Thomas Appio: Yes, I’ll take the second point of that question. Of course, divestitures, you know, as a publicly held company, you know, we’re always considering all options. We have a lot of great assets in this company. So if someone comes forward and is interested in looking at our assets, we’re always entertained at. Clearly the assets we have today as we saw in terms of the results of the third quarter, you know, we’re performing well. However, you know, clearly if there is any interest, we would entertain it. Operator, next question?
Operator: The next question is coming from Douglas Miehm with RBC Capital Markets.
Douglas Miehm: Yes, good morning. Just a couple of questions on Xifaxan, number one, with respect to the growth at around 13% relative to the flat and prescription. So is it fair to say then, you know, a small part price increase and the bulk of it was stocking and maybe you could actually delineate what that number was? And then the second question has to do with the Aplenzin and Wellbutrin. We saw strong, actually, you know, fairly strong growth relative to the weakness and prescriptions? Can you walk us through what’s going on there as well? I know that you indicated that into Q4 things are going to reverse themselves, but just curious as to what happened there.
Thomas Appio: Yes, Doug, I’ll take some of those questions and then John might add a few things. You know, when we took — take a look at Xifaxan, you know, clearly in the quarter, it was a good quarter. I did mention in my prepared remarks there was some changes on inventory and our pricing. We did have a good opportunity to get some price with a higher net price, got a $17 million. Overall, when we take a look at the extended units, they were up, you know, 0.5% in the third quarter. You know, the non-retail extended units grew by 4%, when we take a look from an outpatient perspective, there are things happening and shifting of patients, and especially on the HE side. As we look at it, if I take a look at the TRX growth, it was for IBSD, it was 0.5% in line with the trend.
When I look at HE, on the HE side, it did decline slightly from a total TRX standpoint. But the NRX trend is good. So one of the things we’re going to be focusing on is refill rates as we — into the fourth quarter. As you know, also I’ve talked about in previous calls, your AI project that now has been rolled out to our large field force both on the primary care side and the specialty side and that as we look at what our messaging is, what our targets are, is going to help improve the volume performance going forward. When I take a look at the volume and also then what the wholesalers bought and the data that they’re looking at and the trends that they see. But there’s a lot of things that we’re doing there. From a direct-to-consumer advertising, I mentioned the Bellamy Young opportunity about speaking about the need to address HE.
There’s a lot of things happening there that will help our Salix business going forward. When we take a look at Aplenzin and Wellbutrin, you know, clearly in the quarter, we had opportunities there from looking at what the other competitors had in terms of inventory movements. We did launch the Aplenzin SAD campaign, which we’re really excited about. That is the only product approved for SAD. And we think that we have a really good opportunity to drive growth, not only in the fourth quarter, but good momentum going into next year. Operator, next question?
Operator: Your next question is coming from Les Sulewski with Truist Securities.
Les Sulewski: Good morning. Thank you for taking my questions. So first, on the EBITDA guidance for BHC, excluding Bausch & Lomb. Can you just talk about some of the puts and takes on the narrowing down of the guidance there? And then second, on the RED-C program, how is this enrollment trending and any agency feedbacks from specifically from Asia Pacific region? Thank you.
Thomas Appio: Yes, so why don’t I take the first question on the RED-C and then John will take the question on guidance. Really excited about the RED-C program. Again, this is a global program. As you know, today we only have approval for, you know, to market Xifaxan in the United States. This would be an opportunity globally. The enrollment of two global, you know, Phase III trials is on track. One of the reasons why, you know, you see the increase in spend in R&D, we put more investment behind this program to accelerate the program, so we have an approval — an earlier approval. So we expect these three Phase III trials to be completed in 2025, to file in 2026, and to launch a commercial product in the first-half of 2027. When I look at the opportunity here, of course, we need the data, but we look at the opportunity for RED-C globally.
It’s a really great opportunity for our company. And the R&D team has been doing a real good job on the recruitment and have many investigator meetings both in Europe and also in Asia Pacific and trying to get as many sites up and running as possible and making sure that even looking at our opportunities to run a trial in China, which would be, again, an area of focus for us. John, you want to take the other question on guidance?
John Barresi: Sure, in terms of the puts and takes on guidance, Les, yes, I think there are a few things in there. One, you know, you start with the — we’re going to talk about adjusted EBITDA, but it starts with top line, right, and as you can see, we’ve increased our organic growth guidance, a point on the top end, 2 points on the bottom end, but FX has really shifted since the last time we provided guidance in August and has become much more of a headwind, which carries through down to the bottom line to a degree. And then when we look at some of the other factors, we talked about the R&D spend that we’ve accelerated into 2023. The Emerade recall that happened in Q2 and trails were a little bit into Q3. We’ve continued to try to be really thoughtful about cost and expense, but when we look at how all of that rolls together I think we thought it was prudent to narrow our range to the 2.3 to 2.35 range. That hopefully that helps answer your question.
Les Sulewski: That’s helpful. And if I may squeeze one more on the recent approval of CABTREO, what’s the market opportunity here? Just talk about salesforce ads for 1Q launch, pricing, reimbursement strategy, and then essentially a duration of compliance rates that you’d expect from the product? Thank you.
John Barresi: You know, what I would say, CABTREO we’re really, of course, excited that we gained FDA approval. The team, the R&D team, the regulatory team have worked really hard to get, bring this product to fruition. What I would say is the acne is clearly a focus for us and we see it as a good opportunity. Of course, as you know, the medical [Technical Difficulty] space, in terms of the payer perspective, is a challenge. And therefore, we’re looking at what our pricing will be, looking at various ways to maximize the molecule, whether it be from a payer perspective, but also from a cash pay perspective. We think that this product is the best-in-class for the treatment of acne. So the team is still working on finalizing the launch plans as we work, as we’re going to launch this in the first quarter of 2024.
