Earnings Labs

Sanofi (SNY)

Q2 2020 Earnings Call· Wed, Jul 29, 2020

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Transcript

Operator

Operator

Ladies and gentlemen, thank you for standing by. Welcome to Sanofi’s investor call on the Q2 2020 earnings. I would now like to turn the call over to Eva Schaefer-Jansen from Sanofi Investor Relations. Please go ahead, madam.

Eva Schaefer-Jansen

Management

Thank you. Good morning and good afternoon and good evening to those joining us from Asia to review Sanofi’s second quarter results. As usual, you can find the slides to this call on the Investors page of our website at sanofi.com. Next slide, please. I would like to remind you that information presented in this call contain forward-looking statements that involve known and unknown risks, uncertainties and other factors that may cause actual results to differ materially. I refer you to our Form 20-F document on file with the SEC and also our Document d’Enregistrement Universel for a description of these risk factors. If we could please move to Slide 3. Our speakers on the call today are Paul Hudson, Chief Executive Officer; and Jean-Baptiste de Chatillon, Executive Vice President and Chief Financial Officer. Paul will review the first quarter business performance after which Jean-Baptiste will review the financials. After concluding remarks, we will close with a Q&A session, during which we will be joined by the members of the Executive Committee. With that, I would like to turn the call over to Paul.

Paul Hudson

Management

Well, good morning, good afternoon to everybody. Thank you to Eva, very happy to have you on the team and leading IR. So welcome formally to Sanofi. Let me start by saying that I’m delighted with our performance in Q2. Our organization has worked incredibly hard to keep the business running in what are challenging times for everybody and ensuring that the supply of medicines to patients continues. I’m especially proud of our organization focusing and keeping up our momentum on the transformation journey that we’re undergoing here at Sanofi. Looking at our financial performance. I’ve seen some of the notes this morning. I understand people’s balanced view and recognition of the Regeneron one-off. And whilst it is technically important, we can talk about it a little bit later. I do think it’s important for everybody to realize that there’s been an incredible amount of work gone into making sure that our transformation continued in one of the most challenging times for any company. So I am proud, but I’m also very pleased with how we’re executing and what that’s going to mean to the future of this company. So due to the COVID-related trading patterns this year, the performance of Sanofi during 2Q needs to be seen in light of the half year. So I’m presenting here the first half figures that, in our view, are the best way of describing our performance to date. Our first half sales increased by 2% driven by Dupixent. We’ve delivered truly outstanding results growing at double-digit rate over prior quarter, we’ll go into more detail later, which is absolutely remarkable and perhaps unparalleled in the context of the pandemic. Our entire specialty business has been very resilient and continues to grow. Clearly, we did experience significant headwinds from COVID seen elsewhere with…

Jean-Baptiste de Chatillon

Management

Thank you, Paul. Good morning, good afternoon. On Slide 18, while sales were down 3.4% in the second quarter, in line with our guidance for a low single-digit decline. On the other hand, BOI grew by 5.3%, and our BOI margin increased by 200 basis points. Looking through the lines of the P&L, you will identify that while the gross profit was down, the increase in BOI was driven by lower OpEx as well as lower other current operating income and expenses. Let me explain this effect during the following slide. On Slide 19, looking first at our gross margin, we saw a 160 basis point reduction in the second quarter to 70.4%. And for our first half of the year, our gross margin was 71.3%. So let me go into some details on the evolution of our gross margin in Q2. Benefits from Specialty Care growth and productivity gains of around EUR 30 million in the quarter were more than offset by the impact of price reductions in China on Plavix and Aprovel as a result of VBP and also by geographic mix considerations, including the expected U.S. diabetes pricing pressure and lower vaccine sales in the U.S. When we look forward, the VBP impact will start to annualize in the fourth quarter as the implementation of this program began in December 2019. Meanwhile, the tailwinds from Specialty Care growth and efficiency gains should continue. However, keep in mind that our gross margin is typically lower in the second half than in the first half due to product mix with a higher proportion of vaccine sales with the flu season. And this will be even more so this year with what we expect to be a record flu season. So, when we look on Slide 20 at our OpEx,…

Paul Hudson

Management

Thank you, Jean-Baptiste. Walking the talk as normal. Thank you for a very clear explanation of why we’re on track and why we’re likely to exceed our initial guidance to deliver – and also deliver our mid- to long-term financial ambition. I think it’s worth just remembering, again, a lot of companies have tried to work through the crisis. I think what’s unique about this company at least, at least it feels for me, is that we launched an ambitious plan to transform the company last December. And we’ve continued that transformation. I hope those that have been following us closely, certainly to R&D, operational excellence and shaping of our team to go forth and deliver on this, I think you can start to see it happen. So, it would have been perhaps easy for the organization to sit back and just trying to keep going. This is not what’s happened here. It gives me even more confidence in how we’re emerging from the transformation with a common and single-minded purpose, and we really will deliver on it. I think it’s been a difficult time, but I think it’s been very inspiring for me and for everybody that’s been part of it. So, I think there’s one or two things that are worth mentioning. Not only are we transforming, not only were we delivering in line and with a better full-year outlook, we’ve also been working right at the front line on vaccines in particular. And you may have seen in the news this morning, we announced the deal with the UK government for 60 million doses in partnership with GSK. We’re in very late-stage conversations with the European Union and, of course, with the U.S. And we would hope those things go according to plan, there’ll be announcements not…

Eva Schaefer-Jansen

Management

Correct. So, we will now open up the call to your questions. So, get ready. As a reminder, we would like to ask you to limit your questions to two each.

Operator

Operator

[Operator Instructions] The first question comes from the line of Richard Vosser with JPMorgan. Please go ahead.

Richard Vosser

Analyst

Hi, thanks for taking my questions. First question on consumer. And I wonder whether you could give us an update on the OTC switches. And with the change of leader for that business, does that signal a change of emphasis for the business and the carve-out compared to the Capital Markets Day? And then second question. Just thinking about the savings that have been made both from COVID and underlying, that’s obviously very impressive. So just of the savings of COVID, how many of those or how much of those do you think will be sustainable going forward? What learnings can you get to drive more savings? And you seem to be running pretty ahead of plan. So how should we think about that in terms of the plans and driving towards your margin target? Thanks very much.

Paul Hudson

Management

Okay, Richard. Thank you. I’ll toss the second part to Jean-Baptiste in a moment. But upfront, the change in leader is unrelated to the strategy. Alan Main’s decision to explore other opportunities just gave us a moment to reflect on what we needed and what we could look like going forward. The regulatory conversations pretty much with the FDA uniquely continued to progress positively. We are gaining confidence. There’s still a bit of a way to go, but we’re gaining confidence. And we’re quite bullish about what it could look like in the launch, particularly Tamiflu and Cialis combined, in the sort of late 2024, 2025 horizon, we think could really be significant, you know that and change the trajectory, perhaps even have us as the fastest-growing in consumer in that timeframe. Perhaps the difference will be with Julie joining us is that a deeper customer insight and a digital-first mindset may, if you put yourself forward a couple of years, will probably be the minimum expectation to take advantage of Rx OTC switches. So, I think we’ve got stronger in that context, so feeling quite confident about that. Jean- Baptiste, the savings, first of all, congratulations from Richard on how you did that, and then what would it mean next?

Jean-Baptiste de Chatillon

Management

Well, thanks, Richard. But as you know, I don’t like to be behind schedule. So, it’s normal that we move fast on that aspect, and we still have much more to do. So the savings related to COVID, I guess they will rebound because they are linked to our sales force going back on the field, and I want them back on the field like everyone. But it’s nothing to do with our global journey. And without those COVID-related savings, we want to hit the EUR 2 billion target, and we are marching in that direction with a lot of determination. As you know, we have done some of the things which we have entered and that’s public now into discussion with our unions on how to rightsize further our company, and those discussions are going on in France, in Germany, in many other countries. And they will help really hitting our targets of EUR 2 billion and the quicker, the better.

Richard Vosser

Analyst

Okay, good. Thank you.

Paul Hudson

Management

Next question.

Operator

Operator

The next question comes from the line of Peter Verdult with Citi. Please go ahead.

Peter Verdult

Analyst · Citi. Please go ahead.

Yes, thanks. Pete Verdult with Citi. One for Jean-Baptiste, please. Just more simply, just on the savings you’ve achieved so far, would you give us a ballpark percentage as to how much has been planned or reinvested back in the business? Secondly, for Paul or Thomas, we know seasonal flu vaccines in Europe are around EUR 5 to EUR 10 a shot. We’ve got recent industry COVID contracts signed in the U.S. around $20 a shot. Now, I totally understand that you’re not going to go into the specifics of the contract you’ve signed with the UK government today. But just in terms of book marking or book ending the likely COVID vaccine price, are those two price points good bookends for us to use? And then if I may very cheekily, because it only requires a one-word answer, what is the price point you’ve gone into with Dupixent in China? Thank you.

Paul Hudson

Management

Okay. So maybe, J-B, if you want to take another go?

Jean-Baptiste de Chatillon

Management

Yes, Peter. On understanding what do we reinvest, what you can imagine with the growth we deliver on Dupixent, with what we are looking at behind vaccines, we are – we have started this reinvestment quite significantly on – as you know, we are not limiting ourselves in terms of reinvestment because we are piloting the global performance with an anchor point, which is to deliver our BOI margin target in 2022. So second half of the year, you will see, as I mentioned, some other investments, especially in R&D. We have already the Synthorx cost, which is in our OpEx in Q2. We have the DTC campaigns. We have the increase in the sales force activity behind Dupixent. So, all of this makes the bulk of the reinvestment. And we can pilot what we want to see trickling down to the bottom line depending on the strength of what it triggers in term of growth. So, we will go on like this, and we have room of maneuver to do that.

Peter Verdult

Analyst · Citi. Please go ahead.

Thank you, Jean-Baptiste. Tom, price?

Thomas Triomphe

Analyst · Citi. Please go ahead.

So, COVID-19 price, if I understood correctly the question.

Paul Hudson

Management

Yes.

Thomas Triomphe

Analyst · Citi. Please go ahead.

So, as you know very well, we are not disclosing further details for the UK deals and the ones that are in the press release. What I can still say in terms of COVID-19 pricing is that, as you know, we’ve committed to do a pricing that is affordable and that enables access to the larger population. That’s very important for us. However, I want also to tell you that it’s very important for us to think about the sustainability of our operations. And therefore, we want to make sure that the way we will do it will be in a sustainable way moving forward. And that’s the way we’ll price the product. Of course, there will be a bit more information as we come closer to the development of the next step of this vaccine.

Paul Hudson

Management

As for the question on the price of Dupixent in China, well, it’s around CNY 22,000 annual treatment cost. That price may be a little bit lower due to the patient access programs. And of course, we – a couple of things to remember. One is we have the NRDL a year or two away. So that will be another opportunity to discuss price, I’m sure. And we really do believe we have incredible potential in China. So exciting times actually for Dupixent.

Peter Verdult

Analyst · Citi. Please go ahead.

Thank you.

Operator

Operator

The next question comes from the line of Graham Parry with Bank of America. Please go ahead.

Graham Parry

Analyst · Bank of America. Please go ahead.

Thanks for taking my questions. So, first one is on flu vaccine. So you talked about potential to ship up to – or sell up to 80 million doses in the U.S. I think that’s up about 20% on last year, if you can confirm that’s right. And because of the increased demand that there is, are you anticipating better pricing on top of that as well? And if you could help us understand the mix benefit here as well that you could get on price from going to the more innovative high-dose vaccines? And then secondly, on your SERD, you just hinted that you were talking about starting first-line studies in coming months. Does that mean you have the CDK4/6 combination data in-house now? And if not, when do you expect it? And what form might we see that externally? Thank you.

Paul Hudson

Management

Okay. Thank you, Graham. So maybe, Tom, to you. I think we – the question about volume and also importantly, a question on potential mix in blue.

Thomas Triomphe

Analyst · Bank of America. Please go ahead.

Thank you very much for the question, Graham. So indeed, we’ve alluded to the 80 million doses target for the U.S. market alone, which is a significant increase. You mentioned, if I recall correctly, the equivalent of 20% additional volume, let’s say, but it’s in the ballpark of what we are targeting at. That’s very important. It’s for this year. You also know in parallel that we keep increasing our capacity in the U.S. with a new facility coming available next year, but also beyond the U.S. So, it’s very important that we are there at the rendezvous, if you wish, for this flu vaccination coverage rate increase that we are planning for the coming few years. And our industrial network is proving reliable here. Now in terms of margin and the evolution of the product mix, obviously, it’s not important to have more flu vaccine, it’s important to have more flu-differentiated vaccines because that’s what the larger part of the world is actually looking for. And you know that it’s important to have prospective, randomized clinical trials, differentiated vaccine against standard dose vaccines. And Flublok and Fluzone High-Dose are two such products that have demonstrated their differentiation in prospective positive. We are going to further increase the supply of these two differentiated products at a higher rate than the overall flu volumes growth in terms of volume. So you can imagine that it will have a beneficial impact in terms of margin.

Paul Hudson

Management

Okay. Thanks, Tom. Jean maybe, you’d like to take the third question. Can you hear us, John?

John Reed

Analyst · Bank of America. Please go ahead.

Yes, I can. Can you repeat the question, please?

Paul Hudson

Management

The question was – sorry.

Graham Parry

Analyst · Bank of America. Please go ahead.

Yes. So it was just – I think you were talking about starting the third first-line studies in coming months. I just wondered if you had the CDK4/6 combo data in-house that was I think you said in a hurdle to start that study? And if not, when do you expect it? And what form might we see that externally?

Paul Hudson

Management

Yes, yes. We have data, we wanted to have a bit more, but recruitment has been slower in the COVID situation. Actually, right now, at the point of doing the internal analysis, we have a meeting in fact after this to review. So we think imminently, we’ll be able to make a decision on that. The – in terms of an external presentation, I don’t have a specific date for you on that.

Graham Parry

Analyst · Bank of America. Please go ahead.

Thank you.

Paul Hudson

Management

Okay. Thank you, John. Thank you, Graham. Next question, please.

Operator

Operator

The next question comes from the line of Jo Walton with Credit Suisse. Please go ahead.

Jo Walton

Analyst · Credit Suisse. Please go ahead.

Thank you. Just a quick follow-up on the flu question that we just had. I’m assuming that there’s so much demand that we’ll see much more of your flu delivery in the third quarter than the fourth quarter. So just checking that this is likely to be a really amazing third quarter because of that. And the second question is the elephant in the room about U.S. health care reform. I know that the price differential of Dupixent is less than some other dermatology products between the U.S. and the EU. But I wonder if you could just tell us what you think might happen to you and maybe news a bit about potential U.S. health care reforms with particular reference to international reference pricing please?

Paul Hudson

Management

Yes. Tom, do you want to take the flu follow-up question?

Thomas Triomphe

Analyst · Credit Suisse. Please go ahead.

On the first question, so regarding flu, Jo, what’s important to have in mind is that last year, you remember that the strain selection was done a little bit later stage by WHO. That’s not the case this year. Strain selection has been on time. And as mentioned before, we have been the first one to starting delivering doses in the U.S. about a week ago. So indeed, compared to last year, we expect a stronger trend towards Q3 versus Q4 through deliveries.

Paul Hudson

Management

Jo, to the question on the – I think you’re referring to the executive order discussion from last Friday, I think it was. There’s a few things to jump to mind. One, as a company, you could take it both ways, but we are a little less exposed in the U.S. compared to some of the other big players. I think secondly, a quick read, and there is not a great load of detail as you’ll imagine, but a quick read is that it may be more towards Part B where the challenges may be. And I think, again, we’re even less exposed versus our peer group and the rest of the industry. I think on IPI, it’s too convenient a headline. I mean it’s a bit of a blunt instrument. People want to compare their prices. And you know they said I need to explain this to you and others, but that conveying a price to a country where the price may be lower and there’s zero access and the society is struggling to get its innovation is not really a truthful comparison nor the lack of understanding of rebates in the United States to what the actual net prices are. So, I find that there’s a lot of talk. I think the first thing I would say is not expecting any impact from these conversations this year, of course, with preelection, so it’s a very convenient subject matter. We do believe in reforms that help the out of pocket, particularly the elderly in the pharmacy and not moving money around between different actors in the chain. If we thought we’d be open, we personally rebate reform, for example, and making sure that those that need it get it in their own pocket is much more important to us, and we support those. So, I’m open-minded to what will happen. We just need more detail. And as always, if there’s some stimulus, maybe something good also can come from it. But we’re less exposed that it’s not a factor to alarm us at the moment.

Jo Walton

Analyst · Credit Suisse. Please go ahead.

Thank you.

Paul Hudson

Management

Next question, please.

Operator

Operator

The next question comes from the line of Thibault Boutherin with Morgan Stanley. Please go ahead.

Thibault Boutherin

Analyst · Morgan Stanley. Please go ahead.

Thank you for taking my questions. Maybe, to come back on to flu vaccines, you quantified the increased volume in the U.S. Could you comment on the rest of the North Hemisphere and in particular in Europe, do you have enough volume to address an increase in demand in Europe? And do you anticipate any shortage overall of flu vaccines this season? And maybe a second quick one on guidance. It seems that the upgrade of the full year 2020 guidance corresponds roughly to the positive one-off you had on the revaluation of the Regeneron share. So is there a fundamental improvement in the business that you would highlight that underpin this guidance upgrade?

Paul Hudson

Management

Okay. Thank you. Tom, two questions.

Thomas Triomphe

Analyst · Morgan Stanley. Please go ahead.

Hello, Thibault, flu ex-U.S. is a good question. And indeed, it’s important to look at it because we see increasing flu vaccination coverage not just in the U.S., but all over the world, especially in Europe. You’ve seen probably about over the past two to three years, I would say that more and more European Ministers of Health have understood the importance of increasing flu VCR. And obviously, with COVID-19 pandemic and the fact that the most at risk for flu are the ones that are also the most at risk for COVID-19. There is an extreme importance to make sure that everybody is protected against the preventable disease in order to make sure that hospitals are not overwhelmed by hospitalization. So, we are – to come back to numbers in your questions, we are, therefore, expecting a significant double-digit increase in every part of the world, definitely in Europe. And indeed, from a supply perspective, we are expecting to deliver a significant increase not just in U.S. but also ex-U.S. in order to be able to meet the demand. The second part of your question, if I understood correctly, was about will there be a shortage? That will be a little bit crystal ball looking from my part to be able to say that. What I can say is that at Sanofi Pasteur level at least, we have significantly upscaled our industrial capabilities in order to make sure to tackle the demand that we have received. We will make sure that we are there and we are delivering on time. It’s difficult for me to comment for the other suppliers, but I do expect a very, very strong non-fundamental [ph] 2020 flu season.

Paul Hudson

Management

Thank you. Jean-Baptiste, the question comes back to the one-off and the guidance. I think it probably underappreciates the good work that’s going on to try and make sure that we’re in line, particularly when I look across the industry at such a challenging time, but maybe you’d like to add a comment?

Jean-Baptiste de Chatillon

Management

Yes. Because I think you’re perfectly right. It’s more important to consider our 2022 underlying upgrades than the one of this year. On – what it means, yes, because staying on 30%, I’ve seen some modelings that, in fact, it went to 29%. We are maintaining the 30%. And what it means, it is – and you’re asking which part of the business, well, the part of the business is the human part, which is the most important. And it’s showing the confidence on the quality of the team, which is being built around Paul – under Paul leadership. And that means that we hold the wheel firmly of Sanofi and that we will not get derailed easily, and that’s the main message, really. What makes us confident is that the team really understand and sees what we want to achieve, better science, early science to really trigger innovative medicines.

Paul Hudson

Management

Well said, Jean-Baptiste. The – we are well aware of the commitments we’ve made externally for 2022 and 2025. So we will – whilst we’re going through the transformation, whilst handling the pandemic, at least what’s in our control, effectively, we are still sticking firm to what we’ve committed for 2022 and 2025. And we have to see our journey to that. So whilst the points were made on 2020, I think our longer-term commitments, as J-B said, are the – become the most interesting. Okay, next question please.

Operator

Operator

The next question comes from the line of Naresh Chouhan with Intron Health. Please go ahead.

Naresh Chouhan

Analyst · Intron Health. Please go ahead.

Hi, there. Thanks for taking my questions. A couple on Dupixent, please, particularly on the level of investment behind Dupixent. So in Q2, the Regeneron antibody alliance profit was a bit lower than we had forecasted. So have there been any material investments behind Dupixent in Q2, for example, the China launch? And more importantly, when should we be thinking about the investment phase starting to plateau? I suspect it’s probably a while away. But at that point, we should presumably expect Dupixent profitability to really take off. So a bit of color around timing on that would be helpful. And then on flu, as you mentioned earlier, this is the first time in a few years where you’ve been first, and being first generally is the better price. So is it fair to assume that the 9% price rises you’ve taken on the differentiated vaccines that the majority of that is likely to stick? Thanks.

Paul Hudson

Management

Okay. Right. Some good questions in there. Before I’d come to – well, Thomas, to flu first, and then maybe I’ll throw it to Bill on the investment levels going forward on Dupixent.

Thomas Triomphe

Analyst · Intron Health. Please go ahead.

Maybe on the flu pricing first. As you know, in – it’s not done like this North America flu 2020 season. If you look at the Fluzone High-Dose product in the U.S., we are 100% switching from Fluzone High-Dose trivalent to Fluzone High-Dose quadrivalent, which I think what you have in mind with the 9% increase. So I would say roughly, yes, based on the fact that we have a solid alignment of supply coming down the road and that we are starting to deliver well. We expect some price increase versus last year, the final extent of which will be depending on how the final deliveries will happen, but there will be some pricing elements into it. But overall, again, the vast majority will come from volume also.

Paul Hudson

Management

Okay. So I may toss it to Bill if he’s connected. But Jean-Baptiste, any comment on the investment level through Q2 in Dupixent?

Jean-Baptiste de Chatillon

Management

Well, yes. As I said, we are investing behind Dupixent. And in Q2, there were significant both personnel costs on OpEx increase. You’re right to say that it’s not the end of it. We are going to go on backing this growth because we are just at the beginning of it. What I like is when I see the profile of the drug, and I’m looking at when do we get it accretive to our BOI margin, and it’s quite exciting to see at which speed we see the improvements. So that’s the right balance right now. Maybe Bill can give you more color.

Bill Sibold

Analyst · Intron Health. Please go ahead.

Yes. No. Thanks for the question. And look, as Paul had said, we are growing a product here that is truly transformational. And we have launches that are going on all throughout the year. 89 launches in 2020 alone, and as Paul said, we’re at 35 launches and we have 54 to go. So when you’re building a global brand, we are absolutely investing for launch success all over the world. And we’ve continued in the U.S. with investments in DTC, et cetera. We feel as though these are all important investments to drive what this brand can become. And we’ll continue.

Jean-Baptiste de Chatillon

Management

Yes. Thanks, Bill, on that. The sad thing would be not to be able to afford it. And we are – that’s why we are so determined. The strong determination we show in our selling plan is that really to make that happen.

Paul Hudson

Management

Yes. Well, look, I’m going to add to that, too. Jean-Baptiste said it. He never misses an opportunity to remind me he’d like us to be accretive as fast as possible. The truth is we are building for the long term, but just important caveat, I think Bill touched on it, too. When you’re adding specialty capability, the marginal cost is much lower. It’s not like we’re adding primary care field forces. You look at the data that’s coming out. If you look to this in a fairly [indiscernible], if you look, this is a best-in-class, first-in-class data, we have to rise to meet that. We have to be efficient, and we have to make choices elsewhere in the portfolio to do it because we – to remind you, we’ve already committed to what our business shape needs to look like. And you know that. This, well, retold from Capital Markets Day. But if these additional investments are modest by comparison, they will come, but they will become because we’ll be first and best-in-class in having new patient population. Okay, next question.

Operator

Operator

The Next question comes from the line of Wimal Kapadia with Bernstein. Please go ahead.

Wimal Kapadia

Analyst · Bernstein. Please go ahead.

Great. Thank you very much for taking my questions. Wimal Kapadia with Bernstein. Just another one for Thomas. The U.S PPH franchise saw a reasonably strong decline in 2Q while the rest of the world bounced back quite nicely. So should we assume a similar outcome in the U.S. in Q3? And if you could just talk a little bit about what you’ve seen in the U.S. market in July for the PPH franchise, that’d be really helpful. And then my second question is this on the BTK and some of the rumors on a potential Principia acquisition. I know you can’t comment specifically on that rumor. But just given the level of confidence in the asset internally, how does Sanofi think about the economics of the product today? And wound an opt-in from Principia change your thinking about allocating capital to ensure that you maximize the value of that product? Thank you.

Paul Hudson

Management

So maybe I’ll deal with the last one first and absolutely nothing to say about any rumors that you can read about anything. I will repeat, we’re very excited about the BTK. We think it’s going to be a major part of our future. We touched on it. The data we think is under appreciated actually at the moment. And we look forward to working through the four Phase IIIs and demonstrating that. And we have a great partnership? So that continues. Tom, your initial first, I’ll call you’re getting plenty of attention, if you want to…

Thomas Triomphe

Analyst · Bernstein. Please go ahead.

I’m sorry to take on.

Paul Hudson

Management

It’s okay.

Thomas Triomphe

Analyst · Bernstein. Please go ahead.

Thanks for the question, Wimal. It’s an important point. I truly believe we should all pause for a second and look into it. Your question is about pediatric combinations and the performance that we had in Q2. I think it’s not secret to say first that the world of pediatric commission vaccines is not full of 20 different suppliers. So there’s a certain limitation of number of providers. And as you mentioned, yes, we have a negative customers in Q2 year in the U.S. If you look at the graph, was talking about minus 22% on PPH range on a year-to-year basis in U.S, but it’s also quite interesting to look at the various increase in terms of customers in rest of the world. And in Europe, I think Europe was also hit by the COVID-19 situation. So a couple of points I’d like to further drive them to these when we look at the U.S. PPH product range of customers. I think first and foremost, it’s always related. So it’s interesting to look at the performance of this product range in U.S. versus maybe the performance of the similar product range from the competition. And I think that we have not to be shy at all about our performers. We’ve done extremely well in the second quarter of the year. I think also the second point I would allude to is the fact that this is on a quarterly basis. And of course, it’s three different months. The heat we have had from the COVID-19 pandemic situation differs a lot from a month-to-month perspective. And without going into a extremely debt, I would say, well, we started April with a serious impact compared to last year with any of the quarters in June with an increase versus last year. So, I think that we are training well on to PPH performance, especially, of course, are the lower than one year-old kids. Those new birth need to be vaccinated. And I think that there has been significant number of course, for medical association, as well as from the CDC to make sure that the mothers and parents in bring back the new born to the basic of disease to make sure that those are protective before the COVID-19 or potential.

Paul Hudson

Management

Okay. Thank you, Thomas. Next question, please.

Operator

Operator

Next question comes from the line of Peter Welford with Jefferies. Please go ahead.

Peter Welford

Analyst · Jefferies. Please go ahead.

Hi, thanks for taking my questions. Two, firstly, just on the battle of virus vaccine for COVID-19. Thanks for the details on the timing. I wonder if you could confirm will this be just investigating in Phase 1/2 of one dose regimen, or will you also be investing in a two dose regimen as well? And can we also, see will there be a cohort that excludes and excludes the adjuvant? Or will, all the cohorts include the adjuvant as a matter of course? And then secondly, just on Sarclisa. So you discontinued the combination with Libtayo in myeloma. I wonder would you, if you could comment whether there’s any change in your thinking regarding that combination in solid tumors and also an update perhaps on the use of Sarclisa in some of your other combinations and whether or not there’s any data or insights you got from that study at all that I have any other implications? Thank you.

Paul Hudson

Management

Okay. Thanks, Peter. Jean I’ll come to in a moment about Sarclisa and Libtayo. But before that back to virus, number of doses taking forward and whether without the adjuvant?

Jean-Baptiste de Chatillon

Management

Thanks for the question. And, I use it also about the timing of candidate vaccine. First of all back to the actual the regimen, I would say, and the need for an adjuvant without them telling you to the details of the Phase I, Phase II study, that we tend to start early part of September, and that’s looking good from maintaining that perspective. We expect to actually add a two dose regimen in the end link to the fact that the coronavirus protections, where they’re coming from natural infection, the disease often mechanism we are not too sure at all about how long it would remit. So, so everything we’ve seen, I think from actually immunology or from the earlier results we’ve seen everywhere, seems to indicate that we go through regimen and that’s what we should count on. And I think that’s the same manufacturer. Now for the same reason, we also expect to need a regimen. So that’s why it’s very important to have this partnership with GSK. And that’s why it’s very important to have all companies bringing up SSS, and we believe that the adjuvant would do keyhole. So my bet would be on two doses with adjuvant moving forward. Final point maybe, and these vaccine candidate a month ago, we had the R&D and we were saying that we will start the Phase III as soon as possible. And then maybe to confirm today that as soon as possibility is not anymore in January, 2021, but in December, 2020, we are aiming to further accelerate the vaccines. And we want to start the Phase III I believe in the first half of December of 2020.

Paul Hudson

Management

Okay. Thank you. Yes. So, as you know, there has been a theory that CD38, the target of Sarclisa might have a broader role to play as immune checkpoint and so that was the hypothesis that we were testing in these combination studies and did small signal seeking studies across eight indications. So although all data, not yet in so far, we’ve not seen compelling evidence that this is going to be an attractive combination for going into a variety of types of either solid or hematologic malignancies. So at this point, it doesn’t look like the hypothesis of CD38 having that broad role across a number of malignancy is bearing out. The caveat I would just say is that we’re still finishing the studies for a couple of the indications. I think more broadly in terms of Sarclisa and the recent data from our IKEMA trial, we continue to see a differentiated profile for this molecule, which has a different mechanism of action compared to some of the other molecules that also targets CD38. And that was born out in the IKEMA data with a superior hazard ratio compared to similar studies, similar drug combinations of therapeutics that have been conducted in this second line population. So, we remain very bullish, I would say, on the quality and characteristics of Sarclisa and we’ll look forward to some of the data in the frontline setting in treatment naïve patients as they begin to emerge next year. Thank you, John. Maybe we get time for one more question I think.

Operator

Operator

The next question comes from the line of Geoffrey Porges with SVB Leerink. Please go ahead.

Geoffrey Porges

Analyst · SVB Leerink. Please go ahead.

Thank you very much. I appreciate you squeezing me in. First a question for you Paul, you built out your management team and you well on the way with restructuring the business. Could you talk about do you view your organization as being operationally, strategically and financially in a position to do a substantial acquisition, not the sort of tuck-ins that you’re doing, because clearly you have the bounce sheet capacity? And then just a follow-up question on Libtayo. John, if you could perhaps give us an insight into the basal cell carcinoma readout and when you think that you could be in a position to file there, particularly interested in whether there is benefit in the form of stable disease in the patients who are the non-responders and how quickly you’re seeing those responses in, what’s typically a pretty indolent tumor? Thanks.

Paul Hudson

Management

Thank you for the question, Jean will come to you in a moment on BCC. For me, I’m trying to break you’ll question into two pods. I think you’ve touched on it. We have the right team. Is it capable? Is it efficient? Do we have the financial, I think you tried to say, I guess, where I’m heading is, I’m very in the executive team and indeed increasingly at all levels of the organization, we have new people to come in still, of course, that our discipline and our ability to execute and to execute in line with strategy is growing all the time. So, the organization is responding much faster than I would have expected, which allows lots of opportunities for us. Our first responsibility is to deliver a minimum of what we’ve committed to externally. As for M&A and I think you biased it towards sizable or instead of tuck-in, I can’t remember the exact language. You know I think upfront we have a great financial potential as we are. I think we have a great mid-stage pipeline. That’s going to come through the middle of the decade. I do think when you look at Austin Forex deal and our recent collaborations we are, if we have a choice, there’ll be much more in that scale of the single mid-digit billion deals, just because we want to go out to science that can break new ground that can set the pace and if possible also add value to our existing pipeline in combination where, for example, with oncology. So, we feel, we don’t have to do anything more different to that to outperform and build something quite special in terms of financially capabilities and scientifically, in reverse order. So, I think we’re, I think that’s probably the most I can say right now at Jean, do you have any comment on a basal cell?

Jean-Baptiste de Chatillon

Management

Yes, thanks for the question. I’m not going to be able to answer all your questions, but just to recap in that study population, the overall response rate was approximately 30% and the durability was impressive about 85% of patients who achieved a response remained maintain that response for over a year. So the activity, we felt in this second line population of patients who had already failed hedgehog inhibitors. And so therefore a very aggressive disease, we felt was worthy of moving to a submission of the supplemental BLA. So that is in the works. And we do plan to do that in terms of the I think you asked about how rapidly do we see responses I would have, we would have to get back to you on that.

Geoffrey Porges

Analyst · SVB Leerink. Please go ahead.

Thanks very much.

Paul Hudson

Management

Well, thank you. I will follow up on that last point. I think bringing us to a close as you’ll start to just drop off the – as I approach a year in, I’m thrilled with the progress we’re making the, of the work being done, the scientific transformation in the company, the expense discipline, and somewhat obsessive nature in delivery of Dupixent and against unmet medical need and what it means to our business. And I think that it’s the right balance. I think we’ve covered a lot of ground and most of it we’ve covered at least 30% or 40% of it during a pandemic. So, we haven’t settled on just keeping moving. We have continue accelerate the underlying fundamentals, many of which you won’t see until time passes, but as you do, I think you’ll start to see the momentum building and we’re in exactly the right place part. So, ahead of where I personally thought we’d be at this point.

Paul Hudson

Management

Thank you to the team for everything. I hope everybody gets a little bit of a break and thank you to everybody that joined on the call. Thank you.

Operator

Operator

Ladies and gentlemen, the conference is now over. Thank you for choosing chorus call and thank you for participating in the conference. You may now disconnect your lines.