Frank Lee: Yeah. Gary, so it’s an important question. There’ll be certainly quite a bit more effort this year in terms of planning and thinking through what we need to do. But in terms of any sort of spend and investment largely that will be ahead of us in ’25, ’26 and ’27 and so we’re excited about it. As I mentioned, we have had an opportunity to review the data with the scientific advisory board. We’ve also presented some of the data, as I mentioned, at ORS and this week at ASGCT. And so we continue to vet the data. We also continue to think through clinical development strategy going forward. But in terms of activity, a lot of it this year will be vetting our strategy and planning, and the investments will largely occur in ’25 and beyond.
Operator: Your next questions come from the line of Les Sulewski with Truist Securities. Please go ahead.
Unidentified Analyst: Hi, this is Jeremy [ph] on for Les. Thanks for taking our questions. How do you view the opportunity with PCRX-201 and how exactly does the recent designation help you? Thanks.
Frank Lee: Yeah, it’s a very interesting opportunity because this is the first RMAT designation for gene therapy and osteoarthritis. And what that means is that the FDA and the company will work closely as we think about further vetting the data and development strategy. So this is a wonderful opportunity to make sure that we stay close with the FDA. And to the extent that we develop this asset going forward, this could truly be transformational for patients. As I mentioned earlier, based on our market research and discussions with thought leaders, current treatments offer patients three months to six months of benefit and durability, whereas we know that from market research, twelve months or more is considered transformational.
And so to the extent that PCRX-201 can deliver that, this could be an important new treatment option for patients. So we’ll continue to vet the data, put the development plan together, but we’re very excited about the data and obviously based on the RMAT designation, FDA as well.
Operator: Your next questions come from the line of [indiscernible]. Please go ahead. Thanks.
Unidentified Analyst: Thanks. Congrats on a pretty clean quarter. A couple questions, just to build on earlier questions about the commercial follow on after NOPAIN kicks in, I just want to make sure I understand what we’re talking about here. Obviously, you have pretty small overall market share of the broader landscape of procedures. I think you’ve highlighted in the past about 12 million relevant outpatient commercial procedures. And so I just want to understand, when you talk about following on, do you mean plans are just not covering EXPAREL at all, hence your small market share now and they’ll maybe feel compelled to cover it if CMS is, or is it about improvement in terms and access with those plans. Just help me understand what we’re even talking about here, big picture. I do have a follow up.
Frank Lee: Yeah. So thanks for that question, Oren. What I’m talking about is oftentimes CMS will come out first with reimbursement, and commercial plans will take some time to evaluate when and if they’ll cover the new therapy. And so, our task at hand now is to work very closely with the commercial payers to accelerate that adoption on the commercial side of things. Now, that said, we do have a C code, and oftentimes that can be reimbursed in the ASC setting currently, but it’s not straightforward as it could be. And so here we have an opportunity with NOPAIN and CMS reimbursement to use this now to engage commercial payers to follow suit sooner than they normally would. And so that’s really it. But I’ll remind you again that there’s a substantial opportunity just with the CMS patients. What we’re trying to do now is to really make this even a broader impact. So that’s the idea.
Unidentified Analyst: Okay. So just so I’m clear, you obviously have a lot of outpatient use now, like you said. it’s a $500 million, $600 million product, not all inpatient. So I just wanted to understand is how that’s being done now, suboptimal, even across the entire board of your commercial outpatient reimbursement and that could change meaningfully at some point afterward.
Frank Lee: Yeah. What’s important with the NOPAIN legislation is in the outpatient setting, it provides for ASP Plus 6% reimbursement, which, for example, in the HOPD is pulling that thing out of the bundle. So this is important. So the product will be reimbursed separately. So now if you add up favourable access through 340-B or GPOs, and you add on top of that ASP Plus-6 reimbursement, I think this provides for an attractive value proposition, given what EXPAREL delivers on the clinical setting and oftentimes, some of the cost issues have been a barrier. So this is important. So to the extent that that sort of reimbursement formula is followed to any extent by commercial payers, this will be something that further EXPAREL launch.
Unidentified Analyst: Okay. And then just to follow up, I don’t want to parse your language too closely. I know that can be pretty irritating. But you said to the extent we develop this asset going forward, and I want to know if I should interpret that as just to the extent it, payers developing going forward based on how the data turns out, or maybe if you are looking to out license this to another company for someone else to take it forward potentially.
Frank Lee: I’m sorry, which product are we talking about?
Unidentified Analyst: PCRX-201. Yeah.
Frank Lee: I see. Look, at first, we’re very excited about 201. We’re going to go through a lot of thinking here about our development strategy. We have no plans to do anything but that right now. So that’s what I’d say to you.
Operator: Your next question comes from the line of Balaji Prasad with Barclays. Please go ahead.
Balaji Prasad: Hi. Good evening and thanks for the questions. So, a couple from me, while I can understand the rationale for the [indiscernible], I’m curious to know the capital allocation factors, which went to deciding the quantum of $150 million that’s one. And two, I’m not sure if you covered this already. So again, if you can take us through the growth dynamics of the quarter and how it changed was in previous quarter and what cadence we expect for the year, and maybe just on second EXPAREL on the 18 million procedures that are going to be covered are these 18 million procedures which we fully incremented to EXPAREL credit? Thanks.
Frank Lee: Hey, Balaji, you were breaking up on me there a little bit. So I think your first question was related to the stock repurchase, if that’s correct and so again, so what I’ll underscore here is the confidence we have in our growth outlook and the fact that it’s an attractive investment, given that outlook going forward. If your question is about sort of the cadence and the amount, maybe I can turn that over to Charlie.
