Sanofi SA (NASDAQ:SNY) 41st Annual J.P. Morgan Healthcare Conference January 10, 2023 1:30 PM ET
Company Participants
Paul Hudson – CEO
Conference Call Participants
Richard Vosser – JPMorgan
Richard Vosser
Welcome to the Sanofi presentation at the 41st JPMorgan Healthcare Conference. I’m Richard Vosser, European Pharma Analyst at JPMorgan, and it’s my great pleasure to introduce Paul Hudson, the CEO of Sanofi.
Before I hand over to Paul, just to remind everyone, we will take Q&A after Paul’s presentation in this room. Please put your hand up and wait for a microphone, and then we’ll take your question. Paul, welcome to the conference.
Paul Hudson
Okay. Thank you, Richard. Thank you. Can you hear me okay? What a wonderful and warm introduction, Richard, thank you very much for that. It’s three years since that we’ve been here together at least, and it used to be the big room, I think, and then a scramble to get to the small room for the Q&A. I think I prefer this already. So let’s see how far we get.
In those three years, an awful lot has happened for us at Sanofi. We’ve really been on our journey, really transforming the company, really modernizing what we’re doing. And over the next few minutes, I’m going to share with you a little bit about what that looks like.
Behind the scenes, there’s a lot of work going on. But visibly, of course, nine consecutive quarters of growth, an outstanding performance and outperform against the objectives we set ourselves back in 2019. We said that we would introduce these four pillars, we would deliver against them, and we would also drive a higher performance in vaccines. We would go past EUR 10 billion with Dupixent and that we would double down on our pipeline.
We’ve made huge progress transforming the company what you can see. What you can see on the financials, what’s going on in the background? I’m going to try and bring that alive a little bit for everybody.
It’s important, I think, to see how rigorous we’ve been on delivery, how important it has been from our own credibility perspective, to make sure that we’re getting the important things done whilst transforming this amazing company, not least in terms of the sales performance has been incredible. The BOI performance, which we committed to 30% in 2022 and a 32% in 2025.
We wanted people to really understand that we were going to completely renew this amazing organization and deliver the financials at the same time. And you can see for EPS in 2022, our guidance, we’ve got full year results coming up in the next few weeks. We’re very proud of the delivery and what we’ve been able to do whilst modernizing and whilst transforming.
Of course, to do that and to deliver those numbers without any consequence to reinvest in the pipeline to have trouble the number of programs that we have. We’ve done it by a well-managed and directed EUR 2.5 billion resource reallocation initiative, most of which has gone back into helping drive the top line and to driving through an increased and more important pipeline.
This sort of takes us to a point now this — for Sanofi is what an average sort of year should look like. This is what we’ve been working towards since we got together as a team laid out our strategy at the end of 2019, indeed early in 2020 here. This is what we were gunning for, which was the sort of steady state as our organization, an organization of our size.
We took our first in humans to double digit for the first time in the company’s history. We made enough progress to know that we’re now on a cadence of launches. This year, we’ll do two first-in-class, best-in-class launches for the first time in the company’s history. We’ll launched Fortis in RSV. We launched Eluvia in hemophilia A. And we hope to really demonstrate not only can we bring to our science, but we can really commercialize it and do important work for patients.
We have two pivotal readouts. We have tolebrutinib in relapsing remitting MS, and we’ll also have Dupixent in COPD. Both, we hope to be breakthrough data sets, particularly in COPD. When you think about the huge unmet need and the challenges that patients face, this could be a real game changer.
And then this number of 27 readouts over the next 18 months. I can tell you, having joined the company in late ’19. This number, this internal ambition seemed like a real stretch at the time, incredible work by John Reed, the team in R&D and everybody pulling forward to really do things that are meaningful. Between 90% and 95% of our pipeline is first and/or best-in-class.
That comes with some risk, of course, because when you’re trying to break new ground, some things won’t work, but this is the new cadence for our company. This is what we’re doing. This is why we’re here. This is trying to do transformational things for patients. This is what a typical year, certainly for launches and readouts should look like for our company. We’re proud, really proud of the progress that we’ve made.
So when we came in the beginning of ’20, we laid out the fact that we thought Dupixent would go beyond EUR 10 billion on his journey. And in fact, when we laid that out at the end of ’19 as well, there were some raised brows about what was, in fact, possible. Could it be done? Atopic dermatitis, for example, was not a well-understood disease. It’s taken us five years to get to this point. And then certainly, in the last three years, we’ve accelerated our performance. We’ve committed and we will go — we will cross EUR 10 billion in 2023 in annual sales.
It’s an incredible performance. It’s an incredible performance given how difficult the markets are, how challenging it is for payers and reimbursement, but the unwavering absolute best-in-class efficacy and safety profile and meaning that this medicine is going on to do incredible things.
Now at the same time, we’re often asked, well, where could this end up? How big could this be? Well, we’ve said our next waypoint, and it is a deliberate use of the word waypoint. Waypoint is, of course, the next grid reference on the map for us will be EUR 13 billion. We didn’t say it ends there. We just said that’s the next compass bearing that we will give.
So we’ll go through EUR 10 billion in 2023. We have a compass bearing for EUR 13 billion, and we have COPD results to read out on top of that. Where this could take us could be absolutely incredible. In addition, back in ’19, it was not accretive to group. Right now, it’s accretive to group. So each time we make progress, we improved the overall performance of the company.
The economies of scales that are coming from that, the refined manufacturing processes, the improvements that we’ve made that will yield a massive reduction in cost of goods over the next three years. The equivalent, in fact, of launching a blockbuster in scale in terms of saving on cost of goods over the next three years.
COPD, well, if we get the data later this year and the data is positive and you know the unmet need will come back and will help dimensionalize for people what that looks like. We will owe it to everybody to share how important can this be for patients? And indeed, what sort of size will this look like? This is a really big moment for us. And the work we’re doing with Dupixent and how we’re building it out is pretty fabulous.
We take our moment to recognize that even with this astonishing performance, that we are really only penetrating a very small percentage of the eligible patient population. About 0.5 million patients are already being treated with Dupixent. We added over 225,000 new patients in approved indications already. We’re now moving into a chronic spontaneous early carrier, another 300,000 patients. But as you can see, there are over 7 million eligible patients, biologic eligible patients for DUPIXENT across indications. And we are in the hundreds of thousands.
I get letters every day for people thanking me not that I did too much for the incredible work on how this medicine has transformed their lives or their children’s lives. But we haven’t even touched the surface yet. We have so much more to do and so much opportunity to really make a massive difference. It’s just the beginning for Dupixent.
So we move into our launches. It’s first-in-class, best-in-class time. So Altuvio, our factor will move forward and launch, we hope, getting approval by the end of February. And why is this such a big deal? Well, you know this, I think for many of you that have been around hemophilia A, 2, 3 infusions a week is a lot. Or going out to a longer interval and having less efficacy is a choice that has to be made by patients.
We’ve really broken new ground here. We have a best-in-class factor. We should become the factor of choice. There should be no need to use any other factor at all. And why? Well, it’s weekly, already a major breakthrough certainly for those patients that just can’t infuse three times a week.
But a near normal factor level and what that means for patients, that is a complete breakthrough. It was at ISTH in London last year. And it was quite clear from the profession of the hematologist. This will be standard of care in factor.
But it gets a tiny bit more exciting than that, too. Because we know Hemlibra worthy competitor, we know a large proportion of their patients are also on weekly treatment. And we recognize that when you’re weekly versus weekly, having a normal factor level will be a new and improved choice. We’re going to be able to even go after the newest entrant on a weekly basis.
The expectations for us are very high. You can read the quote. You can see a patient, and you can get a very clear understanding that for those that want to live a near normal life, it is finally possible with hemophilia A. Its outstanding work done by the team excited about what it’s going to mean, and it is really going to mean a huge deal for these patients. And it’s just around the corner. And on our journey, deliver the financials, develop the pipeline, commercialize the assets, do it to a high standard, do it first-in-class, best-in-class. This is another major point.
So this year, the American Academy of Pediatrics asked the White House to declare a national emergency for RSV. The alarming surge in cases of RSV, the number of young children less than one year of age, infant babies that were being admitted invade distressing circumstances became almost unmanageable across the world, but in particular, in the United States.
Bay Fortis will launch later this year. We hope in time for the season, which can change everything for these patients. We will reduce hospital admissions in RSV by 80%. Now of course, that not only helps relieve the stress on the system for the first time. First time this has ever been done at scale. But at the same time, it reduces the stress on parents, particularly new parents who’ve never been in this situation before watching an infant struggling to breathe.
This is a new game in town. This is two medicines that will be best-in-class, 1 first-in-class invest and in hemophilia A best-in-class. This is game-changing for us. This is the sort of work we’ve been aspiring to since we put the strategy together back in 2019. This is the new Sanofi and how we’re operating.
Behind the scenes, again, I use immunology as an example because I think it’s important for everybody to understand that we’re not just running asset to asset. We’re really trying to build something very special here. Of course, we have Dupixent as a cornerstone in what we’re doing in immunology, but it goes much, much deeper than that.
We’ve been able to put together over the last few years, a very sophisticated and deliberate portfolio in immunology that can change everything. This is not waiting to a mega blockbuster drug as during patent exclusivity loss.
This is doing something deliberate for patients now. This is recognizing they’re not all drugs for all patients, certainly not immunology. This is recognizing the need for orals, we’ve just advanced our RAC 4 from Chimera into Phase II. We have a BTKI. We have a topical. We have an OX40 ligand. Many of the patients that finished the study are still symptom-free because of the incredible disease modification opportunity that this medicine may present.
We’ll also pull through our Nanobody platform. We’ll see an IL-13-TSLB combination that will raise the bar of efficacy in asthma, set a new standard. When you’re the leader in immunology, and we will be the world’s leading immunology company. There’s some special moments to do things for patients looking end-to-end at the patient journey and recognizing when you look at RA, psoriasis, other treatment areas, the patient heterogeneity that our responsibility to develop medicines for subpopulations to such a precise standard that we can help these patients go on their end-to-end journey is our responsibility.
And we’re really going to change everything with this. Nobody has got anything like this in immunology. We worked very hard to put this together, and this is just the beginning for us. This road map in immunology is what we’re building out in rare disease in neurology, in vaccines. We’re really now starting to put together a long-term and coherent plan to bring first-in-class, best-in-class at scale right across our organization. And this is going to be a real gift for patients.
We mentioned at the bottom, 9 new NMEs before the end of the decade. Greater than EUR 22 billion in sales in immunology alone, which will mean 9 medicines in flight in the second half of the decade on their launch trajectory. What it means for patients is phenomenal. What it means for us and the organization is pretty fantastic.
While all that sexy cool work is going on, there’s even more important work going on behind the scenes across the rest of the portfolio. Our consumer business, which was trailing the industry is now growing faster than market and it has been doing for a number of months.
We carved it in. We gave it agility. We put it back where it needs to be. We started to invest in it. We’ve doubled down on e-commerce. We’ve radically overhauled the pipeline — the portfolio, we’ve shut down things and reduce families, made ourselves more efficient. So we can contribute back to R&D, of course, but also we can run a more agile, fast-growing business. And we’re seeing the proof of it. It was a long time before we cut up with market growth. And now we’re ahead with a regular cadence showing what we’re capable of.
And shout out to our General Medicines business, which is a huge business for us. But it’s a very important business because, of course, within it, it hides incredible growth opportunities. And that’s why we split it between core and non-core assets. And we do that because while some assets have been declined, of course, through price or end of life, there are real magical assets, our transplant business, for example, are now emerging type 1 diabetes business. These provide real opportunities to change the way our General Medicines business is viewed and to really celebrate the excellence.
We’ve moved to distributor models. We’ve reduced costs. We’ve reduced product families. We’ve streamlined. It’s allowed us to deliver on our overall BOI objectives. It’s allowed us to reinvest in R&D, but it’s allowed us to innovate at scale. And that’s never been done before in our organization. So even the two big areas that we don’t talk about frequently are on their own innovation journey, and we’re making staggering progress.
It’s — you normally come to the end of a slide presentation and you get to these moments and you — people put in a few slides on DNI or on corporate social responsibility. And we know people do it with the right meaning and the right intent. For us, it’s non-negotiable.
For us, there’s no point winning on all of the things that we’ve laid out in terms of science for patients a change in the practice of medicine unless we’re doing it the right way. Unless we’re building a company that is representative of society, and we believe we’re well underway on that journey. 34% representation of people of color here in the United States, 41% of women in leadership roles. It’s not there yet.
We’re not declaring victory. We’re saying that it is not acceptable to change the partisan medicine, deliver for investors unless we are absolutely responsible for the workforce that we have a contract with to make sure that they look like the society that they live in and represent as patients that this point is non-negotiable for us.
Likewise, 95% of our clinical studies have diversity objectives. It is non-negotiable not to do that anymore. These are minimum standards. That’s why the fast-rising investment opportunity for us in our operation and our operating expense is in diverse and inclusive suppliers. This takes a lot of energy and effort from everybody across the company. These are non-negotiables now.
If we think we can just pass through and celebrate the odd scientific breakthrough, it is not enough. We need to win, we need to do it the right way, and we need to do it absolutely categorically by doing things and celebrating them the right way.
I touched on the ERGs, which doesn’t get talked about a lot, it’s the employee resource groups. Why should you even mention it in a group like this because people need to see people like them in organizations? So people need to talk to people like them in organizations in a safe environment and feel championed, feel a safe place to talk about who they are and what it needs to include them.
And we have found and rightly, and I don’t think it’s a surprise to anybody that the more people see people like them in our company and the more they can be the best version of themselves, the more productive, the more fun, the more engagement and all those things come together. This is not coming too late. This is coming at the right time. It is not acceptable not to deliver this while delivering amazing science.
Maybe for our last slide, I think one last distinguishing factor in our transformation, we’re a really fabulous company, but we were a collection of 300 acquisitions over 3 decades. We weren’t always fully integrated in terms of data lakes, and we were indeed often patched together in terms of architecture and infrastructure. We made a conscious decision that we could try and fix all that, which we will, and reduce the cost to serve those technical aspects.
But at the same time that we were a company in transformation that should jump straight to AI. For most of us in our industry, the AI question is really in R&D, perhaps in supply. It’s not really an everyday for everybody. We’ve made a conscious decision. We’re partnering with a company called Daily, but we made a conscious decision to go after AI-driven insights for the vast majority of the people in the organization.
And after 18 months, we have over 8,000 people being informed with insights and predictive analytics in a snackable format on their mobile phone similar to Instagram stories about where they should be spending their time, where we may go out of stock in Q3 2024. Where are we on quality issues? Where can we be on inventory? Where can we be on investing more in an asset in Brazil, where could we be pulling back in an asset, say, in Australia and getting informed insights right across our business real time.
Imagine that’s in your hand, not many companies have done. And I would argue not only do people not have it, but they don’t have it at scale. Our ambition will be to use AI at scale and to have almost all of our organization benefiting from it on our journey over the next 12 to 18 months and be well ahead of the rest of the industry.
So massive progress, a massive transformation for us. We’re delighted with that. At the same time, pipeline is coming 27 readouts to come over the next 18 months, 9 consecutive quarters of growth, outstanding success with DUPIXENT, not even started. Two first-in-class, or best-in-class launches this year and at the same time, modernizing a company that truly reflects society. That’s the work we’re doing. That’s why we’re proud of what we’re doing. And thank you for your attention.
Question-and-Answer Session
Q – Richard Vosser
Thanks very much, Paul. We’re moving to the Q&A session. So if you have a question, please put your hand up. Shy as always. So maybe I’ll ask a question to start us off on Dupixent. Clearly, very, very strong growth and accelerating growth, as you highlighted.
When we think about the pressures on the immunology space, maybe biosimilars coming not of your product at Humira and pressures on payers. How are you thinking about that over the next few years? And also the growth within the in-line indications that you’ve got? And then maybe I’ve got another one.
Paul Hudson
Well, I think at the very beginning of it all, the best way to protect yourself from payer pressure is to have transformational innovation. And the biologics have often provided that for all of us. And this medicine, in particular, has provided opportunities for patients to have normal labs.
I was speaking to something this mentioned just yesterday who said that their sister had suffered from AD for 20 years. She moved to Dupixent, and she finally up to see what a normal life was like and the impact it had on her mental health and those around in her family. This was just yesterday. This happens all the time. If you don’t have that level of transformational impact, then it can be a stretch in terms of reimbursement.
You mentioned biosimilars and other things. I’ve worked around biologics for a long time. We’re always surprised by the number of biologics that can coexist in, say, psoriasis or rheumatoid arthritis to different areas. And we shouldn’t be in immunology and autoimmune disease, patients are very heterogeneous.
There are a lot of different stages. That’s why we’re building out such a sophisticated pipeline in immunology inadequate responders, partial responders, pre-biologic, on top of biologic, after biologic disease modification, topical. And you have to innovate. You have to have the right patient subpopulations. And you’ll find that, I believe, that you can more than justify your position in the market and be rewarded.
Like we said, we’re 9% penetrated of AD eligibles. And we will annualize — we will have annual sales issue of more than EUR 10 billion, 9%. We have work to do, and new entrants, new competition, bring in education, bring in investment dollars. It’s all going to help make sure those patients. Whether it’s not our drug is perhaps slightly less relevant that patients who need access for advanced therapies can get it.
Richard Vosser
And maybe on the profitability, you touched on it in terms of new manufacturing and actually being accretive to the margin. How should we think about that coming forward? You’re going to be adding — I mean, you’re hitting EUR 10 billion, you could be adding EUR 1 billion, EUR 2 billion of sales this year. How should we think about that when it — in terms of adding to the profitability of Sanofi?
Paul Hudson
Yes. It’s not just a great drug. It’s an incredible also that on this fantastic drug, we can deploy on all our manufacturing site, a new process, which will some lower COGS. And that will come up progressively and the full impact will be by 25%, which is when we want to expand our margin by another 200 bps. So that’s quite timely.
As you know, Dupixent, we declared was already accretive to our threshold of 30% in 2022. I thought at the beginning, it would be by year-end. In fact, it was from January onwards. So we are going quicker than what we expected.
And the last piece of negotiation we had around Libtayo, also help us to recoup our development costs that we spent initially on Dupixent and have an accelerated reimbursement, which makes our share of the Vixen profit for the years to come closer to 60%. So great growth and great contribution on our road map to 32% in 2025.
Richard Vosser
Any questions? I think we’ve got a question over there.
Unidentified Analyst
Yes. So you didn’t mention your vaccine business. What is the future of that looking ahead?
Paul Hudson
Well, I mentioned at the beginning that we said it was a priority also shared the RSV launch that is coming up later this year. So we did touch on it. But we, like many have moved rapidly towards mRNA, created a center of excellence, investing between $400 million and $500 million a year in purely developing in mRNA, taking it into new opportunities, for example, such as acne and doing things that have never been done before.
We’re also in flu. And it’s quite interesting, really what’s being done because we know how to do, say, influenza. And we know the expectation is that you have to have something that has no side effects and in a prefilled syringe as thermo stable. Nobody wants to get sick to two days with mRNA and flu to avoid being sick for four days, right? That’s not great math.
So we know how to set a high bar. We know what it needs to look like. Our team are doing that because we know how to do it really well. But we go beyond that into Mining, we go into pediatrics and much broader. We are really setting ourselves up for if there’s an opportunity to take from innovation and mRNA will take it, plus our own continuous innovation on through new McCorkle [ph]. Maybe you want to add to it, you [indiscernible]
Unidentified Company Representative
Well, yes, because thanks for your question because effectively, it’s not just about the success of flu, which is great because with the lower immunization rate in the U.S., we’ve been able to increase our net sales during the last three years, which is a great kudos to the team, honestly, because it was really moving very fast to this differentiated flu. We own the standard of care for flu.
But mRNA platform, you mentioned, of course, acne, which huge unmet need. We have also clammed on the bench. But outside of mRNA, we are also gave you some information about other products like PCB, MenB, RSV Toddler, and we will come back to you in ’23 with more information on those developments. RSV Toddler would be a great complement to our franchise on all infants with RSV.
So you see vaccine is top of mind and well gone delivering. You remember, we said that it would be mid-to high single-digit growth, and we are delivering on our promise. And we said that we want to double this franchise by 2030. So we are on our way.
Paul Hudson
Yes. Just on RSV, I mean I won’t ask for a share of hands, but almost everybody has had a child or know somebody who’s had a tough experience with an infant with RSV. I mean that’s it’s pretty much everybody gets touched at some point.
And I want to be clear again that what we’re doing with Bay Fortis, which sort of kicks off the renaissance and what we’re doing in vaccines. — is truly transformation. Imagine it doesn’t matter when a baby is born, if a baby is born in the season, they’ll be protected with Bay Fortis.
This is not a maternal vaccine where you’re playing serendipity with when the baby is conceived and when the baby is injected and all the variables that go with that. There’s just no need for that. You can just really protect those infants at risk fast. And so I think that marks a sort of the next chapter for vaccines and of course, the expectations on growth, which is — which are impressive.
Richard Vosser
We have a question on the right.
Unidentified Analyst
Thanks for your presentation, earlier. I have a tolebrutinib question. I think back end of last year, you had alluded on our conference call that the IDMC was lifting the clinical hold, but we still haven’t heard from the FDA. Can you just provide the latest thoughts on that, please?
Paul Hudson
Yes. So thank you for the question. So just to remind everybody that tolebrutinib is a brain — active brain-penetrant, BTKI. So the whole rationale was if you can cross the brain barrier, you have a shot at treating the progressive nature of the disease and the microglia, and this was always our goal. Our goal was to be able to go after superior efficacy in relapsing remitting and/or indeed doing something very important for patients with progressive disease, which we know, particularly in secondary progressive, is a horribly debilitating and inevitable journey.
What people don’t realize that whilst we were discussing the clinical hold in the country at the moment, we fully recruited both relapsing remitting studies and the second reprogressive study, and we continue with primary progressive. So they’re all on track, on deadline, nothing has changed. Patients from what we understand, doing very well. So our hypothesis about where this can help hold true.
For the DMC, of course, nothing has changed for them either. Everything is on track. It’s really only our back and forth now with the FDA on the partial hold. And we’re in very active dialogue, exchanging information because them, like us, are interested in making sure we can choose the right patients that will benefit.
There is clearly a class effect here in terms of what might happen with initiation of BTKI. But anybody that’s been around MS for a long time will tell you. Efficacy is the objective. Finding the right criteria to start a patient on drug, monitoring them, managing them and getting them to very much as normal a life as possible holds true. Nothing has changed for us. The dialogue is ongoing. And when we have the latest update, we’ll share it in an earnings call or indeed in a more public communication.
Richard Vosser
Further questions? At the front and then okay.
Unidentified Analyst
Yes. Thanks for taking my question. Elizabeth Jones, Ivy. I was wondering if you could just talk a little bit about the COPD opportunity. I don’t think of COPD as a highly allergic disease. So I just wanted to understand if there’s — who you’re targeting within that broad population and the size of the opportunity.
Paul Hudson
So I think I think CBD is one of the top 3 or 4 list of killers for patients and is an absolutely devastating impact and you imagine reading through a straw for most of your day, you sort of get a sense of what it’s like to field constrained that way. I think you also probably know that inhalers have been the standard of care or oxygen in an acute care setting. This is not a good situation. That really hasn’t evolved. Some of the anticholinergic, for example, have been around for 20 or 30 years.
So we went after it to try and change the pace of medicine literally. And we looked at 2 different types of COPD. We looked at a Th2-driven disease, those with an inflammatory component those almost towards the asthma-COPD overlap syndrome to see what could be done to try and reverse that. What could we do to give people 200 milliliters in FEV 1 back or reduce submissions acute emissions into hospital? And we set a high bar, but we’ll get the data soon enough.
And we’ve seen it with biologics when they first enter huge unmet needs, they move very quickly in terms of opportunity if you can show a benefit. If a patient can walk upstairs unassisted to a bed, that is major. If you can avoid going to hospital, that is major.
And then behind that, of course, we have the IL-33 Itepekimab. We’ll get results next year in the pivotal readouts, which is less Th2-driven disease and, of course, more looking at the fundamentals and around IL-33 itself. So we think we’re going to provide 2 very important advanced therapies.
Now they have to work. We haven’t seen the data. We have no indication yet what it will read out. But the earlier phase data was really encouraging really encouraging and in particular, in subsets, say, for example, former smokers.
So we will see. We’ll turn the cards over. I have to say, and it’s interesting for us because Sanofi not really been for many decades, people waiting on us to turn over a pivotal study to see if you can change the practice of medicine. We’re moving into that territory now. And we have to take these bets. And we’re well organized, we know the areas we’ll turn the cards over, and we’ll see what we have.
We remain optimistic, right? We’ve done everything right. But of course, you never know. But if we can provide an advanced therapy for COPD patients, I mean, that’s why we’ve kept COPD. Whenever we talk about Dupixent, we’ve always had COPD as the addition because depending on the profile of the data is good, we have to recalibrate for everybody what the model looks like because there’s so many patients struggling. So that will be on us. Let’s get the data and then let’s see if it’s good and what that looks like.
Richard Vosser
Question in the middle.
Unidentified Analyst
Thank you for the session. So just to proudly announce that we are your partner since December in Indonesia. So we have come from the Kobe. So we are continuing to grow your Genmab business and also vaccine in the country. So I just want to see what you have thought about the country or region that is still concerned about affordability because it’s very important for Indonesia or the Asian countries that talk about the Gen-med even it’s still a bit old products, but I think the accessibility is very important. What do you think about it?
Paul Hudson
Yes, let’s not confuse age of products with usefulness for patients, and we all know that, right? And we moved to a distributor model, and thank you for your support in many countries because we were carrying a lot of infrastructure that we could reinvest in R&D and many of the local distributors could do a better job and really understood the local market even more in a more sophisticated way than we did.
So that will continue. We think that’s important work. And that’s the modernization, the stuff you never hear about you do, but others don’t that allows us to free up BOI and reinvest and go and go and go on science.
On a more fundamental note, we committed through our corporate social responsibility agenda to give 40 essential medicines as defined by the WHO at cost to the 30 poorest countries in the world and we agreed to do that through the Sanofi Impact brands to make sure that those that needed a central medicines got them, and there was no reason for anybody to go without.
And often, this is in cardiovascular and diabetes, for example. Fully committed to that. We’ve launched the initiative. It’s up and running, patients already benefiting. And we do it at cost because we want people to understand they have to recruit more physicians. They have to educate the up to train. Often, they just don’t have the right infrastructure. We’re in the right place now for what that looks like.
Richard Vosser
Another question here at the front.
Unidentified Analyst
Yes. Have you dropped your interest in the generics business?
Paul Hudson
Well, we did have a generics business that was divested, I think, before my time. So maybe you want to?
Unidentified Company Representative
No, thank you. That’s not the focus. We still have some activities through our Gen Med portfolio. And it’s working very well, but to focus is on innovative science for us clearly.
Richard Vosser
Just wanted to come back to Bayer Fortis and the launch. Clearly, a very bad RSV season here and globally. Is that the urgency, particularly in the U.S. from the regulators to sort of get the product approved so that it can be recommended by ACIP by regulators so that you can get there?
Paul Hudson
Yes. Look, there’s — the regulators are — have; been incredibly supportive. They’re finding these of baby Tylenol and different things to try and make sure that those suffering now without a treatment can really get there. There’ve been a lot of energy and time invested the — I’ve got to complement the FDA. They really understand how important this is, and they know what it’s going to take.
But let’s also remember, this is a monoclonal antibody, a lot of vaccine. So it takes a little bit of time to make sure that everybody understands, not often when you bring a map through, it’s for a population health strategy, right? So it’s taken a bit of energy to get there. The season in RSV is still happening. And the ACIP meeting, I think, is in June, something like that for the next guidelines and then one again early fall. So if we get the approval sometime around then, we’ll have the guidelines updated and we’ll move very fast.
There’s a huge amount. I can’t even tell you whether it’s ASIC, the AAP, patient groups, everybody is asking, can we get it? Can we move? When can we protect people? Crying out for an alternative. Literally deciding which infant gets a bed in a critical care unit is a choice being made in the United States, choosing between infants.
So the pull is massive. So if we can get ourselves set up well, it’s better if we get approved earlier, gives us more time in prep gives us the guidelines. But even if it comes a little bit later as we start the season, the appetite is huge.
Richard Vosser
And maybe just a last question on flu. There’s a bit of vaccine apathy or exhaustion that COVID has brought, that may be detectable in the flu market this year, but then flu is quite severe. So how should we — it’s a severe season. So how should we think about sort of flu in ’23, flu in ’22 and the ongoing growth of flu?
Paul Hudson
Well, we’ve had three record flu seasons, right? So let’s be clear about that contract, you look.
Unidentified Company Representative
Yes, in spite of our immunization rate, as I was saying. So you know that the time line is always the same. Once you have flu, you don’t run for a shot. You remember the following year. Well, I have to do better, and I have to be — to get my shot early in the season. And that’s what normally happens when you look at statistic on long period. So normally, we should see a rebound of the immunization rate in 2023 in the U.S. and across the world, while the COVID-19 problematic will dwindle.
Richard Vosser
Excellent. I think we’ve run out of time. So thank you very much. Paul, thank you.
Paul Hudson
Thank you, everybody.
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