Gregory Renza: Great. That’s really helpful. Maybe just one last quick one and helpful to have you and lay out the lower extremity and sNDA. I’m just curious how you’re thinking about prospects for an AdCom? Are you preparing for one? What is the likelihood there?
Dave Stack: Yes. No, and I’ll comment and see if Roy has any different idea. Now the p-value here, Greg, there’s no — I mean the data is, I should say, astonishingly positive. But in my mind, the data is astonishingly positive given it’s a 10 ml dose and the comparator was bupivacaine. So 0.007 for both pain control and opioids with a 10 ml dose for the adductor canal and 0.001 for the foot and ankle that was on bunionectomy trial, but it’s a popliteal block in the — I’m sorry, it’s sciatic block in the popliteal portion. And that also was a 10 ml dose and the 0.00001 was both for opioids and pain control. So, I don’t — not getting share here at all, but we filed this in January. We’re moving along in the regulatory process.
We’ll get our 74-day letter here relatively soon. I don’t see why there would be anybody that would say that they need help from the medical community, providing guidance on whether this is a useful agent in the marketplace or not. Roy, if you have any different ideas?
Roy Winston: And I’ll just add one thing to that, Gregory. The other studies that we’ve always submitted for NDA, sNDA with EXPAREL have always been against a placebo comparator, right? And this time, we went against bupivacaine, and we demonstrated superiority to bupivacaine in two studies. So, we’re actually asking for a superiority claim in the label. And I think that one of the criticisms we’ve had — and keep in mind, the FDA originally asked us to go against placebo when we first started. But people say, well, how come you don’t go against an active comparator? Well, here, these — both of these studies went against an active comparator. And like Dave said, it was only a 10 ml dose instead of the 20, and it demonstrated such meaningful clinically, meaningful reductions and statistical significance. I think we’re always prepared for an AdCom, but I do feel like the chances of it are extremely low.
Operator: This question comes from the line of Oren Livnat of H.C. Wainwright. Your line is open.
Oren Livnat: Really appreciate you returning to guidance. A couple for me. Firstly, on the EXPAREL guidance, I noticed you said global sales for that. And I’m wondering if you can help quantify sort of the significance of ex-U.S. sales in 2023. And then on 340B, I appreciate your commentary about the, I guess, neutral to slight revenue accretion by end 2023. And I just want to understand that, does that reflect sort of steady uptake already that’s begun eventually sort of surpassing that effective price decrease by year-end? Or is there a lag that we’re still seeing and as expected, between the initial price increase and even beginning to see uptake in new customers or uptake in existing customers such that maybe in 2024, do you expect acceleration on that front with 340B? Or do we have to wait for NOPAIN to kick in, in 2025 ostensibly to see that acceleration?
Dave Stack: Yes. So, the EXPAREL sales ex-U.S. are not significant in 2023. It is — we are doing well and it is increasing quite rapidly on a percentage basis, but it is not anything that’s going to be material to the 2023 numbers. Important as we go forward, but in 2023, we’re still putting the pieces in place and going through the formulary process and teaching people how to use the products effectively. Interestingly, there is a great deal of interest in ioveraº in Europe, and we’re training many of the high-end spasticity folks across Europe. Paul Winston is going over there regularly now and training these folks. So Europe will be important, but 2023 is not material. You’ve got all of the pieces for 340B. So, we have a list of people who are currently purchasing EXPAREL, and we forecasted off of that list how much of that business would convert to 340B pricing, and that’s where the 5% comes from.
