Marc Goodman: 2 questions. First, can you talk about LABALVI and the gross to net, just review how you’re thinking about it for this year and whether we should be expecting that to continue changing over the next couple of years? Just the strategy there? And then also secondly, on VIVITROL, just a little more color on what is happening with the opioid dependence versus the alcohol dependence maybe just from the quarter and your expectations this year? I mean is opioid declining completely? Or is it just — are they both growing ones growing a little faster? Just help us with that.
Richard Pops: Yes, absolutely. So I’ll take both of those. First, gross to net with LaVaVI.So for Q4, gross-to-net was approximately 29%. The increase was driven by higher Medicaid utilization and some onetime events. Our expectation going into the year is that it should be relatively stable at this point. So that’s what we’re expecting for the full year. I will say as well that we’re in constant discussions with payers. And to the extent that we do sign some additional agreements that gross to net would widen, but the expectation for 2024 is that it would be in the upper 20s. In terms of VIVITROL right now, we’re seeing really strong growth with our alcohol dependence strategy. And that’s, as you know, is the largest part of the market, more than 24 million Americans.
We did see some headwinds in Q4 for opioid dependence, but that’s really a subnational phenomenon. So it’s state dependent. It’s setting of care dependent. So — there was a little bit more of a decline overall for that indication, but the alcohol dependence is actually offsetting that. So our strategy is, again, is 75% of all of the volume and the units are coming through from alcohol dependents. And we’ve been transforming VIVITROL over the last several years. And our strategy is to continue to really go after that very large addressable market and really drive the brand through alcohol dependence.
Operator: The next question is from the line of Ashwani Verma with UBS.
Ashwani Verma: So I have 2 on Baldi [ph] First one, can you update us where you are on the Lialda commercial contracting? I think previously, like during the second half of last year, you said that you were looking at expanding presence in more commercial plans, just where we are in this process? And then second, so for the ballets still a little bit of a weight gain issue, but still much better than olanzapine [ph] So my question is, as these obesity products become a little bit more affordable on commonplace, would patients on these weight loss drugs be more willing to consider LYBALVI versus not?
Richard Pops: Yes, absolutely. Ashwani, I’ll take that. So in terms of market access, the way that we really think about market access, as you know, there’s 3 channels Medicaid, Medicare and commercial. And access is really dependent upon the formulator design of each of those payers. LYBALVI has very strong access and there is a pathway to access for patients. So we think about this in terms of providing a healthy balance of contracting plus services to help patients get on therapy. The reason why we do that is we know that once you start increasing gross to net, it’s very difficult to pull that back. So our primary focus really is net sales profitability for each unit. Our expectation for the year is that gross to net would be relatively stable to where we ended 2024.
But it’s a constant discussion that we have with commercial payers. And we’re constantly we look at each discussion, each opportunity on an individual basis by individual payers, and we have to balance and we look at what is the gross to net expectation versus the volume expectation and our focus is really net sales. At this point right now, we think that LYBALVI continues to be available to the majority of patients. We hear that from HCPs. Their perception is that the access is similar to the other branded agents. So we’re not seeing that as a rate-limiting step at this point right now. In terms of weight gain, there was — in term — that was the big hypothesis behind developing LABAVI. That’s always a rate-limiting step with olanzapine is the metabolic profile and also weight gain, and we addressed that with LAVAVI.And so our expectation right now is that based upon the efficacy of olanzapine, we’re going to continue to see broad utilization.
The benefit to weight gain actually just supports it to be a foundational therapy for maintenance treatment. So it will be yet to be determined what’s going to happen with some of the weight loss products that come into the marketplace right now. But our expectation is that we will continue to see strong demand for LavaVIin 24.
Operator: Our final question is from the line of [indiscernible] with Mizuho Securities.
Unidentified Analyst: Could you, I guess, speak a little bit about the — what’s your expectations are for the gross and net for ball notably, VIVITROL and ARISTADA for 2024. And also, can you sort of speak about what came out of the SG&A in 2023 versus 2024, if you were able to quantify that a little that be great. Just wondering how much you’re planning to spend on DTC going into 2024. And a quick third question. What’s the timing for the data readout for NT2IH?
A -: This is Blair. Why don’t I start with just the SG&A. So I think it’s important to recognize as you compare ’23 to ’24, that it becomes difficult because ’23 was such a complicated year for us, a year where we had a number of activities that were ongoing. We have an efficiency program that we’re running through the organization to ensure that we’re driving efficiency on every line item. We also had a number of onetime expenses along in SG&A, particularly in the G&A element of that associated with the separation of the Mural [ph] oncology business. So those things really drive the predominant difference between 23 and 24. And I’ll turn it over to Todd to answer specific questions on TCC.
Todd Nichols: Yes, absolutely. In terms of DTC, again, we feel really good about the overall program that we have. It tested very well in market research, and we’re starting to see the benefits of — to new patient starts. It’s a broad campaign that includes TV plus digital assets. Our plan is to continue that in 2024. Yes, obviously, for competitive reasons, I’m not going to get into the specifics on the spend level, but we watch it very closely throughout the year. We watch it on a quarterly basis, and we’re going to continue to invest in DTC. In terms of gross to net, for VIVITROL and for ARISTADA, we expect both of those products to be fairly consistent with the recent trends. So approximately 54% for VIVITROL and approximately 56% for ARISTADA for 2024.
Unidentified Analyst: And when do you expect the readout for the NT2 and IH Phase I study?
Richard Pops: It’s Rich. We’re completing that enrollment as we speak. So when we clean up those data I’m looking to Sandy, but I think what we’ll probably do is top line those data because there’s not an immediate medical meeting until early summer or the fall. So it’ll probably give us a sense on the top line of the results and then wait for a medical meeting for the full disclosure.
Operator: Thank you. At this time, we’ve reached the end of the question-and-answer session. I’ll now turn the call over to Sandy Coombs for closing remarks.
Sandra Coombs: All right. Thanks, Rob. Thanks, everyone, for joining us on the call today. Please don’t hesitate to reach out to us at the company for any follow-up questions. Thank you.
Operator: This concludes today’s conference. You may disconnect your lines at this time. Thank you for your participation.+
