So that’s maintained gross to net at a relatively consistent 26% level. I think, ultimately, gross to nets all trend towards that 35% to 40%. It’s just a question of timing. So for the remainder of the year, we would expect to continue around the 26% level and then we’ll provide more information specifically to 2024 on our year-end earnings call in February.
Operator: The next question is coming from Uy Ear of Mizuho.
Uy Ear: Could you share what the dose was in the MAD study where you saw insomnia? And the slide is not listed – insomnia is not listed as part of the SAD study. Just wondering, like, why is that the case? That’s my first question. And I guess my second question is, so we often get this question over and over, with the current script trend for LYBALVI and, like, what are other avenues would allow you essentially to hit your 2024 profitability guidance?
Craig Hopkinson: In terms of our SAD and MAD experience, essentially, the most common adverse event that we saw was more hypervigilance that was equally distributed across placebo and active. So, two a piece there. That was more denoted as increased alertness in these patients. But, once again, equally matched, active versus placebo. And I think the single case of insomnia was seen in the [indiscernible] continuation of patient at 25 milligram dose.
Todd Nichols: Let me start with just the seasonal trend or the trends in general with LYBALVI, which coming through Q3 are solid relative to the seasonal dip. Again, TRxs grew quarter-over-quarter by 10%, year-over-year by over 80%. So we’re really encouraged by that. And that’s really being driven by all three parts of our marketing mix, which is our sales force promotion, which is driving intent to prescribe increases. Secondly, our disciplined market access strategy, as Iain mentioned earlier, and we’re seeing utilization across all three channels within market access. And again, we’re at the very beginning of our DTC campaign and all of the metrics are heading in the right direction. So we have a lot of confidence in our strategy. Execution is improving quarter-over-quarter and utilization and the perception of the brand is improving quarter-over-quarter. So we have a lot of confidence in what the long term outlook looks like for LYBALVI.
Iain Brown: Just to add to that, and other aspects of the business, LYBALVI is a key growth driver for us. We anticipate continued growth of VIVITROL, ARISTADA, VUMERITY should continue to grow as well. I think with the spinoff of the oncology business, that’s going to take a significant amount of spend out of the R&D line. Our gross margins should improve as the volumes of all our proprietary products continue to grow. And as you saw, we delivered GAAP and non-GAAP profitability this quarter. So hopefully that gives you a path to us being able to achieve the profitability targets next year.
Operator: The next question is coming from Douglas Tsao of H.C. Wainwright.
Douglas Tsao: Just really quickly on the orexin, I was just curious if you were seeing any evidence of impact on sleep quality. Obviously, you saw some insomnia. But were there any other impacts on sort of sleep consolidation?
Craig Hopkinson: Essentially, sleep quality is going to be a really important endpoint for us moving forward. This wasn’t specifically measured, given the nature of the design of a single dose from our crossover studies. Anecdotally, as the patient experience was positive, but obviously this will be built into our polysomnography assessments in Phase 2 program as we move forward.
Douglas Tsao: And from a tolerability standpoint, would you anticipate this being used in conjunction with one of the promoting agents?
Craig Hopkinson: At this point in time, we’re studying 2680 as a monotherapy and our entire program is designed as such. So I think what will be really important is to really assess sleep quality after 2680 as we get those polysomnography assessments in the Phase 2. We’re also building a number of PROs into our Phase 2 program and that will get a better handle on that as well
Operator: The next question is coming from Ash Verma of UBS.
Ashwani Verma: For LYBALVI commercial payer discussions, has the aggressive contracting by Latuda over the years or some inching up on gross to net for this category in general broadly changed the expectations for payers on how much volume they’re willing to give in return for a wider gross to net? A second, on the orexin, so just wanted to get your initial reaction on competitor Centessa. We just saw the preclinical data, ORX750 showing significant activity at lower doses. Granted this is pre-clinical, but just seems to be getting crowded on the orexin. So any thoughts there would be helpful.
Todd Nichols: I’ll start with the market access question. So I think the key elements to keep in mind here is there’s three channels, Medicaid, Medicare, and commercial. There’s relatively an equal split across the category, depending upon what the indications are for these brands. We have a pathway of access and really clear line of sight across Medicaid and Medicare and we see good utilization. Within the commercial space, we do have agreements in place with commercial payers where we are constantly in ongoing discussions. But we know from our history, specifically with ARISTADA that we launched several years ago, that once you start going into contracts with large rebates, it’s very difficult or virtually impossible to pull those rebates back.
So our plan right now is to continue to drive volume through intent of prescribing, which is increasing through patient activation, again, which we’re seeing good activation levels with our consumer campaign. And then, over time, our belief and our plan is to expand access within the commercial space. But we’re doing that in a very measured approach to make sure that we’re maximizing the profitability of each unit.
Craig Hopkinson: With regard to the question on the Centessa data, I think those data were being presented in parallel with this meeting, so we haven’t actually seen those data at this point in time yet, and so can’t really comment on that.
Operator: The last question for today is coming from Charles Duncan of Cantor Fitzgerald.
Charles Duncan: I have just a couple of quick ones. For 2680, if you think about the future, for NDA enabling purposes and given the potential safety and waning activity of another agent in the class, what is the length of exposure that you are expecting to be a minimum? Is it 3, 6 or 12 months or some other period to rule out safety and rule in durable efficacy?
