Q1 2020 Novo Nordisk A/S Earnings Call
All participants will be in listen only mode and afterwards, Debbie a question and answer session. Today I'm pleased to my son Losh credit card Shagun Singh. Please go ahead your meeting.
Thank you.
Welcome to that's my first conference call regarding whole first quarter performance and no nascent Alco put 20 to 22.
Oh gosh broke our children. So this year on orders.
Let me know how about your financial <unk>, Chief Financial Officer, Cosmos, <unk>, and how Chief Science Officer Scorecard Thompson.
Personally and available for the <unk> session, our executive Vice President and head of commercial struck a corporate success can be the service and executive Vice President and head of corporate life quantity I actually feel like we're that's well Oh investor relations purposes.
Correct or expertise and despite this call I made available on our website North America.
Please note that this conference call is being what cost lives and ever costs would be made available on the Illinois website.
Lets call. It is scheduled to last for one Pablo.
The presentation structure.
And on strike true will begin by addressing all noticed response to the cobot 19 pandemic.
Going into the quarterly performance.
Please note all saves and operating profit statements will be at constant exchange rates on this or otherwise specified.
Thank you nice person would have begun in about 25 minutes.
Please turn to slide three.
Well, it's always on your advice you that this call will contain forward looking statements such forward looking statements are subject to risks and uncertainty, but could cause actual results could differ materially from expectations.
For information on the best practices in coatings I'm Senators licenses pertaining to covert Nike. Please see the earnings release personally and this nice prepared for this presentation.
Please turn to the next light.
[laughter] Fremont <unk> constant currency has been extremely unusual giving the koby 19 pandemic. This crisis in its without precedent in our lifetime and each day to prevent new challenges to governments healthcare systems a companies across the globe has a dose to all of us on a personal level.
Core global organization, we're working hard to tackle the new challenges Koby 19 coaches, we're prioritizing three things in particular, ensuring the what are being about creams safeguarding the supply about lifesaving medicines to patients that meet the at during our pop to help society by supporting local approaches.
For the resources and expertise.
The cost of anger chain. The cobot Notching pandemic has had an impact on how we go about all business within a production why do we have been prepared giving the contingency plans is that missed colleagues and I've never been HEICO sites are finding new ways of working to ensure that all supply medicines is maintained.
That's gonna start or not affecting sites continue to operate and medicines I still available to patients worldwide.
Within research and development, we continue to conduct ongoing thinker trials I do not expect significant delays what drives near completion.
What drives that are currently recouping, however, recruitment of new patients has been negatively impacted.
Sequentially, so I'm trying to maybe delayed.
Hurdle to help limit constraint on the health care system No new clinical trials are currently being initiated.
The majority of North medicines are used for treating chronic diseases. However, during the period of social goodness implemented in many markets. Your new patients are tempered temporarily expected to initiate treatment.
Especially impacts across products and products with a short stay time.
Again, we also have a responsibility it was caught society as much as possible.
We not sit out to do this by for example, donating free answering to select humanitarian organizations, increasing affordability options for those in the U.S., who have lost the health insurance.
As well, that's providing emergency mutations in countries across the world.
I sincerely hope that will soon grain do you all behind on Kirby 1940 in the meantime, I'm proud to be part of an industry that is working around the clock to discover effective treatments and vaccines or north will continue to support these efforts in anyway. Okay.
Please go to slide five.
In 2019, when all is going to June a comprehensive approach describing future growth aspirations of the company onto the headline strategic aspirations 2025.
That's what she'd be aspirations consist of four components purpose of sustainability innovation that they appear to brokers commercial execution and financials.
Beginning with purpose that sustainability, that's already mentioned during my introduction no north has focused on its purpose of being respected for any regulatory society.
We have engaged in numerous initiatives supporting patients employees at society. During this challenging time.
Additionally, in the first quarter, we reached all exploration of sourcing, 100% renewable power across all production sites.
Now, let's sort of multiple developments within our nation that therapeutic focus aspiration for diabetes bounces was approved in the European Union and the United Kingdom for treatment of type two diabetes also you aseptic marketing or Cassation application was submitted in China.
For Biopharm, we unfortunately had to cost the development of consumer that's gonna sort of three nonfatal somebody could think that's doing occurring in the phase three program.
Hi presenter continuation of the project is currently being evaluated.
Within our Sears Kaka Caesars, we have resource of the phase two trial investigating superglue tied in the treatment Nash mats will elaborate on that in a few minutes.
Moving to current commercial execution and financials copy the sales increased by 13% with no normally seen it'd be this value market share leadership expand to tweak it trends, 8.7% and tier one sales continued to perform well at 37% sales growth.
From sales increased by 16%.
Total sales increased by 14% were international operations growing by 19% and North America operations growing at 9% when adjusting for the corporate 19 related stocking effect sales growth was around 7%.
The stocking impact was distributed approximately equally between international operations and North America operations.
The same score is reflected in operating profit, which increased by 12% totaling 16 billion things grown on operating profit was positively impacted by productivity improvements within manufacturing and administration.
Please turn to slide six.
The forward as cost saves across the business, you'll notice a different reporting structure for the areas in its aspirations.
As of the first on April 20 to 20 Nineth celebrations units has been reorganized we're starting in the following your way of reporting EMEA Curbing Europe Middle East Africa.
Within China, covering mainland, China, Hong Kong and Taiwan.
That's one of rest of work covering all our country conscious except for the tool within North America operations.
North America operations was not impacted by the reorganization. It's still includes the USA and Canada.
Again sales increased by 14%, which was supported by growth across all areas and of course or therapies when adjusting for the corporate 19 relate to stocking the sales growth was 7%.
The stocking impact impacts were seeing mainly as a result of increased patient prescription trends and wholesaler inventory levels, particularly in the U.S. and EMEA.
Underlying growth with solid particular in assessing operations, where all areas and or therapies continue.
Contribute to the continued growth.
North America operations increased by 9% positively impacted by the carbon 19 related search and demand most driven by stocking that patient level as one of prescription refills policies, where adjusted.
This growth also reflects the continued outperformance of the just one will be to care at Viacom segments instrument sales declined by 15%.
Please turn to slide seven.
In the core sales growth was driven by all therapy areas. The stocking impact came mainly from screen at tier one and to address extend from the biopharm and obesity care franchises.
Global investment sales increased by 2%, despite 16% sales decline in the U.S., but.
The USA decline was driven by lower realized prices due to the unfavorable or channel mix.
Higher rebates the knocks off affordability.
Additionally, affordability programs and changes in coverage gap biggest nation.
The decline were offset by a 14% increase in international operations, where all investment categories contributed to growth.
Good for lunch sales increased by 37% driven by 55% sales growth in the past operations and 30% sense growth in North America operations.
Underlying growth reflects the continued penetration of Pacific along with the launch of rebels was.
No North has expanded both its global insight when volume market leadership as well as its year could one magnets.
Let us were solid in the previous convention expansion of North Global diabetes market leadership now at 28.7%.
Well beauty care sales grew by 30% with both operating units contributing to growth.
Viacom sales increased by 16% driven by both Norditropin and hemophilia products.
Please turn to slide eight.
In the in the US with your from one market continues to grow more than 30% in volume driven by once we could you had one products with the uptake over centric and the loss of rebels was no noise cost neutral Brian market share leadership of nearly 58% and use the GLP one market leader measured on top of marks prescriptions.
When around 48% markets yes.
The real early uptake of analysis in the US was encouraging prior to covert 19.
The weakening neutral brand prescription market several overdoses is 9% with a total prescription share around 2%.
Additionally market access is progressing now with more than 50% unrestricted access.
Well said the continues to increase its market share in the us.
As of neutral Brad prescriptions with epic is curve to 37% and attempt to total prescriptions septic markets here is slightly more than 24%.
Furthermore, the towards continued its declining market share for both new to brand subscriptions and total prescriptions. Please turn to slide nine.
No north because increasing its diabetes market share in international operations as indicated by the near by the near 23% shekel versus a market share of around 22%.
Market share increases in its aspirations is driven by both instrument and just the one in all reporting areas both franchises since our growing.
And then to international operations, the diabetes franchise represents nearly 80% share growth within stress share growth at 44% aunt Jemima once you have grown at 35%.
Please turn to slide 10.
Due to savings care increased by 30% driven by driven equally by North America operations and International relations, reflecting continued uptake in EMEA and rest of world.
We are committed to driving change in a beep scale with extend to having been lost in four to six continents globally and continuing investments in market development activities.
Please turn to slide 11.
Viacom sales grew by 16% in the first quarter driven by a 17% since both in celebrations and by 14% sales growth in North America operations since were impacted by curbing 19 related stocking.
And changes in inventories and timing of shipments.
Victor element was driven by growth across both the hemophilia ankle disorder franchises.
The 9% hemophilia sales growth was supported by increased no seven cents as well as the continued rollout of the portfolio of innovative products with the fix yet at this product.
North American sales increased by 28% driven by changes in inventory grew 19 relate this talking as well as an additional demand resulting from changes in the competitive landscape in selected countries with this brought to mess for an update on R&D.
Thank you lost please turn to slide 12.
The next couple of slides I'll discuss our commitment to develop the some appetite molecule into additional therapy areas beginning with the phase two results in Nash and then moving onto the phase three program for Semaglutide obesity.
In April the phase Twob trial investigating some accurate side in the treatment of non alcoholic Steatohepatitis also known as Nash was completed.
This was 72 week blinded biopsy based trial comparing the effects of subcutaneous semaglutide administered once the hubris because zibo in achieving two store lasik histologic resolution of Nash stages, if one so if we.
The trial enrolled a total of 329 patients that were randomized try that 1.112, 0.4 milligram doses up to macro site or two placebo.
The primary endpoint, what's the proportion of patients achieving an extra solution without worsening of fibrosis after 72 weeks.
At trial completion, the what's a statistically significantly higher proportion of patients meeting the primary endpoint put some appetite with an impressive 59% achieving an extra solution at the high dose versus 17% for the placebo arm.
There were also a number of secondary endpoints in the trial and while there was not a statistically significant difference in the proportion of patients achieving histological improvement liver fibrosis with no worsening of Nash there were a number of pinpoints, showing a statistically significant and dose dependent reduction in the progression of fibrosis as assist price.
Histology biomarker panels as well as in the stock would be using 5% imaging.
Additionally, marked improvements were seen in liver enzyme levels and the usual metabolic endpoints with type two diabetes patients reaching HP. Once you have rose, 6.9% accompanied also by double digit percent waitrose.
The Tolerability and safety profile. It's we're good with only two patients discontinued so gi side effects at the high stopes in total only for patients in each of the high dose and placebo arms, respectively discontinued due to adverse events. The next steps will now discuss with regulatory agencies. Please turn to slide 13.
The some appetite in the BCG phase three step program represents an important part of our strategic exploration so develop at leading portfolio of superior obesity treatment solutions.
The obesity program will begin to report restart soon starting with stepped full dip. According to the tail step for its 68 week safety and efficacy trial of scimeca side versus placebo in 900 overweight or obese adults the trial displays and unusual so called withdrawal design, implying that after 20 regret.
Appeared for Semaglutide in all patients they will be randomized aware antibody. So I understand some ACA fact, all switch to placebo treatment, hence withdrawing active drug therapy.
Based on this the trough seeks to investigate the weight difference between the one off continuing versus the other discontinuing scimeca type therapy from entered the station at 22, the end of trial at week six to eight.
This will provide meaningful data on the consequences for patients discontinued PC therapy. After five months as compared to if she or he continued on a beauty therapy for more than a year.
Step forward also indicate other endpoints, including weight change up to 68 weeks of some appetite.
Stepped foot will be followed by Readouts from the classic obesity stick one trial the diabetes two trial and the combined intervention sticks, we trial the upcoming months.
Overall, the step program has enrolled approximately 4.5 thousand docs, who by the overweight and competitions obesity as defined by PMI of Oxford.
Well beef, which is a chronic disease that has been shown to require long term management with both pharmacological and behavioral therapy.
It is associated with minutes years health consequences decreased life expectancy and great subtypes societal cost.
Some appetite is expected to treat the PC offering the patient powerful weight loss mediated by will decline mechanisms in the brain, causing decreased appetite and increased feeding of society.
Please turn to slide 14.
In the first quarter of this year a number of argue milestones were reached.
As mentioned by the ASR symbolic was submitted for marketing authorization in China. We built this received approval you end, the UK and phase to put some appetite dinesh competes hydraulic system.
Additionally, the once we get combination of selected side and the novel GRP unlocked in GDP swap.
Furthermore, the core also brought with it phase one initiation of a novel in hybrid molecule that combines base will interconnection with Pcsknine inhibition.
In Biopharma the once weekly growth among some Apache Tom was submitted for marketing authorization in Japan in adults.
The submission was based on data from the pivotal phase three trial real one.
Supported by data from the local Japanese trial, real Japan, which are both 60 previous to treat patients grew from a deficiency.
Yeah.
We have announced that two clinical trials in the consumer phase three program have been products due to the occurrence of lumpy from participants we patients.
Potential be initiation of the program would modify dosing regimens wouldnt Mount now, we discuss with regulatory agencies.
The remainder of the year promises a number of important milestones starting with the doses approval in Japan Expectedly this quarter, along with multiple trial, readouts and significant product approvals across the portfolio.
With that but what's causing for an update on the financial results.
Thank you ma'am.
Please turn to slide 15.
In the first three months of Twentytwenty sales increased by 60% things Corona and by 40% at constant exchange rate.
The cross marketing was 84.1% compared to 83.8% in the first quarter of 2019.
The increase in cross marketing reflect across the product mix driven by increased June twond sales.
Productivity improvements in manufacturing and a positive currency impact of 0.2 percentage points.
This was partly countered by a negative impact from the what realized prices in the us.
Since distribution costs increased by 9%, the Danish kroner and by 7% at constant exchange rates.
Reflecting increased investments in GLP, one and a BDC, partly countered by lower promotional spend points from proximity us.
The cost increase was driven by global promotional activities for CMP noble loans efforts to build and expand the beast markets as well and nos activities for adults in us and promotional activities for insulin in places such as China.
Research and development cost increased by 41% endings grew by 40% at constant exchange rates.
The cost increase is impacted by the reversal of frac pounds or macro type pre launch inventory in the first quarter 2019, and low level of spending in the first quarter 2019.
The underlying R&D cost increase is driven by higher activity levels within officers chronic diseases, namely for the next and cardiovascular disease projects.
Administration costs increased by 2% things go and buy one person at constant exchange rates.
Fixing broadly unchanged spend across upcoming subsidiary.
Operating profit increased by 40% and didn't grow and by 12% at constant exchange rates.
When adjusting for increased sales due to cope with 19 redid stocking and 2019 reversal of also macro type pre launch inventory.
Operating profit increased by around 4%.
Net financial items showed a loss of rock 1.3 billion Danish kroner.
Which is compared to a loss of around 1 billion in Q1 2019.
This development reflects losses on commercial positions, mainly due to declines in emerging market currencies in March 20 to 20.
Diluted earnings per share increased by 60% to five qunar and five.
Free cash flow increased by 50% to 7.7 billion things coma.
Please turn to slide 16.
For 2026 growth is still expected to be between three and 6%.
The guidance reflects an expectation from robust performance of the tier one be diabetes canopies to care products.
As well as positive contributions from the new generate instant portfolio and key byproduct product.
The guidance also still reflects intensified competition within diabetes can biopharm continued pricing pressure within diabetes care as well as the expansion of affordability initiatives.
Given the current exchange rates versus the Danish kroner growth reported Danish kroner is expected to be around one percentage point higher than at constant exchange rates.
The current qubic matching pandemic causes uncertainty to the outlook regarding patient flow and subside for impact so the unemployment rate in the us with impacting healthcare insurance coverage.
The safety for Jason is based on a number of assumptions related to the superiority and duration of impacts from Qubic, Nike, including a gradual normalization across geographies.
Patient flow in the third and fourth quarter of Twentytwenty as well as a gradual rigorously during 20 to 20 and 20 to 21 of the increased stock levels experienced in March 20 trenching.
Operating profit growth still expected to be 1% to 5%.
The guidance primarily reflects this growth outlook continued focus on efficiency and resource allocation.
And continued investments in current and future growth drivers across the operating units.
Growth reported earnings growth.
Expected to be around one percentage point higher than at constant exchange rate.
Financial items is now expected to be a loss of around 2.5 beginnings cool.
The high loss, mainly reflects losses associated with foreign exchange hedging contracts.
Primarily related to the U.S dollar versus the things groom.
And losses from non hits crisis, two to depreciate across most emerging market currencies.
We still expect a free cash flow between 36, and 41 billion things grow 20 to 20.
And now Capex loss for closing remarks.
Thank you cost please turn to slide 17.
Sciences are severely impacted by the code 19 outbreak and during the pandemic. Our key products is obviously it caught on for use continue the supply of olives lifesaving medicines and use our expertise resources and grow reads reached with helps to sides is around the world fighting dependent.
Cobot 19 related stocking at the patient there was significantly impacted our results. However, we are satisfied with the underlying commercial performance as well as the progression of our pipeline with the approval of the doses in the EU and the encouraging phase two data for Semaglutide investors.
Lastly to take care of yourselves and those around two during these challenging times. So because of we can and will overcome this crisis. Thank you very much with that we're now ready for the Kunaev, where kind to ask or participants to limit him or herself to two questions. Please operator, we're now ready to take the first person.
Thank you if you'd like to ask your question. Please press star one on your telephone keypad. If you wish to withdraw your question you may get to buy pricing seems like chief counsel.
No one if you would like to ask a question.
First question is from Emmanuel quicker from Barclays. Please go ahead. Your line is open.
Thanks type question medical products Baucus, maybe out kick over 2000 payer mix overseeing some significant unemployment figures in the US perhaps you could help us think trippy like on timing and magnitude essentially impact in terms of.
Well business the us in particular across both.
Insulins angio, perhaps more important GLP, one commercial book of business.
The Conference Committee, Oakland and maybe.
I'll take one on Norditropin.
So pretty stellar Q1.
You had a couple of good quarters now part of a more sustainable trends, what kind of an impact should be anticipating potential compares to launch lace investment second off the FTC can remain equates assets this year and deal. Thank you.
So thank you remain.
Constant.
Both questions for you you can Nicola please so firstly the payer mix impact on internship one and then our outlook for north token.
Yes. So thank you for those Crescent said.
Yeah.
One off at the consequences South.
Of the Qubic and iconic crisis is that you alluded to.
Impacting the economies across wealth and more specifically in the us where we've seen.
Incremental unemployment to increasing by some 30 million.
People.
When modeling unemployment like that and you have to take into consideration better.
Yeah first of all.
Some of 30 million, whether with the come from and today and what is the transition onto watts other forms of health insurance and to what extent do they have dependency also that you have to have to a comfortable.
And then finally you have to also include that day that the American economy.
It's an moving faster than than say some other economies in terms of people, losing unemployment and than when they become improves than the rest to get the implied again in in some of some of these apartments.
So.
We have included to an impact in our guidance sensor. We believe it's covered in our guidance said the channel mix.
The exact magnitude and modeling that too many moving parts and uncertainties to go into spins fees on that but needless to say.
Yes.
You can say patients who are previously on commercial insurance and then moving on I Thats uninsured are moving on to Medicaid insurance will have a negative impact on our business at during.
The net a part of this yet and also into into the common, yes, and hence and negative channel mix.
In terms of.
Of growth hormone and today and the growth we had with seeing there.
Then you.
You can say on the the backdrop of fear of the growth hormone marketed that that we have a rather mature market in terms of no all global volume our growth and a.
Rob a competitive nature aftermarket with the with the number of plants in the markets and hence a.
Relatively though all digimarc growth as well the reason for our.
Sizeable.
This growth in the first quarter this year has.
Couple of complements ahead.
One being.
Yes.
The de stocking we saw in the US last year, so an easier compare to in terms of inventory levels in the first quarter. This year when comparing to and from last year as one factor and then also we've seen in a in some geographies we've seen impacts from there.
Supply changes from from one of our competitors. So those are the main Texas and hence you should see our Q1 sales growth there for not shopping and or offline and today and growth coming down in future quarters.
Thank you cost will figure minimum floor that set of questions. So nets next question. Please.
Our next question is venue capacity from Bernstein. Please go ahead. Your line is open.
Great. Thank very much for taking my questions I will talk about it advancing so if we just thought with Nash clearly the headline.
Very strong, but how does novo differentiate between obesity in Nash now given most nash patients obese and will drive of treatment actually be obesity. Given there is only to biopsy deliver so what I'm really asking is naturally just obesity annual merit and then tied to that can you provided a bit of color on the efficacy in patients who lost less weight trying to get a bit on.
Download benefit independent weight loss. If there was any my second question is it's on Saxenda NVR active down pretty big 40% in the U.S.
Given the average day time is about four to five months I'm. Just curious if you could provide a little bit more color on what you're assuming for the rest of the year from an obesity perspective and in tied to that we are entering the recession. How do you think about there'll be some potential longer term given the remains quite an out of pocket market I'll use. Thank you.
Thank you have out of that was at least a couple of questions I think several messages dot on the on Nash and then causing you can talk a bit to the to the guidance on the on six Anda.
Yes, absolutely.
And these are good questions first of all just could you talk to spend will now if we look at at the study population here is properly presymptomatic.
What is happening in the real world, we actually had 60% of the patients coming in with diabetes type two diabetes and varying degrees of overweight and obesity some of them actually not being better profit just overweight around 20%. So the remaining for exhibit the patients was to get these patients without pieces being diabetes.
So I think the metabolic dimensions associated with obesity and type two diabetes together data for what's happening in the before offer people Nash and you can say the patients we have treating many of these were actually if we patients and these I actually on the verge of progressing to at four of which is new busted Roses and to me.
The most important hallmarks of a therapy in this field is actually to be able to at risk the progression in reversibility I'd Nash cirrhosis. So so I think these are really exciting data and intermediates. The first time that immediate Arctic agent actually shows that secondarily to be metabolic improvements you see reduced he puts us.
In the best as assessed by the beginning in the month of the National and that is been total fiber juice scarring of the tissue, which is the politics reaction to put the winning in the sales. So I think Nash is should we see that's something that is beat atop the bigger cardio metabolic syndrome, and not simply just net LPG or for that matter.
As diabetes and some people quoted a knife span indication thats being discussed, but thats, maybe a bit premature to speculate on I think you should weakness and mobility treatment modality going forward and some appetite is probably the.
Kind of hold back off of such therapies that address the different needs that forward with aging.
There was also a question of the differentiation between body weight that impact on Nash the best way I can address that dispatching at 8.1 milligram dose that corresponds to Opex had been mix of cement the week that corresponds to 1.8 milligram victoza. So that you see with a modest weight loss of three killed. So so that 40% in this trial had measure solution.
In the Beacon study published by political news from five years ago. It was 39 cents individuals. So getting 940 that similar the clock doses are bio equipment. So that that fits and then you can add that what we see more at the high dose that will point Fourm diagram.
More potent fixed on weightless double digit waitkus, ultimately goes with diabetes plus significant impacts on the Roger Biomarkers ranging from apoptosis Biomarkers interleukin, one receptor and tech women's knit parameters et cetera, et cetera, et cetera, all pointing towards a improvement in the master solution rate as compare.
So what you achieve with a standard deal to one therapy. So wait drive some of it but engine penetrating other maintenance of infection nearly drive other elements of.
Thank you invest very exciting cost.
Sex and the performance in the in this current environment.
So and so now you're spot on and when we look at to cope with 19 impacts on the on sex and that and if we take the us marketers.
As as a proxy for for that than a and b or exit scripts are down to 240%.
In April compared to a pre codependent 19.
Eric said script levels and as you point out than if they stay time is.
Recounting in a in months for four six in there. So you should expect ethics and the tour to be hit more than some of our other products and therapies.
For the company.
That does change the fact that that with Duke assuring tool to double our BT franchise as we laid out in our strategic aspirations. We believe the pacing potential with that said the 650 million people globally.
In scope for treatment.
It's relevant.
With that program reporting out in Q2, we believe that that we have the pipeline.
With the SDMA in obesity and potentially that fields on anything coming even and later.
So we believe we hit the pipeline for for this population. So so we still see strategically.
BT business as an asset growth investment to enter at something that we see dumping or over the coming yes, and then on a smaller final note than we actually also tended to get reimbursement in Switzerland. Today, just a small exam, but with the continued to progress on that on reimbursement in BC.
Thank you probably think of remains very much next set of questions. Please.
And our next question is on PDF agile from Citi. Please go ahead. Your line is open.
Mike muted.
Sorry, Peter we conducted you.
And our next question is from Simon Baker from that and please go ahead. Your line is open.
Thank you for taking my questions two questions and have a quick request.
Firstly I just wonder if you could update us on the outlook for SMP can China's starting February.
You could give us.
Expectations for when you.
Be looking to launch and how he will launch I'm, assuming this will be different too.
Victoza cannibalization strategy, given the more nascent market, so any thoughts that would be would be useful.
I think going back to women's question on obesity I'm clearly there was some challenges now.
Looking at around.
We've seen a lot of early evidence that.
Obesity is a.
Negative prognostic factor in Capex 19.
Longer term VAT, focusing mines, perhaps more on looking at initiating Beastie.
And the quick request you frequently gave us the restated.
Sales numbers for 2019.
And if you could also give us the growth rates for those new regions. Thanks, so much.
Thank you Simon and that's why I think it's maybe too early to go into commercialization strategy for Olympic in China. Thank you could talk a bit to the clinical development.
And then I think center brings up an interesting purposes on the link between visa to include 90, maybe told to us.
Yes, Thank you lost and thank you Simon.
Visa be specific approved in China with the FDA. The as you recall historically there has been very long regulatory timelines they have committed to change that.
And seek to get more close to classic Western Europe.
US bandits and in principle that to a groups of approval once called the expedited review, where you can expect approximate people take one yet proven time and the others. The most and wet even today you still expect around two years and we should be do not know at this point we of course hope for past approval, but we'll we'll keep you posted on that one and then.
You are very interesting remark and lumpy. This is still extreme speaking to to the consist of forward looking cascading statement. However, it is so that in todays journal BCG. The what's the publication by Us in German researchers that people with the fact loaded at the precise pixels, they expressed middle east to building.
Which just by chances to Percepta for the Cove the sauce.
We will be to a virus and that implies that people, who are eddie close or will be sorry, they will be inclined to meet the uptick more viral particles that might even serving as the reservoir of device and fiction, giving a more permanent infection rupees individuals at least we knew these from epidemiology lots of note that in.
Certain as dealer sales in the long compartment baskets that also get loaded with tech profits and they also express more ways to you had the big situation, where the cytokine storm with the long smart might pick up so agents that reduce obesity agents that reduced blood pressure agents that reduce HP won't see so that the immune system.
Is this impacted by hyperglycemia and so once support should all be seen as as relevant remedies in the future Almond, Tim also to reduce risk of could be 19 in the susceptible individuals.
Thank you.
Thank you Miss on the request on the comp capacity data will be happy to providers.
Thank you Simon Thanks on our next set of questions. Please.
And our next question is from PDAC back some handelsbanken. Please go ahead. Please open.
Thank you.
For me.
Yes.
We cannot here could you speak up please.
Better now.
A bit better what does that hold on I mean, it will just turn up volume here.
Please go ahead.
We are ready for your question Peter.
Okay. Thank you so formats on select study population have hes not that could describe the data could you give us some update on what we should expect in terms of background CV risk and also at this study, which sort of has some kind of secondary prevention characteristics similar studies with key Pcsknine inhibitors have aimed at.
50%.
Benefit relative to placebo is that what do we should look for he as well and otherwise any sort of flavor on the design of the study would be appreciated at forecasting in terms of what you're seeing in terms of trends into you with respect to.
[music].
The drop or change in patients new patients coming into the clinic, how much that has dropped and also in terms of the refill rates could you will give us some data of those two parameters and also some sort of you know since for how we should expect this for the duration of these two.
Impacts on prescription behavior. Thank you.
Thanks, Peter CMS, Firstly on the started population in the summit.
Yes. So so very briefly these are patients who are obese and at high risk of cardiovascular disease typically because of.
Event.
They are quite prevalent for better or worse.
Millions and millions of those and we have included not people with diabetes, because we want to show that's magnetite has cut to protected purposes in the non diabetic environment. However, there will be people with its glycaemic I'd think diabetic conditions included and you're absolutely correct one element in looking into secondary endpoints.
The progression towards type two diabetes pretty much as we did in the scale diabetes and obesity trial as you recall, where there was at 80% deduction in the onset of type two diabetes.
With people treated with that with six and so that is the eliminate the meat element of course is the major adverse cardiovascular of into occurrence and the been great I cannot tell you exactly what it will be but he's not going to be 4% accidents in a classic beat assisting six the kind of setting because these are not people with diabetes, it's more likely to be around half of that.
Jeff 17000 patients you should matching the each point that means that Vince.
Yes, when the cotton spinning road and then you could do we go next on the timing of the crop.
Thing investment cost on the on trend patient flow.
So.
So on the patient closer than there.
Kind of that it would take the simple data points that way we look at.
As a proxy for for patient close.
What has happened to two neutral brand scrip side, Gregg said grieco with and then our in April than in rough terms, what we've seen is that the insulin and Greg is down 20%.
Year to one and rates are down 30% and the as we've discussed before.
And the in breaks are down 40%.
Then as to request non on stay time.
We do we do not have had detailed data on that but the one could speculates that to add that in the currency situation and focus on that on health that debt net adherence to therapy would would be going up so that people would be less likely to be skipping doses in a in an environment like this but there but.
We do not have data supporting that at this point in time.
In terms of the duration add fall off for the impact on on on patient dose.
Ed.
What we put into our announcement is that we expect that based close to two normalized during the third and fourth quarter, but of course all of that hinges on society opening a backup Andy would take a kind of global two on there on that logic and then we feed China correctly opening up.
With the reps out.
Visiting Doctor said to some extent now with hospitals opening up and there for our patients. So we see China entered and some Asian countries opening up and we see some gradual science in other geographies says as well in terms of opening up and in the US also that.
It's not to have one size fits all but the that different approaches in the different states in the us, but I think Baltimore.
The dialogue is around how and when to have now and less about to filtering down and containing so so we believe that day. It is enacted that patient flow should normalize and during the second half of this year.
Thank you Miss brand next set of questions. Please and thank you all computer.
And next question is some key data from Citi. Please go ahead. Your line is open.
Thank you good afternoon can you hear me.
Yes.
Yes, sorry earlier.
Capital here from Citi two questions. Please on the pipeline.
Mads just on the go forward strategy.
On Nash could you clarify that you would happily take.
The point full make a dose forward into food phase three given the profile that you've seen in the data should you decide to do that.
In terms of the gating factors around that phase III.
Go no go decision.
Will you be waiting for the combo data with the give you added assets later this year and data in the full patients are things coming end of next year before making phase III go no go decision. So question number one of them Nash.
Then secondly, just switching gears to.
Glip jip.
The data we've seen the commentary from you the commentary from Kale wells, there's a growing belief the high dose summer can be competitive with his appetite on a on a one city of koby superior weights and that it on going to pay in the community about ship actually brings to the table so with that sort of in mind I am interested into here.
The reasoning why novo start seeing the Semichem phase, one or reentering, the sort of flip chip arena can you describe what can you make that decision.
Thank you Peter for I counter three questions.
And the first one on on Thats approach, noting that is diluted dates when considering how to go by that and then the second one.
No.
Bye bye presume combinations when you have high dose so that's where can you.
So on that I think when when I see the data coming out from this if you have to be trial they are very compelling.
And actually points for a disease mechanism, which has the potential to a risk the progression of the disease, including the fibrosis.
Obviously, the way that it seems to retail we have to be conducted according to the BOP guidance from the food and drug administration is that you can get you a drug approval based on show natural solution without worsening fibrosis, and then you need to continue the trial. After you up launch the product until you have some hot outcomes and based on what we have seen today. There's good reason to believe.
That achievement of improvement in hot outcomes over time should be should be a dual however, as to which those our company management with decide to take into phase three I will not speculate on that but it's quite clear to me that are numerous biomarkers.
Moving on to some hardcore ones there was a clear yet dose response relationship implying that ophthalmic medical multiple ours suggest that to go towards the higher soubriquet doses of this agent, but we'll get back to where I come to unfortunate decide all these things alone when it's the whole executive management and the board of directors.
Within the business, we have not having to await the TV at redoubts by any means and michels because the data we have today.
Some active side looks to be able to become also a standalone entity and may be and contract in the field of Nash. So we're not depending on the other topsy turvy, we can make decisions based off of this readout.
In the future.
That was a question about Oh, yes.
Thats factual breakfast good question.
So again this is Pete border cloud will hopefully as show that what you said Peter So so fingers crossed for fourth quarter on the readout for sustained awarded.
There is even within Novo Nordisk big discussions about the will if any of keeping in adding further.
Thanks for the pop art to GLP, one was at the agonism that remains uncertain and I have to admit that personally I, maybe just talk a bit either in the educated achieved between tier one risk that comes from an eminent agonism.
In both wheat and potentially other indication areas because some of the preclinical data are more supportive, but they would have to provide clinical data and hopefully we can come with those to you a decrease in the season. So so this is kind of out of the state of the cautionary pill that we've decided to take your once we did you can keep the put together with him and see.
With that let you see is there.
Thank you are mess. So thank you Peter next set of questions. Please.
And our next question is found Jo Walton from Credit Suisse. Please go ahead. Your line is open.
Thank you Tim Wilson from Credit Suisse.
A question surrounding rebel sits in the question on the on the piano, so starting with rebel since I Wonder if you could tell us a little bit about the sources of the new patients that you look I think are you seeing them coming from.
Other GLP easy seeing limb trading up from although oral and if you could also help us with.
It typical level of co pay is it more expensive for patient to move to your oral from of oral so little bit background and given that we've had a quarter now with strong growth throughout this my second question would be on the face of the PNM you had 7% extra sales from Cove eight now.
I would imagine that they came three with a very high contribution margin and therefore always quite surprised that the profitability of the from wasn't more impacted as they need to appear to be well I. Appreciate that they was the one time R&D aspect, but I think we will.
Adjusted for that to the right back at the oral summer. So if you could just tell us a little bit if they were it was anything else in terms of light an extra cost. So we'll patient assistance that kept the profitability down when the sales were up say strongly thank you.
Thank you Joe and commuter first on the on road doses.
What what we see so far north early days.
Yes, so our Navy Thats this RBC.
For businesses that more than 70% comes from outside the GLP, one class and gains primarily for all funds all and segment.
If there any Dave and by the also connecting and what patients would have started on an injectable GLP one button tough call.
I think that we'll be able to Norton taken feature with regards to co pay we havent very competitive solution, meaning that the co pay fall deductions.
Begins to 10 dollar and that's the same off at for other elements. So already now we are very happy with the uptake of B. Thats, a 74 call the 19 and beauty that many encouraging there. We also now at cannot mention any I have a combined phenomena accidents up more than 50% and gain.
We also expect that this will gradually increased and oh by the more so thats the statements on the Thats whats going on.
Thank you communicated in constant.
On PNM and flow through from top line to bottom line.
Now so so on on piano so.
So the cost of goods associated with them with this additional stocking is 50% so actually slightly less than ideal.
Group cost Matson, so apart from that nothing wins, especially on that.
On the cross marketing and contribution marketing that no additional costs to on the selling and distribution offer the down that the piano only dropped to 50% the cost of goods on the tubing indicate extra sales.
That could cause thank you Joe next question. Please.
Our next question is on Richard Vosser from JP Morgan. Please go ahead coming from.
Hi, Thanks, taking my questions just came back the Nash I wanted to achieve.
Give us some more detail of side effects.
It was that a day and then high level of nausea, and de thing you'd have to buy trait that put up more slightly in each city to result that.
And also aligned no details on the dating back, but why wouldn't you moves to a weekly injection from a daily injection given your previous modeling around eight to 10 and you when that way.
Second question, just add on mass as well just thinking about less hydrated level can you just from fund you said nice statistical improvement in high grade that the highest dates get quite at night.
25 basis, we'll call. It could you clarify one that may be.
Kneecap sneak one more that's all my policy, it's already seen any improvement in the winning.
Prescribing take out the quota conduct business as the right now in the last.
Recall that level.
Thanks Anna.
Thank you Richard and finance.
We bundle that into one long question.
Side effects weekly injection versus daily and what we saw in terms of approaches yes, well first of all that because one thing budget.
It's.
In the old days that we had Vince idea about once daily Semaglutide. It does not borne out to two have any merits. So by definition that seems to be conducted dedication up once weekly.
Some appetite at at whatever reasonable dose and in terms of post election, I would just repeat what I said that the fact that you're going up 80 patients in the high dose arm, an 80 patients in Pittsburgh and improved comps that we felt patients eyeq, 5% discontinued due to adverse events and only two of these payroll related to.
GI side effects and also of the placebo related to non PCI side of it the Tokyo story of up nine contributed two parts of that will not be preventative any kind of post election. The type question regimen that we have deployed in the state program. Let me just we might be able to fewer forgotten. It is open to five to attract.
One to 1.72 0.4, and that's the kind of boosting titration regimen that you to foresee also in a in a messaging depending on the the final dose of course in terms of fibrosis, well XT. When we look at type books is using.
Let's talk of according to type scan imaging the built to test combining the two pilot running Cadseventy BNP Biomarkers, we actually see improvement in five posted as we also do in the biopsies in terms of.
I'm showing a boost decreasing the progression of type purposes at but it is true that in the categorization of improved one step at doses that was when we couldn't be but the trends.
A positive and when I look at the overall.
So if the blue belt, the air biomarker pen et cetera, So very compelling story of the secondary pick up but those instead, it's beneficial but driven by the middle boating and information related improvements.
So mark more time revenues showed us.
Yes, and Thats why you would have to see the as part of the extension trial in the fees to be situation, where you get the approval. According to NPD based on show next for solution improvements, but then it is true that to continue the cross attracted us taking us and their communication on the robustness and willingness to prescribe.
So.
As we get talked about we expected it doesn't compete upticking renewal than the patient dynamics and get the impacted by Cobot mountain almost anything thats on how do you feel yet to come kinda Angola, yes to what extent become will be booking of we saw very strong.
Performance of the products difficulty 19, and we have no reason to believe that would that were not pickup as soon as we are in the field ligand.
Thank you Camilla and widgets and the next set of assumptions.
Our next question in some markets all from Morgan Stanley. Please go ahead Lngs open.
Thank you very much at Smartpost fell from Morgan Stanley two questions Firstly on rebelliousness us dynamics within following the dynamics.
Endocrinologist Bmws share was 19% in December and fell to seven percents in March was Pcps was 14% in March. So do you have any further thoughts in terms of weather Endos just simply prefer.
Pickup.
I felt so whether there's any other reasons why you saw which used to suit fibrosis bye.
And technologist ahead of the caveat impact in March.
Whether that be treating a bolus of patients to who were on injectable GLP, one that was struggling or anything else in terms of clinical experience and then secondly, doubling down on Nash mass could you give us your thoughts on on diagnostics, both internal external efforts and whether you're waiting for any new developments on the diagnostic side.
Incorporate them into into phase three trial. So we'll get dates on the Genfare I say. This this this year, obviously roshe quite a number of of efforts ongoing at diagnostic panels to try and look.
Diagnosing the various key aspects of Nash and whether you could look to double down on your pipeline as well beyond just stopping the FGF 21 product in phase two in Nash, thanks very much.
Thank you Mark and starting with the Camilla split on the in those on Primerica.
Yes, so way yet again, if there any Dave Pat down what we do see AIDS that expectedly Thats is compatible with centers at the time of balance we passes.
So much laughing extend trading five primary care and that.
Cost to be expected at this event, our contact ending easy to initiate and Dan Thats why you see a different distribution intense half who is driving an adjunctive scripts.
Thank you and mess on diagnosis for Mitch.
Yes. So so it's really good point, Mark and the Nordics just for information is MEMP approved of the deliver forum the list and the nipple console check, which us in European things consult Jeff or seeking to define noninvasive diagnostic tools for for the diagnosis that follow up on.
Umesh add DFT EMEA and are they can sell also present in some of those consultant so were working closely with them and it is important for us.
Some of these data to move forward I would say that with what we know today.
Activity forgive me personally in terms of absolute signs of combining the stock of fee imaging together with thing since the ELD biomarker panel is fully on par with the biopsies to pet diagnosis and categorization of fibrosis bleach, but the regulators at this point do not find that these biomarkers have.
We validated yet so a part of the processes to ensure dedication, but I can tell you we have probably around the full year. So biomarkers that didnt have time to go into in this trial and some of them a highly predictive of different elements Clinton CK 18 at the which is biomarker is highly predictive of beginning at Celtic and we saw a very strong.
Nice does depend the effect on net markets. So we're learning as we go in that on and we would shed this with the regulators and by the path for whats towards meditation I'll start with its noninvasive, we see thats pretty competitive if we want to with anyone including Roche, Let me just a few things.
Yes. Thank you Mark we'll take one last quick set of questions.
And our next question is from Steve Scala from Cowen. Please go ahead orphan.
Oh. Thank you so much how would you characterize the expected unwinding of stock in 2020 is the bulk of the unwinding expected to occur in the second quarter and did you already start to see that during the month of April and then on some of grew tied in Nash, what where the rates of fibrosis improvement in the.
Semih grew tied group and the placebo group many thanks.
Thank you bid so carton quickly on stocking unwind.
[music].
Yeah, so and so the tubingen Duquesne in stocking as we say we expect inventories through.
To reverse.
During 2020, and 20 to 21 and the reason for that statement is that the majority of Destocking machine is that patient level. So you would expect quick destocking is submitted to wholesalers, but thats not the case, so thats why its hard to predict accurately, but Dave we expected to take some time before it reverses.
In order to mess.
Yet we don't discuss specific dates on all in point, but the numeric difference in favor of some magnetite, what's to the tune up 10% more patients.
Okay, and seeing fibrosis improvement going down in graduation pets, we reduced dataset at conferences that with two would be.
Running one way or.
In the months or so.
Yes, thanks, Pete So this routes off our conference call today.
In mind that we will have to conduct our road show virtually the this this quarter, we hope to be back on the road soon.
Ladies and our conference call virtually tomorrow, so there's no chance for you to diving and.
Ask questions to two to us. So thank you for an interest in north can have a great day. Thank you bye bye.
[music].
And.
[music].
Our first quarter performance and our financial outlook for 2020.
I'm, Josh broke out Jorgensen this year of Novo Nordisk.
With me I have our chief financial Chief Financial Officer, Cosmos, Gluten and our Chief Science Officer, Mr. Thompson.
Also present and available for the Q&A session are executive Vice President and head of commercial strategy and corporate affairs commuter serviced and executive Vice President and head of product supply quality and I T.
As well as our Investor relations offices.
Today's earnings release, and the slides for this call I made available on our web site North Dakota.
Please note that this conference call is being webcast live and a recording will be made available on the annuities website.
This call is scheduled to last for one hour.
The presentation is structured as outlined on slide two we will begin by addressing the enormous response to the COVID-19 pandemic before moving into the quarterly performance.
Please note all sales and operating profit statements would it be at constant exchange rates on this otherwise specified the.
The Q&A session will begin in about 25 minutes.
Please turn to slide three.
As always I need to advise you that this call will contain forward looking statements such forward looking statements are subject to risks and uncertainty that could cause actual results to differ materially from expectations.
For further information on the risk factors, including the uncertainties uncertainties pertaining to COVID-19, Please see the earnings release press release and the slides prepared for this presentation.
Please turn to the next slide.
The first three months of 2020 has been extremely unusual given the COVID-19 pandemic. This crisis is without precedent in our lifetime and each day it prevents new challenges to governments health care systems and companies across the globe as it does to all of us on a personal level.
Across our global organization, we are working hard to tackle the new challenges COVID-19 poses we have prioritized three things in particular, ensuring the well being of our employees safeguarding the supply of our life saving medicines to the patients that need them and doing our part to help society by supporting local approaches.
With resources and expertise.
Across the value chain. The COVID-19 pandemic has had an impact on how we go about our business within production, while we have been prepared given the contingency plans established colleagues at our global manufacturing sites are finding new ways of working to ensure that our supply of medicines is maintained.
And as a result, all manufacturing sites continue to operate and medicines are still available to patients worldwide.
During occurring in the phase III program.
A potential continuation of the project is currently being evaluated.
Within other serious chronic diseases, we have results of the phase II trial investigating <unk> in the treatment of mesh mess will elaborate on that in a few minutes.
Moving to commercial execution and financials diabetes sales increased by 13% with Novo Nordisk seeing its diabetes value market share leadership expand to tweak it tends to eight 7% and GOP one sales continued to perform well at 37% sales growth Biopharma.
Biopharm sales increased by 16%.
Total sales increased by 14% with international operations growing by 19% and North America operations growing at 9%.
When adjusting for the COVID-19 related stocking effect sales growth was around 7%.
The stocking impact was distributed approximately equally between international operations and North America operations.
The sales growth is reflected in operating profit, which increased by 12% totaling 16 billion Danish kroner.
Operating profit was positively impacted by productivity improvements within manufacturing and administration.
Please turn to slide six.
Before we discuss sales across the business you will notice a different reporting structure for the areas in SaaS operations.
22%.
Market share increases in saturation is driven by both instrument and <unk> in all reporting areas. Both franchises sales are growing.
In international operations, the diabetes franchise represents nearly 80% share growth with insulin share growth at 44% and you have the one share of growth at 35%.
Please turn to slide 10.
<unk> sales increased by 30% driven by driven equally by North America operations and international operations, reflecting continued uptake in EMEA and rest of world.
We are committed to driving change in obesity care with <unk>, having been launched in four to six countries globally and continuing investments in market development activities.
Turning to slide 11.
Yes.
Biopharm sales grew by 16% in the first quarter driven by a 17% sales growth in international operations and by 14% sales growth in North America operations.
Sales were impacted by COVID-19 related stocking.
And changes in inventories and timing of shipments.
Safety element was driven by growth across both the hemophilia and growth disorder franchises.
9% hemophilia sales growth was supported by increase in or seven sales as well as the continued rollout of the portfolio of innovative products was the fixture and disrupt.
Northern European sales increased by 28% driven by changes in inventory COVID-19 related stocking as well as an additional demand resulting from changes in the competitive landscape in selected countries with this autonomous for update on R&D.
Thank you Ross Please turn to slide 12 on the next couple of slides I will discuss our commitment to develop the <unk> molecule in two additional therapy areas beginning with the phase II results in Nash and then moving onto the phase III program for <unk> in obesity.
In April the phase <unk> trial investigating <unk> in the treatment of non alcoholic schedule hit the tightest also known as Nash was completed.
This was a 72 week blinded biopsy based trial comparing the effects of subcutaneous <unk> administered once daily versus placebo.
<unk> histologic histologic resolution of Nash stages, if one three.
Alright update on the financial results.
Thank you ma'am.
You tend to slide 15.
And the first three months of 2020th sales increased by 60 per cent and things Corona and 514 per cent at constantly change rates.
The cross Martin was 84.1% compared to 83.8% in the first quarter of 2019.
The increase in Crossmatching reflects acrostic product makes driven by increased just one sales.
For our church improvements in manufacturing and a positive currency impact of 0.2 percentage points.
This was partly countered by a negative impact from Louisville realized prices and the U S.
Save for distribution costs increased by 9% in Danish krone, and by 7% a conflict change rates, reflecting increased investments idiots, you won and obesity, partly countered by the work promotional spent for insulin pumps in the U S.
The cost increase was driven pipe yoga promotion activities for San Pig global launch efforts to build and expand UBC Margaret as well as north activities for the doses in the U S and promotional activities for insulin in places such as China.
Research and development costs increased by 41% in Danish krone, and by 40% a constant exchange rates.
The cost increase is impacted by the reversal of write Downs force Macrocyte prelaunch inventory in the first quarter of 2019, and a low level of spending in the first quarter of 2019.
The underlying R&D cost increase is driven by high activity level within officers chronic diseases, mainly for the next and cardiovascular disease projects.
The backdrop of.
Of the growth hormone market is that that we have a <unk>.
Rather mature market in terms of <unk>.
So all global volume market growth and a.
Rather competitive nature of the market with it with a number of players in the market and hence a.
The relatively low or value market growth as well the reason for our.
Sizable.
Sales growth in the first quarter of this year has a couple of continents.
The one P C.
The Destocking, we saw in the U S last year, so an easier comparator in terms of inventory levels in the first quarter of this year when comparing to last year at.
That's one factor and then also we've seen in some geographies we've seen impacts from there.
Supply changes from from one of our competitors. So those are the main factors and hence you should see our Q1 sales growth for not shopping as in all our plants.
And growth coming down in future quarters. Thank.
Thank you Carsten. Thank you have a minimum floor that set of questions. So next next questions. Please.
Our next question is from Daniel Kapadia from Bernstein. Please go ahead. Your line is open.
Great. Thanks, very much for taking my questions that we'll talk about it from Bernstein.
We just start with Nash clearly the headlines.
Very strong, but how does novo differentiate between obesity and Nash given most Nash patients L. B.
Drybulk treatment actually be obesity, given there is no need to biopsy deliver so what I'm really asking is naturally just obesity in your mind and then tied to that can you provide a little bit of color on the efficacy in patients who lost less weight I'm trying to get a better understanding of benefit independent of weight loss. If there was any my second question is just on sex and the NBA Rx is down.
T bag I think about 40% in the U S.
The average stay time is around four to five months I'm. Just curious if you could provide a little bit more color on what youre, assuming for the rest of the year from an obesity perspective.
And tied to that we are entering a recession, how do you think about the obesity potential longer term given it remains quite an out of pocket market. Thank.
Thank you.
Yes.
Thank you everybody there was at least a couple of questions I think sort of a mess if you start on the <unk>.
On Nash and then Karsten you can talk a bit to the guidance on the onset center.
Yes, absolutely.
These are good questions first of all just for you to understand where now if we look at the study population here, it's probably pretty symptomatic.
What is happening in the real world, we actually had 60% of the patients coming in with diabetes type two diabetes and varying degrees of overweight and obesity some of them actually not being that obese proper just overweight around 20% or so the remaining 40% of the patients were simply obese patients without peach listing diabetes.
So I think the metabolic derangements shaded with obesity and type two diabetes together cater for what's happening in the liver of people with Nash and you can say the patients. We are treating many of these were three.
Three patients and these are actually on the verge of progressing to <unk>, which leave us your grosses and to me one of the most important hallmarks of a therapy in this field is actually to be able to arrest the progression to irreversible itchy I E. Nash cirrhosis. So so I think these are really exciting data and to me. It's the first time that <unk>.
Pollack agent actually shows that secondarily to the metabolic improvements you see reduced he put to cellular test as assessed by the ballooning element of the Nash score and that is then followed by reduced scarring of the tissue, which is the body's reaction to ballooning in the cells. So I think Nash is to be seen.
Something that is peak across the bigger cardio metabolic syndrome, and not simply just net it will be.
Or for that matter diabetes, and some people call. It a lifespan indication that's being discussed, but that's maybe a bit premature to speculate on I think you should witness a more holistic treatment modality going forward and some hepatitis properly.
Kind of hallmark of such therapies that address different needs that follow with aging.
There was also a question on the differentiation between body weight and impact on Nash the best way I can address that is pricing at the <unk>. One milligram dose that corresponds to open have been mixed up similar per week that corresponds to one eight milligram victoza. So that you see with a modest weight loss of three kilos or so that 40% in this trial had master solution in.
The beam study published by political news from five years ago. It was 39% Victoza. So 3900 40 that similar the drug doses are bio equivalent so that that fits and then you can add that what we are seeing more at the high dose. The <unk> four milligram is more potent effects on weight loss double digit weight us also in those with diabetes plus.
Significant impacts on a variety of biomarkers ranging from apoptosis Biomarkers interleukin, one receptor antagonist lipid parameters et cetera, et cetera, et cetera, all pointing towards a improvement in domestic solution rate as compared to what you achieved with the standard tier one therapy, so wait drive some of it but anti inflammatory and <unk>.
Other maintenance of infection, clearly drive other elements of it.
That's very exciting constant.
And the performance in this current environment.
Yep so.
Youre spot on when we look at.
COVID-19 impacts on the <unk> and if we take the U S market.
As a proxy for that then.
MPLX scripts are down to the tune of 40%.
In April compared to a pre COVID-19.
Script levels and as you point out there and if they stay time is.
We're counting in months four six and so you should expect this center to be hit more than some of our products and therapies.
And for the company.
It doesn't change the fact that that will do for sure into tabla obesity franchise as we laid out in our strategic aspirations, we believe the patient potential with the <unk> 650 million people globally.
In scope for treatment is.
As relevant.
With the step program reporting out in Q2, we believe that we have a pipeline.
With sema in obesity and potentially let's see also on amylin coming even later.
So we believe we have the pipeline for this population. So so we still see strategically.
These two business.
As a growth investment.
Something that we see doubling over the coming years and then on AR.
Small final note then we actually also did.
Get reimbursement in Switzerland, just as a small example, but we're still continuing to progress on that.
Reimbursement in obesity.
What kind of things to think of an autonomous next set of questions. Please.
And our next question is from Peter <unk> from Citi. Please go ahead. Your line is open.
Okay.
Might be muted.
To repeat if we cannot hear you.
Yeah.
And our next question is from Simon Baker from that then please go ahead. Your line is open.
Thank you for taking my questions two questions I have a quick request firstly I just wonder if you could update us on the outlook for I shouldn't pick in China, which was filed in February .
And if you could give us expectations for when you would.
Would be looking to launch and how he will launch I'm, assuming this will be different to victoza cannibalization strategy given the more nascent market over there. So any thoughts there would be would be useful.
And then coming back to women's question on obesity.
Clearly there was some challenges now flipping it around we've.
Seen a lot of early evidence that obesity is a.
Negative prognostic factor in COVID-19.
See longer term that focusing minds, perhaps more on looking at initiating obesity.
And the quick request you very kindly gave us the restated sales numbers for 2019 I Wonder if you could also give us the growth rates for those new regions. Thanks, so much.
Thank you Simon and that's why I think it's maybe too early to go into commercialization strategy for something in China. I think you can talk a bit to the clinical development.
And then I think Simon brings up an interesting hypothesis on the link between obesity and COVID-19, maybe talk a bit to that.
Thank you Lasse and thank you Simon.
This would be a civic approved in China with the FDA that as you recall historically there has been very long regulatory time lines. They have committed to change that.
And seek to get more close to classical Western Europe .
U S standards and in principle. There are two routes of approval. One is called the expedited review, where you can expect approximately give or take one year approval time and the others. The more standard where even today you should still expect around two years and we should be do not know at this point, we of course hope for fast approval, but we'll keep you posted on that one and.
Then you have very interesting remark and albeit this is still extremely speculative. This is a forward looking disclaiming statement. However, it is so that in today's journal obesity, but what's a publication by U S and German researchers that people with fat loaded adipocyte fat cells. They express more <unk> protein.
At least we know this from epidemiology. We also note that in certain alveolar cells in the lung compartment there.