Q3 2020 Sanofi SA Earnings Call
And I know that's been intense focus on the insulin market in recent years as you know Sanofi has acted to consistently improve patient access and affordability.
To summarize based on what we know now I remain very confident about <unk> prospects in the U.S. in the coming years.
You've heard me talk about the return to growth in China in the fourth quarter, driven by our successful B B P bidding strategy and the just to go to market model.
Clearly in this important market, we pivot towards so another took medicines in specialty care and vaccines in line with China's healthcare projects.
The approval and launch of Dupixent in record time, we said that I think in the last quarter has been followed by an incredible uptick with over 1100, a topic dermatitis patients on therapy.
Eight weeks now while there is some pent up demand initially the uptake remains it remains incredibly strong remember dupixent is only available in the private pay market at this time, so a very impressive early demand.
With fast expanding our vaccines business in China, playing an important role in increasing immunization rates in this large population.
Most strongly from the crisis that envelop the sector in the past couple of years and fin Tech Siemens hit more than 100 million euros of sales in the third quarter were low.
As we expect to return to growth in China, we are pivoting towards a rejuvenation of our portfolio and expect recently launched products such as dupixent to jail and prevalent to contribute to sales in Twentytwenty one.
Over the next five years, China is expected to be a key growth contributor to Sanofi [noise].
[noise] [noise] on slide seven let me just say the play to win isn't simply a slogan here.
We are currently accelerating and delivering on transformational science and business execution, including all key growth driver in the second largest pharma market, making a meaningful acquisition principia and not in yet another breakthrough designation for Dupixent.
I'm excited to John will share with you some detail and a important updates on our progress in R&D later on the call.
You know it is also with me, saying just before I go to the slide that that I feel the company is perhaps even uniquely positioned to take on what is ahead of US you know we have a wide portfolio. We have a growing assets. We have dupixent at the head of that pipeline is moving and we are doing all this.
And the progress that I said that we made in Q3 is incredible given the nature of the locked down and everything that we face as a company as an industry and as a society. So the progress that we have made during these difficult times I think is unique.
I think it's a sustainable and I think that's going to be very important as you look forward. How we operate in this great company.
So slide eight and before I turn it over to Bill.
Let me reiterate the critical importance of all social sustainability and and how we're integrating that into a play to win a promise how do we make it sustainable over time I want to draw your attention to a few points. Let me also add that as we get into the sea US all work, it's probably been the most interesting thing for me.
To work on with the team over the time that I've been in the company not just did we want to do something incredible for the planet and I'll talk about that in a moment. We also ones that do things that only we could do and importantly, eradicate disease isn't take different approaches and I and I think this is more than opposed to buy an elevator. This is a real thing that.
Aligns perfectly with our business.
So as I said I don't.
Start with two picks and where we achieved the landmark of blockbuster dollar sales in the quarter. This is an important milestone for depicts it at a high level sales growth of nearly 70% was driven by strong performance across all three main indications of atopic dermatitis.
Asthma and nasal polyps furthered by the very strong launch in pediatric patients with atopic dermatitis.
How'd you can see from the chart X U S markets, including Europe contributed nicely to growth and now account for 21% of do picks and sales when thinking about our performance outside the U S. Keep in mind that we took a 20% price cut in Japan in April and that we are still rolling out the full range of indications and age groups.
By the time, we closed 2020, we expect to have launched two picks in and around 50 countries as Paul already mentioned. This list includes China, where we have been encouraged with the early up taken the private market.
Focusing on the U S do picks and ended the quarter with weekly new to brand prescriptions nearing pre covid levels as in office visits began to resume telemedicine appointments declined.
In office patient visits with dermatologists, an allergist are still around 20% below the levels, we saw before the pandemic.
Market research suggests that most of dermatologists believe it will be impossible to reach normal pre covid patient volume due to safety restrictions and precautions that have been put in place at the state and local levels. So overall, we delivered again, a strong franchise performance and it's still difficult environment and remained fully confident.
In our greater than 10 billion Euro peak ambition.
Other highlights in the quarter included several important regulatory and development milestones, which will help drive the future growth of do pick sent these.
These included the positive cgmp opinion in a D for children six to 11 years old the successful read out of our pivotal pediatric asthma study for the same age group and the F. D. A breakthrough therapy designation in eosinophilic esophagitis.
On slide 10, specifically looking at the U S. New to brand prescriptions here you can see both to pick since rebound and he picks and sustained leadership position in Q3 among dermatologists.
Prescription trends suggest that you pick sent has the best in class profile and the Covid environment with dermatologists.
The type two pathway is not involved in viral defense and do picks and is not an immunosuppressant.
On the previous slide I, just discussed our expansion into pediatric AIDS patients and this success was driven picks it's unparalleled safety profile.
Lastly, do picks and does not require any lab monitoring and can be administered at home.
Slide 11 provides further evidence of you pick since differentiated profile.
In <unk> the pediatric pivotal study.
Two picks and showed meaningful reduction in exacerbations and an improvement in lung function. This is important since these children approximately 75000 in the U S alone often struggled to breathe due to impaired lung function.
This is consistent with our adult and adolescent data and reflects do picks since anti I O. Four I owe 13 mechanism of action that targets underlying type two inflammation typed.
Type two inflammation in asthma incumbrances, both the allergic and eosinophilic phenotypes and represents approximately 80% of moderate to severe asthma and might even be more prevalent in children.
And many asthma patients start their patient journey as children.
On slide 12, looking across her entire specialty care portfolio sales grew strongly by 24% in the third quarter.
While depicts sent remains the largest contributor to growth we saw higher sales across all of our specialty franchises. Despite new patient starts continuing to be impacted by covid in oncology sales from the newly launched products contributed to the strong performance in Q3 and multiple sclerosis Baggio grew.
7%, reflecting favorable pricing in the U S in Germany, partially offset by lower new patient starts, which we expect to continue due to market entrance new market entrants with that I hand over to Thomas.
Thank you for Ya and delighted to report that son of Investor achieve new record produces in the south whether it was here with group of more than 50% exiting 1 billion you're willing to do.
Before.
Within this group Wilson I would like to add some important dynamics first of all flew sent in Q3 representative.
Expecting to global sale.
This number the split between Q3 and Q4 used to be around 60% then close to 40% last year, but we are seeing now and you know, whereas we've reviewed by 50% moving forward, especially now that prove that condition coverage would increase and that has the authority to run the world bitter undescended Vaccinating too early can actually be counter.
Especially for seniors.
So we know abuse recognition.
Print out more evenly on two three and two following fuller.
The second screw dynamics I'd like doing that you said about the fact that we are seeing a favorable mix shift portfolio.
Sure differentiated vaccines account for the majority of global Truces in the quarter.
In total we expect to deliver 30 million to the differentiated flu vaccines to the U S.
Which more than 60% has actually been boot into three.
X U S. You can expect to see a similar evolution to begin in Europe.
And two three actually the first shipment of.
Aw Quadrillion I, just drew vaccine and we received a positive surgeon view opinion for soup Indic the European Info U S who broke.
Overall, we're confident to mention a global market is a sheet.
With a shipment of approximately a quarter billion flu vaccine disease worldwide in 2020.
Simultaneously the expansion of our manufacturing capacity is on track to meet the projected increase in worldwide.
Against you.
In addition, the basic portfolio so called BPH. Both for you one of those are strong performer in this quarter sales increase was driven by benefit catch up in the U S and Europe and by the continued strength of pentazocine in China.
As anticipated the pandemic continue to wait on a travel meningitis and as a booster vaccines.
Overall, the two or three business diamond in vaccine are expected to remain similar in the remainder of the year is somebody's with I'd like to do in just a minute.
With that I know virtually.
Thank you Thomas.
Quarter General Medicine sales benefited public continued gradual recovery and demand sales down 6%.
Roughly offer rates, we experienced in queue too.
An established product we saw punk performance from Logan ups and the rest of the World region. This resulted from inclusion of slow motive waste efforts in W. H U a guidelines for anti globalization ask utilized covid patients.
On the other hand, Gladys in our province decline in line with the expectation in China, where we successfully drove from volume growth for these two products largely offset by pipe erosion Hum BBB Pogo.
You may remembers at this time last year, we had him sedated the dynamics of the bidding process and encouraged that we are able to deliver hardness of more than 60% volume growth.
Global diabetes declined by 4% both for the quarter and you're up to date.
Lodge in business.
Client moderate below 9% in Q3 <unk>.
No that we expect us diabetes performance to be impacted in the fourth quarter, Hi, Emily due to business sneaks way too towards development channels, including typical johanns torps.
Looking to two of 21, we are pleased resolved broad formula recover its fall use diagnoses fault for you, which remained largely unchanged compared with tools.
In terms of our play to win initiative, we continue to streamlines agenda Hall medicine portfolio.
To drive simplicity, and agility as well as optimized.
Cash flows we have been ambitious working on identifying close opportunities for our last part of the general Medicine fault for Ya.
And we expect to share his strategy plan with you at an upcoming investor events.
Translation will be part of it.
In summary, I'm extremely confident making heartbeat.
With that hand back to Paul.
So thank you Bill Thomas and Olivier pretty updates on our businesses and now I want to introduce the newest member of the GPU leadership team Julie Van.
Julie joined Sanofi at the beginning of September and so little early to get Ah up here talking but I'm really excited about the impact she's having already she brings a deep knowledge of consumers of course, and digital marketing to accelerate the growth opportunities for Sanofi consumer healthcare.
<unk>, so Judy welcome and over to you.
Thank you Paul is a pleasure to speak to you in my first earnings call. It had a sanofi consumer healthcare actually I'm Super excited about the opportunities that lie ahead of it but before I spend on this I will briefly in the third quarter performance.
As you've seen overall sales were broadly set if you exclude the sales from Zentec from the same choir last year without zantac, we've seen good momentum and most of our categories in Q3, and particularly in the U S where allergy sales were very strong growing for 17% regarding zantac, we will remember.
That the impact of that cares voluntary recall washes out it over and we will return.
Like for like comparison basis.
I'm truly honored to join the Executive Committee, which has been charged by Paul to transfer them to know.
And to <unk> your question as to why I've taken up this role let me believe briefly remind you of three core strength of Sinarquist consumer healthcare basis.
First I, we are already are a leading global player in THC with strong physicians in key markets and existing footprint in China, and our exposure to emerging market is in particular strength seconds.
Seconds, we have an attractive portfolio of brands with strong brand equity across all categories, we plane and we clearly have a number of leading brands would still significant sales potential.
And you have of course heard.
That we have two major switch opportunities in <unk>, which could lift our performance significantly above market growth in the coming years.
A major part of my previous experience in the beauty industry has been leveraging consumer insights and maximizing digital an E Commerce channel I truly believe our TFC business has untapped potential here, we have the opportunity to reach our consumers cutting edge digital platforms I also think.
We need to focus to build a true hero products and leverage strong consumer innovation in other words I can see major opportunities to drive our top and bottom line.
Let me stop here, but in summary, and Super excited to be here and I see really promising outlook for sch, you've been a business.
And I very much look forward to sharing my plans with you at our upcoming investor event with that and handing it over to our CFO stomach.
Particularly.
There are ready to work together.
On slide 16.
Sales increased five seven persons into the third quarter, we've delivered another quarter of.
Driven by further efficiency.
Consequently, biwa by 9.2% on our view on margin increased by 30 business points 259 to 61, 49% of the border.
Turning to gross margin, we saw 50 basis points prediction 232, 79%, which is consistent with your outlook we provided in July.
As you May recall swiggum half gross margin is typically low workman's comp due to vaccine on this will be Buffalo, new because it was the 20 due to the record sales from programs.
In addition, we continue to see an underlying mix of gross margin coverings from productivity gains from specialty care sales growth, which are more than those sent by jove dishabituate headwinds from pricing reductions in China on lower use but.
As mentioned, we continue to believe or meaningful editions and a quarter with.
Jimmy RMB, both broadly flat versus a prior period.
Remove during the lines I would highlight although authority and carbon expense, which increased significantly versus a prior period.
Here is a higher outflow associated with original monoclonal antibody collaboration.
Increases the quarter.
$229 million compared with two six.
$6 million in Q3 2019.
As your nose issue the Misfeature, which includes three components. So sure Protostome look through Denora.
Embarrassment of commercialization expenses incurred Byron Jerome.
Reimbursement by region around the power development costs.
When we look more quickly okay from flight of indeed, combined with Jimmy on Rmb's been treated by 0.4.
On by four.
7% into the first nine months.
Overall ticker women.
We continued to lower authority expenses confirmed increased investment.
Both drivers.
Resource Yogish.
In R&D, we have previously guidance. It's two 2020 expenses to be line is from 2019 at this is.
So in the third quarter, we've been friends from our discontinued diabetes and cardiovascular programs reallocated 12 priority effort as well as our recent incremental beady on them and activities to transcend the pipeline such as in <unk>.
Approved point of this is our ability to stock driven new faith Street programs without meaningful change to Orange spin.
Or Jimmy Outsmart spending initiatives how.
Two lower expenses slightly in the quarter, while investing into bixin on flu vaccine DTC copay.
Overall, I am very confident but we remain on track to meet <unk> margin target of 30%.
You too.
On slide 18 will be summarized as it pushes them fools for all different businesses.
In pharmaceuticals, we expect new patients thoughts and specialty care to be around 80% to 90% of precocious.
There August we expect the impact from you as diabetes Rebating on the Caribbean.
Partially offset by growth in China.
In vaccine increased through a peavey observe expect it to be partially offset by trouble.
Boosters omitting Judy.
<unk>, we expect to see some of a guy.
We have seen in history as well as the realisation also contact withdrawal.
Olympics, we will continue to deliver further efficiencies gona way R&D spending the civil half is likely to be similar to the signal half of 2019.
Mentioned before.
Or my looks like we are raising our from your guidance for printed 20 business appears we know expected to grow by around 7% to 8% of TR and improvement of 100 basis points compared with our previous governments.
The increase reflects a strong performance in the first nine months together with our expectations for various headwinds October into the fourth quarter.
When we turned preferring exchange.
Fact is expected to be negotiate by 627% based on October other agents to exchange rates.
This compare with the basic currency impact.
With our circle and quarter results of between minus three or minus four person on.
On the queue for we expect it to be between minus 11 on minus 13%. These for a team back.
I know turn the call over to John John to you.
Okay. Thank you J b.
<unk> challenges or the coronavirus pandemic notwithstanding.
Hope it continues to make rapid progress advancing our pipeline Ah.
A lot has been accomplished since our last update at the Q2 earnings call as illustrated by this slide.
It's just one month ago, we completed the acquisition of Principia, which brings us full control a total of <unk> call, a brute nude bar brain, penetrant, PTK and get better as well as adding another be TK inhibitor reels of brute near to our pipeline.
We're also moving fast food initiate six additional base reprograms, including our oral selected actually reset your Degrader 859, which we now call am soon Edward.
If you'd combination with Pavel cichlid in.
First line metastatic breast cancer.
Three new indications for do fix it.
Ah based <unk> study to evaluate reels ibrutinib in patients with immune thrombocytopenia is about to open.
And finally, we plan to initiate a bakery program for our anti I owe thirty-three antibody you could pick a map N C. O P. D. After obtaining very insightful beta in our face to study.
437 O seven our next generation interleukin two molecule, we have today announced an exciting collaboration with Merck too broadly explore this engineered lymphokine in combination with firmware listen ma'am.
And last on COVID-19, we have shown scientific leadership in our efforts to develop applicators and safe COVID-19 vaccine candidates in this pandemic.
We beliefs nope. He has one of the most advanced adjuvant Rick.
For Communist protein base Covid vaccines in the industry and we're excited to announce today that the phase one to trial is fully enrolled and we anticipate results in early December.
In addition, we have also fully enrolled buffets <unk> study of our partner Rip kinase inhibitor has the potential novel therapeutic approach and hospitalized covid patients.
If I start with the Principia acquisition on slide 21.
We are moving full steam ahead with tall are rooted in multiple sclerosis. All four bakeries trials are open for enrollment and Meanwhile, we have achieved an astonishing 98% patient retention rate in our long term extension study coming out of the phase two trial.
While we continue to collect data on relapses in the long term extension study, we know that meaningful data will require longer larger phase three trials.
Beyond M. S now with full longer ship, we have the possibility of evaluating additional neurology indications for this exciting bringing penetrating PTK inhibitor.
The acquisition also adds the reversible covalent PTK inhibitor rules Abbreviature late stage pipeline here.
Here phased redevelopment is underway in the.
Auto immune dermatological condition, pemphigus, where we expect NDA, enabling data the second half of 2021.
Another basically a starting for the blood clotting disorder immune <unk> building unpromising base to data.
Well pet because N I T. P illustrate the utility a V P. K inhibition in auto antibody driven diseases, which is a broad class of disorders. It spans room into logical dermatological hematological and neurological indications.
Additionally base to study in the auto immune condition I G G four disease.
Is also be an initiate to test additional b P. K relevant mechanisms that as a potential gateway indication December leather auto immune disorders.
Given the strong rationale for the B T K targeting many allergic an auto immune diseases, we anticipate a broad program for Rosa root beer and will provide updates in the future.
On slide 22, we provide a brief update on our too exciting wholly owned oncology agents and <unk> indoor seven O seven.
The news on our oral Sir Damson afternoon is that we're starting the mirror five pivotal trial in first line metastatic breast cancer in combination with Pibal sickly.
The date of that set the stage, where they say three pickled study where generated in our phase one be trial, a mere one which.
Which we plan to presented a medical Congress next year.
As a proof point for our commitment to moving with much faster pace.
The time from the last day to cut through the secret to start the three was less than one week in the trial was now open for Roman less than one week since taking that decision.
Because we previously communicated we think are molecule has the potential to be the best in class oral Sir.
Biomarker data presented it asthma support our hypothesis that antimetric.
Results in almost complete estrogen receptor degradation, while I was playing a very benign safety profile.
We continue to collect data also and the new address been setting to prepare for future adamant studies or absent aspirin and early breast cancer.
And finally are pivotal study of Anson Astrue monotherapy in second and third line metastatic hormone receptor positive breast cancer mirror at three is expected to read out in the first half of next year. It's an event driven trial. So the precise time he is uncertain.
Now switching the four seven O seven one of my favorite topics I Hope you all saw the news of our agreement with Mark under which we will investigate the combination of our non alpha I O two molecule with Merck's Keytruda and various cancers. We were told that this represents works most extensive collaboration of any novel, even though oncology drug <unk>.
Combination, which is nice and dormant endorsement of our view the door seven O seven has the potential to deliver a best in class profile or an engineered I O two molecule.
In terms of development, we expect to move towards seven O seven into multiple furlough base to a signal seeking studies in the first half of next year. Once we have a line on our recommended dose for our ongoing things one mono therapy and paid one be drug combination studies.
On slide twenty-three, we moved from oncology to respiratory specifically chronic obstructive pulmonary disease C O P D.
He picks it has shown evidence of significantly improving lung function C. O P. D patients that have high levels of circulating eosinophils, namely a subset of C. O P. D patients who have a tight too inflammatory component to their disease.
283 studies are underway, we do picks it in C. O P D patients having it eosinophilic me to type with results do in 2023.
Now what's new since our last update is that we have decided jointly with our partner Regeneron to advance our anti I L. 33 antibody now dubbed eat to pick a ma'am also into pivotal studies per C. O P D.
This may come as a surprise you given the previous clinical findings of the I L 33 class of biologics and other indications however.
Phase two study of a diverse population C. O P. D patients, we identified a potential responder subpopulation into prespecified subset of former smokers.
Those data will be sure it'd be a publication or didn't upcoming Congress.
A moderate to severe C O P D.
But to give me a lot.
Abbadid reality evaluation suggests it roughly 70% of quit smoking embarrassed molecular studies. It illustrated differences in the biology of C. O P D and former smokers compared to active smokers.
Our phase two data show a striking it back among former smokers in exacerbation reductions and lung function improvement regardless of eosinophil levels.
We plan to start to parallel pivotal phase III trials and expect to have sites activated possibly before the end of the year. Despite the challenges with the ongoing pandemic the.
The readout will likely be 2024.
Altogether.
Fix it and eat the pack of my address roughly 80% of the monitor C or C. O P. D population, which defines an exciting opportunity for Essex there'll be to leave the field of the use of biologics is C. O P. D. A disease that ranks among the top five leading cause of death worldwide.
Now if I moved back to do pick someone fly 24, we.
<unk> briefly talked about leveraging a real world evidence platform, an external case study evidence to identify and prioritize unmet needs in the type to inflammation space.
By utilizing this approach we've been lying down three new indications that each impact quality of life and that we believe are worthy of study with you fix them.
One of the damage illogical condition chronic inducible heard of Caria.
The other two are respiratory conditions, namely chronic Brian your sinus without visa polyposis and allergic Bongo on your site. It's Vegas in each case, we will begin a pivotal phase three trial this quarter and it's successful we do expect to make regulatory submissions in the 2022 to 2023 timeframe.
On my final Slide let me close by looking forward to 2021, when we're going to keep you busy with proof points of our priority molecules and or other pipeline programs.
With the inclusion of reels of brute <unk> been pemphigus.
We are now looking forward in 2021 to the results of at least nine pivotal studies.
<unk> will be the read out of our Serge <unk> in second and third like Minnesota breast cancer.
As well as the much anticipated basically results of our two key hemophilia therapeutics, but to surround and did a double O. One.
The read out it'd be picks it in chronic spontaneous urticaria is also gonna be very important for us given the size of that there which logical indication.
And it goes without saying that the entire world will be eagerly watching for the read out of our coronavirus vaccines.
Will be turned to face two readouts I'm, especially excited about <unk>.
<unk>, our pipeline an appeal for rare and not so rare diseases, where we expect important results in are fully enrolled G. B, a parkinson study, which is an opportunity for us to potentially paved the way for the world's first disease modifying therapy for Parkinson's.
And as mentioned we are currently working on our phase two plans, especially for Reals, a brute <unk> and Thor seven O seven it will share those externally next year.
We also plan to refresh our pipeline in 2021 with multiple first in class bench in class and the claim to enter the pipeline and entered the clinic Uhm next year.
Including so I'm, Vermont antibody platform.
So we expect 20th 192021 to be a news rich here for this and I Hope you pipeline as we continue to execute on our strategy.
That I had it back to Paul.
Well, thanks, John and as usual you leave me inspired but the innovative thinking the cutting edge science.
As we leverage to literally changed the practice of medicine, I think things that shouldn't be missed by the way in terms come and saw the speed speed from last look at data to decision to open for enrollment covered two week period.
Covered that says something not only about the company will be coming to standards. We set but also important about what is possible to do touring covid.
Proud by the way of everything we're doing and the company, but Ah trial look and indeed, our manufacturing which is here in France, almost 100% at capacity. So we may surprise, everybody with the resiliency that I talked about earlier, the portfolio and how well, it's balanced and the opportunity and this great company.
So to summarize the quarter, we made excellent progress in the transformation of Sanofi throw a play to win strategy as mentioned with a little bit solid strong sales and EPS growth, which underscores the strength of our business in this difficult environment and allowed us to raise our affiliate guidance.
Performance was driven by the strong momentum of leadership of do pixel across age groups and Geography's as well as a record flute performance, which we think is a leading indicator of increasing immunization rates going forward.
Taken together I'm proud of what we've achieved in my first year is C. O somewhere else. We still have work to do I'm confident we are absolutely on the right track so with that why don't we open it up for Q&A. Please.
Cleveland now open up the car to your question as I get as high interest in posting questions. So.
Restaurant, if we could ask you to limit to your question to one each of two very short questions.
We will now begin with a question and answer session anyone wishes to ask a question or make a come in me Prescott and want on their Touchtone telephone you will hear account to confirm that you have entered the queue.
It was to remove your suffered a question can you make <unk> participants are requested to use only handsets what else can I question anyone who has a question or a comment in the Prescott and one at this time.
First question is from Grand Perry from both please go ahead.
Great. Thanks for taking my questions. So first the on fleet could you just remind us that the provisions that was taken against and none or 10000 last year is any of that being written back and could that benefit key full and how should we think about moving into next year would you you can expect.
See similar levels of fat demands Grace and as we've seen in 2021, and then secondly with days away from you a selection, obviously and perhaps you could just updates on your thoughts of both the industry and <unk> ability to it for the bite and administration intensive preserving incentives to innovate and farmer. Thank you.
Oh, Thank you Graham Uhm, we'll start with flu, maybe and Thomas and then I'll come in a little bit on the web is done so we could have an election.
Thank you for your question. So a couple of points in your question maybe for those of US beef I mean, yeah, but the process tourist on Oh, we do treat Foo region somebody each year as you know we book a provision to cover the flu return of the ongoing campaign. So that's an <unk> look on the campaign.
Based on Dixon returned into.
Cruel easily into three okay. Oliver exceptionally this year due to the COVID-19 context in the lead to return by the physician from last year.
We do the truck on me with in the queue for a quarter and nothing to three we expect Oliver.
Emerge invisible impacting you for.
When we have to deidre now moving fall out for the signal.
Question of 2021.
It's clear but.
We are seeing very well right now that prevention is extremely important.
<unk>, we expect to calm VCR.
2020 season of occurrence, either and I wouldn't expect overall very good uptake.
The disease.
Putting into the market I think said that as you have seen for.
For the first time ever providing a quarter billion those into the market.
Uniquely musician too.
The end of December.
Thanks, Thomas and answer to your question about the upcoming election, I mean, well.
Well, let's wait and see what happens next week.
I think we need a few things for effect about our own company we know.
We have a good balance portfolio in the US we mentioned earlier about exposure and Medicare medic.
Medicaid.
Reference to do pick some majority 70% of the business in the commercial channel.
We are more than prepared to demonstrate of value whatever the administration and will bring the very best to that so.
So we look forward to finding out what happens next week, but as you can imagine we prepare full cases. So next question.
The next question from the Phonies from the line of female <unk> from Bernstein. Please go ahead.
Oh, great. Thank you very much for taking my questions that I will not quite a convincing so just coming back up the full yeah go ahead I'm sorry for the detailed question Uhm, but you did 4.64 euro in business E. P. S for the first nine months and if I take the midpoint of your guidance and the ethics assumptions, where you're looking at an M. P. S for the full yeah about $5.
Seven at the midpoint, Miss which which would suggest around one point O six business EPS in full cute so not even when I sent to me in the very painful ethics assumptions you just outline for <unk> that would still represent minimal growth and constant exchange rate year. When you have a <unk> or possibly even a declining earnings.
And <unk>. So are there any one of <unk> that we should be aware of while you're just being Super Conservative and then my second question is just on principle principally acquisition now that it's close I wonder if if you could give a bit more insight into what was it for Tonight I mean, the the face too and pemphigus slipped away anybody compelling. So I just want to get your expectations heading into the faithfully read out and.
The second half of 21, and just to get a sense of your level of confidence oldest indication given we'd seen such good phase two data. Thank you.
So.
Thank you for your comment about you anticipations.
Q full.
I'll, let John Batiste comment throw some of <unk> of course, how things will play out in terms of rolling look down some of the things, but some of taste.
Well I Love your question honestly.
Over conservatism on a quarter like this it's it's funny because.
Because I hope you don't find out that would be very conservative.
We want to deliver on.
An outburst on each quarter.
What we see some unknown of course in queue for.
Might have led for elective procedures with.
Starting up again in Europe prostate.
<unk> pharmacy, but the overall picture is very good because we have a residual business and we have a strong team and we are fully confident that we will deliver on we're not expecting a while nose.
Are expecting to deliver strongly as we have delivered so far but in a very uncertain.
Four Q4, yeah.
Yeah, and I think it's also what's happening is that the script data.
Available in the U S shows that we started October.
In reasonable shape, certainly on the major great drivers so.
We look forward to to reporting on those results when we have the actuals.
John I'm going to come to you on.
Principia in particular will subordinate but.
Just to remind everybody and we said this at the time. It then come the I I'll call. We're really excited about taller Britain Abe.
And what it could do NMS of course, we wanted to have all of the economic rights because it makes sense to be less incumbent going forward, particularly with the excitement around the top medicine.
But as we got into the diligence of course, we get increasing covenant some of those and what it could do it in that dawn.
I got is equally excited and exquisite chemistry that went on to <unk>.
Different ptk's, but John I'll, let you.
Give a comment about what excited you maybe you could come in on the number of patients to remain in.
Open label extension photographers.
Sure Yeah. Thanks, Paul the that we're very excited about the principia portfolio of.
<unk> Ah tolerate and of course, we've been talking about since the last capital markets day and were blow steam ahead with that.
The the open label study, 98% of the patients have stayed on drug and were equally collecting data on them and doing other studies at all or that they three studies or the pivotal so sorry merchant road now the question was typically go about Rosa.
We're very excited about this molecule the reversible covalent nature of this molecule. We think provides a best in class profile, where the Kobe, let's see aspect of it gives a best in class potency, while the reverse ability gives a best in class safety, we believe.
We've seen very well tolerate medicine, the phase two data <unk>, I guess, where nothing short of stunning similarly, very promising data in immune thrombocytopenic appropriate I T P.
Those are both very clearly auto antibody driven diseases, where the immune system is making antibodies that attack certain tissues in one case the scan the other case platelets, but to see such stunning data in both indications clearly.
Is validated the hypothesis that B T. K plays a pivotal role in these auto antibody driven diseases and that's a broad category of disorders that we tend to fully exploit over the next several years.
So we're very excited we're also excited to see the rat, how rapidly the pemphigus patients improve which which.
Validates one of the mechanistic aspects of <unk> M. B T K and probably suggest that what we're seeing is that important role. The V. P. K place in the signal transduction by the F. C receptors. So that's I think something that we were delighted to see how those data and suggest.
A very broad an important new mechanism berken bobbing auto immune an allergic diseases going forward.
Great. Thank you for anything sharp.
Thanks, Donna just mentioned I think I paid to the question, but just to keep US moving the home is almost 100% of the patients.
Tolerant upstate until booting up at the high dose in the open label extension. So next question.
The next question from the phony from the line of Pink I've heard that from city. Please go ahead.
Thanks people it'll city two questions. Please on China, just let his thoughts on when you might get N D. O L. This thing for the picks and and then separately just can show that again, how you're thinking about plavix another probe beyond.
20, and we will know what's going on this year with EVP, but when we think about 2021 and beyond is this a.
Return to growth personality that you envisage or something wherever it a couple of years, we got a new V. P. P program to sort of step wise decline and then secondly, Thomas on Covid what are the implications for your plans phase III studies, if we do see posted expedite you. Some other sponsors before you start I'm asking that question in light of some of the commentary.
Coming up for last week's S. T Advisory Committee meeting so do you still think you'll be able to undertake.
Zebra control studies in this scenario and if not how would you manage crossover risk. Thank you.
Okay. Peter Thank you very much at Bill. It's good question is the question I would like to ask us to build when when we get G. T N O D L in China.
Well. Thanks for the question Pete you know we've been very impressed by the changes that we've been seeing in China first of all just be unprecedented time for approval and then our unprecedented.
Time to launch so.
Things remain always possible in China, and we are certainly.
I'm doing everything that we can to see if there's a way to actually be successful. This year with an R. D. L. Again, we're gonna we're gonna plan and look to see what's possible. However, we don't have a certainty on that yet so we'll see how the how the process unfold, but our long term.
Prospects in China as we have stated before we expect this to be blockbuster status. There in time, we think the opportunities great and as I said the environment within China's making that possible.
So more to come.
Thanks. Thanks, Bill can we were approved in 25 days or something like that in terms of made available. So so you know we really do have to be listed within a year it would be a tremendous achievement.
Maybe olivier to give us an update for what you see going forward for Plavix in Provo in China.
Thank you for your question of course, we are very happy resolved performance and we think that they made the right decision in terms of participating into the BBB last year. When we are looking ahead on this edition and a little bit different for Plavix and that's novel in terms of potential for growth.
Into a 21 and two it was to the.
Two of 21 off a pleasant the molecules now.
Is Kevin see growing year, two days, 13% and we believe that leads me to stabilize at around 10 or 11% of next year and talking here about the total molecule, we seeing that who will stay at bar with the market. So in other words, we seem that they're still potential for growth for volume in China.
Two of 21, I would add one element, which is important as a split between us spittle in retail as soon significantly after the implementation of BBB and now we have only 75% of sales it all made through us beetle, which means that the retail segment there is.
Lots of stickiness has been in kissing softly, So Ah fault ethics, a significant growth in two of 21 of the upheaval feminist a little bit different time terms of volume growth here. The the market is stable even slightly declining so what we have in mind.
The market into a 21 and two of 22 will be will be stable, maybe a little bit.
Planning on your question more specifically on BBB, and what's going to happen into a 21 22.
It was.
On a two year contract.
To the new for an additional year, which means that into a 21 month of course, we are not sticking and if it was up highest degrees in two of 22. The extension of the condition of the extension and what would be the impact of not yet been disclosed bye bye.
Thanks, Olivia and I remember it was my first one is called last year, where we sort of introduced the BBB and the impact and I have to say and cute us to Olivia in the team in China recorded absolutely right. Likewise the growth in volume maybe Thomas on the complexities of the company has been fluid data with COVID-19, where does that leave us.
And and executing on the study.
Peter So when it comes to do indeed, COVID-19 feed prevention development, where indeed looking at the.
And looking at the different scenarios, we believe that we have a very good plan that can be activity not number of countries and site.
Based on the fusion of course, the potential of the AVG of leather COVID-19, vaccines, which is something we are of course.
In planning and taking into account as well as diversion feasibility of activity equal Blue thing. So once we got stuck eating is probably doing a phase III.
More than 10 in more than 10 country in order.
To avoid that risk.
This is of course, something we've been discussing as you can imagine and blending with inflation lusby.
And it's also important to note that we will be leveraging pretty keep in any deep regarding COVID-19.
To ensure that of course, we reached recruitment targets in the study had comes as rapid yet placebo. Good admits in before is to come to market towards the end of the first half of 2021 and that's how we are actively money during decisions on COVID-19.
Tell us next question. Thank you for the next question.
The next question is from your kept all set from J P. Morgan. Please go ahead.
Hi, Thanks for taking my questions first question on the on the third Uhm is obviously according to the <unk> 12 very quickly the amount of 512 could you just give us some insights on what you've seen in terms of the combination efficacy with probably take Clinton and how that looks relative to the competitive that's giving me that confidence.
Sauce, and just a line to that.
And have a seat kept the standard of cab how should we think about the adjuvant setting of course at different syndicate forsakes, He's gonna be probably taking that market and then secondly, just coming back to the to the guidance does seem to imply quite a large S. T N a increase.
It seems unlikely in the current private environment, maybe something that tastes could talk about thoughts that set for the rest of your night and and the cost base in in queue for on going for it thanks very much.
So so thank you Richard off said of course now known as <unk>. So uhm, let's let's try and the Chinese I can forward John over to you on on what date I'm not sure what we've shed <unk> was carefully and then.
Whether this is the right combination Kevin.
<unk>.
Potential combinations, an adjuvant Senate.
Yeah, Thanks, Paul and thanks for the questions of course, we're very excited about am semester and for their and White and that's why we featured it in this report.
Uhm the data that gave us accomplish the mood board will be presented at at a Congress next year, where we're not going into details but.
Clearly we continue to see.
The you know signs of accuracy and and and best in class safety that gave us a confidence the mood board.
Including in combination with <unk>. So that's.
That's probably about all I can say for now with.
With respect me as you make you raise a good issue about.
Whether the C. D K four class will become part of the the the paradigm for that input which patients. The the date with Abby back in the high risk patients suggest that.
That that may become one of the standards and so we'll be factoring natty and as we develop are playing around the argument therapies, where.
Any advanced discussions with some of the cooperative groups about what that might look like and and and we'll b B a X.
Exploring maybe maybe more than one way of approaching the admin space going forward.
Thanks, John Uhm.
Some of tests, we're getting the second question is Tim from from Richard a little bit around trying to calculate the final quota and the potential increase in SG&A.
Did you want to add any additional color.
Yes, I am sorry to tease me that Richard.
Okay, well nice looking at.
Ficials books growing on making room for more science.
Of course going on driving growth.
Okay.
So no worries on that front.
So many so many.
<unk> sees to unlock so many opportunities incentive.
It's just the beginning of.
Of improvements, which will allow us to deliver on okay. So no worries for Q4.
Thank you next question.
The next question is from the line of Skeef parties from FCB Leerink. Please go ahead.
Hi, Thanks for the question is does check for just and thanks for all the color on the call first could you just clarify what your expectations off here and cooked increase supply of flu vaccine next year and do you expect.
This vaccination right to persist secondly, Paul somewhat ominously said.
Uniquely positioned to take on what is ahead of us and I was just wondering if you could clarify for us what that means and then just to help with that same question, which is could you give us a sense of your share Vincent vaccinations, you talked about the overall market trend recovering it.
Talk about your shared where that might go to in the future. There was nice growth in that line.
That was our questions vaccine.
Thank you very much.
I'll have to Thomas do that on the ominous comment on that it really was than a poor choice of words on my part I think what I was trying to do and will continue to try and do is to remind everybody how well positioned we always a company I mean I watched through the earning seasonal what's everybody else.
Look at <unk>, and and yet I looked at our results and they stand they stand strong on their own and you know I think we have the right portfolio mentioned it to pick some growing 69%.
Quarter over last year when many other innovative companies are struggling struggling in the dermatology office, let's be honest to get new patient starts and yet I feel somehow.
Progress made as a little discounted so I <unk>.
Like to reassert wherever I can that we are well positioned with a broad portfolio with high performing drive drivers with a laser guided cost control and still advancing the pipeline and I and it's early maybe in People's understanding of.
It was still a show me story, but I'm here and I can tell you.
We're ahead of where I thought we'd be despite the challenges externally.
So maybe Thomas to you on.
How big the flu season will be in 2021, and the relative performance of the companies.
Okay. So first of all regarding flu.
Indeed, as we've seen b.
As we are seeing somebody guarantee prevention and therefore, the place of ignition you to me about that.
Mmm.
Because we need to look at it I think.
Both volumes in vain as I mentioned to you when you look at the.
In that light before.
Extremely important to begin to think that the market is going to us differentiated pooh vaccine and flew blood and for.
And I knew it the only two different <unk> banking, we do see pension and that growth of different injected to keep going into the new year. So that's another venue.
And we have plenty of course.
Cannot lead in terms of manufacturing to sustain that growth in finance on the 15th.
Very important to remind 12th it what is the current liver a vaccine or a dream and we do see.
Some homes.
Interesting to see that the not the need for example, if you can.
In.
70% of being.
Being vaccinated agenda, meaning 30% I'm not but if you look at what's going on in Europe pregnant, but this year, we are seeing expansion of Hula Commendation in Europe, where the actual pironkova is Lola addressing decision into new <unk>, which is very good moving 12 hours, but we think to us a good direction.
Against Similarly, if you look at the rest of the world fighting up in China, but other market very well, but the vaccination covid draining into the new either renewal and the flight to your significant improvement placebo fallback affected covid drinking too. So that's we just pump pillar two days, but I have been able to do that at the moment. So.
And when it comes to the overall I would too.
So.
<unk> position, if I understood doing a second question.
I think you are referring to when we positioning versus the other I think it's interesting to to look at the fact that we are not a new flu you at the moment.
Like that but I said, but in this cluster spending to buy more than 50% well actually it's more than 50% increase in you in more than 50% increase in more than 50% increase in the rest of the world. So that all of us in.
<unk> I think it's very important to look at this moment Anthony Sunshine.
We are growing and they invited to look at the restaurant different competitor, we have the only one growing in that segment.
So I think that's showing the way we are doing in this important signal.
Pessimists, which is beginning portfolio and.
And then of course, it also interesting even though sometimes we'll be comparing opposed to minimize that you're looking at.
Or vaccines.
<unk>.
If you look at well we have a cyst competition I think on the on the first three quarters altogether Sanofi vaccines division in providing a 6%.
Nine months I think it's a positive one it may not be the case.
That's in my condition and companies I think we want to keep them that trend, but very important for us.
Thank you.
So thank you but.
Good stuff Thomas maybe we get to the next question.
The next question is from North halfway from UBS. Please go ahead.
Hello. Thank you Uhm strategic question for Paul Please on how you view the longtime cute cat there I just need the ZIP man and kind of put this as it is D. C. A pressing need to entities any more new my diabetes alongside and establish contact you have and.
And then secondly on you have a come the ninth <unk> can I get vaccine that phase one to trial design says that you're testing, but it's with the J F. K I T a and I'm with you right.
And is that because the call is ultimately and how's the entire project.
Okay, lower thank you and maybe I'll throw this to bill, but just a quick comment upfront some red diseases.
You know we are incredibly proud by the way the history and the Genzyme peace part of Sanofi Genzyme.
I think we still do incredible work, it's a growing business.
Don't Miss in the mix that Bhangra step, which is got some readouts. Thanks, you, including by the way GVA Parkinson's.
We really believe that we could have a small molecule innervated Z space on top of what we're doing within antibodies in glucose today's the rest of the.
The current lineup and launches.
It could be game changing for that group and I think that perhaps by the way the best company in rare diseases, and then a little further out of course, we have the gene therapy work that we're doing across the number of red diseases, and we've shed at a previous meeting I think our strategy around that but.
Pretty excited about what it means is you'll remember visa low infrastructure investments, but incredibly rewarding for patients and we have some brilliant science supports it built trying to add anything.
No I think that's I think that's right look we are we are the leaders in this area and the business. It performed very well as you say year to date, where at plus 7%, which is in line with a mid single digit 2020 expectations and you know as Paul said, we have some we think exciting products that are launching I think.
From our perspective, we look and see Where's the unmet need and then what would be the right approach to fulfilling that unmet need whether that be enzyme replacement or another technology is you know Paul highlighted with bangalow Staten ultimately some of our gene therapy effort. So we think that this is remains of high unmet need area.
There's a lot of rare diseases that have no solution. They are rare, but that doesn't mean that they're not devastating diseases for those who have them. So we.
We will continue to pursue and follow the biology and yeah.
Yeah provide solutions area, it's a exciting area that we've been in for a lotta years.
Yeah, Thanks, Bill and just remind everybody I think we're at 7% growth I think coming through Q3, and red diseases, which is perfectly in line with our expectations and.
Given the complexities of starting new patients and Everything's shows you, what we're able to do virtually in.
In cooperation with physicians.
And Ah Middle point again May get missed is the fact that all are in some replacement products now available in China.
Also something to Miss as the health priorities swing into action.
Thomas Yes, when it comes to reconvene Inputting COVID-19 mix.
The plan.
Was very important of course is to have impact.
On the Dizzy and and the second public schools, but we do.
Look into the sand and that service to resent, but just mention in the Saint <unk>. Two we have two adjuvant because you know that we have on that event tend to them and we are moving on.
Hold on and off for Ya, but we want to have the Bachelor so which means that we need to go fast because this is a pandemic bigger than.
Getting first to market is very important and the fact that the flu putting that was a really nice huh.
Given that film being late.
Get these activities are basically in terms of beta.
Into market, so with that in mind, but slightly did not between those two hours, but moving followed we have committed to grow with the just schedule at three.
Further method are being impacted food against the disease and the three D.
Come there.
<unk> next question please.
The next question is from the line as soon as that that far from Brian Company. Please go ahead.
Thanks for taking my question. The first one is on depicts center off cause they're very strong performance. During the first 939 months despite the covid.
And what time they make situation how old are you. He was a consensus was it food you at 3.5 billion.
Too high in line or.
Below you'll you'll you'll like technician or one could be really.
After the first nine months and second question is.
Ah regarding once again, sorry about the flu some of the one of you can pick your two alluded to today that Ah flu.
Flu vaccination may continuing big.
Beginning of next year, which isn't that unusual.
It was for flu.
As a nation.
Do you share such a view on his yes would you be able to provide a flu vaccine in January February which is once again unusual for this type of vaccination. Thank you.
Okay. Thank you, maybe we'll start with flu.
Thank you very acquaintance so.
Sure.
Could that you use it.
And could you tell me if I made it possible, but definitely be increased.
The amount of Echinacea engineering temporary.
This is a good thing because if you look at the past 20 years.
The vast majority of the peak of the <unk> community was during the month of February and March So actually Vaccinating in January from a medical perspective. He has another venting Ethel and much better than the recognition. So it's very wind placebo, but we could see a little bit more of January a recognition, but then you hear the good news is that we had $40.
Market share Murphy.
That was one market we have significant capability.
I do as we have seen before we have about the.
Vision disease that we've done to ship.
We believe that some of these shipment as I mentioned before we don't put in November and December and that's why we have a difference.
2324, and we believe those shipments would be very important actually.
Send those would have other work to make sure that it.
Potential vaccination that could actually happen.
Thanks, So much I think all of that and I think a Christian camp a little bit earlier around.
Will this new record flu season is it something that could be sustained on the out years.
There's a mix history of that after H one N. One another things, but I think for us what's really interesting for me, particularly as well is that a lot of people are getting a flu vaccine for the first time, who never really got around with the I think we're opening up to a a new sort of treatable population if you'd like to have seen how easy it as a comedian is in the peace of mind that I think we.
Macy.
A different shape going forward and for for Us to me coming into the business.
To see that the potential for flu may be significantly more over the coming years, and we expected given how well positioned differentiated vaccines market share is pretty incredible.
Bill I'll leave it to you to Dodge the question on queue full asked expertly, but.
We have to accept that maybe you could add some more color that we're doing in dermatology offices, what really no other product.
Product in any of the company is able to do.
That's exactly right and as we started off the call.
We are extremely confident about the greater than 10 billion Euro peak that this product is going to have this is a great product. It is just a product that we.
Have you been in the industry industry, a longtime never worked on anything at quite as exciting as S. And the reason why it's because the biology is fundamental to take two diseases. That's what we're focusing on we take if we look at the two key indications with atopic dermatitis, we now have.
<unk> and 200000 patients, which is really quite a remarkable number to think about when you think that we've been on the market for just three years now and that's because that profile. The efficacy is best and the safety is best and as we look at.
At the specifically in atopic dermatitis.
People are looking for efficacy, but dermatologist are extremely safety conscious.
And as we continue to generate long term data weird presented three year data on the safety coming up at.
A D V, which shows that it maintained it safe profile and when we look at the asthma indication. We believe we've got the best profiled there as well remember that about 80% of the asthma population is type two and we are fundamental to type too. So we really believe that we're going to continue.
To grow and.
Exceed that 10 billion euro number so nothing on queue for other than all the.
Indicators are positive towards the brand.
Despite the challenges of Covid, we've been able to continue to grow the brand and there's really a lot to look forward to this as we increase our geographic spread in new indications.
So I'll leave it there.
Yeah. Thanks, Bill I mean, it's still you know.
Listening to how other medicines have struggled and the guns office.
A lot of it of course is about execution, Sanofi, but but as Bill said. This medicine is very special in the profile that it has.
Israeli at a moment and we're really proud to be bringing the benefit that we actually also next question.
The next question is from the line of France hang from well can research. Please go ahead.
Oh, Hi, this is Tim Anderson.
And Wolf I have a question on spending levels as we close out 2020th movement of 2021. It seems that during the whole work from home thing most drug companies have reported results have commonly been a little bit light on revenues, but they've made it up on earnings.
Through lower operational and and one concern I have is that analysts potentially erroneous Lee is the 20th 20th spending levels of the base when that might be artificially depressed.
At the same time, what is kind of struck me as odd sometimes.
<unk> with new management came in you've talked about fixing things get simultaneously cutting costs and usually when something's broken you have to spend to fix it. So my question is ahead of giving 2021 official guidance can you give us some idea of what Opex in 2021 might look like relative to the 20th 20 base.
Is it likely to be lower in absolute terms or flat or higher. Thank you.
So I'll, let John what is coming to the second Tim.
We were on a small.
Smart spending initiatives before I arrived be full covid before everything I think your insights it's absolutely spot on.
Think as expenses declined it through the pandemic I think some top line Mrs for a lot of companies have been compensated for by.
By the electro spending the discipline that we have.
Is from before and will retain after Covid you member as Jamba T sitting said we've.
Started seven phase Three's.
And we're absorbing that within our cost base and moving along relentlessly on this journey and you can't comment about what my predecessors or the new C. As a set about fixing things, but what I can say is that.
What you should never Miss it the reallocation a reduction in reallocation and I think what we're spending our time on his prioritizing. So there's an awful lot on a new Chief Digital Officer would tell you were given the over reliance on third parties and the opportunity that we have that that there is a lot of spend that will that will not take it from the top line, but that can be.
Reallocated to future growth.
And still allow us to deliver on.
This overall cost reduction the discipline on this law bedroom of taste is unlike anything I've ever seen before so while so that companies may have got a little bit fortunate just because it stopped organically. This as a disciplined active program Sanofi somatist.
Yes that sounds <unk>.
Because what you expressed disbelief that first to spend more to fix things is.
Is already come up on the on widely spread but if we are here with the team will come team is not to do the expected.
And expected, which is to fix things by relocating on not by first spending spending more so don't worry about especially the price coast based in 2020 because of Covid that could rebound no. That's not the way we do it we are really changing structural things within Tennessee.
Of the mindset is not just to deliver what is what is known what you expected.
Do something a bit exceptional it's much more fun and we are here on committed to deliver it.
I was put in by the way is a really critical point.
Change in the structural drivers of cost was I think a lot of pay is benefiting from the discretion. We spend that is clearly come down in that piece of the fundamentals mean that is terrible for us we'll see what.
We don't worry about anybody else, we'll just do what we do but we know how to do this so maybe next question.
We've done on question.
I'm sorry, this is pretty care I cannot see the next question just hold on a second please.
So on the system were looking like there are more questions, but when not being able to hear them. So.
I operate ahead with the next question Sir I'm sorry, it's from the line of people posting from Morgan Stanley. Please go ahead.
Hello, Thank you for taking my questions.
I would just like to come back on your comments around selections in the uptake of different.
Vaccines.
If you look at the situation X U S. I think he's trying Kenny.
Go down and then I've been a bit twitchy sent to give access cinram Beth.
Could you just give us some cut out on the house at conversation.
On this front.
And Silicon question Tonight to this could you give us an update on the case comment on to study.
I used to be expecting and can carry him and then he said on the end of each year and is there anything you get you could share with the market.
I'm in the incoming coming months.
Okay. Thank you may.
Maybe I'll just share some of the anecdotes that I've had around the differentiate flu vaccine, particularly high dose.
And then tried to Thomas you know the number of incoming calls that we've had from leaders in health care and ministries of health around Europe and the world.
To accelerate the conversations on high dose differentiated flu vaccine has been incredible many places.
Skip forward.
Both an availability and in reimbursement conversations.
What was it you know a little bit of a slow process traditionally because of Covid has really accelerated everything and the determination to understand the value of that the high.
Does differentiate the flu vaccine brings has been frankly unprecedented and and.
And very very positive maybe should add Thomas yes.
So.
The question is about the expansion of differentiating between as you mentioned, Tennessee.
Into it this year.
Think of course before I think when a developer Atlanta.
So that's the starting points that we have been thank which is your info blood.
Received as I mentioned before <unk>, so let's expected legislation will be around the month of November December this.
<unk>, that's a very important.
And of course.
That'd be nice and then we color. So the first shipment happen in Q3 in Europe, and then talking about one contributing multiple countries of course, there's nothing with you, but my wisdom.
Expecting to be some height, there and I mentioned before.
Include the previous question and flu, it's very important that we keep this momentum I think more and more people getting some young we start with the gender are starting to understand what it means and associate them, leaving so it's inevitable progression neighborhood to have a flu vaccine, but these 20 of 30% bitter and clinic.
<unk> plenty intense of thousands of ambition compared to actually used on the 23rd.
The most important that you need to stop my Avenue flu vaccine, but if you'll frame if we need to differentiate collecting significantly back under profusion, David and that's why will receiving some so many requests.
It comes and Dinah because as you know we.
We have extended the facility.
Susan managing what we could do building 79 into too.
Putting a nine starting next year with additional investments, but as I mentioned in England, I think expanding capacity and that's very important to be able to some type of all of these markets.
But this osbourne was starting to get interest no. Thanks, you have an ex North America whole length of the world and that's something of course, who will keep looking moving forward. So I think the appreciation of the value of prevention is there.
It's been until the vaccine and I think the usually run into the difficulty to get payors to be treated.
Changing and we think it is trained cause of the kinds of femininity study.
The third year on the study so we will expect.
One year later and the reason why we value.
Let's deal with it.
Mhm Bye COVID-19, <unk>. So therefore, we should get the response when you're on right now so probably be the end of 21 or early twenties. Thanks, Thomas So as we got a little bit close to the top of the conscious and that we have quite a list.
And we want to try and keep it to one question only if we can that would be really helpful. So next question. Please.
The next question is from the lineup tell Walton. Please go ahead.
Alright, Thank you and one question only I'm going to ask about the pandemic vaccine capability.
<unk>, you talk about potentially being able to do a billion doses next year, depending on taste and healed.
How much of a stretch target is that balian. If you don't get your if it takes you a little bit longer to get them approved would you still be able to tell me Oh balian in 2021, because presumably you'll making them throughout the year and you just have a big a bolus.
Nine point, which you get to launch and how could we think about how this would be booked in terms of sales and presumably baltar income or whatever that you've been presumably getting all ready to help you fund the build out.
So Tom over to you should answers Olson.
And can you just try to call back.
<unk> since covid.
COVID-19 capability enjoyed is a bit early to be able to be precise clearly targeting wouldn't be incapacity as you mentioned, but as you know they when would you say to do and to get them. We have to detect on sale to value site, which we have initiated so so different if you didn't we can get there, but we need to have a few more proof points.
And on the way and but the classical Lucia percent developments as we've been doing some and.
When it comes to booking same.
Same thing here <unk>.
Of course, none of that there is no COVID-19, Mexicans influence in Q3 arena that you have seen a bit about sharing we do today and now if we lose.
Need to have a positive phase III reserves and the legislation and then we'll be on our first two.
Boucher, but it'd be too early to get done.
I think maybe it's also without interest very quickly that that.
This is not something that's going to be solved with all the vaccine makers quickly.
Quickly in 2021, so you know we still have.
Plan to be sort of May June next year.
In terms of the phase III readout, and we whatever dose as we have at that point, we are optimistic that all of them would be needed.
Know pretty well already from everybody else that it's it's going to take multi billions of doses to get.
Back to a new normal if you'd like and so we're pretty confident that all our doses will be needed at some point in 21, and then of course, we have them on at the end of next year, hopefully and that may or may not be needed. So next question.
The next question is from the lineup Louisa Hector from there and back. Please go ahead.
Hello. Thank you for taking my question. So it can get <unk> can you give us a split I'll give you a sales by April asthma and could you can just little color on where you are in 10 50.
<unk> investment cycle.
You have a wheel that can take them. You asked me today do you have a number of indications so rolling out and you'll say the competitive situation will develop pay the time. So I just wanted it whether we should have seen an ongoing lamp I'm just calling for a phone number just to come.
Bill.
Yeah. So first of all for the U S. We won't give a split between.
Asthma and a D.
Fair to say that the majority of the sales as we stated in the past or coming from a D.
But again.
Strong prospects for both the indications regarding continued investment look at the product continues to grow and new opportunities present themselves.
There in the form of new indications et cetera will continue to invest in the brand. So.
We are not at the anywhere near the peak of sales and we have a lot still to roll out. So we'll continue to invest appropriately for the opportunity.
And again, I think probably worth adding that specialty care infrastructure deployments of modest so.
In in comparison to what we're trying to do here and how quickly this medicine is growing.
No.
With discipline, but it's modest so the team is doing an incredible job.
Okay next question.
Oh.
The next question is from the line of Seamus Hernandez from going insecurity tendency. Please go ahead.
Thanks, very much so I really just wanted to focus in on a B C. K E N.
And then goes that opportunity I think you guys have talked about the opportunity for a an accelerated filing on the basis of kidney volume.
Measures, just hoping you'd get update us on whether or not you've had had discussions with FDA or other regulatory authorities on that potential and point.
And how enrollment in that study continue if we're still on track for a potential accelerated filing in 2022. Thanks so much.
So I will throw that I think too John Reid to give us an update on where we stand on that.
It's engine question 80, PK D. Because it's the first major volume patient population that we'll get to a English that and cause of the Parkinson's readout.
Next year, which which by the way includes a percentage of non GBA Parkinson's patients. So there's a significant unmet patient needs to so John we're always can you show, where we are in enrollment in central finally, yes.
Yes, Paul so at the.
We're doing two parallel studies or two sequential studies the.
First one.
Is using total kidney volume as the primary endpoint that's been fully enrolled.
We expect those date probably.
Uhm I believe it's gonna be early 2021, <unk>, maybe for a second quarter of 2021 and.
And you know the discussions have been encourage you with the help that already has around using a T. K V. Total kidney volume is a as in it and I'm 44 accelerated approval followed them by the functional read out or got married or filtration rate but of course.
One rarely gets guaranteed suddenly help authorities about these the part B study, which is focusing on GFR is an important he is actively enrolling.
And we expect to have that enrollment probably.
Probably completed towards the end of this and of this year I would hope.
And and then that'll lead out you know probably close to a year after the other one.
That's a longer it takes longer so that we can read out. So we're we're we're hopeful because told kidney volume does correlate very well with the ultimate renal function issue. So we're hopeful but no guarantees in my comments really refer to F D a and.
E M. A in Europe. Another other territory, you say, they're gonna really insist on the functional read out.
Thanks, John Okay, but maybe we have the chance for the last question.
If if anybody has one and then we'll bring us to a close.
The last question is from the lineup Pierre Park from Goldman Sachs. Please go ahead.
Thank you and and then also just a big picture one number cleared it seems like you and your team I'm, making tremendous effort kind of and changing the culture of the company and kind of providing can just kind of execution and get the stock price doesn't seem to reflect some of the progress that you've made over the course of the law.
12 months. So I was wondering if you might be able to share, but that's kind of your thoughts on what it is that'd be might be missing I've been investing community.
<unk> kind of the future kind of value creation. Unfortunately lives in the near Tom. Thank you.
Excellent question.
And a good place to finished you have touched on it a few times during the more formal presentation is the fact that you know.
I think we're making more progress some people actually fundamentally realize.
I have to accept that perhaps some of the legacy view of the company is that we may never move quite fast enough I've been told by some of your colleagues was still the show me story.
But I think frankly, it's missing the fundamentals of the changes going on here, we touched on how quickly will move in drugs through the development cycle do.
Two picks and 69% growth in Q3.
Proactive cost management, not getting lucky because of everybody in doors.
I think we're really doing something pretty extraordinary and at a pace that I didn't imagine and at a time that you would consider the most difficult.
[noise] team in the culture that we put together the team will put together and of six.
Or obsessive nature on prioritization and reallocation is a real thing now why is that not reflected in the share price you tell me.
Maybe it's we're gonna have to be.
Said this to the team you know, we'll just keep moving through the quotas advancing all science delivering on our expectations and showing people that serious and you know I.
Is that the company has made promises before not always got the wood different company different ahead of R&D drug development finance.
New leadership in our business units I mean, you look every which way so.
So yeah, I think as we keep showing you were serious and getting it done hopefully.
Confidence will built in on the buy side and everywhere else will start to say is is a sensible choice but.
I feel very good about where we are and if it takes time for the rest to follow them.
Where it needs to be because we're making exactly the right choices are moving faster than people, perhaps like certainly fully realized with that thank you to everybody for joining the cool. Thank you for your interest in the company, we look forward to updating you.
Full year results I guess in the early part of next year. Thank you.
Ladies and gentlemen, the conference is now over thank you for choosing cars call and thank you for participating in the conference you May now disconnect your lines Goodbye.
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