Andy Plump: Sure. Thanks, Christopher. Thans, Hashiguchi-san, so not to steal the thunder from the presentation that’s coming up in just a few weeks. Let me just make a few high-level comments. The first is that — it’s very important to look at the study differences between our study and previous studies in psoriatic arthritis and in particular, the timing of the endpoint. So we’re looking at a 12-week time point and most other studies look at a 16-week endpoint. It’s also important to look at the differences in the underlying patient population, and we’ll discuss some of those differences at the presentation next month. And then the third point I’ll make is that the psoriatic arthritis is often misunderstood in terms of its disease presentation.
It’s actually in a continuum with psoriasis. So most patients with psoriatic arthritis have skin lesions, plaque and most patients with psoriasis actually end up developing some joint problems. And so the two diseases are highly related. And so when we’re looking at endpoints in psoriatic arthritis, we’re looking at both joint end points and skin endpoints. What we’ve learned through multiple mechanisms in these that inhibit these cytokines, IL-12, IL-23 interferon is that the dose response characteristics on the joint endpoints tend to be fairly flat. That’s something that we consistently see across therapies. We’re expecting to see significant differentiation from our competitors is again going to be on the skin endpoints. So you’ll see more of those data, and we’ll provide some additional details around those data during the presentation.
Kazuaki Hashiguchi: Thank you very much.
Christopher O’Reilly: Thank you very much for the question. Okay. So next, we’d like to take a question from Cowen, Mike Nedelcovych. Please unmute and ask your question.
Michael Nedelcovych: Thank you for the question. My question is on ENTYVIO. It’s a bit surprising to hear that COVID is still measurably affecting IBD diagnosis and treatment rates. And I imagine, it’s difficult to tease that impact out from other factors. So I’m curious, are you seeing that diagnosis and treatment in other therapeutic categories are showing a lingering effect of the pandemic? And if not, what do you think is different about IBD? And what is your best guess when we might see normalization? And then on the subcutaneous launch, I know it’s very early, but I’m curious if you see any early indicators that the subcutaneous product will push ENTYVIO toward the higher end of management’s peak sales guidance? Or do you think that headwinds, such as the competition you described and the lingering effects of COVID might cause you to lean more cautiously?
Christopher O’Reilly: Thanks, Mike. Julie, would you like to answer that question or those questions?
Julie Kim: Yes, sure. Thanks Mike for the questions. In terms of the comments around the suppression of diagnosis, what we we’re looking at is in terms of claims data. There are a number of different claims databases that you can see in the U.S. to give you an indication. And when we look at, for example, Crohn’s disease, in particular, across two different claims databases in the U.S., there’s a roughly one shows 8% to 10% decline in diagnosis and in Crohn’s disease in particular, and the other shows closer to 20% decline in diagnosis in the last 12 months that we have in terms of the claims data. So that’s why we’re saying that the diagnosis rates are still being impacted post-COVID. Now you asked about other areas. So we did take a look at a number of other areas.
And while I don’t have the specific numbers on the top of my head, we did see similar suppression, although not at the high level of Crohn’s disease, but we did see similar suppression and diagnosis in a few other areas as well. So not quite sure why. There are some theories out there in terms of the suppression of inflammation overall because of COVID, but it’s something that we are keeping a close eye on and continuing to monitor. We’re focusing on what we can focus on in terms of supporting the need for treatment based on the mechanism of action of ENTYVIO and our continued demonstration of safety in the IBD space. And so the subcutaneous pen is another opportunity for us to demonstrate the value of ENTYVIO in IBD, and we’re very excited about that.
I think I covered all of them, Chris, but if I miss something, please.
Christopher O’Reilly: I think there’s a question on peak sales. Maybe Christophe, if you’d like to jump in on the peak sales and how subcu impacts the potential?
Christophe Weber: Hey, thank you Mike for the question. Well, when we look at ENTYVIO positioning and it’s the market share that ENTYVIO has, especially for bionaive patients. Combined with the launch of the ENTYVIO Pen, combined with the growth of ENTYVIO actually also outside of the U.S., we are very much confident about our peak estimate of between $7.5 million and $9 billion. Actually, if you do the math, compared to the current situation, our current revenue in 2023, it will record a peak of 7.5% to 9%. That’s equivalent to a CAGR between four and six for the product. So we feel it’s completely achievable, considering the strength of the ENTYVIO profile, as well as the launch of the pen. Thank you.
Michael Nedelcovych: Thank you.
Christopher O’Reilly: Thank you, Mike. Okay. Next question, we’d like to call upon Miki Sogi from Bernstein. Please unmute and ask your question.
Miki Sogi: Thank you. I also have a question regarding the ENTYVIO. So I understand that you are expecting the subcu to be a new growth driver for this product. But I also like to understand the source of business for the subcutaneous the formulation. I imagine that the majority of the source of business is coming from existing ENTYVIO patients. And potentially, add more of the — additional growth will come from new patients. Is that the right understanding? And also when you say 30% to 40% of the IBD patients will be on SC. So is this something additional? Is this — or just — it’s just replacing being in the current market?
Christopher O’Reilly: So a question about the source of business for ENTYVIO subcutaneous. Perhaps, I would like to ask Ramona to comment on experience that we’ve seen in markets where we’ve already launched the subcutaneous device in Europe is, of course, one example. And then if Julie has anything to add after that, please jump in. Ramona?
Ramona Sequeira: Yes, absolutely. Hi, this is Ramona here. So as we look at launching the subcu in the U.S. and take the learnings from what we’ve seen when we’ve launched the subcu in a number of markets in Europe now and are launching in other parts of the world. And including Japan, there’s two things that happen. One is we are able to go to new customers. So if you think about the U.S., we’ve got — as well as Europe and other markets, we’ve got customers that are heavy infusion prescribers. But we’ve got other customers that aren’t as linked to infusion clinics and tend to prescribe much more subcu. Our focus has been more on the infusion providers at this stage, to this stage in ENTYVIO’s life cycle. As we bring the subcu out, it gives us new customers, new providers to go to, and that allows us to access new patients.
