Sanofi (EPA:SAN)
France flag France · Delayed Price · Currency is EUR
80.08
-1.68 (-2.05%)
Apr 24, 2026, 5:38 PM CET
← View all transcripts

Goldman Sachs 44th Annual Global Healthcare Conference

Jun 14, 2023

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

I know there's opportunities. I've known Salveen Richter for, like, 20 years.

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

Yeah.

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

Yeah, so it's been great.

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

Great.

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

Let's carry on, shall we? Welcome to our continued morning here at the 3rd day of the Goldman Sachs Healthcare Conference. My name is Chris Shibutani, member of the research team on the global front, along with many strong associates across the board who are being very supportive and very helpful. We are super pleased to be able to have Sanofi join us here. A very important discovery. Perhaps you can say your last name because I think even folks in your C-suite are doing variations on it, so here's your chance, man.

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

See, that's disappointing to hear folks in the C-suite saying that, but I don't know. It's Bill Sibold.

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

Okay, Bill, tell us a little bit about your professional journey. I always like to make this a conversation between us in this moment of time. Probably a lot of grumpy people out there are gonna say, "You didn't cover this," or, "You didn't cover that," but we have, like, 34 minutes remaining. I'm talking to you. Tell me about your professional journey. It helps us understand kind of the head, the voice, the decision-making, where this is coming from.

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

Yeah. Great. I've been in the industry over 30 years now. Have worked in small and large companies. It's mostly been in the specialty space, and also have worked outside of pure pharma and the clinical trial world. Mostly, as I said, commercial, but a pretty good view across the whole value chain. Worked in the U.S., Australia, from Canada originally, and have had careers with Amgen, Biogen, Lilly, and now Sanofi. Been with Sanofi now for almost 12 years and have seen a real remarkable transformation of the company in that time, and I really believe that we've moved to a position of being able to win, and that has really accelerated over the last four years with Paul.

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

Yeah, no, I think You use some of the key buzzwords and the vocabulary around this, Play to Win. Just the evolution of companies. All these global pharmaceutical organizations have gone through various phases as a function of what's happening with the portfolio, with what's happening externally as well, to put emphasis and to reshape. I know that your focus is on specialty care and, you know, the tremendous IR team at Sanofi had made sure to make sure that our discussion is very relevant to your topic, I'll talk to you a little bit in terms of just, like, the general shape. Help us understand what you think the key rationale is for the reshaping here.

Cause there's a couple moving parts with Sanofi, you know, overall, consumer side, but just the shaping and why you think you have the best job in the house.

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

Well, look, I think when Paul got here and we did our Play to Win strategy in 2019.

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

Mm.

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

It was very much focused on specialty and on vaccines.

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

Right.

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

I think that is taking advantage of just kinda some of the industry dynamics. We see with the science moving forward, you can go after some of these very complicated diseases like you haven't been able to in the past. Our research and development efforts really ended up focusing in that space. We went with more of a first-in-class, best-in-class approach.

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

Mm-hmm.

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

We weren't looking for any me-too lates any longer. It required us to improve our scientific capabilities. I think we brought the right teams in. I'll say specifically in immunology.

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

Mm-hmm.

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

I think we have a great team, and I think that the fruits of that is really showing right now. When you look at where we are in specialty, for instance, and I do think I have a great job, and I think it is the best job that's in the company. You know, we cover really five therapeutic areas: immunology, oncology, rare blood, and neurology.

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

Mm-hmm.

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

If you go back all the way to the acquisition of Genzyme in 2011 by Sanofi.

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

Mm-hmm.

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

-you know, that was purchasing kind of that rare disease business and capability, which really became our Specialty Care, foundation, if you will.

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

Right.

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

We added multiple sclerosis to that and then oncology, immunology, and then built into rare blood disorders. It's been quite a journey, and I think that we're focused in the places that are the high-growth spots in the industry, and I think we begin to differentiate ourselves there as well.

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

The golden goose, Dupixent. What a ride! What a drug. What opportunities continue to unfold here? Right now, what we have is we have some tremendous numbers here, EUR 13 billion, peak sales currently. Everyone is like, "Come on, man, we know that we have further to go." We have some COPD data. We'll talk a little bit about sort of, like, the journey of, like, finding out when we have the conviction to sort of tack that on to the numbers. This does not include the opportunity for COPD now that we've had one trial readout. Is that correct?

Help us think about, because I know that Tarek will get really angry with you and some other folks if you put a number on this, but how do we think about, sort of the peak sales upside scope that could come from that, COPD?

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

Well, you're right. It has been a wonderful journey with Dupixent. We've had our partner, Regeneron, that we've been working on this for so many years. We did say the most recent waypoint that we gave was EUR 13 billion. We also said that we were expecting EUR 10 billion this year from Dupixent.

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

Mm-hmm.

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

At the same time, we talked about the 13, we said that we'd expect EUR 22 billion for immunology overall by the end of the decade.

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

Mm-hmm.

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

Clearly, if you just at the most recent ATS meeting, et cetera, we've had a lot of readouts, including COPD, and at, you know, this point, we would expect probably later in the year, with the interest to come back and have a discussion to contextualize the opportunity for us in immunology and Dupixent a little better.

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

Okay.

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

you know, I'm not giving you a number. You're absolutely right.

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

Mm-hmm.

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

It didn't include COPD. I think when you look at COPD, the dynamics are really favorable. You know, across the G10, there's about two million COPD patients. It's the third leading killer in the world-... There has been no innovation for 10 years.

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

Mm-hmm.

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

We now have Dupixent, which, for if you look at that G7, it's about 550,000 patients, and in the U.S. alone, 300,000 patients. These patients have really nowhere else to go at the moment. They are literally at a dead end, and when we have the efficacy that we've shown, that is a real opportunity. We're excited about that, but also right behind it, we have itepekimab.

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

Mm-hmm.

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

Between itepekimab and Dupixent, we get to about 80% of the opportunity in COPD. Two very different mechanisms. Two products are gonna be in almost entirely different segments, so that's a real exciting opportunity for us. You know, now that we have data, we're in a little bit better position to begin to dimensionalize what that opportunity is.

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

Let's go through a couple of points there. Phil, on my part, I kind of gave you an off-ramp, although you were very kind, you sort of unlocked the key. To help think about the COPD opportunity here, but let's talk concrete, as we do on the street, about some sort of timelines. COPD, U.S., and European regulatory submissions in 2024, that's the current plan, correct?

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

Yes, we are looking forward to our discussions with the regulators about the single study that we have, with Dupixent.

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

Okay. Therefore, is there potential to move that forward?

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

Well, I mean, we'll have to see. It depends on those discussions. We're have the second study, the confirmatory study, the NOTUS study next year.

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

Right. Mm-hmm.

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

Typically you would need the two. We'll start the discussions with the regulators now.

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

Remind us how the readout that we've already had from BOREAS informs the probability of success on NOTUS?

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

Look, I think, our expectations are that it would be positive. I mean, we don't see The studies are very similar, so there shouldn't be any differences.

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

Okay. Then you also brought up, the breadth of the pipeline, the IL33, itepekimab.

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

Yes, very good.

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

You talked about, the word you used was different segments of the market.

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

Yeah.

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

Say more, help us understand.

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

It's actually really quite unique. Let me start with Dupixent. We look at that in Type 2 diseases. That's the one thing, you know, I was talking with somebody earlier today, and they, you know, what makes Dupixent successful? It's because the biology is so pure. It is so targeted. The IL4, IL13 focus really allows us to tackle all these Type 2 diseases. When we look at Dupixent, when we look at COPD, there is a segment of patients in that 30%, 20%-30% range that are Type 2.

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

Mm-hmm.

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

That is both, in smokers and former smokers. That's where we see this opportunity, and that's where I gave the number of 550,000 on the G7, 300,000 in the U.S. When you expand out, though, and you look at that non-Type 2 population as well, that's the remainder of the, of it. For IL33, we did the study. The study is being done in former smokers.

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

Mm-hmm.

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

Either Type 2 or non-Type 2. That opens up, you know, quite a large segment and expands us to about 80% overall of the COPD opportunity between the two assets. We think that they are, you know, highly differentiated. There is some overlap. Between the two of them, we cover the overwhelming majority of the COPD opportunity.

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

Okay. With the golden goose Dupixent, maybe you can comment about demand trends, update us on the latest, for the various indications, AD, asthma, and chronic rhinosinusitis with nasal polyposis. By the way, what do you call that in-house? You can't possibly say that.

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

No, we usually say, nasal polyps.

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

Okay, cool. Demand trends in each of those different end market segments?

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

Yeah. I mean, look, I think we're, top line, we're winning in each of the segments. Clearly, in AD, any of the competitors that have come in to date have, not really been able to establish much of a foothold for the simple reason that the biology isn't as clean as ours is. We really do, are seeing that the efficacy and safety is driven by the targeting that we have.

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

Mm-hmm.

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

Now, as you know, in AD, we're down to six-month-year-olds.

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

Mm-hmm.

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

Which is just six-month-olds, I should say, not six-month-year-olds.

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

Mm-hmm.

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

Six-month-olds, that says a lot about safety. There's no other biologic that is approved down to that area.

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

Mm-hmm.

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

Where we are, though, with the growth there is we're still only at about 10% penetration, biopenetration overall in that segment. There's a long way to go to grow that market. If you look at where we were at a comparative time versus psoriasis...

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

Mm-hmm.

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

There's greater biopenetration in atopic dermatitis than there was in psoriasis at this point.

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

Okay.

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

Our hope is that we exceed the biopenetration of the, you know, low 20s to mid-20s of psoriasis and move it up closer to 30%+. It's a more challenging disease, more uncomfortable disease, that we think the unmet need will end up leading to greater biopenetration. Because the profile of a product like Dupixent is so good, that it should really answer any of the concerns of the dermatology community. Looking at asthma, as we reported on Q1, you know, we are the leaders in respiratory, including asthma.

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

Mm-hmm.

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

Again, I think it's based on the profile of the product. Type 2 asthma, which is about 80%, is where we focus, and so we're seeing great results there. In the nasal polyp space, boy, we are number one in there as well, I think by a long shot. In all these areas, I think it's really just showing just what a great profile drug can do.

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

Yeah. No, appreciate the quantification.

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

Yeah.

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

That's confidence and leadership, so I'm a fan. Dupixent has, as it continues to grow and it's had a tremendous margin contribution. What's the incremental margin contribution like from this point on forward?

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

Well, I mean, look, we've, one of the things that we've been working on is, the manufacturing of the product-.

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

Okay.

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

next generation of, process improvements. That's something which you've heard us talk about, where we see that, in, by 2025, when we see the full effect of it, you can have, overall about a EUR 600 million, gross margin in improvement, about EUR 300 million to each, of, ourselves and our partners. You know, you back that all the way, it's like an incremental EUR 1 billion in top line. We're looking at ways to make it a more profitable, better product. When you think about how we are evolving from an indication perspective, you know, we have done a lot of the build already, and the new indications that are coming in fit-

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

Right.

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

-in with the existing infrastructure that we have. We're gonna continue to make adjustments to that. You know, we'll build more for COPD, et cetera, but for the most part, the big infrastructure piece is already in place. In time, you know, you're driving top line, your cost of goods looks good, and your investment is, for the most part, the bulk of it's there, it's complete, you know, it begins to look better and better over time.

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

Got it. In immunology-

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

Yeah.

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

beyond Dupixent, what else are you excited about? We talked a little about the IL33. I'll make sure that we don't end this segment of the discussion without talking about the oral TNF, which is something that got a little buzzy during the earnings call there. Without leading you too much, even though I just led you, what are you excited about in immunology ex Dupixent?

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

amlitelimab-

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

Okay.

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

is really exciting. That's our OX40-L igand.

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

Yep.

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

We are gonna have this year phase IIb AD data. Next year, we will have the asthma data. This looks like it is a product that could have very strong efficacy and, you know, very convenient dosing as well, up to 12 weeks and up to a 12-week interval, which is a profile that would be very convenient for patients. We're really very excited about that asset and think that, you know, I think when you think about immunology assets, you've got to think about multiple indication selection or development.

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

Sure.

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

I, you know, I think that you, it's become harder and harder to do things just in series. If you look at Dupixent, we did a lot of things in parallel.

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

Mm-hmm.

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

We got out of the gates early with AD and asthma.

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

Mm-hmm.

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

We rapidly followed it with multiple indications, and I think that's the way you have to think about immunology development.

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

Mm-hmm.

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

As we have a product like amlitelimab, we'll look to see where does the biology take us, and those are the indications that we'll go after. Right now, we see atopic dermatitis, and we'll wait for those results, and then asthma, but then, assuming that works, you would expect that we would look at other indications as well. Amlitelimab, we've designated a priority asset.

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

Okay.

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

Which, Dupixent is one of the priority assets as well, obviously. It's getting, you know, a lot of attention by us internally. Just one of the, you know, ATS that we were just at, American Thoracic Society.

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

Yep.

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

-is in D.C., a couple of weeks ago now, or a few weeks ago now. We reported out on our IL13 TSLP nanobody bispecific with some asthma data, and, you know, early reads of that looks like it could be a best in best-in-class, best-in-disease, actually. That's another one that we're excited about, and as we move along a little further, we'll see what the data says and come back with a full development plan. You mentioned the oral TNF.

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

Mm-hmm.

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

You know, that's something which has been kind of a holy grail for people for so many years. Ever since I've been in the industry, but soon after, when the TNFs came out, people would say, "You know, great product, but I wish it was a pill." There's been a lot of efforts along the years, and people have failed with that. You know, we think we have something here that looks like, you know, a very compelling product for us. You know, the question is how are you gonna position that?

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

Mm-hmm.

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

It's gonna be based upon the data that we ultimately generate. One could look at it, if the efficacy is there, if efficacy is very strong, it could be a substitute for a biologic, or it could be a step through to a biologic and think of it as a safe oral that people would step through prior to a biologic. We'll look with our development plan to be able to answer the question of exactly what the positioning is, but certainly, the economics of it are very attractive when you think about the size of the TNF market today, and you think of the indications where TNFs work and what that is, what that potentially means.

You know, more to come, and we'll be talking a little bit more about that asset a little bit later this year at one of at a major meeting.

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

Yeah, I know. It's interesting because obviously TNFs were foundational historically. It's, you know, the OG in terms of just thinking about major mechanisms and drugs that really able to get momentum and become critical mass leaders here. Oral, what's been sort of like technologically the holdback here? You know, are we coming up with an oral version that is later to the party, and the party is more crowded? Because actually, this trend of coming up with oral agents in the immune space to kind of hit that very large middle section of the moderately affected patients, and as you say, kind of a transition to the more biologics and the severes there. Talk a little bit about sort of what the technological challenge is to help us think about probability of success. You know, sort of how do you feel?

TNF, you know, very familiar, new, cool stuff. Should we still think that familiar is good?

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

Yeah. Lots of questions there.

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

Yeah, sorry.

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

No, no. No, that's great, and I think that, I think everyone knows the journey for search of small molecules is always challenging. You always have to worry about off-target effects, et cetera. You know, it, as appealing as it is, it also has its set of challenges. You know, that's why as well, we have, rilzabrutinib, which again, an oral that we think, would fit that setting of a safe, oral. We have the IRAK4 degrader-

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

Yes.

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

that we're working on. You know, we're really excited about that. We see that the early data that we've seen gives us, you know, real confidence to move forward into a broader development program. I think one of the not prerequisites, but certainly one of the things that you want to do when you're looking at a small molecule strategy is, you know, you don't always just have a single shot on goal. I think you pick the pathways that you think are going to be the highest likelihood of success and try to move in parallel with a number of them, and that's certainly what we've been doing.

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

Yeah, no, I appreciate you bringing up the IRAK4. I have an embedded interest in the broad scope of, you know, the coverage there. That's a Kymera asset here. KT-474, last December, the announcement of the decision to move into a phase II program, two opportunities. I think HS, hidradenitis suppurativa-

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

Yeah.

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

-was, sort of like listed ahead of AD. Can you help us understand any underpinning behind that? Maybe help us with some of the timing of where you think, the phase IIs could kick off for both of those respectively?

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

I think that, as I said earlier, with immunology products, you're gonna have more than one indication.

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

Yep.

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

We like both the indications, obviously, and working closely with the team. It's been a great team to work with at Kymera. We're looking at as early as next year as we'll be in the clinic.

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

For both of the-.

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

Yeah

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

... indications.

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

Early

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

2024.

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

Yeah.

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

Okay, great. The commitment is there?

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

Commitment's there. Yeah. I mean, look, we'll do everything we can to accelerate as well. The date I could be, you know, plus/minus. The teams are working really well together. We're really excited about it. We think it's an exciting asset. I think that this whole degrader.

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

Mm-hmm

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

... approach is one that, certainly not everyone's looking at. It's something that, as I said, our teams are excited about.

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

Right, oral delivery as well. Immunology, very much center of gravity, but tangentially from a mechanism standpoint, neurology, MS. Let's talk about some of those opportunities there. There's an oral BTK, brain penetrant, tolebrutinib.

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

Mm-hmm.

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

Once a day. Recruitment is ongoing here. I think we have an update. Most recently, three out of the four studies are fully recruited. GEMINI, there's so many different subsegments of the MS population. Just remind us where the landscape is, and you as the boss, how pleased you are with how progress is with the program?

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

Yeah, look, MS is really near and dear to me. I've been in that space for 25 years-

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

Mm.

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

Have been involved in the development and launch of a lot of the products that are on the market today. We've had an interest, strong interest in MS. We were very selective in what would be the next segment to go for.

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

Mm

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

... in MS. We had had AUBAGIO and LEMTRADA. What was gonna be next? We didn't do a CD20. We saw that BTKI was going to be something of interest, not just BTKI, but brain-penetrant BTKI.

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

Mm-hmm.

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

We were very specific when we went out and got one, actually two. We wanted one that was brain penetrant. Principia was the result of that. The reason being is we think you have to get into the brain to have an effect on the fundamental biology of progression. That's what we've shown with tolebrutinib in studies, that it does get to a therapeutic level in the brain. Of course, we have to wait for the trials to see if that is actually proven out. In our phase II trial, we were very satisfied with the efficacy. It was essentially from an imaging perspective, like a CD20.

It also, if you go back to our phase II, we still have about 85% of patients that are on the trial, which says all that's tolerability and actually the satisfaction, people have with it. The 4 trials, and this is the largest MS development program that's actually ever been done.

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

Hmm

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

with tolebrutinib. We have two trials in relapsing-remitting. that's the GEMINI trial. We have the HERCULES trial, which is a non-relapsing secondary progressive disease.

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

Right.

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

We have finally PERSEUS, which is the primary progressive disease. Three of the four, the only one that isn't fully enrolled is PERSEUS, which is the primary progressive.

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

Okay.

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

We're working towards that. We see that, you know, the real winner is progressive disease, and if you can have an effect on that.

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

Sure

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

... because the unmet need is still just so high, despite the multiple therapies that exist today in multiple sclerosis.

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

That is the segment positioning really there?

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

Yeah.

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

You actually have kind of this cluster.

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

Yeah.

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

There's a bit of a scrum here with multiple BTKs, everolimus, fenebrutinib, remibrutinib-

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

Yeah

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

... et cetera, tolebrutinib. It seems as if it would be helpful to understand where the relative positioning. Is it a bit of a bake off or?

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

Well, I mean, none of them. As I said, ours is the most comprehensive.

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

Yeah

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

That's ever been launched in MS. Ours is the only one that is brain penetrant to a meaningful level.

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

Mm-hmm.

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

We believe that's really important. We also, not all of them are studying in progressive.

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

Right.

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

You know, we're the most complete plan. I think we have the best profile. Of course, you know, it'd be remiss not to discuss the fact that, you know, we have managed through, or we are managing through, some of the liver challenges that we saw.

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

Right.

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

FDA has us, we're on a partial clinical hold. We've been working with the FDA on that. It only relates to the one study now, which is PERSEUS, which is the only one that's still ongoing. We're looking at ways to mitigate the risk, look for any kind of markers of who may be at greater risk for liver injury, et cetera. We think that we have the profile and the development plan, that if there's going to be success with BTKIs, is we think it's gonna be tolerable.

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

What's a prudent investor is thinking about the timeline for being able to reinitiate U.S. enrollment in PERSEUS?

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

You know, we're enrolling around the world.

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

Yes.

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

So in some ways-

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

Okay.

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

it's really, it's a nice to have, but not a need to have to finish off that development program. As I said, we'll continue our discussions with the FDA.

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

Okay, fair enough. GEMINI, we're gonna get readouts on GEMINI 1 and 2, I believe, second half of the year here. The outcome measure here is-

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

No, we're saying 2024 now.

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

Oh, 2024?

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

Yeah.

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

Okay.

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

First half of 2024, I believe.

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

Appreciate the clarification. Outcome measure is number of relapses on an annual basis, and it's being measured against, AUBAGIO.

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

Mm-hmm.

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

What's a good result look like?

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

Well, I mean, look, I think that it's got to be superior. All right. I mean, we're gonna look across. Actually, it's actually interesting. You can't cross trial compare, we're gonna look across to see what are the best, what's best in class, from an imaging perspective and from a relapse perspective.

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

Mm-hmm.

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

It's not a single, it's not a single point measure. We'll be looking across all the metrics in MS. I think what's gonna be most important. Well, I think GEMINI is very important because it will confirm what we saw in the phase II. As we move to HERCULES in the non-relapsing secondary progressive, I think that's the real inflection of what do we expect from an effect on progression, which is, as I said, more the Holy Grail.

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

Okay, fair enough. Let's stick to MS.

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

Okay.

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

Talk about another pipeline asset, frexalimab, anti-CD40-L igand here. We had some phase two data recently, I believe, and plans are to move into phase three. Timeline is next year.

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

Yes.

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

Is that correct?

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

Yes.

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

Talk about the phase two data here, your confidence level, and as we head into this important transition to phase three.

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

You know, listen, it is frexalimab, really. I thought the data looked great. I mean, having looked at a lot of MS trials over the years, I think when you look at the imaging data, the Gad-enhancing lesions, you know, you're talking about very robust effects that are, you know, at or above where you have CD20s right now. We set a really high bar for this program because what the world doesn't need is another me-too MS product.

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

Mm-hmm.

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

Right? We saw enough that we think that there is a real path forward there for it. The MS community that we've spoken with has actually been quite receptive. We were at the CMSC meeting a couple weeks ago where we presented the data, and there was a lot of positive enthusiasm. You know, one of the things that you have to think about for the timing of when that would launch, you know, CD20s are becoming kind of the leading class within MS, and it's actually, I have to say, I'm happy to see that it's moved to a high efficacy. It's taken years, actually, to get the MS community to be focused on high-efficacy products. You know, there's gonna be a question, though, about depleting B cells...

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

Mm-hmm.

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

chronically, and if there's an opportunity with other mechanisms that provide high efficacy to be options for people to switch to or to continue to grow the market in high efficacy, that's why we like the asset. We also have the RIPK1 inhibitor in MS as well.

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

Mm-hmm.

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

We have three programs that are headed towards MS, and I don't think people all the time realize the commitment that we've made to the space. You know, people think about, "Well, you're just coming off of AUBAGIO.

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

Mm-hmm.

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

you know, what's next?" Well, we do have what's next, and I think it's three quite exciting programs.

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

Say a little bit more about sort of like the importance of this non-lymphocyte depleting aspect of the mechanism of action.

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

Yeah, I mean, look, that's very important. You know, we are trying to be exceptionally targeted, and it's this with CD40-Ligand, we, it is a blocker of this co-stimulatory mechanism that affect, that, pardon me, that affects the, we think, the fundamental cause of MS. It'll allow us to get both inside the brain and outside the brain, in the periphery and in central. We think that you need to have the profile that is going to be as least disruptive as possible to the bad players, if you will, in the disease.

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

Okay. Let's move on and talk about hemophilia, which I believe is also part of your remit.

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

It is. Correct.

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

ALTUVIIIO, fitusiran. Very opportunely situated. There are some competitive advantages to ALTUVIIIO. Talk about the hemophilia landscape and where you see this fitting in?

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

Yeah, I mean, listen, we are in a great spot in hemophilia A and B. We obviously have a legacy of a product in A, Eloctate, which has been really kind of a leader in the space. When you bring in HEMLIBRA. Pardon me. HEMLIBRA, when HEMLIBRA came into the market, it was a big shock to, I think, all of hemophilia A. People weren't expecting, I don't think, as rapid an uptake as it had. It, you know, I, you know, lots of credit, there's a real niche of convenience being so important. The subcutaneous injection was very important to the market, especially with kids. It was quite traumatic for parents to have to hold a kid down and to do an IV of them, of a factor.

We now have, with our portfolio, ALTUVIIO, which has been approved. The thing about ALTUVIIO, you know, people talk about it being a weekly infusion. That's great, but what really matters is the new level of efficacy that it can provide. With hemophilia, you measure factor levels, and, you know, normal would be in that close to 50%. With ALTUVIIO, you get into, you know, over 40%, 45%, so you're in this normal to near normal range for the majority of the week. Other factors, by the end of the week, are dipping down into low single digits and maybe flash up to a, you know, greater than 30 briefly, and then back down. For a patient, what does that mean?

That means in a once a week infusion, you have the majority of the week covered at a new level of factor protection that has never been available before.

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

Mm-hmm.

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

The possibilities of what you can do from an activity level perspective, that begins to change. That isn't just for factor patients, that's for any hemophilia A patient that is interested in having a better, factor level throughout the week, closer to normal.

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

Mm-hmm.

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

Fitusiran is really very interesting in that that is something where, with as little as six injections per year.

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

Right.

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

Every two months, you could have coverage across hemophilia A, B, with inhibitors, without inhibitors.

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

Yeah.

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

the population. That between those two, if you're looking at the high efficacy or you're looking at efficacy with very infrequent dosing, gives hemophilia patients a lot of options within our portfolio.

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

I think we're gonna get for fitusiran some pivotal readouts the second half of this year.

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

That is correct.

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

Speak to your confidence there and, you know, help us think about appropriately sizing the potential opportunity commercially.

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

Yeah, look, I think we also had Lancet publications fairly recently. That was on the 80mg fitusiran. We subsequently have a alternate dosing regimen. That's what we'll be reading out a little bit later this year. You think about the market, and it's about a $10 billion, we're anticipating $10 billion hemophilia A non-inhibitor marketplace as you project throughout the rest of the decade. When you've got two products that are so well positioned, one for, I'd like to say, really super high efficacy, and then another one that is kind of a completely new approach, looking at antithrombin and certainly a very convenient profile. I think all of a sudden, when we look across the global opportunity, we're in a real position to lead.

We look at this as a, you know, EUR multi-billion franchise for us.

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

Great. As we close, special kudos to the investor relations team that works hard to create these special events. I think the immunology group had an event in Kendall about a year plus ago.

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

That's right.

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

That was tremendously informative here, and folks like Eva and Felix have been working very hard. Let you do a little bit of a commercial for the next upcoming event at the end of this month.

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

Yes.

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

Focus on vaccines.

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

Yes, June twenty-ninth.

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

What's the, what's the teaser there? What are we gonna learn?

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

Look, I think that we have a lot going on, obviously, with vaccines. We have the nirsevimab or Beyfortus for RSV. We had our advisory committee meeting last week, with, you know, very, very positive feedback. I think that is something which is, we anticipate for this RSV season will be available. You're gonna hear about that, and you're gonna hear about just the other innovation that's taking place in the vaccine space, and I think it'll be a great place to come and hear from Thomas Triomphe and his team.

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

Okay.

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

They've done a great job.

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

Yeah. Terrific. Vaccines, 10 years ago, we would have said, "Ugh, kind of the burdens of this business." So much happening there, real barriers to entry with those opportunities. Look forward to that meeting for sure.

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

That's right, We'll have an R&D day as well, a little bit later this year that we'll announce.

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

Excellent. Bill, thank you very much for coming to join us.

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

Thank you.

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

Appreciate the conversation and thoughtful responses.

Bill Sibold
EVP and Global Head of Specialty Care, Sanofi

Real pleasure. Thank you very much.

Chris Shibutani
Senior Biotechnology Analyst, Goldman Sachs

Thank you, everyone.

Powered by