Sanofi (SAN) Earnings Call Transcript & Summary

January 12, 2021

Euronext Paris FR Health Care Pharmaceuticals conference_presentation 42 min

Earnings Call Speaker Segments

Richard Vosser

analyst
#1

Good afternoon. Welcome to the 39th JPMorgan Healthcare Conference. I'm Richard Vosser, European pharma analyst at JPMorgan, and it gives me great pleasure to introduce Paul Hudson, CEO of Sanofi. And with him today is Arnaud Robert, the Chief Digital Officer of Sanofi. Before I hand over to Paul, I would remind you that if you'd like to ask a question in the Q&A portion, then you can do that through the Q&A section on the website, and then I will read out your question. With that, I'd like to say great welcome to Paul Hudson, and over to you, Paul.

Paul Hudson

executive
#2

Thanks, Richard, and good morning, good afternoon to everybody. Thanks for joining. Of course, we're delighted to participate. I think we'll move directly into the presentation, if that's okay. Next slide, please. Just to remember the forward-looking statements, I won't read it out, but I think we know what it means. If we could go to Slide 3, please. So I am joined indeed by Arnaud Robert, our Chief Digital Officer. He has some things to share, but it's also to get a great perspective on what it's like coming into our company from outside and understanding where the opportunities are. It's 13 months since Capital Markets Day in December '19, and it's been a real journey for us and a really constructive journey. And what we hope to do over the next few minutes is to give you a sort of lay of the land of how much progress we've made tied back to what we thought was important in December 2019 and show you our optimism for the future. Next slide, please, Slide 4. JPMorgan wouldn't be JPMorgan without a deal or 2 happening and, of course, other things were no exception. Of course, you have set out for these things to culminate the day before a presentation like this, but it is what it is. Thanks to the team for pulling this together. But the reality is we've closed the deal with -- can't say we've closed the deal. We made a deal with Kymab and we're very impressed by the OX40-Ligand technology. We think there's some real opportunity for us to really fully press home and become a leading company in immunology. Now we'll talk at Capital Markets Day on February 5 about how we're fitting together all of our immunology pipeline and portfolio. But of course, with Dupixent as our cornerstone, setting ourselves up for long-term success is really incredibly important. Besides that, I think it shows how focused we are in doing BD and M&A right in the areas where we're strong from a capability perspective, where there's low marginal cost to commercialize, where accretion can be reached faster but more important than any of that, where we can bring home breakthrough science in partnership and where we can get it done for the benefit of patients. So we're delighted and more to follow at Capital Markets Day on February 5. Next slide, please, Slide 5. So just a little look back in these figures through quarter 3, as you know, Dupixent annualizing at EUR 3.5 billion, differentiated flu vaccine growing to over 67%. We have 60% volume growth in China recovering from the VBP. And incidentally, we don't have any assets in way forward of the VBP. 12 Phase III is initiated right across our most important pipeline assets, tolebrutinib, Dupixent, rilzabrutinib, amcenestrant and itepekimab, all that, all in play and 12 3 -- 12 Phase III studies initiated. Seven upcoming pivotal readouts, we'll talk about those in a moment or 2. And just to remind people, though we took a voluntary pause on fitusiran, we've made huge progress in our conversations with the regulators. We've been encouraged strongly by the community and lots of anecdotal feedback about patients living lives free of hemophilia. Of course, it's only anecdotal. So we found a way back. We're really comfortable with the choices we've made, and we'll share the details on that protocol update on February 5 also. Significant almost double-digit growth in BOI, 9 months in, EUR 1 billion of savings, which are redeploying and dropping to the bottom line. And today, I think we announced that we'll launch our stand-alone API business that will be an IPO in 2022. So continuing to make progress right across the portfolio and in terms of our capital allocation choices. We've made progress also culturally, our top 200 leaders also linked to total shareholder returns, linked to our ESG initiatives and importantly, I think, coming with us on the journey to make sure that we can transform this great company. Lastly, and Arnaud will talk about it, but our digital initiatives and acceleration are now fully under way. And we're starting to really get a sense of what's possible for us to be able to do. Slide 6, please. So Dupixent continues over 200,000 patients making tremendous progress on this wonderful medicine, recently approved in the 6- to 11-year-olds in AD, fantastic for us, fantastic for them, real breakthrough, such an unmet need, such a difficult patient population. And the progress we made through Q3 and the script trends are also very positive as we enter Q4, is really despite the fact that only 80% of the derm's offices are open. With all this in mind, we felt very confident in December '19 declaring our ambition to be greater than EUR 10 billion for Dupixent in sales, and we feel even more so as we progress through this year. So great foundations laid down for what we could do. More to come for Dupixent. So if we could go to Slide 7. You can see the reason why we believe the scale of the development plan, the assets and opportunities that we'll bring forward. Let's look at some of the opportunities. For example, chronic spontaneous urticaria, we'll get the data coming up in the next few months towards the end of the year. We will also take on COPD. We're in our second pivotal study. And despite that, we'll get that data and have an opportunity. That number and that breakthrough in COPD is not even included in our math for bidding and exceeding $10 billion in peak. So we are really under way. Next slide, please. I'm having trouble seeing the slides, by the way. In terms of Slide 8, we are also making progress in our vaccine business. We have, as I mentioned earlier, strong growth in our differentiated flu business. We're the leader in pediatric vaccines. We recently also got included in the German immunization and vaccination commission guidelines for everybody over the age of 65 to benefit from our high-dose flu vaccine, a real statement of what that could mean and why the growth could come from there. In addition, we see a massive opportunity for us in the future with nirsevimab. We know that it really will be the true and definitive medicine that could change the fate for the #1 reason for acute hospital admissions of newborns in the United States and indeed in many other countries. At Slide 9, please. Now a lot has been made of the fact that mRNA has entered and delivered in COVID-19. Just a couple of things. I think we've all learned that in a single antigen environment, we have to accept that the mRNA platform is the fastest to come to market for a pandemic. Now of course, that's a single antigen. But I think we accept that and we understand that. I think it's also worth remembering that we've had a long-standing relationship by at least back to 2018 with Translate Bio. And that relationship has all been about trying to make sure that we were also going to be heavily involved in messenger RNA. In June of last year, before we even had a readout in mRNA, we also knew that there was an opportunity for us to double down. So we widened that collaboration. So we took all targets, all assets and tech transfers, so we could really make sure that we could participate in the future, if mRNA is successful. Now we're seeing one of the biggest proof of concepts, and we're pleased for everybody, society and all the teams involved. But the reality is that we're going to be there, and we're going to be playing our part alongside our established platforms. If you think about it, back in June when we announced this collaboration, we also said that we'll be putting a flu vaccine -- mRNA flu vaccine in the clinic in 2021, and we're still on target to do that. Importantly, as we touch on flu, it's very important for everybody to notice that this is not COVID-19 with no standard of care and moving quickly in a pandemic. This is influenza. So mRNA is going to have to demonstrate multi-season effect. It's going to have to be able to demonstrate against a very effective standard of care. We set that bar for others, but we set it for ourselves, too. There's no difference. We expect to have to deliver our mRNA flu vaccine and beat standard of care, and we'll set out to do that. But we think the bar and the hurdle is high, but we will pursue it. And of course, there are a large group of targets that are really addressable by mRNA, and the polysaccharide and the multivalent protein approaches will be critically important. So put simply, we believe that over the next decade plus, we have the right platform of technologies to take advantage. And I strongly encourage anybody to have a good look at what we've done with Translate Bio and why we're well positioned. We also see that our growth, as communicated at Capital Markets Day last in 2019, our mid- to high single-digit growth continues, and we're very confident in that through 2025. We see the mRNA opportunities coming for all players in the second half of the decade. Next slide, please, Slide 10. In oncology, we make progress again. We will have approval in second line for Sarclisa in the first half of the year, and we'll have data in first line towards the end of the year. In the rest of our portfolio for amcenestrant, we'll read out our second-line data, we hope, in the first part of this year. And we'll continue our study in combination with CDK4/6, which is recruiting well. So we think those plus our continued commitment to Libtayo and, indeed, THOR-707, our tie-up with Merck and KEYTRUDA. We think it's very sensible. And also, we look forward to sharing data on that at the upcoming ASCO and, indeed, on what we think is a very exciting development plan and strategy that's not too far behind. So a lot going on in oncology. Slide 11, please. Thank you. We've been excited from the very beginning about tolebrutinib. We take nothing for granted. Just to be clear, that 98% of patients that went into our open-label extension are still on drug and have been for quite a long time. One, in fact, stepping up because of a planned pregnancy. So we're in good shape and how we're doing to date. We get a lot of questions about our R&D productivity, and we made the decision not to keep looking back but to set new standards going forward. When we're clear about how quickly we move with tolebrutinib from Phase II to Phase III, 4 months or less and how quickly we hope to get Phase III readouts of an ambitious program in 3.5 years or less, it shows you that we're serious. And it shows you that we expect to beat industry cycle times. We can, of course, look back, but I think it's almost equally important to make sure we're looking forward, setting new standards for ourselves in R&D and then sticking with them. And that's definitely something that we're doing here at Sanofi. So with that, maybe I'll hand over for a few moments to Arnaud Robert to share some of his observations and opportunities in digital and data. Arnaud, over to you.

Arnaud Robert

executive
#3

Thank you, Paul. If we can move to Slide 12. I joined Sanofi 6 months ago. And I must say that its challenges in data, digital and technology are quite real in the pharma context. And at the same time, the digital opportunity at Sanofi is greater than any company I've worked at and, frankly, any industries I've worked in, so very excited. Our digital strategy is really grounded in 2 dimensions. The first one is to drive efficiencies across the company. And the second one is to actively participate in the growth of the company with the intent, obviously, to allow us to reinvest in science. You can see on the slide our 8 priorities that we've defined, very clear priorities aligned with Play to Win. I'm going to highlight maybe a few on the left-hand side. First is new platforms to engage HCPs, which obviously COVID has accelerated that demand; two, using data to accelerate R&D, e-commerce as well as new patient experiences where we feel innovation could play a big role. If we can move to Slide 13, please. Another very important aspect, and we spend quite a bit of time and energy, is the digital culture and the new ways of working. We think that not only it is essential to the digital transformation, but it will also accelerate the overall company's cultural change, and we're quite excited about that. You see here a few dimensions that we're focusing on. But if I can bring your attention to the bottom right. Agile, first of all, where we think that iteration and speed will become part of everything we do from planning to strategy to execution. And the second one on the bottom left, very dear to my heart, is in-sourcing of differentiating capabilities after years of over-reliance on external partners and vendors. We think that has stemmed really the innovation. And we think that in-sourcing will be a critical advantage for us. If we can move to Slide 14, please. Well, the journey, as Paul mentioned, has already started. It's been 6 months, but it feels it's gone quite fast. And you can see on the left side the few achievements we did in 2020. Again, we'll bring your attention to the bottom line because it really is a sentiment of the culture we're trying to establish, so working with the start-up. In 6 weeks, we've built a new application that only shows sales across products and geographies, but we're using artificial intelligence to do sales forecasting with a quite remarkable degree of accuracy, all that on a new platform, new architecture, new user experience, all that in 6 weeks in a true agile fashion. And since then, we've iterated on the application and provided new features on a weekly basis. On the right-hand side, you see our focus for '21 and then '22 across the GBUs. And again, just the interest of time, bring your attention maybe to the bottom. On the left side on CHC, we feel that using data and e-commerce, we can not only drive sales but also improve the ROI of our digital marketing expenses. We feel that, that will contribute to EUR 100 million of BOI by the end of 2022. Just right of that, in R&D, we feel that data and specifically artificial intelligence will play a significant role. It's still nascent. It's still early days. But we have some indication, especially in conventional studies, where using real-world evidence we're able to accelerate the time lines of the studies. So we have a proof points you like that this is an area we will continue to invest in and that we're very excited about. Overall, our dual strategy is focused, it's practical, it's curated, and we feel that will drive efficiencies and actively participate in the growth in the company, and that's quite exciting. Back to you, Paul.

Paul Hudson

executive
#4

Thanks, Arnaud. It's a pleasure to work with you. It's great to have fresh eyes in the business. For those that are observing our transformation, you don't get a look too often at how we support, reinvest, make it better inside the company for our people, focusing on user experience, saving money with third parties, putting that back into R&D. We do Kymab and other things. I long-listed them from last year. We have to make sure that we can reinvest from elsewhere in our organization. There's lots of opportunity, but somebody with fresh eyes can be quite sobering. Not everything is perfect, but I'm delighted with the progress made. Also, when you look at the democratization of data and how we're using AI, it also takes a lot of the suspicion and also the gray areas of people's interpretation around numbers allows us to reallocate resources much faster in the real time and shows us, by the way, a large company like ourselves [ would go ] with a small company like [ Kailey ] really, really fast without actually breaking strides. So when I look back to the final slide, Slide 15, this is the slide that we showed back in Capital Markets Day. And I think of this as something to take home from thinking about us through this meeting, is that we set out to do everything we said we would do. We recognize that perhaps we've not always had the strongest reputation for getting things done. We've laid out a plan in December 2019 that we fully intend to execute. And right across the board from R&D acceleration, to commercial, to our key assets, Dupixent to vaccines and importantly, to do it by reallocating resource and having great capital allocation. You've seen it in our M&A and BD. You're seeing us take decisive actions and not hesitate. Today, of course, we announced the spin-out and identity of our manufacturing and API sites. There's a reality check here that as you follow our story, you'll see the science come. We can't speed up biology, but what you can judge us by how we're executing the things that we said we would. And I'm really proud, frankly, of the organization and how it's doing it. The short term was always about delivering on the fundamentals, getting us set up, getting us in shape to do what we need to do. And the longer term, '23 onwards effectively, was about those launches. We have enough in our mid late-stage pipeline to be able to deliver on our 2020-2025 objectives and even to exceed those objectives. We have Dupixent as the cover on top of that. And as we add to our science, we hope to build a very attractive pipeline internally and externally 2025 onwards. So we're doing what we said we would do. We're enjoying it as you would expect. We don't say that it's easy, but we do say that we're getting it done. And with that, maybe I would encourage people to watch our story unfold even further and to hand back to Richard for potentially some questions to the wider group that we have from ExComm. Thank you.

Richard Vosser

analyst
#5

Thanks, Paul. We already have questions on the website. So if people want to submit more, that's where you do them. And maybe the first question is on business development. And you mentioned Kymab and obviously, last year as well, Principia was done. Maybe you could just give us an overview of your strategy, what you're looking for. I think you mentioned more sort of building the late stage with the business development strategy. But just what are you looking for?

Paul Hudson

executive
#6

Well, I think we made it very clear last year that we felt underrepresented in science in some of our key areas and that we would accelerate programs within. For Sanofi to double down and do 4 Phase IIIs in MS simultaneously in a crisis, let's not forget that, I think we're showing that when we think we have winners, we double down and move fast. There's no hesitation. I think where our focus has been is not in the late but in the earlier science. We've also drawn some criticism historically for some of the later-stage deals we've done. And we don't feel that we need to do that. We feel that we needed to add to the science earlier. OX40-Ligand is early as [ IIA ], but it's still important enough for us to think it's going to play a critical role. I think there's a couple of lenses. The first one is making sure that we can deliver science that is transformational, first in class, best in class. But at the same time that we're doing it in areas where we have capabilities and expertise or, in fact, we think we can bring it to commercialization at a lower marginal cost because we're already deployed. It doesn't mean we exclude real breakthrough transformation opportunities as they come. But what it does mean is that we have an opportunity to turn great science into great opportunities for patients and fastly accreting or accretive opportunities for the company. So we've tried, if you see what we've done, to keep it in areas where we're strong, where we know we can win, where we know what to do. But of course, we remain open-minded.

Richard Vosser

analyst
#7

Excellent. There are a number of questions about Dupixent. Obviously, a great growth driver. I suppose the first one is looking at China and the recent NDRL that you've got. And the person is asking how to frame that Chinese opportunity within the greater opportunity -- or the overall opportunity set for Dupixent.

Paul Hudson

executive
#8

Yes. Well, what I neglected to mention earlier, but the truth is we've gone from approval to launch in, I think, 25 days. That was a record. And for those been around as long as me, you'll know that historically, NRDL could have been 6, 7, 8, 9 years waiting and we were there in 5 months. So we'll be on the NRDL in March. You know that we have close to 200,000 patients on Dupixent worldwide. You know that we have about 150,000 patient opportunity immediately in China. Once we're listed, that opportunity grows significantly closer to 900,000 patients over time with education. Patients need to be identified, et cetera. So that will be a build, but I think we are excited about what we'll do in China, what it will mean for patients and how it will add to the acceleration.

Richard Vosser

analyst
#9

Excellent. And another gentleman is asking about the breakdown of Dupixent between the indications. And how you see the sales split evolving given the competitive dynamics in atopic dermatitis relative to the JAKs?

Paul Hudson

executive
#10

Maybe it's a good chance to bring Bill in. Bill, if you're ready and unmuted, maybe you could just give a -- your perspective from the breakdown.

William Sibold

executive
#11

Yes. I'm here, Paul. Thanks very much. We haven't been breaking the -- we haven't been presenting the breakout, but the majority of it is atopic dermatitis. You have to remember that was the first indication. And we're still, even with atopic dermatitis, at the very beginning of the journey. We're talking about under 5% of patients or around that range that are being treated today. So there's plenty of opportunity, and we see actually with the competition coming in, it's going to help expand the market. And really, it's a story of expansion of the atopic dermatitis market. Now we entered a little bit different market with asthma where it was already a competitive set, but I think what we've seen is that even as new competitive data is introduced, there's nothing that we've seen that changes our belief that we have the best profile in asthma as well. So it's a little bit more developed market. Bio-penetration is a little higher but still lots of room to grow. So we think across those 2 main indications and then the other indications that we're moving into, again, we've got a lot of runway left with Dupixent.

Richard Vosser

analyst
#12

Excellent. And another gentleman sort of asking beyond Dupixent. I think, Paul, you highlighted in your presentation the confidence in the 2025 targets with the opportunity set you have. This person is asking about sort of beyond Dupixent and the growth there, how is the base business and what you have going to offset the Aubagio LOE, and get you to that sort of 32% margin target or larger?

Paul Hudson

executive
#13

Yes. I think we're showing that we -- through Q3, we're -- we have a resilient portfolio. And maybe Jean-Baptiste would like to comment on how we'll expand the margin through the time frame. JB?

Jean-Baptiste de Chatillon

executive
#14

Yes. We are clearly looking at going on our journey of going -- doing both things, expanding margins but at the same time, clearly pushing the reinvestment in the pipeline. And we've just seen with Kymab but also beyond -- behind our growth drivers. So the growth journey we are in is really happening at speed as we plan the Capital Market Day. And we're delivering quite strongly.

Paul Hudson

executive
#15

Thank you. Richard, back to you.

Richard Vosser

analyst
#16

Excellent. Maybe moving to the flu. There's a gentleman here asking a question on the flu season. He says the flu season has been quite weak. I suppose we're all shut in our houses, so there's not much opportunity, but the person's asking -- to get infected. The person is asking about flu vaccine orders have been strong in 2020, but is there a risk of flowback next year given a weak flu season?

Paul Hudson

executive
#17

Okay. Great question. Thomas, would you like to comment?

Thomas Triomphe

executive
#18

Sure. Happy to do so. Thanks for the question. Actually, what we are seeing is a significant increase in terms of demand overall for the market in terms of demand and injections on the season 2020, 2021, so the current winter. It's true, as we said before, that the overall epidemiology will -- remains low to date. We're still early Jan. So we have multiple years in the past where February and March have been the peaks of the epidemiology. So let's wait, but I think we're confident going forward.

Paul Hudson

executive
#19

Yes. Thank you, Thomas. I understand the question entirely, and we are, of course, very vigilant. But people wanting to get vaccinated, it remains even if the flu season is predicted to be small because, of course, masks and sanitizer and everything else. So we will keep you updated on that as we get in -- further into 2021. Richard?

Richard Vosser

analyst
#20

Paul, you touched on the idea of the German recommendation of vaccination. And of course, you're launching in Europe the more efficacious flu right now. So I mean, difficult to say where we are now, but maybe you could dimensionalize the opportunity going forward for flu in '21 and beyond. It seems like governments would be more willing to actually pay and get people vaccinated but just your thoughts.

Paul Hudson

executive
#21

Well, look, I'll let Thomas comment in a second. But clearly, there is an improving acceptance of population health management and a front of mindedness that is allowing us to have those conversations and to predict what may happen in subsequent seasons. I think everybody knows that these are tremendously health economic beneficial strategies to take. So they must and will be taken. There's a lot of first-time people getting a flu vaccine this year. And I think that's interesting in itself and what that means and how many will continue. I think the German nationwide desire to have our high-dose flu vaccine at the -- for everybody over 65 in a demanding health economic country such that shows you the value that it brings. So I think we are just opening the door. We haven't had high-dose flu vaccine in Europe for that long. So we just started, but it perhaps -- as difficult as this pandemic is, there are some opportunities to try and do things differently after this, maybe more. Thomas, is there anything you'd like to add?

Thomas Triomphe

executive
#22

No, I think you said it. Basically, awareness has been increasing for flu vaccination in Europe over the past 3 to 4 years before pandemic. And as you can imagine, the pandemic just crystallize that even further. And people don't want just to get high immunization rate. They want the best product in order to protect the most vulnerable people against the disease. And clearly, there are not so many vaccines that have shown superiority against standard flu vaccine. Two in the world actually. One is Fluzone High-Dose and the other one is Flublok. And both tend to be in the Sanofi flu portfolio, so it's very [ appealing ]. Until now, we've had limited supply. So we were really focused on the North American continent. As we've said before, we are expanding supply. We have new facility coming online. So now it's time to expand that beyond. And of course, Europe is the first market and there's a good appetite for it. So definitely very excited by starting in Germany and going beyond.

Paul Hudson

executive
#23

Yes. Let's be clear again, Richard. And we get a lot of questions on this, what does mRNA mean if your established flu business and for your whole portfolio? I'm trying to be clear, and I hope it's coming across that way. We have an incredible vaccine business that is established and runs very smoothly. It was put to the test in a pandemic, but I think we understand why. On top of that, we're now in mRNA. And on top of that, we know how to run flu studies, and we'll have one in the clinic with mRNA in 2021. So when you bring it together with high-dose flu vaccine with an mRNA in our future and with everything lined up, again, we believe our growth rate mid- to high single digit through 2025 is sound. And we think there's opportunities for new targets beyond that. So it's an exciting time, certainly given the -- also the payer health system and social awareness of the importance of population health management.

Richard Vosser

analyst
#24

And you touched on mRNA, and I've got a question here on the plan for Translate Bio beyond the 2 vaccine programs you've discussed. The person is asking about expanding in IO, which I presume is international operations. But maybe I've read that wrong. But just your thoughts then essentially on that...

Paul Hudson

executive
#25

Maybe you didn't read that wrong. Thomas, do you want to comment beyond the traditional targets?

Thomas Triomphe

executive
#26

Definitely very excited by the mRNA opportunity. Proof-of-concept has obviously been given in 2020. We had identified that opportunity before. We've made the partnership with Translate Bio which includes -- and that's an important statement, commercialization but also manufacturing and developing of all the vaccines possible against infectious disease. So really interesting opportunity. We're looking at it, of course, especially for new targets. Why? Because we believe it gives us an opportunity go in Phase I quicker than what we would have done with other platforms. So that's very exciting. There's a lot of viral platforms that we can target with this. It's very important to go in Phase I and see how much we can get in terms of neutralizing antibodies, especially. So that's a very exciting opportunity for us moving forward. So we have 2 Phase I clinical readouts this year. And of course, we keep moving forward.

Richard Vosser

analyst
#27

Excellent. Shifting gears. We have a question here, which is, please could you tell us about the future of the CHC division? But maybe I'll just broaden that out and add to that. And just we -- at Capital Markets Day, you talked about the initiatives to bring Cialis and Tamiflu to OTC. Maybe you could just give us an update there. And yes, I'll stop there.

Paul Hudson

executive
#28

So that's, by the way, the teaser, Richard. Thank you for that because at Capital Markets Day, we'll focus on a few things on February 5 straight after full year results. One of them will be, of course, progress in the pipeline in general. The other will be a deeper dive into general medicine and into consumer health because we realized Genmab, which is a big part of our business, people need to understand how it'll contribute to financing R&D, helping us deliver breakthroughs and to run even more efficiently being BOI accretive for group. And that's definitely going to be an important thing for us to discuss. Olivier Charmeil will lead that. And Julie will take you through our CHC strategy. To remind everybody, it was to carve it out to make it stand alone so that it could be more agile. They can get it back on industry growth, which we hope to, at some point, at the end of this year, maybe next year. And then to prepare or simultaneously to prepare for the switches because we know the switches are EUR 1 billion combined in top line, which would make us the fastest-growing consumer business in the sort of '23, '24, '25 horizon, somewhere in there, perhaps more likely '24, to be honest. And we're advancing. We -- you'll hear more about it on February 5, but we'll take a massive step forward with a first patient in an actual use study for Cialis in the first half of 2021. And that's very important for the reason that never the ED medicine has made it this far in the journey with the regulator. So that will be a real statement of intent that we're going to get this done. And you'll hear more in detail from Julie then, but we're very excited about the switches. And again, to touch on the comment made by Richard earlier, so Richard, your question about influenza, the appetite for Tamiflu to be over the counter, you'd be amazed how that's also appreciated. So one way or the other, things have moved towards us. And that's certainly good for our consumer business.

Richard Vosser

analyst
#29

Perfect. A couple of questions on data here as well. One of them was on the use of real-world data in advancing Sanofi's strategies. The person's basically asking how that's integrated now and how Arnaud contributes to that.

Paul Hudson

executive
#30

So there's really -- well, maybe I'll get Dietmar, if you're connected, to make a quick comment and then maybe Arnaud to talk about how we're supporting that. Dietmar?

Dietmar Berger

executive
#31

Yes, sure. Thank you, Paul. Real-world data has emerged as one of the key data sources for us very broadly in development, and we're utilizing real-world data already. And we're trying to move that beyond the pure, for example, pharmacovigilance study really into generating important data that will also help us with registration projects, with data that's important for payers and also with more patient-related data. And it's really integrated into this broader, digital initiative that we're working on together with Arnaud.

Paul Hudson

executive
#32

And maybe Arnaud, you want to comment because we -- you've inherited a responsibility for digital and data that comes from quite a fragmented organization historically. So maybe you want a quick comment on how you're trying to bring our data together.

Arnaud Robert

executive
#33

Thank you. Thank you, Dietmar, as well for the context. I think for us, it's pretty simple in some sense. Hard to execute, but we have a lot of data, and it's everywhere in the company. And we're trying to find the right platforms to allow Dietmar's team effectively to exploit that data in the most efficient way. And so a lot of our focus, frankly, for the next 1.5 years, 2 years is to build that data foundation that allows not only us to access sources of data, primary and tertiary sources of data, but also put it in a platform where it can be exploited, I would say, "in real time" by Dietmar and his team. So that's where a lot of the focus is.

Paul Hudson

executive
#34

Yes. And it's both a challenge but a huge opportunity for us, Richard, because when we look across our business, remember the company is, if you like, one of the younger, if you like, mega cap pharma companies. But it is also one that has been served well by a strategy of no medicine too small, no country too small for a decade plus. And -- but that's allowed us to be quite fragmented and quite country up and side up. And as we're addressing these things, whilst they're a challenge, the opportunities that come from them, which you can't really see from the outside, are both -- are significant both in data, user experience, speed and also throwing resources back into science or to the bottom line. And I think we're feeling more and more confident. They're not easy tasks, but they're the right thing to do. And there is only really opportunity, and deep breath sometimes, I know for Arnaud in the digital and data, but making a huge progress even in 6 months.

Richard Vosser

analyst
#35

Excellent. Question here on gene therapy and just your progress and thoughts about gene therapy. It's a very broad question. Maybe I'll ask about in rare disease but thoughts on gene therapy.

Paul Hudson

executive
#36

So we sort of touched on it, I think, a quarter or so ago that we have some programs. I'm going to ask John to comment in a second. We have some programs that we're excited about. We've been pretty demanding on the hurdle they have to reach to continue. But we also recognize that it's been patchy the successes in gene therapy. And even when there's been effectively miracles They've not always been readily adopted. And I think we understand as a team what it's going to take to address cost of goods and allow for pricing to drive a broader access for patients that would automatically be excluded, and we don't want that. And we've got some programs in -- that go beyond rare diseases if we were to include hemophilia in that. And John, maybe you want to make a quick comment on the medicines unit, the gene therapy medicines unit, and progress made?

John Reed

executive
#37

Yes. Thanks, Paul. Just for context, the company, through its Genzyme heritage, had worked in gene therapy well over a decade ago and put a couple of AAV vectors into the clinic for ophthalmology. But it was never really embraced and supported in order [Audio Gap] that it needed to, but there were some intrinsic core competencies there. And then I've also referenced in previous sessions that the manufacturing process for making viral-based gene therapy is very similar to some of the technologies that are used in our [ virale ] -- in our vaccines group at Sanofi Pasteur, and you saw in Paul's slide that nice ensemble of technologies. Well, they use very, very similar technologies to produce viral and various types of vaccines at scale. And so leveraging those as internal competencies, we now have organized our gene therapy into an end-to-end unit we call the Genomic Medicines Unit. We recruited a really stellar gene therapy drug discovery scientist, Christian Mueller, to lead that. We've built a strong CMC team around him, joined at the hip as an integrated whole and all the other components needed. And now we're very actively not only progressing our own, starting with an AAV platform, but we're also very actively in the business development front, building partnerships to access a larger toolbox of next-generation tools that we can then build the next generation of gene therapy products. We'll start in rare diseases like others, but another area that we're going to be doubling down on very shortly is now with cell-based therapies where we connect vivo, do genome modification with the announcement that we intend to acquire Kiadis, an NK-cell platform company for immuno-oncology. We are beginning that journey now modifying the genome of those cells, customizing them so that they can be designed to attack specific types of cancer. And our first foray will be in myeloma where we have a good complement to Sarclisa, our anti-CD38 antibody.

Richard Vosser

analyst
#38

Thanks, John. Thanks, Paul. We're at the top of the 40 minutes. So I'd like to say thanks very much to everyone for watching. Thanks very much for the Sanofi team, and I hope everyone has a good day.

Paul Hudson

executive
#39

Thank you. Thanks, Richard. Thank you, everybody, for connecting. Thank you.

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