James: Hi, this is James on for Umer. Thank you for taking our questions. Two questions, if I may. First, in the scenario that Norwich loses the patent appeal, will they reignite their [indiscernible] appeal, and if so, what would be the angle? Secondly, can we get more color on the [indiscernible] increase in fourth quarter and your expectation in 2024? Thank you.
Thomas Appio: On the first part of your question, what specifically were you asking on Norwich? I’m trying to understand what you’re actually asking there.
James: Let me repeat. In the scenario that Norwich loses the patent appeal case, will they reignite their APA against FDA case, if so, what will be the angle?
Thomas Appio: Yes, I can’t comment on what they would do on their litigation if they were to lose. Again, I can’t comment on the call of what their steps would be, but again we feel confident in our appeal and in our intellectual property. Next question?
Operator: Thank you very much. Your next question is coming from Jason Gerberry of Bank of America. Jason, your line is live.
Chi: Hi, this is Chi [ph] on for Jason. Thanks for taking our questions. A couple from us. Regarding the Xifaxan appeal decision that you expect later in first quarter or early second quarter, let’s say if the appeal is favorable to Bausch, how does a favorable appeal ruling impact your thinking on the separation of BLCO? Would you look to move quickly once that particular legal matter is resolved, or are there other settlements and legal matters contingent? My second question is on Amiselimod. You ran a Phase II in mild to moderate, and it sounds like you are moving–thinking about moving Phase III to moderate to severe population, so I’m curious what prompted that change, given there are multiple other S1Ps already approved or in development in the moderate or moderate to severe population. Thanks.
Thomas Appio: Okay, on your first part of the question regarding Xifaxan, what I would say is this – as you know, we had the appeal that was heard, the oral arguments were heard in January. We believe it went well. What I would say is we believe that if we were to win, there are still factors that we need to consider. We believe that separation continues to make strategic sense, and there are many factors that will go into the timing of any potential distribution and there’s no committed timeline at this time. What I would say on Amiselimod, when we look at the data and the positive data that we saw – as you know, we ran the trial mild to moderate, we think that Amiselimod has the potential to be very broad in what the data shows.
When the trial was running, we did have mild to moderate, but as we look at it, we can move it more into moderate to severe on the Phase III program, and as I said in my prepared remarks, probably treat all, but that’s still under discussion. Operator, next question?
Operator: Thank you very much. Your next question is coming from Douglas Miehm of RBC Capital Markets. Douglas, your line is live.
Douglas Miehm: Great, thank you. My question has to do with Q4 for Xifaxan and Trulance, where it looked like it was all flat; and forgive me if you spoke about this already, just curious as to why that occurred given the strong prescription strength during the quarter, and also the pricing increase you took at the beginning of the year. Then perhaps related to that, you can expand on the commentary that was made around prescription growth in the guidance, 2024, and how that could be impacted by, I think it was managed care that you talked about? Thank you.
Thomas Appio: Yes, so let me just overall–you know, when we look at Xifaxan and the TRx growth, if you look at the product for the full year, we had an increase of 8%, 3% on price, 5% on volume, and we talked about some of the inventory channel that we had. But overall, the TRx growth as we looked at it for the year was strong, and when we looked at the fourth quarter on the IBS-D side, we were exiting at much higher than what the full year looked like. When we look at HE in the long term care space, that was over 6%, so the product–the performance as we ramped up the investments, okay, and launched different activities during the year, you could see it benefited from the second half. I’ll let John talk specifically about the second part of the question.
John Barresi: Yes, on the revenue trends, if you remember in the third quarter, Salix was plus-13, I believe, for the third quarter, and we saw–at the time, we spoke about some pull forward of the demand increase that we’d normally see in Q4 into the later stages of Q3, and so that, I think is the biggest driver of the difference between revenue growth and TRx growth for Q4 on the Xifaxan and the Trulance side. Then on the question on the Q4 guidance, I think what we had said was we expect expansion of the growth of TRx, however we did end 2023 a little bit higher in the wholesale channel than we ended 2022, and so we had a little bit of a build there. It’s possible, right – the wholesalers have their own algorithms for how and when they buy, but it’s possible that if we see that revert back a little, that it could temper some of the benefit from a revenue standpoint of the underlying demand growth.
Thomas Appio: Then lastly, when we just take a look at it to frame it, when we look at IBS-D, there’s 2.2 million patients that are diagnosed but only about 140,000 receive treatment, so again–with a second line medication like Xifaxan, so clearly still a large unmet need and some of the investments that we have made this year and last year, and we will continue to make in 2024 to capture that. On the HE side, if you look at the analytics that we look at, there’s about 190,000 patients that potentially have HE, and only 50,000 approximately are treated with Xifaxan, which is the standard of care and the only approved medication for HE, so again large unmet need that we’re going to continue to invest behind. Operator, next question?
Operator: Thank you very much. Your next question is coming from Michael Nedelcovych of TD Cowen. Michael, your line is live.
