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Goldman Sachs 45th Annual Global Healthcare Conference

Jun 11, 2024

James Quigley
European Pharma Analyst, Goldman Sachs

Perfect. So, good afternoon, everybody. I'm still James Quigley, European Pharma Analyst here at Goldman. I'm pleased to welcome you to this session with Sanofi. We're joined today by the Sanofi CFO, François Roger. So thank you for joining us, François. To kick off, again, you're still relatively new in the role, so two months or so, or two, three months. So it's still, again, early. But, in your assessment of the business, what have you identified as your, as your key priorities?

François Roger
CFO, Sanofi

Well, first of all, I'm very happy to have joined Sanofi about two months ago. I think that Sanofi has everything that it takes in order to be successful. I think that we have a very clear strategy, which is extremely focused on a limited number of therapeutic areas. I mean, namely immunology, rare disease, neurology, and vaccines to start with, where we have really real knowledge and know-how. I think that we have a strong leadership as well, with a clear leader at the top as well, with Paul. We have a pipeline that is really valuable with 12 potential blockbusters. They won't all make it, but I think that we are in a very good position, and especially to prepare for the LOE of DUPIXENT in as probably at the end of 2031 or potentially 2032, or potentially even later than that.

We have a strong balance sheet as well that we will use with a lot of care. And talking about LOE as well, we are in a very fortunate position, which is relatively unique in our industry, to be able to enjoy a high level of growth in the coming years because we don't have any LOE till 2031, so which is a relatively unique position. In terms of priority for me in the short term, I would say I would mention probably the main two ones. One of them is clearly to make sure that we deliver against our expectation as far as 2024 and 2025 is concerned.

It's absolutely critical, and I'm really focusing on that. And after two months in the organization, I'm extremely confident on the fact that we should get there. There is one other opportunity that we don't want to miss, which is that separation of the consumer healthcare business, which is coming in Q4 2024, or at the latest in Q1 2025. It's a sizable transaction. We want to make sure that we create value for shareholders.

James Quigley
European Pharma Analyst, Goldman Sachs

Okay. Perfect. And in terms of your experience and your background, you joined from Nestlé, but started in pharma. So you've come full circle in that respect. But what can you take from your broad experience across non-pharma businesses as well that can drive operational improvements within the pharma bio-pharma business?

François Roger
CFO, Sanofi

Well, certainly, I've been, I've been CFO of a public company for 15 years, but the idea is not to do a copy and paste of what I experienced in my former company, Nestlé, which is, by the way, in another industry. But I've been working in the pharmaceutical industry for 16 years as well, just before Sanofi and at the beginning of my career in what was Sanofi at that time. But I think that, through my experience, I can really leverage on, some of the, some of the successes that we have had before, which can be from a strategic point of view as well, to revisit our portfolio, to be extremely focused, as we said, to make the right choices as well.

In terms of resource allocation, which is absolutely critical, in terms of capital allocation as well, to be very disciplined in terms of M&A, which is really the intention, at Sanofi in terms you touch on it in terms of cost discipline as well, where I have a very large experience in my former organization, as well. But clearly, the idea is not to copy and paste. But, no, let me just give you another, interesting, lesson that I can draw. Whatever we are doing today, we will be doing with the separation of CHC. I had, for example, in my former company, a similar experience where we have created similar, very significant value in similar transactions. So I can certainly leverage on my own experience, even if it is in another industry.

James Quigley
European Pharma Analyst, Goldman Sachs

Okay. Perfect. One fairly recent news item has been an update on the Zantac litigation with the Delaware Daubert hearings. I think it's around 25,000 cases of the 75,000 cases where Sanofi is named as a defendant. So what are the next steps here? I know that there's an appeal. What is it? What are the next steps, and where is Sanofi potentially exposed?

François Roger
CFO, Sanofi

Okay. We appealed yesterday, by the way.

James Quigley
European Pharma Analyst, Goldman Sachs

Yeah.

François Roger
CFO, Sanofi

First and foremost, because there is no evidence of any causality between the use of Zantac and the development of cancer, which is the most important part. We have settled on non-Delaware cases. A very reasonable cost. Happy to have done that with, which represent about 75% of the cases. In the Delaware cases that you mentioned, we are not the only defendant party.

James Quigley
European Pharma Analyst, Goldman Sachs

Yeah.

François Roger
CFO, Sanofi

For example. So we were named in a limited number of cases, as a co-defendant there. We have appealed because we are absolutely sure of having not done anything wrong there. In terms of liability, don't expect anything major. I mean, I've obviously reviewed carefully this case as a CFO of the company, even for the last two months. I'm very confident as of today that I don't see any significant liability beyond whatever we have accrued in our books. This is something, by the way, that we review very closely and regularly with our external auditors to make sure that we reflect in our accounts. Whatever exposure we may have. So, but I'm not worried with whatever I have access to today in terms of significant potential liability.

James Quigley
European Pharma Analyst, Goldman Sachs

Okay. Perfect. And two more sort of quick questions on, on Zantac. So, do you have any sense of timing in terms of the appeal, number one? And then number two, how much of your time is, and management time is, is Zantac taking up currently?

François Roger
CFO, Sanofi

On the second one, not very much for me.

James Quigley
European Pharma Analyst, Goldman Sachs

Okay.

François Roger
CFO, Sanofi

I just want to make sure that I understand what's happening on the legal side. Obviously, for my colleague with the general counsel, I think it does represent a significant amount of the time that he spent. But, I think it's manageable. These things will probably drag for some time.

James Quigley
European Pharma Analyst, Goldman Sachs

Yeah.

François Roger
CFO, Sanofi

because, I mean, it's going to take some time, probably at least another 18 months for some of these cases to develop.

James Quigley
European Pharma Analyst, Goldman Sachs

Okay. Perfect. Good stuff. So we'll move on to some of the product questions and, maybe a bit more of a positive light. So Beyfortus, so how is the manufacturing ramp-up progressing? And should we, at what point should we expect sort of a fully debottlenecked supply chain?

François Roger
CFO, Sanofi

Well, we are in a much better situation this year. Last year, we were supply constrained. But in spite of that, I mean, we did extremely well last year. So we had only one line available last year. This year, we have three lines. So we have commissioned two new lines, which for which we are still waiting for the approval of the FDA, which is going to come in the course of the summer. We are, by the way, basically in a weekly talk with them in order to make sure that we will get a positive clearance, which we really expect to happen in the course of the summer. So with three lines, we are less capacity constraints in 2024, but still a bit. In spite of that, in spite of these capacity constraints, we do expect that Beyfortus will be a blockbuster this year.

Potentially, even it could be more than EUR 1 billion, certainly this year. In 2025, it's still early to say, but we expect to have no or limited supply constraints in 2025. It's really amazing to see the fact that we have been able to reach a blockbuster status in the first year of commercialization in 2024.

James Quigley
European Pharma Analyst, Goldman Sachs

Got it.

François Roger
CFO, Sanofi

I mean, the results are really outstanding, reduction of hospitalization for babies between 0 and 1 year for bronchiolitis by 82% with real-world evidence is really amazing.

James Quigley
European Pharma Analyst, Goldman Sachs

Okay. Awesome. Then thinking about the impact in 2024, is there a scenario where there could be upside to that number? I mean, if you think about your manufacturing plants now, yes, you need to have approval, but is it a case of once you get the tick in the box, you then go all out to produce as much as you can? So is there an upside scenario to the EUR 1 billion that you've spoken?

François Roger
CFO, Sanofi

Yes, even for 2024. I mean, if we get full clearance, as we are manufacturing full speed, we will exceed the EUR 1 billion.

James Quigley
European Pharma Analyst, Goldman Sachs

Yeah.

François Roger
CFO, Sanofi

I don't want to give precise numbers for the time being, but no, no, the EUR 1 billion is a minimum for 2024.

James Quigley
European Pharma Analyst, Goldman Sachs

Okay. Perfect. And then when you think about the ex-US opportunity for Beyfortus and launching out there, how would you sort of characterize the challenges versus the US market and overall, what do you see as the commercial opportunity?

François Roger
CFO, Sanofi

The commercial opportunity is very big. We have been very successful already in France and Spain, but in the context of supply limitation. Just be aware of one thing. There are more babies born outside of the U.S. than in the U.S. So I think it speaks by itself. There is obviously a very big opportunity, even if the birth rate is declining in China. But even in a private market, for example, given that usually when you have less babies, parents do tend to invest more to protect their babies. So China is certainly, potentially a very good opportunity, beyond Europe and many other markets. We were actually very positively surprised to see that because we saw that in Q1, even in the southern hemisphere, in countries like, obviously Australia and New Zealand, but I mean, Chile as well. So where we did extremely well with a very attractive level of sales in Chile, which is an emerging market.

James Quigley
European Pharma Analyst, Goldman Sachs

Okay. Perfect. So moving on to tolebrutinib, pipeline asset, the BTK inhibitor in multiple sclerosis. What are the sort of internal expectations for this drug? The data in the second half of the year, you look at competitors, you know, Merck and evobrutinib, they had a disappointing result there. So how are you thinking about the risk of the trial and then the commercial opportunity that's gonna drive off the back of a successful trial?

François Roger
CFO, Sanofi

Well, we are obviously positive about it, but as long as we don't have the results, it's difficult to say. We will know more at the end of August, beginning of September. I think that the mode of action of our molecule is actually different from the one that you mentioned earlier. So, we remain extremely positive. We know that they are clear on medical needs as well. So we have two important readouts, which may come at the same time in September, or August, September, or maybe with a week or two of time difference. But we remain extremely positive about it. But once again, as long as we have not seen any of the results, it's difficult to comment.

James Quigley
European Pharma Analyst, Goldman Sachs

Got it. And in terms of investing for the launch, have you already started to invest behind manufacturing and some of the sales, or are you waiting for the trial? Where, when do you pull the trigger on the launch?

François Roger
CFO, Sanofi

No, we always plan for the better and prepare for the worse. So, I mean, we are basically ready both in terms of manufacturing facility. I mean, we have already part of the sales force, which was already available, which we have kept available, but we always prepare for the better.

James Quigley
European Pharma Analyst, Goldman Sachs

Okay. And then in the negative scenario, what does that mean for cost allocation? If you look at your portfolio, you have frexalimab, which is down the line in multiple sclerosis as well. Is there a risk of some stranded costs within the MS field force until the data in 2027, or how easy is it to dismantle and reallocate the sales force already?

François Roger
CFO, Sanofi

Dismantle, I don't think that we should dismantle because we need to keep the knowledge as well and the know-how. But I mean, it's more about using these resources in an appropriate way in the meantime. But exactly as you said, I mean, we have frexalimab coming later on. Be aware of one thing as well is that tolebrutinib, we have a certain number of clinical trials. It's not only one. So we have two readouts this year, and we have two other ones later on that are coming as well. So it's not binary on just one single outcome, so which means that it gives us a little bit of flexibility as well.

James Quigley
European Pharma Analyst, Goldman Sachs

Okay. Perfect. So moving on to DUPIXENT. So had a bit of a disappointment with COPD, and the FDA extending the PDUFA date. So can you talk us through the reasons that the FDA gave you for the extension?

François Roger
CFO, Sanofi

I think that they needed a little bit of time to assess. It's the first to assess the case. But we are not concerned in substance. I mean, the decision. I mean, we are waiting, obviously, for the decision, but we understand that they needed a little bit of time. It's the first biologic in COPD. And by the way, we are 3-4 years ahead of competition. So we understand fully that the FDA needed a little bit more time to assess the case. But we have no major concern about, or no concern about, the outcome, even if it comes 3 months later. Don't forget that we had priority status before where we gained 4 months, and we are losing to a certain extent another 3. But net, it's even 1 month of gain. In the meantime, we got an accelerated approval in Europe. At the same time, so which gives us even more confidence about the outcome for the U.S.

James Quigley
European Pharma Analyst, Goldman Sachs

Okay.

François Roger
CFO, Sanofi

I just want to reassure everybody as well. As a consequence of this three-month delay, which obviously we are not pleased with it, but no drama. I mean, it doesn't lead us to revisit our guidance for DUPIXENT this year. We confirmed the guidance of sales level for 2024, around EUR 13 billion for this year. And it doesn't impact either our guidance for the medium term, which is a low double-digit growth for the coming years.

James Quigley
European Pharma Analyst, Goldman Sachs

Okay. Perfect. When you think about DUPIXENT from a sort of a high-level perspective as well, there's obviously it's been a hugely successful drug. It's gone into many different areas, particularly in associated with Type 2 inflammation, but then success draws in competitive competition as well. So what's management's views on the sort of the high-level competitive environment across the indications for DUPIXENT?

François Roger
CFO, Sanofi

It's always good to have competition, and we respect competition. But, you know, as you are aware as well, I mean, the level of use of biologics in many of these indications is actually very low. I believe that for AD, it's something like 17%. I think for asthma, it's 10%. It's even 10%. So which means for COPD, it's zero. So, I mean, even with competition, I think that there is a lot of empty space there. So, we are not worried, which is the reason why we provided that guidance of an expectation of a low double-digit growth for the coming years.

James Quigley
European Pharma Analyst, Goldman Sachs

Okay. Perfect. And when you were in London last, and you had a Southside breakfast, Paul mentioned that you're working hard on the DUPIXENT loss of exclusivity and looking for ways to extend that. So how are you thinking about extending the life of GP post-2031?

François Roger
CFO, Sanofi

Well, we have a certain number of patents that could help us to extend the protection for DUPIXENT, and we are working on it. I think it's too early. We are eight years ahead of time, so, still early to comment about it. But there is a possibility that the LOE could be enforced at a later stage. There is one other thing that we know as well, is that we don't expect that this LOE is going to be a huge cliff, where the entire business is going to disappear over time. I mean, if you look at other cases like Humira and other cases.

James Quigley
European Pharma Analyst, Goldman Sachs

Yeah.

François Roger
CFO, Sanofi

It is very clear that it's rather a soft landing rather than something which is a very hard landing overnight.

James Quigley
European Pharma Analyst, Goldman Sachs

Yep. Okay. Perfect.

François Roger
CFO, Sanofi

But I mean, we have time to prepare for that because we have 8 years, which is the reason why we are very happy to have this strong pipeline with 12 blockbusters. Even if they don't all make it, it will help us to mitigate all or part of the coming LOE. Plus, I mean, we have a strong balance sheet that will help us to complement it as well. Even if we know that we have 8 years in front of us, we feel a certain sense of urgency because we don't want to delay any action that will help us to mitigate that significant event in 2032.

James Quigley
European Pharma Analyst, Goldman Sachs

Got it. And when you think about your 12 pipeline assets and how that could potentially offset DUPIXENT, now you've got a massive thing in your favor in that you own 100% or more than 50% of the economics for most of those assets that are in development. So when you think about replacing GP, is management's view to replace the top line, or is management's view to replace the profit that you did have with GP, or is it?

François Roger
CFO, Sanofi

I would say both. But obviously, I mean, the bottom line has more value.

James Quigley
European Pharma Analyst, Goldman Sachs

Yeah.

François Roger
CFO, Sanofi

So which is, I would say, to a certain extent, easier to replace. And even if you look at our own pipeline, I mean, with, I think one exception with G, which is itepekimab, where we still have profit sharing.

James Quigley
European Pharma Analyst, Goldman Sachs

Yeah.

François Roger
CFO, Sanofi

The rest of it, we don't have. So, we may have some milestones. We may have some royalties, but it doesn't have the same impact on the bottom line, which means that we are not in an easy position to substitute DUPIXENT, but to a certain extent, I mean.

James Quigley
European Pharma Analyst, Goldman Sachs

Yeah.

François Roger
CFO, Sanofi

It's, I mean, half of the job will be already done.

James Quigley
European Pharma Analyst, Goldman Sachs

Exactly. That makes sense. And then another launch product, ALTUVIIIO, showed strong data, but the market is becoming more and more competitive. We had Novo was sat in the chair. Roche was sat in the chair this morning. So the factor, or the hemophilia market is becoming more and more competitive. But how are you seeing the ALTUVIIIO launch? Where do you think the peak potential could be?

François Roger
CFO, Sanofi

So far, very successful. I mean, we are very happy with the development of ALTUVIIIO, and we are gaining market share, actually, in that space. And we are above our own expectations. So really very happy with what we have seen so far. But we believe that it's only the beginning of the journey, but so far, above expectations.

James Quigley
European Pharma Analyst, Goldman Sachs

Okay. Perfect. So moving on to some of the, the P&L items. So from an R&D expense evolution, standpoint, so you've already flagged a step up in R&D this year, with the several assets entering phase III. But can you talk about the, you know, the pushes and pulls for R&D as we move, you know, beyond 2024? You know, what studies are moving on, beyond phase or, you know, into approval versus entering into phase III? Sort of what's the balance there in terms of, you know, that EUR 7.7 billion, which is where you're heading? Where does that go and what are the key considerations you have around that number?

François Roger
CFO, Sanofi

Well, so we indicated at the end of last year that we have an expectation to increase our R&D spend in 2024 by about EUR 700 million. I can confirm as of today that we are working on it, and we should be close to that level. So it's a significant investment, which personally as a newcomer in the organization, I see that as very positive news. First of all, very positive news because we had positive readouts to start with. And that, frankly speaking, it's much better that we invest in our own pipeline.

James Quigley
European Pharma Analyst, Goldman Sachs

Yep.

François Roger
CFO, Sanofi

Where we have a full control. We have visibility on our POS. We have visibility on what we invest upon rather than, I mean, spending huge amounts of money in M&A. Maybe we'll talk about that later on, or BD, where the probability to destroy value is actually much larger.

James Quigley
European Pharma Analyst, Goldman Sachs

Yep.

François Roger
CFO, Sanofi

So I'm very happy with that. And then after that, we have an expectation to be reasonably flat in 2025. The flat is actually the outcome of some projects that will be completed. Tolebrutinib is one, r ilzabrutinib is another one. So on which, I mean, obviously, we will have less spend on these items in 2025 and probably some new ones with positive phase II readouts. So the pluses and the minuses, we expect to be, roughly speaking, around flat for 2025.

James Quigley
European Pharma Analyst, Goldman Sachs

Okay. Perfect. And, I think historically, the view has been that Sanofi's R&D productivity has been, you know, towards the lower end of the industry. Again, from a CFO's perspective, how can you influence that? How can you sort of help the R&D organization with reallocation and bringing the R&D productivity? Again, it depends on the assets. It depends on picking the right assets, etc. But to what extent can a CFO have influence on that?

François Roger
CFO, Sanofi

Oh, the CFO can obviously have an impact. But I mean, it's a teamwork, first of all. It's not only me. It's, I mean, R&D, the R&D organization and my colleagues, the head of R&D as well as the CEO have a critical, on my commercial colleagues as well because they have a view on the commercial side of things. These are very often, I would say, difficult decisions. But I just want to clarify one thing as well. You know, as a newcomer, I think that there is a perception maybe that Sanofi has not been always delivering, as you say, in terms of R&D. I think this is probably a fair comment on the discovery side because, I mean, facts are speaking by themselves. But frankly speaking, on the development side, I think that we have demonstrated unique capabilities.

We were talking a lot about DUPIXENT. We did participate very actively, obviously, for the development of DUPIXENT five indications already today, more coming in. So I think that, I mean, a large part of the credit goes to Sanofi. Look at what has happened with Beyfortus as well. And I mean, these are two very good examples of our unique capability in terms of development. Likewise, I mean, it's not only about research and development. It's about commercialization and marketing capabilities. I think where we have demonstrated unique capabilities, Beyfortus, take it, as an example again, the fact of reaching a blockbuster status, having positioned that product, which could have been positioned as a niche product. For $2,000 for cost of treatment, rather into all-in-fund strategy, which has really paid off. So I think that I'm actually quite positive on our capacity, but we need to fix the discovery side for sure.

James Quigley
European Pharma Analyst, Goldman Sachs

Yes.

François Roger
CFO, Sanofi

Which is something that we're actively working upon.

James Quigley
European Pharma Analyst, Goldman Sachs

Got it. Perfect. And then one line that I think seems the broad consensus of the broad consensus of everybody is the other operating income and expense and the DUPIXENT's profit share. So you've said that the Regeneron reimbursement of the development cost ends in 2026, which could be a meaningful impact to operating profit. Again, sort of the consensus or heading towards EUR 1 billion in terms of the repayments and the offset of the profit share. So are there any levers you can pull to mitigate that headwind in 2026 or beyond?

François Roger
CFO, Sanofi

Yes. We did not give any dates. Maybe our partner may have given this, but we did not, ourselves. It's going to spread probably over two years, in a couple of years. That's a reality anyway. That's a fact. And we have been transparent anyway. It's part of our disclosure. I'm not worried about it because, as you just said, we have some positive factors that will help to mitigate it. I would mention two. One of them is, this new, manufacturing technology that we call C3 for the active principal of DUPIXENT. We have indicated in the past that it's a major, improvement in terms of yield. That is, in terms of impact on the bottom line, equivalent to a blockbuster in sales, huh? But so which is really material.

It happened that it is gradually phased over a couple of years, and the timing is relatively equivalent to what we see in terms of reduction for us of the reimbursement of R&D costs. This is one factor. In addition to that, I mean, from 2025, we do expect to have additional sales as well coming from new products that we will be able to market that will mitigate part of the impact. So net-net, in our own business case, we don't plan any big drop or any drop at all of our BOI in 2026 or 2027, even if, okay, there is one negative, which is that one, but there are other positives that will be mitigating it.

James Quigley
European Pharma Analyst, Goldman Sachs

Okay. Perfect. And 2025, and you haven't quantified the EPS rebound, but you've said that it should be a it could be a significant rebound. So what are the key sort of factors we should be thinking about when working with models in 2025?

François Roger
CFO, Sanofi

Okay. Just to help everybody, I think that the consensus is for a rebound of about 13%, next year. So I'm very confident with what I've been seeing, after 10 weeks in the job. First of all, you saw it. We had already in Q1 a good level of organic sales growth. We were at 6.7%.

We did say that it will accelerate as we progress into the year and in 2025 as well, above that level as a consequence of the fact that in Q1, we were still suffering from negative comparables last year. I'm talking of COVID-19 vaccine sales. And I'm talking as well of the impact of the AUBAGIO LOE in the U.S. and in Europe in Q1. As the impact of the AUBAGIO loss of exclusivity in the U.S. will disappear from Q2 onwards, and it will disappear from Q4 onwards as far as Europe is concerned. So it's going to help us combined with Beyfortus. Beyfortus, we had a good level of sales for the southern hemisphere in Q1, zero sales in Q2 because there is no seasonality there.

Strong sales, obviously, if we want to reach a blockbuster status, very strong sales in Q3 and to a lesser extent in Q4. You will see an acceleration of sales in the rest of the balance of 2024 and in 2025 as well. Our gross margin was having a negative development in Q1, but it will restore itself as we progress into the year. Do monitor closely our gross margin next year, but I do expect to see some improvement there. As we have indicated, tight control of SG&A costs and around flat in terms of R&D costs. We will get the gross leverage impact, which will help us certainly on BOI to start with and as a consequence of that, to secure that strong rebound of EPS next year.

James Quigley
European Pharma Analyst, Goldman Sachs

Okay. Perfect.

François Roger
CFO, Sanofi

Whenever, by the way, if we can see something that we are always reviewing, if we can accelerate that rebound even earlier in 2024, obviously, as you can guess, we would not hesitate to do it.

James Quigley
European Pharma Analyst, Goldman Sachs

Okay. Perfect. And with the sort of the announcement of increasing R&D, I appreciate back in the last year and you hadn't started in the job yet. There were EUR 2 billion of cost savings that were earmarked. Now that you have been in the job for a couple of months, how do you view that? Is there upside? Is it realistic? Is it challenging in terms of hitting that EUR 2 billion?

François Roger
CFO, Sanofi

No, no. I'm confident about our capacity to deliver it. What I want to make sure is to secure quality delivery. By quality delivery, I mean we need to I need to make sure and we need to make sure that we execute structural savings, that these are not, you know, variable costs, that we don't, I don't know, travel less or cut marketing expenses that we can reinstate the next day. So I'm really insisting on the quality of what we deliver to make sure that this is sustainable, for, for the longer term. It's not going to stop. I'm not maybe we'll do a little bit more than EUR 2 billion. I don't know. But let's make sure that we deliver this EUR 2 billion.

Beyond that, it's not something that is going to stop in 2025. I think that it has to persist to be continued later on. We have already identified a couple of projects that will help us to sustain maybe not the same level because roughly speaking, it's EUR 2 billion over 2 years, which means roughly speaking EUR 1 billion a year. I'm not sure that we will be able to sustain.

James Quigley
European Pharma Analyst, Goldman Sachs

Okay.

François Roger
CFO, Sanofi

In the future the same level. But this is not about discontinuing and stopping the program in 2025.

James Quigley
European Pharma Analyst, Goldman Sachs

Okay. And then I think we've pretty much asked every one from management teams in terms of the Inflation Reduction Act impact on Sanofi. It feels fairly limited, but in terms of moving into COPD for DUPIXENT, is that a risk that you're thinking about in terms of, you know, the pace of rollout for some of your assets? And how has IRA impacted your planning and investment decisions?

François Roger
CFO, Sanofi

So IRA has a limited impact on Sanofi. I think it's well documented. It starts with the fact that, I mean, DUPIXENT, for example, on many of our products are not for elder people.

James Quigley
European Pharma Analyst, Goldman Sachs

Yeah.

François Roger
CFO, Sanofi

Actually, so which means that we have a far lower exposure than many of our peers as a consequence of that. I'm not saying that there is none, but certainly far less than. Some of our peers, with whatever we know from the law because the law could always evolve. But with whatever we know today, we are not necessarily worried about it.

James Quigley
European Pharma Analyst, Goldman Sachs

Perfect. And then.

François Roger
CFO, Sanofi

The other thing is the price point that we have is not either, I mean, the most acute either.

James Quigley
European Pharma Analyst, Goldman Sachs

Yeah.

François Roger
CFO, Sanofi

So we have a strategy of responsible pricing, I think, as well.

James Quigley
European Pharma Analyst, Goldman Sachs

Okay. And then onto capital allocation. So, I mean, Sanofi's got a healthy, healthy, healthy balance sheet. So how are you thinking about M&A optionality? Are there any sort of therapeutic areas? And, and then thinking about size of size of potential deals as well.

François Roger
CFO, Sanofi

We are in a comfortable position of having a strong balance sheet without being desperate to do any M&A moves or BD moves. So, we see that opportunity more as an opportunity to do some tactical moves of our own, which means we have even been a little bit more specific saying that we expect to do deals potentially within the EUR 2 to 5 billion.

We are not, even if we could afford it, we are not chasing large M&A transactions. We don't need it because we have a strong pipeline, but we can go for some tactical acquisitions. We have been even a little bit more specific saying that we are more interested in order to avoid putting additional pressure on our R&D line to focus essentially on early-stage assets with less R&D spend or late-stage assets because very quickly we will come with additional sales to help to finance whatever it will be needed. So we have been very specific. But once again, we can afford making moves if that makes sense, but we don't need to go into desperate moves because we have LOEs that we need to cover.

James Quigley
European Pharma Analyst, Goldman Sachs

Yeah.

François Roger
CFO, Sanofi

Tomorrow or the day after tomorrow. So which is a comfortable position. I will make sure as well as the CFO alongside with my colleagues from the executive team that we remain very disciplined in what we do, even if this is a risky business, but, that we will remain very, very disciplined.

James Quigley
European Pharma Analyst, Goldman Sachs

Okay. Perfect. Sanofi did again, before your time, but Sanofi did approach Horizon, as we've seen in the SEC filings. But what would, and you said you're not chasing big deals, but what would an opportunistic larger deal have to look like for you to become interested?

François Roger
CFO, Sanofi

Well, first of all, this Horizon transaction was two years ago, as well.

James Quigley
European Pharma Analyst, Goldman Sachs

Yeah.

François Roger
CFO, Sanofi

I think that our strategy has changed, as I said. But as I just indicated, we are rather pursuing deals between EUR 2 to 5 billion. But I want to make sure there is no misunderstanding either. We have a duty to look at a certain number of opportunities that arrive on the market. So, I mean, we know what is of interest to us. You don't know what can be available tomorrow either. I think also, we have a duty to look at what could make sense from a strategic point of view given our presence in our therapeutic areas, but without any specific move. And once again, no interest for sizable transactions.

James Quigley
European Pharma Analyst, Goldman Sachs

Okay. Perfect. And then, so, from a high level of returns to shareholders via dividends, buybacks, and where does that fit in terms of your capital allocation hierarchy?

François Roger
CFO, Sanofi

We have a clear policy there, which is first, we prefer to invest in our business, which is what we do.

James Quigley
European Pharma Analyst, Goldman Sachs

Yeah.

François Roger
CFO, Sanofi

We just talked about investment in R&D, but I mean, it's investment on the commercial side of things as well. Frankly speaking, I don't mind investing in sales and marketing, provided that it has a good return and it's a relatively short-term return if we see that there is a compelling case to do so. Industrial side as well. I mean, in terms of CapEx, we have restructured quite a lot our industrial base, but we do invest and it does make sense as well. So first of all, invest in our business. Secure, we have a well-established dividend practice and policy of increasing our dividend year after year.

We need to continue in that direction. M&A BD, we just discussed about it. So rather small to medium-sized deals, but not large deals. And then share as an opportunity, I would say, not necessarily as a last recourse, but we don't want to be sitting on piles of cash either. So we have been very explicit about it, in the context of the separation of the CHC business. If in two of the three options that we are contemplating, we do get some cash inflow, we will return some of the cash to our shareholders. Most probably in terms of share buyback, it's not my decision. It's a decision from the board of directors, but most probably in terms of share buyback because it will allow at the same time to mitigate the impact of the EPS dilution of the separation of that business.

James Quigley
European Pharma Analyst, Goldman Sachs

Okay. Perfect. And we've got a lot about two minutes left. So two sort of final questions. So you've come at the story with fresh eyes. So what do you see as the key parts of the Sanofi equity story that are misunderstood or underappreciated by the market?

François Roger
CFO, Sanofi

Well, difficult to say after two months, but I think that we need to make sure, in my opinion, that we under-promise and over-deliver. I think that's very important. We need to make sure that the market understands as well that it is correct that we have certainly under-delivered on our side, but on the development side and on the commercialization side. I think that there is certainly an effort to be done on our side to make sure that the market understands that we have genuine capabilities there. We are fully aware of the fact that as far as our pipeline is concerned, there is a little bit of a wait-and-see attitude. I think that it's clearly very clear that we have clear milestones, I mean, meeting points with our investor community in 2024 for the balance of the year, in 2025 and 2026.

James Quigley
European Pharma Analyst, Goldman Sachs

Okay. And, just to round off, so what are the key events, catalysts, or news flow items that investors should be focused on over the next sort of 6-12 months?

François Roger
CFO, Sanofi

Rollout of tolebrutinib, which is coming in August, September. Delivery on our financial results in Q2 to start with for 2024. Then after that, we can, I mean, review what we expect to reach in 2025. And let's look very carefully as well at the way that we do that separation of CHC to maximize shareholder value. We will come back to the market in the course of the summer. Probably not. I'm not sure that we will be in a position to do it before or at the occasion of our H1 results, but if we can, we will. If it is not at that date, it will be a little bit later. I think that these are the important delivery points.

James Quigley
European Pharma Analyst, Goldman Sachs

Excellent. François, thank you for joining us.

François Roger
CFO, Sanofi

Thank you, James.

James Quigley
European Pharma Analyst, Goldman Sachs

I hope you enjoy the rest of the conference. Thank you, everyone, for, for your interest and for joining.

François Roger
CFO, Sanofi

Thank you.

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