NVO income name for the length finishing December 31, 2024.
Symbol supply: The Motley Idiot.
Novo Nordisk (NVO 4.59%)This fall 2024 Income CallFeb 05, 2025, 7:00 a.m. ET
Contents:
Ready Remarks Questions and Solutions Name Individuals
Ready Remarks:
Operator
Excellent day, and thanks for status by way of. Welcome to the full-year 2024 Novo Nordisk income convention name. [Operator instructions] Please be instructed that as of late’s convention is being recorded. I might now like handy the convention over on your first speaker as of late, Jacob Martin Wiborg Rode, head of investor family members.
Please move forward, sir.
Jacob Martin Wiborg Rode — Head of Investor Members of the family
Thanks. Welcome to this Novo Nordisk income name for the total yr of 2024. My identify is Jacob Rode, and I am the top of investor family members at Novo Nordisk. With me as of late, I’ve CEO of Novo Nordisk, Lars Fruergaard Jorgensen; Government Vice President and Head of Industrial Technique and Company Affairs Camilla Sylvest; Government Vice President, U.S.
Operations and Head of International Trade Building Dave Moore; Government Vice President and Head of Building Martin Holst Lange; and after all, Leader Monetary Officer Karsten Munk Knudsen. All audio system might be to be had for the Q&A consultation. These days’s announcement and the slides for this name are to be had on our web page, novonordisk.com. Please notice that the decision is being webcast reside, and a recording might be made to be had on our web page as effectively.
The decision is scheduled to remaining one hour and quarter-hour. Please flip to a better slide. The presentation is structured as defined on Slide 2. Please notice that each one gross sales and running benefit expansion statements might be at consistent alternate charges, until differently specified.
Please flip to a better slide. We wish to advise you that this name will include forward-looking statements. Those are matter to matter to dangers and uncertainties that would motive exact effects to range materially from expectancies. For additional knowledge on possibility components, please see the corporate announcement for the total yr of 2024 and the slides ready for this presentation.
With that, over to you, Lars, for an replace on our strategic aspirations.
Lars Fruergaard Jorgensen — President and Leader Government Officer
Thanks, Jacob. Subsequent slide, please. In 2024, we delivered 26% gross sales expansion and 26% running benefit expansion. I wish to get started this name by way of going throughout the efficiency highlights throughout our strategic aspirations prior to delivering the phrase to my colleagues.
Beginning with our focal point on objective and sustainability, we at the moment are serving greater than 45 million sufferers with our diabetes and weight problems remedies. This is a rise of virtually 4 million sufferers in comparison to remaining yr and displays our persisted capability growth efforts. Our general carbon emissions rose by way of 23% in comparison to 2023. This was once basically pushed by way of our higher manufacturing volumes and higher investments in capital expenditure to fulfill the excessive call for for our cutting edge remedies.
To uphold our dedication of being a sustainable employer, we expanded the selection of ladies in senior management positions to 42%, in comparison to round 41% remaining yr. In R&D, we’ve got — we had a number of thrilling weight problems readouts this quarter, comparable to CagriSema, semaglutide 7.2 milligrams, and amycretin. Those effects improve our strategic aspiration of growing awesome medicine answers for other folks residing with weight problems. For CagriSema, we stay assured in its potent biology and sit up for additional exploring its attainable and to creating it to be had to sufferers.
Martin will come again to this and all R&D milestones later. The quarterly gross sales expansion displays cast business execution throughout each running gadgets. Camilla and Dave will undergo the main points later. Karsten will move throughout the monetary main points, however I am happy with the gross sales expansion of 26% in 2024, in addition to horny expansion outlook for 2025.
Now I wish to surrender the phrase to Camilla for an replace on business execution of 2024.
Camilla Sylvest — Government Vice President, Industrial Technique and Company Affairs
Thanks, Lars and please flip to a better slide. In 2024, our general gross sales higher by way of 26%. The gross sales expansion was once pushed by way of each running gadgets with North The usa operations rising 30% and global operations rising 19%. Within the U.S., gross sales expansion was once definitely impacted by way of gross-to-net gross sales changes.
Our GLP-1 gross sales in diabetes higher by way of 22%, pushed by way of North The usa operations rising 23% and global operations rising 18%. Insulin gross sales higher by way of 17%, pushed by way of North The usa operations rising 52%, definitely impacted by way of gross-to-net gross sales changes and global operations rising 6%. Weight problems care gross sales higher 57%, pushed by way of North The usa operations rising 45% and global operations rising 107%. In each geographies, expansion was once pushed by way of Wegovy, partially offset by way of declining Saxenda gross sales because the weight problems care marketplace is shifting towards as soon as weekly remedies.
Uncommon illness gross sales higher by way of 9%, pushed by way of a 20% building up in North The usa operations, and uncommon the gross sales — uncommon illness gross sales in global operations remained unchanged in comparison to remaining yr. Please flip to a better slide. I wish to reiterate our dedication to proceed achieving extra sufferers with our cutting edge remedies. These days.
Novo Nordisk is the worldwide GLP-1 quantity marketplace chief, serving just about two-thirds of all sufferers on GLP-1 remedies throughout diabetes and weight problems. Our ongoing scaling efforts have supported a nearly tripling of GLP-1 affected person achieve over the past 3 years. In December 2024, we introduced that the purchase of the Catalent websites from Nova Holdings was once finished. This transaction helps our ongoing scaling efforts and can increase Novo Nordisk world fill and end footprint from 11 to fourteen websites.
We nonetheless be expecting the 3 websites to steadily building up marketplace provide past our preexisting CMO contracts to the marketplace from 26 and make allowance us to achieve considerably extra sufferers within the years yet to come. Please flip to a better slide. Inside of diabetes care, gross sales expansion was once 20%, pushed by way of our GLP-1 portfolio and insulins. We sustained our diabetes worth marketplace proportion management with an unchanged marketplace proportion of 33.7% in comparison to remaining yr.
This stays above our strategic aspiration of achieving one-third of the worldwide diabetes worth marketplace in 2025. Please flip to a better slide. In global operations, diabetes care gross sales higher by way of 12% in 2024, which was once basically pushed by way of GLP-1 diabetes care gross sales rising 18%. Novo Nordisk stays the marketplace chief in global operations with the GLP-1 diabetes worth marketplace proportion of virtually 64%.
And with that, I might surrender the phrase to Dave.
David Moore — Government Vice President, US Operations and International Trade Building
Thanks, Camilla. Please flip to a better slide. Gross sales of GLP-1 diabetes care merchandise within the U.S. higher by way of 24%.
The gross sales building up was once basically pushed by way of the continuing uptake of Ozempic and the GLP-1 magnificence expansion. Novo Nordisk stays the marketplace chief within the U.S. with greater than 52% marketplace proportion measured by way of general per thirty days prescriptions. Please flip to a better slide.
Wegovy gross sales higher by way of 86% globally, pushed by way of a 59% expansion in North The usa operations, and Wegovy gross sales in global operations have reached greater than DKK 11 billion. The worldwide general branded weight problems marketplace greater than doubled with a expansion price of 119%. Within the U.S., the Wegovy gross sales expansion was once pushed by way of higher volumes, partly countered by way of decrease discovered costs within the U.S. The sure quantity construction was once additionally mirrored within the Wegovy prescription tendencies within the U.S., which these days is round 200,000 weekly prescriptions.
That is in comparison to round 100,000 weekly prescriptions in January 2024. We’ve reached vast formulary get entry to for Wegovy within the U.S. and proceed to paintings on increasing it additional. Lately, Wegovy has protection for round 55 million other folks residing with weight problems in america.
In global operations, Wegovy has now been introduced in additional than 15 international locations, underlining our dedication to achieving extra sufferers. Subsequent slide, please. Our uncommon illness gross sales higher by way of 9%. This was once pushed by way of gross sales in North The usa operations of 20%, whilst gross sales in global operations have been unchanged.
Gross sales of uncommon endocrine dysfunction merchandise higher by way of 31%, pushed by way of launches of Sogroya and higher Norditropin provide, in addition to a favorable affect from gross-to-net gross sales changes within the U.S. Uncommon blood issues gross sales higher by way of 3%, pushed by way of an building up in hemophilia B gross sales. Now I will be able to flip it over to Martin for an R&D replace.
Martin Holst Lange — Government Vice President, Building
Thanks, Dave. Please flip to a better slide. In December, Novo Nordisk launched the headline effects from the primary pivotal trial with CagriSema REDEFINE 1 in other folks residing with weight problems or obese. Ahead of coming into the consequences, I wish to briefly comment on the trial design.
In keeping with the CagriSema weight reduction information seen in Section 1 and a couple of trials, we integrated a versatile protocol in REDEFINE 1. The protocol adopted a 16-week titration time table and authorised dose adjustments in keeping with tolerability or considerations about over the top weight reduction all the way through the trial. This was once carried out to stability efficacy, tolerability, and trial dropout. REDEFINE 1 was once a 68-week efficacy and protection trial with 3,417 other folks enrolled.
Other people have been randomly assigned to both obtain CagriSema, a fixed-dose mixture of cagrilintide 2.4 milligrams and semaglutide 2.4 milligrams, or cagrilintide 2.4 milligrams in monotherapy, semaglutide 2.4 milligrams in monotherapy, or placebo. In step with regulatory pointers, the aim of the trial was once to show superiority of CagriSema over placebo, cagrilintide and semaglutide on frame weight loss. Subsequent slide, please. Earlier trials and our modeling indicated that CagriSema may provide a possible weight lack of roughly 25%, whilst the 25% weight reduction was once now not seen in REDEFINE 1, we’re inspired by way of the load loss profile of CagriSema which stands proud as one of the crucial considerable weight discounts seen in a scientific Section 3a trial.
From an average baseline frame weight of 106.9 kg, CagriSema demonstrated a awesome and clinically related lack of 22.7% of frame weight after 68 weeks, in comparison to discounts of eleven.8% with cagrilintide, 16.1% with semaglutide, and a couple of.3% with placebo. Within the trial, CagriSema seemed to have a protected and well-tolerated profile. The commonest hostile occasions have been gastrointestinal with the overwhelming majority being gentle to average and reducing over the years, consistent with GLP-1 receptor agonist magnificence. Most often, we seen a low point of gastrointestinal hostile occasions.
Other people on CagriSema skilled 2.8 gastrointestinal occasions consistent with affected person consistent with yr, in comparison to 1.2 on cagrilintide and a couple of.6 on semaglutide 2.4 milligrams. Discontinuation charges because of gastrointestinal-related hostile occasions have been additionally low with 3% — 3.6% within the CagriSema arm. For each the cagrilintide and the semaglutide arm, the gastrointestinal discontinuation have been 1.3%. Particularly, the severity of gastrointestinal occasions for cagrilintide was once very similar to the comparator arm.
As a reference, in step 1, semaglutide 2.4 milligrams had a discontinuation price because of gastrointestinal-related hostile occasions of four.5%. Finally, the full discontinuation price for CagriSema was once 11.7%. For comparability, semaglutide confirmed a discontinuation price of 17% in step 1. Within the REDEFINE 1 trial, the level of dose amendment brought on us to behavior a closer research of other folks receiving the best dose at 68 weeks, adopted by way of an research of other folks on decrease doses at 68 weeks.
Within the following slide, I will be able to information you thru a post-hoc research in keeping with those two subgroups and proportion some reflections and concerns in regards to the information. Subsequent slide, please. The primary subgroup comprised 57% of the overall inhabitants and consisted of other folks within the trial who ended at the best 2.4 milligrams dose of CagriSema at 68 weeks. The second one team accounted for 29% of the inhabitants consisted of those that have been at decrease doses of CagriSema at 68 weeks.
The rest 14% of the inhabitants have been on both medicine pause or have been discontinued at 68 weeks. The primary subgroup completed a 12.7% imply weight reduction at 20 weeks and a complete 22.2% imply weight reduction at 68 weeks. The burden loss trajectory for the primary subgroup didn’t plateau at 68 weeks. CagriSema confirmed a excessive tolerability with fewer gastrointestinal hostile occasions in comparison to semaglutide 2.4 milligrams.
This implies that further weight reduction might be completed with a tribulation of longer period. The second one subgroup confirmed a potent medicine reaction by way of reaching 15.9% imply weight reduction at 20 weeks and 25.1% at 68 weeks, drawing near a standard BMI on the finish of medicine. The typical medicine dose was once 1.1 milligrams at 68 weeks. The ones discounts passed off from the mid-trial to finish of medicine and didn’t happen to gastrointestinal hostile occasions on my own.
This team of other folks may probably succeed in larger weight reduction with larger doses thru higher focal point on dose escalation — dose reescalation, in addition to longer medicine period. General, CagriSema demonstrates a potent medicine reaction leading to a awesome weight reduction efficacy in comparison to semaglutide. Moreover, the REDEFINE 1 information point out {that a} patient-centric and individualized medicine routine which take the preliminary dose escalation — dose reescalation and trial period under consideration may probably strengthen efficacy of CagriSema whilst keeping up a positive protection profile. Whilst it’s going to seem counterintuitive that decrease doses of CagriSema ends up in extra considerable weight reduction.
This patent is in step with the observations from the step and step-up trials with semaglutide. Then again, it sounds as if to be extra pronounced with the potent biology of CagriSema. As well as, we’ve got prior to now seen very responses to anti-obesity drugs throughout other populations. In keeping with the insights from REDEFINE 1 and the mirrored image I have simply shared with you at the information will additional discover Cagrisema attainable in a brand new Section 3 trial, REDEFINE 11.
The trial can have an extended trial period and concentrate on dose escalation and reescalation. Subsequent slide, please. Turning towards the next move for CagriSema. We’re these days expecting the result of REDEFINE 2 within the first quarter of 2025.
The REDEFINE 11 trial might be initiated within the first part of 2025 and we now be expecting to put up CagriSema within the first quarter of 2026. The adjusted timelines don’t seem to be associated with the redefined construction program however pushed by way of provide chain reticentness when launching into a big and swiftly increasing marketplace of weight problems. Subsequent slide, please. Previous this yr, Novo Nordisk introduced the headline effects from the Section 3 trial step-up with semaglutide 7.2 milligram.
The 72-week efficacy and protection trial investigated subcutaneous semaglutide 7.2 milligram, in comparison to semaglutide 2.4 milligram and placebo. 1,407 other folks with weight problems have been enrolled within the trial with a BMI of 30 or larger with out diabetes. The imply baseline frame weight was once 113 kilograms. When comparing the consequences of medicine when all persons are right here to medicine after 72 weeks, semaglutide 7.2 milligram completed a awesome weight lack of 20.7%, in comparison to a discount of 17.5% of semaglutide 2.4 milligram and a couple of.4% with placebo.
Within the trial, semaglutide 7.2 milligrams seem to have a protected and well-tolerated profile. We’ve additionally finished the step-up trial in an overweight inhabitants with kind 2 diabetes and at the moment are comparing a better steps in gentle of our general weight problems portfolio. Subsequent slide, please. Lately, we introduced the headline effects from the Section 2b/2a trial with once-weekly subcutaneous amycretin in 125 other folks with obese weight problems.
The trial was once a mixed unmarried ascending dose, a couple of ascending dose, and dose reaction trial investigating 3 other upkeep doses with a complete medicine period of as much as 36 weeks. The principle endpoint was once a medicine was once treatment-emergent hostile occasions. The commonest hostile occasions have been gastrointestinal and the overwhelming majority have been gentle to average in severity. General, the protection profile of amycretin was once in step with amycretin-based remedies.
Other people within the dose-response a part of the trial had a baseline frame weight of 92.7 kilograms. Other people handled with amycretin completed an estimated frame weight lack of 0.7%, 16.2%, and 22% at their respective doses. This was once completed on 1.2 — sorry, 1.25 milligrams, 5 milligrams, and 20 milligrams, respectively. This in comparison to a frame weight acquire of between 1.9% to two.3% for other folks handled with placebo.
The impact of medicine was once evaluated if all other folks have been adherent to medicine. We’re very inspired by way of the consequences for subcutaneous amycretin for other folks residing with obese weight problems. And in keeping with the consequences, we at the moment are making plans for additional scientific construction of amycretin in other folks with obese weight problems. Subsequent slide, please.
General, we’ve got a aggressive portfolio in weight problems underlined by way of the new readouts from CagriSema, semaglutide 7.3 milligrams, and subcutaneous amycretin. Our strategic ambitions stays to construct a portfolio of awesome medicine choices in weight problems and a focal point on efficacy, protection, and scalability, be it injectable in any respect. Our advertised portfolio began with Saxenda. We then set the bar with the Wegovy’s horny scientific profile with double-digit weight reduction and a confirmed cardiovascular possibility relief from the SELECT trial.
Within the quick time period, we predict to extend our competitiveness additional with semaglutide 7.2 milligrams, in addition to oral semaglutide 25 milligrams. As illustrated at the right-hand aspect of the slide, the next-generation anti-obesity drugs in our pipeline characteristic a couple of other mode of movements that may deal with other segments within the weight problems marketplace. Decided on highlights are the deliberate Section 3 trial with cagrilintide in additional treatment, additional construction in keeping with the promising amycretin Section 1/2 information and the initiation of our triple agonist Section 1 trial. We sit up for sharing information from all of those trials after they learn out.
Subsequent slide, please. Turning to the impending R&D milestones. We sit up for a yr with many thrilling trial readouts. Ahead of turning to 2025, I wish to spotlight a couple of milestones from the previous few months.
We proceed our focal point on investigating how our cutting edge medicine affect connected comorbidities in diabetes and weight problems. Definitely, Ozempic is now the one GLP-1 receptor agonist confirmed to cut back the chance of persistent kidney illness in other folks with kind 2 diabetes and protracted kidney illness. That is in keeping with the information from the FLOW trial and sure opinion from the Ecu regulatory government and a U.S. FDA approval.
We’ve additionally submitted the label extension packages for oral to mega web page 14 milligram at the Rybelsus emblem to U.S. and the Ecu government in keeping with the information from the [Inaudible]. Additional, we’ve got resubmitted the consequences from the STEP HFpEF trials with a magnetite 2.4 milligram in other folks with weight problems to the U.S. FDA.
The submission comprises information from FLOW and so, additional substantiating some great benefits of semaglutide for sufferers with middle failure. Excitingly, we’ve got initiated a Section 1 trial with a once-weekly subcutaneous triagonist in other folks with obese weight problems within the fourth quarter of 2024. Shifting to the milestones in 2025. I would really like first of all a couple of thrilling information readouts in kind 2 diabetes in the second one part that helps our aspirations of elevating the innovation bar.
Particularly, we predict the primary Section 3 effects from CagriSema, in addition to Section 2 effects for each subcutaneous and amycretin and as soon as weekly GIP/GLP-1 co-agonist. Shifting to weight problems and the primary part of ’25. We at the moment are anticipating to put up or semaglutide 25 milligram for other folks with weight problems to the U.S. regulatory government within the first quarter.
Moreover, we additionally be expecting Section 2 effects from the once-weekly GLP-1, GIP co-agonist. For CagriSema, in particular, we predict effects from REDEFINE 2 and REDEFINE 4, all through 2025 and to begin the brand new REDEFINE 1 trial later all through the primary part of 2025. Inside of uncommon illness, we predict regulatory submissions of Mim8 within the U.S. and within the EU within the first part — sorry, in the second one part of 2025.
With then cardiovascular and rising treatment spaces, we sit up for learn out the — sorry, we sit up for the readout of the evoke and the evoke+ trials in sufferers with early Alzheimer’s illness. With that, over to you, Karsten.
Karsten Munk Knudsen — Government Vice President, Leader Monetary Officer
Thanks, Martin. Please flip to a better slide. In 2024, our gross sales grew by way of 25% in Danish kroner and by way of 26% at consistent alternate charges, pushed by way of each running gadgets. Within the U.S., gross sales expansion was once definitely impacted by way of gross-to-net gross sales changes.
The gross margin higher to 84.7%, in comparison to 84.6% in 2023. The rise is basically pushed by way of a favorable value affect because of expansion to internet gross sales changes within the U.S. and the sure product combine. That is partly countered by way of prices associated with ongoing capability expansions.
Gross sales and distribution prices higher by way of 9% in Danish kroner and by way of 10% at consistent alternate charges. In North The usa operations, the fee building up is basically pushed by way of promotional actions associated with Wegovy. In global operations, the rise is basically associated with weight problems care marketplace construction actions, Wegovy release actions, in addition to promotional actions for GLP-1 diabetes merchandise. Moreover, the rise in gross sales establishment prices is negatively impacted by way of an adjustment to felony provisions in 2023.
Analysis and construction prices higher by way of 48%, each measured in Danish kroner and at consistent alternate charges. The rise in price is basically reflecting higher late-stage scientific trial process, higher early analysis actions, in addition to impairment losses associated with intangible property. Management prices higher by way of 9% in each Danish kroner and at consistent alternate charges. Running benefit higher by way of 25% measured in Danish kroner and by way of 26% at consistent alternate charges.
Running benefit is definitely impacted by way of gross-to-net gross sales changes within the U.S. and negatively impacted by way of impairment losses. EBITDA higher by way of 32% in Danish Kroner and 33% at consistent alternate charges. Internet monetary pieces confirmed a internet lack of DKK 1.1 billion, in comparison to a internet acquire of DKK 2.1 billion remaining yr.
This basically displays losses on nonhedged currencies. The efficient tax price was once 20.6% in 2024, in comparison to 20.1% in 2023. Internet benefit higher by way of 21% and diluted income consistent with proportion higher by way of 22% to DKK 22.63. Internet benefit and diluted income consistent with proportion are impacted by way of the impairments associated with intangible property.
Money drift from running actions in 2024 was once discovered at DKK 121 billion, an building up of DKK 12 billion as opposed to 2023. As for allocation of DKK 47 billion to capex for provide chain and round DKK 82 billion associated with Catalent web page acquisition ends up in unfastened money drift of minus DKK 14.7 billion. This compares to DKK 68.3 billion in 2023. Please move to a better slide.
In step with our strategic aspiration to ship horny capital allocation to shareholders, we’ve got returned DKK 64.3 billion to shareholders by means of dividends and proportion buyback all through 2024. At the yearly basic assembly on twenty seventh of March 2025, the board of administrators will suggest a last dividend of DKK 7.90 for a complete 2024 dividend of DKK 11.40 together with the meantime dividend paid in August 2024. This can be a 21% building up in comparison to 2023, making it the twenty ninth consecutive yr with expanding dividend consistent with proportion. Along with the dividend, the DKK 20 billion proportion buyback program for the previous twelve months has been concluded.
Novo Nordisk capital allocation priorities prioritize horny investments into the corporate, together with provide chain expansions and R&D, in addition to constant dividend payout. As a result, following the additional step-up in capex, Novo Nordisk isn’t starting up a brand new proportion buyback program at this day and age. Please move to a better slide. We persisted the expansion momentum in 2025 and be expecting the gross sales expansion to be between 16% and 24% at consistent alternate charges.
That is in keeping with a number of assumptions as described within the corporate bulletins. The steering displays growth expectancies for gross sales expansion in each North The usa operations and global operations. the gross sales expansion is predicted to be basically pushed by way of quantity expansion of GLP-1-based medicine for weight problems and diabetes care, additionally reflecting our persisted scaling of our provide chain. Our reported gross sales are anticipated to be 3 proportion issues larger in comparison to consistent alternate charges and running benefit is predicted to be 5 proportion issues larger in comparison to consistent alternate charges.
We think that the running benefit will develop between 19% and 27% at consistent alternate charges. This basically displays the gross sales expansion outlook and persisted investments in present and long term expansion drivers inside of analysis, construction, and business. And adverse mid-single-digit running benefit expansion affect associated with the purchase of the 3 Catalent production websites could also be integrated within the steering. For 2025, we predict internet monetary pieces to quantity to a lack of round DKK 9 billion.
This basically displays losses on currencies, basically the U.S. buck, and higher hobby bills associated with investment of the Catalent web page transaction as this acquistition was once basically debt financed. The efficient tax price for 2025 is predicted to be within the vary of 21% to 23% and. The rise in comparison to 2024 is basically pushed by way of nation and treatment gross sales combine.
Capex is predicted to be round DKK 65 billion in 2025, reflecting growth of the provision chain. Within the coming years, capex to gross sales ratio remains to be anticipated to be within the low double digits. The unfastened money drift is predicted to be DKK 75 million to DKK 85 billion, reflecting the gross sales expansion, a positive affect from rebates within the U.S. countered by way of higher investments in production amenities.
That covers the outlook for 2025.Now again to you, Lars.
Lars Fruergaard Jorgensen — President and Leader Government Officer
Thanks, Karsten. Please flip to the general slide. We’re happy with the efficiency in 2024, the place 26% gross sales expansion displays that greater than 45 million other folks at the moment are making the most of our remedies. Additional, we finished the purchase of 3 Catalent websites.
And all through the yr, we stepped forward our R&D pipeline, together with weight problems tasks, comparable to CagriSema and amycretin. With efficient 2025 outlook, we can proceed to concentrate on sturdy business execution and the development of our early and late-stage R&D pipeline, and at the growth of our manufacturing capability. With that, I wish to hand the phrase again to Jacob.
Jacob Martin Wiborg Rode — Head of Investor Members of the family
Thanks, Lars. Subsequent slide, please. With that, we at the moment are in a position for the Q&A. [Operator instructions] Operator, we at the moment are in a position to take the primary query, please.
Questions & Solutions:
Operator
Thanks. [Operator instructions] And your first query comes from the road of Richard Vosser from J.P. Morgan. Please move forward.
Richard Vosser — Analyst
Hello. Thank you for taking my questions. Two questions, please. In the beginning, on Wegovy, may you give us some extra main points of what is conserving again the U.S.
prescriptions within the remaining quarter of ’24 and the early a part of ’25? What are you able to do about it? And the way must we look forward to the expansion in prescriptions from right here? And 2d query, simply thank you for all of the dosing information. However in keeping with that, and what you may have observed in REDEFINE 1 and the tolerability that you have proven, how do you assume the profile of CagriSema will stack up as opposed to rebound in REDEFINE 4? Thank you very a lot.
Jacob Martin Wiborg Rode — Head of Investor Members of the family
Thanks, Richard, for the ones two questions. At the first one, on Wegovy prescription tendencies, we will flip to you, David.
David Moore — Government Vice President, US Operations and International Trade Building
Thanks, Richard, for the query. I feel you need to keep in mind that the overall marketplace for anti-obesity drugs grew within the U.S. remaining yr by way of 160%. And so the tale remains to be about marketplace growth for weight problems.
And for our personal emblem, Wegovy, recall, we began remaining yr with round 100,000 prescriptions and ended with over 200,000 prescriptions. And so the scaling efforts are identified and that’s the reason being pulled thru out there. At first of the yr, and that is commonplace, there are actions in receive advantages plans and sufferers converting when it comes to their co-pays and co-insurance. That is commonplace, nevertheless it does have an affect with general prescriptions to start with of the yr in addition to coming thru vacations, in addition to Martin Luther King vacation to start with of the yr.
It will be significant to keep in mind, we are treating 1.2 million sufferers with Wegovy as of late, and we’ve got get entry to of 55 million other folks residing with weight problems within the U.S. Riding new prescriptions is, after all, our focal point. And what we will say about this is we’re delivery extra of the starter doses as we discuss. The ones began doses are making their approach throughout the provide chain from the wholesaler to a store, which could also be new for us to have this quantity of latest starter doses.
And now it is our alternative to drag thru this marketplace growth and fasten extra other folks with Wegovy within the U.S.
Jacob Martin Wiborg Rode — Head of Investor Members of the family
Thanks, Dave. After which we flip to the second one query, which matches to you Martin on present ideas on CagriSema profile additionally searching forward to REDEFINE 4.
Martin Holst Lange — Government Vice President, Building
Yeah. Thanks very a lot, Richard. So REDEFINE 4, as you rightly discussed, this had trial CagriSema as opposed to semaglutide. The primary statistical trying out might be non-inferiority and in keeping with what we have now observed with REDEFINE 1, there is a excellent assumption that can pop out with non-inferiority established.
2d take a look at for superiority. And once more, I feel it is too early to invest, however we can see the information when we can see them, however this is take a look at quantity two.
Jacob Martin Wiborg Rode — Head of Investor Members of the family
Thanks, Martin, and thanks, Richard. Then we’re in a position for a better set of questions, please.
Operator
Thanks. Your subsequent query comes from Harry Sephton from UBS. Please move forward.
Harry Sephton — UBS — Analyst
Hello there. Thanks for taking my questions. It is Harry Sephton from UBS. I would like first of all the REDEFINE 1 effects, and are we able to deal with this distinction between the load loss profile that does not display a regular dose reaction? You mentioned the truth that fewer sufferers completed on the larger dose within the preliminary effects as a possible rationalization to the weaker weight reduction as opposed to your modeling, the information you may have proven as of late slightly contradicts this.
So what have you ever observed to provide an explanation for this discrepancy? Is it a velocity of titration factor? Or are there different components you’ll be able to assist provide an explanation for this? And what learn throughout are you able to take from those information for the approaching REDEFINE 2 information? My 2d query is following the amycretin subcu information. How do you spot the site of this product as opposed to CagriSema sooner or later? Do we want incremental efficacy from right here? Or does the have the benefit of amycretin extra come from scalability and the versatility of each the injectable and oral formulations? And what’s the timing for the initiation of your Section 3 program for amycretin? Thanks.
Jacob Martin Wiborg Rode — Head of Investor Members of the family
Thanks, Harry, for the ones two questions. At the first one, when it comes to REDEFINE 1 information, we will flip it to you, Martin.
Martin Holst Lange — Government Vice President, Building
Yeah. Thanks very a lot, Harry. So to begin with, I feel you need to name out, we do not truly see discrepancies. We see an image rising that we have now observed to an extent within the step unquestionably within the step-up learn about systems, and we see that still now in REDEFINE 1.
We see a bunch of people that titrate with very sturdy protection and tolerability to the fullest dose. They’ve an overly considerable weight reduction. And in particular in REDEFINE 1, we see the opportunity of even additional weight reduction with longer medicine period. Then we see some early responders who obviously shed extra pounds quicker than the opposite team.
Additionally they seem to have the possible to lose greater than the opposite team. And what we will see from that is mainly that on reasonable, that team which is greater than what we have now in most cases observed in our trials, losers in truth an average of 25.2 proportion level on the finish of trial, drawing near a BMI that will point out nonobesity. That in truth then performs right into a dynamic as a result of those sufferers have relatively extra gastrointestinal unintended effects, additionally they — a few of them expressed considerations in regards to the velocity of weight reduction. And subsequently, they begin to titrate a bit of bit down.
That, once more, is a large attainable as a result of they may be able to in truth lose extra weight. It is on your level, permitting them to do particular person dose titration. — titrate a bit of bit slower after which coming as much as larger doses, balancing the velocity in their weight reduction and the gastrointestinal unintended effects. Clearly, this inhabitants additionally appears to be making the most of a good — or might be making the most of a good longer trial period.
And that mainly manner we see two distinct teams, one being what we name early or excessive responders. However each teams in truth appearing extra weight reduction attainable. We will be able to make the most of that sooner or later systems for Cagrisema, in particular beginning with REDEFINE 11. However we will unquestionably additionally use the ones information once we designed the amycretin program the usage of the similar biology.
Jacob Martin Wiborg Rode — Head of Investor Members of the family
Thanks, Martin. And for the second one query on amycretin, CagriSema, and having a portfolio, I’m going to flip it to you, Camilla.
Camilla Sylvest — Government Vice President, Industrial Technique and Company Affairs
Thanks very a lot. Yeah. There is not any doubt that with the scale of the weight problems marketplace, it is going to be a key power to have a vast portfolio of goods like Martin shared with you within the slides simply prior to. We imagine we’ve got an overly sturdy portfolio that permits us to paintings with optionality, optionality when it comes to other affected person segments and other markets to deal with the large unmet want that there’s.
Have in mind, there may be only a few proportion issues of the overall inhabitants this is these days being handled. And I feel traditionally, we have now mentioned form of the folk with weight problems as one team. However as we increase our portfolio, we can goal other wishes of various segments, in addition to other geographies. So we’ve got stay very assured, after all, in CagriSema and likewise in amycretin.
Jacob Martin Wiborg Rode — Head of Investor Members of the family
Thanks, Camilla. Thanks, Martin, and thanks, Harry, for the ones two questions. Then we’re in a position for a better set of questions, please.
Operator
Thanks. Your subsequent query comes from the road of Michael Nedelcovych from TD Cowen. Please move forward.
Mike Nedelcovych — TD Cowen — Analyst
Thanks for the questions. I’ve two. My first is on provide. Lilly has indicated that it could actually spice up its building up in provide by way of 60% within the coming months.
You all have by no means quantified capability, however do you’re feeling that your efforts to spice up manufacturing might be aggressive with this quantity? This could be an oversimplification, but when we grant the prescription tendencies within the U.S. are in large part reflective of provide slightly than call for than it could appear your competitor could also be ramping capability extra impulsively. Do you assume that is an even interpretation? After which my 2d query is on oral semaglutide 25 milligrams, which you currently plan to record for weight reduction within the U.S. It is notable that you’re not pursuing the 50-milligram dose.
I suppose this choice was once connected to offer concerns, however please proper me if I am improper. And the way must we take into consideration the eventual release of this providing? Simply for instance, you may have used the time period capped because it pertains to Wegovy’s ex-U.S. launches. Must we additionally call to mind oral semaglutide weight reduction release as capped?
Jacob Martin Wiborg Rode — Head of Investor Members of the family
Thanks, Mike, for the ones two questions, one on provide after which on release concerns round oral sema. First, our provide will flip to you, Karsten.
Karsten Munk Knudsen — Government Vice President, Leader Monetary Officer
Michael, thank you for this query. And let me get started mainly my resolution at the slide we confirmed previous on. So we scaled our affected person achieve with [Inaudible] by way of nearly an element 2 over the past 3 years, and newest information level from IQVIA, and that is in keeping with IQVIA newest information level, we’re serving nearly two-thirds of the worldwide GLP-1 marketplace after which pageant sitting at the closing one-third. Particularly for the remaining yr, simply to have onerous information, we’ve got expanded affected person achieve, once more, in keeping with IQVIA numbers, extra in absolute numbers, greater than another competitor on this marketplace.
So in truth, we’ve got grown quicker when it comes to serving extra sufferers over the past twelve months in keeping with IQVIA — then I would say as a forward-looking observation when it comes to our scaling into 2025. With the steering we’ve got and the scale of the bottom we’ve got, you’ll be able to say, a gross sales expansion in, say, a midpoint of 20%, you then follow rebate enhancement and few combine affects and proportion of the overall portfolio, then you then get to a scaling quantity scaling of GLP-1 franchise when it comes to sufferers served properly in far more than 30% into this yr. So I feel we’re very aggressive when it comes to scaling.
Jacob Martin Wiborg Rode — Head of Investor Members of the family
Thanks, Karsten. After which on oral semaglutide 25 milligram, almost definitely too early to speak about release and positioning, however the high-level worth proposition of all [Inaudible] Camilla.
Camilla Sylvest — Government Vice President, Industrial Technique and Company Affairs
Top-level worth proposition again to what we mentioned prior to. It’s most probably that there might be an all section in weight problems as there was in truth additionally prior to, however because of tolerability problems, this has been somewhat small. Now we’ve got product this is shifting when it comes to scientific trials and efficacy with a 16% weight reduction or semaglutide 25 milligram. And naturally, that provides us a chance to release this in decided on markets.
And with that, we can, after all, have the benefit of some great benefits of semaglutide on the whole, and this provides us optionality to deal with an oral extra in particular. In order that’s a part of our plans and our order portfolio.
Jacob Martin Wiborg Rode — Head of Investor Members of the family
Thanks, Camilla, and thanks, Mike, for the ones two questions. Then we flip to a better set of questions, please.
Operator
Thanks. Your subsequent query comes from Sachin Jain, Financial institution of The usa. Please move forward.
Sachin Jain — Analyst
Hello. Thank you very a lot. Thank you for taking my two questions. Two questions, an identical subjects, if I would possibly.
So again on CagriSema, Martin professional detailed rationalization. Simply questioning if Dave or Camilla may contact on how you are going to translate that right into a business message. So very merely, what doses must sufferers be on how titrate and on the doses they get to, what do you assume the profile as opposed to [Inaudible]? And the way are you occupied with positioning this relative to Wegovy, simply turns out somewhat complicated to me? And the second is only for Karsten at the vast steering vary. You began with 8% this yr at first of remaining yr, backside to best finish, what are the important thing spaces of uncertainty or delta’s view as you take into consideration ’25?
Jacob Martin Wiborg Rode — Head of Investor Members of the family
Thanks, Sachin, for the ones two questions. In the beginning, on CagriSema and the worth of the individualized medicine on you Camilla.
Camilla Sylvest — Government Vice President, Industrial Technique and Company Affairs
Yeah. So agree, after all, with the consequences we’ve got observed, we’re very assured within the product. We’re very assured in our portfolio, and it is truly the optionality that we’re running with on methods to goal particular segments and particular geographies. I feel it is a little bit untimely for us to expose our complete business way as to how we’re using some great benefits of those other choices that we have got in our pipeline, however it’s the sum of the pipeline that we simply talked to that can truly allow us to deal with increasingly other folks residing with weight problems.
In order that’s how we’re shifting ahead. And why you are going to additionally see us addressing several types of merchandise with other optionalities as we simply mentioned all now CagriSema, amycretin, and naturally, additionally higher-dose Wegovy. That is all a part of our alternative to play in weight problems.
Jacob Martin Wiborg Rode — Head of Investor Members of the family
Thanks, Camilla. Then on the second one query, we flip to you Karsten.
Karsten Munk Knudsen — Government Vice President, Leader Monetary Officer
Yeah. Sachin, thanks for that — so our steering vary breadth is consistent with what we had remaining yr and could also be reflective of the fast expansion price that we are handing over as an organization. The primary swing components which will all be each sure and adverse, I might name out 3 primary ones, one being provide as we have now observed in prior years and extra provide could make us achieve extra sufferers and and extra markets. And naturally, adverse provide fluctuations would affect the wrong way.
In order that’s primary. Quantity two is pageant and magnitude of pageant. after all, we wouldn’t have forward-looking visibility to we see what is out there as of late. So it is in keeping with our present learn of the markets.
After which the 0.33 issue is gross-to-net changes the place we have now observed some sizable gross-to-net changes within the U.S. during the last few years, reflecting a 69% unfold between gross and internet gross sales within the U.S. and that swing issue too can each be sure and adverse. In order that will be the primary 3 components.
Jacob Martin Wiborg Rode — Head of Investor Members of the family
Thanks, Karsten. Thanks to you as effectively, Sachin. Then we’re in a position for a better query, please.
Operator
Thanks. Your subsequent query comes from the road of Richard Parkes, BNP Paribas. Please move forward.
Richard Parkes — Analyst
Sure. Thank you for taking my questions. In the beginning, on CagriSema, I have were given sound nonetheless a bit of bit at a loss for words at the inverse dose reaction. I am simply questioning — why has this now not been observed in any of the pains as of late? I am not simply to conclude that now not all sufferers want the 20% plus weight reduction that may be completed.
So I am simply questioning more or less why that isn’t been observed prior to. After which when it comes to the prescription call for these days, I imply, you flagged formulary adjustments, however your internet get entry to sounds adore it hasn’t modified. So has there been some more or less large formulary adjustments, however the internet get entry to general is identical? I am simply questioning what affect compounding pharmacies are having on call for these days.
Jacob Martin Wiborg Rode — Head of Investor Members of the family
Thanks very a lot for the ones two questions. In the beginning, on CagriSema, we will flip to you, Lars.
Lars Fruergaard Jorgensen — President and Leader Government Officer
Yeah. So thanks, Richard. So simply to offer a viewpoint on how we see this. So Martin alluded to that still up to now, have we observed a distinction in how sufferers reply.
That has been in keeping with, say, decrease efficiency merchandise. So we noticed a an identical — once we evolved Wegovy however with much less, say, unfold, to be able to say. And in our view, we need to relate to that whilst you broaden extremely potent biologies like what we see with CagriSema, those variations might be amplified. So the truth that sufferers are other and reply differently implies that we will see increasingly more as we transfer up and broaden extremely efficacy merchandise, you are going to see this distinction in reaction.
And when it comes to use out there additionally to the prior query, I feel it is in all probability much less complicated for physicians than we imagine as a result of they in truth use to sufferers responding somewhat another way on medicine. And that is going for weight problems, nevertheless it additionally is going for any, say, persistent illness that sufferers reply another way to drugs. So physicians are used to a extra patient-centric medicine regime. And I feel what truly issues this is that we have got a extremely potent biology that more or less does the activity.
And the opposite factor it is up for — for the remainder of us to recognize that this can be a new signal we get in large-scale scientific construction, however it is truly connected to the efficiency of the product. And I look forward to that we see an identical indicators as we broaden similarly potent biologies sooner or later. So I am somewhat happy with the profile and likewise that it really works for sufferers and that it is going to additionally paintings within the fingers of physicians who’re used to extra individualized medicine of sufferers.
Jacob Martin Wiborg Rode — Head of Investor Members of the family
Thanks, Lars. After which on — for a better query, I’m going to flip to you, Dave, on get entry to/formulary actions within the U.S.
David Moore — Government Vice President, US Operations and International Trade Building
Yeah. Thanks for the query, Richard. It will be significant that we reiterate that — it is our trust that development a sustainable weight problems marketplace for the long run is thru marketplace get entry to and having sufferers have an affordable co-pay and get entry to to the medication. I am satisfied to mention for 2025 that we have got maintained our vast get entry to for Wegovy, overlaying 55 million other folks with weight problems.
There have been no primary adjustments with opt-ins and opt-outs. It’s a must to notice that those sufferers have Wegovy to be had at a low out-of-pocket price, greater than 80% of them paying not up to $25 for a prescription. And this could also be, as well as, we’ve got now greater than 20 states that still duvet Wegovy thru Medicaid. You additionally had a query about compounding.
Our newest marketplace intelligence does let us know and display us that it’s having an affect, and it’s rising quicker than we had expected. I need to remind everybody that we don’t provide compounding, and we’ve got important movements in position to curtail this. Our focal point is on affected person protection and instructing sufferers and suppliers that this isn’t sema and likewise to paintings with the regulators to curtail compounding as effectively.
Jacob Martin Wiborg Rode — Head of Investor Members of the family
Thanks, Dave, and thanks, Richard, for the ones two questions. Then we will flip to a better query, please.
Operator
Thanks. Your subsequent query comes from Emily Box from Barclays. Please move forward.
Emily Box — Barclays — Analyst
Thanks. Simply to stick to up at the compounding level, for a couple of months now, all of the doses of semaglutide had been marked is to be had at the FDA drug scarcity web page, however the molecule remains to be marked as in scarcity. When do you are expecting that to be got rid of? After which would that result in a an identical more or less off-ramp from the FDA for the compounders that we noticed FDA issued a directive in December for trazepatide? After which secondly, some other query on REDEFINE 1. The purple curve for the sufferers that have been at the decrease dose on the finish of medicine, is it truthful to mention {that a} important selection of the ones sufferers did move as much as 2.4 milligram after which titrated down whether or not for tolerability or that they have been very, very speedy responders to the load loss.
Jacob Martin Wiborg Rode — Head of Investor Members of the family
Thanks, Emily. And at the first one, a follow-up query on compounding, we will flip to you, Dave.
David Moore — Government Vice President, US Operations and International Trade Building
Yeah. As you discussed, we’re nonetheless indexed at the drug scarcity listing. We’re in lively discussion with FDA. It’s ongoing.
In fact, as we building up the resilience in our provide that has an affect on our talent to get off the drug scarcity listing, and we’re fascinated by doing that as speedy as imaginable as we imagine this may assist our additional movements to curtail compounding sooner or later.
Jacob Martin Wiborg Rode — Head of Investor Members of the family
Thanks, Dave. After which at the early responder curve, we will flip to you, Martin.
Martin Holst Lange — Government Vice President, Building
Yeah. Completely. I need to return to Lars’ level that weight problems is a posh illness. And sufferers have particular person reaction to medicine.
So within the team the place sufferers didn’t titrate to complete dose at finish of trial, the imply dose at week 20 was once round 1.5 milligrams, indicating that only a few in truth opted to check out to check out to complete 2.4 milligram dose. That is extra to be observed as a bunch of speedy and excessive reaction. And subsequently, with the load loss that they accumulated, which was once then additionally quicker than the opposite team, they began to decelerate to stability the velocity in their weight reduction, their gastrointestinal unintended effects, but in addition the truth that they have been drawing near a degree underneath the definition of weight problems. And subsequently, once more, it speaks to the very robust biology that we see, but in addition the wish to individualize medicine.
And once more, I’m going to simply remind you, that is the trial at a inhabitants point the place we have now observed only a few gastrointestinal unintended effects on the point of Wegovy. And subsequently, that isn’t the key driving force of the way sufferers select to titrate, correct? I feel Lars has a truly excellent level. Sufferers understand how to do that along side their physicians.
Jacob Martin Wiborg Rode — Head of Investor Members of the family
Thank you so much, Martin, and thanks, Emily, for the 2 set of questions. With that, we’re in a position for a better query, please.
Operator
Thanks. Your subsequent query comes from the road of Florent Cespedes from Bernstein. Please move forward.
Florent Cespedes — Analyst
Excellent afternoon. Thanks for taking my questions. Two fast ones, please. First for Dave.
May you give us your view at the state of affairs within the U.S. for semaglutide relating to IRA, Inflation Aid Act, as a result of now you might be at the listing? So may you remind us how you are going to arrange the location for 2027? And when must we’ve got the general point of rebates, if you need to remind us that the method can be nice? 2d query for Martin on Monludaban. Possibly may you give us some colour at the Section 2 if from the kidney trial, significantly at the tolerance if there may be any readout at the tolerance aspect that would perhaps let you to design or modify the remainder of the scientific — ongoing scientific trials.
Jacob Martin Wiborg Rode — Head of Investor Members of the family
Thank you so much, Florent. At the first one, IRA, after all, I’ve to talk an excessive amount of, however with that, over to you Dave.
David Moore — Government Vice President, US Operations and International Trade Building
Yeah. Thanks, Florent. As anticipated, semaglutide-containing merchandise, Ozempic, Rybelsus, Sema, Wegovy. They’re decided on for the second one spherical of CMS negotiations.
It is too early to invest at the attainable affect. As we have now mentioned up to now, we oppose executive value atmosphere like we’ve got from the start. The method, even though, is as follows: the negotiations will finish to start with of November. The utmost truthful value might be printed by way of the top of November, and it is going to be efficient within the 1st of January 2027.
And only for background, the tough U.S. channel combine throughout our portfolio is set 50%, business; 30%, Medicare; 10%, Medicaid; and 10%, different.
Jacob Martin Wiborg Rode — Head of Investor Members of the family
Thanks, Dave. And at the subsequent query at the monobrand in diabetic kidney illness, we will flip to you, Martin.
Martin Holst Lange — Government Vice President, Building
Thanks very a lot for that query. So that you could remind us, one being we by no means did the purchase of Boludabant to broaden it purely for diabetic kidney illness. Our focal point was once at the weight reduction attainable. 2d, I’m going to simply remind you that those are small research.
So clearly, we attempt to see them within the context of the total photograph. So we don’t seem to be discouraged by way of the truth that we didn’t see affect on the true diabetic kidney illness. That learn about did verify a weight reduction attainable for molunobant. And once we take a look at the protection and tolerability profile, it was once similar, albeit with relatively decrease charges than within the devoted weight problems tale, mainly indicating that we will nonetheless have an aspiration of exploring this additional in Section 2b with decrease doses searching at weight reduction attainable however clearly additionally — and this has been the try from the get move, additionally ruling out a capability — a possible protection fear.
Jacob Martin Wiborg Rode — Head of Investor Members of the family
Thanks, Martin. Sure. Thanks as effectively, Florent. After which we’re in a position for a better set of questions, please?
Operator
Thanks. Your subsequent query comes from the road of Evan Seigerman from BMO Capital Markets. Please move forward.
Evan Seigerman — Analyst
Hello, all. Thanks such a lot for taking my questions. Roughly a big-picture query. There appears to be an obsession with absolute weight reduction, whether or not a p.c kind of could make a winner or a loser and in particular regarding CagriSema.
Possibly stroll me thru the way you view the perfect product profile of an asset. Is it higher weight reduction, notating tolerability, longer appearing, higher supply? As you take into consideration your portfolio what do you want to look in more or less your next-generation merchandise?
Jacob Martin Wiborg Rode — Head of Investor Members of the family
Thanks, Evan. I feel at the high-level weight problems query, we will flip to you, Lars.
Lars Fruergaard Jorgensen — President and Leader Government Officer
Thanks, Evan, for bringing that up. I feel it is truly be a excellent subject to talk about. And clearly, it is a somewhat vast subject. And I feel it — the dialogue opens up with what we now see when it comes to this situation’s biologies since you say that with former era merchandise like Wegovy, you need to, in idea, say, load sufferers up and all would say tolerate the load loss they see.
And in addition the GI tolerability, we all know, is excellent. However whilst you get into, say, the next-generation merchandise, the place you magnify the load loss, you tease out the adaptation between other sufferers who we’re nonetheless seeking to glance into the omics and work out what defines the adaptation. And we’ve got a large number of information. So we will get started in truth discovering concepts about who will reply in sure tactics and from a velocity of weight reduction, and many others.
In order that — then we are into the subject of, say, high quality of weight reduction. And I feel within the early days of weight problems, we’ve got all been obsessed by way of the share over the years. And I feel that is a problematic ratio as a result of in case you have lived with weight problems, a excellent a part of your lifestyles and unexpectedly, you lose, say 25%, in some much more p.c weight reduction in a question of, say, part yr to a yr, that is an overly, very dramatic, say, alternate on your lifestyles and now not essentially what somebody would really like. In order that’s one.
After which, after all, we’ve got all of the comorbidities. And increasingly more, I feel with the status quo of CV advantages, liver advantages, and many others., it additionally turns into a question of, say, the well being end result enhancements you might have. So on this, say, alternative house, I feel it is vital so that you could deal with the ones alternatives with other form of brokers, to cater for those variations. Brief time period, as I discussed prior to, I feel sufferers along side the doctor are somewhat relaxed in managing this adventure.
And I feel we’re in all probability suffering a little in doing the very best segmentation of what this marketplace will appear to be. However I feel we will glance into all of the information we’ve got and to find tactics to additionally extra centered direct particular merchandise to sure subsegments. So I feel that is some other instance of the truth that we are within the early days of figuring out weight problems, how sufferers are other. And I feel it is all alternative for us with the breadth of the portfolio we’ve got and all of the information we’ve got.
So sure, proportion of weight reduction issues what high quality of weight reduction and receive advantages on comorbidities, and many others., and many others., additionally issues. And it is a internet general equation that I feel we’ve got a truly thrilling alternative for steady management within the house.
Jacob Martin Wiborg Rode — Head of Investor Members of the family
Thanks, Lars, and thanks, Evan, for the questions. Then we’ve got time for 2 extra units of questions, and let’s get started with the primary one, please.
Operator
Thanks. The following query comes from the road of Luisa Hector from Berenberg. Please move forward.
Luisa Hector — Berenberg Capital Markets — Analyst
Hi. Thank you for taking my questions. For REDEFINE 1, may you simply touch upon what proportion of sufferers down-titrated? And any colour at the timing at which that came about. And in all probability at the best dose, what the discontinuation price was once? After which I wonder whether I may ask you a query on amycretin and development there.
So once I pulled in combination your feedback on CagriSema, the excessive efficiency, particular person affected person responses after which we layer within the proposed FDA pointers that say Section 2 information must be enough to seize maximal or new maximal weight loss results with the dosing regime. Do you’re feeling that you’ve got sufficient information to growth into Section 3? Or would in all probability some other Section 2 be beneficial?
Jacob Martin Wiborg Rode — Head of Investor Members of the family
Thanks for the ones two questions, Luisa. I feel either one of them for you, Martin, get started with the primary one. So at the information in REDEFINE 1.
Martin Holst Lange — Government Vice President, Building
Yeah. So to begin with, we had those two very transparent distinct teams. The bigger team of 57% of the folk titrating to two.4 milligram. Simply to come up with an instance, they have been at an average dose of two.2 milligram at 20 weeks.
And so they then proceed to the total 2.4 milligram% and seem to stick on that. There have been a couple of sufferers doing ups and downs, however it could now not be significant to check out to tease them out. In a similar way, I simply need to remind you, at week 20, the opposite team have been at 1.5 milligram they usually down titrated a bit of bit as a bunch so as to add Endotrial 1.1 whilst the — whilst mainly securing a weight reduction that was once larger than what we have now observed prior to, specifically 25.2%. On the identical time, this manner of permitting sufferers to do — I do not need to say private titration however with reference to in truth allowed us to look the bottom general dropout ever observed in a Section 3 pivotal trial but in addition very low, and once more, the bottom gastrointestinal dropouts observed within the pivotal trial.
And only a reminder, CagriSema in REDEFINE 1, 3.6% dropout; semaglutide in step 1, 4.5% dropout because of gastrointestinal unintended effects. So we are in truth somewhat inspired by way of the information. And as Lars additionally alluded to, by way of using this particular person way to sufferers shifting ahead, we will truly leverage the total advantage of now not handiest CagriSema but in addition our pipeline merchandise.
Jacob Martin Wiborg Rode — Head of Investor Members of the family
After which on the second one query on amycretin, we will flip to you, Martin, once more, and at the subsequent steps.
Martin Holst Lange — Government Vice President, Building
In order you realize, we’ve got generated the information at the oral model of amycretin. They’re very in step with the information that we see with the subcutaneous model of amycretin in sufferers with weight problems. We’ve an ongoing Section 2 trial in sufferers with kind 2 diabetes. Our present review is that we are living as much as the spirit of the FDA draft steering.
Clearly, as in any development of scientific construction, we had to talk about with the regulatory government, which we will do in brief order.
Jacob Martin Wiborg Rode — Head of Investor Members of the family
Thanks, Martin, and because of you as effectively, Luisa. After which we’re in a position for a last set of questions, please.
Operator
Thanks. Your ultimate query as of late comes from the road of Michael Novod from Nordea. Please move forward.
Michael Novod — Nordea Markets — Analyst
Thanks very a lot. Michael Novod from Nordea. Additionally, two questions. So the primary one with the information available with CagriSema and the versatility and extra form of individualized medicine, in addition to form of your plans for amycretin.
Have you ever modified any form of view on whether or not — methods to form of climate the LOE on semaglutide in 2032, and the best way of form of changing Wegovy with both of those medication? After which secondly, are you able to tease out additionally on — whilst you take a look at the very early information on CagriSema and likewise amycretin, the rest extra so as to add on whether or not amycretin seems other when it comes to tolerability? I are aware of it’s very early information you might have, however what kind of attempt to pin down on how this would glance in later-stage trials, whether or not it is simply as tolerable as CagriSema?
Jacob Martin Wiborg Rode — Head of Investor Members of the family
Michael, thank you for the ones two questions. I feel first, at the general view on CagriSema and amycretin, will flip to you, Camilla. And afterwards, on amycretin tolerability, we will flip to you, Martin. However over to you, Camilla.
Camilla Sylvest — Government Vice President, Industrial Technique and Company Affairs
Yeah. Thank you so much. So when it comes to whether or not we’ve got modified the rest in our view towards lack of exclusivity, I might say we’ve got now not. What we’ve got discovered now’s, after all, that little bit extra readability on other segments.
We mentioned particular person lifestyles medicine. We be told extra about how every product works, nevertheless it handiest offers upward thrust to us getting extra details about how we’re going to place this port portfolio of alternatives that we have got. So the quick resolution isn’t any, and we additionally proceed to, after all, construct on semaglutide franchise. You simply noticed the brand new indications that we were given.
So complete velocity on that going ahead, but in addition complete velocity at the new innovation, merely organising this complete portfolio. So no radical adjustments to that in any respect.
Jacob Martin Wiborg Rode — Head of Investor Members of the family
Thanks, Camilla. After which at the amycretin information to you, Martin?
Martin Holst Lange — Government Vice President, Building
Thanks very a lot. It is early days. And clearly, what we will say at this day and age is we’re running with two robust biologies. They seem to have an identical efficacy, but in addition protection and tolerability attainable.
And clearly, that still implies that we need to assume within the energy of the mix biology into our amycretin construction program to accrue the total attainable, each when it comes to weight reduction, but in addition protection and tolerability and probably additionally comorbidities once we do broaden amycretin and CagriSema shifting ahead.
Jacob Martin Wiborg Rode — Head of Investor Members of the family
Thanks, Martin, and likewise thanks to you, Michael. Now that concludes the Q&A consultation. Thanks for collaborating and be happy to touch investor family members relating to any follow-up questions that you’ll have. Ahead of we absolutely shut the decision, I wish to surrender the phrase to you, Lars, for ultimate remarks.
Lars Fruergaard Jorgensen — President and Leader Government Officer
Thanks, Jacob. I am very happy with the 2024 gross sales expansion of 26%, pushed by way of our GLP-1 portfolio in each running gadgets. And inside of R&D, we see a robust momentum, as we simply mentioned in our pipeline, is underlined by way of the new readouts in weight problems, each for CagriSema and amycretin. And naturally, I am additionally very happy with the anticipated 2025 outlook.
We proceed to focal point closely on business execution and at the development of our R&D pipeline and the growth of our manufacturing capability. So the plan may be very transparent, and we all know what it takes to execute in this. So additionally thanks from me on behalf of control in your time as of late. We respect the chance to talk about our industry with you.
Thanks very a lot. Bye-bye.
Operator
[Operator signoff]
Period: 0 mins
Name individuals:
Jacob Martin Wiborg Rode — Head of Investor Members of the family
Lars Fruergaard Jorgensen — President and Leader Government Officer
Camilla Sylvest — Government Vice President, Industrial Technique and Company Affairs
David Moore — Government Vice President, US Operations and International Trade Building
Martin Holst Lange — Government Vice President, Building
Karsten Munk Knudsen — Government Vice President, Leader Monetary Officer
Richard Vosser — Analyst
Dave Moore — Government Vice President, US Operations and International Trade Building
Harry Sephton — UBS — Analyst
Mike Nedelcovych — TD Cowen — Analyst
Sachin Jain — Analyst
Richard Parkes — Analyst
Emily Box — Barclays — Analyst
Florent Cespedes — Analyst
Evan Seigerman — Analyst
Luisa Hector — Berenberg Capital Markets — Analyst
Michael Novod — Nordea Markets — Analyst
Extra NVO research
All income name transcripts
