Okay, good morning, everyone. Thank you for joining us. For our next presentation, we're excited to have Pacira BioSciences with us. Representing the company is Charlie Reinhart, who's the CFO to my left, and Susan Mesco, who heads the investor relations function, is sitting here in the front row. So if anyone has any questions, please feel free to contact her or myself, and we're happy to try to help you out. I'll just quickly introduce myself. For those of you who don't know me, I'm Glen Santangelo. I cover the specialty pharmaceutical sector at Jefferies, as well as animal health and healthcare information technology. But with that said, why don't we sort of get started? Charlie, welcome. Thanks, thanks for joining us.
Thanks for having us.
Perfect. Listen, I get it that we're already three to four weeks past the first quarter, but maybe the ink isn't completely dry on the press release, so maybe I thought it was a good place to start and level set the conversation. We can do sort of a quick review of 1Q. The company reported just over sort of 4% growth. I'm kind of curious as to maybe, you know, how that fared relative to your expectations, maybe what came in maybe a little bit stronger than you thought, maybe what was a little bit weaker than you thought? And then we can sort of dive in from there.
Sure. So I think Q1 top-line results were pretty much right where we expected them to be. You know, I think it was, it was a nice performance by each of the three products in the portfolio, and, you know, we expect that to continue and strengthen as the year goes on.
Okay. So, I mean, the EXPAREL growth, you know, some more... I think it was one and change, right? ZILRETTA was 3%, so that was kind of essentially what you thought. iovera°, but fairly in line. I guess sort of when you look at those 1Q results, I don't know if we can unpack the EXPAREL a little bit, a little bit more and think about it in terms of volume and price impact on 1Q, just so we can maybe better understand the underlying trend.
So, volume was up roughly 3% for the quarter, and price was up roughly 2%. So volume was a little ahead. We did sign one GPO contract in January, so that had a modest impact as well. But remember, when we started the year, we provided guidance, and the guidance was mid-single-digit growth for EXPAREL from a volume perspective. We anticipated signing 3 GPO contracts during the year, kind of one in each of the first 3 quarters, and that the ramifications of that from a gross to net spread would kind of offset a good chunk of the volume growth. And the third impact is the lower extremity nerve block label expansion that happened at the end of 2023. So that was launched commercially at the beginning of January as well.
So those are kind of the three big moving pieces, but-
Just quick-
All in all, it came out okay.
Okay, maybe just one, one more on the quarter. I mean, within that press release, you also sort of reiterated that full year revenue guidance of $685 million-$705 million, which is 1%-4% growth. I mean, maybe a little bit slower for the full year relative to what you did in one quarter. I mean, anything specific or worth sort of calling out within that guidance relative to the one Q trend?
Only that in Q1, there was one out of three anticipated GPOs, so the pricing and the downside of cost of the GPOs was just getting started.
Okay. Maybe as the GPOs come on, we'll see a little bit more volume benefit and a little bit more price and pressure.
Yeah, that's fair.
Okay. All right, you know, in the past, you know, you've given us product-specific level guidance, but this year the company has refrained from giving that product level guidance. Any reason for that, or anything we should read into that?
No, just that the, you know, we have a new CEO, and he has a slightly different philosophy, and decided, from his perspective, it made more sense to give a packaged top-line guidance, and so that's what we did.
Okay. All right, you know, with EXPAREL being the key focus here, right? Given it's over 80% of your revenues, and you talked about the GPO partnerships, and, you know, you're focusing on one a quarter for the first three quarters. I mean, maybe could you just update us what you publicly announced and sort of how we should think about, you know, the balance of 2Q and 3Q-
Mm-hmm
... at least in terms of those GPO partnerships are concerned and what we should expect.
Earlier this year, we announced that we had signed a GPO contract with Premier. That happened back in January.
Mm.
The other two we have been speaking with for, actually a fairly long time. Most of those conversations started last year. While we're almost done Q2, I would say one is pretty close to being signed. Actually, I think both of them are pretty far along the path at this point, so I'm pretty-
All right, so I mean, you feel like you're still on track with those three GPOs that you promised?
Yeah.
As it relates to Premier, there were no terms disclosed or anything like that?
No.
But as we think about it, is it reasonable to sort of think that, you know, we'll continue to see volume benefits from those with modest pricing pressure as a result, with the offset?
The objective here is to maximize the ability for EXPAREL to penetrate the market, Glen, and so we had been hearing through the sales force that they're running up against people commenting that we're a non-compliant spend, which means we're not on their GPO, and we wanna remove as many barriers to adoption as we can, particularly in advance of NOPAIN .
Yeah, and, you know, maybe that's a good point for the, the, the general session, right? I mean, Can you maybe just sort of review NOPAIN , you know, at the highest level and, and how that's gonna change reimbursement? And then we can sort of dig in, because I have some questions specifically about that, but-
Sure
... I'm guessing maybe everybody kind of knows what NOPAIN is, but just in case someone's here to learn a little bit more about the story.
Happy to do that. So NOPAIN is the name of a piece of legislation that was passed that requires CMS to provide reimbursement for a category of post-surgical, non-opioid pain medications in the HOPD setting. And so that's a big deal because roughly 40% of our business is in the HOPD setting, and at this point, both the hospital inpatient and hospital outpatient were part of the bundle. And, you know, that, the bundle was created a number of years ago, and the concept was that the reimbursement for a surgical procedure included everything that was done and all products used prior to the end of surgery.
It just so happens that EXPAREL is a post-surgical pain medication that happens to be administered prior to the end of surgery. We got sucked up into the bundle, and it took us a couple of years. We got CMS to carve us out for the ASC setting, which I think was a pretty unusual event. And now we're getting through an act of Congress, we're getting them to carve us out of the HOPD side of it. You know, roughly 70%-75% of the TAM is going through those two sites of care, so it's a big issue for us.
I'm sorry, how big, how big is the TAM?
It's roughly 70%-72% of our EXPAREL's TAM is in the two sites of care, HOPD and ASC combined.
Yep, okay. So, you know, last year I feel like it was similar but different story as it relates to the 340B program, right? It was all about starting to alleviate the friction in getting the physicians or the surgeons used to sort of using the product, and I feel like we're on a similar journey this year with the GPO contracts. You know, we don't talk about 340B as much. You know, if you sort of go back and do a postmortem over the last sort of 12, 18 months in the experience in 340B, you know, has it lived up to the expectations? I don't know if there's any high-level commentary you can give us in terms of the experience within 340B.
You know, I think you hit the nail on the head when you said we're trying to reduce friction. That was absolutely correct, and so 340B was a point of friction. It is no longer. You know, we have seen growth in the 340B business. It's also the most highly discounted, so if I had my druthers, I'd rather see growth in the business outside of 340B. But 340B is a way to make sure that patients who are arguably the highest risk from an opioid epidemic perspective, you know, the under or uninsured, can get coverage. That's part of the company's mission. The company's mission has been to help as many people as we can and reduce the opioid epidemic to the extent we can.
Right.
So that was all in line with participating in 340B.
Right. So to be clear, 340B and the GPO endeavor is really all about just sort of reducing friction and getting people... as many people comfortable with the product, and so-
Yes
... the company generally seems satisfied, but there's more work you can do on the GPO side. Is that a fair assessment?
That's fair, yes.
Okay, you know, this is, you know, the calm before the storm, right? 2024, people have been focused on this eVenus, you know, PIV litigation, and, you know, we're expecting a decision by June thirtieth from the February hearing. Now, I know, you know, each side, I think, petitioned for a 30-day extension and pushed that out to either July 31st or August 1st-
Right
... whatever the date is. I don't know, could you simply, and I don't know, maybe sort of summarize the situation for us? Do we have, you know, the those dates correct? And, you know, when we think about the litigation that took place in February, right, I believe there's another trial on a different patent that is upcoming, and so how do we think about the fact that there's two sort of separate trials going on at the same time? Could you maybe just sort of walk people through that issue and clarify-
Mm-hmm
... a couple things for everyone?
So first, for the initial patent, yes, we had closing arguments in May. At the end of the closing arguments, the judge asked for a 30-day extension, and so both parties agreed to it.
Okay.
So it used to be that we anticipated a result at the end of June. We now, now the date's August one, and that wasn't at request of either of the two parties, it was the judge that asked for it.
Yep.
So you noted that there was a second patent, you know, that started off, and I think basically both sides agreed, "Let's finish the first patent before we get to the second patent." So that's exactly what we're doing, but the second-
There's no timeline set for that second patent.
No
... at this point?
No. And that's the second of a number of others. So there's three and probably four that are waiting, and they weren't started because at the time, eVenus didn't notice us on those. So you don't start the clock doesn't start. You know, when a generic filer sends you notice that that patent isn't applicable to them, then you've got 45 days to sue them.
But how do we think about the decision tree from here, right, if you're eVenus? If you're successful on August first, let's just say, you're clearly gonna maybe move forward with the other patent, but what if you're unsuccessful, and in the event that Pacira is successful, do you think they move forward on that other patent?
I don't want to hypothesize, frankly, Glen, because I really don't know what their thought process is. I can tell you what our thought process is, and that is that we're confident in a whole series of Orange Book listed patents that exist, that we're kind of ready, as soon as we get notice, we're ready to start those trials.
But maybe, but maybe from your perspective, right, if you're successful on August first, probably the, the concerns around the second patent become less relevant for you.... Is that a fair assessment?
I think if we're successful on the first, the discussion is over.
Hmm. Are you aware or not of whether eVenus has tentative approval on this product at this point?
We know that there have been ongoing discussions between eVenus and the FDA. We're not privy to those specifics of those discussions, but there are obviously some back and forth happening.
You're not sure then, I guess, you're- 'cause you're not privy to them.
They have not received conditional approval, we know that. There's nothing that's been publicly announced, and that would be publicly announced. But where they are between 0 and, you know, the end zone, I have no idea.
Okay. Maybe, maybe I'll ask for a little bit more speculation on your part. I mean, in terms of their manufacturing capability, I think people maybe don't fully appreciate how difficult it is to manufacture the product, so maybe you could talk a little bit about that. And I don't know if you've had. If you have any ability to do any assessment on their ability to manufacture this product.
So my understanding of the Paragraph IV process is that somewhere along the way, we were supposed to be supplied a sample of their product. That has yet to happen. We've heard excuses about the fact that they don't have any that's not expired, because they haven't made it in a while. I can only assume that that's true. I don't know what their ability to manufacture is, 'cause, you know, it's a challenge. But, you know, I will say this, whether they can or they can't, they would have to make it, and if they don't have any currently valid material, they have to start up the process again, and they wouldn't do that until they've got, you know, approval.
And so I think there's a number of hurdles before anything like that could be relevant.
Hmm. All right, maybe let's, let's shift gears away from that, 'cause I guess we'll, we'll know in the next 50-something days, right?
Mm-hmm.
I mean, we'll know one way or another. Could we just shift back to sort of the reimbursement landscape? You know, we talked about NOPAIN in the HOPD setting, right? Could you talk about the ASC setting, right, and how maybe the reimbursement is a little bit different, and you sort of talked about the percentage of your patients that flow through the HOPD and the ASC, and maybe talk about the differences between those two settings-
Mm-hmm
... on the reimbursement side, just so it's clear for people.
So EXPAREL is currently reimbursed by CMS at the ASP plus six in the ASC setting. At this point, or I should say today, the makeup of the patients going through the ASC setting is roughly 20%-ish CMS, and therefore, the rest 80%-ish commercial payers. So commercial payers usually follow the reimbursement practices of CMS, but it takes you some time to do that. And so, the commercial or CMS reimbursement in the ASC setting has been a useful driver of growth in that setting. But it has been a little bit slower than we would've liked, and part of that is the fact that there's only 20% of that marketplace that's really subject to that reimbursement.
And is it frustrating that the commercial payers haven't sort of followed suit?
It's a process, and it takes time. And, you know, we have had some interactions, but we haven't fully invested in the reimbursement side of the business, which is-
Do you think those conversations could be accelerated post Gen 1 after NOPAIN is implemented in HOPD?
I think part of our expectation is that the commercial payers of an HOPD in the same geographic region as the ASC would be the same commercial payers. So if you're going to a commercial payer and saying, "CMS is reimbursing an HOPD, you should follow suit," we think it's likely that they, that significantly strengthens the argument that you should do it in HOPD and ASC at the same time.
Yeah.
So yeah, I think one helps the other.
Yeah. Could you maybe give some of those also comparable numbers in the HOPD-
Sure
... setting?
So in the HOPD setting, there's roughly a 50/50. It's slightly heavier in the CMS side. So instead of going to a business and saying, "You know, 20% of your customers, you can get free EXPAREL, the 80% not," that's a harder sell for them to change one overall clinical protocol. But if you've got 50/50, that's a much stronger argument, and so we expect the commercial people to follow much more closely in the ASC setting.
Have you started to even think about how meaningful of an impact this can have on your business in 2025?
Sure. So if you think about EXPAREL's business in 2023, we provided EXPAREL for roughly 2.2 million procedures. If you then ask, you know, what is the potential upside from just the CMS side, so there are roughly 3.5 million procedures that relate to CMS in the HOPD setting, and another 2.5 in the ASC. So-
I'm sorry, you said 3.5 in HOPD, and how much?
2 and 2.5. It's a combination of 6 million procedures that would now be in the outpatient setting, fully reimbursed. So we think it's a huge opportunity, and that excludes anything from the commercial side.
I'm sorry, you did 2.2 million procedures in 2023, and there's 6 million total CMS reimbursed procedures in the combination of ASC and HOPD, so-
That's, that's correct.
... Not quite 3x, but,
Yeah
... And so the obvious question is, I mean, you know, it's hard to sort of put some numbers around that, and I'm not asking you to, but it's kind of interesting when I look at, you know, the 2025 consensus numbers. And again, I'm not asking you to give guidance, but the Street has revenues modeled up 9% from, call it, 3% this year. So there seems to be maybe a little bit of a disconnect. I mean, I don't know if there's any high-level commentary you could make, but it seems like the market's not really expecting that meaningful of a lift.
I don't know, nine months ago maybe, we were having this conversation about 2024 and 2025 expectations, and both of them were kind of in the 9%-10% range. It was flat. Our comment at the time was that 2024 expectations were too aggressive and 2025 expectations were too conservative. That's really all we've ever said about 2025, and so-
I'm sorry. So we said 2024 was too aggressive.
Right. And-
That was after we knew that NOPAIN got shifted from-
Exactly
... one more 2024 to 2025?
Yeah. Yeah, yeah.
Too conservative... I'm sorry, too aggressive and too conservative.
Yeah.
Perfect. Okay. All right. So I mean, I guess... All right, then I'll skip my next question because I think you kind of answered it. I was thinking about, you know, if we're looking at mid-single-digit volume growth, I mean, it's obviously seems reasonable that we're gonna have much higher volume growth next year, you would think, if 3x the procedures are gonna be fully reimbursed with a revenue benefit attached to it.
We clearly think that NOPAIN is a major driver of medium and long-term growth in top line. I don't want people to leave here thinking it's a light switch, that on January 1, you know, revenue goes up a huge amount.
Do you think there's some education that needs to take place?
There's absolutely education that needs to take place, and we-
What is the organization doing to sort of ramp up its commercial awareness?
So, you know, we've made major investments or have plans to continue making major investments in the commercial infrastructure. So we have, you know, we have a search going on for a chief commercial officer. We just hired two senior new marketing folks.
Yep.
We are investing in market access and, you know, payer education, reimbursement and, national accounts, strategic accounts, a lot of these, you know, key interfaces that would help us do that education, new marketing programs, you know, new focus.
Could you maybe talk to the audience about the recent indication expansion into lower extremity and how meaningful that can be-
Mm-hmm
... and maybe how the company sort of thinks about that opportunity?
Absolutely. So in the fourth quarter of 2023, we received FDA approval to launch in what is referred to as lower extremity nerve block, which is basically knees and foot and ankle surgeries. So EXPAREL has been utilized in the knee for, you know, ever since it's launched, frankly. It's one of our bigger indications, but not using this nerve block. It's using infiltration, i.e., direct injection into the surgical incision. And so we're well-known in knee. We expect that people will evolve their administration technique away from infiltration and do a combination of nerve block and maybe some infiltration into the posterior capsule. We think that's a possibility. The lower extremity, the foot and ankle side is relatively new ground for us.
We do not have a lot of use in that at this point, so we think that is a nice upside for us. And we continue to think of this as, you know, a $100 million opportunity in four or five years timeframe. So it's a nice additional piece-
The reimbursement dynamics there?
Yeah, same.
Yeah. Okay. All right, let's switch gears to the competitive landscape. We get a lot of questions around Vertex, right? They have an acute pain program. They reported phase III data, you know, in bunionectomy, as well as other indications, and it didn't really seem that superior relative to Vicodin. Is this at all on your sort of competitive radar screen? And I'll sort of also throw Zynrelef out there in the interest of time. What's on your competitive radar screen?
So clearly, the Vertex product is on the radar screen, but we don't really think of it as competitive. We think it of as more as complementary. So EXPAREL is used in a protocol, usually a multimodal protocol that includes certain drugs before surgery, includes EXPAREL after surgery or at the end of surgery, and then there's usually some kind of pharmaceuticals that go home with the patient. And we think that the Vertex product makes sense, you know, as the patient walks out the door. So it becomes a Med D part, not a Med B as in boy.
Hmm. And nothing on Zynrelef?
Listen, Zynrelef's been on the market, I think it's 2.5 years. I think the latest numbers put them at a $5 million a quarter run rate. I'm not sure I need to say anything else.
Okay. All right, all right. You got the San Diego manufacturing facility approved. Does that-
Yep
... help gross margins throughout the balance of the year?
I think it'll really be next year.
Okay.
I mean, the actual commercial manufacturing will begin in the second half, and so you have to make it, then you have to sell it before it hits the gross margin. But ultimately, yes, that's the answer.
All right, we got 45 seconds, and I got 2 questions left. Let's talk about the balance sheet really quick. $325 million of cash in short-term investments. How should we think about the capital allocation strategy? The company obviously recently announced that $150 million dollar-
Mm-hmm
... share repurchase authorization. Is the company in the market now buying back stock, or is it just one of those good corporate planning, let's have the authorization out there in case we need it?
I'm not gonna tell you what we're doing now. I'll tell you after we did it.
Okay.
That's the way the game is played.
Okay.
In all fairness-
By the way
... it, I think it's an important part of the capital allocation strategy. It... We did our first amount during in conjunction with the convert, and we've got $125 million left, and we'll use that opportunistically at the time that we think it makes the most sense to help our business. But we also have the term, you know, Term Loan A outstanding, and the number one priority is to make sure the balance sheet is strong enough and flexible enough to attack NOPAIN in any way that Frank wants to.
Okay, maybe last question on 2Q. Anything we should be thinking about in terms of volumes, pricing, margins, anything, you know, that you can comment at this point, that you should remind us or we should be thinking about as it relates to 2Q?
No, the second GPO contract is not gonna have an impact on Q2. Even if we signed it tomorrow, it's not gonna be around long enough, so that's not, you know... I would've said a month or two ago that that would be the thing to take into consideration, but, it isn't at this point. So, you know, I think, you know, guidance is good, and-
Within your guidance, I mean, did you assume much in 2Q for a second GPO benefit in the second quarter?
A little bit.
A little bit.
A little bit.
Okay. All right, well, I see triple zeros. Thank you very much, Charlie Reinhart. He's the CFO of Pacira, and Susan Mesco heads up-