All right, good afternoon, everybody. Thanks for braving the wintry mix outside and joining us this afternoon. For those of you who don't know me, I'm Glenn Santangelo. I cover the specialty pharmaceutical sector at Jefferies and a couple of other things, and we're delighted to have Pacira BioSciences here with us. Representing the company, to my right is Frank Lee, the CEO. Kristen Williams, to his right is the General Counsel, very relevant for today's conversation. So thank you, Kristen, and Susan Mesco, who heads the Investor Relations function that I think many of you may be familiar with. So why don't we just dive right into it? We got 25 minutes for some Q&A here, and let's just get right after it.
So, I mean, the question of the day, we're going to talk about EXPAREL in a lot of different directions, but why don't we start with 3Q revenue growth, and EXPAREL was up 2.6%. That was a mix of volume up 3%, price up 1%, maybe a little bit of mix offset that on the vial size and stuff. But overall, 2.5%-3% growth in the second quarter, pretty consistent, like low single-digit sort of growth for the recent past. And I mean, I think I've heard you say before, it's kind of a good job if we can sell the product in this environment with this sort of reimbursement structure. Think about what we'll be able to do at NOPAIN . But maybe a good place to start is, how many months has it been you've been CEO now?
I think it's been about 10. Feels maybe a touch long.
10 months. So maybe why don't you just talk about sort of the three quarters you now have under your belt and the job you did sort of on EXPAREL and sort of priming the pump as we gear up for NOPAIN in 2025. But let's start with 2024.
Yeah, so first off, I'm really pleased with third quarter performance. And it's now, Glenn, three quarters in a row that we've met guidance, right? So not that I'm counting. It's something like that. As we started the year, we said we wanted to do three things. First is to really refresh our mission and values and our culture, and we've done that. Second is to zero in on our therapeutic area strategy. And so we've said publicly now we're very much interested in musculoskeletal disease, pain, and adjacencies. So those are home for us, and we can talk about what we're doing to further that. The third piece is to really modernize our commercial, medical, and market access capabilities. And we've done that to a substantial extent. I can talk about that in more detail.
One of the things that we're very pleased about as a result of that is you may have noticed that we got a J-code for the first time for EXPAREL, which is important. We also got Iovera included as part of NOPAIN. So that's two out of the 11 products including NOPAIN. So for Iovera, that'll mean up to another $255 per procedure on top of what physicians already get for that procedure. So those are some of the short-term highlights.
Okay, and then when you think about pricing drivers, we've talked in the past about the 340B Program that the company's participating in. You've signed a number of GPO contracts, right, and talk about the impact that that's had on your business from a volume and pricing standpoint this year.
So we think the GPOs, signing those agreements, number one, is the right thing to do. So we signed Premier earlier in the year. We signed Vizient in September, and we're in the process of signing the third, HPG, likely by sometime first quarter of next year. And so when it's all said and done, we'll have approximately 80% of the business under GPO contracts. And in terms of impact, we think that's going to be sort of mid-single-digit margin impact. And so now going forward, it'll be important to drive volume growth. And we think that based on the catalysts ahead, that is NOPAIN. In addition to that, all the work that we've done around commercial, medical, and market access will help going forward.
Okay. I'm sorry. So you said 80% of the business will be under GPO contract. That'll impact your margins by about mid-single, but you think you'll more than offset on the volume side. Is that a fair characterization?
We think the NOPAIN is going to be certainly. We're seeing good engagement with our stakeholders, also with our tracking studies putting the right way leading up to the launch. We think the majority of the impact that we'll see on NOPAIN will be second half of next year. It'll just take some time for our customers to adopt this new reimbursement, which is, as you know, ASP plus six for Medicare patients.
Let's talk about that pricing under NOPAIN when you look to 2025 and you start to maybe lap some of the GPO contract signings. I mean, overall, do you think pricing will be neutral or positive to growth as you look next year?
Yeah, so in terms of lapping, so we'll lap the full year impact of Premier. The full year impact of Premier will be early this coming year, and then, of course, September next year will be Vizient, and then the year after will be HPG, so it'll be a gradual impact, Glen, over time, so it won't be abrupt, and so I feel very good about the fact that that's going to happen and also the potential for volume gains going forward.
All right. Give me those dates again. Premier, you said, was early 2025. And when was Vizient?
Vizient, the one-year anniversary will be September of next year. And then HPG will be what it'll be. And likely it's going to be in the 2026.
Okay. All right. Let's transition, you know, or segue into the no pain opportunity. I mean, you just were sort of talking a minute ago about some of the tracking studies you've done, and we'll take this in two separate pieces, EXPAREL and Iovera, a little bit later in the conversation, but let's start with EXPAREL, given that that's where a lot of the focus is. Can you talk about sort of how you think the market opportunity expands from a procedure volume perspective? Maybe that's a good place to start, and these tracking studies you mentioned, if you could elaborate on that a little bit.
Sure. And just by way of background, I think most folks here know, but just to provide a little bit of perspective on NOPAIN, this effort took the company, along with many other stakeholders, seven years to get across the line. This will come into effect in January 2025. And as most of you know, this came about because the company saw that these procedures that were being performed and then the opioids that were prescribed were causing or leading to a lot of opioid abuse. So that was the rationale behind it. And then the underlying assumption was that, look, the way that the reimbursement structure is as of at that time and still today is bundled. So now what NOPAIN does is it pulls this product cost out of that bundle and reimburses it separately for Medicare patients.
All told, we think that's about a 6 million patient or procedure opportunity. This is important because CMS has looked at it and said, "Hey, there's value here to pulling that out of the bundle." Now we'll have a situation where our hospital stakeholders primarily, and of course, our ASCs as well, are all under cost pressures. This will help to alleviate that.
So you're increasing the TAM, you said, by six million procedures on a base of.
Some are used now, but that's a total potential.
On a basis of, in terms of the reimbursement, you have like ASC%.
Total TAM is about six million.
Okay. Total TAM. All right.
Second to that is, as we all know, commercial payers lag Medicare, and so it'll be our job to make sure that commercial payers are aware of this and pull it through, but that'll take a little bit more time.
Yeah. And so I think you were sort of implying that it's, "Hey, this is not going to be a light switch that gets flicked on January 1st." Even though the reimbursement changes, you think there's going to be an education period, a marketing period, a discussion period that will start to benefit the company more in the second half of 2025. How should we think about the cadence of seeing the uptick in this procedure volume in 2025?
First, we're going to provide more definitive guidance as we issue that guidance early next year. That is number one. Number two, what we're doing differently this year leading up to NOPAIN is we are now actively calling on some key stakeholders in the hospital, that is, directors of pharmacy and the C-suite. We have folks who are calling on national and strategic accounts. By those kinds of interactions, we're seeing that this is having an effect. This is a positive discussion that we're having with these stakeholders about how this new reimbursement is going to allow them to access EXPAREL, perhaps more than they are now, or right now they may not be using it at all. Those are positive discussions that we're having. In addition to that, we've done a number of tracking studies.
We've done now a couple of waves of tracking studies, and we know that awareness and education and intent to take action are all moving in the right direction. Come early next year, we'll provide some more definitive guidance about where we think the growth is going to be. But as you might imagine, one of the places that you'll likely see are existing customers who may be able to utilize it more. There may be existing customers who may only be utilizing it for certain procedures. And then, of course, there's an impact on new customers through both GPO and this arrangement with NOPAIN that'll come in. They'll be your classic sort of early adopters, middle adopters, and late adopters, and we'll prioritize our time accordingly.
So is there any way you can sort of characterize how enthusiastic you are about the uptick in the volume lift? Because you're able to sell the product as part of the bundle, and now it goes to be a fully reimbursed moneymaker for the hospital. It seems logical to think that we should see a pretty sizable uptick in volumes. And you're trying to temper the enthusiasm, which is maybe appropriate, given the track record you're trying to build to beating expectations. But is there any way to sort of help us think about those tracking studies and maybe how enthusiastic or not enthusiastic we should get?
One of the things that always impressed me about EXPAREL is it's a good product, and people want to use it. What has been the major barrier? It's been reimbursement and the impact on budgets. You can talk to many an administrator, and they'll tell you the same thing. Patients love it. Doctors love it. It's just this reimbursement piece that's been troublesome over time. Oftentimes, when it takes hold and institutions use it more and more, it becomes on the radar. There's a question about, is it on the GPO contract? Then there's a question about, should we keep using it at this budget level?
That's how oftentimes these things kind of develop. I think that with the reimbursement and cost barrier being lower, at least for a fraction of the patients, this is going to be good over time. But it won't be overnight.
Okay. All right. Well, let's segue into the litigation side of things because that's clearly on everyone's mind. Kristen, obviously, the '495 Patent was deemed to be invalid. And that was obviously had a big negative impact on the stock. The company sort of filed its appeal. Could you sort of give us the timeline on how long you think it takes for that appeals process to sort of play itself out and when we should have more visibility on that?
Absolutely. The '495 Patent decision was in August of this year, and so a few weeks after that, we filed our appeal. 15-18 months is what it says on paper it should take. We're seeing more around 18 months, so I would expect end of Q1 2026 to be around the time, give or take a few months, when we would see a decision there.
Okay. All right. And in the interim, eVenus, they have that full FDA approval. And initially on that day, a number of analysts had cut their ratings. They slashed their estimates and the expectation that we're going to see some type of an at-risk launch. And so from your perspective, we haven't seen that yet. I mean, what are your expectations at this point?
That's a good question. We don't believe an at-risk launch is imminent for a number of reasons. We'll be able to access the product once they're able to make it for testing purposes, and so that's important. And also, we're certainly keeping an eye on competitive intelligence as well. In addition to that, now, what's also important to bear in mind is we continue to innovate, so of course, we've got the two patents that are being litigated now, but again, we continue to innovate, and we expect that additional patents will be issued, so that's a journey ahead. We think we've got a long journey ahead when it comes to the legal proceedings.
Just to be clear on this point, because I think it's pretty valid for people, I mean, will you know in advance if eVenus plans to launch at risk? Is there anything that requires them to give you product, give you a heads up? Like, will you have full knowledge in advance of any potential launch outside of the competitive intelligence you might be gathering?
It's one of the benefits of being in litigation with them around this product. They are required to give us samples of the product for testing. We have not only the appeal, but there's another case on a different patent we have pending with them, and they have not yet given us any samples there. So we will have a heads up from that front as well as the other endeavors we're taking to.
And so I don't know how to assess that. I mean, do you think they have product and they're just not giving it to you because they don't plan to launch at risk or they maybe don't have any product manufacturing at this point?
When they turn on their manufacturing and create any nonclinical product.
Whether they're going to launch or not.
Correct. They have to give it to us because of these lawsuits.
All right.
Just to further that a little bit, so we haven't taken action to file a preliminary injunction because an at-risk launch is not available.
But you're prepared to do that.
We're prepared if that situation comes up. And the other question sometimes is, are there other ANDA filers? And that's no. And so we believe this is the only ANDA filer on the horizon that we can see. And if you just sort of add up the time that it takes to get that approved, et cetera, we're going to be with this one generic potentially for a long time. The other idea here is if and when another generic were to launch that is eVenus through Fresenius, when you take a look at the erosion curves, typically what you see for these kinds of situations is 10%-15% price erosion. So there's a business to be had there. And if that winds up being the case, which we don't believe right now, then we're ready to compete.
Yeah. Okay. Obviously, Kristen, a lot of focus has shifted to the '574 Patent. I think the company is sort of waiting to have its day in court. We're waiting for a court date, which I don't think we have at this point. I mean, can you hazard a guess as to when you think you'll have your day in court on that patent?
Yep. It's up to the courts to set a schedule and a trial date, and because this is not the first one we're litigating, you don't have that 30-month stay and that faster track, so I would not expect before the end of this year to have a trial date set whenever they deem themselves ready to set one. I think it would be the earliest, the end of this year, and then six months after that.
So you think the earliest time will be a trial date in the middle of 2025 with a decision soon thereafter on that?
End of 2025 trial is my best guess. Middle 2026 decision on 574.
Assuming that didn't fall the company's way, that would start another sort of appeals process that could take 12-18 months.
Exactly. Yep.
So in your mind, I mean, it would be some type of quasi at-risk launch in any scenario, at least for the next kind of couple of years.
Yes, and as Frank mentioned, any additional patents that we file lawsuits on as we're thinking about that strategically would, again, add a few years to that.
And so it sounds like there are multiple layers of patents here, and the company feels like each incremental patent is getting a little bit stronger than the original '495 Patent.
Correct.
There's hopefully or potentially more to come.
Correct.
And just to add on to that, we have increased our investment in our commercial medical and market access capabilities because we know that we can continue to drive business based on the catalysts that we have ahead of us. So we're not pulling back from investment.
You know, Frank, given the market hates uncertainty, is there any sort of scenario where you think a settlement could make sense with eVenus so we get out of this sort of flywheel of trying to think about when the next patent trial is? I mean, given you have IP on the product out to the early 2040s.
Sure. First off, the company that has license to launch here in the U.S. is Fresenius, not eVenus, which is a subsidiary of Hengrui, the Chinese company. So it's Fresenius. And you all can do your own research on Fresenius. They're a long-standing German company in the space. They're not your typical generic company. Okay?
So that's number one. So as it relates to any sort of settlement, what I've said very consistently is we like certainty as much as any other investor does. Certainty brings, I think, value when it comes to our market cap. It brings value to the organization and our people. But it's got to be under the right terms. And so we believe we're in a good position based on the IP that we have now and also perhaps the pending IP to be announced in the future. So that'll have to be balanced.
Okay. All right. I want to give some time to ZILRETTA and Iovera in the pipeline. So let's talk about Iovera, since you brought it up in the beginning of the conversation with respect to another beneficiary under no pain. I think you said an additional $255 million per procedure?
Not million.
Not million. I'm sorry. Dollars, dollars. That'd be a lot of money per procedure. $255 per procedure.
We could charge that, but we might not sell much. So yeah, another $255 incremental per procedure. So whatever they're getting now, plus an additional $255, and this is significant.
Have you been going through the education process on that product as well? Do you think that that'll take quarters to sort of play itself out and the cadence as people sort of ramp up? Or do you feel like the orthopedics that you've been in touch with kind of already realize this and can start to realize those benefits sooner rather than later?
Yeah. It'll take some time as well. But you know what I really like is the way we've really focused our selling and marketing efforts. So there's a dedicated group selling EXPAREL, a dedicated group selling ZILRETTA, and now a dedicated group selling Iovera. Because these are very different businesses. As you know, a medical device is very different than especially pharma product. So we do think there's upside there. And we do think that we'll see some of that come next year. And then as we get traction, particularly on our overall value story that we'll tell payers, because we do have data sets, they just need to be organized in a way that's payer-friendly.
Okay, and ZILRETTA? I mean, it feels like sales have been kind of. I don't want to say flat is the right word, but kind of up and down a little bit each and every quarter. I mean, how would you assess the company's performance as far as ZILRETTA is concerned? And how do you think about the growth algorithm going forward?
You know, I always say that among the three children, ZILRETTA has been the one that's been malnourished at the dinner table, so to speak. A lot of attention paid to EXPAREL, a lot of attention paid to Iovera because it's such a remarkable product when you use it. There's immediate relief, and so it's a bright, shiny object. I really believe there's upside in ZILRETTA. We know that it's promotionally responsive.
We've done the work. We've done the analytics to show that it is promotionally responsive, and so we're going to dial that in. So there's going to be some mix of personal, non-personal that we dial in. And there's some other opportunities and stakeholders that are outside of orthopedics as well. So I'm bullish on ZILRETTA. And as you know, we've got a shoulder study that's ongoing with ZILRETTA that'll read out in 2026.
If that's approved, that'll be the first long-acting steroid for shoulder. That's about a million procedures a year. Then we also have a spasticity study ongoing for Iovera. As you know, many patients that have cerebral palsy or other kinds of deficits, they can't move. There's both a pulling and a pushing to the muscle. That study will read out in 2026 as well. We've got a number of things going on in addition to 201, which.
Yeah, let's talk about 201 because you just recently presented some data. So could you just give us a quick update on that program and the timeline and market opportunity?
Yeah. I have to tell you that when I first joined the company, I said no to this program because I said we're not going to get into gene therapy. But in fact, this is sort of the anti-gene therapy of gene therapy. And I'm glad we made the decision to move forward with it. This is a locally administered gene therapy for common diseases like osteoarthritis of the knee. So this program, PCRX-201, was the first program to be granted RMAT designation, which is the equivalent of breakthrough for osteoarthritis of the knee by the FDA. We've just completed sharing the two-year data at the American College of Rheumatology. And what that said is that at two years, there was over about 70% of patients achieved a 50% or greater improvement from baseline at two years.
So if you follow the OA studies, you don't see that kind of response. And most of the time, the response wanes after three to six months. And so we think there's great promise here and great unmet need. So again, this is locally administered, which really helps the safety profile, right? It's not systemic. It also helps cost of goods as well. And this is for common diseases, not rare diseases like most of the gene therapies targeted to today. So we're excited about this. And you might think about where else we could take this platform when you think about locally administered gene therapies.
Frank, maybe, and hopefully this doesn't anger Susan, but can we just sort of wade through these consensus estimates that are out there for 2025? I appreciate you don't want to give guidance, but it just seems like people are modeling EXPAREL sales down next year. And I think after sort of the invalidity ruling, a lot of people sort of cut their estimates. And now you have this very bifurcated sort of consensus estimate out there for next year.
I mean, without sort of giving us guidance, recognizing you'll do that in February when you report for a Q. But how will you think about things and what types of assumptions might you make when starting to think about forming that guidance given the legal situation sort of sits where it is with the reimbursement change coming into effect on January 1? Is there anything you can tell us to help us navigate how to think about that?
We're not going to be guiding to a decrease in sales. How's that? Number one. Number two, my sense of it is if you think about kind of the way we're going now, that might not be unreasonable for first half of next year. Really the question is, come second half, how quickly do we grow into the second half, into the first half the following year? I think that's what I'll say at this point in time. We're definitely not modeling a decrease in sales.
Yeah. Okay. All right. We're out of time, but I want to give you the last sort of 20 seconds. I don't know if there's anything you want to leave the audience with, anything that we didn't cover that you think is kind of important. I'll give you 20 seconds to close or however much time you need before they kick us out.
Okay. Well, first off, thanks for your interest in the company. What you'll see going forward is we're going to continue to grow our existing pipeline. I think we have opportunities not only in the U.S., but also with the right partners outside of the U.S. to grow our existing products. That's number one. And that'll fuel our investment, our careful investment in the pipeline. And so we're making the pivot from specialty pharma into innovative pharma. That transition will happen in the coming years. And what you'll expect from that is a greater investment in research and development. And ultimately, we believe that's going to show up as greater value as represented by the market cap and the company.
Okay. Thank you very much. Appreciate it, Kristen, Susan, Frank. Thank you very much.