Q3 2021 Sanofi SA Earnings Call

Waiting for additional indications for <unk> three in dermatology and now showing clear benefits in our gastroenterology disease.

Our anti PD, one medicine lip Tayo also delivered a competitive phase III performance in frontline non small cell lung cancer in combination with chemotherapy.

A small phase III study of our reversible covalent <unk> inhibitor known as <unk> Ibrutinib failed.

Build to meet the target endpoint in pemphigus vulgaris likely due to in part to effects of background medications in the placebo arm.

But we will share encouraging phase two data for the <unk> indication at a major medical Congress later this year and we also expect a publication sharing the details of our ATP data in the near future.

With regards to recent approvals, we're proud to have launched <unk> in the U S and Japan, establishing a new standard of care for patients living with Pompe disease.

On the right side of slide number six.

Why your attention to some of our upcoming milestones over the next six to nine months, including submissions to bring benefits to infants, namely do pixel and infant atopic dermatitis and near seven Nab the potential first all infant protection against RSV respiratory syncytial virus.

Pivotal trial Readouts expected in the next few months include the much anticipated recombinant COVID-19 vaccine.

And a mere three for <unk> in second line and third line breast cancer.

The <unk> trial is event driven now expected to occur end of Q4 or in Q1 based on the latest update on projected event rates.

As of now approximately 90% of the required number of events have accumulated suggesting that we will have data soon.

Also in oncology the event driven in raws trial, which investigates.

Sorry, Lisa in newly diagnosed transplant in eligible myeloma patients combined with <unk>.

<unk> Velcade and dexamethasone is expected to readout in the first half of 2022.

Initial data for frontline myeloma patients who are eligible for transplant will be shared at a major hematology Congress later this year.

In hemophilia.

<unk> Alfa our long acting factor eight therapy with the potential to transform replacement therapy for people living with hemophilia a is expected to read out in Q1.

With regards to for <unk>, our first in class <unk> targeting anti thrombin III that rebalancing that efficient coagulation cascade with a convenient subcutaneous small volume injection delivered once monthly or even every other month.

We will share data later this year at an upcoming medical Congress for patients treated for nine months with the original 80 milligram dose on a monthly schedule.

Seeking to optimize the coagulation rebalancing effects of producer in a lower dose has been recently introduced into the protocol and we will continue to collect data to provide longer efficacy and safety follow up data for patients with hemophilia, a and b with or without inhibitors.

Conversations with health authorities continue about the registration requirements.

But altogether timelines have likely shifted by around 18 months.

Now moving to slide seven.

If you attended our R&D day last year, you heard me describe Sanofi has an immunology company with strong core competencies in immuno science that stretch into multiple therapeutic areas, including auto Muni and inflammation immuno oncology and hematology.

Today, I would like to provide some insights into our work in neuro immunology with updates on two molecules.

First <unk> the brain penetrant, <unk> inhibitor, which is expected to be disease modifying for multiple sclerosis, and potentially other neuro inflammatory diseases.

We initiated four phase III trials Portola routed immediately following achieving proof of concept.

I'm delighted to say that despite the pandemic patient enrollment in this program is progressing well.

Earlier this month, we presented encouraging data at <unk> from the phase III long term extension program.

Those data demonstrated a low annualized relapse rate over the 48 week treatment period with 98% of patients remaining in the study.

These data indicate that <unk> has the potential to slow disability accumulation and this spring renewed hope to people suffering with difficult to treat EMS.

Unlike other non brain penetrant PTK inhibitors.

<unk> has two mechanisms number one inhibiting b cells in the periphery and in the brain.

And number two inhibiting inflammatory micro glial cells inside the brain, which sets total ibrutinib apart from all other PTK inhibitors.

Our scientists are continuing to build the body of data showing the impact of toll ibrutinib on human microbial Leah.

Which supports the thesis that brain penetrant <unk>.

Modulates neuro inflammatory processes directly within the central nervous system.

A second example of Sanofi is emerging strengths in neuro inflammation is found in SAR <unk>, a brain penetrant rip kinase inhibitor.

Targets Negra Ptotic cell death, cytokine release and inflammatory pathways.

Besides exploring its potential activity in progressive Ms. This molecule has recently received U S fast track designation for the treatment of ALS our.

A phase III study is set to start early next year.

With that I hand over to Bill Siebel <unk> biggest fan of medicines tackling their inflammation following his experience developing and launching our MS franchise Bill. Thank you Jon Indeed, it is exciting for me personally to see the progress we are making towards practice changing new medicines for MFS AOS and other neuro.

A logical disorders.

Continuing with the theme of translating excellence in immuno science into transformative medicines I'll start with an update on <unk> on slide number eight.

<unk>, our Mega brand delivered an excellent quarter with worldwide growth of 55% and added 500 million euros in sales compared to the same quarter last year.

As Paul mentioned earlier depicts and strong performance in the U S was further accelerated by impressive sales growth across other geographies, where we continued to expand in our new country markets in younger age groups in the third quarter, 25% of sales came from markets outside the U S supported.

Supported by the strong contribution from growth around the globe do pixel sales nearly tripled over the period of the last two years when compared with the third quarter of 2019.

Annualized at close to 6 billion euros, and well on its trajectory to achieve our greater than 10 billion peak sales ambition do pixel for the first time the one.

Reached for the first time, the 1 billion euros sales milestone in a single corner in the U S.

At the same time in office visits remain below pre COVID-19 levels, but are now steadily recovering.

While we are executing on the tremendous commercial potential of <unk> across approved indications and geographies. We remain focused on delivering milestones for future growth, which I will explain in more detail on my next slide.

Moving to slide nine I want to highlight a number of important achievements since Q2.

We have consistently delivered on multiple milestones for growth even during the challenging challenging times of the pandemic and atopic dermatitis, we have recently announced positive positive pivotal phase III results in six months to five year olds. After a 10 month trial acceleration and we are about to unlock.

Growth beyond the adult population in China. Following the Swift approval of <unk> in adolescence, and asthma are second core indication, we continue to emphasize our strong safety and efficacy profile by receiving approval of the pediatric indication in asthma.

Encouraged by the recent positive data Readouts in CSU Eo and Pn, we are optimistic that <unk> has the potential to become a new treatment option for patients suffering from the burden of these debilitating and underserved diseases. In 2022, we will continue to execute on our robust clinical development program.

And our agenda of planned submissions in multiple adjacent type two indications all of which are expected to become future growth drivers. As a reminder, the indications mentioned on the slide combined have the potential to address a population of almost half a million U S patients further adding to the greater than 3 million.

Patients already addressable today.

Advancing to slide 10, and turning to the other specialty care franchises, we saw good business momentum in the quarter in.

In rare diseases, our Pompe <unk> franchise grew double digit in the period with strong performance across all geographies, primarily driven by patient accruals in August we launched next design in the U S. And we are now working on establishing <unk> as the next standard of care for the treatment of Pompe disease and global markets.

<unk> was also approved in Japan in September strong growth of <unk> Zara was mainly driven by the inclusion of the interleukin six receptor blockers in the updated July <unk> guidelines for the treatment of patients with severe or critical COVID-19 kept zara is not approved or authorized.

For emergency use for the treatment of COVID-19 anywhere in the world and we will continue to prioritize access for indicated patients with rheumatoid arthritis.

As a result of the continued increase in worldwide demand for IL six receptor blockers supply is expected to be constrained until early 2022.

The uptake of our new oncology portfolio is progressing well with the launches of <unk> and Lyft Tayo for <unk>, we saw strong performance, particularly in Japan, France, and Germany. The highlight of the quarter was the presentation of the phase III trial of lip Tayo combination data in patients with first line advanced non <unk>.

Small cell lung cancer with a submission plan for later this year rare blood disorder grew 7% when excluding the industrial supply sales of hemophilia products to <unk> strong sales growth of <unk> from new country launches in Europe was the key driver for the franchise in the quarter with that I hand over to Thomas to.

Update you on the vaccines business.

Thank you Bill in the third quarter vaccines reach a new record with $2 4 billion you ring fence.

The highest quarterly sales in our history.

This strong Q3 performance was largely driven by our influenza franchise.

In the U S. Thanks to our annuity license facility producing Susan Idose, we were able to ship larger quantities in a record time.

Europe grew 88% due to successfully implement the expansion menu, resulting from particular recommendation in Germany.

<unk> also recognized by the European Centre for disease Prevention and control are superior to standout influenza vaccines.

Let me also share good news regarding the central lab.

With the additional long acting antibody under development with Astrazeneca, which is.

Which is designed to protect all in for the first RSV season with one single dose.

During the <unk> Congress, we presented the positive results of the <unk> trial in this <unk> phase III study a single dose ethnicity, Mab showed a 74, 5% reduction in lower respiratory tract infections caused by RSV and a requirement to requiring medical care in athene.

The safety profile of <unk> was favorable and similar to placebo in these infants.

We will share more data on the safety results of the medalist study for which we already announced similar safety and tolerability compared to visually map.

At the reserving at conference in November so stay tuned for more exciting that that when you're sitting in that.

Moving on to slide 12, it is important to remember that evidenced at communicate over 10 years as demonstrated year after year, that's fluid on idose.

Provides protection beyond fuel, which means protection against cardiovascular events as well as protection against the pneumonia hospitalizations.

This extensive body of evidence is clearly clearly the driver of our flu franchise success in.

In Q3.

Differentiated flu sales amount to close to 900 million and represents two third of the total franchise sales when it was less than 400 million.

Just two years ago.

This quarter, we launched a new DTC campaign in the U S to communicate the unique benefits of <unk> and we're very glad to see that other as kept partners recognize the superiority of these projects as illustrated by the by the Walgreens communication on the right side of the slide.

To conclude we flew we recently announced a multi sign them at an equivalent flu vaccine in the clinic in 2020 to.

For this new program the benchmark in terms of clinical benefit for the elderly is fluzone idose as it is becoming the standoff care for seniors.

Simply demonstrating immunogen, Steve as regular in terms of vaccines will not be sufficient and this festival in market.

Let's now look at slide 13, and talk about <unk> COVID-19 vaccine program developed with adjuvant, if our partner GSK.

This slide describes the ongoing phase III safety and efficacy study conducted over four continents.

Now, but the enrollment stage of stage one part of the study testing the 10 microgram dose of the <unk> trend is about to complete we do expect to have efficacy readout by year end when we have accrued a significant number of cases, the sufficient number of cases.

In parallel the enrollment of stage two of the study testing <unk> in combination of five microgram, Terence Trent and five microgram beta strain.

Starting this month.

Let's now turn on the booster steady at the lower part of the slide It says the immune response in EDA previously immunized with a vaccine using either <unk> protein.

Victor technologies.

The first arm of the study is testing a five microgram dose clearance trained and we do expect key that that will be available by year end.

Prevent previously mentioned.

Aspiration is to develop a practical universal booster vaccines, they almost stable at normal refrigeration temperature and agnostic to which vaccine technology was previously used in the primary series.

With that I now hand over to OTT.

Thank you Tomas.

Moving to general Medicine on Slide 14, we are very pleased with our performance in this third quarter. The execution of our strategy continues to deliver and focus on opco assets.

<unk> consistently positive results in recent quarters General medicine sales each suite.

Billion Euro with Ofcom.

5% supported by the solid performance.

Vascular and diabetes brand in our portfolio.

So demand driven strong double digit growth, Brazil, and so of course must yoga seasons, a quarter, while <unk> growth of 6% was mainly due to our volumes in China, whereas our product, including the GBP program already for the second year.

Harlan savings increased strongly mainly as a result of the best performance in Europe.

And due to the ongoing launch in China. When you exclude the effect of putting sales with engine, they're running in the U S, which ended beginning of 'twenty one the brand grew 64% in the quarter.

<unk>, our largest go asset by sales grew 4% and continued to benefit from inclusion in W. H soul guidelines for the treatment of hospitalized COVID-19 patients.

The light last quarter gross of loving us started to slow in the period due to the high base of comparison in the third quarter of 2000, and we expect sales will slightly decrease during the remainder of the year.

Sales of non core assets of the general Medicine business were lower in the quarter in line with expectation is a decline of 6% reflected the impact from the divesture of products, which are part of our ongoing strategy both for us seem lining efforts.

We are consequently, reducing the number of smaller product families with the objective to drive efficiencies and to increase profitability.

I will provide more insights into reducing the complexity of the portfolio in just 10 minutes.

Now on Slide 15, Paul has already mentioned, a compelling strategic fit and tongue rational of the announced <unk> acquisition tons plant is a well established growth area for our general medicine business driven by expertise in this market and anchored on our core assets most of the bill.

And time will globally, both brands reported solid growth in the last nine months.

14% and 16% respectively.

The acquisition of 10 months added a significant growth opportunity for us and builds on our experience in the transplant arena.

We intend to further expand our harvest commercial presence with a complementary portfolio.

You will have seen that Ken months key assets because the law was approved by the U S. FDA only this summer.

It is a first in class treatment for adult and pediatric patients.

Yours and older with Clinique cost versus us disease with failed at least two prior lines of systemic therapy.

Steroid, but Kevin stemmed out of care in frontline <unk> Tvs D treatment, but roughly half of the patients estimated to fail on steroid therapy.

I later lines of therapy, and also I, just know that efficacy adverse events mean patient often fail to tolerate.

Finding efforts have resulted in almost 1 billion euro of cash policies.

To reduce the complexity of our business, we have already the past you created yourself footprint in nonstrategic markets and cancer distribution activities with Serb party covering already more than 40 countries.

We are also making significant progress in advancing in a digital transformation digitalization of health care has been accelerated due to the pandemic, we are engaging with doctors and patients well on the on that channel.

Prose, which leverage are increasing capabilities and data digital and AI positioning Sanofi as a keep your partner to hep's more than 60% of our HCP interaction Uhm now supported by digital platform compared to only 30% to nine.

Team to.

To conclude we are making solid progress with the implementation of a package of piracy, which he keeps us on track to deliver on our objective was that I and over the cold to Julie.

Thank you yeah filing a return to growth last quarter I'm very glad glad to report continuous growth in the third quarter.

As a result of good performance from algae or graffiti and almost all categories. These positive results show that the execution of our strategic roadmap is starting to deliver I went to specifically highlight that I'm cutting in embracing complexity. We've been successful in our simplification effort knowing that out of her twin plus.

Plus brands, we have already discontinued the production or announce divestments for 111 brands or 45% of our brands.

We're also continuing our simplification in dever at many other levels to further increase our focus on our priorities.

At the same time, the prioritization of our wellness categories continues to pay off with the digestive wellness brands and Dow Jeremy nine Bouska band performing very strongly as well as our magnesium Brandon mental illness and in Q3. The good performance of pain received an additional boost with consumer purchasing dirty Pan and eve, while getting their COVID-19.

Vaccination.

Lastly, I'm pleased to report that cough and cold is back to growth, although from a low 2020 base.

On our second strategic priority of becoming a true fast moving consumer health care company. The creation of a stand alone is a key business a neighbor.

And I'm happy to report, we're progressing as planned with more than half of the legal entities created as of today and with the next significant wave expected on January 1st 2022.

More importantly, we are already see great benefits of the burnt progress made to date, allowing our teams to a depth new processes policies and overall ways of working as a result to move faster and be more consumer centric.

We've also been able to successfully reallocate A&P investments to our must win brands and countries to accelerate growth as a conclusion.

You might remember that historically or get versus market growth has been substantial.

In 2020, this gaffe was close to five points.

On a rolling 12 months, we have reduced this gaffe to less than two points and I'm very happy to share that year to date, we divided this gap by four two less than half a point.

With that I handed over to our CFO stomach.

Thank you very much trips like surgery on slide 18, turning to our friends for performance company filled increased 10.1 percentage was headquarter driven by excellent growth of Dupixent zero differentiated flew on consumer health.

We said, we would be improving one oh gross margin only we are delivering based on the February Bowl Pulford your shift to specialty care products on efficiencies within industrial affairs.

Quarter to vaccines business contribute. It also is complete is improvement for more than 200, <unk> you too partial recovery of the meningitis vaccines business in the U S.

We are committed to science whenever I already spend increased during the quarter driven by advancements of all priority as it.

We also continue to add I'm Gonna do you spend from recent acquisitions.

D N a spend it was driven mainly by commercial investment spearing specialty care grill.

<unk> drivers on flu vaccine patio set by continued streamlining of Jimmy.

Order of parity income benefited from mid gangs from disposal of around 130 million versus around 60 million lost your contributing to a b Y Martinez, 44.1% in the quarter.

Just think fourth fifth in both ears, B Y clearly outgrows sales.

On slide 19 them.

We have achieved around 2.1 billion accumulated savings to.

2 billion in notebooks are shown on this slide but also went under the million and cokes.

We already achieved I'll target of 500 million savings and are indeed, you to prioritization of specialty care on exiting diabetes and cardiovascular.

Addition, permanent deficiencies were generated by consolidating functions across sites improving out trial, so to speak and reducing cycle time for more dried governance <unk>.

The same period spending R&D increased by 500 million behind our priority I said on due to recent acquisitions such as Principia came album title.

We have a similar picture on his journey, where we invested around 1 billion more behind our growth drivers and specialty care on vaccines.

It was pretty upset by permanent savings achieved ingen made as explained by your D. D. E. D complex. He finds a business focusing on key market unemployment digitally enabled go to market model.

General and let nutrition across all areas of Sanofi contributed and she likes 120, 21 $400 million to smart spending initiatives real estate efficiencies preferred to blow your modal on digitalization.

So room and we are on track to achieve all target of 2.5 billion sitting by 2022 with most of this year's a mixture.

Savings to be relocated beyond Oh gross drivers on key programs in R&D.

So it's like 20, we summarize expect the dynamics for Q4.

Two four of 2021, so far farmer, we expect continued growth from Dupixent, Jim Midcourse. It I expected to grow with loving notes were coming to stable died.

<unk> will have a negative effect on established products.

Latest round of China, BBB will be implemented Lake Q4. This year on the uncertainties remain around with future Mckenzie I'm for insulin class conclusion.

Four vaccines, we expect you for sales to be lying versus last year with flu vaccines have grows driven by Europe.

Compensated by continued weakness of trouble vaccines on lower U M. B P. S sales following the vaccines loans.

We expect consumer health to grow in line with marketing two four.

<unk> will grow.

Especially with the impact on our end.

Of two by you on potentially cadman clothing.

So it's like 21 big on this phone results during the first nine months of this year, we are raising out for your guidance for 2021 business EPS. We know we expect <unk> to grow around 14% of consultations right.

Yeah, we took regarding for any change impact continues to be negative I minus 3.5 to minus four five based on October ovulate exchange rate and with that I have to go back to pose as an important date on our is G roadmap.

Well, thanks, Jamie and today, we announced our ambition to strengthen our commitment to the planet with a target to reach carbon neutrality by 2030. This marks a 20 year acceleration versus all previous targets. The building on great was done a cost of organization that has allowed us to already be choose submissions of activities by 20.

Three 7% since 2015, but it's important we know introduced on net zero target by 2050, we will take the opportunity of <unk> 26 to set a common initiatives within the industry.

<unk> looked at a few key initiatives were really against you have set that clear ambition of 100% renewable electricity a cost of operations by 2030, but.

Cause I'm moving full speed ahead, and delighted to highlight and all our site some France, Oh now entirely powered by renewable electricity.

We're taking decisive actions to reduce the environmental footprint about products and is a leading as an industry leading global manufacturer of hundreds of millions of vaccines every year.

Made recyclable eco friendly product packaging, a priority with the aim to reduce blister free vaccines by 2027.

Reached the first milestone with approximately 25% of all three vaccines packaged and it says in sustainable materials already this year.

Yeah. The film industry itself is heavily regulated and they would be easy to hide behind complex supply chains interactions with regulators and regulatory agencies et cetera, but the reality is that climate change is already here. So the time for sustainable action is simply now.

But that I think it's time to open up for Q&A and a hand back to heaven.

We can now open the car to your question as a reminder, we would ask you to limit your questions <unk> each.

The Q&A you have two options to participate option one flick your right hand icon.

At the bottom of your screen you will be notified when your line is open to ask you a question at that time. Please make sure you are neutral microphone.

Option to submit your question by kicking the Q&A icon at the bottom of the screen. Your question will be read by our Kennedy's and.

And now what would take the first question and Simon matter ethics payment.

Hi, Craig.

My line.

Second question about two feet long.

And secondly, long announced lessons.

We do have a very strong operational execution once again the quartet.

Nine months or exceeded your file.

Alright.

And these costs are significantly actually did you say to extending 2025 alright.

Can you help me understand why we shouldn't assume upward pressure.

That makes sense.

Especially considering a previous comment that you've made.

Can it be modest increases in.

2022.

Is there anything specific you you.

Call out of 2020, Carrington Hershey call anytime into account.

And then secondly on Emirate free.

Recent data from Mary.

Mary Emerald trial increase your level of ultimate around the Doctor.

And given the similarities in the two trial design.

Can you just say your community to remind us of the crazy franchising.

Next drink.

Alright, thank you.

Southern and I'm not sure I was two questions, but we'll do our best I think it and thank you for vacation resolve at J B. So the question of course from BLI were checking ahead, what does it mean for now and let's see 2022 and the guidance that we've already given them think it would be good for you to share your view.

Simon Thank you very much for your kind words about our operational execution on I see you are perfectly right to think that there's no personal reasons to change that trend as there is no reason to change our way.

The way, we manage the company, which is really <unk>.

I'm, we can why we are respecting the guy knows for 2022 and 2025, we take the opportunity to.

Add to the science to add 12 pipeline you see what we're doing with.

It was T. By you will see what we are trying to do with Cadman I mean, all of those versions. We aim to go on.

Each time, we have room to do it so it's not about beating expectations on our B Y margin guidance, it's really about relocating from cost savings into the science to Oh meant valuation of all pipelines.

Really is a very simple on it we have not changed since December 19, yeah, well such a b I mean, it's the truth. We gave you some guidance for 2022 2025 should look like and to get ahead.

<unk> ton about you by accelerating a doubling down on our own science or adding so great.

Great position to be and to be honest, John Reid at coming on and there were three and which I think you've already sort of set but then more importantly, the data from that can give us men a medium radius and what that means yes.

Yeah. So I mean, thanks for the question indeed the.

The resolved for <unk> does increase our confidence in a mere three because.

The Bill was really lacking robust data from a C. D. K four six experienced patient population and now we have it through those data will look forward to the details of the data at the San Antonio breast cancer calm breeze, but.

That is encouraging for our study and even more so I think because you know <unk> seems to have a preference for the mutant form of the estrogen receptor and not so active against the wild type form Where's our molecule lamps, an astronaut is equally active against both forms and of course the safety profile.

Is really best in class Ramzan, Astro, whereas the radius compound has a history of great three safety events, so, so where where I'm even more bullish I think after seeing those data.

Thanks, John very clear I think for everybody have maybe we gave to the next question.

The next question is from <unk> at city.

Yeah. Thanks people don't city Uhm, two topics that usually don't get much airtime, despite being Christian styles, Uhm consumer and Genmab, Judy just pulling up from your.

Prepared remarks, I mean, if you wish to characterize Q3, how much of it is just a function of easy comes for US is clear evidence of the measures that you put in place coming through and when you I think you hate to say this but it sounds to me that you believe this time that you consume business can deliver.

Can get back to intrude, even groschen 2022, I just wanted to sort of take the size there and if you could very quickly just remind us <unk>. The timeline style that you're working T. For these are extra ATC launches on Charlie's some time asleep.

And then something similar for Olivier again.

I noted your prepared remarks kind of just push it on D V. P insulin ballpark quantification of the likely impact and that'll mess Iraq lots of enthusiasm consensus Kapaun was about billion is that something that you feel is fair or D. B U in time at Santa Fe have higher expectations in terms of the peeks out expectations for.

<unk>. Thank you.

Okay, good Kevin really getting into it G. How much of it is favorable come so I think the terrorists. He said and how much of it is just sheer excellent execution, which but it's well for the future.

So first day. Thank you for your question I think our our growth is very coming from three sources.

Yes, there is an additional boost of COVID-19 vaccination in pain, specifically, but basically representing only 40% of our fingers.

At some carried there is a low base. Some other calories there is a very high base talking about caffeine called and and and also as I mentioned earlier, indeed, clearly improve brand activations, resulting from increased consumer Centricity already which is for me a key component of our strategic roadmap N N also.

Guarantee for a future success, though so when you ask about lots of questions actually our future growth and an outlet for for next year I mean, our goal is to continue to reduce our gap.

Versus market as as we also shared with capital market day, and I shared earlier and grow our priority brands really above market as early as 2022. So as early as next year and T. Geography's again by delivering our strategic priorities, which I I mean, we have multiple proof points.

And I think you had.

Yeah that was another question the <unk> R X ray to see switches timeline, just like some of the time I just Wanna.

I'll pick that one up if we had to.

Truly be but I wanted to jump in because I wanted to say, it's quite extraordinary the transformation that's going on in the consumer business and I feel like it's gaining momentum and it's got a strong staying power what's going on so so you know I need to pay close attention to that this really cool mist. If you didn't see people to sit in the numbers at some point the switching.

Is that not much has changed its around the middle of the decade of things to be talked about telephone. So all of this with you around about the same time.

One little nugget that that I think is we haven't shed yet is that with Ah completed one of our self selection.

<unk> successful.

And it's just the digital piece of fun, we got another one to go before we get talking to the regulators again, but his steps go you know we continue to make good progress behind the scenes and although we have a ways to go of course would never said anything other than that that was a.

Good old milestone for us to show that we know how to do these things because there's a lot to happen between now and then but we were pleased to get that first step.

So over two on B B P incident.

So thank you for your question we at that we have to say that of course email plan that we had incorporated though E insulin DB impact I'm starting to have twins too. So what was the the policy is not yet fully disclosed and will probably be released in the course of the month of November.

We I expected the bidding process to start is at the end of November or beginning of December. So on intimidation that is going to start in H, one two or 22, so really no surprise in line with our expectation I would add that we.

We are very happy with the continued performance of <unk> that shows the ability to go volume not only the first you're gonna have a 91% for Plavix a first year of the implementation of V. P. But also we continue to grow on a nice space and we continue to seems especially in the field of.

Diabetes.

S T. The letter potential to the whole wall.

With regard to your question with on the edge of luck. We are very excited bye bye bye cadman, we have a very positive anecdotal feedback coming from key opinion leaders.

We are expecting a clothing to take place further to stockholder approval beginning of November.

We are very much looking forward to be in the field and.

We look to the upcoming years towards 22 is going to be a very exciting here and I can tell you is that we.

We think that's into a 20, the the Zip lock.

Is going to be elusive and we are very much looking forward to enter into a 22, so as you walk.

Yes.

Not expecting it to be diluted in.

In the 1922.

I will say and it's worth having that.

What we've done and we mentioned a few times in my comments, but you have me mentioned capital market statement to 19, a few times because.

We're trying to.

Keep delivering on our commitments and promises even when we're anticipating quite far ahead I think we're doing that when you've been in the actually but Ah February 5th was the other landmark president Mr Consumer and Jim It and of course immunology piece, but I'm consuming Jim how that can be pretty effusive about transformation, that's underway and Jeanette I think we just under appreciated.

What we're gonna be able to do on such a large piece of business that you said, it's silly half our revenue at the front of your question and frankly, you know the work that's being done in the breakthrough gives us a huge confidence in what we have ahead of us some fueling everything else that was doing some delight with that so the next question.

The next one is from the master <unk> attention.

Oh, great. Thank you very much for taking my my questions. The first I need to ask about the the anti secam five things. So maybe it's a little bit of an unfair question, but typically you don't Wanna target that looks at Hardy prevalent across multiple tumor types you would see several players focused on the target. Despite the sale is that you need somebody to say this but let me see.

So is this a sanofi being ahead of the competition was it because of the strength of the molecule. So just curious to hear your thoughts down and then just tied to that how do you think about the potential competition from the trunk to target with respect to the anti Secam Fries and then my second question Uhm, Sir I can't pronounce the name. So I'm just gonna say that <unk> 001, just in terms of.

Efficacy I should we expect to see a better clinical outcomes best is assisting factor hates or duration of usage. The most likely to your advantage and then just some commercialization how should we think about the launch trajectory <unk> given the stickiness of patients.

The previous Faq to hate launches, but now it's been several years. So maybe there's a little bit more appetite for switches best is the past. So just curious to hear your thoughts there as well. Thank you.

And some of them loving it they were getting into the pipeline conversation said, John and maybe two cent minimum we ahead of everybody else and has it compared to the other mechanisms with some notorious.

Yes, we are you know the that class of targets.

E. A karsner embryonic antigen is complex, but unfortunately, our scientists really were able to focus on a variant. She cam five that is very tumor specific in his expression <unk>.

Scarcely expression any normal tissues and that really I think turned out to be the the key attribute here of the molecule that's allowed us to succeed where perhaps others had not so we're we're very excited about the current molecule and I think we've also chaired that we want to do more with it and put put put different pay.

Clothes on their molecule for different kinds of cancers. So you know, we're we're very eager to generate the data around that we will next year have I think for phase two studies that will deliver data next year, including gastric cancer, including a combo studying lung cancer and together with.

Randy Susan Ma'am, sorry, Ramzan incur.

Including data in breast and pancreatic as well as some data in frontline long together with a P. D. One room inhibitor. So make sure it'll be a rich year for some readouts, while we continue to pay three journey with a pivotal study and in terms of the comparison with Trump too we.

We'd like this diamond Trump too because according to our data.

Trope too is not as clean in terms of expression in normal tissues versus the tumor tissues compared to seek M. Five so we thank our therapeutic index will be superior.

Thanks, John.

Maybe bill you'd comment on ethanol talk to <unk> or visit there was zero one yeah, well why don't we just call. It alpha that'll that'll make it that makes it a lot easier for me I can I can I can certainly tell you that but Dino were really really excited about it and you know this is not only going to bring longer.

Dosing interval, but a degree of higher protection and.

And you know I'll just from the September 2020, New England Journal of Medicine publication. It was there that it was reference as a potential new class of factory replacement therapy with a weekly treatment interval that would transform severe hemophilia a into a mild disease. That's the promise.

This is a game changer and hemophilia a we believe there is no reason that anyone who's on factor is in on that.

That's how good it is it's gonna get people back to a more normal level. So yeah. We're really excited now there's been a lot of change in the market, obviously with different mechanisms coming in which increase the switch right that slowed down a little bit during a tour.

<unk> 19, we expect though and you know a lot of the market is still remains a factor market. We're excited about getting up out there and really seeing it becoming the leading factor.

Great. Thank you very much.

Right, Okay, Thank you and stuff uhm.

The next question is from just project at hearings tough.

Alright.

Jessica.

Okay. So in the meantime.

Okay, Yeah, I can be taken out thanks, very much first of all I transferred congratulations on making the commitment on climate change Paul I think that's that's pretty impressive and encouraging.

So a couple of questions first are on <unk>.

A sense of <unk> I'm, sorry could you give us a sense of.

What you saw in the roles of Pemphigus diet, I, Patricia <unk> pretty clear that the primary and secondary endpoints, we're not mad, but now you've announced additional studies. So it's wrong for something that we shouldn't say as a as a future value driver contributor or not so could you help us understand that and then secondly therapy, you're analyzing at 6 billion euros.

Yeah, right now you're growing up have been 50 per cent it.

It looks like you'll hit the 10 billion your target in about 18 months if that correct continued issue fracturing you indications, you're just getting started around the world.

And yet the straight really is tethered to that 10 billion in your number call are you willing to update it and why isn't that 15 or 20 billion.

Okay, great great Great Christians, Indeed uhm.

Thanks for the coming up front about climate change and Ah. There's a lot of responsibilities come with this the role that I have and one of the privileges of being here is that.

He's got a company that perhaps not well publicized but was doing an incredible amount two in the benefit that's all contract with society, what's up and down in a few places being very excited about that uhm declass. Some other shed industry perspective set top 26, which is not that far away but.

We have an absolute responsibility as I set up front to do something and and it's not just for posted by the elevator, it's real work being done by hold organization on a daily basis. So.

Really proud of the organization long way to go like everybody long way to go but really proud John Wills I think you touched on upfront maybe there was some factors in the placebo.

The treatments and things like that but to be candid you know, we how do you feel about how we performed on what the opportunity to be around the corner.

Yeah. Thanks for the question Jesse you know in that study there was.

Background glucocorticoids.

High levels of those that patients were on.

In both a placebo in the treatment arm.

And then one of the it was a complex endpoint, but part of it was you know how quickly can patients get to lower doses steroids and.

And we saw a couple of things one was that the response rate in the placebo arm.

It was three to four times higher than has been seen in any other peavey study. So evidently those high doses of glucocorticoids in the control arm really interfere with their ability to see the signal.

Also the the trial, which we inherited from Principia. It was ongoing when we bought the company.

The <unk> the criteria for positions treating patients on the study.

In terms of determining what threat.

Threshold would meet the requirements for reducing steroid doses were not very strenuous. So there was quite a bit of.

Heterogeneity in terms of when positions decided to titrate downstairs roids background steroids. So.

Bad and some other lessons learned from the study lead us to believe that you know we could have had a better design study and and that that indication. We would have approached in a different way going forward.

As I said you know the other day to we have coming from my T. P. Though on the other hand is very encouraging so that you know boosts our confidence that the molecule has merit.

Those data showed a good response rate of very compared response rate excellent durability as well.

Where in the phase three it's progressing well, we'll have an opportunity to share details of the phase two data at upcoming Congress's as well as in a publication and we are pursuing Rosemary and other indications. So we have a high hopes that that molecule given the importance of the V T K target occur.

Cross a number of auto immune allergic diseases will will be a big player in our portfolio on a go forward basis.

I finished chum Chum uhm.

Uhm.

Bill who would you <unk> tradition, we're getting a lot. So good to share your view on view on potential peak 50 pixel well first of all Jeff. Thanks for the question and for the the stats that you gave them leading into it it's really been impressive what we've been able to do in in the law.

Last quarter, it's been incredibly impressive as well just since Q2, we've had six milestones, which is just really unbelievable pace, which were going and the thing that I find really reassuring as you know this is a global brand truly with 25% of the sales now coming from outside of the U S and.

It is not a U S product by any means it is a global brand.

Now if you look towards what was in that 10 billion plus forecast that we gave COPD wasn't in that so naturally. We you may think that after we announced that in 2023 would be a time to change our our guy.

<unk>, but you know given the rocket ship performance and the distance to 2023, we think it is important to update prior and we're currently discussing the timing of that so let's say stay tuned for the moment.

Great. Thanks very much.

Great. Thank you great questions Uhm, maybe when were you in the next question is from grandparents.

Bank of America crime.

Okay can you hear me Okay Yep.

<unk> and yeah, So I'm gonna follow it touch on and they were three and if you could just remind us when recruitment with complete and so how long have you actually ever you hats and patients on on dragging that steady for now and to what extent G. C is an encouraging sign thing is taking longer for a cruel events and does it changes.

Testicle analysis planet tool and John on the second quote to call I think he said that just looking at how events recurring you're looking at four to six months pay F. S. Just wanted was that for all patients was that <unk>, referring to the control all the drug in the study and then a second question for John investors, often say just paste a mere three.

Not a lot going on in Santa Fe R&D until 2023, so perhaps you could just help us with what data in 2022, you'll makes looking for T. Thanks.

And play them ma'am.

I wanted to jump nobody's seen any of the data right with with if the the difference of course since Q2 is one sided because we've seen the memory radius data. So so that's you know a good.

<unk>, but we haven't seen any of the data.

Anything that needs shed in fact is that 90% of the events have been a treat and we haven't even declared how many events, we're actually expecting to see.

John and then whether you want to add anything, but I'm not sure there is much but I'll need the team yeah, I don't know that there's a lot more to add you know one should always be cautious about over interpreting the fact that an event driven study is continuing on and on.

We'll just have to wait for the day that we're not planning to do at this point to changes physical analysis plan, but you know, we'll we'll take a look at what we learn from the data of radius when they presented at the San Antonio meeting in and see if you know if there's any second dog, we have around that but right now we're staying the course and waiting for the.

Vance and as I said, 90% of them approximately have occurred. So we are hopeful in the next few weeks that we may get there.

So yeah I think we all just have to <unk>.

Remain patient fluffy for like.

The the curtains open here and to see you know turn it over the card here.

In terms of events for next year Gosh, there's.

A number of things that we could be excited about I mentioned some of the frontline's that there will be frontline data for shark, Lisa next year with the most modern background backbone therapy that'll be an important opportunity for us to move into the frontline space with and see if we continue to them.

Australia Best in class profile, among the C. D 38 class and myeloma, so far to add it to.

There's gonna be more data presented at an upcoming Congress. The end of this year, which will get further insight. So I think that's certainly something will will be watching.

I made sure there will be some face to reach out to them to submit a man.

And additionally, vacations or in combinations with other medicines. So I think that's gonna help.

Further establish.

The level of excitement to have in that molecule based on what we see in those studies.

Data will be trickling in four sorry, 245, or non F. I L. Two throughout the year next year, we have it started in.

For a indications at least now and so you know those data will be accruing and this the signal seeking studies across dermatology across long across G. I N.

And I had met cancer so.

We'll we'll we'll be getting more and more insights into that molecule in combination with P. D. One.

Evidence Octachord was mentioned, we're gonna have the readout on that next year. So that's that's really exciting.

So that those are you know a few off the top they had we we can refer you to the backup slides. It shows all the wreath out next year and you know if we think it's gonna be a good year for us.

Thank you. Thanks. Thanks.

Thanks, John for that summary that that list is getting longer I notice.

The I just want to come back so <unk> no misunderstanding from anybody a military.

Never seen any data with 90 per cent of crude we've been confident throughout the process. We believe in the pathway.

Great men some of the great Uhm a.

Balance of safety and efficacy and the recent data from memory radius gives us even more confidence. So you know we will turn it cause I was always upheld game, but we're we're optimistic about sending them over so let's see what we get to <unk>.

Next question.

So the next question from my question I couldn't kismet.

Thank you two questions. Please.

Sticking with the pipeline firstly [noise] excuse me.

It's us around it had a chequered history. We've now got an 18 month delay to the read out is there anything that will see between now and 2023 24 that will allow investors to understand your continued optimism for the molecule.

And then just a quick while I'm on the Covid Universal Peace. The strategy can you tell us whether now the pricing for that program. If it's profitable if it's positive apologize would be for profit.

Whether it would remain one why you would aim for not for profit pricing. Thank you.

Okay, Matthew Thank you.

I'll I'll, let tulsa to build to choose from but but you know since I joined the company I've been with a lot of a lot of diligence joined the company and then a 30 days when it got in houses able to see the data.

And was always excited about the to surround plus would seem what can leave it done we saw how fickle the market was how quickly with news.

We look ahead to walk for to surround will compete with even with the delay.

It is is the management team will look at that and get can we still spread the needle on an exquisite profile and we know that we will have to go to a lower dose probably a little experience that and we also know that all interval to stretch further. So so you know there isn't that much excitement in in follow on some other companies. So.

It's it's it's a needle sits fled but if we get it done and that's why we stick at it I think we can really make ourselves a very successful medicine is so and so on you know it is one of those things where I think we are a little bit of ways from from when we need to be but but we keep making progress would keep learning we're excited.

About the profile on this at every turn at every turn in any data. We picked up there are patients that have responded like the living disease free. So we know that we just have to balances things in that journey. So far is still with the trade for us and we feel that way to this point I don't want the genre bill ones that anything else.

Paul just to Echo all your comments. This has a really unique profile, whether you're looking at any gene therapy or anything else a potential every other month. So six injections per year. That's a it's a great profile small subcu administration. So.

Let's see I think John mentioned is in its statements at an upcoming meeting this year will be reporting at some of the 80 milligram dosing. So stay tuned alright, yeah, that's right you're asking what.

What date or what we might be able to provide the investor community to help.

Help me understand why we remain excited about the asset and it'd be there'll be.

There'll be a presentation of data that upcoming Congress later, this year and probably in the next year as well, whether we have the full data set on the original 80 milligram Q monthly dose for the two main base re studies one of those with with patients with inhibitors and the other was without so.

Those data will be shared with the community in the next few weeks and months and and then we go from there and brother up you know with the studies were doing now to explore the lower dose and the and the more.

But less frequent dosing in a row. The one thing I would just say you know because this is an S. Iron a drug we have to all remember that that class of drugs has non traditional pharmacology right. They have.

What I would call a depot like effect and you know <unk>.

Doing some titration of that is perhaps not unexpected we know what levels, we have to hit of Andy thrombin, three reduction to get that sweet spot and we're just dialing into that right now.

Thank you both at Tama boosters.

Thank you Mad Southern question could be 19 boosters, let me stop squeaking by saying that a strong engagement on the COVID-19 centimeters kismet about the financial beach when it could be 19 booster or for the very often under viewed 500 million disease.

Vaccines that were manufacturing from three different manufacturers on top without one development.

But to your initial question as we can we can before it's really going to be an affordable pricing and we have no change away from that at all that's the strategy. So we go recently fell that'd be south of 10 euros no change there and now it's up to the face where you read out that's coming pretty soon.

Okay. Thank you okay.

So I'm going to take the next question from the Cats add those factors from bad back and the first question undertake send it's actually a free online can you Tonight.

Alright, and the tension type the China launch progressing and you continue to note here.

Alright, you have the name Smacky I'll take her with them yet.

And the second.

Seal COVID-19 come with vaccines do you continue to believe that demand for such a combo would be no I permission to move forward on this despite ending Coovick M I L.

Okay. Good good I I kind of useful questions for 10-K at at Bill sales split I'm not sure frankly, how much was sure on that beyond the geographies that you've already said uhm and China update in person visit numbers to us and then at some welcome to for <unk>.

Come in the Medicine cabinet.

So thanks for the question maybe starting in in the reverse order there about pace of opening and we were encouraged actually to see between last quarter and this quarter trend up closer to 85% and that there is obviously by specialty as far as when does it get back to normal it's really a question of code.

Alright, if if we could if we can predict that we can predict when we're gonna open up.

And you know again, we think that we see some some really encouraging signs you know I will just reiterate that not all specialties were affected the same through the pandemic as it relates to Dupixent, we saw with Pulmonologists and any of the respiratory.

Physicians that it was they were harder hit oftentimes.

<unk>, we had pulmonologist being pulled into icy use and so forth to take care of patients there and also patients with any respiratory illness. Because they were so susceptible were really kind of hunkering down at home. So you didn't see the same exacerbation rates et cetera, and I think that reached through an asthma as well as COPD as well, so just a little bit of context there.

We're not going to break out the indication split within the U S or anywhere for that matter, but I can say that there is strong growth across all of the all the indications Uhm you had a specific question about China and we've been really really impressed with the work that the team has done in China.

Anna since getting the N R. D L lifting in March and this is tracking to be one of the most successful immunology launches in China ever and as we've stated we think this is going to be a blockbuster in China on its own and will become a real leader in ini.

In the next three years the labeled population in China will expand children a D. Six to 11 and 2022, but then we also expect infant 80, and 2023 and asthma in 2024. So we really are at the beginning with Dupixent in China. So we're building a strong foundation.

A strong base, where accelerating hospital list things, we're doing policy shaping we're growing the number of prescribers and we're really accelerating access to patients. So this is a long term story, it's off to a great start and we'll look forward to reporting more on at any time.

<unk> said, though thank you at Tama flew.

Flu Covid you know approach.

So your question is about the fluke of in 19 Commendation interest need visitors can you could provide for any combination and you know that we know commission steady wail as we what do I hear a fiercely combinations. We're always looking at what's the need for it what problems are we trying to solve this is the clinical benefit.

So if need weird ways to get what the convenience and convenience you knew about two days in most of the countries in the world in one single Divvied, you can receive could be 19 boosters and flew in the same visit so you you're not saving any visit now and the second that is Tom can you can pull 30 perspective, what are we looking for and as <unk> as we've shared before.

And that's shown by the success of a growth of influence that differentiate vaccines clearly people that are looking at <unk> influenza vaccines. So that's the bar to reach and jumps on <unk> safety and if he can see so as I mentioned today independent nation.

We have a look at we able we scream out I need to read the best clinical 50, and did you get the bar and then we'll move on but there's a lot to go there very confident with the first one did you live in place and we're looking forward to share each with you on December 1st.

Yeah, I was gonna add that and I think the December the first meeting you'll get to share. Some interesting insights perspective, some data, which I think will help bring some clarity to the flu landscape and in general to the vaccine landscapes. So so you know make sure you're available for that is what I would say okay. Good question. The next.

Question from Richard cluster at two P. Morgan <unk>.

Hi.

Two place just on this isn't that obviously strong headline at data in in in the article, but the hospitalizations I think on the on the Prime May look at that didn't meet city. So a significant say just your thoughts on whether that impacts at any of the sort of reimbursement no recommendations.

That that that pay is oh, the I C. H C. A I C P might not might make and then second question just on that list and just thoughts on the uptake there and what's going on with that P. P. H vaccines, thanks very much.

Thank you me too okay empty it huh.

Thank you rich hands on the <unk> on the first part unnecessary map into important to clarify that your specialization specifically in the minute you try and what is not a pie million point.

So the so the city wasn't a spell it for that very important to say that specified pooling of hospitalization across the face to be in phase III, maybe try west.

55, and we've made that cut out yeah with the D. M V P to prevent three oh, the faultless position. So so we're not worried I thought I'd like to pay us perspective on this so I think very good pulse I am yes, any ma'am again to be able to speak of these Asian in a set up a pretty much is the number one <unk> goes to the new bones in the world.

So that that funding you send that an event for the second question on Vexillate.

That we've launched vaccines in the U S. In June 2021, we are still in the early stage of these the lunch is doing very well, but you probably know that when you are switching vaccines from one P. A twinkie musician can use it to another it takes them fluffy decisions to go through the existing vaccines and move onto the next one.

I'm very happy with what we see in the vaccine is lounge and of course, I remind everyone, but as we've discussed last time vaccines. He says on the books in the sense line, Yeah sure available Soviet the JV smirk with some of the pastor and if that the profit line, but you received.

And the coffee Tonight, so although overload I will say that cities good launch going well. Most importantly P. P. S is doing well as we noted before we <unk>, we have a decreasing best cool despite that you'll see that we are doing today with M. P. P yourself.

Yeah.

Thank you for that I think we're really pleased with the launch but also at.

At the same time, you see when you're in an established vaccine marketplace with a good standard of care you know it takes time to educate them to change and that's fine for us, but we used to doing that so I was the leader uhm.

Uhm.

<unk> to have in the back of your mind as you think about what happens in the future if.

Films, including our own by the way has successfully I'm on a flu.

What motivates in the pandemic is very different in peace time, So, let's let's just get deep into his conversations on December 1st, which I keep trying to advertise okay any other questions.

The next question is from K O panic at Goldman Sachs care.

Okay in the meantime, we can probably half chocolate, Sir I pray and I need some checks.

Yeah can you hear me okay.

Mexican at two questions first for Tomorrow, if I understand correctly yoga recommend in recombinant coffee vaccines presented in two virus one for the antigen and one for the agent. Therefore don't you think that just presentation could kill you see showdowns of use of your vaccines b.

<unk> not sounding equal booster a primary vaccination booster sorry.

And do you plan to improve this presentation, if not already done to have for example, you're ready to use C Ranch, that's not really a question and the second one is for <unk>, yeah guidance for E. P is gross.

P S to imply our senior she can slow down for some <unk>.

How would you interpret that to what could be the reason for this.

Slow down.

Thanks you.

Mmk. Thank thank you so much J V. Let's start with you what about the rest of the and what does that mean.

Yeah, I think it's important to to have in mind. This is a very specific phasing of our b Y on EPS growth during your photos border.

The fourth quarter the.

He never age looking at the pastures 829 first of edge point below the age of the short first quarter thing. It's very it's very normal to have a cyst drained.

Nothing nothing will because slowed down and of course, we want to accelerate but if we want to accelerate in science and innovation, So that's where we.

We are looking at and that's why we will be with the closing of two by you which has occurred on that we'd be of course.

Maybe it took 10 minutes if it's closed before your <unk> you will see some more R&D cost speaking up in Q4, which is expected.

Great. Thank you and Tomas maybe help clarify what will we actually think we'll play in primary before you get into some of the mechanics.

So so indeed, so could be 19.

The situation is evolving and we are supplying and where we all needed. So we are trying to be rid of it what does that mean completely it means that the product. We are developing ended up with our partners in Europe and North America. The explains demand <unk> booster Doozy, that's primarily vaccination disease and of course back to your <unk>.

<unk> in terms of presentation of course, but what else <unk>, a new day weight, but this is an <unk> and divide up at events adapt premixed a bit title of it. So so that's very clear it didn't prevent them at all as I mentioned previously to to place order. So that we can move for Awhile, then 2022 as soon as we.

You have phase III redoubt, but I remind everyone again, but as I mentioned initially Ah contribution.

Contribution and I'll engagement and could be 19 is not about the furniture, it's about having an impact on the bun.

Yeah, Thanks for that and I think that in addition, you know there is there is a real there is an opportunity to do so just to play a part and that's our focus uhm, but whilst we think the method of administration is really you know not a complication at tool is what's important to them.

Things that would thermostable and so you know I think would depend them. It can be you will be getting into those details, but they are they are important details. So what happens next in the roles of the established platforms and I'm on a and different things like that but if we if we if we get good data as a booster then we'll be making what is it.

75 million doses have been preordered.

Yeah European countries that southern European countries. So you know so if we if we get that in this profile thermostable I'm Gonna play in Nepal that will just be a great thing to do and I think it'll be a great probably an organization to see us do two alright. So so thank you for that.

And maybe it's the last question, yes, we can take the final question from Quito Welford at different Peter.

[noise] Hi, yes, that's taking my questions at two that that's neat and just on at two Sam <unk> and just the regarding the timing at that and I think.

It looks as that'd be <unk> may have gone into 2023 from 22. These kind of fries that has been driven or would you to enroll simulated you pick B C. O P. D. It's not that may not be filed 24 is that it will take you to one of the studies be checked it uhm and then the second largest brewer going on strike.

Right.

We're obviously, saying that the b crowd parakeets and the C V 20 antibody.

Taking a lot of market share and been widely adopted and curious what you'll be amazed at this point on fantasies prices and multiple sclerosis. Uhm are you looking at getting into the Bee I'll set you up with a pilot checks you think you'd need that to compete long.

<unk> crisis or has led charge or an experienced that that they need to take with guys put you off having a pilot you give me a my space. Thank you.

Okay. So I think I'm gonna ask bill in a moment to come in on why we think we have the winning proposition.

Oh, and then C. C D 20th and also to come in on the COPD I think I heard you correctly, which was the move by a quota on COPD nothing special on that but will you can come in for what you like and Sean to submit a ma'am.

Yeah. They it's really covered related and the original read out what it's gonna be K O M at twenty-three and so it just slipped by a couple of months into 24, but these these pipeline delays are very they're covered related and you know in the in the sea.

P O P. D. One is bill I think reference with social distancing et cetera.

<unk> are having fewer exacerbations and you know we we have criteria for a certain number of exacerbations to be eligible for this study otherwise.

That being the primary endpoint, there's gonna be available to measure. So you know it's sort of a secondary consequence of the covered as well. So those are those are really pandemic related delays, okay. And then bill M. S. As you you know with the godfather of how bad here and everything else. So.

I'll do what do you want to say.

Well thanks for the question look Thaler Burton.

Is we consider the best and disease potential has burst into these potential across the whole M. S disease continuum and why is that well you know, it's brain penetrant and its brain penetrant at a level that actually makes a difference we believe you've had.

A lot of people try to come into the space and say they've got a b T. K I that does that does that but we're not concerned at the moment. We believe that ours is the first we think it's gonna be the best we have an incredibly comprehensive development program and you know when we've talked about this asset you brought up the <unk>.

Depleters, we don't think jumping into a second or third version of Rituxan are okay with Oprah lives in that I should say uhm would be the thing for us to do and when we'd be comparing tall, a brute nib, we've been comparing it to the C D 20th.

In the sense that if you look at the impact that we have an MRI, it's consistent with with those products and if you. Let the recent data that we announced that Atkins, which looks at relapse rate. It's consistent so that's the comparator the difference is it.

Does that <unk>, we believe that's important for progressive disease to get inside the brain rather knocking on the outside in the periphery.

And so we believe that this is really the product and being an oral once a day that can be the winner in this space.

I'll leave it at that now that's a good place to leave it. So I think we've come to the end and just.

To remind everybody has some travel is returning to normal in many places the vaccines day, which I'm not sure I mentioned on December the first will be in Paris. So I'm hopeful that uhm does that count will feel able motivated you should come I can assure you uhm it'll be very interest.

<unk> compelling day, so yeah, we look forward to that thanks, the team great progress by Sanofi through two three just the beginning and we look forward to updating it full yeah. So thank you very much.