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Thank you for standing by. My name is Hermione. And I will be your conference operator today. At this time, I would like to welcome everyone to Q1 2024 Pacira BioSciences Earnings Conference Call. [Operator Instructions] I would now like to turn the call over to Susan Mesco, Head of Investor Relations. Please go ahead.

Thank you, and good afternoon, everyone. Welcome to today's conference call to discuss our first quarter 2024 financial results. Joining me are Frank Lee, Chief Executive Officer; and Charlie Reinhart, Chief Financial Officer. Jonathan Slonin, Chief Medical Officer, is also here for today's question-and-answer session. Before we begin, let me remind you that this call will include forward-looking statements based on current expectations. Such statements represent our judgment as of today and may involve risks and uncertainties. For information concerning risk factors that could affect the company, please refer to our filings with the SEC, which are available from the SEC or the Pacira website. With that, I will now turn the call over to Frank Lee.

Thank you, Susan, and good afternoon, everyone. It's been an exciting and productive time since I joined the company earlier this year. And I'm pleased to say sales are off to a solid start and on track for all 3 of our trusted opioids-sparing products, which continue to make an important impact on patients' lives. This year, our priority is EXPAREL, which is we're all focused on today. I'll also touch briefly on PCRX-201. Let's start with EXPAREL. Our goals are centered on preparing the organization and marketplace to fully realize its long-term potential. Let me walk you through the progress we've made in advancing 3 key drivers for 2024: First, advancing the launch of EXPAREL in 2 new lower extremity nerve block indications; second, progressing our awareness and educational activities around separate Medicare reimbursement and average selling price, or ASP, plus 6% in outpatient settings beginning in 2025 with the implementation of NOPAIN; and third, expanding patient access to EXPAREL through 340B pricing and new GPO partnerships such as Premier. I'll start with lower extremity nerve block, where we're seeing positive market receptivity across all sites of care, delivering 4 days of opioid-sparing pain control with a single 10 ml EXPAREL dose is an attractive value proposition to the anesthesia and surgical community for knee, foot and ankle surgeries. Physicians are also reporting consistent results with some patients not taking any opioids following very painful lower extremity procedures. To remind you, we launched with a strong presence in the TKA segment. We're also working to build relationships and advanced product uptake through education and training in other lower extremity procedures like ACL repair, foot and ankle procedures. We would expect a slower uptake in this segment of the market. Turning now to the opportunity ahead with the upcoming changes in EXPAREL reimbursement for outpatient procedures. Separate CMS reimbursement of EXPAREL across all outpatient settings marks an important milestone. It will eliminate the cost barrier by fully reimbursing EXPAREL at ASP plus 6% beginning in January of 2025. Given the market steady migration away from hospital inpatient care, we see ample room for expanding EXPAREL utilization in outpatient settings. We've allocated resources to drive education and help health care systems implement EXPAREL as best practice standard of care for CMS patients. There are roughly 6 million annual CMS procedures in the outpatient settings with a split of roughly 3.5 million procedures in the hospital outpatient settings and 2.5 million procedures performed at ambulatory surgical centers. To maximize this important opportunity, we're enhancing our organization with new talent and capabilities to ensure operational excellence within critical functions such as marketing, strategic accounts, medical and market access. In parallel, we're advancing initiatives to drive awareness, education, action across key decision makers. We're also paving the way for NOPAIN through our participation in 340B pricing and new GPO partnerships. Earlier this year, we announced a partnership with Premier whose significant network of hospitals and health care systems covers nearly 20% of EXPAREL relevant market procedures. Through these preferential pricing programs, we're helping health care systems afford the opportunity to be at the forefront of opioid-sparing pain management. While still early days, we're pleased with the initial data we're seeing from our partnership with Premier. In the first 2 months of post-launch, EXPAREL volumes at Premier accounts are up with only a modest impact on net sales dollars. In short, this partnership is starting to do what we expect it to do. Importantly, we have 2 additional GPO partnerships in process. As for

Thank you, Frank, and good afternoon to all on the call. To remind you, I will be discussing non-GAAP financial measures this morning. A description of these metrics, along with our reconciliation to GAAP, can be found in the news release we issued this afternoon. I'll start with an update on sales and margin trends. Starting with EXPAREL. First quarter EXPAREL sales increased to $132.4 million versus $130.4 million in 2023, driven by volume growth of 3%, which was partially offset by contracted discounts with the rollout of our Premier partnership in January as well as a modest shift in vial mix. First quarter

Thank you, Charlie. In closing, I'm very pleased with the progress we've made thus far in 2024, leveraging growth opportunities for EXPAREL, launching new indications, preparing for the significant reimbursement opportunity that lies ahead next year, and also growing

[Operator Instructions] And your first question comes from the line of Gregory Renza with RBC Capital Markets.

Congrats on the progress. Frank, I appreciate all the updates and the color on EXPAREL for the quarter, especially on Premier and the GPO contract. So wondering if you and the team could just comment on how you view the cadence of the contracting that you alluded to with a couple more potentially coming online, how should we be thinking about that and its impact and the influence on EXPAREL performance over 2024?

Yes, thanks, Greg. Thanks for the question. We're excited about what we're seeing. It's still early days, right? Because we signed this thing in January, it's early days, but we're excited about what we're seeing per my comments. And we're working on a couple more, as you mentioned. Let me turn it over to Charlie to give a little bit more color on that.

Hey, Greg, so the expectation from a rollout perspective is that we would likely have a second contract kind of later in the second quarter and maybe another one in the third quarter. So the contracts are rolling in throughout the year. And as Frank said, the first quarter of the activity probably isn't at its peak. So it takes a little time for them to get warmed up. But we anticipate by the end of this year that we'll have 3 active GPO relationships.

And let me just add some additional color there in addition to the contracts, what this enables us to do is to partner with the GPOs to better educate their membership on what's coming with respect to outpatient reimbursement at ASP plus 6 starting in January 2025.

Got it. That makes sense. And maybe keeping with a similar theme for my question. And I know it's too early to tell when it comes to 2025, as you just mentioned. But when it comes to that, call it, a bolus of patients with NOPAIN, at what point would you have some comfort in talking about what that trajectory could look like, of course, with the 6 million patients at CMS? And then that additional as a double when it comes to the commercial opportunity, at what point should we start thinking about your comfort level as you prepare for kind of that trajectory of those patients and capturing that opportunity from 2025 and beyond?

Yes, that's a good question, Greg. And we're doing a lot of work now. So as you know, from prior discussions, we've reallocated our resources toward NOPAIN. And so a lot of folks are working on getting not only our sales prepared but the market prepared. We're going to have a better view as we get closer to the end of the year. And I know that there's quite a bit of interest in terms of thinking about how we model the uptake of NOPAIN. And my sense is that the work that we're doing now with a number of partners and having discussions in various settings, along with some qualitative and quantitative research that we're doing in partnership with various parties, we're going to have much better insight into the uptake of NOPAIN come towards the end of the year. And we'll be able to provide some better clarity in terms of what segments we think are going to uptake earlier on versus later. And of course, as we mentioned, it will take some time for commercial payers to follow suit. And so we're focused on that as well. Broadly speaking, as we mentioned before, Susan Mesco, our Head of IR, will be hosting some information settings in the fall. And those -- that timing will release in due course, which will provide better clarity on some initial feedback that we're getting from the marketplace. I think, Greg, if there are no other questions, we can move to the next caller.

Your next question comes from the line of David Amsellem with Piper Sandler.

I have a couple of questions. First, I know you said, Frank, that it's going to take some time for commercial payers to follow suit as it relates to NOPAIN. I guess, my question here is, can you talk to your dialogue with commercial plans, and ultimately, your confidence that these commercial plans will indeed follow suit? And then secondly, when you talk about that lag time, if you will, with commercial plans, is that more of a 2026 event? Just help us understand how long it might take for them to follow the lead of CMS? And then the last question is just on the cost structure. You talked about 201, and of course, allocating resources to NOPAIN. I'm wondering where

David, thanks for the questions. First, let me just provide a little bit of context on the opportunity known as NOPAIN, but I think we're trying to really make sure we focused on this one as outpatient reimbursement at ASP plus 6 for CMS patients. Initially, as you know, we've quantified that as approximately 4 million patients in the HOPD setting and about 4 million in the ASC setting, which is quite substantial. So we've got a fair amount of opportunity right in front of us that we need to make sure that we do a good job of education in the marketplace to provide those patients with access to EXPAREL. As we stand up the broader commercial organization, and I think you've heard me say before that we are bolstering our commercial resources, commercial, medical, and importantly, market access, so that's in progress. We've reallocated resources from other parts of the company to bolster that area. And as we start to further now make progress there, and again, I think that's going to be more towards the end of the year, we're going to have much better clarity in terms of specifically how we see NOPAIN playing out over the course of '25, '26 and '27. So that's where we are with that. With regard to

David, this is Charlie. Just building on your comment of 201, please note, we are investing in clinical trials for both

Your next question comes from the line of Hardik Parikh, JPMorgan.

Just had a couple of questions on the 495 patent challenge from eVenus. I was just wondering if you guys could give us some latest kind of thinking you guys have in terms of where some of the more likely scenarios that could play out and what actions, kind of market actions eVenus could take in the meantime based on the ruling? And I just wanted to confirm, is the expectation that the ruling from the judge comes -- still comes in July? Or is there any kind of change on that front?

Thanks for the question, Hardik. Just a little bit of background. And so we do expect the ruling on the first patent litigation sometime by end of June. And so that's what -- that's consistent with what we said before. And just to remind, we've got a number of other patents that will need to be litigated. In addition, of course, eVenus will need to get their product approved and eventually decide to launch the product at some point. So there are a number of things ahead, but let me turn it over to Kristen to provide some additional color here.

Thanks. As Frank said, there really isn't an update since we talked to you all at the end of February on 495 trial. We still expect it to read out by July 1, which is when the 30-month stay is up. So we look forward to the court's opinion being issued before then. And as Frank mentioned, and as we've reiterated and we actually put a little detail in our release, we continue to produce new IP around EXPAREL, Orange Book listed patents, and those are additional hurdles that eVenus would need to get through in order to eventually launch a product. So it's in our release, but we did just have in March 3 additional Orange Book listed patents, 2 method of use, and another composition of matter, and those are in addition to the other ones after 495. So there are quite a few patents that we still need to get through. But as I said, we're looking forward to getting resolution to 495 here in short order. And then we'll continue to produce new IP and they will continue to have to work through other patents that are all on the Orange Book here.

Great. And then just one more on -- you mentioned the EXPAREL gross margin was within the full year guidance range. I was wondering if you could give a little bit more kind of granular detail about how margins are progressing among the various facilities, for example, the one in the U.K. versus in San Diego?

Yes. Thanks for that, Hardik. And I think, overall, we're progressing well. We haven't really broken it down specifically by site. As you know, the 200-liter facility is coming in -- is going to come online later on this year. I don't know, Charlie, if you want to say a few words about margins.

No, listen in the long term, the improvement in gross margins is going to be driven by two major factors for EXPAREL. One is the manufacturing equipment the vials manufactured on. So the 200-liter is generally less expensive than the 45s. But probably even more importantly is the total volume. So we're focused on expanding top line, driving vial volume and so that margins can follow.

Your next question comes from the line of Gary Nachman with Raymond James.

Frank, first, talk more about your progress with the modernization of the commercial organization. Do you think you'll have most of that in place by midyear as you prepare for NOPAIN next year? I think that's been the target that what big hires still need to take place? And then how aggressive do you plan on being with the share buyback? How is that contemplated with the convert coming due next year? And you have to maintain a certain amount of cash for that. So maybe talk through that as well.

Great. Thanks for the questions, Gary. First, on the commercial organization. As I mentioned earlier, we're making very good progress on modernizing and bolstering the commercial, medical, and market access organizations. At a high level, we've talked about plans, and we're making good progress on plans to hire a Chief Commercial Officer, and that's on track. In addition, we're expanding the number of folks in our field reimbursement management team, payer team as well as market access strategy and operations. So those are all things that are on track. In addition, we're looking very carefully at the broader commercial organization, including bolstering our resourcing of our marketing teams and medical teams. So those things are right on track and again, supported by reallocating our resources away from certain areas of the company and investing them here, where we believe it's going to make a difference here for our NOPAIN launch. So that's a comment on our commercial organization, and I'd characterize it as we're making good progress. And largely speaking, we expect that to be in place sometime in the second half of the year. With respect to the share buyback, let me turn it to Charlie here. I'll just say that it really does underscore our confidence in our growth outlook. And it's an attractive investment given the value that we believe is ahead. So Charlie, let me turn it over to you.

Thank you, Frank. And Gary, thanks for the question. So listen, as you point out, that we have a business that's operationally cash flow positive, we generate cash every year. We just reported having roughly $326 million on the balance sheet. As you point out, we do need a certain amount of money on the balance sheet to repay the $400 million of August '25 notes next year. And so we're going to balance priorities, and we're not going to make any commitments about whether we -- when we're going to spend the $150 million that we're going to use it opportunistically as we think benefits our shareholders. And we will balance all of the needs from a cash flow perspective over time.

All right. Great. Actually, maybe one follow-up for Frank. Just what are the next steps for 201? You seem pretty excited about the data you've seen there so far following the Phase I. What comes next? What sort of resources will you put behind it? Charlie, you mentioned before, you are investing a little bit in pipeline. So I'm curious, is that something that could start this year? Or will you likely wait until to see how things unfold next year?

Yes, Gary. So it's an important question. There will 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 OARSI, 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, we'll be vetting our strategy and planning and the investments will largely occur in '25 and beyond.

Your next question comes from the line of Les Sulewski with Truist Securities.

This is Jeremy on for Les. How do you view the opportunity with PCRX-201? And how exactly does the recent designation help you?

Yes. It's a very interesting opportunity because this is the first RMAT designation for gene therapy in 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 3 to 6 months of benefit and durability, whereas we know that from market research, 12 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 and put the development plan together, but we're very excited about the data, and obviously based on the RMAT designation FDA as well.

Your next question comes from the line of Oren Livnat, H.C. Wainwright.

Congrats on a pretty clean quarter. A couple of 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. Like 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 that are just not covering EXPAREL at all, hence your small market share now, and they'll make you 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 [indiscernible] And I do have a follow-up.

Yes. 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 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. But what we're trying to do now is to really make this even a broader impact. So that's the idea.

Okay. So just so I'm clear, I mean, you obviously have a lot of outpatient use now, like you said, I mean, it's a $500 million, $600 million product, not all in patients. 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 afterwards?

Yes. What's important with 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 favorable access through 340B 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 in 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 accelerates launch.

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 that there is 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?

I'm sorry, which product are we talking about? 201?

Yes.

I see, I see. Look, 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 about that right now. So that's what I'd say to you.

Your next question comes from the line of Balaji Prasad with Barclays.

So a couple from me. While I can understand the rationale for the [indiscernible] I'm curious to know the capital allocation factors, which you went to deciding the quantum of $150 million? That's one. And two, I'm not sure if you covered this already. So [indiscernible] growth in the dynamics in the quarter and how it changed versus the previous quarter? And what sort of cadence that we expect for the year? And maybe just from EXPAREL [indiscernible] on the 18 million procedures that are going to be covered, of these 18 million procedures fully incremental [indiscernible].

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, yes, 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.

Balaji, it's Charlie here. And -- so I think one of your questions might have been about the amount. And so from our perspective, we looked at what typical first-time people size, and it was kind of 10% to 15% of market cap. And that's really how we came up with $150 million. We also note that we have between now and the end of 2026 to utilize it. But if we utilize it more quickly, we'll -- and it makes sense, we can go back to the well and get another authorization. So this is something we're going to try, we're going to use it opportunistically, and hopefully, to everybody's benefit.

Thanks, Charlie. And I think, Balaji, your other question was about broadly NOPAIN and just some numbers. So 18 million total that we believe are outpatient procedures that could fall under NOPAIN. Now specifically with respect to the settings and patient populations, so out of that 18 million, 6 million CMS and 12 million commercial. And so inside that 6 million is roughly about 4 million that lie within the HOPD setting and 2 million that are within the ASC setting, whereas in the commercial, that 12 million in the commercial is roughly about 4 million in the HOPD setting and about 8 million in the ASC setting. So hopefully, that's clear.

If I could ask a follow-up there, Frank. Just what percent of these 18 million procedures will be incremental to EXPAREL that is those or not an EXPAREL today through any pathway?

Yes. I think, by and large, this is going to be a very favorable impact. And particularly, if I think about the CMS patients right out of gate, 6 million CMS patients in the HOPD specifically and ASC, I can't give you a hard number right now about how much is incremental. But what I can say is that our penetration, largely speaking, is fairly low, and a lot of that is due to the cost barriers that have existed. And hence, that was the thinking behind making sure that we drive NOPAIN legislation to passage. And so the company saw that early on and has worked over the past 7 years with our voices coalition in partnership and that's why this thing was passed. And so fundamentally, it's pulling the drug reimbursement or product reimbursement out of the bundle. So there's not a financial disincentive to use the best product for the patients. So hopefully, that's clear. So I think given our low share penetration in this marketplace, we've got substantial room to further penetrate where those cost barriers are the real issue.

Your last question comes from the line of Serge Belanger with Needham & Company.

This is John on for Serge. We have two questions regarding EXPAREL pricing for this year and beyond. First, can you provide some context on what the discount looks like right now to improve the user base? And what the strategy might look like for the rest of the year based on what you've seen so far? And then when NOPAIN comes into effect next year, what does the pricing strategy look like at that point with improved reimbursement?

Yes. So Charlie, maybe you want to talk a little bit about EXPAREL pricing strategy. What I'll say here is that, when you think about what we're doing with GPO and access to 340B, that's very favorable. So I'll say that. And with NOPAIN, obviously, the reimbursement then gets better as opposed to the pricing. And so beyond that, Charlie, maybe you can provide a little bit of color.

Sure. So If we think about EXPAREL's total gross to net at this point, it's a hair under 84%, and that includes product returns and prompt-pay discount. It includes 340B, a series of individual customer contracts. And over time, it will also include the GPOs as well. I think that was probably your question. If you're talking about pricing -- actually, price increases, we've been pretty modest in that regard. We did one in January. And we're really focused on expansion of the top line by volume, not so much price.

Yes. I think really just for next year when NOPAIN comes to effect, do you see the pricing kind of taking a -- I don't know, a more lumpy change at the beginning of the year? Or do you see more of a gradual flip from a discount to a price increase?

So ASP plus 6 is critically important in the outpatient setting to drive volume. ASP plus 6 has nothing to do with our WACC or the prices we'll charge. So I don't know that we will change our strategy in any way, shape or form. We're just going to try to educate our potential customers so that they can benefit from ASP plus 6 and we can benefit from volume.

John, I want to go back to -- we're sharply focused on growth. Doing so solves a lot of things, including margin some of the questions earlier. And this is the opportunity for us to drive penetration and growth with this catalyst of NOPAIN. So that's where we're focused on.

That concludes our Q&A session. I will now turn the conference back over to Susan Mesco, Head of Investor Relations, for closing remarks.

Thank you, Hermione, and thanks to all on the call for your questions and time today. We are excited about the opportunities that lie ahead for us. Throughout the balance of the year, we will continue to ensure we are well positioned for long-term success. The opioid epidemic continues to be a national crisis, underscoring the vital importance of our mission. Thank you, and stay well.