measure was the cumulative incidence and hazard ratio of NAION.

Data analysis of the effects of semaglutide

Among the 16,827 study patients, 710 had type 2 diabetes and 979 were overweight or obese. Of those with type 2 diabetes, 194 had been treated with semaglutide and 516 with non–GLP-1 RA antidiabetic medications; of those who were overweight or obese, 361 had been treated with semaglutide and 618 with non–GLP-1 RA weight-loss medications.

injectors for Ozempic and Wegovy. (Image Credit: AdobeStock/K KStock)

injectors for Ozempic and Wegovy. (Image Credit: AdobeStock/K KStock)

novo nordisk investor presentation 2023

In the patients with type 2 diabetes, the authors reported that “17 NAION events occurred in patients prescribed semaglutide vs 6 in the non–GLP-1 RA antidiabetes cohort. The cumulative incidence rates of NAION for the semaglutide and non–GLP-1 RA cohorts over 36 months were 8.9% (95% confidence interval [CI], 4.5%-13.1%) and 1.8% (95% CI, 0%-3.5%), respectively.”

The analysis showed that patients treated with semaglutide had a higher risk of developing NAION compared with non-GLP-1 RA antidiabetes medications (hazard ratio [HR], 4.28; 95% CI, 1.62-11.29); P  < 0.001).

Among the patients who were overweight or obese, a similar picture emerged. The investigators reported that 20 NAION events occurred in patients treated with semaglutide compared with 3 in the non–GLP-1 RA cohort. This resulted in cumulative incidence rates of NAION for the semaglutide vs non–GLP-1 RA cohorts over 36 months of 6.7% (95% CI, 3.6%-9.7%) and 0.8% (95% CI, 0%-1.8%), respectively. This difference was also significant (HR, 7.64; 95% CI, 2.21-26.36; P  <0 .001).

Hathaway and colleagues concluded, “This study’s findings suggest an association between semaglutide and NAION. As this was an observational study, future study is required to assess causality.”

References:

Hathaway jt, shah mp, hathaway db, et al. risk of nonarteritic anterior ischemic optic neuropathy in patients prescribed semaglutide. jama ophthalmol. published online july 3, 2024. doi:10.1001/jamaophthalmol.2024.2296, novo nordisk. q1 2023 presentation, page 15. accessed december 20, 2023.  https://investor.novonordisk.com/q1-2023-presentation/page=15.

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Stock NOVO B

Novo Nordisk A/S

Dk0062498333, pharmaceuticals.

Market Closed - Nasdaq Copenhagen 11:20:00 2024-07-09 EDT 5-day change 1st Jan Change
966 -1.89% -2.77% +38.38%
06:05pm MT
05:14pm MT
  • Novo Nordisk : Q3 Investor presentation

Novo Nordisk

-a focused healthcare company

Investor presentation

First nine months of 2023

RAFAEL VALVERDE Rafael lives with obesity Mexico

2

Investor presentation

First nine months of 2023

Progress on Strategic Aspirations 2025 Commercial execution

Innovation and therapeutic focus Financials

3

Investor presentation

First nine months of 2023

Novo Nordisk®

Forward-looking statements

Novo Nordisk's reports filed with or furnished to the US Securities and Exchange Commission (SEC), including the statutory Annual Report 2022 and Form 20-F, which both were filed with the SEC in February 2023 in continuation of the publication of this Annual Report 2022, this presentation, and written information released, or oral statements made, to the public in the future by or on behalf of Novo Nordisk, may contain forward-looking statements. Words such as 'believe', 'expect, 'may', 'will', 'plan', 'strategy', 'prospect', 'foresee', 'estimate', 'project', 'anticipate', 'can', 'intend', 'target' and other words and terms of similar meaning in connection with any discussion of future operating or financial performance identify forward-looking statements. Examples of such forward-looking statements include, but are not limited to:

  • Statements of targets, plans, objectives or goals for future operations, including those related to Novo Nordisk's products, product research, product development, product introductions and product approvals as well as cooperation in relation thereto,
  • Statements containing projections of or targets for revenues, costs, income (or loss), earnings per share, capital expenditures, dividends, capital structure, net financials and other financial measures,
  • Statements regarding future economic performance, future actions and outcome of contingencies such as legal proceedings, and
  • Statements regarding the assumptions underlying or relating to such statements.

These statements are based on current plans, estimates and projections. By their very nature, forward-looking statements involve inherent risks and uncertainties, both general and specific. Novo Nordisk cautions that a number of important factors, including those described in this presentation, could cause actual results to differ materially from those contemplated in any forward-looking statements.

Factors that may affect future results include, but are not limited to, global as well as local political and economic conditions, such as interest rate and currency exchange rate fluctuations, delay or failure of projects related to research and/or development, unplanned loss of patents, interruptions of supplies and production, including as a result of interruptions or delays affecting supply chains on which Novo Nordisk relies, shortages of supplies, including energy supplies, product recalls, unexpected contract breaches or terminations, government- mandated or market-driven price decreases for Novo Nordisk's products, introduction of competing products, reliance on information technology including the risk of cybersecurity breeches, Novo Nordisk's ability to successfully market current and new products, exposure to product liability and legal proceedings and investigations, changes in governmental laws and related interpretation thereof, including on reimbursement, intellectual property protection and regulatory controls on testing, approval, manufacturing and marketing, perceived or actual failure to adhere to ethical marketing practices, investments in and divestitures of domestic and foreign companies, unexpected growth in costs and expenses, strikes and other labour market dispute, failure to recruit and retain the right employees, failure to maintain a culture of compliance, and epidemics, pandemics or other public health crises, and the effects of domestic or international crises, civil unrest, war or other conflict.

For an overview of some, but not all, of the risks that could adversely affect Novo Nordisk's results or the accuracy of forward-looking statements in this Annual Report 2022, reference is made to the overview of risk factors in 'Risk management' of this Annual Report 2022.

Unless required by law, Novo Nordisk is under no duty and undertakes no obligation to update or revise any forward-looking statement after the distribution of this Annual Report 2022, whether as a result of new information, future events, or otherwise.

Important drug information

Victoza ® and Ozempic ® are approved for the management of type 2 diabetes only

Saxenda ® and Wegovy ® are approved for the treatment of obesity only

4

Investor presentation

First nine months of 2023

Novo Nordisk®

Strategic Aspirations 2025 | Highlights first nine months of 2023

Progress towards zero environmental impact

Carbon emissions decreased by 28% vs first 9M 20191

Adding value to society

• Medical treatment to ~40 million people with diabetes

andPurpose sustainability (ESG)

• Reached more than 46,000 children in Changing

Diabetes® in Children programme

Partnership with Aspen to produce human insulin for

Africa

Being recognised as a sustainable employer

Share of women in senior leadership positions has

increased to 41% from 38% at end of September 2022

Diabetes value market share increased by 1.8%-points

to 33.3%2

Commercial execution

Obesity care sales of DKK 30.4 billion (+174% at CER)

Rare disease sales of DKK 12.6 billion (-18%at CER)

Light blue indicates developments in Q3 2023

Further raise innovation bar for Diabetes treatment

• Regulatory submission of once-weekly insulin icodec

• Initiation of phase 3 trial with CagriSema T2D

therapeuticfocus

• FLOW stopped for efficacy based on interim analysis

Innovationand

Develop superior treatment solutions for obesity

• Regulatory submission of SELECT CVOT

Strengthen and progress Rare Disease pipeline

• Concizumab approved for HAwI/HBwI in Japan

Establish presence in other serious chronic diseases

• Acquisition of ocedurenone within CVD

Sales growth of 33% (CER) and operating profit growth

of 37% (CER)

Operational leverage reflecting sales growth

Financials

Free cash flow of DKK 75.6 billion and DKK 52.0 billion

returned to shareholders

1 Scope 1,2 and partial scope 3 limited to CO2 emissions from business flights and product distribution; 2 MAT (Moving annual total) value market share CER: Constant exchange rates; 9M: Nine months; HAwI/HBwI: Haemophilia A/B with inhibitors

Note: The strategic aspirations are not a projection of Novo Nordisk's financial outlook or expected growth

5

Investor presentation

First nine months of 2023

Novo Nordisk®

Sales growth of 33% driven by both operating units

Reported geographic sales split for first nine months of 2023

DKK

Insulin

GLP-1

Other diabetes

billion

Obesity care

Rare disease

Growth at CER

100

49%

80

17%

International Operations

60

40

19%

20

16%

12%

0

NAO

IO

EMEA

China

RoW

Reported therapy area sales and growth for first nine months of 2023

DKK

North America Operations

International Operations

billion

Growth at CER

180

33%

49%

-7%

174%

-18%

150

90

60

60%

IO

-1%

IO

52%

NAO

-24%

NAO

244%

IO

-22%

30

49%

NAO

43%

-13%

0

Total1

GLP-1

Insulin Obesity care Rare disease

1 'Other diabetes' is included in Total

IO: International Operations; EMEA: Europe, Middle East and Africa; China: Mainland China, Hong Kong and Taiwan; RoW: Rest of World; NAO: North America Operations; CER: Constant exchange rates

Note: Unless otherwise specified, sales growth rates are at CER

6

Investor presentation

First nine months of 2023

Novo Nordisk®

Diabetes value market leadership reached 33.3%

Novo Nordisk global diabetes value market shares

Diabetes GLP-1 Insulin

55.7%

54.3%

52.1%

49.9%

44.6%

44.0%

44.2%

44.1%

Diabetes value market leadership expansion

driven by the GLP-1 franchise

Diabetes care sales grew by 25% (CER) with global value market share increase driven by market share gains in both IO and NAO.

• Global diabetes value market share increased by 1.8%-

points to 33.3%

• Novo Nordisk continues to be the global market leader in

the GLP-1 segment with a 54.3% value market share

• Estimated global GLP-1 share of total diabetes

prescriptions is ~6%

29.2% 29.9%

2020

2021

2022

2023

CER: Constant exchange rates; IO: International Operations; NAO: North America Operations

Note: Sales growth rates are at CER

Source: IQVIA MAT, Aug 2023 (Spot rate); Volume growth based on Moving Annual Total (MAT); Market values are based on the list prices

7

Investor presentation

First nine months of 2023

Novo Nordisk®

International Operations diabetes care sales growth is driven by

GLP-1 performance

Reported Diabetes care sales and growth per IO geography

DKK

billion

Insulin GLP-1

Growth at CER

50

Geographical regions

40

60%

30

23%

20

50%

26%

-1%

13%

10

61%

95%

2%

0

-10%

5%

IO

EMEA

China

RoW

GLP-1 patients and value market share in IO

Number of

Value

patients (millions)

market share

Class growth >35%

8

68.7%

75%

6

60%

45.8%

45%

4

27.5%

30%

2

12.4%

15%

10.5%

0

2.3%

0%

Aug

Aug

Aug

2021

2022

2023

GLP-1 patients

Ozempic®

Victoza®

Rybelsus®

dulaglutide

tirzepatide

IO: International Operations; NN: Novo Nordisk; EMEA: Europe, Middle East and Africa; China: Mainland China, Hong Kong and Taiwan; RoW: Rest of World; CER: Constant exchange rates Note that the market share and patient numbers are based on countries with IQVIA coverage. GLP-1 class growth calculated as Jun'23-Aug'23 vs Jun'22-Aug'22 (Rolling 3-month average) Source: IQVIA MAT, Aug 2023 (Spot rate). Volume packs are converted into full-year patients based on WHO assumptions for average daily doses; Market values are based on the list prices

8

Investor presentation

First nine months of 2023

Novo Nordisk®

GLP-1 class expansion continues in the US in the first nine months of 2023

US GLP-1 weekly NBRx prescriptions

US GLP-1 TRx market share

Weekly NBRx

TRx share

Total GLP-1 scripts

scripts ('000s)

(millions)

Class growth ~50%

90

80%

7

6

60

60%

53.1%

5

40%

42.3%

4

3

30

26.6%

19.5%

2

20%

7.2%

1

3.7%

0

Oct

Oct

0%

Oct

Oct

0

2021

2023

2021

2023

Ozempic®

Rybelsus®

Victoza®

NN GLP-1

dulaglutide

tirzepatide

Total monthly GLP-1 scripts

NBRx: New-to-brand prescriptions; TRx: Total prescriptions; NN: Novo Nordisk; Scripts: Prescriptions; US: United States

Note: Class growth calculated as Q3 2023 vs Q3 2022

Source: IQVIA Xponent, NBRx data from week ending 13 Oct 2023. TRx data from week ending 13 Oct 2023. Each data points represents a rolling four-week average

9

Investor presentation

First nine months of 2023

Novo Nordisk®

Obesity care sales grew by 174% in the first nine months of 2023

mainly driven by the US

NN sales and volume BAOM market growth

Branded AOM TRx in the US2

within Obesity care

DKK billion

TRx count ('000s)

15

55%1

84%1

174%1

180

94%

95%

160

The US

12

75%

140

• Commercial relaunch in January 2023

• Broad commercial formulary access

120

109

9

55%

100

While supply capacity is gradually

98

being expanded, the supply of the

6

80

lower dose strengths will remain

35%

60

restricted to safeguard continuity of

care

3

15%

40

International Operations

20

• Wegovy® launched in Denmark,

0

-5%

0

3

Norway, Germany, UK and Iceland

• Volume capped launches in IO in

2021

2022

2023

June

October

2023, balancing supply and demand

2021

2023

IO

NAO

BAOM Market growth (RHS)

Saxenda®

Wegovy®

NN sales growth at CER

Branded AOM market

1 Annual growth at CER. Each TRx data points represents one week of data; 2 IQVIA weekly, 20 October 2023

NAO: North America operations; IO: International operations; RHS: Right-hand side axis; TRx: Total Prescriptions; AOM: Anti-Obesity Medications (includes Wegovy ® , Saxenda ® , Qsymia, Belviq and Contrave); BAOM: Branded AOM market; CER: Constant exchange rates

Note: Sales growth at constant exchange rates. 94% volume growth for Global BAOM market growth refers to moving annual total.

10

Investor presentation

First nine months of 2023

Novo Nordisk®

Rare disease sales decreased by 18% driven by temporary reduction in manufacturing output

Reported Rare disease sales

Rare disease sales driven by global commercial execution

DKK

billion

Growth at CER

Rare disease sales decrease is driven by:

15

-18%

2%

15%

44%

-5%

-54%

12

9

Rare blood disorders

6

3

0

Total1

Rare

Haem.

Haem.

Novo-

Rare

blood

A

B

Seven®

endocrine

disorders2

disorders3

  • 13% sales decline in North America Operations
  • 22% sales decline in International Operations

Rare blood disorders sales increased by 2%, driven by:

  • Launch products in haemophilia A and B, partially countered by NovoSeven®

Rare endocrine disorders sales decreased by 54% driven by:

  • Sales for Norditropin ® declined by 50% in NAO and 56% in IO, reflecting a temporary reduction in manufacturing output
  • Novo Nordisk has a value market share of 24.6% in the global human growth disorder market

1 Total includes "Other Rare disease", which consists of primarily Vagifem ® and Activelle ® ; 2 Comprises NovoSeven ® , NovoEight ® , Esperoct ® , Refixia ® and NovoThirteen ® ; 3 Primarily Norditropin ®

CER: Constant exchange rates; Haem. A: Haemophilia A; Haem. B: Haemophilia B; NAO: North America operations; IO: International operations; Unless otherwise specified, sales growth is at constant exchange rates

Note: NovoThirteen ® is not shown for Rare blood disorders breakdown, only for the total bar.

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Novo Nordisk A/S published this content on 02 November 2023 and is solely responsible for the information contained therein. Distributed by Public , unedited and unaltered, on 02 November 2023 11:10:02 UTC .

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Novo Nordisk CEO:  Demand for Wegovy outstrips supply

Novo Nordisk CEO: Demand for Wegovy outstrips supply

May 02, 2024 at 12:36 pm

NOVO NORDISK : Q1 beat; guidance upgrade but sentiment nonetheless dampened by price reductions

Novo Nordisk doesn't disappoint

Novo Nordisk doesn't disappoint

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Semaglutide may be associated with non-arteritic ischemic optic neuropathy (NAION)

GLP-1 receptor agonists, such as Wegovy, Ozempic and Novo Nordisk, are becoming more prolific

A 2mg branded Ozempic injector. Image credit: ©Fernanda – stock.adobe.com

Researchers used propensity matching to determine if semaglutide was associated with NAION. Image credit: ©Fernanda – stock.adobe.com

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Researchers led by first author Jimena Tatiana Hathaway, MD, MPH, reported that there is a potential risk of the development of non-arteritic ischemic optic neuropathy (NAION) 1 associated with prescriptions for semaglutide (Wegovy, Ozempic, Novo Nordisk). In Europe and the US, semaglutide is approved to treat obesity and type 2 diabetes. Dr Hathaway is from the Harvard T.H. Chan School of Public Health, the Department of Ophthalmology, and Neuro-Ophthalmology Service Massachusetts Eye and Ear, Harvard Medical School, all in Boston.

The authors cited anecdotal experience that suggested that semaglutide, a glucagon-like peptide 1 receptor agonist (GLP-1 RA), may be associated with development of NAION. Investigators recognised that this association may be important considering that the use of GLP-1 RA drugs has been rapidly increasing. In the US, weekly new-to-brand prescriptions of GLP-1 RA drugs has increased by about 60% from 2021 to 2023, according to figures from Novo Nordisk. 2

In light of this, the authors conducted a retrospective matched-cohort study to determine if this association was valid. They searched a centralised data registry of patients who had undergone neuro-ophthalmologic evaluations at one academic institution from December 1, 2017, through November 30, 2023, for International Statistical Classification of Diseases and Related Health Problems, Tenth Revision, code H47.01 (ischemic optic neuropathy) to identify patients.

They used propensity matching to determine if semaglutide was associated with NAION in patients who had type 2 diabetes or those who were overweight or obese. For each case, they accounted for covarying factors (sex, age, systemic hypertension, type 2 diabetes, obstructive sleep apnea, obesity, hyperlipidemia and coronary artery disease) and contraindications to the use of semaglutide. All patients had been treated with semaglutide or a non–GLP-1 RA medication to manage type 2 diabetes or weight.

The main outcome measure was the cumulative incidence and hazard ratio of NAION.

Data analysis of the effects of semaglutide

Among the 1,689 study patients, 710 had type 2 diabetes and 979 were overweight or obese. Of those with type 2 diabetes, 194 had been treated with semaglutide and 516 with non–GLP-1 RA antidiabetic medications; of those who were overweight or obese, 361 had been treated with semaglutide and 618 with non–GLP-1 RA weight-loss medications.

In the patients with type 2 diabetes, the authors reported that “17 NAION events occurred in patients prescribed semaglutide vs 6 in the non–GLP-1 RA antidiabetes cohort. The cumulative incidence rates of NAION for the semaglutide and non–GLP-1 RA cohorts over 36 months were 8.9% (95% confidence interval [CI], 4.5%-13.1%) and 1.8% (95% CI, 0%-3.5%), respectively.”

The analysis showed that patients treated with semaglutide had a higher risk of developing NAION compared with non-GLP-1 RA antidiabetes medications (hazard ratio [HR], 4.28; 95% CI, 1.62-11.29); P  < 0.001).

Among the patients who were overweight or obese, a similar picture emerged. The investigators reported that 20 NAION events occurred in patients treated with semaglutide compared with three in the non–GLP-1 RA cohort. This resulted in cumulative incidence rates of NAION for the semaglutide vs non–GLP-1 RA cohorts over 36 months of 6.7% (95% CI, 3.6%-9.7%) and 0.8% (95% CI, 0%-1.8%), respectively. This difference was also significant (HR, 7.64; 95% CI, 2.21-26.36; P  <0 .001).

Dr Hathaway and colleagues concluded, “This study’s findings suggest an association between semaglutide and NAION. As this was an observational study, future study is required to assess causality.”

1. Hathaway JT, Shah MP, Hathaway DB, et al. Risk of nonarteritic anterior ischemic optic neuropathy in patients prescribed semaglutide. JAMA Ophthalmol. Published online July 3, 2024. doi:10.1001/jamaophthalmol.2024.2296

2. novo nordisk. q1 2023 presentation, page 15. accessed december 20, 2023.  https://investor.novonordisk.com/q1-2023-presentation/page=15.

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  • Novo Nordisk A/S - share repurchase programme Jul 08 2024
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Lilly’s obesity drug looks more potent than Novo’s in observational study

Elaine Chen

By Elaine Chen July 9, 2024

Eli Lilly headquarters

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox.

Good morning. STAT published an investigation this morning on the untold story of the Human Genome Project and ethics concerns surrounding the ambitious project. Check it out  here .

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The need-to-know this morning

  • Pfizer  Chief Scientific Officer and R&D Chief Mikael Dolsten is  leaving the company  after 15 years. A search for his successor is expected to last until early next year, the pharma giant said.
  • UniQure  said its experimental gene therapy called AMT-130  slowed the progression of Huntington’s disease  by 80% compared to an external control group in a mid-stage clinical trial.

Interius to start first ever in-vivo CAR-T clinical trial

Interius Biotherapeutics will soon begin the world’s first clinical trial of in-vivo CAR-T therapy. Patients will receive an IV infusion designed to transform their immune cells into cancer killers inside their bodies.

Traditional CAR-T therapy is “ex-vivo,” meaning the immune cells are manipulated outside the body. It’s a complicated and expensive process that involves extracting the cells from the patient, shipping them to a specialized facility to be worked on, and then reinfusing the cells back into the patient.

Traditional CAR-T is out of reach for many patients, and researchers hope that the new in-vivo approach could provide a cheaper and more scalable option.

Read more  from STAT’s Jason Mast.

Pharma is losing friends on Capitol Hill

Pharma’s position in Washington has already been weakening over the past few years, as underscored by the passage of the Inflation Reduction Act, which allowed Medicare to negotiate drug prices. The industry’s influence is set to wane even more as some of its closest allies leave Capitol Hill.

My colleague Rachel Cohrs Zhang reports that at least six key pharma-friendly lawmakers are expected to have left their seats by the beginning of next year, and their likely replacements are less friendly to the industry and less interested in health care.

One example is Sen. Bob Menendez of New Jersey, home of pharma giants Johnson & Johnson, Merck, and Bristol Myers Squibb. Menendez is currently on trial for bribery charges, and the Democrat vying to replace him, Rep. Andy Kim, supports the party’s more ambitious drug pricing plans.

Read more  on the other allies pharma will be losing.

Lilly’s obesity drug looks more potent than Novo’s in observational study

In its pivotal Phase 3 trial, Eli Lilly’s tirzepatide (sold as Mounjaro/Zepbound) led to more weight loss than what was seen in the trial of Novo Nordisk’s semaglutide (sold as Ozempic/Wegovy). It’s been hard to directly compare the two drugs, though, since there haven’t yet been results from any head-to-head trials, but a new observational study suggests Lilly’s drug may indeed lead to greater weight loss.

The study,  published yesterday in JAMA Internal Medicine , analyzed the health records of over 18,000 people and found that those on tirzepatide had about 15% weight loss at one year, while those on semaglutide had about 8%. Additionally, 42% of patients on tirzepatide achieved more than 15% weight loss, compared with 18% of patients on semaglutide.

Since it’s a retrospective observational study, there are many limitations. For example, patients may have encountered shortages and may not have been able to consistently take their medications. Patients may have also been on different diets and exercise regimens.

We’ll be watching for results of  a randomized head-to-head trial  that Lilly is running that’s expected to complete in November this year.

A private equity approach to investing in neuro drugs

Investors have long been reluctant to invest in drug programs for neurological disorders. There’s been a history of failed studies and many trial endpoints are subjective and difficult to measure.

Bruce Leuchter, CEO of Neurvati Neurosciences, a Blackstone Life Sciences portfolio company, argues in a new opinion piece that investors should adopt a a “private equity model” to invest in neurology drug candidates.

This means looking at molecules later in the development lifecycle rather than at early-stage drugs that the classic venture model focuses on. While the costs to acquire a later-stage drug will be higher, investors would be able to better vet the program and confirm the rationale behind the drug’s mechanism, Leuchter writes.

Read more .

  • When can pharma companies correct online misinformation? FDA explains,  Endpoints
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  • Trump’s 2024 platform abandons calls to cut Medicare, broadly restrict abortion,  STAT
  • New study sparks debate about whether H5N1 virus in cows is adapted to better infect humans,  STAT

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Elaine chen.

National Biotech Reporter

Elaine Chen covers biotech and co-writes the The Readout newsletter.

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Q1 2023 Presentation

3 Investor presentation First three months of 2023 Forward-looking statements Novo Nordisk’s reports filed with or furnished to the US Securities and Exchange Commission (SEC), in February 2023 in continuation of the publication of this Annual Report 2022, this presentation, and wr Novo Nordisk, may contain forward- looking statements. Words such as ‘believe’, ‘expect, ‘may’, ‘will’, ‘p words and terms of similar meaning in connection with any discussion of future operating or financial include, but are not limited to: • Statements of targets, plans, objectives or goals for future operations, including those related to product approvals as well as cooperation in relation thereto, • Statements containing projections of or targets for revenues, costs, income (or loss), earnings pe measures, • Statements regarding future economic performance, future actions and outcome of contingencie • Statements regarding the assumptions underlying or relating to such statements. These statements are based on current plans, estimates and projections. By their very nature, forward Nordisk cautions that a number of important factors, including those described in this presentation, co statements. Factors that may affect future results include, but are not limited to, global as well as local political and of projects related to research and/or development, unplanned loss of patents, interruptions of suppli Novo Nordisk relies, shortages of supplies, including energy supplies, product recalls, unexpected con Nordisk’s products, introduction of competing products, reliance on information technology including products, exposure to product liability and legal proceedings and investigations, changes in governme protection and regulatory controls on testing, approval, manufacturing and marketing, perceived or a and foreign companies, unexpected growth in costs and expenses, strikes and other labour market dis and epidemics, pandemics or other public health crises, and the effects of domestic or international cr For an overview of some, but not all, of the risks that could adversely affect Novo Nordisk’s results or t overview of risk factors in ‘Risk management’ of this Annual Report 2022. Unless required by law, Novo Nordisk is under no duty and undertakes no obligation to update or revi result of new information, future events, or otherwise. Important drug information Victoza ® and Ozempic ® are approved for the management of type 2 diabetes only Saxenda ® and Wegovy ® are approved for the treatment of obesity only

 alt=

Novo Nordisk

2024-06-24T18:16:34Z

Novo Nordisk announces 4.1 billion USD investment to expand US manufacturing capacity

In 2024, Novo Nordisk plans to boost its current investments, aiming to allocate USD 6.8 billion towards production, a significant increase from the previous year's investment of USD 3.9 billion*.

Bagsværd, Denmark, 24 June 2024 – Novo Nordisk today announced plans to invest 4.1 billion US dollars (approx 27 billion Danish kroner) to build a second fill and finishing manufacturing facility in Clayton, North Carolina, and grow its ability to produce current and future injectable treatments for people with obesity and other serious chronic diseases.

Marking one of the largest manufacturing investments in Novo Nordisk’s history, the expansion will add 1.4 million square feet of production space for aseptic manufacturing and finished production processes, doubling the combined square footage of all three of the company’s existing facilities in North Carolina. It will also add 1,000 new jobs, besides the nearly 2,500 Novo Nordisk employees already working in the region, a central hub for innovation and biotechnology in the United States. “It took us a century to reach 40 million patients, but through this expansion and continued investment in our global production, we’re building Novo Nordisk’s ability to serve millions more people living with serious chronic diseases in the future,” said Lars Fruergaard Jørgensen, president and CEO of Novo Nordisk. “This is yet another real signal of our efforts to scale up our production to meet the growing global need for our life-changing medicines and the patients of tomorrow.”

Utilising state-of-the-art technology, roof-top solar panels and innovative water strategies, the facility is designed in an efficient and environmentally sustainable way to deliver the highest-quality products to patients around the world. The goal is to obtain LEED Gold certification, recognised as a standard of excellence in constructing healthy, efficient, carbon and cost-saving green buildings. “Clayton was the first manufacturing site for Novo Nordisk in the US, and this new, large-scale investment confirms the continued importance of our production facilities there as cornerstones of our company’s growth,” said Henrik Wulff, executive vice president, Product Supply, Quality & IT, Novo Nordisk. “For decades, we have partnered to foster a well-trained, dedicated and diverse local workforce in North Carolina. In Clayton and across our global manufacturing sites, we are driven by one purpose: to deliver more for the millions of people living with chronic diseases – and this facility will help us achieve just that.”

Early clearing and foundational work are already underway to prepare the 56-acre facility footprint. Construction will gradually be finalized between 2027 and 2029. Around 2,000 external contractors will be engaged at the height of the project.

“It’s a historic day for Johnston County,” said Butch Lawter, Chair of the Johnston County Board of Commissioners, who, during today’s press conference, announced county grants to further support the expansion project. “Thirty-one years ago, Novo Nordisk decided to make a new home here in Clayton. Then, in 2016, they announced a new facility right across the street - the single largest life sciences investment on state record at the time. Today, they’re breaking that record again… with a third facility, 1,000 new jobs and a vote of confidence in the partnerships we have forged in the community over the decades.” In 2024, Novo Nordisk will increase actual investments in production and plans to invest approx USD 6.8 billion (DKK 45 billion) in production compared to actual investments of USD 3.9 (DKK 26 billion) last year* to increase supply.

Visit novonordisk.com for photos and b-roll supporting this press release.

About Novo Nordisk manufacturing Novo Nordisk has a global manufacturing setup with five strategic production sites located in Denmark, US, France, Brazil and China. All Novo Nordisk’s medicines are manufactured at these sites and subsequently distributed to patients around the globe. This includes producing almost half of the world’s insulin, GLP-1 medicines for the treatment of diabetes and obesity and medicines to treat rare diseases such as haemophilia and growth disorders. Novo Nordisk’s manufacturing unit has almost 20,000 employees who are dedicated to delivering the highest quality to patients globally in an efficient and environmentally sustainable way.

About Novo Nordisk Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases, built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 66,000 people in 80 countries and markets its products in around 170 countries. For more information, visit novonordisk.com , Facebook , Instagram , X , LinkedIn and YouTube .

Contacts for further information

 

+45 3079 9289



+1 609 917 0632


 

+45 3075 5956



+45 3077 6915



+45 3079 6656



+45 3075 8259



+45 3077 5649




+1 848 213 3219


*not including acquisitions

  • PR240624-Clayton-Investment

novo nordisk investor presentation 2023

COMMENTS

  1. PDF Novo Nordisk -a focused healthcare company

    3 Novo Nordisk Investor presentation First three months of 2023 Forward-looking statements Novo Nordisk's reports filed with or furnished to the US Securities and Exchange Commission (SEC), including the statutory Annual Report 2022 and Form 20-F, which both were filed with the SEC in

  2. PDF Novo Nordisk a focused healthcare company

    4 Novo Nordisk Investor presentation Full year 2023 1Scope 1,2 and partial scope 3 limited to CO2 emissions from business flights and product distribution.Carbon emissions decreased by 8% in 2023 compared to 2022; 2MAT (Moving annual total) value market share CER: Constant exchange rates; CV: Cardiovascular; CVOT: Cardiovascular outcomes trial

  3. Q4_Full Presentation_2023

    Q4_Full Presentation_2023. Q4_Full Presentation_2023. 1 Investor presentation First six months of 2023 RAFAEL VALVERDE Rafael lives with obesity Mexico. Page 2. Download PDF file.

  4. Financial results and events overview

    Financial results and events overview - Novo Nordisk. Today 2 May 2024, we announced our financial results for the three first months of 2024. Company announcement. Financial workbook (xlsx) Investor presentation. Earnings conference call webcast. London conference call. We will announce our financial results for the first six months of 2024 at ...

  5. Q1 2023 Presentation

    Q1 2023 Presentation. Q1 2023 Presentation. 1 Investor presentation First three months of 2023 Erik Hageman (on the right) is one of Denmark's longest -living people with type 1 diabetes, pictured here with his son Lars, who also has type 1 diabetes, and his grandchildren (from the left) Clara, Emilie and Holger. Page 2. Download PDF file.

  6. Q3 2023 Presentation

    Q3 2023 Presentation. Q3 2023 Presentation. 1 Investor presentation First six months of 2023 RAFAEL VALVERDE Rafael lives with obesity Mexico. Page 2. Download PDF file.

  7. Novo Nordisk (NVO) Q4 2023 Earnings Call Transcript

    The effective tax rate is 20.1% in 2023 compared to 19.6% in 2022. Consequently, net profit increased by 51%, and diluted earnings per share increased by 52% to 18.62 Danish kroner. Free cash flow ...

  8. PDF Innovation to drive sustainable growth in Vaccines

    8 Strong positive pipeline news flow in H1 2023 Vaccines Investor Event Submissions Dupixent® CSU US 300,000 people with CSU inadequately controlled by antihistamines Read-outs Dupixent® COPD Phase 3 Around 900,000 patients in G7 itepekimab (IL-33) COPD Phase 3 IA Around 1.8m patients in G7 amlitelimab (OX40L) AD Phase 2b Moving in phase 3 frexalimab (CD40L) MS Phase 2b Moving in phase 3

  9. Novo Nordisk : Q3 Investor presentation

    Forward-looking statements Novo Nordisk's reports filed with or furnished to the US Securities and Exchange Commission (SEC), including the statutory Annual Report 2022 and Form 20-F, which both were filed with the SEC in February 2023 in continuation of the publication of this Annual Report 2022, this presentation, and written information released, or oral statements made, to the public in ...

  10. PDF Novo Nordisk

    Novo Nordisk's reports filed with or furnished to the US Securities and Exchange Commission (SEC), including this presentation as well as the company's statutory Annual Report 2020 and Form 20-F, which was filed with the SEC in February 2021 in continuation of the publication of the Annual Report 2020, and written information released, or ...

  11. Risk of Nonarteritic Anterior Ischemic Optic Neuropathy in Patients

    The first 2 injectable GLP-1 RA drugs (Ozempic and Wegovy) accounted for the highest and second highest number of weekly new-to-brand prescriptions in the United States as of April 2023, and 1.7% of all patients in the United States through much of 2023 received prescriptions for semaglutide. 15 New injectable and oral GLP-1 RA formulations are ...

  12. Study suggests potential link between semaglutide and risk of non

    Boston researchers led by first author Jimena Tatiana Hathaway, MD, MPH, reported that there is a potential risk of the development of non-arteritic ischemic optic neuropathy (NAION) 1 associated with prescriptions for semaglutide (Wegovy, Ozempic, Novo Nordisk). Prescriptions with semaglutide are FDA approved to treat obesity and type 2 diabetes, respectively.

  13. Investors

    Investor highlights Financial results, events and calendar Annual Report 2023 ESG Share information Investor Portal Bond information Company announcements and press releases Annual General Meeting 2024 Contact Investor Relations. NOVO NORDISK HQ. Novo Nordisk A/S Novo Alle 1 2880 Bagsværd Denmark

  14. Novo Nordisk : Q3 Investor presentation -November 02, 2023 at 07:11 am

    Novo Nordisk -a focused healthcare company Investor presentation First nine months of...

  15. Q2 2023 Presentation—Page 9

    Q2 2023 Presentation. 5 Investor presentation First six months of 2023 Sales growth of 30% driven by bo Reported geographic sales split for first half of 2023 DKK billion 60 Insulin Obesity care 44% 17% GLP-1 Rare disease Other diabetes Growth at CER International Operations 40 19% 20 18% 12% 0 NAO IO EMEA China RoW 1 'Other diabetes' is ...

  16. Novo Nordisk's Wegovy lags Lilly's Mounjaro in speed and size of weight

    The stock of Danish biotech Novo Nordisk was down 1.7% premarket Tuesday, after a study found that the company's obesity drug Wegovy lags its main rival, Eli Lilly & Co. Inc.'s Mounjaro, in ...

  17. Novo Nordisk Stock Falls After Biden Slams Drugmaker For

    Novo Nordisk stock fell as low as 139.03 before paring losses to down 1.7% at 142.99, back above the 21-day moving average. Eli Lilly stock slumped 0.8% to 906.87. LLY stock slid to 878.50 soon ...

  18. Copper And Gold Miners Lead Five Stocks Near Buy Points

    The stock market continues to flash a green signal to investors. ... In 2023, Novo Nordisk earnings per share boomed 54% on 30% sales growth. Year to date, Novo Nordisk stock has ripped 38% higher.

  19. PDF Novo Nordisk -a focused healthcare company

    1 Investor presentation Full year 2022 Erik Hageman (on the right) is one of Denmark's longest-living people with type 1 diabetes, pictured here with his son Lars, who also has type 1 diabetes, and his grandchildren (from the left) Clara, Emilie and Holger. Novo Nordisk -a focused healthcare company Investor presentation Full year 2022

  20. Semaglutide may be associated with non-arteritic ischemic optic

    Investigators recognised that this association may be important considering that the use of GLP-1 RA drugs has been rapidly increasing. In the US, weekly new-to-brand prescriptions of GLP-1 RA drugs has increased by about 60% from 2021 to 2023, according to figures from Novo Nordisk. 2

  21. Novo Nordisk A/S (NVO) Earnings Date and Reports 2024

    Novo Nordisk A/S has generated $2.90 earnings per share over the last year ($2.90 diluted earnings per share) and currently has a price-to-earnings ratio of 49.4. Earnings for Novo Nordisk A/S are expected to grow by 25.29% in the coming year, from $3.44 to $4.31 per share.

  22. Q4_Full Presentation_2023—Page 25

    Q4_Full Presentation_2023. 137 Investor presentation Full year 2023 Diabetes market share and mark North America Operations Diabetes market growth and Novo Nordisk market share 50% 43% 40% 35% 30% 30% 20% 23% 10% 0% Nov 2020 NN market share Market growth NN share of growth NN growth Nov 2023 NN: Novo Nordisk Note: Due to contractual obligations competitor names are not disclosed.

  23. Novo Nordisk conference calls for media and investors

    Novo Nordisk A/S hosted a R&D investor call in relation to the annual ADA conference. This year the conference is hosted in San Diego, CA. ... Full-year 2022 financial results were published 01 February 2023, 7:30 CET: Company announcement; Investor presentation; Financial workbook (xlsx) The conference call took place 01 February 2023, 13:00 ...

  24. Novo Nordisk A/S, NONOF:PKC summary

    Novo Nordisk A/S - share repurchase programme Jul 08 2024; Novo Nordisk stops the ocedurenone CLARION-CKD trial and recognises impairment loss Jun 26 2024; Novo Nordisk announces 4.1 billion USD investment to expand US manufacturing capacity adline Jun 24 2024; Novo Nordisk announces presentation of data from key semaglutide clinical trials in diabetes, obesity and chronic kidney disease at ...

  25. Readout Newsletter: Eli Lilly, Pfizer, Interius, UniQure latest

    In a study of over 18,000 people, Eli Lilly's tirzepatide (sold as Mounjaro/Zepbound) led to more weight loss than what was seen in the trial of Novo Nordisk's semaglutide (sold as Ozempic/Wegovy ...

  26. Novo Nordisk shares shrug off concerns over study linking weight ...

    Novo Nordisk shares were little changed on Thursday, dipping in early morning trade before rising just 0.1% as of 11:00 a.m. London time. ... Novo Nordisk investors appeared unperturbed Thursday ...

  27. Q1 2023 Presentation—Page 5

    Q1 2023 Presentation. 3 Investor presentation First three months of 2023 Forward-looking statements Novo Nordisk's reports filed with or furnished to the US Securities and Exchange Commission (SEC), in February 2023 in continuation of the publication of this Annual Report 2022, this presentation, and wr Novo Nordisk, may contain forward- looking statements.

  28. Dow Jones Jumps 162 Points As Powell Says This On Rate Cuts; Tesla

    NOW PLAYING Nasdaq Leads Market; Weatherford, Goldman Sachs, Novo Nordisk In Focus. The Dow Jones average ended the day up 162 points, or 0.4%. The Nasdaq composite rose 0.8%. The S&P 500 added 0. ...

  29. News Details

    Investors; News & media; Patient help; Healthcare professionals; Contact us; Novo Nordisk. 2024-06-24T18:16:34Z. 2024-06-24T18:16:34Z. Announcement.pdf Novo Nordisk announces 4.1 billion USD investment to expand US manufacturing capacity. In 2024, Novo Nordisk plans to boost its current investments, aiming to allocate USD 6.8 billion towards ...

  30. Myricx Bio Announces £90m ($114m) Series A Financing to

    £90m ($114m) series A co-led by new leading life science investors Novo Holdings and AbingworthAdditional new investors British Patient Capital, Cancer...