Q4 2020 Sanofi SA Earnings Call

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You have joined the meeting as an attendee and will be needed throughout the meeting.

This meeting is being recorded.

Ladies and gentlemen, thank you for standing by welcome to the Sanofi fourth quarter of 2020 earnings call and mutual capital markets day, we have planned for a 15 minute break between both Evens you may remain connected to these doomed link for old sessions.

I would now like to turn the call over to Eva Shipper Yung Kim head of Sanofi Investor Relations. Please go ahead Eva.

Good morning, good afternoon, and good evening to everyone and thank you for joining us to review <unk> 2024th quarter results, followed by a dedicated Q&A session in about an hour. We will begin our virtual capital markets day presentation and discussion as usual you can find the slides to both sessions on the investors page of our website.

At <unk> Dot com.

Moving to slide two I would like to remind you that information presented in this call contain forward looking statements that involve known and unknown risks uncertainties and other factors that may cause actual results to differ materially I refer you to our form 20-F document on file with the SEC and also our document all washes through.

<unk> sales for a description of these risk factors with that please advance to slide three.

Our speakers for the earnings portion of the presentation today are Paul Hudson, Chief Executive Officer, The Global business unit heads Bill Sypolt, Thomas Triomphe, Olivier Xiaomi, and Judy are unauthorized and Joe Machista Chatillon, Chief Financial Officer, Paul will make some introductory remarks, followed by our G. B you heads who.

Bill review, the fourth quarter performance of their respective businesses.

The jumbo Keith will provide an overview on the key financials and we will then open for the dedicated Q4 earnings Q&A session.

For the Q&A you have two options to participate option one click the raise hand icon at the bottom of your screen you will be notified when your line is open to ask a question at that time. Please make sure you're on mute your microphone or option to submit your question by clicking the Q&A icon at the bottom of the screen with that I'd like to.

The 10 day, turning the call over to Paul.

Well, thank you Heather and welcome to everyone and thank you for joining us today are probably a record number of join us. So.

Obviously, creating a lot of interest in the story and how we're doing so 13 months. Following the announcement of our play to win strategy and the year of a global pandemic would.

We're delivering 3.3% sales growth in constant currency ahead of the two 8% growth day before.

I'm extremely proud of our achievements debate some has become so net because number one product in 2020, reaching $3 5 billion yours and sales and then the growth rate of 74%.

Our influenza vaccine franchise, Costa 2 billion Euro Mark responding to the public health needs without differentiated for a differentiated flu products.

<unk> grew strongly during 2020 and despite fewer new patient starts due to the COVID-19 environment.

General Medicine sales in 2020 were lower reflecting the implementation of the V. BP in China. So we've made progress on volume and then further impacted by elective procedure delays, especially during Q2.

Our bottom line grew faster than our top line as we continue to identify efficiencies and Reed reallocated spending to our key growth drivers.

Cross the sector, we saw companies lowering their spending from the pandemic. The difference is that we are implementing a disciplined active program of overall cost reduction and reallocation that will remain after COVID-19.

As J P. What explained we have already achieved approximately 85% of our 'twenty 'twenty two savings target in just one year and feel confident to increase our target overall.

This year has proven that we have resilient yet attractive businesses that set us up well for continued growth I'm really confident that we will emerge stronger from this continuing crisis slide five transition now to quarter four performance, we delivered a tremendous quarter sales grew four 2% while business EPS.

Grew nine 8%, which bodes very well for 2021 overall Kim.

Great are key growth drivers where to pick some 54% up compared to the same quarter last year, and our differentiated vaccine business, which grew 15% with flu sales up 25% in the quarter.

To achieve a nearly double digit EPS growth, we delivered another quarter of P&L leverage supported by further efficiencies and reallocating spending to growth drivers.

With that I'm now turning it over to the GPU Hudson to provide more details on their respective businesses, let's first start with two Pixar and bill over to you.

Thank you Paul starting with depicts and sales reached $3 5 billion euros for the year a growth of 1.5 billion euros over 2019 strong sales momentum continued into Q4 with sales of 982 million euros, reflecting outstanding performance both in the U S and ex U S across.

All three approved indications.

This was all done in the backdrop of the second wave of COVID-19 in the U S. Patient visits continued to be approximately 80% of pre COVID-19 levels and outside the U S. Local lockdowns prevented many patients from visiting their doctors.

Other highlights in the quarter included depicts since listing on the China N. R. D. L. Just five months after launch one year earlier than the initial best case scenario enlarging the accessible adult population with atopic dermatitis to at least 150000 as of March a number almost as large as the <unk>.

<unk> 230000 patients treated with depicts worldwide today the opportunity in China may grow to around 900000 patients over time for adult a D alone.

In Europe do pixel is now approved for children six to 11 years of age with severe atopic dermatitis do pixel is the first and only biologic medicine approved in the pediatric patient population base.

Based on the continued successful launch execution, we are more than ever before convinced and are greater than 10 billion Euro peak ambition.

On slide seven I would like to share with you. Some insights that further exemplified you pick things uniqueness.

Depiction deadly increased sales quarter after quarter in the U S. During 2020, but that wasn't true for every other dermatology biologics over the past four quarters, what set depiction of part in 2020 was the commercial execution and its product profile.

As we move into 'twenty and 'twenty. One we are even more confident in depicts since market leadership recent topline data readouts from potential future entries in dermatology and respiratory have not changed our confidence in <unk> position as the first choice systemic therapy based on its clinical profile balancing.

Rapid and sustained efficacy with long term safety.

On slide eight looking across our specialty care franchises sales grew strongly by 18% in the fourth quarter. Besides two picks in oncology sales grew strongly driven by the newly launched products SAARC, Lisa and Lib Tayo.

Rare blood disorder growth was higher than prior quarters as sales of our products and to lock paid to our collaboration partner sobey were higher than usual due to a change in the supply agreement.

Multiple sclerosis are baggio's growth slowed to 4% globally and was flat in the U S. Following the entry of competition.

With around 2 billion in annual sales of Boswell, probably reached its peak in 2020 with that I'll hand, it over to Thomas to update you on the vaccines business.

Thank you Bill Q4, 2020 delivered a strong quarter of growth in the mid teens driven by higher influenza sales.

But before we dive further into the two franchise performance I would like to highlight the continuous strong performance across our pediatric combination vaccine portfolio growing by 20%.

Main driver with exact team our ex Evelyn pediatric vaccine, especially in the rest of the world area heads by a favorable phasing of a polio vaccines.

Importantly, our meningitis franchise returned to growth in the quarter driven by catch up in the U S. Following COVID-19 related delays earlier in 2020.

Finally as expected the pandemic continued to weigh on our travel and adult booster vaccines.

For the full year using that we grew 9% in 2020, the second year in a row of ice single digit growth at the upper hand of our mid to high single digit growth outlook announced at capital market day in December 2019.

Next slide.

Yeah, you can see focusing on flu vaccines as already mentioned Michael earlier, our flu franchise exceeded the 2 billion Mark for the first time ever an increase of 38% compared to 2019.

There are three main reasons from that first we responded to an increased demand and ship more than 250 million to reed worldwide up over 20%.

So again, we benefited from an acceleration of vaccination rates as a result of the pandemic, especially in Europe and.

And third we continue to execute on our strategy to shift our portfolio to differentiated vaccines that offer higher degree of protection for the most vulnerable people.

Differentiated vaccines accounted for nearly half of our global flu sales in 2020.

From a rope around 35% only four years ago.

Our successful differentiated products in the U S. Fluzone Idose Andrew block are now available in Europe under the brand names of if you're a leader and <unk> respectively.

We therefore remain confident on the future growth prospect of our flu franchise. Our differentiated products currently said that stand out in terms of efficacy and they are expected to remain a significant growth writer in the coming years with broader availability outside of the United States of America.

Finally, let me use this opportunity to say a few words on the mrna technology, which seems to work really well on COVID-19, and could also be applicable for flu.

Having said that clinical data in season influenza still have to be generated and will have to surpass the efficacy as well as a strong safety benchmark set by off from influenza differentiated vaccines.

We are now getting ready to start a phase one trial of an mrna vaccine this year as part of our collaboration with translate bio.

Regardless of Idaho's recombinant protein M&A or a combination of both platforms. We do intend to remain the leading provider of flu vaccines worldwide protecting people all around the globe.

With that I hand over to Olivier.

Thank you Thomas.

As expected our general Medicine, China business return to growth in the fourth quarter growing at 4% with strong volume gains from Plavix and go up per barrel up 78% for the year. This current trend confirm our successful bidding strategy, which delivered as planned.

While the usual air Europe true up took place in the U S. In Q4, we know that globally. The decline in the diabetes business saw significant moderation compare to previous years.

This positive trend that we are sitting in our diabetes business is mainly driven by the growth of two zero in Europe, and the rest of the world as well as siliqua uptake in all geographies with the launch of two zero in China. In Q4, we are confident in the outlook of the diabetes business in our key Mark.

I will elaborate on this in more detail at the CMT session.

In established products, we saw strong performance from Lovenox globally benefiting from its continued inclusion in WH guidelines for hospitalized COVID-19 patients.

David products of the EP portfolio in emerging markets faced some headwinds from the Covid environment.

Going forward to improve the growth profile of the business. We continue with the portfolio streamlining and we are making solid progress in driving simplicity and agility such our go to markets digital model.

I look forward to sharing with you more on our strategic priorities for the general medicine portfolio.

A little bit later today with that I'll hand, the call over to Julie.

Thank you D day similarity I look forward to speaking with you again later today to share with you our team strategic priorities to change the trajectory of our CTG business to grow our topline while continuously improving our bottom line, but.

But let me now very briefly touch base on our fourth quarter performance of the CTG business.

Following the amortization of <unk>. The U S returned to growth with strong performance from the allergy digestive and sleep category and as a result, I'm happy to share we're back to gaining share in the U S. OTC markets into October I would especially like to highlight the U S allergy category, which grew by 13% in Q4 with strong performance of our brands Allegra.

Idaho, both benefiting from strong 360 marketing programs anxiety from product placement in our popular chain of U S membership only clubs.

Globally digestive health brands sincerely enjoyed Kodak performed well as many consumers adapted to different lifestyles.

Pandemic, including a more sedentary lifestyle outside the U S. The cough and cold category was down 31% driven by our high penetration and cost in Europe and over a weak cough and cold season across regions because of social distancing as well as lowering pharmacy foot traffic with that I hand, it over to our CFO.

Thank you Julie.

So Paul mentioned in October that we are committed to fully embrace sustainability and our play to win strategy on it it's happening it's happening across the company as an example, so finance team have linked the renewal of our 8 billion euro revolving credit facility with some of our key targets, we had seen many green bond in the past.

This was just one where the first with an ESG revolving credit facility. When you will see over time many of the proof points across the company.

On slide 14.

Let's turn to financial performance company sales increased four 2% in the fourth quarter.

An acceleration versus previous quarters we.

We delivered another quarter of P&L leverage driven by further efficiencies.

Within the lower R&D spend that you have already a higher spend on the specialty care franchise due to the reallocation from diabetes and cardiovascular.

These operating expense efficiencies more than offset a decline of 120 basis points in gross margin due to U S diabetes trips on product mix of the general medicines business.

Currently Bill I grew almost 10%.

On our Boi margin increased by 60 basis points to 21, 9% into quarter.

So we have been able to deliver this margin improvement.

At the same time as accelerating investment in Duke sent on vaccines on absorbing this interact from Principia R&D spend.

On slide 15, full year 2020, P&L well.

Well I would like to draw your attention to the last line on the slide our Boi margin in.

Increased 120 basis points to 27, 1% well on track toward our communicated Bureau margin ambition of 30% by 2022.

So going forward you can expect.

Operating expenses to grow again due to investments.

Into our expanding pipeline on future launch activities.

At the same time, you can expect to see gross margin improvement from this low point of 2020.

With this in mind, let me give you an update on our progress to accelerate efficiencies.

On slide 16.

As you know we communicated in December 2019, our plan to deliver $2 billion in cost savings by 2022.

Of this total we expected around $500 million to come from reduced spending deep prioritize businesses.

One 1 billion from a range of smart spending initiatives on the first of the 500 million from operational excellence, including Cogs.

In 2020, we have achieved around one 7 billion of savings almost 85% of our 2022 target we made progress across all potential sources of savings, especially from day prioritize businesses on operational excellence, where we have surpassed the target.

Following these accomplishments we are increasing our cost savings target by 500 million to $2 5 billion by 2022.

These savings will be derived from continued operational excellence and we plan to reinvest 100% of this extra 500 million of savings to drive the top line on sensor pipeline.

On slide 17.

We delivered another Europe of strong free cash flow growth, mainly driven by Sanofi solid business performance on smart spending initiatives.

Free cash flow increased by more than 70% against full year 2018.

So we delivered a strong underlying performance and as a matter of principle, we do not update our midterm targets with I guess, you will understand that controlling your free cash flow, we will maximize it as much as we can.

On slide 18.

I want to transition to Sanofi as annual dividend payment, which the company has consistently grown for the last 2026 years as a result of Sanofi is performance in 2020, we announce that the board has proposed a 5% uplift in the dividend to three euros 20.

We're growing dividend remains an important element of our capital allocation policy that runs behind organic investment.

Business development, which are our main priority.

On my final slide we have set out our full year guidance for 2021 business EPS.

To grow in the high single digits at constant exchange rates.

On Forex, we see around 5% negative foreign currency impact based on January average exchange rates.

Lastly, I want to highlight pushes and pulls from 2021.

On the upside we expect strong growth from Dubai sent on vaccines on continued efficiency benefits to be reinvested in growth engines on pipeline.

In addition, we will have the and realization of the China V BP impact from flooding from court approval.

Also <unk> tax rate for 2021 is now expected to trend towards 'twenty. One person. This is our estimate including the positive impact of the French taxation reform, but our current forecast does not include the potential change in UX in U S tax legislation.

On the downside, we expect the COVID-19 environment to continue to impact us in each one with potential gradual normalization in the second half of the year. In addition, we expect adverse impact of foreign currencies, primarily in the first half of the year on continued U S diabetes price erosion.

So taken together.

These factors suggest that our growth will be weighted to the second half. In addition, you should note that I'm sure you have it in mind that the first quarter will face a high basis for comparison as Q1 2020 does not fully reflect current market dynamics due to the pandemic.

Well so after six eight person gross adds here in 2019 on nine two in 2020, but we are on track for another year of high single digit growth.

While you can look back from past performance, but definitely this is not the same sanofi.

Let's open the call now to Q&A.

We will now open the call to your question as a reminder, we would ask you to limit your questions to two each.

Two options option, one click the race and I can at the bottom of your screen you will be notified when your line is open to ask a question at that time. Please make sure you're on mute your microphone or option to submit your questions by clicking the Q&A I can at the bottom of the screen and I've seen some have already started so Chris.

<unk> will be read out by our panelists.

And now we'll take the first question from Keith vessels at Pete. Please go ahead.

Yeah, Thanks, very much pizza dough city.

Two questions, maybe kicking off with come off first on vaccines.

Could you comment on where vaccination rates.

Ended up this past winter.

In Europe and the U S.

You've given us a split by value could you just remind us perhaps from a volume perspective, the mix between differentiated and commodity flu business.

And then secondly for John on upcoming Serge data.

Is the day penthouse, yet can you remind us whether we will see PFS as well as our data and should we be using the telemetry and monarch two data as the benchmarks when we assess the said data. Thank you.

Okay, Peter Thank you.

Tomo every day.

Thank you Peter and first in regards to the vaccination coverage rates, we don't yet have final numbers. Because this is a stellar ongoing are by every single country in terms of for North America or Europe, but it's it's clear to say that due to the COVID-19 pandemic, we've seen from increase in the VCR I would expect a roughly in.

Increase of the U S market by around 14% one four.

But again, that's not final numbers is with us on the interim IQ via EBITDA.

And then Youll up if you don't see a significant increase in the on the on the vaccination coverage rates or through a few points, but we'll know more by here in the next couple of months when we have the final numbers now.

Now when it comes to value and volume split overall on the overall flu business. If I look at 2020, you've seen better roughly it's a balance between volume and value in terms of the 38% increase in the food business and of course as mentioned, we're going to increase further differentiate you from portfolio. We are very happy as we've seen the.

Production, if a if well day in Europe, we believe it will be a strong driver of growth in Europe in 2021, and two years. After so I would say that we'll see more and more increase of the differentiated flu in both in volume and in value in next year.

Thank you Tom John Reed, maybe you could update on what data we have in house.

The outlook for sharing data on our third I'm sonesta.

Thanks, Paul So we'll be sharing data on the phase one B study, which.

Set the stage for the pivotal study in combination with Powerball that'll be shared at a medical conference middle of this year in terms of the first pivotal readout.

That will occur the first half of this year in the second and third line setting as a monotherapy that primary endpoint is progression free survival of course will have overall response rates and clinical benefit rates as well as secondary endpoints.

It will be the PFS will be the primary endpoint.

Thanks, John.

The next question is from the mass capacity our advanced email. Please go ahead.

Great. Thank you very much for taking my questions are one Michael Potter from Bernstein.

On when glues that please clearly disappointing to see the update on GB Apd, but given safety continue to be favorable and the biomarker showed consistent unpredictable G. L. One reductions about the plasma and cerebrospinal fluid have your views of success actually changed for the product in a D. P. J D power for the pivotal data in.

2022, and then just tied to that should we still be expecting kidney volume data this year, which might be available with FDA, depending on the outcomes and then my second question is again back to influenza.

Okay, we are strong for Q and a stronger stronger than the third two which was above your previous comments. So I guess can I just ask what drove the stronger than three key performance.

And secondly, how should we think about the flu progress in 'twenty. One you would expect patients who took a vaccine. This year that typically do not to fall off in 'twenty, one and should the pandemic be in a better position or do you expect incremental demand in 'twenty one thank you.

Thanks from all I'll come to Bang the start in a moment.

I could comment before John but let's just do flu, while we have the town. So Q4 over Q3 and also outlook for 'twenty one.

So Q4 versus Q3.

It's related to the three drivers we've mentioned before and clearly COVID-19.

As shown an increase of in transit rate in 2020, and therefore, there was an expansion I would say of the season and the balance between Q4 and Q3 are.

Moving forward, we expect to see Q3, and Q4 are roughly 50, 50% balanced of course, there are many different different factors influencing that for example, what will be the new strains when theyre announced with the impact so as we get more data points will be able to give you some more guidelines from that in the coming quarter now when it comes to 'twenty one outlook.

We've observed in the past is a slight decrease in VCR post pandemic sufficient so there might be a couple of points down next year in terms of overall in front of us here, but with very very important and very specific to the Sanofi Pasteur portfolio influenza vaccines is that is the growth of our differentiated flu vaccine, which come with a premium in terms of.

Efficacy, but also playing them in terms of pricing and the and I think that from a value perspective, we'll be able to be well positioned to deliver on our mid to high single digit growth.

Ambition that we have other GPU and influence that would be a part of that.

Thanks, Tom and John will come from Bang and stuff, but maybe you know we are going to go through it a little bit more detail later, our capital markets day, and I think we're among your Yo Yo summary, if you like was spot on at least how I felt when I saw the data there was a.

It's one of those.

Paradoxical moments where.

Although we were disappointed in Parkinson's for those that are struggling we increased our confidence outside of that so maybe I'll, let John.

Answer.

Yes. Thanks for the question just to get to the question that you asked about controlling kidney volume and when we will have those data that will be next year.

John will have that readout.

But in terms of the mechanistic hypotheses. We're testing it is different from the Parkinson's situation in the context of the autosomal dominant polycystic kidney disease.

The Glycosphingolipid said are being impacted through the modulation of that pathway.

Our acting like signal transduction molecules that affect differentiation.

The kidney sales and so it really is a different mechanistic hypothesis really an independent hypothesis compared to what we tested in Parkinson's.

Great. Thanks very much.

Okay, Jonathan will Ebix will come a little bit more later, the read across but I think you got to the number of them next question the net.

Question from Jo Walton at Credit Suisse.

Please make sure you're on mute your phone.

Okay. So let's move to Graham Parry at Bank of America Merrill Lynch Graham.

Great. Thanks can you hear me, yes, okay perfect.

Just going back to vaccines again, I'm afraid to say could you just help us understand what growth in vaccines is assumed in guidance in particular for flu I think Thomas did you say that growth should be a couple of points down on 2020, but you're still expecting safely grow off that two and a half billion base and what sort of recovery in cadence of coverage.

Expecting in travel meningitis and based his and presumably that's all sort of second half loaded and secondly on detection, obviously accelerating growth in fourth quarter on prescriptions and can you just help us understand what's happening on pricing as you go into this year has it been any pressure from payers at all or are you still enjoying.

Pretty good coverage without too much pressure there and then third question is just on other operating income and that was around 100 million lower or the expense saves let it about 100 million lighter than consensus we actually have quite a high regeneron pay away and that is it just are there some low level one off gains are sitting in that if you could just.

Help us understand the size of day. Thank you.

Okay, well, we'll start with Tama I would just add that I think we would all believe as much we'd love to be back traveling again.

The the more exotic travel apps will be much later in the year and perhaps the beginning of the following year, but Tom I'll leave it to you.

Thank you Hi, Graham.

Basically no what I was telling thing is that it's important to be precise. The overall vaccines GPU growth is expected into the mid to high single digit trajectory as we've committed from the 28 to 2025.

When I was mentioning minus 2% to 3% is on the vaccination coverage rate for the full market. So it's not about Sanofi Pasteur and when it comes to US we expect influenza to remain a key growth driver of our overall trajectory next year and the years after and again, it's about a few factors you understood the importance of it.

If we had <unk> who's an idose growth in Europe, and still in North America. That's very important we expect this of Hoobler growth.

To keep going.

What's also important for you to know that we discussed it in the past, but you know that we will keep investing in our capacity, notably in 2021, we'd have to start of a new U S facility for Susan antigen that will start to produce from the year 2021, we've committed in the bad but of course, that's an important driver when it comes to frozen idose.

Same thing we are also investing into our vaccine grip influenza trial vaccine sorry in France in order to make sure that we can we can meet the demand. So that's very important moving forward for flu in parallel to sustain the mid to high single digit growth of the GPU the recovery in meningitis, you've seen in the Q4 that the meningitis.

Turning positive and therefore, we expect these to come back in 'twenty. One that's an important part of the driver as mentioned by Paul I expect traveled on that image to still be impact in 'twenty. One for the obvious reasons. We know that's more of a 'twenty. Two play you know all of you.

But you've also seen it I, let it at the beginning of the call that the pediatric combination have done well this year like the previous year and we are seeing that in emerging markets. They will keep their growth trajectory in 'twenty one.

And as Thomas Bill, maybe you want to jump in on two P access quarter, one and onwards, what you see as the dynamics yeah. So thanks Graham So first of all we're in a really highly favorable access position, we have greater than 95% of commercial lives, having established U M criteria for a b and.

Asthma and you know, it's we've as we as we launch the product we know a couple of things we knew that we'd be in multiple indications and we knew that there would be competition in the future. So we've yeah, Chris just strategically approach this and we've and we've done very well looking ahead to Q1 and Q1, you would expect like in every other.

Q1, you have kind of a resetting of patient.

Insurance, so your patient assistant programs and so forth have that impact, but we believe we're in a really strong position clearly when you have competition coming in and.

The more companies there are you expect some.

Impact on gross to net but you know as I said, we started out with a plan knowing exactly how the market was going down in Baltimore, We think we're in a really favorable position for Q1 in 2021 in general.

Thank you and then to be right.

Yes Graham.

You just put it perfectly effectively we have a prime accumulation of smaller deals you know we are very active on the fault of divesting some of our.

Molecules they need people from both of your billings in that goes from a household so.

To execute on our commitment to the capital market day, and we are effectively executed on it's almost computing to a 100 million below 100 million EBITDA.

Quite clear on Q4.

Cash why is that it's much more important what we are doing but as you know we are pushing down some goodwill accounting wise when we are when.

When we account for those sales so it's not very.

Really impacting and be right, but Q4 was higher.

Thank you our next question so.

So I have on the caps and two questions from sales.

The first one is on 2021 R&D news flow specifically with regards to this day by day, everyone institutes around at what the new timelines or the second one is could you be more specific in where you intend to redeploy the 500 million additional savings.

Okay, well then John maybe you want to update on there was there a want him to Tucson for this year and other elements of a more broad question about news flow for this.

For 2021, Yep, John Yes.

Yes, thanks, Paul So bib tableau, one which is now known as Fnf's Okta Cog Alpha.

Alright, we have dosed.

The last patient is now the stroke study is fully enrolled last patient has been enrolled.

A 52 week study so that'll be reading out early in the following year.

So we are slightly delayed due to COVID-19, but are still expecting to have a submission in roughly the same timeframe that we've disclosed previously with the tusa ran after the voluntary hold to reconsider dosing schedule. This study has now been restarted.

97% of patients remained on study the investigators and patients were very eager to resume and we're delighted that we were able to get back on track with that study will be having dialogue throughout the first part of this year with the health authorities in terms of what.

Additional evidence they'll want to see in order to submit the NDA.

So we don't yet have an update for you on the timing for the virtues of Ram final submission.

John broader news flow.

For 2021.

Wherever 'twenty 'twenty, one we will have eight pivotal readouts that will include the amps and instrument in the first half of the year for the monotherapy and the second and third line breast cancer as well as two lib Tayo readout.

And then in the second half of this year, we will have to do picks and readouts.

For spontaneous urticaria, chronic spontaneous urticaria as well as for.

Pemphigus nausea layers. So two more dermatology indications will also have rails ibrutinib pivotal data for pemphigus Vulgaris. Another dermatology indication and then we will have a readout for short clues.

In the frontline myeloma context for the transplant eligible population, so expect a rich near year of new flow throughout 2021.

Thanks, John maybe just add them and maybe we'll talk about a bit later, but the investigative feedback from Tucson, and everybody was disappointed that we'd be on a voluntary hold but actually has provided us with some much richer insights into what the potentials for interval in dosing, which while nobody wants to take a short delay actually we think the profile main.

Improve so we will see we'll see what the data says, but it was we wouldn't have found this out I think unless we've been on this journey so okay.

Next question, Yes, another question from the cash.

From Geoff Porges.

Yeah.

What proportion of your volume now in the U S and globally and premium brands. This is for influenza vaccines.

Volume question on splits.

And second part is underway with a combined few COVID-19 vaccine and do you believe COVID-19 will become another repeated.

Yeah.

And Todd just before you answer those great questions I did neglect to throw the question to JP on the reallocation into R&D.

Oh, yes. Thank you.

And final question to read through what happened already in 2020.

Because it was a very significant swinging to the half a billion.

Savings in 2020 from effectively.

B trash within our portfolio. So it wasn't happening very quickly and you're sitting on my on my slides about savings.

That's why in 2020 already we saw an acceleration of the spend of R&D in specialty care and that's where we are of course investing efficiencies are also helped.

Accelerating this level of spend in R&D in specialty care. So you were asking of the 500 millions of next 500. When you yes. It will come a lot of them will come this time from Cogs.

Which will of course Tayo, Chris the improvement we are expecting on the gross margin and yes. We are looking at reinvesting them, because we are gaining confidence on our topline growth. So we it makes us much more confident that we can reinvest it behind our pipeline, which is of course more and more promising we need to invest into.

So you remember that with centre ex Principia Archea. These came up all.

All those companies we are required we will have the underlies them of their cost in 2021. So you can expect to see effectively R&D spend.

It's been going up but in a completely different contexts, and before instead of being spread out all over the place it's really connected to our priorities in specialty care on an in vaccines.

Yeah, I think I hope it gives more color to what we are we're executing actually being tomo.

So that first two are two influenza and then I took about COVID-19 saw influenza again I think what's important to have in mind is that with the new fluids and antigen building coming.

And online in 'twenty 'twenty, one usually expect a growth of both our differentiated vaccine E. Susan Idose EBITDA.

And two blocks at that day I do expect the growth on both sides of the bone in North America and in Europe, especially for again, if you're a death when they do.

You will see that in North America, you will see that in Germany.

I expect maybe a.

Significant growth in volume and value from the difference you need to know what would be the impact on the standout those flu remains to be seen that's more linked to the vaccination coverage rate as we've discussed before now when it comes to COVID-19 in influenza.

Great question, a little bit too early to have a definitive answer still many things are in terms of our ability to do COVID-19 and flow together you know.

Very well by two as of the day specific logistic that is an annual vaccination, we still need to see what the what's going to be the need for boosting by when.

The COVID-19 shut the duration. So many questions to answer there, but you have noticed that we are very interested you have notice that we're starting phase one of our 19 flu vaccine. This year, knowing that we had the influenza vaccine was light and knowing that we have two shots on goal with COVID-19 should there be an opportunity will be just around the corner.

Thank you Thomas next question. Please. The next question is from Jo Walton Joe. Please go ahead.

Okay. So let's move on to Richard Foster RTP Richard.

Hi, Thanks for taking my questions.

First question, just on China, and the recovery that just your thoughts on the sustainability of that recovery in China.

And and future price pressure and and then aligned to that just a E. J P. You you you highlighted the increasing confidence in the growing top line and I know that you're sort of saying general medicine should be flat out to 'twenty five say do you feel confident enough to give a.

A target like you get the vaccines and consumer in terms of Grace now it looks like it's all grace I'm at going forward, but just your thoughts there. Thanks.

Okay. Thanks, Richard Joe We've tried a couple of times. So maybe you should you want to submit a question on.

Online for kind of would try again, a little bit later, sorry in cases.

Responsibility, let's go to China Olivier Shawn May maybe you have some views on the outlook.

Yeah. Thank you.

The market has suffered of course into 'twenty, mainly due to COVID-19.

Definitely numbers not yet no not for the decrease of the market, but probably in the range of 10% to 11% the markets going to bounce back and we expecting four to a 21 gross or that he's going to be significant 678% net to say more of course as has been the highest pressure and with the implementation of.

EBITDA in the last two years, we see that of course.

The volume growth continued to be very strong in our hand, and we are very happy with the outperformance both on Plavix and <unk> further to the implementation of the BBB.

The China market that remains volume markets in general Medicine and in specialty of course, we continue to see with the legislation Olympic sent an E.

It starts that chorus signed the future a significant portion of our growth will come from from specialty.

Olivier J B, why you're not providing guidance on the future of the business.

Richard I'm glad I'm glad they're captured my my optimism that's fine.

And that's exactly where I am.

I think our guidance, which is quite clear from 2022.

Bureau ratio.

Yeah, we are really committed to deliver on it or whatever.

A nice set of.

Our guidance are there to help your modeling.

We'll deliver on 2022, and maybe just add to that it's our responsibility as the executive team and the wider organization to toggle that way and remember back in capital markets Day 19, we said that we wanted to be able to stick.

Stick to the Beeline, Delever and saying, we couldnt, you've just seen from the numbers full year 'twenty.

You know with the 120 basis points improvement that where.

You can see the line to where we're going and you should expect us to do to deliver those things in them will anchor from that next question. Please.

We will take our final question from and it sounds like a fair a plane.

Please go ahead.

Thank you.

Bill come back on the flu vaccine.

And for clarity.

Should we assume that you will be able to add again about $500 million in sales. This year as you did last year.

And if yes, how can we see as a capacity manufacturing capacity. Even if you are successful with the Covid Your COVID-19 vaccines, which I assume will take some of them from manufacturing all easy new use factory enough to delivers additional flow.

Doses.

Sure.

Tom.

Thank you, yes, so we have.

We have made sure that we always.

Make sure that we secure the day Manafort Kiran vaccines, and then manufacturing and supplying a lot of different vaccines that are critically needed even in COVID-19 pandemic times and we made sure that are.

Our supply capabilities are going and it's not linked to the COVID-19 vaccines development that we're doing so so we have everything we need to increase this.

Before the Fluzone antigen building.

Already up and running and they're starting to produce as we speak now for 2021 Northern hemisphere.

Very important for us moving forward.

Okay. Good.

Looking at things.

It assumes that you may you will be able to add again 500 million about.

No.

So no again.

The story of influenza is going to be a growth trajectory.

Which is a question in between growth from differentiated vaccine versus non differentiated vaccines in a market that most likely in non pandemic per yard compared to pandemic bed will be probably lower so I expect us to perform well in a declining market for flu just on next year, but we are not in the main duda for 500 million.

And of course, because we are not in a pandemic situation I don't know so you need to look at a continuous growth compared to the average trend.

Ideas like that.

Yeah.

Okay. So time is over for the first part so let's meet in 12 minutes Ah study our capital market day. Thank you everyone.

Yeah.

They're recording has stopped.

Okay.

Okay.

Yeah.

Yes.

Yeah.

Okay.

Okay.

Okay.

Yes.

This meeting is being recorded.

Ladies and gentlemen, thank you for standing by and welcome back we are now going to begin to virtual Sanofi capital markets day 'twenty 'twenty one.

Of two days even.

Following the initial presentation, we have planned for a five minute break before the second section of the <unk>.

You may remain connected to this zoom link for <unk> session.

I would now like to turn the call over to Eva Schaeffer Yung Kim head of Sanofi Investor relation Eva. Please go ahead.

Thank you Natalie and glaucoma, we're looking forward to spending the next couple of hours together with you in various members of the Sanofi leadership team to share and discuss the overall progress we are making in implementing our strategy and core parts of our business as well as from transformation R&D as usual you can find the slides on the investors page of our website at Sanofi.

Dot com moving.

Moving to slide two I would like to remind you that information presented in this call contain forward looking statements that involve known and unknown risks uncertainties and other factors that may cause actual results to differ materially I refer you to our form 20-F document on file with the SEC and also our document delicious tumor cell for a description of.

These risk factors now let me take you briefly through the agenda for today, Paul Hudson, Our Chief Executive Officer would start with opening remarks, followed by Dick My bag I head of global development, and Chief Medical Officer, who will provide an update on the late stage priority assets naturally Bickford Chief people Officer will then introduce us to the culture change yet.

On a fee, which is imperative to live in our play to win strategy obligation may head of General Medicine, and Julian on the valve head of consumer Health care will then discuss the new strategic priorities of their respective businesses followed by a Q&A session with that I'd like to turn the call over to Paul.

Well. Thank you earlier today on just a few minutes ago. Many of you participated on our Q4 earnings call and I. Thank every one of you for joining us.

With us for the 2021 virtual couple market.

It's been a little bit over a year since we met at our 2019 capital markets day, and where we embarked on our play to win strategy.

Today, we want to give you a snapshot of our progress. It has been an exciting journey for us and I hope to you at the end of today will be as confident as we are and our amazing future with Sanofi.

Let me start by saying that we are ahead of our six year plan and the one that we shared with you in December 2019. This is even more reassuring in the backdrop of the unprecedented times that we have been facing joined the pandemic.

Ross the organization our teams have been relentlessly executing on this plan and I want to take this opportunity to express my gratitude for all their hard work.

Together, we continue to be entirely focused on achieving the targets, which we have set out for 2022 and 2025.

Our three core growth drivers have delivered in 2020 do pixel with $3 5 billion Europe sales in 2020 has now reached blockbuster status in a quarter and continues to grow strongly. It is Sanofi is biggest contributor to sales growth and this is just the beginning from two pixels amazing growth trajectory later today, Bryan Ford is going to share it.

How he and his team are expanding around this mega brand in type two COPD chronic sinusitis without M P and other diseases and where we are convinced of its sales potential of being greater than 10 billion euros.

Vaccine franchises generated 6 billion in sales in 2020 influenza was certainly the strong driver, but also the P. P. H portfolio grew double digits over $2 billion in annual sales I'm extremely confident that we will continue on a mid to high single digit growth ambitions going forward.

Pipeline is getting significant momentum as we continue to follow the science and we are only accelerating demonstrated by 12 projects entering phase III in 2020 alone John and his leadership team will share with you the progress on the R&D transformation.

So looking at slide seven you can see how it demonstrates our ability to execute on capital allocation over the last 12 months or so we engaged in multiple M&A and BD transactions employing our capital capital to bolster the pipeline in existing priority areas supported by the proceeds from the sale of a passive stake.

And regeneron.

What is driving us, adding exciting science and first in class technologies to our pipeline. We're doing this scenarios, where you ask where we are strong from a capability perspective, whether it was low marginal cost to commercialize and we're accretion can be reached even faster.

Starting with synthetics acquisition, adding four seven or seven the combined so well with other assets in our oncology pipeline and for the first time today, we will speak about four eight O nine fitting perfectly into our immunology pipeline.

This has the potential to address a wide variety of autoimmune diseases.

Moving onto translate bio I think it's worth remembering that we have had a strong relationship dating back to 2018 and that relationship has all been about trying to make sure that we're also going to be heavily involved in messenger RNA now in June of last year before we'd even had a readout in mrna. We also knew that it was an opportunity for us to simply.

Double down so we widened that collaboration we took all of the targets only assets tech transfers. So we could really make sure that we could participate fully in the future if mrna become successful and as we know now suddenly in a pandemic that has proven to be the case.

Chimera in the IRAK four you'll also here today, it's a great fit with our immunology franchise, and we're getting ready to move the first molecule about collaborations into the clinic this year.

The Principia deal gave us full control of Tullow Bruton at the brain parent from Pizza K I, a potentially truly disease modifying asset that we put into four four phase III trials straight up to park a park in the middle of a pandemic. We also picked up reels ibrutinib. Another exquisitely selective PTK I, you'll hear more about this.

Today.

So this is the path we want to continue on to add to the sustainable growth of this company.

We are consistently seeking value, creating opportunities and here, we took decisive action to create a new European industry champion in API manufacturing, we've started with the carve out activities appointed as CEO and we're on track towards a potential IPO in 2022, we will set up this company for success and plan to maintain up to.

Apply chain with euro API, while reducing the complexity within our own Sanofi industrial network.

When we set out on our margin targets in 2019, I remember that many of you questioned our ability to be sufficiently disciplined to reach them well, we are well on our way with margin expansion and increased OBO Oi by Bill our margin by 120 basis points in 2020.

This evidence should leave you with absolutely no doubt that we will not only achieve the 30% target in 2022, but also reached the target of more than 32% in 2025.

Drivers for this improvement will include the continued strong growth of depicts him and we announced today that two pixel is expected to be accretive to be Oi margin by the end of 2022 I suspect that's faster than many had assumed.

On Slide 10, you can see a snapshot of the 2020 sales performance of our four global business units.

We created them in 2019 for more autonomy and more accountability in our execution.

Specialty care and vaccines are delivering healthy growth rates as we are freeing up resources across the group and investing behind our growth engines.

Our focus of our discussions today of the strategic choices, we're making in our general medicines and consumer health businesses in general medicines Olivier will explain to the importance of prioritizing co brands key markets and digitalization.

Judy will give you her management perspective, and how to bring consumer health care back to growth the progress towards a standalone unit and where you where we are importantly on the switches to OTC for tamiflu and see all of this.

So what do we hope you will take away from today, well that we set out to do everything we said we would do now not everything is perfect. We don't pretend to be the case without challenges, but I'm really proud of the organization and delighted with the progress that we've made we are delivering on the fundamentals.

<unk> is in shape to do what we need to do so many great things are happening internally every day that are simply not visible or appreciated outside we want to take the opportunity to talk about some of them today the longer term twenty-three onwards. This is about the pipeline I would like to ask people.

Get you on the status of our late stage priority assets demo over to you. Thank you Paul It's my pleasure to be here with all of you today.

'twenty 'twenty has been a year of true progress in our R&D portfolio transformation and John will provide you with a full update later today.

I want to share highlights on the development progress of our six priority assets.

As you know the Covid pandemic has posed unprecedented challenges for all of us and I'm proud of the agility and innovative approaches to secure the continuity of our many clinical development programs.

Find it remarkable that we were able to enroll more than 4000, new patients in clinical trials in 2020, while maintaining 98% of patients in our ongoing studies with timelines largely unaffected.

So let us turn to the priority assets. Our success story of two picks and continues as we were able to rapidly rolled out our development plan in several new indications, we initiated three new pivotal studies in 2020, and Bryan Ford will provide more details on our ambitions in new indications later today.

We continue to remain excited about our fully owned Serge called Emerson net trend, which is a potential best in class endocrine backbone in hormone receptor positive breast cancer across treatment lines. We expect the pivotal data from our Amira three trial in second line and third line metastatic breast cancer later this year.

We are also looking forward to sharing the compelling combination data from our mirror, one trial, which led us to rapidly initiate our first line pivotal trial in combination with Pelosi glib.

Honestly it was Iran. We have encouraging news to share first Fitoussi ran received fast track designation from the FDA in December and second we resumed dosing in patients in our pivotal trial program in January less than three months. After we had initiated a voluntary pause more under fits with their own program and <unk>.

A minute.

<unk> Oh, one we completed enrollment to meet the end of study criteria in our pivotal trial in December the <unk>.

Study includes a 52 week follow up period and due to the Covid pandemic, we now plan to share topline pivotal results in early 2022.

Then blues that continues to be a highly attractive program for us while we are disappointed by the results of the phase two trial in the GBA Parkinson's disease population biomarker data confirm the mechanism of action of <unk> with both meaningful and predictable G. L. One reductions in plasma.

The cerebral spinal fluid more on the progress of <unk> development in a moment.

And as for near seven Mab Untoward Ibrutinib, all phase III programs continue and we remain confident in the plan submission dates of 2023 and 2024, respectively.

On slide 13, a few more details on fit with your main we remain committed to improving therapy for patients suffering from hemophilia through an innovative portfolio, including the first in class SA RNA. If it was <unk>, which has the potential to rebalance the decision the coagulation cascade without.

Sacrificing efficacy for convenience.

Later today. So it was a rent amended protocol and dosing will be presented to the scientific community in an oral presentation at the annual Congress of the European Association for Hemophilia and while we cannot share all the data gets you to the conference embargo what I can tell you is that the new protocols.

Yes, potentially stronger profile of it towards Iran through a lower dose and extend its treatment intervals in the coming months, we will be engaging with health authorities to discuss the regulatory path forward. So more to come on submission timelines following our alignment with our regulators but.

Early feedback from investigators and the hemophilia community has been positive and the vast majority of patients are continuing the trials at this point.

And on slide 14, I want to reemphasize, our conviction that when glues that has the potential to become a transformative medicine across multiple diseases. As a reminder, when bluestem is a next generation oral brain penetrant, lucasville, ceramide synthase or gcs inhibitor.

With clear proof of concept data in gaucher type three in fob rate diseases, and a potentially transformative effect in the treatment of polycystic kidney disease.

And while the recently completed moves the day study demonstrates that effective gcs inhibition does not show benefit in Parkinson's, it's important to note that the underlying biology and Parkinson's disease.

Is entirely different from rare lysosomal storage disorders, or ADP KD biomarker findings from the move speedy confirmed that when Glu said exquisitely targets gcs and leads to consistent predictable GL one reductions in both plasma and the CSF.

And this reaffirms our confidence in moving forward with vent loose studying our three lysosomal storage disease indications as well as in ADP JD with even greater conviction the safety profile of the assets do.

Due to Covid, we're now expecting pivotal data in ADP <unk> in the first half of 2022, which leaves the submission on track for 2022, as previously guided and with that I hand back to Paul.

Well, thank you deem off for that update and as I mentioned in the last M. D. Not every molecule proved to be successful, but you know that is the natural risk you run, especially when aiming for first in class.

I mean, very confident though in the science, the unmet medical need and the commercial opportunity for all priority assets I think we have some real real game changers in a late stage development, so I'm not going to hand over to Olivier and Julie who will give you an update on the strategic priorities. The businesses. They lead are a big part of our company.

Contribute to amongst other things, helping us finance R&D, helping us to deliver breakthrough medicines, we will run general medicines, even more efficiently being b O Y accretive for the group and on consumer health care, we're making good progress to make it a standalone. So it can be more agile and get back to growth.

Thank you Paul.

I'm excited to talk to you about our new priority engine and unmet.

We are in the process of drastically changing our business model as you read and we remember in the past Sanofi is manta was no small products no small countries. Since then our market environment has evolved and requires a radically different approach in the net.

What got US here, we would not take US there we are now focusing on our core assets in key markets.

This will enable general medicine to remain a significant contributor to group, Hawaii and will fund Sanofi specialty care pipeline.

As you can see from the chart on the left Gen Med GB with sales have been declining consistently over the past years, mainly as a result of the loss of exclusivity of parts of our portfolio. Most of the decline has been driven by price while overall volumes have been strong.

Capitalizing in recent years in fact, cardiovascular and metabolic medicines remain critically important for chronic disease management among large population.

Especially in emerging markets. We're at a scary from policies are Amy at improved patient access and affordability.

We believe that I'll call Ive said switch today in total represented 40% of general Medicine sales.

Potential to grow mid single digit Geiger over the period up to a 20 to 25.

By two of 25, we expect these assets to grow to 60% about sales base.

Within key markets, we will deploy our innovative go to market model to unlock the full potential of these markets. We are progressing well with streamlining Sanofi long tail of small products at the same time, we are reshaping our industrial network to reduce our cost of goods and improve our gross margin.

Our commitment is to generate the same level of sales into a 25 as we did into 'twenty, thus stabilizing sales of general medicine overtime.

This however excludes the sales of your API, which I expect it to be the consolidated into 'twenty two.

The overall resilience of our business makes us very confident in our ability to deliver significant upside to come onto a 25 consensus estimates coupled with a net creative and stable.

Margin ratio throughout the two of 22 to 25 period.

Moving now to the next slide and taking a closer look at all of patent established product portfolio, we benefit from two important trends first the graphic on the left of this slide depicts the global volumes are stabilizing and the recent jurors following the meaningful impact from L. O E such as Red envelope.

U S and Plavix, Japan in prior year's second loving nooks and Plavix off standard of care treatments in treatment protocols, which offer the potential to capitalize on growth opportunities in China and emerging market.

The low molecular weight heparin markets continue to grow with Sanofi as a market leader. In addition, we expect label expansion for Lovenox into cancer associated thrombosis. Later this year regarding plavix. The antiplatelet market continues to grow in volume, especially in emerging markets driven.

By an aging population, increasing incidence of coronary artery disease, and ischemic stroke and in China, whereas the penetration into the Antiplatelet market is telling me that usually low off successful BBB strategy that is 90% nine zero volume growth into 'twenty.

Going to next slide in our core assets portfolio, we have four patented brand with meaningful differentiation potential as discussed earlier, we intend to focus on selected markets with class expansion opportunity. For example, praluent is the only pieces canine associated with.

The reduction in all cause mortality and offering a one monthly single injection in the play.

It will depend.

Cholesterol lowering market has gone to expanding at a rate driven by improved cardiovascular outcomes, we will particularly focus on China, where we launched <unk> in April and have already more than 5000 patients treated.

We intend to re launch pilot in Germany, which is our largest markets in Europe.

Now, let's talk about smelter.

This is the only on TRA pig drug to reduce the risk of serious visualization for arterial fibrillation and the only drug currently actively promoted in the U S. You data was recently published showing the CV benefit of controlling the reason early in Afib patients.

Moving now to diabetes, we will compete in selected markets across Europe, and key emerging markets continuing to drive market share expansion as mentioned to zero a leading next generation basal insulin is expected to continue to grow driven by new launches in that part.

Emerging markets, such as China, Algeria, and Turkey.

We expect further study readouts during this year in both type one diabetes and cognate chronic kidney disease moves.

Moving now to <unk>, our focus will be a large emerging markets, where approximately 70% of global EM excuse is located in the U S. We are shifting our promotional efforts as opposed to weigh these segments for patient with a one C levels above nine bottom line we are.

For differentiated core assets with potential for key markets.

Let me now and over to Alexander <unk> head of our global cardiovascular and established product from China to share some more detail on our tactical approaches. Thank.

Thank you Olivier I know, everyone and very nice to be with you today moving to slide 19, we have thoroughly analyze our portfolio in the markets, where we compete because I'm taking from this analysis, we plan to focus from 13 key markets without causing which include the U S. China, you find and select key emerging markets, such as Brazil, Russia and India.

Yeah.

You can see from the Pie chart on the slide these markets are expected to make up roughly three quarter on for John.

Our own medicine sales in 2025, we will continue to adapt the operating model in the other markets I'll focus on key markets correlates with a significant amplification of digitally enabled customer interaction. So that we can address the needs of a customer in a more efficient.

What is impactful we our goal is to become the 70% of our HCP interactions supported by digital platforms over the next three years compared to only 30% in 2019. This is a bold move and we are confident in achieving this target actually it's already went underway treat a reason why we have confidence.

Our digital material provide relevant trustworthy and fresh content. We have received very positive which is very positive feedback from our STP customer, which has provided us with evidence of their acceptance and appreciation, especially during the pandemic second we have recently built digital infrastructure.

And between food, a large scale content factory and haven't really reach a critical mass on <unk> mission of around 60% of HCP target universe.

Is this we are already generating positive interaction with a large volume per customer.

Lastly, we aim to integrate our main digital channel in all our key markets by the end of this year. This will enable us to further improve them individualized customer experience and progress towards our next best action powered by artificial intelligence is that activity.

Thanks, Alexander now moving to the next slide you may remember that at the capital market day in 2019, we announced our intention to streamline our third product from around 300 branded product families down to one annoyed by 225.

We are making great progress and already reduced our mature portfolio to 180 product families by end of 'twenty.

I had a target clearly reducing the complexity of our portfolio is a critical lever to free up resources and unlock value from our core brands.

At the same time, we are optimizing the remaining assets using the number of skus and concentrating them in the top decile plants.

Is shaping our industrial network to achieve higher utilization rates and greater focus is expected to lead to cost of goods improvements and contribute to our objective of keeping the gen. Med D. Oi margin ratio stable during the next five years.

In summary on my Lifeline I hope, we were able to convey some of the excitement around our decisive actions that will be fundamentally changing our alcohol business approach and go to market model.

Inside General medicine with scar assets in key markets.

In executing on our plan. The Gen Med business is expected to be accretive to group B Oi margin and they're resilient contributor to group Hawaii.

This transformation is already underway.

And while it would require some time before stabilization of general medicine sales will be achieved I expect to be able to share initial successes of our strategies choice along the way with that I and over to Julie. Thank you and this is I'm delighted to be here today to share with you.

My perspective on the role of THC and Sanofi is transformational journey I've only been with Sanofi for five months and I'm convinced that there is a significant value to unlocking our kids. He didn't I also have with me Josephine for Barbara Our Chief Science Officer for CTG, who comes with a wealth of expertise on switches.

Starting on slide 23, as you know over the past couple of years, our CLC business has been performing below market growth. Therefore, it together with my team as part of our play to win strategy. We have decided to focus on three pragmatic strategic priorities to unlock growth.

First we will address our legacy of Nevada complex portfolio, but over 250 brands.

Our performance has the impact that year, the byproduct related issues on many of our children.

The good news is that we have a very well diversified portfolio across countries and categories, which still untapped potential in both or a strong global and local brands and.

And we have the opportunity to build on these strong acid embracing our complexity to unleash the potential of this brand.

You'll see here a similarity between what Olivier Sheridan Gen Med divesting, where it makes sense to free up resources to focus on what adds value.

In other words, we will reduce the complexity of our portfolio portfolio, sorry by swiftly divesting our tail brands concretely, reducing the number of brands, we operate by roughly 60% in two years from over 250 to about 100 Grand.

We will also optimize our go to market model, we will remain present in all the countries. We are in today, but our model will be more tailored by geography.

At the same time, we are embracing our complexity by taking a more granular approach not being only focused on the big categories and global brand, but focusing unattractive subcategories in key geographies based on consumer trends and our portfolio strength and opportunities with the ambition to outperform the market as early as 2022 and he specific.

Areas.

And in addition, as you're well aware, we have two major switches.

She Alice in Tennessee, which are expected to be key pillars of our future growth Trust my team and I are getting are putting significant effort behind these opportunities, which should contribute to reaching above market growth from 2024.

Second key pillar of our future success is to change our mindset to become a holistic consumer centric brand building business, a mouthful, but very important to unleash that untapped potential of our brands delivering consumer driven innovation and bring sustainability at the core.

Becoming a fully integrated Standalone PC business is a key enabler to move faster in this journey finally obvious digital.

A key driver of this strategy and we're accelerating our digital journey by building a true data and digital edge ranging from data driven decision, making to accelerating E commerce and developing it still has opportunities.

My vision is really to make our business the best consumer business.

In the World and four day work to achieve this as of this year as of now my focus is on a flawless execution of our strategic priority.

Moving to the next slide I want to give you an overview of the market potential.

The global OTC market is $130 billion market, which is anticipated to grow four 5% CAGR over the next five years and when including other channels such as E. Commerce. This CAGR is predicted to grow up to five 6%.

As I shared in my previous slide we are taking a more granular approach looking at consumer and market trends, we will from you're focusing on a subset of the overall markets to appropriately capture value and maximize our brands be it local or global brands.

As an example, instead of looking at the allergy cough and cold category, we will focus on allergy, where we are already well positioned and are getting ready to accelerate as you will see on the next slide.

These subcategories, our 51 billion market overall growing faster than the market and that again is excluding ecommerce. So as day represents today about one third of our CTG business.

As you can see on slide 25, and then do we have a rich portfolio of strong global but mostly local brands in these fast moving subcategories.

When looking at our leading brands. We're currently ranked number three in allergy number one in general paint and number three in body pain globally.

You will likely recognize allegra one of our most successful Rx to OTC switches, which along with that though I'll have driven the growth of the business in the U S, making sanofi a preferred switched partner in the industry that you've kind of local love brand and the leader in the pain market in France with around 60% market share and brand awareness is highest Coca Cola at 99%.

And we have more love brands, such as IC Hot America's number one topical pain relief brands or door flex in Brazil, and number one pain relief Brent.

Moving to slide 26, I wanted to share with you. The example of the mental wellness market or more specifically seats, which is a subcategory within attritional.

And as a consequence of the Covid pandemic is anticipated to grow in line with the market over the next five years and I've, obviously faster than the markets. When we include ecommerce.

And then he can these consumer trends and even if it has not been one of our key priorities in the past we have decided to focus on mental wellness and we are already have some high performing local brands, which we want to accelerate in the U S. We have unisom already one of the leaders in OTT sleep and growing faster than the OCC seat category, we're now entering the largest and fastest.

Growing keep a segment, which is natural with the launch this year another.

Another one of our very well known key brands. This time in Europe isn't overnight in December.

We launched a new campaign in France with immediate double digit impact on growth plus 20% growth versus the market at this 12.

Honestly, the more time I spend on our brands the more I see the opportunity to grow them into truelove friend strengthening consumer engagement through insights data and leveraging digital.

And our strategic priorities are all about unleashing the potential of our numerous brands and as a result unlocking growth.

Now on slide 27, the creation of our Standalone business is an important enabler to our strategy execution and we're progressing well.

The design and planning phases are complete we expect to have operation is the majority of our seat she legal entities by the end of 2021 and the relevant social processes are in schedule.

Being standalone means that we will have a fully dedicated organization, making us more agile competitive to unleash the potential of our brands and deliver on our switches.

With that let me hand, it over to Joseph Kim to give you an update on where we are with our two rx to OTC switches.

Thank you Julie Hello, everyone and it is my pleasure to be here with you today.

On slide 28 as mentioned by Julie Sanofi has a successful history and switches with a lag runs ISO language. The 50 largest rx to OTC switch of the last 20 years and we have a very experienced switched them hope at twin them.

Walks on every U S switch over the last 10 years.

With a total of 1 billion euros and sales potential not only do we believe that China's Chris Rx to OTC switch pipeline is the largest in the industry. So far but more importantly, we intend to provide broad access with this switches and thereby help millions of consumers.

Tamiflu in Seattle is which we believe will bill first in class will have a significant impact on sales came in the U S and empower consumers to take ownership of their health and improve the quality of their lives.

Oh SA CCR at least has the potential to allow more sufferers to obtain treatment, whereas safe effective and reliable product without the access protein.

While OTC tamiflu has the potential to reduce the emerging on health care systems due to inflows of office visits and hospitalizations, particularly in situations like we're currently in today with the COVID-19 pandemic.

Inherits with being first in class. These are not easy switches and the planning gets further complicated in the pandemic environment, particularly for Tamiflu. However, we are in continued discussions with the regulators to ensure that these timelines can be maintained both programs are fully underway with extinct studies initiated.

Putting that in 2020 and half of it had been converted to virtual studies. We are currently on track with the case studies, we need to do to meet the target of lunch day. One of those critical started this is the actual use trial, which measures whether it's cash subjects and appropriately use the product. According to the labor line without medical supervision.

Andre has stimulated OTC environment, we believe no other manufacturer has breached the actual use trial phase in the U S for an OTC switch offered erectile dysfunction medication, we believe will be the first to do so.

The first patient in its plans for the actual cash trial for CLS. This year and in 2022 for <unk> with that I'll hand, it back to Jeremy for some concluding remarks.

Thank you Josephine.

So on slide 29, just to summarize we are committed to delivering best in market growth from 2024 with the potential addition of $1 billion to the top line from the two switches.

And as early as 'twenty 'twenty, two we will we plan to have our priority brands in selected geographies growing above market, including the U S and China, the two largest Jean tea markets in the world.

Our model is a true consumer centric model designed to unlock the value.

Supported by consumer insights data digital E commerce sustainability and excellence in execution and.

And our standalone structure structure will allow us to be more agile applying fast moving consumer goods standards, while leveraging Sanofi has expertise and capabilities were more efficient. Thank you with that I'm handing it over to Paul.

Well, thanks to Julie and Olivier and Josephine and Alexander I Hope you get a sense of the major transformation on going on those two businesses and how a prioritized portfolio will enable us to continue to drive growth and innovation.

And we also talked to 2019 capital markets day that is part of the play to win we need to reinvent the way we work.

So it is my pleasure to introduce our new Chief people Officer, Natalie Bickford to talk about how she's going to ensure that we have the culture change that is simply so imperative to deliver on our strategy. That's me.

Thank you Paul and I have to say they don't come in from Chief people officer to be invited to take part in a capital markets day. So I am delighted to be here and to share with you what we're committing to achieve without people in service of a patient.

Let me start by sharing a quick overview of my professional experience because indeed like most of the new members of the X from I haven't joined Sanofi Dara from them.

Online industry.

Many years ago I was the U K charter, if astrazeneca and indeed, what slumped by the young for Hudson, but I've spent the majority of my career in highly consumer facing businesses like kingfisher that.

From a statement, which are low margin high budget organization, but you have to place you back and ruthlessly from central asset.

More recently I've been keen to get back for financing.

Glenn just changed and I felt a strong emotional engagements with Sanofi Pasteur and in particular to the strategy laid out Michael.

So I spent the last five months listening and learning and thinking about the role that HR needs.

The delivery of debates Wayne strategy over the next five years.

And some of my first impressions are that we've had is some more inward looking culture with too much corporate treacle.

Patrick and complex and it weighs about pricing, but what I will say found is that our leaders from a huge amount of energy and enthusiasm to deliver the win strategy.

Accountability and getting actively involved in evolving our culture.

Having all my senior needs is onsite is critical but to really main things, we need to engage the entire workforce and delivering culture change.

But you know coach it can be a difficult and somewhat vague concept to bras. So we've identified four play to win behaviors as proxies for the new culture that we need to live and breathe and by applying these behaviors to every decision that we make and every action that we take real change will come on.

On slide 31 these behaviors.

The stretch, which means taking calculated risks pushing ourselves out of our comfort zone and ruthlessly prioritizing Ottawa.

Take action, which means focusing on outcomes rather than activity and delivering against our priority.

To ask for a patient from customer, meaning freeing up budget to develop a pipeline, making sure that whatever we do we see a really clear linked to how this is done to deliver better outcomes for patients.

And finally think Sanofi fast, which means always prioritizing the tanker company over our own interests. Although it is about our team or a direct business area.

On Slide 32, let me give you a brief I emphasize our Nissan ACP Pro strategy again Bill.

And when we want us as a company to focus and deliver in four priority areas offer.

Our first pillar is healthy organization.

And we want to create a lean and adaptive organization with clear clarity of accountability.

In 2021, we will successfully launch the new consumer how genmab and your API and organizations, we will anticipate and acquire teaches scale needs with a clear focus on digital capability and we must also develop a world class talent pipeline to feed fresh and it's a key role to ensure our future success.

Our second pillar is powerful experience more than ever today, we are in a war for talent.

So it's we're trying to keep the best people, we need to create a highly compelling lack experience and give them a real fundamental Chris apart that.

Not enough people outside of Sanofi appreciate the amazing career opportunities as we can and do provide and this year you will see us delivering highly proprietary and compelling employee value proposition.

I thought there was winning culture, we Mustang from a place to win behaviors that I've just highlighted across the business to ensure that we need to leave our old ways of backing behind them and embrace the new culture, we need and in 2021 from BCA, we will sales the patron behavior into all of our people journey from recruitment performance management learning reward.

And talent management.

The fourth and final pillar, which is particularly close to my heart is by Dusty edge. We've already made strong progress on gender at a group level, but now we need to broaden Alan cover all strong diversity.

The business is provides some advantages that come from driving Barbara if the workforce and an increase of environment of relief from a member, let's say highly committed to drive our relationship with the diverse communities that we serve including better reflecting our communities and clinical trial driving supplier diversity and involving all our leaders and relevant local community project.

This month for a law in Chinese Sanofi DNI strategy with clear deliverables around building representative leadership, creating a work environment, where we can bring up ourselves and engaging with our diverse communities.

So in a nutshell, there's a lot of what to do but I have a clear focus on our robot culture evolution and why the people priority, we're not starting from scratch. It's all with building on solid foundations, but the trick now is to be highly focused on these deliverables that will tangibly drive our company from them.

And more than anything this is a super exciting time to be part of the Sanofi story.

And with that from patchy ever.

Thank you Natalie So we're now moving to our Q&A session interesting now remind you how you can ask a question.

You have two questions do you participate in the Q&A option. One if you would like to ask a question. Please keep the raise hand icon at the bottom of your screen.

It won't be notified when you align you something to ask a question option to you may submit your question by clicking the Q&A I couldn't at the bottom of the screen and your question will be read by a penny East now.

Now we will take the first question from Simon matter at Exane Simon. Please go ahead.

Good afternoon, everybody and thank you for taking my.

My questions and the first question Oh. This is really just maybe some guidance on general medicines, obviously, you want to keep revenues flat between.

Now in 2025, and you delivered $14 7 billion.

In 2020, if you look at consensus estimates.

Significantly below this number and on top of this consensus expectations for your margin are also significantly below.

I was wondering if you'd help square the circle in terms of pace. We should use for 2020 I. Appreciate you have the main currency might be I am coming up so that's one aspect of it I hope that it would.

It would be a very very welcome and then.

And then the second question and maybe this is a bit premature, but just moving on to consumer health and you've outlined your growth aspirations in fact for it to be.

By the end of 2022.

I'm just wondering beyond 'twenty two how we should think about it at the division and whether or not we still believe that.

The best homes from the assets, especially given the strong growth profile that will be.

Entering in 2022.

Thank you Simon.

Olivier comment on the base and the things, but just just my own observation is coming in.

When you look at all John Med business. This isn't a carryover established.

Our products business. This has got some real growth driving opportunities in it and an opportunity to be more efficient. So plus I think sanofi is pretty unique in its ability to work in some of these markets and deliver with this sort of entrepreneurship and you may say well doesn't everybody, who say that I would say how the company was created and its legacy.

Touched on by Olivier New country to smaller medicine, too small I think we have more ability to extract more value. The most which is what made us dig deeper because to get the sales back to where they were and to help you guys understand that estimation on decline is is just too easy given.

And where we think we can actually go and beat that that's a really important fundamental piece of understanding and perhaps a misunderstanding I had before he came in and a much clearer now route that I see it Olivier.

[noise] basis 14, seven this includes 500 million of API that will go with the Oh API project of course, I'm projecting ourselves in the next two or three years, Oh, we're going to get there it's of course, who focus.

On core assets and key countries, where we are going to allocate a significant portion of our resources and it's also about you know, making sure that we stabilize the day gross of our noncore asset sales.

Really grows on the Gulf assets volume growth and of course stabilizing as much as we can the noncore assets.

And and is truly a great work being done already again, just to remind everybody that we were challenged by yourselves and others around the sort of opening the black box a bunch of med business you could get a sense of why you Shouldnt just make an assumption pocketing such an important piece so you'll see it.

Tun as we share the progress made and that's why we think we can be what you guys have in models and why we will update you regularly on that the other question was on.

At creating a more valuable business and always still going to be the best owner I think.

You know our entire effort is standalone increase agility provide focus give julian the team the wind at our back to go and get growing faster than the market. I think you know the switches are such a big opportunity and particularly at a time in our evolution. After a buzzword patent expiry, where I'll focus.

Is single mindedly on growth and preparing for switches and we're not thinking about anything else and we hope to create something incredibly value here inside the organization it's Chris.

The next question is from Luisa Hector at Baring Bank Uhm Peter.

Go ahead.

Yeah.

So net.

Yes.

Thanks for taking my question.

Vaccines.

We are reiterating your target equates to 2025, I, just wonder whether you have a wider spread on that.

That number.

Kevin potential mrna vaccine disruption.

Maybe with that in mind, you could comment on your mrna flu vaccine programs should we see that as an extension of your differentiated offering and flu vaccine.

And is there any color you can provide and presumably this would have to be single day to be competitive and do you think regulators will require head to head studies.

Non inferiority or superiority endpoint.

And maybe if I could just ask a quick one.

And the relative profitability of general medicines that day.

Specialty day, and how you see that in 2025. Thank you.

Okay Luisa. Thank you for those questions, we'll come back to J b on what we have shed or not shoved around relative profitability.

And we'll come to Thomas on.

You know the evolution of the business mrna you know look it's a it's a question that's being asked all over the place maybe you can give a perspective on timelines from potential areas of disruption in areas, where the we don't anticipate disruption than our own role in influenza.

Definitely.

Yes. Thank.

Thank you Luisa so so in terms of M&A descriptions as mentioned before definitely we see ammonia is a very interesting technology.

That's why we started with the TBO partnership in 28 extended in 2020, and where we see the potential is definitely in getting to new territories, especially in a viral diseases. So so we'll start as mentioned before by phase one in flu. So now where is it going to land on the on the influenza.

It's very early to say, we need to have the day that first and we're not there yet.

I need to which there sorry about that.

And so we are in phase one right now.

As you mentioned I think it is very important I can give you my perspective on our two IC and Melanie.

I think it's very important to have in mind first but when you look at the Montney for flu is going to be very different when you look at the development of the vaccine in a pandemic situation that could easily from COVID-19, when we are looking into it once the development of our field, whether it or are we just turned off gear for flu for example, so.

I'm alluding to the second part of your question what will it mean in flu. There is already a standard of care in terms of efficacy in terms of safety. So what we would want to see that with mrna, especially from a Melanie we are building one single shot there almost stable with a rapid logistic all over the world where it's required every.

Single year to provide assured but at the same level of safety milestone that seasonal flu I remind you that the 50, <unk> proven and very strong and the same level of efficacy and I'd remind you of a difference you see two vaccine and seen double digit increases the efficacy when compared to standout those flu vaccine. So there's a lot we need to see it's still extremely exciting.

That's the way, we're getting there, but there's a lot of things we need to see so that's going to take a few years. It will ask phase one phase two phase three when it comes to seasonal flu. It will last for comparison as you mentioned it will probably require multiyear check because you want to see not only one year, but two years, but it's successful but of course when you look at the portfolio, we have in flu and the partner.

We are within a mile of an antibody you, but an interesting opportunity beyond flu and I think that's why it's very interesting. There's a lot of viral targets with mrna vaccines development could be super exciting. We are seeing some target that had been started by the competition. We are of course in the in the.

In the middle of defining exactly where we want to grow of course, we have not communicated on that path for obvious reasons, but it's extremely exciting to look at how fast we can go into phase one trials in the coming years, when some barrel making target now.

The earlier part of your question was more about the <unk>.

I would say target for growth for the vaccines GPU.

I won't say much more specific even though youre probably interested but we are really looking at mid to high single digit growth from 2018 to 2025, but it was a commitment and I think it's very important to highlight that is based not on one single pillar, we're not a flu vaccine company, we are multi vaccine company.

Bill on flu pillar is built on pediatric Commission Peter is built on the coming launch of our Xenial City Mab. So we have a lot of beloved, but we will show that growth.

We'll take it year by year, but we have this mid to high single digit ambition for six year and flavor Ya.

Thanks Thomas.

You know Louisa it doesn't change our commitment of state it doesn't change and will participate in the next wave of innovation we do.

Don't think it's an easy ride for us either by the way of mrna in influenza and et cetera will be that and we know how to do it.

So jamba team, maybe something on the relative profitability.

Yes.

I think youre asking exactly the right question.

On I think you know very much.

What is the answer but let me give more color with what <unk> heard from a from Olivier today.

Yes, John Matt is a very accretive business I mean, it's a b Y play on we have to meet so today.

Not only we want to keep it stable over time in terms of size. When we want also to maintain them. That's what we're looking at this I create accretion overtime. So what's going to happen relatively to specialty care is just that demand will stay where it is why we bring progressively specialty care at a higher level.

Which will help of course global net levels.

You have a first proof point with what's happening on the <unk>, but of course progressively it will also happen with other products.

Now the specialty areas, where we are investing so the R&D effort is increasing on that area. So it will be a slow motion, but it will go into the right direction.

Thank you J P.

Right.

The next question is from Peter Welford Jefferies Peter.

Hi, yes, thanks for taking my question.

Quick question on the consumer and then actually just.

Yeah.

Peter last June.

We may go to the next question I'm sorry, David.

I think Kevin sorry, I think you cut me off.

Right that's right that's what I got a question on consumer.

So.

Curious David with regards to the Rx to OTC switches, there, obviously phallic luxury use trials sooner than tamiflu, how much do you potentially launching before that is that just related to the complexity is obviously the E D markets and flow or is it somebody else could you should read into what's required here and I guess for Paul or maybe also.

Julie just with regards to how important essentially bolt ons are and you can see the strategy you you didn't mention the potential need to bulk up any of your franchises and I guess from pulp perspective.

Education with the risk capital allocated to be able to do that shouldn't be deemed that the best to reach growth.

Sorry, just coming back then to J b.

Just trying to understand maybe you could give us some clarity how many years forward should be think about gen med still being accretive I mean, maybe I'll just quickly you don't get the margins, but could you give us an idea for how.

Longer Gen net is accretive potentially Qi San Jose if you like a crossover I guess is the question.

And then just to Thomas sorry, just back from the mrna is there a phase one I guess immunogenicity or biomarker type Reed, if you could give us a quick yes no.

This is good if you go back say well do we need multi yesterday's tonight.

Okay, Peter well I'm glad you didn't get cut off.

You got quite a fistful of questions Alright, that's all I know is so Josephine maybe you just want to share just some flavor around the switch timelines I mean, I think what we've tried to say is that you know and I think you touched on it the complexity and the journey is one thing and of course Covid is another but.

But we feel confident in and around those guidelines given and we've reached with jealous of as was outlined.

First patient in and actually use study will be this year and nobody has ever even maybe the fall. So we're doing things that have never been done before which also increased the certainty over time, but Josephine maybe you want to.

That's something.

Thank you Paul that's a really great.

I answered the question as well so like you said right. We are advancing the programs we have been able to transform conduct a number of case studies.

In 2020 back actually continue to progress towards the actual your straw policy Alice in 'twenty and 'twenty, one, which we're confident that we're going to be able to meet and then for time, you're familiar we are all going into actual use trial in 2022 and the only reason you see a difference in bow tie. It means it's just because of the timing from when we started with programs and where we are right with it.

David.

The pandemic situation, but again like I said, we remain confident in our ability to conduct these actually as trials in progress this programs to the expected a bunch dates as communicated.

Thanks Josephine. The next question was really about bolt ons or whether you buy things for C. H C. I think what we've tried to say is that we you know we think we have enough organically to make the progress and we have the switches.

I think we're Julie's challenge me is around whether we can add other capabilities in their own digital E Commerce looking at China, and other areas, where we can accelerate our performance, but we really have to think about being accretive I think ultimately.

Buying to bulk up is would not be where we wanted to go as you've seen I think some of the cloud to the Julie's brought is actually slimming down to grow faster based on better choices and so you know I think we would look for capabilities and different things was there anything you know I I again, I hadn't heard person I mean, obviously very well when you say that's exactly what we're at.

Trying to do obviously, we're always looking at ways to grow our business organically and Inorganically and our play to win strategy is not dependent on M&A to deliver the growth ambitions that we have.

That being said we're of course constantly constantly evaluating opportunities to provide greater scale be it in geographies or to add onto our subcategories that we're focusing on.

And as well as Paul said accelerating our digital journey.

Thank you a.

J B Jim Meds.

Accretion.

What is your outlook.

Well, Peter it will be very long.

This business is incredibly resilient.

I love it by the way.

So 2025 after the misses no patent fleets, there's no. So it's really it's all happening there, but with a very active management.

We'll keep you decorative for the long time.

And it should be he loves all our businesses equally Justin.

I point that out and Thomas <unk>.

<unk> in a phase one sort of proof of concept in a fast feedback from you I'm.

I'm afraid, we're not going to be a phase one miracle Reed.

In vaccines.

There is a litany of vaccine development, even from Wyndham tankers that have failed in phase two or phase III beat our net I'm on it would be the same.

So long story short is no phase one phase two phase III, we'd be like why you. Obviously you want to see if you have neutralizing antibodies. If you don't get moving if you have it doesn't mean, it's going to work you need to check the ability of those to indeed predict so all three phases will still be required.

I don't think it's reed changing that back from a maybe you could just I could ask a supplementary on behalf of Peter which is where it wears mrna not hit a home run in the <unk>.

Development so far.

So there are a few product indeed in Australia from anywhere where its not always been successful. So we are indeed in the past there has been some publication for example on the pandemic flu.

<unk> tried but was not in Brazil at all.

We also have noticed probably about <unk> in its public information that Merck has given back the rights that you that don't know us via Melanie with Madonna. So so there are different area, where it's not a homerun things to look at again very promising technologies still and we've seen that with COVID-19, but there are many areas where it might be applicable as many.

With me I'm gonna be a PK, but you all know, but polysaccharides vaccines for example, which is a huge range of the portfolio today will not be applicable to a minus technology. So exciting technology, we're looking at it with modern leukemia with developing it and we're going full steam, but we'll be able to select the right niches in the right markets to be successful.

Yeah, I think and we said it in some of the dialogue earlier day.

And a pandemic I think we're the first company to accept that we're moving at record speed, but but mrna in a pandemic with a single antigen is probably they'll go to no issue. There at all I think we should just be a bit grounded on what the opportunities are again were fully participating but we don't expect everything we try and do an mrna to be a success I don't think anybody should bite.

Across the spectrum because there were.

Some areas, where it was unsuccessful on the leader, but we're thrilled.

That it's Hudson's success in COVID-19, and just to remind you that I'm not the expert the tumor is but when you get to the multivalent strains in terms of solutions with mrna and then even not all M. Rnas are equal in terms of what's the your ability to go after multi strain so.

There's a we're going to be with that so we're not that doesn't scares, but it's interesting.

Okay. Next next question, yes, so I have three questions from Stephen Skalla from Cats first one to actually going to our John Mccain what are the patent expirations on Mantech.

Some of you previously made the decision to deemphasize diabetes research Y and Q week basal insulins attractive opportunity.

And the last one goes to the consumer health team. It is clear that Sanofi gains from owning consumer, but what does consume like gang. Thanks.

Thanks, Tennessee.

Thank you. Thank you Steve provoked you. This maybe elevated took about multi galloway.

Louis towards 'twenty nine.

And then.

Maybe we could look at why Julie you're interested in being part of southern sure I think I think today I think it would be a miss not to benefit from this episode Sanofi basically I want the best of both world I want to be able to to.

Create more agility and more speed by by becoming stand alone, but again it would be remiss not to benefit from from the bigger at Sanofi, especially in areas like science, and and and and data.

Thank you Julien good to note.

Olivier.

Weekly basal insulin we missed so general medicine is of course cookie and instrumental to the success of the play to win strategy in.

In funding the Sanofi specialty pipeline, we are at the beginning mostly in the emerging markets of the story of two zero is that there has not been launched in our in China. For example to be more precise was launched only mid November. We are also at the beginning of our story.

Siliqua, so we have really significant.

Significant runway also request has only been launched in a small number of countries in the emerging markets. So <unk> will be launched into a 22 and up to 'twenty two 'twenty three.

In China, and we all know was that a significant portion of the market in China in insulin remains the clinic market. So still a long runway with our assets that have not been fully deployed especially in emerging markets. We of course are looking at to what the.

The competition is also doing thank you.

The next question is from Seamus Fernandez at Guggenheim Schmidt. Please go ahead.

Hi, Thanks for the question. So just wanted to get a.

Quick update on obviously I I apologize if I missed the questions on Ben Goose that but as it relates to boost that for ADP J D.

Versus some of the data that.

As presented in the press release around G. B, a just wanted to get a better understanding of you know directionally. The fact that you know the placebo actually was performing better.

If you can provide a little bit more color in that regard and then just you know again directionally just remind us again of the day 80, PK D opportunity I believe this is predominantly based on preclinical data.

That's really driving the assumptions here, but just wanted to get a little bit more color on on your conviction in.

In the wake of these data.

Second question is that.

Actually on interest in gene therapy, how has that changed at all in the context of you.

You know some of the updates from the agency it seems like the path for gene therapy.

Maybe growing a little bit more extended and drawn out. So just wanted to get a sense of how Sanofi is thinking along those lines. Thanks, so much.

Okay. Thank you Seamus maybe dietmar do you want to jump in and then we'll also let Sean Reid, if he wants to add or comment on gene therapy the demo.

Yeah right on venues that thank you for the question.

Van do studies is really an interesting molecule.

Considering that it's a pipeline in a pill.

And because it inhibits so so early in the signaling Cascade, we were able to two <unk>.

Evaluate different hypotheses across different types of diseases, and I would think that there are three buckets. One is the lysosomal storage disease bucket, where we have good proof of concept in it and goes hey type three in fabry.

And we're following up on that obviously with studies in those indications and that's simply the the day position basically in the metabolic pathways that are important there.

Then you've got the AEP K D and that's a different hypothesis around signaling actually and in secret Hari.

Information in in kidney sales and in the formation of doses.

That is driven largely by by preclinical data.

Both genetic but then also a preclinical in an animal model that animal model has been quite predictive actually which gives us a lot of confidence there, but it's a different hypothesis different type of disease, and then you've got the Parkinson's with where it was about depth.

Deposition of sin, new clean and can actually the gcs inhibition play a role there and again a different hypothesis. So so the fact that.

What we've seen in the moves PD study.

Demonstrated no clinical benefit.

It has no impact on those other indications what what the most PD study also shows is that the GL one levels.

Our distinctively reduced dose of the drug works.

The drug does what it so it is just that the biology in Parkinson's seems to be different so we remain really confident.

With regards to the other two buckets of indications in.

The other information we got from most P. D is is that the drug has demonstrated a very encouraging safety profile. So even more confident when it comes to that same safety profile as well the ADP K D data. The initial data will be on total kidney volume.

And we're looking forward to see those data then in 2022.

John.

Yeah. Thanks, Thanks, Paul and thanks for the question about gene therapy.

We remain committed to and interested in gene therapy, we see them as a central to include that modality is one of the ways, we tackle problems in the rare disease space of the monogenic disorders, where etcetera.

They are blazing history at Sanofi Genzyme, and then also particularly in the CNS area, we see quite a bit of opportunity there.

We did establish an internal capability, we call the genomic medicines unit.

Recently.

Or.

You don't have assembled a team in the Boston area, taking advantage of our Genzyme Heritage Genzyme did put a couple AAV based gene therapies into the clinic back in the day.

As well as the gene therapy ecosystem of the Boston area and are pursuing both viral and non viral gene therapy solutions for rare diseases and CNS, we expect to generate.

Two development candidates this year in 2021 and to put those into the clinic in 2022.

In terms of the CMC or manufacturing piece of that we've talked before about how at least with the viral vectors. There are many similarities to those manufacturing processes and how we have historically made certain vaccines.

And so we're leveraging those manufacturing capabilities and expect to have our first GMP facility come online this year.

Leon France area, taking advantage of that.

And then finally I would say on the BD front, we're continuing to build up our toolbox of next generation assets for prosecuting the gene therapy space final thing I would mention because I think it is a new exciting development for us is that with the announcement of our intent to acquire T. Adas.

A cell based cell therapeutics company in their case exploring the NK or natural killer cell platform for oncology our projects, they're moving ball genome modification of sales. The first project, we've announced use a CD 38 knockout NK cell engineered specifically for myeloma.

Engineered specifically to combine with our anti <unk> antibody SAARC Lisa.

And that's just the first of what we see is a.

As a as a pipeline of genomic leave edited genomic genetically modified NK cell products that we will customize for various.

Type of cancer in the years ahead. So we are very actively establishing that capability as well.

Thanks, John and maybe I'll, just add a couple of points I mean, it's been an interesting sort of 612 months from there.

The gene therapy landscape.

At least in hemophilia.

I think we John touched on it but we're equally important is CMC or manufacturing I think we all anticipate the future to be.

Well price it will be pressurized in gene therapy and cost of goods for needs will be proportionately lower so we're really focused on trying to make you feel like the affordable gene therapies go to market, we'll see how far we get we do have this extensive history in rare diseases and I think we're all excited about trying to continue to come through a contribution stand on that.

And open minded a little bit about the rest, but it's not a given the uptake of gene therapies longer terms, we have to work very hard to demonstrate the value.

You see now breakthrough data, it's not always.

Confirming the opportunity that you have so I think we're approaching it the right way, Chris Sensibly absolutely. Okay. So do you have time for one more okay. Yeah. Please.

We take from one one last question sorry from can you Patrick at Goldman Sachs can you. Please go ahead.

Thank you and hope you can you guys can you hear me Okay. Two questions. Please the first one for Julie Julie you've kind of laid down in an exciting plan or kind of changing the growth outlook for these key etch business, but I'm wondering if you can talk a bit about kind of your plans from a margin that stronger every day perspectives.

Are you seeing this kind of as a need to reinvest in the New York.

John is going up kind of post the launch of Seattle expanded flow or do you see enough scope for you to kind of take cost out and reinvest to kind of get that growth. That's kind of a question number one and then question number two kind of hope Paul and J B Hunt, Paul We obviously seen kind of some of your peers kind of do a largest acquisition.

So just wondering if you can remind us kind of what your priorities are kind of from an M&A perspective is it still the eastern Torres kind of Principia sized acquisitions, and then linked with that.

B Kim.

Really kind of if you look at multiple as you look at your growth toward Claude the stock seems incredibly cheap.

What's stopping you from being more aggressive on our buyback do you have enough capital you have enough balance sheet leverage so why not pick on one page all that cheap valuation.

Okay. Good so snappy questions that finishes off care. Thank you.

So very quick comment on seats sure Alan So what I can say that our operational profitability is expected to remain stable and among the highest in the industry and divestments will continue in 'twenty, one and 'twenty two and if your question is if we have what we need to unlock the growth that we have planned.

The answer is yes, okay. Thank you for me on M&A, I guess and maybe Jay Bill come in the you know.

Capital allocation I suppose the connected the questions really.

We want to create value, we want to add to our science, we want to do things. We we have said we're more in the bolt on sort of tuck in territory I think the last fall Peter acquisitions over the last year I think would support that we're trying to do things that make sense. We don't think we're a company that needs to do a big piece to consolidate just extra revenue we think we have.

Efficient seize to gain opportunities to reinvest science to accelerate so I think thank you bill perhaps disappointed in is even if we did try and do that so we're sticking to the science and we have enough. In hand, then I think you have to sort of have to understand that having a healthy balance sheet. If you want to describe a life that is J b J B's.

But buybacks were low on our list maybe the last thing on our list because we think we can create more value for shareholders and investors a different way, but J b, what's your view.

Although we are doing a bit of share buyback as you know because we can sell the dilution of any.

Any emission we do so we've just done.

Some of the backend of last year and beginning of this year, but also of course, it shrunk quite Luna priorities.

But what we did is again, increasing from the 2050 or our dividend.

That's a nice way also to return.

Some of the growth on the wealth of the company back to our investors.

Thanks J b.

Hello.

Please hang with us and we will now have a five minute break and we will be back for these take infection.

Kim D called emerging leadership in immunology. Thank you.

Yeah.

Okay.

Okay.

Okay.

Yeah.

Yeah.

Yeah.

Yeah.

Yeah.

We are recording has stopped.

This meeting is being recorded.

So I need to get it all.

Can you hear me.

Yeah.

Only barely John.

Can you hear me now I can hear you.

Okay. I think we are good to.

Hugo I hope you keep it.

I would just take a few words and then I'll hand, it straight to you okay.

Natalie Halloween.

Yes, we are.

You tell me when I can go.

You can go you know.

Okay.

Well come back to the R&D section of <unk> capital markets day in 2021, the Sanofi R&D leadership team is excited to spend the next hour here to share some of these emerging leadership in immunology.

John Reed the opened section with some introductory remarks, followed by Brian Fortune Global franchise head of Department that.

My name is <unk> global head of development Ini Tripe net global head of research and Chief Scientific Officer, and then drawing Reed would return to you with concluding remarks, followed by another Q&A session. So for those who may have just joined US I just want to quickly remind you again on the instruction on how to ask the question you have to opt.

<unk> option, one if you would like to ask a question. Please click the race and I can at the bottom of your screen you will be notified when your line is open to the question. Please remember to a mute yourself.

<unk> you May also submit a question by clicking the Q&A icon at the bottom of the screen and the question reviewed our tenure and at this point I would like to hand, the call over to John.

Thank you well now be a real fine this capital markets day begins as we dive into some of the science behind this Sanofi pipeline today.

Today, we will focus the R&D update answer there'll be emerging leadership and immunological diseases immuno.

Immunology is a very dynamic space for us and we expect rich news flow throughout the year ahead.

Before we dive into our presentation. However, I would like to remind you that since 2018, Sanofi R&D has been undergoing a massive transformation.

The first point I would make is that we have completely reshaped the pipeline in the last three years from heavily primary care oriented to now entirely specialty care.

Within specialty care, we have significantly expanded our portfolios in immunology oncology and hematology to quantify this transformation compared to just three years ago, our immunology portfolio grew from six molecules or products in development to 15.

Compared to just four years ago, our oncology pipeline grew from five molecules or products in active development to also 15, which will grow actually to 18, assuming successful closure of the <unk> and <unk> acquisitions.

And compared to three years ago.

Our portfolio of non malignant hematology grew from just one molecule under active development to nine.

The second point I would make is that we accomplished this pipeline transformation, while maintaining fixed cost essentially flat for the last three years.

This required enormous tradeoffs for example, exiting cardiovascular and diabetes optimizing our sites and reallocating resources on a large scale.

Third in parallel we accelerated our R&D transformation through M&A and business development activities altogether bolting on six companies, providing sanofi with pipelines platforms and talented people, especially top notch scientists.

The new platforms for accelerating our future drug discovery included the nano body platform of AD links acquired in 2018, the synthetic biology platform as <unk> acquired in 2020 the <unk>.

Tailored co balance sheet platform, a principia acquired last year.

And the NK cell therapeutics platform, a key Adas, which we expect to close the first half of this year Youll see examples later today of how these platforms are empowering our pipeline.

And again Big Tradeoffs were made to absorb these costs the cost of these acquisitions.

Altogether, keeping R&D costs.

That between the beginning of 2018 at the end of 2020.

Okay. So onto today's presentation my colleagues will build on the themes that we introduced at last year's R&D day event Investor event.

We will illustrate how our teams leveraging the three PS.

Pathways deep expertise in biological networks connected disease biology patients using molecular profiling digital and data to dissect disease heterogeneity and move towards precision medicine approaches for solving health care problems and finally platforms, where today, we will focus on differentiated platform for <unk>.

Discovery.

<unk> three piece of pathways patients insights and platforms are supported by a foundation of improving capabilities that accelerate execution reduce cycle times and improve overall R&D productivity.

So with that brief introduction I'll hand over to Brian <unk> Global head of the duplicate some franchise that share our vision and plans for <unk>, the cornerstone of Sanofi, assuming LNG pipeline, Brian over to you.

Great. Thank you so much John and again I really want to thank everybody for joining us for today's event. We are extremely pleased with <unk> performance in 2020. The brand has performed exceptionally well throughout this pandemic and that really speaks to an amazing team of individuals around the world, but also the strength and the uniqueness of our profile.

And its acceptance among both physicians and patients around the world.

Now you've probably heard a lot about this amazing medicine at our depicts an R&D event. This past June where we expanded on the innovative science behind it to fix it.

Since then our confidence has only grown into fixing the ability to lead the transformation of the treatment of type two inflammatory diseases.

So now as you as you look at slide eight as you can see from the MB Rx chart on the right hand side. When you look at the combined prescriptions of both dermatologists and respiratory specialists depicts that has emerged as the number one biologic in the U S.

And we enter 2021 in a great position to further accelerate that growth with approximately 230000 patients on therapy across 47 countries and three foundation indications now. This growth is also supported by a best in class profile with clinical data out to three years, So let's move on.

And we're going to share with you a bit about how we're building a mega brand with <unk>.

So this next slide really dimensionalize as a significant growth opportunity in dermatology with a primary focus on atopic dermatitis are depictions first indication.

<unk> is indicated as young as six years of age and moderate to severe patients who are not controlled on topical corticosteroids and we are currently evaluating to fixing in patients from the <unk>.

Below the age of six.

Now today with an estimated $2 2 million biologic eligible patients in the U S alone and only five 1% market penetration to date the growth potential remains significant.

And as we expand beyond the U S to our top eight markets that eligible patient population more than doubled to $4 9 million and this includes the opportunity created by our record in our deal approval in China and that will add approximately 900000 eligible patients over time.

Now beyond geographic expansion I really want to draw your attention to another dimension of growth. We are in the clinic with four adjacent dermatology indications in and also 80 patients below the age of six there is no other advanced therapy pursuing as many dermatologic diseases.

This strengthens <unk> leadership position among dermatologists, while also addressing patients suffering from debilitating dermatologic conditions now.

If these studies are successful we estimate that we would add approximately 500000 patients in the U S alone who could benefit from <unk> in these adjacent indications and also the <unk> expansion.

So in summary on this slide you can see we have an unparalleled opportunity to reach many more patients suffering from dermatologic diseases, driven by underlying type two inflammation.

So now turning to respiratory we see a very similar opportunity for leadership in asthma and adjacent respiratory indications. Despite a more developed asthma marketplace. The biologic penetration rate remains extremely low at actually only 17% thus.

Thus there is ample opportunity to grow via the markets, but also via market share as we exited 2020, our U S. <unk> share was approximately 25%.

There is also significant opportunity to expand outside of the U S marketplace, where depiction is already a leading respiratory biologic in large markets, such as Germany and Japan.

If you look at our top seven markets alone, we estimate there to be about $1 9 million biologic eligible patients and.

And Additionally, there remains significant unmet need in moderate to severe asthma patients in China.

So consistent with our approach in dermatology. We are also investigating adjacent respiratory indications driven by type two inflammation, most notably our type two COPD program, a highly underserved patient population, where no therapies have been approved for almost a decade.

Now beyond our currently approved asthma indication of 12 and above we expect to add approximately 600000 patients eligible for <unk> in the U S alone through age and indication expansions in respiratory.

Again, this uniquely positions <unk> as the leading advanced therapy, and specialty respiratory and certainly supports our leadership ambition in diseases driven by underlying type two inflammation.

So I'm now happy to transfer the call over to name ish, our head of immunology development to discussing that these deepening leadership in type two immunologic diseases beyond <unk> over to you name it.

Thank you Brian so at our depiction R&D event last June we dove deeply into the biology of type two inflammatory diseases and explained why unlocking both IL four and 13 are critical for <unk> the <unk>.

Or was it takes two to tackle type two inflammation and I'm now thrilled to introduce Sanofi is next wave of molecules for type two diseases beyond <unk>.

So our approach to developing the next wave of molecules really leverages, our deep understanding of the type two inflammatory cascade here is a very simplified depiction of the process.

On the left here type two inflammation starts with allergan or pathogens contacting the epithelia bare surfaces, such as skin Airways or Gi tract.

This leads to alarming events with mediators, such as IL 33, or <unk> L P and.

And then the next step Ox 40, Ox 40 ligand co stimulation plays a critical role in immune programming with th two cell differentiation expansion and memory T cell formation.

This is well this is where you can almost say the blueprint is created for chronic inflammation and chronic diseases, such as atopic dermatitis.

These sales then produce cytokines such as IL four IL five IL 13, these cytokines stimuli and prime effector cells, like eosinophils and mast cells and they lead to tissue pathology allergic responses and symptoms such as skin itching thickening and atopic dermatitis.

So from this you can easily see how the mechanism it depicts and blocking IL four IL 13, Potently inhibits type two inflammation in diseases, such as atopic dermatitis type two asthma and Crs with M. P.

But you can also see how Rosa Bruton nib and molecule acquired by Sanofi with the Principia acquisition targets type two inflammation.

PTK enzyme drives allergy by mediating b cell expansion and production of Iga and activation of mast cells eosinophils and basis sales.

Thus reals ibrutinib, a potent and extremely specific PTK inhibitor. We believe has a significant potential to treat type two disease.

And as another example of how Sanofi is really leading with innovation I will share with you in just a moment three new programs for real to route and that that will start this year.

But there are more areas to explore we are also looking upstream and this pathway to develop therapies that afford potential to treat diseases that are not just purely type two but also non type two and mixed phenotype.

This is where our anti IL 33, monoclonal antibody I had to pick a mab is being investigated to reach more COPD patients than any other biologic has attempted.

And today I'm excited to share with you for the very first time, the compelling phase II data that led us to launch our phase III trials in COPD.

And finally, we believe that ox 40 lag and is truly a unique target for type two diseases because it represents a critical co stimulatory step that leads to the programming of immune response for chronic diseases like atopic dermatitis.

<unk> Ky, one 005 monoclonal antibody that's no fee announced intention to acquire holds promise to reprogram immune response, so that durable disease control maybe approach for our cross approach across a number of indications.

And we look forward to discussing more about the promise of Antioch 40 ligand and once the acquisition of Chi Mab is finalized later in the first half of this year.

So now I will dive deeper into these key molecule starting with <unk>, our anti IL 33 for COPD.

So I had to pick I mab could be the first molecule to treat most COPD patients and on a personal note as a pulmonologist who has been.

Practicing for a number of years.

It's quite disheartening to think that so few new mechanisms have entered the COPD treatment paradigm over the last 20 years. Despite the fact, we're COPD is a leading cause of mortality worldwide.

But today I'm glad to say, we really believe that we think we're about to change this.

We think we took the unique step of studying <unk> across the spectrum of moderate to severe COPD because of the known effects of IL 33, and both type two and non type two inflammation.

This is supported by published data shown here on the left and the graph demonstrating that I L 333 levels in advance COPD patients who are former smokers are elevated compared to healthy controls.

And here on the right for the first time, a revealing the results of our phase two study of Isis <unk> in COPD.

In this study of moderate to severe COPD patients I had to pick a mab reduced COPD exacerbations by approximately 40% for zero of 40% and former smokers and importantly, this effect was similar in type two and non type two patients. This effect size is far far and above what has been seen by any other.

You can see COPD, where many competitor phase III studies had been 20% or less in terms of exacerbation improvement.

And this is for the sickest patients with COPD and these results have given us confidence to commence the phase III program in a population where no biologics have succeeded.

Thus, we have started our pivotal pitiful pivotal program with ice pack them out. The objective of these studies is to establish that I'd speck of Mab can reduce COPD exacerbations, and a move and improve lung function in most patients with COPD. This comp. This in combination with the duplex in COPD program has the potential to address greater.

And 80% of patients with COPD with frequent exacerbations.

Turning now to the Realtor Bruton program. We believe this molecule that came to us with a principia ex acquisition has the potential for a pipeline in a product and I'll explain why.

So I mentioned in the first slide that PTK as a key driver of allergy and activation of type two inflammatory cells and it would be logical than that be teekay as a potential strategy to treat type two diseases, such as atopic dermatitis asthma and in order to carry out the <unk>.

It's always been that many of the early PTK inhibitors that were first used in oncology indications in the past have tended to have significant side effects, often because of binding and inhibition of other proteins. Besides P. T K.

And the reason why we're so excited about Rosa Bruton it is.

Is that has been designed to try and avoid these issues as precipitous innovative tailored covalent C platform.

So Taylor covalent see what does that mean that means the drug has two binding sites on the B teekay protein one of which is a reversible covalent bond. These two sites essentially fit like a lock and key increasing the likelihood that the drug will bind the P teekay, but making it less likely that it will have unintended.

Binding to other enzymes.

And bus tailored covalence he has the potential to minimize off target binding and minimize the risk of side effects by store, but still maximizing potency.

And safety is a critical issue for type two diseases, especially among dermatologists and we believe that rules that has the potential to deliver it.

Now what is the evidence to support this potential and our commitment to further investigate this product.

It is the results of the studies with rules of bring them on and on this slide on the left you see the phase II results in patients with pemphigus vulgaris treated with real scrutiny in the study 67% of patients treated with a real scrutiny achieved minimal disease activity by 'twenty four weeks.

This shows the very rapid and potent effect that really from booting of has on this disease, where very few patients would have such a response on steroids alone.

On the right here in the I T. P. Phase two study you can see that 50% of patients treated with Rosa rooting for greater than 12 weeks achieved the primary endpoint of two or more consecutive platelet counts greater than 50%. This is a significant result, when you consider that these patients had failed a median of six other therapies before entering the study.

And most importantly from both of these programs were also Bruton it was well tolerated with no significant safety issues.

So now we would like to reveal our plans for the rails are prudent and program. Our goal is to develop realtor Bruton nib as a pipeline in a product with expansion beyond the typical auto antibody diseases into the type two space. We know for type two diseases safety is of major importance to patients and prescribers and so we believe Rosa.

Via the tailored covalence the platform may be the right molecule to achieve this high bar with oral route of administration and meaningful efficacy.

This target profile, maybe ideal for patients with less severe disease as an option before going to biologics.

Today, we're announcing our plans to start the phase two studies from Rosenberg Nab in atopic dermatitis, and asthma and chronic spontaneous urticaria. These diseases represent a total of $3 5 million patients with high unmet need.

In each of these indications is expected to enter the clinic in the second half of this year.

So on my concluding slide here I want to provide you with an understanding of how we're thinking about these more multiple potential first in class or best in class molecules into type two space.

You saw in Brian's earlier presentation that compare to other disease areas. We are still in the very early days of type two disease. Indeed, it's an exciting time for patients with many potential entries into atopic dermatitis asthma and possibly even COPD.

Starting with atopic dermatitis on the left.

We are building on the foundation of our success is a depiction. This is a very underpenetrated market with heterogeneity in biology and in patient needs.

They're a space, we think from multiple molecules that offer choices to patients to tailor to their biology and individual needs. We're excited about promising oral programs that rules of Bruton nib and the Iraq Ford the greater.

We also look forward to exploring the potential of Antioch 40, once the acquisition of Chi Mab closes.

Moving now to the right. So the respiratory realm, we're pursuing oral and type two plus approach in asthma with a roaster booting them to buy.

Provide patients with potentially the first oral treatment or enter the asthma space for some time.

We also believe that the next wave of transformative molecules in diseases like asthma will require a multi targeting approach to provide step change over current efficacy and we'll get into this in more detail in the next section with the IL 13 P. S. L. P program.

And finally, we have high ambition to transform COPD therapy with Ita Pekka Mab now in addition to do pull mab to address greater than 80% of patients with COPD, where currently there are no biologic therapies.

And with this I hope I've been able to convince you that Sanofi has a lot more coming behind to pixel within immunology pipeline rich in potential first in class and best in class molecules.

For more information now on our next generation of molecules, including narrow body by specifics program day, greater programs and really cool science I will turn it over to Frank Nestle Sanofi as global head of research and Chief Scientific Officer.

Yeah.

Thank you Manish.

Building on the foundations of our winning strategy and type two inflammation I would now like to discuss with you where we go next John.

Tony to becoming a global immunology leader, including and beyond type two inflammation.

I will illustrate this space on multiple emerging immunology assets targeting immune pathways central to tissue inflammation and poised to make inroads in a range of indications.

A major shallow Hussein drug discovery, including immunology and inflammation has been a relatively low probability of success in early clinical trials.

Arguably based on a lack of adequate understanding of inflammatory disease mechanisms.

To address this we have built a unique immunology discovery engine, providing unprecedented insights into inflammatory and autoimmune disease biology.

Our sales cell immune disease engine combined analysis of ethical datasets, including genetics and single cell genomics of disease tissues. For example, blood skin joins kidney and lung with appropriate Terry artificial intelligence algorithms.

Through this drug discovery engine, we obtain deep insights into underlying disease mechanisms stratification of Molecularly defined patient subsets reasons for inadequate response to therapy and opportunities for combination immunotherapy.

We unlocked the resulting drop of insights into novel patient biology, using our advanced technology platforms.

Let me give you a few examples.

Since orange redefine tunable cytokine therapy, and regulatory T cell expansion for durable disease modification.

Multi specific narrow bodies antibodies allow combination therapy in a single molecule.

Reversal of covalent small molecule inhibitors allow precise tuning of target pharmacology according to therapeutic needs.

In the following I would like to give you. Several examples how unlocking patient biology with our advanced technology platform is turned into reality with concrete assets moving into the clinic in 2021.

Several efforts in the biopharmaceutical industry has failed to establish a reliable next generation bio specific biologics platform for immunology and inflammation.

With the acquisition of <unk> the worldwide leader in none nobody therapeutics in 2018, we established a unique position for Sanofi to launch a whole new pipeline of next generation.

And my multi specific biologics with distinct and unique target product profiles.

Today I'm.

I'm happy to share with you. The first example, a multi specific anti IL 13, TLLP nano body entering phase one and 2021.

This asset already benefited from accelerated direct discovery timelines, a general feature of the narrow body platform.

The Nunn Nobody's demonstrates superior efficacy compared to single agent anti <unk> anti <unk> monoclonal antibodies.

Translational irrelevant allergen, driven human tissue mimic SA shown on the right side of the slide.

Target selection rationale is straightforward blocking IL 13 has the potential to enhance the more modest impact of anti to yourself people located on lung function, while anti <unk> targeting provides the opportunity to treat a range of asthma subtypes.

Taken together the combination of targeting IL 13, and TLLP in one molecule promising potential of enhanced efficacy in a broad range of asthma.

Further distinguishing attributes of this multi specific antibody include a straightforward regulatory and development path.

Qunar will half life, and resulting extended dosing schedule and finally convenient patient administration by an auto injector.

Yeah.

Let's move now to protein integrators as next generation products and inflammatory disease.

We have partnered with Primero therapeutics, a world leader in protein degradation to develop the very first oral protein integrator immunology and inflammation targeting atopic dermatitis and hidradenitis suppurativa planned to enter phase one clinical studies in 2021.

<unk> four is a master regulator of T. L. R and all one family dependent inflammation controlling the production of key pro inflammatory cytokines, such as type one interferons.

Six and TNF Alpha.

Iris fall does this via two critical biological functions, a Chinese function and a scuffle function.

First generation attempts of targeting iron flow kind of function using ATP competitive kinase inhibitors validated Arctic for as a targeted indications such as rheumatoid arthritis, but did not reach the level of efficacy required to be competitive as mono therapy in the fast moving oral immunology field.

Yeah.

Sanofi and <unk> next generation Arctic for protein integrator sour for 4656 allows blockade of both the scaffold function of Rx four in addition to the kind of assumption.

Preclinical experiments shown on the right demonstrates the superior inhibition of phosphate and its color Peter.

And is superior inhibition of combined stimulation of Peter Bmc's was CLR and al one stimuli.

It also demonstrates the very potent degradation of aric for protein and critical target organs, such as the skin.

These data provide a convincing framework for advancing our first in class Ini focused Irish folk oral protein integrator into the clinic.

Yeah.

We have spoken a lot about Thor 707, our non alpha IL two for immuno oncology.

Today, I would like to introduce it to a SAR eight or nine hour non beta IL two entering the clinic this year with potential in a broad range of autoimmune diseases.

All eight or nine takes advantage of the same unique synthetic biology platform for precise attachment of polyethylene glycol to IL, two enabling selective targeting of the IL two receptor alpha chain.

The key goal for eight or nine <unk> disease modification and rebalancing of immune system through the expansion of regulatory T cells.

On the right side of the slide you can see pretty clearly experiments demonstrating up to 46 fold expansion of regulatory T cells by authority to nine.

This translates into a superior dose dependent inhibition and control of skin inflammation compared to cyclosporine a.

Today, I hope I was able to convey my excitement with you that bill just getting stuff in immunology with multiple emerging immunology assets moving into the clinic this year and the creation of a sustainable Ini discovery pipeline.

I'll hand, it back to John for concluding remarks.

Thanks, Frank I will now briefly summarize the pillars of the Sanofi strategy for leading in immunology and then we'll provide a more comprehensive overview of our emerging pipeline in immunology medicines.

As we outlined here today do pixel is the foundation.

We will maximize the potential of this remarkable medicine, which is already created medical history as the world's first biologic to be approved for atopic dermatitis. The world's first biologic to be approved for chronic <unk> with nasal polyps and which has the potential to be the first biologic approved for COPD.

To fix it is the cornerstone of Sanofi is emerging leadership in dermatology and also in respiratory.

Next building on the success of new pixel, we have a strong pipeline that continues to focus on the type two inflammatory pathway. While also crossing over into other immunological pathways to tackle diseases that have a more mixed picture.

The molecules referenced here today include each of pick a man the anti IL 33 molecule antibody from the Regeneron Alliance now in phase III for COPD each of Pekka Mab operates at a very upstream step in the type two inflammatory pathway.

Real debris in the oral reversible covalent PTK inhibitor from there principally acquisition now in phase III for a dermatological indication a molecule that we plan to explore in eight different indications by the end of this year.

Sales of brute nib operates at a very distal step in the type two inflammatory pathway and finally, Ky, one oh by the anti at 40 ligand monocle antibody from the <unk> acquisition of course pending regulatory approval, which operates at a nodal point involving teach to sales and regulatory.

Sales with promising data generated so far in atopic dermatitis.

The third pillar in our strategy is to expand beyond the type two and adjacent immuno inflammatory pathways with innovative medicines that leveraged several of their powerful platforms to which Sanofi has recently gained access <unk>.

Examples of potentially transformational molecules in this category include our oral small molecule IRI forward to greater that you heard about which is incidentally the world's first a greater molecule that will enter the clinic for a non oncology indication.

<unk> via the partnership with the biotech company come here.

The Iraq border greater has the potential to play across multiple immuno inflammatory conditions, where IL, one and IL 33 are culprits, but offering an oral medicine option.

Also of note is our non beta interleukin two molecule Thor eight or nine which is produced using the synthetic biology platform coming from this acquisition of <unk>.

Dorado nine has the potential to become a best in class expander of regulatory T cells for restoring immune homeostasis across multiple indications.

And the multi specific antibodies should be mentioned here coming from the <unk> acquisition. Following our acquisition of that company in 2018.

We expect to put multiple manner body drug candidates into the clinic this year, each of which neutralizes not one but two limber kinds are cytokines that have been clinically validated as relevant disease targets.

These antibodies will pushed beyond the limits of mono specific agents.

To break the efficacy ceiling observed currently for most biological treatments.

Here in our last slide illustrate the breadth and depth of the emerging Sanofi pipeline in immunology products and product candidates.

The molecules are organized according to the specialty care area, where they are most likely to play but I should note that many if not most of our molecules have the potential to be effective across several areas of medicine.

Youll note that Sanofi is building, a particularly broad portfolio of product candidates in the dermatology and respiratory spaces, where we aim to lead the industry.

And we are laying the seeds for meaningful participation in Gi in rheumatology in the future.

Altogether Sanofi has today 15 molecules in development for immunology and inflammation indications.

Furthermore, the same immuno science, that's the foundation of our dermatology respiratory and emerging Gi in rheumatology portfolios.

Also spreads into our hematology neurology and immuno oncology therapeutics areas with examples found in the beta <unk> inhibitors, <unk> Ibrutinib and told him route nib as well as our anti CD 40, ligand antibody and our emerging portfolio of complement inhibiting antibodies.

As we pointed out in our R&D investor event last year extra.

Expertise in EMEA Sciences, a core competency at Sanofi, and we Leverages science across the company's entire R&D portfolio because it touches on almost every therapeutic area Embalmer and of course also in vaccines.

I'll close there and open for Q&A for which I'll serve as the moderator.

Thank you John Yeah. So we are moving now into our Q&A session for today with an emphasis on R&D. Since we are now joined by all of our presenters, it's Steve <unk>, Our Chief Medical Officer, and asked the half Kernen German <unk> with me and Bill.

So naturally can leave that to the first question. Please.

Thanks, Stephen So the first question is from Keybanc with him at <unk>.

Peter.

Hello, Hi can you hear me.

Okay. Okay. Thank you very much I think Kim My question. So I just wanted to come back on the development strategy for <unk>, New immunology assets.

And Patrick Kelly in terms of sequencing and combining these assets.

Would you would you consider engaging GPS that boon on which.

Potentially add and new treatments.

EUR approach Mark too.

John.

New your new immune as you push it Chris.

Could you confirm from array of freeing from senior leadership in type two inflammation.

And if you could share your view on the <unk>.

How can determine which patients would benefit from which best way and how to.

The sequence of potentially combine these assets. Thank you very much.

Well thanks for your questions I'm going to call on some of my colleagues to help but I'll start off by just saying of course, we are.

Sure.

Early in the extra exploration in the clinic of many of these molecules.

So really flushing out there theyre fits in the landscape of various hematological diseases as is something that we'll be doing in the months and couple of years ahead.

We do recognize that many immunological diseases are complex and heterogeneous.

That's why we emphasize our efforts in the precision medicine work that Frank outlined and really beginning to better dissect the disease biology and match the right medicine to the right patient.

We think this portfolio will enable a number of different strategic approaches as the data emerge and we have better insights into really how best to position the molecules.

Whether they're combined with new pics and or used for patients that don't respond as well to you do picks and or or tackling.

Those that have maybe a more mixed picture for example that that Navy should outline.

Or patients that are simply their disease evolves over time and they switch to different therapies over time.

Do picks and clearly has a great foundation and it's.

Arguably our best in disease solution today, but we know that there'll be opportunities to build on top and around there. So maybe I'd handover to perhaps break first maybe you can embellish on that a bit in the name of <unk> yeah.

Hi, Peter John and I, just would like to say from a very personal opinion and I think we've built one of the most exciting emerging immunology portfolios in the industry.

All of our decisions of our science and data left I mean this is what we have been doing over the last four or five years, but I think I just would like to remind you. There is there is still a huge unmet need out there in immunology and inflammation and this is really driven by efficacy ceilings, I mean, if youre looking across rheumatology and dermatology and respiratory.

The massive efficacy ceilings, where patients do not get the drugs save yourself durable responses are really.

Just on the horizon, but not really implemented yet.

As John was pointing out they are really different patient population defined by their molecular mechanism. But then also in terms of market penetration. These markets grow physicians, our experience now with biologics and and you can see that if the right medicine comes along which is really transformative patients will come and Fisher.

Prescribe so what do you really need is a portfolio, which is waterproof in the short term medium term and long term and I think in the short term we have first choice Copaxone no no question about it it's a stunning stunning.

Stunning biologic, but with his 15 biologics and oral it's where we're having now in our pipeline. We have also the medium and long term strategy to really create a sustainable portfolio. If you think about it picking up potentially open up the COPD space. If you think about beauty care.

Is it really an oral immunology leader very safe, but going into multiple different immuno mechanisms for example, auto antibody mediated disease are.

In the type two space and finally, then our long term strategy with an oral protein the greater first ever first time ever that a pharmaceutical company is bringing an oral protein integrated targeting.

Eric forward.

Chronic autoimmune disease or our bio specifics platform using nano body, where we can actually mix and match and dial in the appropriate features for winning TPP, including the schedule of dosing breaking efficacy ceilings and actually having hopefully a good cost of goods and good economics with great patient convene.

So it's a portfolio, it's a portfolio of winning portfolio strategy.

My name is there anything to add before we move on.

Thanks.

Frank and then in your both covered it completely I think you know as mentioned.

Atopic dermatitis is Great example, 5% penetration in 95% of patients eligible still haven't taken any and there's things to consider like different biology across that segment different individual patient need. So there's plenty of room for a number of different mechanisms to fit patient needs.

Absolutely I think one thing it's the heterogeneity of patients also.

Plays out in racial differences for example, atopic dermatitis in Asian patients compared to Caucasian patients. For example tends to have different biology same for black patients. So if there really is a need for different mechanisms for different patient populations.

Just a follow up on the another question and I was just wondering I mean this is another bite specifics from development. If you could just maybe give us a bit more color on the points of differentiation.

A few specifics is adding spread from compared to what.

John are doing.

Sure Brian do you want to take that yeah, I mean number one obviously the bi specifics have been a success in immuno oncology specific engagement T cell engagements are really going from success to success. However in the ini space. If we if you look at what is really happening is that a lot of bi specific approaches.

And I have failed either because the targets were not properly engaged or.

No problem.

Problems, where we're a rising so what we actually have field over the last year since our acquisition of <unk>.

Probably what is what is the most advanced what I called Biologics 2.0 of technology using nano bodies now nobody saw very interesting because you can actually combine and like Charles on the string to make multi specifics of example, we can dial in half lives by binding to albumin, we can dial in multiple Todd.

It's because we can sort of combine these narrow bodies in one molecule and actually the clue as not only in the platform, which is differentiated and we have now phase two day.

Demonstrating that that the non nobody platform is really very effective in the clinic and chronic inflammation, but it's also the target selection. This is where the precision immunology element comes in we for example, the targets we were convinced about today and for example, the reason why we are also interested in Oxford Silicon is it.

<unk>.

Is that already in 2016 and 17, we mined data sets and they told US what are the winning targets are going to be and already we are seeing with the targets now in phase III trials are being are winners that we actually make the right fix so theres more to come. This is just titled <unk> assertion emerging so there.

We will be much more coming but we're very confident about our technology platform is very differentiated number one with narrow bodies and second.

Net choice also targets.

Good day, even next question Yes. The next question is from Tim Anderson at Wolfe Research team.

Hi can you hear me okay.

Yes.

Okay I wanted to ask about.

Through your higher priority assets.

We're all Serge and oral B T. K just high level question. So it kind of seems like everyone is claiming to be best in class and not everyone can be best in class. So in the oral Serge space, you and Roche and Astra all climate.

<unk>, you and Roche claim it can.

Can you just update us on why you think your molecules are best in class. It seems like some of the data sets with some of the compounds or just too early to make comparative claims and then second question on <unk>.

In asthma in China.

So you're right those trials are still ongoing.

Be it the timing of getting approval in China and potential in our deal.

Okay. Good so several questions there.

Why don't we do the.

The beaten paid for because that flows right from the presentation. The main escape.

And David can.

Can I ask you to take that day in and explain the differences in the various ppas and why we believe that the Brinci Principia molecule that rehab reels ibrutinib has a potential to be the best in class choice.

Sure so so.

Got into a little bit in the discussion we had just the tailored covalent see part of it. So the issue has been with a lot of be Teekay is that.

They've either had off target side effects, such as liver function abnormalities platelet dysfunction atrial fibrillation that they had they had limited their scope in terms of the indication space.

Reels Ibrutinib Hudson designed specifically with this platform to be very specific to the beat teekay enzyme and limit the off target sort of binding to other proteins that many of these side effects often come from.

So we think it's ideal in that way for the type two space.

You can see some of the other PTK enzymes like or BK inhibitors have tried and CSU for example, but even though the efficacy is there the the safety hasn't quite what is needed in that space to really.

Be a drug that that that prescribers and patients feel safe, taking so I think that that is the crux of the matter our phase two data thus far hasn't shown any similar side effects profile. So that's why we're very confident that we can enter this space with a compound we have.

Yes, and just to add a little more on that.

I'm very familiar with both molecules.

The Roche molecule, what I'd say.

Fully reversible molecule.

The downside with that is getting enough target exposure, what we've learned about BP day is to get the efficacy.

You have to hit the target hard and you have to keep it hit hard which is where the covalent be.

<unk> group that comes in because that completely.

Completely inactivates, the target and keeps the exposure longer and at the same time that tailored aspect of it prevents you from.

Interacting with them staying on other targets. So we think it really thread the needle well in terms of both getting the target exposure you need which has to be like 95%. All the time in order to have the efficacy, but at the same time, avoiding the off target and for that reason, we think it will outperform our fully reversible molecule.

Which is going to be hard to keep that target really engaged all the time.

On the third I'm going to ask.

BARDA help me with that one and why we think this molecule at the Peter will be.

While my answer desperate as again to the <unk> the best in class solution of an oral <unk> for women with hormone receptor positive breast cancer Dietmar.

Happy to thank you John.

And before I go to the surge that limit is talking about the other be teekay, which is totally ibrutinib and again. The question about best in class comes up there and that's really the brain penetrant <unk>. Besides the <unk> inhibition and with the impact on <unk>.

Innate and adaptive immunity and the impact of non peripheral and central but we really think that that we have best in class potential as well.

For all of these molecules and I'm switching to empty nester in here.

Eventually, it's going to be about benefit risk and about applications with a specific patient population.

And you May know, Tim and in hormone receptor positive breast cancer really that that question of benefit risk becomes quite important.

We are looking forward to present more data at a conference towards the middle of the year really the data.

Around from the Phase one B study around the combination with <unk>, a secret that data that gave us confidence to kick off.

Ah study in first line metastatic breast cancer are exactly that combination of pivotal phase III trial, but when we look at the data that we presented so far.

I find efficacy and you look at the data at ESMO last year I find the efficacy data are very encouraging you do see the right clinical benefit rates you do see the right degradation of the estrogen receptor you do see activity in the estrogen receptor mutant in the ESR mutants.

And we do see a.

Really encouraging safety profile, which will be important as we develop this molecule across the different lines of therapy and in the big prizes, obviously UCITS usage in the adjuvant setting and they are the risk profile becomes even more important and as we see the data emerge.

I remain very confident and let's say even more bullish around the molecule that this really has best in class potential youre going to have to see this then eventually sell the data emerging over the year from a benefit risk perspective.

Yeah, Thanks, Steve I think that safety differences.

Most clearly seen in.

The lack of any cardiac signal that we have with them some equity compared to other molecules.

Those effects on cardiac I'm conducting channels the competitor molecules that have.

Resulted in the need to reduce the dose and then you also then jeopardizes the ability to cover the target and get the efficacy you need so.

Threading the needle on the molecules that have those cardiac toxicity issues as it is less than ideal let's say.

That's not a problem with ensign aspirin and it's why we think particularly moving into the places like the adjuvant space, where safety matters. So much.

It will have a best in class profile. Then the final question was about the pigs in China, maybe maybe Eva Brian maybe we can get you into the mix there.

And let you handle that and of course named Peter need markets trying to even if you need any help Bryan yeah, absolutely. Thanks, so much John and obviously, we've got the ongoing program with rehab.

Late 'twenty two early 'twenty three so we're looking at potential approval in the 'twenty three early 'twenty four and typically we assume in NRL and our deal approval about a year later now as witnessed by our record time are pretty fixed and really the local <unk>.

Recognition of innovation I think by the China authorities getting record time for atopic dermatitis in adults are five months it could potentially be shorter than that so we would be optimistic but that's the current timeframe you have for China.

Thank you.

Alright. Thank you good onto the next question neighborhood.

So the next question is from Emmanuel Papadakis at Deutsche Bank.

Yep.

Thank you for taking the questions.

That sounds like a couple of follow ups on <unk>. So first one maybe existing utilization in that smile.

If you have it could you give us a little bit of color on how we use is skewed in the patient population I'm thinking in terms of yes.

Yes.

Markers in particular, and perhaps your perspectives and a lot of that on the potential implications if any of the recent test dependent not day to particularly in the subgroup of patients.

And then a second one on detection just the regional expansion opportunity I mean, you mentioned it earlier, it's still remains extraordinarily depends on the U S has seen for example, the European opportunity like Jean Mirror, what we've seen in the U S is there an inflection point coming on the back of a reimbursement access opening up.

Or is that going to be a slow build.

Brian you can give us a bit more color on the annual deal with day in China and a day what.

What kind of price cut did you have to take when will the volume start to kick in that thank you.

Alright, well. Thank you for your questions I'm going to have Brian.

Tackle those in there.

Any elements around the use of the likelihood that we don't cover there maybe name you still got from now, but Brian over to you.

Yeah for sure. Thank you Emmanuel for your questions really good ones I think from a if you think about the asthma space in that moderate to severe uncontrolled asthma space. It's really the way we look at it is the type two patient population and it's really not just identified by eosinophils, obviously you'd think about fino of course, IGD levels, and we we actually designate about 80% of that population.

<unk> is really tied to.

So we really don't again align ourselves with just the Pheno from US are excuse me the iOS level. So from that standpoint, now that being said we have access to all of those patients actually we are basically above $1 50, as we've shared with you guys before especially in the U S. We have fantastic coverage that we have the access of those for type two patient population above 150 <unk> levels.

Now that said you asked to compare this a little bit to what we've seen with the recent T. S. L. P data and I think the recent T. S. L. P that again really highlights a lot of what the organizations, both Amgen and Astrazeneca articulated that it really largely seems to be sitting in that much smaller patient population below the 150, <unk> levels, which as we articulated that as Oh.

Net about 20% of the patient population alone, but then if you look a bit further as we've seen in the recent failure with ocs dependent patients that actually further narrows that population because they are fixing as you know without an eosinophilic biomarker actually we are approved for ocs patients as well regardless of eosinophilic phenotype. So.

We really feel strongly that our our ports are if you will.

Platform. If you will for depicts at this type two platform and our profile remains the strongest profile in asthma of all the current agents and the agents to come now.

Now a little bit about China, obviously within our D. L. A that was really exciting news obviously record time as we just mentioned five months and that is a really great signal that China is continuing to recognize the innovation of these medicines.

Now from a price standpoint, the price will be out and be public in the March timeframe and again, all we can really share right. Now is that we're extremely positive about their recognition of the value of depicts into in China.

Okay Brian.

Sorry, if I think I'd, just add a little bit color on the T. S. L. P point, I mean going back to the.

Slide I presented on the type two inflammatory Cascade you could see how it depicts and is well aligned and that sort of decision point in the cascade.

IL, four and 13 to hibbett really type two inflammation and that and for asthma. What that really means is the airways information, we know that pheno.

<unk> is a great marker of airway inflammation and two Pixar has a much stronger effect on Pheno and also much stronger effect on lung and from lung function improvement in the type two space compared to T. S. L. P.

And the Ocs population is another example of really a really a type two population the biomarkers arent so reliable for US yes, but we've seen in our studies if you withdraw the ocs the eosinophil counts go up and they're really just type two patients and you can see that T. S. L. P. A wasn't successful in that population, where do Pixar has been hugely successful in that.

Population, so that type two space the type two asthma space, we think your picks and this is.

Really the winning molecule there.

Good day next question Nathan.

We have time for one last question.

Graham Parry Bank of America Merrill Lynch Graham.

Great. Thanks for taking my questions.

Earlier, when you were talking through the necessity 10 data point she didn't highlight the proof of concept study in early breast cancer you have expressed.

The optimism around that data is still coming through the window of opportunity study in early breast cancer proof of concept is that still coming this year or is that being delayed and secondly on the IL 33 with any other biomarkers other than for Mismate because in the phase two the drive the exacerbation reduction any start to find 20 day spine market.

<unk> phase III say any potential sort of target particular sub populations, even if the April data sachets.

Is less successful given us this has been a very difficult indication to get meaningful data in and out.

And then finally on depiction in chronic spontaneous urticaria that could be one of your biggest phase II readouts this year and physicians using it off label with mixed results, suggesting quite a heterogeneous patient population. So as the trial set to detect that they again the use of biomarkers or anything else. Thank you.

Thanks for your question Graeme I'm glad we were able to get to you.

<unk>.

Maybe oh.

I will take the questions in reverse order you mentioned picks in C U.

The trial is ongoing so we.

We won't comment on.

What what investigators may be saying I would only say that as we move into diseases that Jason to our core areas like atopic dermatitis.

Going out into areas that sometimes they have a more mixed picture and so you know.

We have to be prepared that it makes sense.

May not benefit every basin and that's why we do have these other molecules coming if you think about for example, reels Ibrutinib is a really good solution, particularly with CSU at fixed and doesn't resolve their issues.

I don't know if named Richard than anything else to add on that what we're going to fix them.

Sure Yeah, I mean, there are these subpopulations in CSU with.

And auto antibodies to the FC Epsilon receptor and also auto antibodies to thyroid proteins that might have a differential response to xolair.

Beauty of depiction is that the IL four receptor on mass cells, an important activating fact from mass cell phones, it's a different pathway from what Xolair and legalism Mab are targeting so we were.

We're definitely looking at these biomarkers and we'll see how the outcomes come but we think there's actually a potential that we could have really have a differentiated population that response to pick.

Pixar versus.

What what Xolair does in this space.

And then while you have the floor name issue would you comment on Biomarkers.

Each of Peg a mab applications of COPD any any further insight you want to offer there.

Sure so.

Take it take a step back them out about these results for IL 33, COPD as an adult is extremely common 6% of the U S. Population has had a C. O P. D. However, we're zeroing in on a very specific segment of COPD patients, who are extremely having frequent exacerbations and lots.

Of symptoms. So it's a small segment and within this segment you have patients who are still actively smoking about 30% and 70% who are not actively smoking.

And within this the 30% who are actively smoking they are having significant symptoms significant exacerbations and they're smoking, which is essentially tobacco smoke contributing to inhaled particles toxins or other things into the lungs.

Constant exposure and probably and there's lots of biology to tobacco itself. The biology in those patients is probably fundamentally different than the other segment of patients who is no longer smoking yet, they're still having exacerbations frequent symptoms and the like and smoking of course causes of every diffuse sort of immune activation. So it might be a hard.

Thing for a single agent like IL 33 to provide efficacy, whereas in the in the non smokers, there's pretty good preclinical evidence that the patients who are not smoking.

But our extremely symptomatic as I presented have high levels of IL 33 in their lungs, and IL 33 is a specific contributor to both exacerbations.

And in frequent symptoms, we don't necessarily yet have good biomarkers for IL 33, or or the like there's certainly in development, but we think this paradigm of smoking and ex smoking are also up.

Contracted by one internal day data showing that IL 30 slot levels tend to be elevated and former smokers versus current smokers were very confident that we have this population and the clinical data of a 40% reduction in exacerbations really suggests that we've targeted the right population further biomarker development of course is in the works and we're going to have more.

Mechanistic studies to better understand how IL 33 is specifically working in these patients, but we feel like we really have targeted the correct population.

Yeah. Thank you name it I mean, we're really looking forward to getting these data published and presented at meetings, where we can get into more of the details but you.

As you pointed out I mean, a 40% reduction in exacerbations I mean, when do you see that in COPD, its really really quite profound so we are.

We're optimistic about our phase III program and I think we've really we really come onto some interesting biology here.

The difference between some of these subsets of patients. The final question on Amazon aspirin in the window study. This is in the neo adjuvant that has been delayed because of COVID-19.

Fewer women going in for those procedures, but we are re engaging with that and.

Irrespective, we are pushing forward with our plans to move am's net for into the adjuvant space. So the market you provide graham with an update on that.

It's exactly as you said John.

It's a tragedy, but but we do see a delay of.

Our procedures in oncology patients during Covid, having said that we do see solid recruitment into the study, yes, it's delayed but we do have a solid recruitment.

We will be able to utilize study outcomes this year for our internal decision making for sure.

We have not taken a final decision and at what point then to present, the full study data externally but.

Yes, we will have data this year.

Good well thank you Graham.

EBITDA is at all.

For now thank you.

I'm going to hand, now back to Paul for some concluding remarks.

You can see me hopefully you can hear me.

Thank the team for the work today and indeed for the session. This afternoon I think bill lizard. Following the company closely you said he was going to be a transformation story for us.

Personally believe we're ahead of schedule I think all financials are strong we touched on earlier, our confidence going forward is strong our belief and do pick some being the windows from.

When you see the quality of the science and I'm thinking, particularly of immunology and the price of processes that you put your put this afternoon I think just start to see the joined up connected thinking all of all was the amount of the experience the team putting together something quite incredible recognizing subpopulations recognizing heterogeneity what it is.

Understanding the value of builds of booting them, which I think is not well appreciated everybody got excited about celebrating about to realize that just keeps getting better and better than what we understand it.

<unk> on our search for sure, but staying in immunology.

No.

The IL 13 tier soppy none of body.

I inherited the appling.

Deal and I get to see the benefits of that I'm really looking forward to doing some extraordinary stuff.

As a teen pointed out the risks the probably the success in so much higher than on antibody platform and we understand enough about these platforms with tier four piece will disappoint with their teams on the road will disappoint you bring them together exquisitely, which is the word I'm learning more about at Sanofi, you really get to understand some of them.

And then it's a pick them up which was just mentioned.

Perhaps because of a checkered past.

The enthusiasm comes late to some of our assets. So you choose.

To watch from the sidelines a bit long the 40% reduction in exacerbations in COPD is completely game changing yes, we have to get them.

Yes, we have to get that nobody is ahead of us on this so you know the blazing a trail.

Proud of the team that we're putting together and I called you cannot Miss the fact that the prioritization and Genmab and consumer and the desire to free up resources continue to grow but be a strategic to reinvest in these assets to double down and go to play is what we're about as an executive Committee. This is art.

John is to lead the team to make the choices to deliver on the science and deliver the financials their need for many of you will want to see that unfold. It's okay.

But we are ahead of where I expected I'm very proud of the work scope.

Thank you to everybody for joining.

Yeah.

Okay.

Goodbye.