Pacira BioSciences, Inc. ($PCRX)

All right. I think we're good to go. Good afternoon, everyone, and thanks for joining us at the Barclays Miami Conference. I'm joined on stage by Pacira Biosciences and representing the company is the Chief Executive Officer, Frank Lee. Thank you for being here with us today.

Maybe just to kick off the conversation, if you could give us a quick overview of the current product portfolio and then maybe walk us through 2025, how things trended relative to what you expected? And maybe within that, 2025 was an important year because for your biggest product, there was the NOPAIN reimbursement implementation in January. So we'll get into some of the more financial-related questions. But with respect to NOPAIN, maybe just talk about what you've learned in the first year of having that in place?

Well, Jenna, thanks for having me here, and good to see you all. I have to say, last year, we rolled out our 5x30 strategy for value creation, and that was at a different health care conference, and that was January of last year. And so 5x30, what were those things? It's 3 million patients by year 2030, double-digit top line growth, 5-point expansion in margin, 5 pipeline products and 5 partnerships. And so if you go from January of last year to now, I'd tell you, what a difference a year makes in terms of the kind of progress we've made and the progress that the team has made. And just to recap a little bit, last year, some important events. We did have a settlement with Fresenius, a volume limited settlement, which provided visibility on out to 2039, which is very important for us for our lead product, EXPAREL, and subsequently supported the IP estate with many, many more patents that we can get into. And we started to see, as we talked about the second half of the year, how NOPAIN, along with some of our investments on the commercial side has started to accelerate growth. And growth starts with volume, and we started to see a good amount of that. And importantly, we did a lot of work to make sure that our customers could access the product in a good way through GPO contracts as well as from the payers. So if you step back a little bit, EXPAREL is covered period. What we wanted to do is cover it outside of the bundled payment. So NOPAIN provided the outside of the bundle payment for Medicare patients in the outpatient setting at ASP plus 6%. What we want to do is really expand that to the commercial pay. And we ended the year with about 102 million lives covered total outside the bundle. And what we've been able to find is that from a remittance standpoint, what we're seeing on the commercial side is up to ASP plus 29%, which is great. And as you know, from a pipeline perspective, we're advancing PCRX-201. I'd love to talk about that here shortly as well as the AmacaThera product, which could be a nice complement to EXPAREL. And finally, we signed a couple of very important agreements, one with Johnson & Johnson MedTech to triple our reach for ZILRETTA and importantly, LG Chem, the South Korean company that will cover EXPAREL and ZILRETTA in the Asia-Pacific countries.

Awesome. Thank you. And there's a lot of moving pieces, a lot going on in the pipeline, the 5x30 plan, the gross margin outlook, and we're going to touch on all these things. But I guess let's stick with EXPAREL and just so we can better understand how things are trending so we can frame 2026. So we talked about NOPAIN, which provides reimbursement in the hospital outpatient department. You also have signed over the past couple of years, several GPO contracts, the latest of which was around midyear. And so with EXPAREL through 2025, we saw a nice uptick in volumes in the second half. So with NOPAIN and with the GPO contract that you signed, can you just talk about the volume trajectory over the last 4 quarters and maybe any impact on pricing and that can -- that will help set the stage for when we talk about this year and beyond?

Sure. And just to give some additional clarity on NOPAIN, it's certainly for Medicare in the outpatient setting, and that will cover all outpatient settings. So HOPD, ASC as well as any other setting like in offices, it just doesn't cover inpatient. So that's that remaining piece. And then broadly now commercial payers are following suit. And our ambition there is to really expand that to a much larger universe this year. So let's talk about volume growth on EXPAREL. So last year, broadly speaking, we're north of 6% last year in aggregate last year, and that's compared to about 3% the year before. So I always like to say growth begins with volume, and we saw volume growth. And along the way, as you mentioned, Jenna, we signed some important group purchasing organization contracts, GPOs. And we signed 3 of them that cover the vast majority of our business. And the last one we signed was in June of 2025. And we saw a good uptake from that. So we'll lap that GPO contract in June of this year. And also, as you know, we took a price increase across our product line this year. So as we think about this year and reflect on last year, last year, we signed a lot of these agreements at various times in the year, various payers are coming online at different times of the year and we were really launching into this new catalyst called NOPAIN that we had to educate. And so as we have predicted, the second half is when we really started to see the uptake in volume. And my sense is it will start to steadily increase over time. And so we're seeing that. We're seeing that for sure. And likely the second half of this year is when we're going to start to see volume and dollars converge a little more because that's when we lap the last GPO. So that's kind of how we think about it. And we're seeing good growth, and we've set numbers accordingly to make sure that we can hit those numbers.

And I remember when NOPAIN was coming into effect, I just am curious how the clinician community, may be whether they underappreciated it a little bit or there's some education required to get them up to speed because in years past, there was a little bit of a cost-prohibitive nature just given the immediate cheaper generic alternatives, whereas this provides long-acting, reduces opioid consumption. So I'm just wondering now 12 months later, how you feel going into 2026 with just general awareness that this NOPAIN reimbursement structure, moving it out of the bundle is in place.

Yes. What's really great to see is if you go back in time a little bit, the whole idea was that because of the bundled payment, because you get one payment for a procedure, it almost provided a disincentive to use the most innovative products. So what NOPAIN did is say, okay, now you're still going to get paid for the bundle. But now separately, you'll get paid ASP plus 6% or more in the case of commercial, it's up to 29% for 11 products that are included in NOPAIN, of which we have 2 of them, iovera° and EXPAREL, right? So that was the idea. And because of that, then the idea is that the opioid utilization would decrease over time and because these products do have a favorable impact on opioid use. Now here's the good news. We just ran a survey, a very large market research survey, 740 participants in this, pharmacy directors, anesthesiologists, surgeons, awareness is high. About half have already taken action in terms of how they manage patients before, during and after surgery. And so we're making an impact. We're starting to see it, and we're going to continue to run the survey over time. And we've shared these data with CMS, of course, because CMS is looking at, gosh, how long are we going to keep NOPAIN? Initially, it was for 3 years, as we all know. And now we're entering an evaluation period. And so I think the data look promising in terms of the impact that NOPAIN is having, not only directly through Medicare, but also broadly through commercial payer access and reimbursement.

And speaking of the duration of NOPAIN, I mean just common sense would suggest it feels like it would be a negative headline to pull that back. Like how confident are you that this -- it makes sense to keep this in place just given the broader effort across the country to keep lowering opioid consumption in favor of non-opioid alternatives?

Yes. What I'm really pleased to see is the data is starting to point that way. So we're already doing some claims analysis to further support the market research. And my sense is as we progress along and the data will continue to point to better patient outcomes, lower opioid utilization and overall health care costs that are reduced because of that. So this is a good idea, and we'll continue to share information. And we should all be happy that this insight led to our government passing this legislation, and it's already having a good impact.

Awesome. So just shifting gears to your 2026 guidance. Total company revenue expected to grow 3% to 6% EXPAREL a bit higher than that at 4% to 8%. And we appreciate breaking out the EXPAREL specific revenue. I think that's very helpful. Can you talk about -- we mentioned with the GPO contracts, there's some pricing impacts and maybe we lap that. So between the volume and price, just for modeling purposes, talk us through the cadence of how that might play out over the year?

We feel comfortable breaking out EXPAREL because I think -- and of course, people want to know exactly what we're thinking about EXPAREL. So we feel comfortable with that guidance. And we've set guidance in a way where we want to make sure that we deliver on that this year. Last year, there were a lot of different moving parts because it's year 1, year 1 of not only NOPAIN, but year 1 of 5x3 and a lot of things that we're doing. So what are we doing to ensure that we hit our numbers this year? First is, as you know, last year, we broke apart our selling efforts. So we've got one dedicated field force previously selling all 3 products. But now we have 3 separate field forces, each selling their individual product because these are very different products. And -- so last year, we went through a bit of a reorganization, particularly in the second half of the year for ZILRETTA and iovera° while keeping EXPAREL selling effort where it is. So we took that one sales force and said, just sell EXPAREL, stay focused. That's the priority. We'll restructure and add new sales forces for ZILRETTA and iovera°. And my sense is that effort will pay off this year. But we've been conservative about guidance on ZILRETTA and iovera° because I want to see that growth before I guide to a bigger number. And so my sense is that we're positioned well this year.

And I have a few questions on ZILRETTA and iovera°, and there's also some pipeline developments there as well. But just one last one on the EXPAREL guidance. So as you mentioned, 2024 was a nice uptick in volumes. And then when you think about the total revenue guidance in 2026 versus 2025, the high end, another nice step up, the low end, a slight deceleration. So just between -- and you mentioned a layer of conservatism and wanting to set a bar that you feel very comfortable with. So just can you talk about maybe what would take you to the higher end of that range?

Yes. So we continue to execute on expanding payer coverage, so outside of the bundle. So that's going to be important as more and more commercial payers reimburse at up to what we're seeing and, again, ASP plus 29%, which is substantial. And certainly, pulling through the GPO agreements. So we have a number of people on the ground that help to educate people like pharmacy directors, billing and reimbursement folks and health care professionals that now it's available to the GPO. So I think it's really more about execution this year because a lot of the year 1 moving parts have settled a bit, right? And as I mentioned earlier, and you mentioned, we'll lap the GPO, the third one mid this year, and that's when volume and dollars will start to converge a little more. So I'm excited about this year. I'm excited because a lot of the things that we put in place. And like I said, if I step back, what a difference a year makes. Last year, in January, we were just rolling out NOPAIN. There was some uncertainty about EXPAREL's IP runway. Now we have a lot more visibility about not only the IP runway, but also the impact of NOPAIN and people in place in the field now that are really executing in a way that we start to see growth. And just to remind you, EXPAREL has been around a long time. And to get them more of a late life cycle product to grow again like we have, let me tell you something. You don't see that very often in this industry where it was relatively flat before then we went to 3% to 6%, right? So that's -- I want to just recognize the team for that.

And before we focus more on the 5x30 with -- and mostly with ZILRETTA because you announced the J&J partnership, and we'll talk about iovera°. And maybe within this question, for those 2 products, if you could remind us of the pipeline updates that you expect next? And just thinking about the trend from last year, what you're seeing in those products this year, how the J&J partnership can impact ZILRETTA and also the pipeline updates for those?

So what's great is with ZILRETTA, Johnson & Johnson DePuy Synthes now will triple our reach. So last year was a lot about getting that partnership set up, folks in the field trained and working together. So this year will be about executing. And so -- but I didn't want to bake all of that in until we start to really see it, right, and have actual evidence of that. For iovera°, it was really about let's get medical device people to sell a medical device. And we saw the impact of that in the second half of last year. And so I expect to see that continue going forward. And just so we step back here a little bit. This year, in addition to the base business and what we're doing, it's the first year where we've actually had data events coming up. So we'll have ZILRETTA of the shoulder interim analysis coming up. We'll have iovera° and spasticity, both of those registrational trials and PCRX-201, the Part A reading out at the end of this year.

Awesome. And with the margin -- the gross margin target as part of the 5x30 plan, can you just help us bridge the 5 points of expansion and then there's a little bit of a step down this year. And then also with 4Q and maybe the OpEx guidance for this year, just you're clearly investing. There's a lot of different things to invest in. So maybe help us unpack that a little bit.

Yes. And there, again, I'd say what a difference a year makes because if you go back in time not too long ago, the margin was 76%. And the company was, in many ways, living hand to mouth on inventory. We've gone from that to a very robust process, and we almost got to the 5 points just last year in the first year, as you know. And so what that wound up doing is we didn't was a much more efficient process. We didn't throw away as much product, and we built up inventory. And so cost per unit went down. We'll kind of work through that this year. And so that's why it's a little lower in terms of guide this year than last year. But we're well on our way to achieving 5x30. So we'll have continuous improvement just on the process, number one. And number two is that as volumes go up, the margins get better.

Awesome. So it feels like for 2026, EXPAREL, likely another step-up in growth. Things are tracking well, ZILRETTA, iovera°. You also have several pipeline readouts and you also announced a partnership in Asia Pac with LG Chem on EXPAREL. So I want to spend a minute there and just talk through maybe some of the due diligence and what gave you confidence and maybe just given in the United States, what we saw were some issues with the cost. So I'm just curious on how you view the adoption over there. And eventually, we're going to talk about the 201 and how all of this will build towards that double-digit growth, but we'll start with the LG Chem.

And I'm really pleased at the quality of partners that we've been able to sign deals with. So J&J DePuy, leader in their field, LG Chem, a leader in Asia Pacific. And when I think about partnerships outside of the U.S., as we've looked at these partnerships in the various regions, and we look to sign something in Europe, Latin America, Japan to build on the broadly South Korea and Asia Pacific partnership with LG Chem. We won't guide to this until next year, but these revenues will be important. They're not insignificant. And in fact, if you think about how they ramp, it builds nicely so that they really start to peak around the time frame that we might have a little bit of erosion from Fresenius, right? And so historically, as you know, several years back, the company tried to execute more of an ex U.S. strategy by itself. And so we're taking a different tack here with leading partners who have presence in that space. And so in Asia, we expect a lot of this to come from private pay. And as you know, the price of our product isn't thousands or tens of thousands, it's hundreds of dollars. So it's more accessible, right? And so that's the difference. And so we're excited about signing these ex U.S. agreements, which will often, just like the LG Chem involve an upfront, a transfer price and royalties, and it won't be insignificant. So that's that piece of it. And of course, we can talk about the pipeline as well.

Yes. And on the pipeline, probably the most -- the program that's getting the most attention right now is PCRX-201. And I just wanted to get your thoughts on what is driving the excitement in that, how you view this opportunity, how much of a potential game changer it is in OA pain, just -- and maybe the timing of when you would expect that update?

I have to say I'm really excited about this one. This could be truly transformational. I don't use that word lightly. This could be the first gene therapy that's local for the masses as opposed to systemic gene therapy for the few rare disease. And so we're studying this for osteoarthritis, and there are some impressive results for Phase I, 72 patients. And we'll report out on Phase II Part A at the end of this year. And as we go through the course of this year, we're going to try and set some, I would say, context as to how to think about the data that we'll see during the course of this year and also the path to regulatory approval. So if you think about this a little bit, some context, we already know what short-acting steroids and HA deliver. It's a few months of durability, right? When we went out to the marketplace, we said, hey, what would be transformational? And what we got back is if you have durability out to 12 months, that is transformational. But the low bar is about 3 months because that's what you typically get with steroids and HA. So we've got a wide band there. And as we know from our Phase I data, the durability was quite impressive out to many years. So that's one lens that we'll look at through. The other lens is we know what the safety profile of PCRX-201 is, and it's very favorable, 72 patients that we followed for 3 years. And so we're looking to see something similar to that, that we saw earlier. So I think we'll have some context. And just as a reminder now, this study isn't powered for efficacy, it's primarily a safety study. But what we'll see are trends toward efficacy, and that will inform our future development. And as you know, we have RMAT designation for this. And so we'll be looking at ways to accelerate the development path to approval.

And on that front with accelerated the path to potentially accelerated approval in the 5x30 double-digit growth. So you have the 3 products on the market. You have a bunch in the pipeline and new indication for ZILRETTA, iovera°. Can you just talk about the double-digit 5x30, like which products are going to contribute to that? And what maybe in your pipeline is a little bit beyond 2030 and the growth driver more long term?

Yes. I suspect that we'll get there in aggregate. To break it down individually, it's going to be hard, but it will get there certainly, and you can see the early signs of it. And the proof in the pudding will be how we report out first quarter and second quarter this year, but I believe we're well on track to that double digit. And as we talked about, we're well on track with margin, tremendous improvement there. And so my sense of this is we'll step back this year and say, gosh, the numbers look good. We're on track here with delivering 201. We set expectations accordingly. And then we'll have some other interesting data readouts. And now along the way, as you all know, we bought back a fair amount of stock last year because we felt like there's a disconnect between what we think the valuation is versus the market. But as we go forward, we'll have to look at that carefully and also consider some BD deals that could be accretive. So now we have a commercial medical market access infrastructure, so you could easily drop a product or 2 into that.

Yes. And on the capital allocation, just -- and you mentioned BD before we close out, I just wanted to give you an opportunity to remind people of your balance sheet situation. The company has low leverage and just your capacity to do deals.

Yes. We're in very strong financial shape. So not very much leverage. So we do have a fair amount of capacity in terms of firepower. We're going to be very disciplined about this. So the first place we're going to look are going to be places where it could be accretive out of the gate because, of course, we shrunk the denominator now in terms of the number of shares outstanding. So it will be nice to continue on this momentum of delivering top line and perhaps more with something that could be accretive. So as I say to people, this is a year of Pacira. And so what a difference a year makes.

Yes, that's fantastic. Your core driver right now is picking up growth, different volume tailwinds, big pipeline with updates coming this year. And yes, thank you for attending the conference, and we appreciate it.

Thanks, Jenna.