Ash Verma: Thanks.
Operator: Thank you. Our next question comes from Jason Gerberry with Bank of America. Jason, your line is now open. Please go ahead.
Jason Gerberry: Hey guys, thanks for taking my question. My question is on the biosimilars. I’m wondering if you think you could potentially make hay with this biosimilar Humira if you get the interchangeability designation with the February approval. Can you leverage that to get a big, chunky contract as a preferred biosimilar supplier? I know that the other non-interchangeable high concentrates have struggled to get share. Then, how that maybe carries over into 2025, right? I mean, there’s a question about Stelara and is the PBM biosimilar space sort of broken, you know, with innovators playing the rebating game, or could you leverage a portfolio play with interchangeable Humira and then layering on top of that Stelara? So just kind of wondering your overall perspective on what you’ve observed with the PBM biosimilars and whether you think there’s an opportunity there. Thanks.
Richard Francis: Yes, thanks Jason. Thanks for the question. On the biosimilar one, starting with biosimilar Humira, it really obviously depends on the FDA giving a successful inspection of our partner, Alvotech’s facility in Iceland. Now, if that does happen, and we’ll hopefully know relatively soon, then it does give us an opportunity to launch. I think there’s obviously a lot to play for there still, because 2023 was slow with regard to penetration of the biosimilars. That said, there are a lot of uncertain variables – will we get the FDA approval of the site and be able to launch it, and then the timing of that launch and, to your point, how we can penetrate with the PBM. What I would say is we’re having good conversations.
People are very interested in hearing about when our product can come to the market. I think a lot of that is based on the product profile, not just the interchangeability, the auto-injector, so I see opportunity here. The way I’ve always characterized it is it’s opportunity over short, medium and long term. I think Humira could add revenue to our business this year. I think it definitely will in ’25, ’26 and ’27. I think the direction of travel will be very clear for biosimilars. I think Humira doesn’t define in ’23 what happens going forward, so that’s what I think about Humira, but we have some caveats there with regard to when we actually get this product approved. I think to talk about Stelara, I think that what I’ve learned in biosimilars, and I’ve been in it quite a long time, is one product doesn’t set the precedent for the next one.
I think Stelara has many things that are different around it: one, that is has a lot less competitors, for one; and two, we have a clear line of sight of when we’re going to be approved or be launched, which is in February of 2025, so we’re very optimistic about that. We see that as a sizeable asset, and so we see that as something that can generate significant revenue. Once again with regard to the speed of uptake, we’ll have to see how that plays out. I think the important thing for Teva is we’re not being very–we’re not hanging on the fact that these products need to come to market and deliver quick revenues, because we have a portfolio in play. We have 13 assets to bring to market; as I mentioned, we’ve got five that we’re going to launch by 2027.
I think they’ll all generate good return and drive our top line and bottom line, but to be very specific about which ones will generate which revenue when, I think is something I don’t want to do because of the unpredictability that we’ve seen in the last year. Hopefully that goes some way to answer your question, Jason.
Jason Gerberry: Got it, thank you.
Operator: Thank you. Our next question comes from Umer Raffat of Evercore. Your line is now open, please go ahead.
Umer Raffat: Hi guys, thanks for taking my question. A couple here, if I may. First, maybe just on the design of your UC Crohn’s study at baseline, are you expecting mild to moderate or moderate to severe patients, and what percentage may be biologics experienced in your expectations? Secondly, I noticed for your Crohn’s study, the endpoint you’re using, which is endoscopic response, is actually different than what FDA wants for their co-primary. There’s a couple of your secondary endpoints on CDI less than 150, or endoscopic remission, which is what FDA is very focused on for co-primary, so should we really be focused on those secondary end points as the primary basis of determining how the Crohn’s trial looked? Then finally, if you could just give a quick update on your recent generic launch of Korlym, given all the interest, and how the launch is going to date? Thank you.
Eric Hughes: Thank you Umer. Richard, I’ll take this question, if you don’t mind. With regard to the inclusion criteria for our study, we’re focused on the mild to moderate patients that we see coming into the study right now. That’s typical of the studies that have been run recently. We’re happy to see that our inclusion criteria in the study has been able to enrol well; in fact, our inclusion criteria and our study execution has got an accelerated pace of not only the ulcerative colitis but actually the Crohn’s patients as well, which is very encouraging to see, because this is one of the first well controlled–placebo controlled study for Crohn’s in this new MOA. The criteria is focused on those patients coming into the study right now.
With regard to the end points, the end points that we’ve included in the study are the FDA accepted study end points that we’ve discussed with FDA. They’re pretty common across the different studies. I think one of the criteria that you have to pay attention to is how you count some of the clinical end points, that might change how you see your placebo response compare to your active. We’re confident in the way we’ve designed the study, we’ve done this in conjunction with FDA. Then your final question on Korlym, I know that–Richard, you want to take that?
