Conference Transcript - PCRX 2026-03-11

Operator

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 Passera Biosciences and representing the company as the Chief Executive Officer, frankly. 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, you know, 2025 was an important year because for your biggest product, there was the no pain reimbursement implementation in January. So we'll get into some of the more financial related questions, but with respect to no pain, maybe just talk about what you've learned in the first year of having that in place. Well, Jenna, thanks for having me

Frank D. Lee, CEO

here and good to see you all. I have to say last year we rolled out our five by 30 strategy for value creation, and that was at a different healthcare conference, and that was January of last year. And so five by 30, what were those things? You know, it's three million patients by year 2030, double digit top line growth, five point expansion and margin, five pipeline products and five partnerships. And so if you go from January of last year to now, I 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 Presenius, a volume limited settlement, which provided visibility on out to 2039, which is very important for us, for our lead product, Expiril, 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 no pain 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 you know if you step back a little bit Expiril is covered period what we wanted to do is cover it outside of the bundle payment. So no pain provided the outside of the bundle payment for Medicare patients in the outpatient setting at ASP plus 6%. What we wanted to really expand that to the commercial pay. And we ended the year with about 102 million lives covered total outside of 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 PSARX 201 I'd love to talk about that here shortly as well as the Amica Thera product which could be a nice complement to Expiril and finally we signed a couple of very important agreements one with Johnson & Johnson medtech to triple our reach for Zoretta and importantly LG Chem the South Korean company that'll cover Expiril and Zoretta in the Asia-Pacific countries. Awesome. Thank you. And

Operator

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 Expiril and just so we can better understand how things are trending so we can frame 2026. So we talked about no pain, 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 mid year. And so with X4L through 2025, we saw a nice uptick in volume in the second half. So with no pain and with the gpo contract that you signed can you just talk about the volume trajectory over the last four quarters and maybe any impact on pricing and that can that will help set the

Frank D. Lee, CEO

stage for when we talk about this year and beyond sure and just uh to give some additional clarity on no pain it's certainly for medicare in the outpatient setting and that'll 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 Expiril. So, you know, 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, you know, 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 three 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 were coming online at different times of the year. And we were really launching into this new catalyst called No Pain 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 where 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, you know, we're seeing good growth, and we've set numbers accordingly to make sure that we can hit those numbers.

Operator

And I remember, you know, when no pain was coming into effect, I just am curious how the clinician community maybe 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 no pain reimbursement structure, moving it out of the bundle is

Frank D. Lee, CEO

you know in place yeah you know what's really great to see is you know 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 no pain did is say okay now you're still going to get paid for the bundle but now separately you'll get paid at ASP plus 6% or more, in the case of commercial, it's up to 29%, for 11 products that are included in no pain, of which we have two of them, Ayovera and Expiril, 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, you know, of course, because CMS is looking at, gosh, you know, how long are we going to keep no pain? Initially, it was for three years, as we all know, and now we're entering an evaluation period. And so I think the data looked promising in terms of the impact that no pain is having, not only directly through Medicare, but also broadly through commercial payer access and reimbursement.

Operator

And speaking of the duration of no pain, 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 at this? It makes sense to keep this in place, just given the broader effort across the country to keep lowering opioid consumption and in favor of non-opioid alternatives.

Frank D. Lee, CEO

Yeah, what I'm really pleased to see is the data 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, 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, you know, this insight led to our government passing this legislation, and it's already having a good impact.

Operator

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

Frank D. Lee, CEO

You know, we feel comfortable breaking out Expiril because I think in that, of course, people want to know exactly what we're thinking about Expiril. 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. You know, last year there were a lot of different moving parts because it's year one. Year one of not only no pain, but year one of 5x30 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 three products. But now we have three 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 the second half of the year, for Zolretta and Ayvera, while keeping Expiral selling effort where it is. So we took that one sales force and said, just sell Expiral. Stay focused. That's the priority. We'll restructure and add new sales forces for Zilretta and Ayovera. And my sense is that effort will pay off this year. But we've been conservative about guidance on Zilretta and Ayovera 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.

Operator

And I have a few questions on Zilretta and Iovera, and there's also some pipeline development there as well. But just one last one on the XBRL 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, you know, 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? Yeah, so we continue to execute on

Frank D. Lee, CEO

expanding payer coverage, you know, so outside of the bundle. So that's going to be important as more and more commercial payers reimburse it up to what we're seeing in, again, ASP plus 29%, which is substantial. And certainly pulling through the GPO agreement, so we have a number of people on the ground that help to educate people like pharmacy directors, billing and reimbursement folks, and healthcare 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 one 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. You know, last year in January, we were just rolling out no pain. There was some uncertainty about Xparel's IP runway. Now we have a lot more visibility about not only the IP runway, but also the impact of no pain. 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, Xperl has been around a long time. And to get a much more of a late-life cycle product to grow again like we have, let me tell you something. And you don't see that very often in this industry where it was relatively flat before that we went to 3% to 6%, right? So I want to just recognize the team for that.

Operator

And before we focus more on the 5x30, and mostly with Zellretta, because you announced the J&J partnership, and we'll talk about Iovera, and maybe within this question, for those two products, if you could remind us of the pipeline updates that you expect next and just thinking about the trends 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,

Frank D. Lee, CEO

Johnson & Johnson, DePue sent these 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 that in until we started to really see it right and have actual evidence of that for ayovera 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 you know 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 Zoretta of the shoulder interim analysis coming up. We'll have Iovera and spasticity, both of those registrational trials, and PCRX-201, and the Part A reading out at the end of this year. Awesome. And, you know, with the margin,

Operator

the gross margin target as part of the 530 plan, can you just help us bridge the five points of expansion? And then, you know, 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. Yeah. And there again,

Frank D. Lee, CEO

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 five points just last year, in the first year, as you know. And so what that wound up doing is, you know, we didn't – it 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.

Operator

So it feels like for 2026, XBRL, 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 AsiaPAC with LG Chem on XBRL. So I wanted to spend a minute there and just, you know, 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, you know, 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

Frank D. Lee, CEO

with the LG Chem. And, you know, I'm really pleased at the quality of partners that we've been able to sign deals with. So, J&J DePue, leader in their field, LG Chem, a leader in Asia Pacific. And, And, you know, when I think about partnerships outside of the U.S., you know, 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 Kim, 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 timeframe that we might have a little bit of erosion from Residious, right? And so historically, as you know, several years back, the company tried to execute more of an ex-US 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-US 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.

Operator

Yeah, and on the pipeline, probably 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 in maybe the timing of when you would expect that update.

Frank D. Lee, CEO

You know, 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, you know, we're studying this for osteoarthritis, and there were 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 after 12 months, that is transformational. But the low bar is about three months, you know, 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 one data, the durability was quite impressive, you know, out to many years. So that's one lens that we'll look at through the other lenses. We know what the safety profile of PCRX 201 is, and it's very favorable. You know, 72 patients that we follow for three years. And so, you know, 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.

Operator

And on that front with the path to potentially accelerated approval and the 5x30 double-digit growth, so you have the three products on the market, you have a bunch in the pipeline, and new indications for Zilretta, Iovera. Can you just talk about the double-digit five-by-30, like which products are going to contribute to that and what may be in your pipeline is a little bit beyond 2030 and the growth driver more long-term?

Frank D. Lee, CEO

Yeah, I suspect that, you know, we'll get there in aggregate. You know, to break it down individually, it's going to be hard, but we'll 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, you know, my sense of this is we'll step back this year and say, gosh, you know, 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, you know, 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 two into that.

Operator

Yeah. 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. You know, the company has low leverage and just your capacity to do deals.

Frank D. Lee, CEO

Yeah, 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 right out of the gate because, of course, we've shrunk the denominator now in terms of the number of shares outstanding. So it would be nice to continue on this momentum of delivering top line and perhaps more with something that could be accretive. So, you know, as I say to people, this is a year of Pissera. And so what a difference a year makes. Yeah, that's fantastic. Your core driver right

Operator

now, picking up growth, different volume tailwinds, big pipeline with updates coming this year, and yeah, thank you for attending the conference, and we appreciate it.