Q1 2025 Novo Nordisk AS Earnings Call
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Speaker Change: Good day, and thank you for sending by. Welcome to the Q-12025 Novo Nordisk AS Earnings Conference call. At this time, all participants are in a listen-only mode. After the speakers presentation, there'll be a question and answer session. To ask a question during the session, you will need to press star one and one on your telephone. You will then hear an automated message, advising your hand is raised. To withdraw your question, please press star one and one again. Please be advised that today's conference is being recorded. Please be advised that today's conference is being recorded.
Speaker Change: I would now like to hand the comments over to your first speaker today, Jacob Rode, head of investor relations, please go ahead sir.
Speaker Change: Thank you, and welcome to this Novo Nordisk earnings call for the first three months of 2025. My name is Jacob Rode and I'm the head of investor relations at Novo Nordisk, and with me today I have CEO of Novo Nordisk Lars Proger Jensen
Speaker Change: Executive Vice-President, U.S. Operations, David Moore, Executive Vice-President, International Operations, Mike Duster, Executive Vice-President, Head of Development, Martin Holtslange, and finally Chief Financial Officer, Karsten Munchlosen. [inaudible]
Speaker Change: All speakers will be available for the Q&A session. Today's announcement and slides for this call are available on our website, Novo Nordisk.com Please note that the call is being
Next slide please
Speaker Change: The presentation is structured as outline on slide two Please note that all sales and operating profit growth statements will be at constant exchange rates unless otherwise specified [inaudible]
Please turn to the next slide.
Speaker Change: We need to advise you that this call will contain four looking statements. These are subject to risk and uncertainty that could cause actual results to differ materially from expectations.
Speaker Change: For further information on the risk factors, please see the company announcements for the first three months of 2025, as well as the slides prepared for this presentation.
Lars: With that, over to you last for an update on our strategic aspirations.
Lars: Thank you, Yarob. Next slide, please. In the first three months of 2025, we delivered 18% sales growth and 20% offering profit growth.
Speaker Change: I would like to start this call by going through the performance highlights across our strategic aspirations before handing over the word to my colleagues
Speaker Change: Starting with our focus on purpose and sustainability, we are now serving nearly 46 million patients with our diabetes and obesity treatments. This is an increase of almost 4 million patients compared to the third three months of 2024.
Speaker Change: Our total carbon emissions rose by 37% compared to the first three months of 2024. This was mainly driven by the acquisition of new production sites and capital expenditure activities related to expansion of manufacturing sites.
Lisa Ottefferts
To meet the high demand for our innovative treatments.
Speaker Change: To uphold our commitment to being a sustainable employer, we expanded the number of women in senior leadership positions to 42% compared to around 41% last year.
Speaker Change: In Andee, we completed the second and final pivotal trial, redefined two, with our next generation obesity treatment, Keckler-Semmer. We remain on track for submission in the first quarter of 2026.
Speaker Change: Recently, our application for we go with 2.4 milligram for the treatment of metabolic dysfunctional associators there to hepatitis or mesh in short, was accepted by the US FDA and granted priority review
Speaker Change: In addition, the new drug application for weight management for all semi-crueltide, 25 mg, or as I personally will call it, with Govy in a pill, has been submitted to the US FDA if approved. This would be the first all-dial bond treatment for obesity in the US.
Speaker Change: Lastly, we are in license two early states' assets that show promise in addressing obesity and other cardamom buttock diseases. Martin will come back to this and our overall anti-miestones later.
The quarterly sales growth is driven by both operating units.
David Mike will go through the details later.
Speaker Change: In terms of financial details, we deliver sales growth 18% in the first three months of 2025. However, we have reduced our full-year outlook due to lower-than-play and branded GLP1 penetration, impacted by the rapid expansion of compounding in the US.
Nornoiske: Mller is actively focused on preventing, unlawful compounding as well as the efforts to expand patient access on our GF1 treatments. Karsten will come back to this later.
Nornoiske: We will continue to drive attractive growth and expand patient access to our innovative treatments in the US. This includes recent initiatives with no care pharmacy, telehealth collaborations, and the CVS formulary decision.
Nornoiske: In his natural relations, there remains a large onmate need for patience and we excited to continue focused commercial efforts in existing and future markets in 2025.
Nornoiske: Furthermore, we realize the significance of our global footprint, including those activities based in the US.
Speaker Change: Novo Nordisk has a strong presence in the U.S. with over 10,000 full-time employees across the value chain.
This includes research and development and substantial manufacturing footprint.
Speaker Change: We have invested over 24 billion U.S. dollars in the U.S. over the past 10 years, including ongoing expansions and improvements to our manufacturing site in Bloomington, Indiana, and Clayson North Carolina.
Speaker Change: The existing U.S. tariffs does not maturely change of financial outlook for 2025. That being said, we are closely following potential tariffs on pharmaceutical products in the U.S.
Speaker Change: Before we move on to the particulars of the first quarter performance, I'd like to update you on changes to execs amendments.
Please turn to the next slide.
Speaker Change: After nearly 30 years with Novo Nordisk, Camilla Sylvest decided to step down. [inaudible]
Speaker Change: Camilla played a pivotal role in establishing our GF1 and obesity franchises and spearheaded the development of our long-term social and environmental goals. I would like to thank Camilla for her meaningful contributions to Novo Nordisk and wish her all the best for the future.
Speaker Change: This development has triggered several organizational changes effective third of April aimed at enhancing the speed of decision making and strengthening the execution focus within our operating units.
Speaker Change: Ludwig Healthgott, formerly executive vice president, RADDCs, now hits a product and portfolio strategy. This is a newly established area designed to forge a closer connection between commercial strategy, medical affairs and business development across all of their areas. [inaudible]
Speaker Change: Tilda Hommel-Böbje, becomes the newest member of the executive management as the executive vice president of quality IT and environmental affairs. The research will also enable Dave Moore to focus exclusively on the U.S. relations as well as Hannah Guilf and C.M. ProxyPlay.
Speaker Change: I would now like to give an update on our commercial execution in the first three months of 2025. Please claim to the next slide.
Speaker Change: As of January , North America operations and international operations were reorganized and financial reporting has been divided into US operations and international operations. More details on the regions can be found in the company announcement. Thank you very much.
Speaker Change: In the third three months, 2025, our sales increased by 18%, the sales growth was driven by both operating units with US operations growing 17% and international operations growing 19% . . . .
Speaker Change: Intel sales increased by 3% by US operations growing 13%
Speaker Change: The sales increase was driven by phasing rebates as well as channel and pair mix cut recounted by a decline volume.
Speaker Change: Is that a raise in sales increased 1% or BCK sales increased 65% during by U.S. a raise in growing 40% partly impacted by compounded GF1s and in a set of raise in growing 137%.
Speaker Change: In both geographies, growths were driven by Wigobi, partly offset by decarning 600 cents.
As the obesity camera is going to watch once we get treatments.
Speaker Change: Red disease sales increased by 3%, driven by 5% sales increased in natural in the in natural rations.
Speaker Change: Radici, Sales in US, Aurasian Group, 1% compared to last year. Please turn to the next slide.
Speaker Change: of ongoing scaling efforts have supported close to a tripling of jet-1 patients reached over the past three years.
Speaker Change: We are dedicated to serving patients who need our medicines and increasing our capacity to meet their needs by integrating the three applied field finish sites and expanding our existing capacity capacities.
Speaker Change: We are ready to reach more patients with serious chronic diseases.
That's our handout today.
Thank you, Lars. Please turn to the next line.
Dave: Sales of GLP-1 diabetes care products in the US increased by 10% in the first three months of 2025.
Dave: The self-increase was mainly driven by the continued uptake of olympic [inaudible]
Dave: Following the US approval of the flow data earlier this year, olympic is now the only JLP1 receptor agnus proven to reduce the risk of chronic kidney disease in people living with type 2 diabetes and chronic kidney disease.
Dave: remains the market leader in the U.S., with more than 50% market share measured by total monthly prescriptions.
Please turn to the next slide.
Dave: We Govy sales increased by 39% in U.S. operations in the first three months of 2025. The We Govy sales growth was driven by increased volumes, which were negatively impacted by wholesale or inventory movements.
This was partially countered by lower realized prices. [inaudible]
Wigoby was around 200,000 weekly prescriptions. [inaudible]
Dave: The total US branded anti obesity market more than doubled with a growth rate of over 160% in the last year.
Dave: The volume of compounded GLP1s in the U.S. is estimated to have impacted the uptake of Louis Prescriptions and the growth of the Grand Adobe City market during the first quarter of 2025.
Dave: In February , the FDA removed some agotide from the drug shortage list. As a result, it is now illegal under US compounding laws to make or sell compounded some agotide drugs except with rare exceptions.
Dave: Novo Nordisk is working to prevent unlawful and unsafe compounding of Somagletide in the US, while making sure patients have access to safe, legitimate Somagletide produced by Novo Nordisk.
Dave: Following the resolution of the semagletized shortage, we have a number of initiatives to support patients with obesity seeking treatment with Widovy.
In March we introduced self-pay.
Dave: It directs a patient delivery of all doses of Wigovie at a reduced cost of $499 US dollars per month through our Novo care pharmacy.
Dave: Access to a goalie for cash paying patients with further expanded in April , with the announcement of collaborations with three telehealth organizations.
Dave: In last week, it was announced that CBS chose would go be to be the only GLP1 medicine covered for obesity on a national template formulary as of July 1st, 2025.
While Novo Nordisk is committed to providing patients with choice leads.
Dave: and did not pursue an exclusive formulary placement. We do believe the formulary decision by CVS speaks to the benefits of Wigley.
They even include established cardiovascular benefits noted on the Wigoldy label. [inaudible]
Dave: and we await the FDA-prior to review of the promising data from the essence trial, the potential inclusion of Mash as a primary indication in the label in the second half of 2025.
Dave: We will continue to identify additional ways to expand access to a GOV.
Mike: Now I'd like to turn it over to Mike for an update on international operations
Mike: Thank you, Dave. If you can go to the next slide please.
Mike: Sales and international operations grew by 19% in the first three months of 2025, driven by GOP1 products.
Gioffi, one diabetes cells increased 13% driven by all regions.
Mike: GEOP1 diabetes cells, growth was negatively impacted by periodic supply constraints.
Mike: Obesity Care Sales, Group by 137% to 6.5 billion DKK Sales of the Govy reached more than 5.5 billion DKK growing at 392% driven by sales across all regions
Next slide, please
Mike: Novo Nordisk remains the market leader in international operations with a total diabetes and obesity gel if you want volume market share of over 72% .
Mike: Diabetes remains a significant global health challenge affecting more than 50 million individuals in I.O.
Mike: Rebelsis is now available in over 40 markets and continues to gain market share in international operations. Meanwhile, Ozempic remains the leading GOP1 diabetes product with denial, having launched in around 80 markets.
Mike: With improved supply, we are now fully focused on our promotional activities to further expand the number of patients reached. Also, within obesity, we see a substantial unmet need, with more than 800 million people living with obesity in Iowa and only a few million of these people being treated.
Mike: We have launched the Gobi in around 25 countries, including three in just the last month, reflecting a greater supply availability and staying true to our commitment in reaching more and more patients. We look very much forward to rolling out the Gobi in many more markets as the year goes through. [inaudible]
Yeah.
Next slide please [inaudible]
Mike: Our rare disease sales increased by 3%, this was driven by sales increase in international operations of 5%, and US operation sales growth of 1%.
Mike: Sales of rare endocrine disorder products increased by 14%, driven by Nordiskropin and improvement in manufacturing output as well as so grow your launch uptake in international operations.
Mike: This is countered by a decrease of 5% in U.S. operations mainly driven by Norditropene, rare blood disorder cells decreased by 1% driven by lower cells of Novo 7. Now over to you Martin for an update on R&D.
Thank you, Mike. Please turn to the next slide. Thank you.
Martin: In March, Novo Nordisk released the headline results from redefine two, the second and final pivotal trial with Kairprosemma.
Mike: The trial included people living with obesity overweight along with type 2 diabetes.
Mike: We define to you was a 68 week efficacy and safety trial with 1,206 people enrolled.
Mike: People were randomly assigned to receive either Cagrosamer, a fixed-dose combination of Cagrelin-type 2.4 milligram and semacletyte 2.4 milligram or placebo.
The mean baseline body weight was 102.2 kilograms. Cramps,
Mike: The redefined two trial, incorporated a flexible trial protocol similar to redefine one. [inaudible]
Mike: After 68 weeks of treatment, assuming all people adhere to treatment, Kagure Semma resulted in a significant weight loss of 15.7% compared to 3.1% in the placebo movement.
Mike: In the trial, Kegri Sema appeared to have a safe and well tolerated profile. [inaudible]
Mike: The most common adverse events were gastrointestinal, with the vast majority being mild moderate and decreasing over time in line with the GLP1 receptor agonist class.
Mike: We've now completed the second and last pivotal calculus semiface three trials for big weight management.
Mike: We look forward to sharing more data from redefined one and two at the American Diabetes Association in June .
Mike: We are on track with scaling of the Cadwis Emma Supply Chain and we still expect to file for the first regulatory approval in the first quarter of 2026.
Next slide, this.
Mike: Building on the learning from redefine one and two trials, we've extended the duration of redefine four, which is now anticipated to read out in the first quarter of 2026.
Mike: Turning to Redefine 11, we expect the trial to be initiated during the second quarter of 2025. The purpose of Redefine 11 is to investigate the potential for further weight loss by prolonging the duration of the trial through eight weeks and focusing on those re-escalation throughout the start. [inaudible]
Next slide please.
Mike: In February , we submitted the All-Semeglussi 25mg to the USFGA as the potential first All-DLP-1 treatment for obesity.
Mike: All Samaglethar 25 milligram demonstrates an overall efficacy and safety profile similar to once-weekly injectable Samaglethar 2.4 milligram
Mike: For context, I would like to revisit the OASIS Fall Results. The OASIS Fall Results.
Mike: Oasis 4 was a 64-week efficacy and safe to try comparing one daily hour of the Megaltyre 25mg to placebo in 307 add-ons with obesity all overweight with one on the comorbidities.
Mike: In the trial, adults were the obesity or overweight, who received all the chemical type 25 milligram, experienced an average weight loss of 16.6% from a baseline body weight of 105.9 kilograms when assuming full adherence to the treatment regimen. [inaudible]
Mike: Around one-third of participants achieved a weight loss greater of 20% or more.
Mike: Secondary end point from where it is full demonstrated improvements in casual mid-bolic risk factors, such as waste circumference, blood pressure and information in patients treated with all 25 milligram versus placebo.
Mike: In addition, all Americans tried to find the milligram appeared to have a safe and well-tolerated profile. On par was the Maggletide 2.4 milligram.
The full publication of race as far as expected later this year.
Mike: Altogether, oral and injectable semagletite has been started in robust clinical development programs with more than 43,000 semagletite exposed patients, an exposure from post-marketing use of over 33 million patient years. [inaudible]
Mike: Eva Proofed, All's Magletyte, 25mg, is expected to be the first all the other one receptor agonist for weight loss.
Mike: The manufacturing of the active pharmaceutical ingredients, bulk, tablet manufacturing, and packaging of all the magenta, 25 milligram are all carried out in the United States, and all manufacturing steps are open running.
Mike: We anticipate the U.S. FDA review will be completed around the turn of this year.
Next slide, please.
Mike: Turning to the upcoming R&D milestones, we look forward to a year with exciting trial readouts.
Mike: Before speaking to the remainder of 2025, I would like to highlight some of the milestone from the last few months.
Mike: In addition to the completion of redefine true, and the summation of all 25 milligrams of magnetite for obesity in the US, Novo Nordisk continues to pursue the expanded treatment optionality for people living with obesity.
Mike: Although not shown in the slide, I would like to mention our newest agreements to analyze the two early stage assets for the treatment of obesity and other kinds of major metabolic diseases.
and Associated Metabolic Disorders, and at GLP1, GIP, Glukegon, Fribble Receptor, Agonist.
The Lera Tribble, G-Esset
Mike: is the second triagonist in our pipeline and we expect the face one results from our internal triagonist in the second half of 2025.
Mike: Within radices, the main phases of two phase 3A trials, real eight and real nine, were successfully completed with the Groyer for non-replacement indications and submitted for regulatory approval in the EU.
Mike: within Cardiovascular and Immurgen, the Pyudic areas, we're excited to have submitted the essence part one file.
Mike: with one weekly semagletile 2.4 milligram for regulatory approval in both EU and US for the treatment of mesh and moderate to advanced labor fibrosis, namely F2 and F3.
As a reminder, isn't achieved both primary inputs? [inaudible]
Mike: By week 72, 37% of people treated with somatic type 2.4 milligram achieved improved liver fibrosis with no worsening of the utero hepatitis.
Mike: While 63% achieved a resolution of theater hepatitis with no worsening of liver fibrosis. [inaudible]
Mike: To put this into perspective, the essence phase three trials, trial results are the best phase three results in mesh to date.
Mike: In US alone, around 13 million people live with mesh and currently have limited treatment options available.
Mike: We're excited that the US FDA has accepted the supplementary new drop drug application and granted priority review for we go into treat mesh in adults with moderate to advanced reproaches, whether the decision anticipated in second half of this year.
Mike: Moving to upcoming milestones in 2025, I would like to start with a few data readouts inside to Davidus in the second hour.
Mike: Specifically, we expect the first place free results from Karygrosemma from Brea Imagine Free, investigating Karygrosemma as an add-on to baseless insulin in people with type 2 diabetes.
Mike: Moreover, we expect results from the subcutaneous and oral amécritian phase 2 trial. [inaudible]
Mike: Our upcoming readouts and clinical programs in obesity demonstrate the breadth of our pipeline in both modalities and mechanisms of actions to meet the need of patients.
Mike: In addition to the initiation of Redefine 11 with Kagusema in the first half of 2025 that I mentioned earlier, we also expect the phase two readout from the once-weekly GIPG up to one co-evenist in the second quarter of 2025.
Mike: We're also very excited to initiate the Phase 3 program for Kirk Williamside and Bono Therapy in late 2025
Mike: Within radices, we expect U.S. submission for Sequoia in non-replacement indications in the second quarter of 2025, as well as regulatory submissions for my mate in the U.S. and EU in the second half of 2025.
Mike: Lastly, we look forward to the readout of the book and evoke plus trials in patients with earlier Alzheimer's disease.
and many more. Thank you. Thank you.
Mike: With that, over to your customer. Thank you, Martin. Please turn to the next slide. Next.
Karsten: In the first three months of 2025, our sales group by 19% in Danish Krona and 18% at Conson exchange rates driven by both operating units
Karsten: The gross margin decreased by 83.5, decreased to 83.5% compared to 84.8% in the first three months of 2024.
Karsten: The decrease mainly reflects amortizations and depreciations related to gasoline, as well as cost related to ongoing capacity expansions, partially countered by positive product mix driven by increased sales of DLQ1 based treatments.
Karsten: Sales and distribution costs increased by 12% in Danish corona and by 10% at constant exchange rates.
Karsten: In your operations, the cost increase is mainly driven by promotional activities related to BigQuery and Osampic.
Karsten: In international operations, the increase is mainly related to approval launch and promotion activities. Francis, Francis, Francis, Francis.
Karsten: The increase in cost is mainly driven by obesity care and reflecting increased late-states clinical trilectivity as well as increased early research activities.
Karsten: Administracing cost increased by 5% both in Danish grown-up and their constant exchange rates. [inaudible]
Karsten: Operating profit as a consequence increased by 22% measured in Danish Kroner and by 20% at Kroner Exchange rates.
Karsten: Ividar, increased by 23% in Danish Krona and by 21% at Karnstok Stenswitz. [inaudible]
Karsten: Net Financial Items showed a net loss of 1.8 billion Danish Kroner compared with the net gain of 72 million Danish Kroner last year
Karsten: This primarily reflects losses on its currencies and financing costs related to the funding of the cattle and transaction.
Karsten: The effective tax rate was 21.6% in the first three months of 2025 compared to 20.4% in 2024
Karsten: Net profit increased by 14% and diluted earnings per share increased by 15% to 6 crore and 53 euro.
Karsten: Three cashflow in the first three months of 2025 was 9.5 billion Danish growner compared to 5 billion Danish growner in the first three months of 2024 24.
Karsten: Free Castle is reflecting high on the cast generated from operating activities partially countered by increased capsule expenditure.
Karsten: Capsule expenditure for property planning equipment was 13.4 billion Danish grown-up compared to 8.4 billion in 2024
Karsten: This was primarily driven by investments in additional capacity for API and Field Finish capacity for both current and future injectable and all products.
Karsten: We have returned 36.7 billion Danish growing up to shareholder's media as dividends in the first three months 2025.
Karsten: Following the step-up in Capix Investments in 2025, Novo Nordisk is not conducting a share-buyback program and authorization to the board of directors to buy back shares was however in line with previous years adopted at the annual general meeting on 27th of March 2025.
Karsten: Schutty, initiation of the CRPYPEC program, data-bedeemed relevance. Thank you very much.
Karsten: The current exchange rate versus Danish corona sales growth reported in Danish corona is expected to be 3% point lower than cons exchange rate growth.
Karsten: The new range reflects the lower than plain penetration of branded DLP-1 treatments in the US impacted by compounded DLP-1s.
Karsten: The outlook reflects expectations for sales growth in U.S. operations and international operations, mainly driven by volume growth of tier-to-one-based treatments for obesity and diabetes.
Karsten: Farming the US FDA removal of semacletite injectables from the drug shortage list, the sales outlook assumes a reduction in patients on compounded yet one treatments during the second half of 2025.
Karsten: The updated guidance reflects several efforts already on the way, as mentioned by Lars, Mike and Dave.
Karsten: Operating profit growth is now expected to be 16% to 24% at constant exchange rates
Karsten: Given the current exchange rates versus Danish Kroner, growth reported in Danish Kroners is expected to be around 5 cents per cent lower than at constant exchange rates.
Karsten: The updated expectation for operating profit growth primarily reflects the lower sales growth outlook partially countered by reduced spending.
Karsten: The effective tax rate for 2025 is still expected to be between 21 and 23% [inaudible]
Karsten: Capsule Expansure is still expected to be around 65-inch coroner in 25, reflecting an expansion of the global supply chain. In the coming years, the capsule expansion to the sales ratio is still expected to be low top of digits.
Karsten: Bricheslow is now expected to be 56 to 66 billion dames coroner, reflecting the lower than expected sales growth, mainly driven by lower volume growth of GF1 treatments in the US.
Karsten: All of the 2025 expectations are based on assumptions that the global and regional macroeconomic and political environment will not change significantly business conditions for known wars during 2025, including changes in tariffs and duties.
Karsten: The announced tariffs currently in effect do not materially change our financial outlook for 2025 However, a potential expansion or increase of tariffs may have a negative impact on Novo Nordisk and our industry [inaudible]
Lars: Let's cover the outlook for 2025, now back to you Lars. [inaudible]
Thank you, Karsten. Please turn to the final slide. Thank you very much.
Lars: The performance in the 4th 3 months of 2025 with 18% sales growth reflects that nearly 46 million people are now benefiting from our treatments Föder, we progress our R&D pipeline, including completing the final pivotal trial for next-generation obesity treatment in the summer . . .
Lars: We have reduced our fully outlook due to lower than planned GF1 penetration which is impacted by the rapid expansion of compounding in the US.
Lars: I'm confident in our recent initiatives in the U.S. to support patients to seek the benefits of our treatment. Furthermore, the obesity of trinity remains large in its natural relations and look forward to reaching more patients with the additional rollouts of the Gobi globally.
Lars: That Novo Nordisk will continue to focus on commercial execution, the progression of our on the pipeline and expansion of our production capacity. In the pursuit of treating more people living with serious consequences, with that we would like to hand over the word to Jacob.
Thank you, Lars. Next slide, please. Thank you.
Speaker Change: And with that we're ready to take the Q&A where I kindly ask all participants to limit her or himself to one or maximum two questions including sub-christians.
Lars: With that operator, we are now ready to take the first question.
Speaker Change: Thank you. To ask a question, you will need to press star one and one on your telephone and wait for your name to be announced. To restore your question, please press star one and one again.
Thank you. Thank you. Thank you.
Speaker Change: We'll now take the first question and your first question comes to the line of Richard Vosser from JP Morgan. Please go ahead.
Richard Foster: Hi, thanks for taking my questions, two please. First one on the compounders in the U.S., you've obviously done a partnership with him in the U.S.
Richard Foster: but him himself suggesting that they will continue to personally compound and have a significant contribution to their business from personal compounding.
Richard Foster: That seems to be at odds with the partnership and on odds with your commentary of trying to reduce compounding and it being only allowed in rare circumstances. So could you just talk about how you expect that to go and how you expect to deal with that in the second half? [inaudible]
Richard Foster: And then a second question if I can, please, just on the competitive effects from Monjaro you're seeing on IO and how easy you expect.
Richard Foster: to be able to grow a Zem Pick once the supply constraints in I.O. are removed. How ready is the sales force? How confident are you on strong growth in I.O.? Thanks very much.
and many more. Thank you.
Speaker Change: Thanks a lot, Richard. Two questions for Dave and Mike respectively. Let's start with the first question on compounding and next steps and hand it over to you Dave.
Speaker Change: Thank you, and thanks for the question, Richard, to be clear. [inaudible]
Speaker Change: We do not support unlawful compounding. We are against the illegal importation and the continuation of compounding in the United States. As you mentioned, we did announce collaborations with telehealth providers.
Speaker Change: The reason for this is increasingly people living with obesity are seeking healthcare through telehealth companies that we need to be where patients are
Speaker Change: and to have an offering for the real Wigovy. These collaborations allow a link to Novo Care Pharmacy where the real Wigovy can be available through these telehealth companies.
As we've mentioned on May 22nd, [inaudible]
fully expect the FDA to enforce the law.
Speaker Change: And at that time, we will continue to fight against unlawful compounding, for example, mass personalization.
Thank you, over to you Mike.
Mike: Thanks very much, David. Richard, I think to answer your question, I'll split it in between Osampic and the Govy.
We have seen an acceleration like...
Mike: You would not have seen before, just in the last couple of months
Mike: six new launches and more to come as we go forward. In terms of share number of prescriptions and volumes, if I just give you a couple of...
Data Points,
We have currently 64% volume market share.
on Injectible GOP1, so on the back of Orzampic,
and Envigovie, and that's 67 percent.
Mike: Marketshire is rather stable, so it's not going down and NNV, of course, hope to be able to continue fueling that with these so-called new launches, as well as, of course, getting back to promoting Ozympic much more assertively than we have been during the constraint period. This is the end of the video.
and many more. Thank you. Thank you.
Thank you.
Speaker Change: Thank you, Mike, and thank you, Dave, and also thank you to Richard. With that, we are ready for the next set of questions please.
Mike: Thank you. Your next question comes from the line of James Quigley from Goldman Sachs, please go ahead.
James Quigley: Great. Thank you for taking our questions. One on the guidance and one follow up on the compounding pharmacy. So, on the guidance, if we sort of assume a similar second quarter as in the first quarter, then the scenarios for progression in the second half are quite wide with around 8% growth for the bottom end in 22-23% growth at the upper end. So, could you reconcile the potential outcomes? What are the most important variables there and what are the key assumptions for both end of those variables? Secondly, on compounding [inaudible]
James Quigley: What the drag is on, we're going to be market share, have you done any surveys or how of what you think how many patients might drop off as you switch to branded and the branded switch to a govy versus switching to, you mentioned you have factored that into the guidance, just wondering how much that is factored into the guidance. [inaudible]
Thank you.
Thank you for joining us. Have a great day.
James Quigley: Thanks a lot James and on the first one on guidance we'll go to you Karsten.
Speaker Change: Yeah, thank you James for that question. Yes, I think for the dynamics we see in our business then we delivered 18 cent growth in the first quarter and of course our aim is to continue to drive attractive growth and that entails increasing script trends in the U.S. and continuing to drive GF1 franchise in I.O.
Speaker Change: So specifically to the guidance ranges, this means in terms of the main drivers that a lot of patients on compound products will go to branded products in the second half of this year.
Speaker Change: We also do have a label update with the match we spoke to before, classic commercial tactics.
Speaker Change: and then of course the CVS collaboration. So the acceleration to deliver guidance is mainly in the second half of the year when we talk about US.
Speaker Change: While in snack operations, we will see a continuous step up over the coming quarters in terms of sales growth.
Speaker Change: So that takes us to kind of the basic fundament of our guidance range.
and I'll say on compounding specifically. [inaudible]
Speaker Change: Given that the data quality on a number of patients on compounding is not very high, then it's based on market research where we're looking at the 1 million or more patients on compounded
Speaker Change: and then we've made estimates based on how many patients will either be able to benefit from the personalized exception or will drop off treatment and as a consequence the rest will go to a branded product.
Speaker Change: So a number of assumptions, but we have a lot of tactics in place to be able to capture patients that will no longer be able to have a compounded product with effect from the second half of this year given. Some patients will also have inventors in place personally and therefore the second half comments. [inaudible]
Thank you, James.
Speaker Change: Thank you, James, and I think that also covered part of question two, anything from you to add, Dave, on what we see currently in terms of magnitude of compounding, potentially split on branded yield to one treatment as well.
Yeah, thank you, Jakobal. I will share that.
Speaker Change: The market research that Karsten mentioned also gives us an idea that certainly Somagletide is overweight. We estimate 70% of compounding is of Somagletide.
Speaker Change: But I'd like you to focus on three things, three actions that we're taking to ensure that we're effective in this transition as compounding starts to wind down.
Speaker Change: We expand the cash offer. The 499 via Noblecare Pharmacy was purposeful and planned at the time when compounding would start to diminish.
Speaker Change: as well as the collaborations with telehealth companies. And soon that cash offering will be available in all 9,000 CVS stores.
Number two, we continue to expand Better Coverage for Wigley.
Speaker Change: This helps for some of those patients that may be on compounding, that have insurance, and would have access to a goalie for a low copay, and number three, as Karsten mentioned, we have targeted commercial efforts aimed at patients
Speaker Change: and healthcare practitioners so that we can focus on semi-the-50 of real-world-go-reverses compounding as well as the availability and the affordability. Thank you.
James Quigley: Thanks a lot, Dave, and also thanks to you two James. With that, we're ready for the next set of questions please.
Speaker Change: Thank you. Your next question comes from the line of Peter Ferdult from B&P Pariva. Please go ahead.
Speaker Change: Yes, thank you, Peter, from B&P Parabat. Lars of Carson, two quick ones. I suppose I'm still struggling just to understand where the disconnect has been with respect to your messaging given at February CMD in London about.
Speaker Change: Commercial Execution, being management's top priority and the either the prescription trends we've seen since then.
Speaker Change: especially when you have, as you said, 40 million commercial lives where most patients have to pay $25 a month.
Speaker Change: to get access to a goby, and you've been smashing it with DTC and reps. So, is it really only about the compounders, or do we have to consider your nearest brand, the competitor doing a better job?
Speaker Change: and then more quickly and secondly, just your thoughts on the recent Orphaglipron, diabetes data, especially given scalability, doesn't seem to be an issue there, so thank you very much.
Thank you. Bye.
Speaker Change: Thanks a lot Pete, I think both of those go to you last but let's start with the first one on commercial execution as a priority.
Lars: Thanks, Pete. You're right. This has been our focus for some time.
Lars: but I think it's important to say that when you assess that based on script trends.
Lars: There's a similar amount of business as what we have in the U.S. on GLP-1.
Lars: So I think they've outlined our tactics and we feel honestly very confident. Thank you very much.
Lars: that we, this is the right moment for us to make a serious change in the market.
Lars: That's paid into our guidance for the second half of the year.
Perception around, we go in the market. Let's get started.
Lars: The added benefits we have on top of the real world experience weight loss is great and that is just getting even better assuming we get the mass indication as well so what you get in one product here is just very very attractive. Thank you very much.
Lars: In terms of awful, I think there's been a lot of interest in how the all categories say it will develop.
Lars: Scaling and efficiency step up in our API facilities in the US, and when we submit the data to USDA, you can assume that we have what it takes to do a full launch in the US.
Lars: Ben Reindt, as was also looted, Purcelli, this is a molecule with tremendous safety data, so more than 30.
and the Million Patient Life.
Lars: I think we shouldn't be able at that point as physicians and patients make choice on a trusted product.
Lars: And of course, the figures is similar to what we have with Gobi, so really, Gobi is in a pill, I think it's a very attractive offering.
Speaker Change: and Assuming Positive Outcome with agency. We're ready to give this a big push and also on this point show a very strong commercial execution. So thank you Pete for that.
Speaker Change: Thanks a lot Lars and thanks a lot Peter as well and with that we are ready to the next set of questions please.
Speaker Change: Thank you. Your next question comes from the line of Martin Parkhoi from SEB, please go ahead.
Speaker Change: that CDS has a win for Novo, win for the Govy, but do you think it's a win for patients in the US to lose optionality and exclude another upbeat as a product?
Speaker Change: Then secondly, also back to the to all summer, 25 million, just understand that you said that you [inaudible]
Speaker Change: You can run with full steam when you launch, but what kind of opportunity do you see? How big of a part of the market would actually like to have the go-we in a pill instead of the go-we as we know it today?
Speaker Change: Great, thanks a lot for those two, Martin, and I think again both will go to you Lars, so firstly on the CBS one.
Lars: Thank you, Martin, for the questions. You are right that we support
Optionality and Open Access to products.
Lars: We believe it's in the best interest of patients and physicians that they can make the choice for the patient and the different patients have different needs so we support that.
Lars: So this is a situation where it's not a season made by us, we have not made a bit on an conclusion for contracts, but it's a choice that CVS has made.
Lars: We appreciate the partnership we have with CVS over many years and Dave also alluded to is a partnership that now also includes our class program in the 9,000 CVS outlets.
So it's that choice.
So it's not really something we have a say in...
for the course we do appreciate.
The perception of the product and what it can. [inaudible]
Lars: and I think it talks to the real world experience of Wigowi.
Lars: and of course also for Pair, what is the tangible value of reducing the risk of cardiovascular disease and hopefully also near-term say the best mesh profile you can think about and getting all of that in one product is very attractive from a Pair perspective. Thank you.
Lars: In terms of the all opportunities, I think it's important to note that this is about competition within a category of those who prefer and all we believe, majority of patients.
Lars: would still benefit the best from being on injectable therapy. That's where you get typically efficacy and also we have learned over the past few years that weekly injection is actually very very convenient.
Lars: Having to deal with your disease once a week in a very simple...
Lars: Dewey's solution is very convenient for patients, and I think the positions are nowadays very, you know, comfortable in prescribing, in taking care of all. [inaudible]
Lars: Having said that there are patients who prefer and all, and we are pleased that we can compete very well in this segment we believe will be, you know, way smaller than the injectable segment.
and being first to the market. [inaudible]
with a known molecule, known efficacy, known safety. Thank you.
Lars: and also some try to say that it's not as convenient. In all of you, it is very convenient. You wake up in the morning to take the tablet with some water.
and you're ready for your day.
Lars: So we believe we can play very well in a smaller segment compared to the overall injectable category and we'll be first assuming a positive regulatory outcome.
Thank you very much.
and many more. Thank you. Thank you.
Speaker Change: Thank you, Lars, and thank you, Martin, and then we're ready to move on to the next question please.
Speaker Change: Thank you. Your next question comes from the line of Michael Nedelcovych from TD Cowham, please go ahead
Michael Nudelkovic: Thank you for the questions. I have two. My first relates to potential political risk. The current administration in the US has at times singled out GLP ones when it raises the issue of apparent price disparities between the US and other countries.
Michael Nudelkovic: Novo is presumably deep into negotiations with CMS about the IRA price discount for some agglutides starting in 2027. Do you sense any risk at the administration plans to take this as an opportunity to make an example of GLP ones and demand a particularly severe price cut? No.
Michael Nudelkovic: That's my first question. And then my second question relates to the pipeline and specifically in McCreeton. I believe Novo has been in discussion with the FDA about phase three planning for an obesity trial, but the R&D milestone slides not include a trial start in 2025.
Michael Nudelkovic: Can you tell us whether a Phase III trial for Emma Cretan could yet start this year and when a Phase III obesity trial does start has a decision been made as to whether the oral or subcutaneous formulation would be advanced first. Thank you for your time.
Michael Nudelkovic: Yeah, thanks a lot for those two, Mike. Again, I think for the first one, we'll go to you, Lars, on GLP1 prize negotiations. Yeah, thank you, Michael. So when you look at it...
Lars: If you take, we go first, we have very limited, we go the exposure in Medicare so far.
Lars: and if you take some of the others, say over all comments, funded channels like VA and Medicaid, those are channels with somewhat lower price points and I think more comparable to what we see in other geographies.
Lars: I've looked at Opsampic, obviously there's a bigger share of business in Medicare, and that's then what's being discussed on the IRA, and I cannot go into specifics around it because it's still relatively early days.
Lars: Part of the thing that isn't a step is to say mechanism in dealing with that. [inaudible]
Lars: This is either lower or is already in ongoing price negotiations compared to perhaps other products that sit in
Lars: in parts of Medicare with higher price point or has not yet been opened up for negotiation. So I see a relative limit to say additional risk compared to what we are already facing. Having said that, it is still early days and an ongoing process. Thank you very much.
Lars: Thanks for that last, and for the second one on Amicrotin, we'll hand it over to you Martin.
Martin Parcoy: Thank you very much for the question, so not a lot of new to add from last quarter, as you know, the processes to submit an end of phase two package specifically to the FDA but also to other regulatory authorities.
Martin Parcoy: We are in that process and respect and outcome within the next couple of months. [inaudible]
Martin Parcoy: and that phase 3 program will be initiated with current Hamlands into one of next year and the focus for the phase 3 program will be both all and injectable.
Martin Parcoy: Thank you, Martin, and thank you, Mike, and then we are ready to take the next set of questions please.
Speaker Change: Thank you. Your next question comes from Sachin Jain, Bank of America. Please go ahead.
Speaker Change: I'll take my questions, I'm just going to try and push her cast and be able to near topics if I make there's any more colour you willing to give
Speaker Change: So, firstly on the compounded semi-sort of patient funnel. Cosmonaut, you could just give us any courage to what you're seeing for the inventory in the system. We've heard estimates as anyway between three and twelve months. [inaudible]
Speaker Change: and then any colour on what percentage you expect to shift to branded, given that they're on compound because they can't afford it or it's not covered.
Speaker Change: and then I'm going to be provocative on the branded catcher. Some of what we hear is, as these patients come off-companied summer, cash patients may prefer Lily given a cheaper syringe on vile strategy, and Zett Bound perception efficacy safety is beginning to edge with Govy, so I know that's provocative, but I want you to just touch on that.
Speaker Change: And then finally, a lot of what we've discussed has been the obesity market, but I wonder if you could such an olympic, at a seem limited compounding impact, market slowing down, you're losing share to Mongera, so it's not exactly clear to me what changes there, second half. Thank you.
Speaker Change: Thank you, Sachin, for those two questions. On the first on compounding, we'll hand it to Karsten, and then we'll hand it over to David, anything to add, before David goes on to the second question on the same page. But firstly, over to you, Karsten.
Speaker Change: Where patients get the incentive through a lower subscription rate if they sign up for longer period of time. So yes, most likely there will be some patients sitting within inventory on May 22nd.
Speaker Change: We don't have really good data on that, but that's also why we're coasting in our outlook section of our company announcement that the market should expect as step up mainly in the second half of this year from compounding, and of course the CVS contract. We'll be right back.
Speaker Change: As to brand and drop off to different solutions, price sensitivity, etc., I'll hand that over to Dave on the in market understanding of that one.
O two days. [inaudible]
and many others. Thank you. Thank you.
Thank you, thank you, question [inaudible]
Speaker Change: We believe the strong label will go thee as well as the brand awareness of will go thee. And the fact that the semi compounded is overweight, we think that there is certainly a focus with healthcare practitioners.
to maintain that continuity of care.
Speaker Change: and what we've heard is the availability branded would go be through these new channels meeting the patients where they are is a very important step in terms of that transition and the funneling of patients.
Speaker Change: As Karsten mentioned, of the total number of compounded patients today, some will drop off, but certainly, as you mentioned in our guidance, we do expect to capture and see a real interest in patients coming over to the real equally.
and then I'll shift over to Ozentik, Sachin.
Speaker Change: As we're seeing this year so far, the growth of the GLP1 class .
Speaker Change: It does continue. It's lower than what we've seen in years past at 15%, but that still leads plenty of opportunities still runway for future growth.
Speaker Change: and this continues to be a game around NBRX and our commercial leverage. So here are the things that we're focused on in the U.S. with Ozempic. [inaudible]
Speaker Change: First of all, our overarching commercial focus is leveraging the olympic label. The broadest of any GOP1 label on the market and continues to be the most widely known GOP1 as well.
Speaker Change: Our commercial efforts during this year include the launch of a new campaign called the olympic era campaign. We are in the olympic era, and our patients are experiencing
Speaker Change: and the understanding of the broad label is something that now both patients as well as physicians understand.
Speaker Change: And then lastly, we continue to focus on decreasing the outflow, maintaining longer stay time and having patients have the full effect and getting to the two milligram dose. Thank you.
Speaker Change: and just billing on Dave's comment before we hand it back to him. So, for Sempick also our market research indicates a certain level of compounding, not a lot but potentially in the mid-single digits of the DLV-1 diabetes treatment in the US. So, after May 22nd, there might also be an uplift there to go for and benefit for with the tactics Dave just covered. [inaudible]
O2, Jacob.
Speaker Change: Thank you, Karsten, and with that I think we are ready for the final set of questions please.
Speaker Change: Thank you. Your final set of questions comes from the line of Joe Walton from UBS. Please go ahead.
Speaker Change: Thank you. You've talked a lot about pricing and your strong commercial focus. Could you give us an idea of what you think a typical price point would be for a compounded somatletide? And how far a drift that is of the
Speaker Change: $500 that you're charging. The reason that I ask is I assume that this is a price sensitive market.
Speaker Change: and yet the starter dose from your competitor is only $350 and I wonder whether people just can't move step up from whatever they're paying today up to that 500 and the 350s are very compelling starting point for the compounder. [inaudible]
Speaker Change: Could I also just ask if you could tell us what the average stay time is, now that you've got less of a supply constraint, whether you're seeing that obesity stay time get longer or whether you're still having to re-acquire patients every few months?
Speaker Change: and if nobody minds, I'd also just like to take this opportunity to let people know that after 40 years as an analyst, this is my last purely farmer self-hide call.
Speaker Change: Novo was one of the first companies outside of the UK that I covered, back before the merger of Novo and Nordisk, so I really am that old, but it'll soon be time for me to move on. I have a couple of projects I need to complete before I leave the UBS team fully in Matthew's very capable hands.
Speaker Change: But I would say it's been an enormous privilege to watch the development of many life cycles of drugs and to work with so many people in Novo and other companies, clients and competitors, many of whom I'm very proud to count as friends.
Speaker Change: Thanks a lot Jo, and first and foremost, from Team Novo, thanks all our congratulations on the very impressive career. On your two questions, let's move to David. David, first of all, on GOP1 pricing for the Real Bikobi as well as for compounded ones, and then on state time.
Speaker Change: Thank you for the question, and also congratulations to you. [inaudible]
David Moore,
Speaker Change: There is a range of prices that we hear in the marketplace and it really does depend on whether or not that is a bundled price with a telehealth company.
Speaker Change: in terms of offering their telehealth services as well as medicine. As you pointed out, it is less for the compound of GLP1 than what we're seeing in terms of the cash prices. No question.
Speaker Change: When we think about the fun all, and when we talked about...
Speaker Change: Certainly, we do expect some patients not to transition, meaning they may be on a compounded GLP1 and they may not transition over to a branded medication.
Speaker Change: One of the things that's important for us, though, is to ensure that we are educating around the availability of a Govy through commercial insurance.
Speaker Change: We have over 55 million Americans that have covered through a goal be where they would receive the medicine for a low branded copain.
Speaker Change: and what we've learned is many patients on compounded GLP1 do have insurance. So educating them, doing insurance verification as part of our commercial efforts is also important.
Speaker Change: And then to answer your question on state time, the current 12-month average state time is around 7.4 months. That continues to increase as the brand grows, and more patients continue with their therapy over time. Thank you.
Speaker Change: Thank you, thank you Dave and thank you Jill, and with that we are done with the Q&A please and I'll hand it over to Lars for a set of final remarks.
We had to lower our...
Lars: I hope you feel we have a clear plan for how to...
Lars: Councillor that, close that down and really use our commercial taxes outlined today to gain a fair share of those patients. We remain very confident in the market opportunity, the number of people with obesity, willing and interested in seeking care.
Lars: and as we do, scale capacity and progress with our R&D pipeline, not least all semi-25mg, and I would also say upcoming data for Kaka Semmer, we feel really excited about our opportunity in this space.
Speaker Change: So I'll close with that and also thank Joe and wish you a best of luck for the future and thank you all for participating in this call. Thank you. Bye-bye
Speaker Change: Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect.
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