Pacira BioSciences, Inc. (PCRX) Earnings Call Transcript & Summary
May 14, 2024
Earnings Call Speaker Segments
Gregory Renza
analystWelcome back to the 2024 RBC Global Healthcare Conference. My name is Greg Renza, one of the equity research analyst here at RBC. And we're pleased to have Pacira BioSciences with us today. Joining us from the company is the Chief Financial Officer, Charlie Reinhart. Charlie, thanks for joining us.
Charles Reinhart
executiveThanks so much for having us. Appreciate it.
Gregory Renza
analystGreat. And a lot to talk about a lot going on, we're just mentioning that it's been an eventful week for Pacira. And maybe we kick things off. You can just give us an overview of Pacira, the recent strategy EXPAREL and also some of the developments that have transpired over the last week.
Charles Reinhart
executiveSo Pacira is focused on being the leader in non-opioid pain management. We have 3 proprietary products, EXPAREL, which is a long-acting formulation of bupivacaine that is labeled for post-surgical pain. We have ZILRETTA, is an intraarticular injection for knee OA. That's a long-acting formulation, a different type of formulation of a steroid. And we have a very interesting medical device named iovera°, which basically uses high temperature -- or excuse me, low temperature, the freeze serves and it's small, but it's got an interesting upside to it.
Gregory Renza
analystGreat. Great. So as far as things that went this week or last week, I should say?
Charles Reinhart
executiveSo our earnings release was at the end of market close on Tuesday of last week. We announced Wednesday evening, the intent to do a convert, and we consummated that transactional Thursday. So it's a really good transaction for us. The market was very strong. We were more than 5x over subscribed. So we hit the tights. We bought a capped call so that we're now up 80%, so [ picks ] the conversion premium a little bit under $55 a share, which was important to us and the pricing on that was really good. So we used the proceeds to buy back roughly $200 million of the August 25, the face value convert. And we also did our first share repurchase. So part of the earnings release last Tuesday was the announcement that the Board had authorized the company to spend up to $150 million over the next couple of years in share repurchases, and we use the convert as the opportunity to do the first one. So we're really happy about that, frankly. I think the transaction was very well received, and we're interested that the Board gave us the opportunity to go on the offensive from a share repurchase perspective. So we think that we're going to use that opportunistically in a way that we think best suits the shareholders.
Gregory Renza
analystGreat. It's been a nice transition point for Pacira, for EXPAREL. As you're alluding to, this has been a foundational quarter setting the stage with the guidance that you gave and the revenue performance. And as you've noted, it is all about volume. It's about expansion. And I think that there are some surgical trends that you and the team alluded to, maybe just from that top down, just talk a little bit about some of those trends across those segments that you're seeing that enable you to take advantage of some of that momentum in the surgical setting for EXPAREL.
Charles Reinhart
executiveSure. So we have important presence in both the hard tissue/orthopedic segments of the business and soft tissue. So as far as the orthopedic side, we're growing roughly in line with the big orthopedic companies, kind of mid-single digits. Soft tissue is a little bit behind that because it has not come back in the number of procedures. So the post-pandemic growth in soft tissue has been a slower rebound. And I suspect, frankly, that people are out there and they're looking at their financial situation, and they're asking themselves, what's my budget look like with respect to the impacts of inflation. And on my rent and food and transportation side. And do I have extra a couple of thousand dollars to fund my share of the co-pay. And I think that's what we're waiting to kind of bounce back a little bit. As you recall, EXPAREL was previously growing in high teens growth rates. And now we're -- from a volume perspective, we're kind of at market with mid-single digits. And so we're asking ourselves, what do we need to do to get back. And that's one of the reasons why we're so excited about the NOPAIN opportunity. And for those who don't know what that is, there's -- CMS will begin reimbursing EXPAREL at ASP plus 6% starting January 1, 2025, in the HOPD setting. And that's really important to us. So there has been a trend of shifting surgical procedures from inpatient to the outpatient setting and the outpatient includes both HOPD and the ASC setting. Roughly 72% of our current TAM is already performed in the outpatient setting. But the EXPAREL's biggest challenge really has been reimbursement. And in the inpatient setting, we didn't have any. And at this point today, you don't have any in HOPD. And that's -- HOPD is a big portion of our business. And so we're really excited about that. So the key focus for the company right now is getting ready for that CMS to start reimbursing. So be the new CEO, he is investing a lot in the internal commercial infrastructure. We're having a new Chief Commercial Officer and new Chief Business Officer. We've -- in next week, I think we have 2 new senior marketing folks starting. So there's a lot of excitement around the company. We're really, really asking all the questions that new CEOs should ask him. And we're really excited and getting ready for NOPAIN.
Gregory Renza
analystYes. And I like how you and Frank and the team talk about NOPAIN as almost a product launch, and I think you're touching on that in your remarks on how you describe that, what is that buildup like? And how are you -- how is that actually setting foot in action that is NOPAIN being almost a product launch for EXPAREL?
Charles Reinhart
executiveSo the first part was to invest in some of the individuals in the company -- what I didn't talk about is we're also making a significant investment in reimbursement internally. So market access team is being built up. We are hiring some reimbursement specialists that will be out in the field with folks. So that's new for us. So we're -- again, there's an awful lot going on. And everything is being kind of we reviewed as the strategic plan and how to best focus really on the reimbursement side.
Gregory Renza
analystExcellent. And related to that, I know certainly the 340B centers, the price and volume mix that you're even referencing. What are your thoughts on the mix there and how that sort of sets up the trending into NOPAIN?
Charles Reinhart
executiveSo when we took a look at what our business was prior to a year or so ago, we really didn't have -- we had a handful of contracts with individual hospitals, but we didn't have any GPOs. We didn't have 340B. And it just made sense to us that if you're going to have a hospital product, you probably need to play in those spaces. So we joined 340B, I guess, 2 years ago. And part of the goal for 2024 is to further solidify the base, so to speak, and join a couple of the larger GPOs. And so we have been hearing from customers that we were noncompliant spend, which was starting a conversation with a [ black X ] next to you, and we decided that, that wasn't the way we wanted to start. And so we're going to join a handful of the GPOs. We signed on with Premier in January. We expect to sign a second in second quarter and a third in the third quarter. So by the end of the year, roughly 85% of our total business will have some form of contract linked to it.
Gregory Renza
analystOkay. And then with the Premier contract, what does that represent in terms of share or EXPAREL-relevant procedures?
Charles Reinhart
executiveThe premier membership is roughly 20% of our total EXPAREL-relevant procedures. So it's a little confusing, because there's 2 ways to look at this. One is, it happens to be true that roughly 80% of our procedures are going to be the combination of the GPOs. Another way to look at it is areas that we have contracted or have discounts. So we have a 340B business, which is roughly 24% of our business today. We have individual contracts that we have signed over time prior to GPOs with specific hospitals. That's about 30% of our business. And then there's going to be the incremental on top of that GPO impact. So it's interesting that either way, gets you to about 80% to 85% of our business. It just so happens that if you look at a GPO like Premier, their [indiscernible] are part of 340B, they may be individual contracts. And if they're not, they'll be hit by -- they'll get into the Premier GPO bucket.
Gregory Renza
analystGot it. So then 2 more and we can look forward to over the course of this year to get to that ramp. And maybe talk a bit about the guidance that you reiterated in those pushes and pulls when it comes to EXPAREL and the portfolio.
Charles Reinhart
executiveOkay. So I mentioned earlier that the big ortho hardware companies were predicting that they were going to grow in the mid-single-digit growth pattern. And so we see ourselves in line with that with maybe a hair less than them, because we have half of our business in soft tissue and that is growing more slowly. So that's the volume side, I think, mid-single digits. The additional investment in getting access to the GPO members is going to cost us roughly offsetting. So from a top line perspective, those 2 numbers are offsetting. We also expanded EXPAREL's label for 2 new lower extremity nerve blocks in late last year. So kind of that kicked off with the national sales meeting and launching that. So we think that will add growth as well. So we guided to a relatively modest increase. We didn't do product by product guidance, but inherent in there is a modest increase in EXPAREL.
Gregory Renza
analystGot it. And then what about the -- on the margin side, we had some consolidated gross margin report and just talk a little bit about the contributions with EXPAREL and ZILRETTA and iovera°?
Charles Reinhart
executiveSo we guided to an annual total gross margin between 74% and 76%. We ended last year at 74%. So we view this as a modest improvement over 2023 actual. First quarter of this year came in at 72%, which is obviously lower than that. But we reiterated guidance, because it's not unusual for some of those, be a little lumpiness in there. Last year, we ended at 74%, and we had a quarter at 72%, a quarter at 73% and the second half in the high 70s. So we're still comfortable with that.
Gregory Renza
analystYes. And as you mentioned, sort of building with market access, what initiatives are you working on with respect to the pharmacies, the billers, the coders to enhance that? And I think this is one of the benefits of Frank coming aboard too is just that the operational granularity that you and the team are really taking. How are you approaching that?
Charles Reinhart
executiveSo we're looking at really all the aspects we can think of. So for example, ZILRETTA has a hub involved to help facilitate patient reimbursement. And we're thinking about does that really make sense for EXPAREL, should be or should we not have a hub. So we're looking at that as an example. We are hiring reimbursement specialists to be in the field in each of the major sales areas, so that they can help educate the sales force and work with specific customers, particularly prepare for NOPAIN. From the access perspective, the GPO is also playing to that because, again, we will no longer be noncompliant spend. So we anticipate that, that will facilitate on doors being open as well.
Gregory Renza
analystAnd then as we look forward and beyond 2024, I think a hot topic has certainly been Paragraph IV filing the case with eVenus and certainly not asking for any color or commentary. But I think one thing that does [indiscernible] mentioned is just you and the team's indication of these 3 recently listed Orange Book patents, terms out to 2043, I believe. But just for context, how should we be thinking about the deliberations there and the fence that you continue to build with the IP state?
Charles Reinhart
executiveI think that's a great description. It is a fence. We're -- we believe that our intellectual property portfolio is strong and really will protect us well. So there is one. It's only one patent at this point that's in the midst of the Paragraph IV challenge. Closing arguments were held last week, at which the judge asked both sides to extend your deadline by a month. So we had originally anticipated hearing a ruling by the end of June because the 30-month stay expired early July. At this point, I think it's now looking like it's going to be late July. And I don't know that either party is going to tell the judge can take a little more time to get to a recent decision. So that's what we anticipate. As you pointed out, we have a full series of patents, and this is one of them. There are 5 or 6 others laying in wait in various aspects of the technology, so most of which, frankly, are broader than the initial one. So we're pretty pleased about that. I mean in all fairness, eVenus filed before they even had any idea what our patent state was. There was only one Orange Book-listed patent that they filed, and that was due to expire at the end of '21, which is in fact, did do. But all of the patents that have been issued recently go out to 2041. And as you point out, something nuances go out to 2043. So we view EXPAREL having a highly protected, very long life in ahead of it, and we're excited about that.
Gregory Renza
analystSure. And EXPAREL is no stranger to competition and drivers that put pressure over the years, and we know that well. This is just another one. Maybe shifting quickly to ZILRETTA and iovera° admittedly maybe less of a focus for the quarter. But how is Pacira aligning the commercial and marketing strategy relative to EXPAREL? How should we be thinking about the other products that you're mentioning?
Charles Reinhart
executiveListen, Frank intentionally told me when he got here that his top 3 talking points were going to be EXPAREL NOPAIN, EXPAREL NOPAIN and EXPAREL NOPAIN. And he's kept his work, and he is really focusing the organization on that because that really is the way we're going to win in the next 12 or 24 months. That's not to say that there's anything wrong with ZILRETTA and iovera°. And in fact, we continue to invest from a clinical perspective, there's a shoulder osteoarthritis study that just tipped off for ZILRETTA. Data for that should be available second half of next year. There is a new clinical study for iovera° in the use with spasticity, which is a really -- it's a really exciting clinical application of iovera°. I don't know that it's the world's biggest market, but it's a very meaningful one, because it really can change the outcome for some of these patients. And that study just got kicked off. And again, like the shoulder OA data should be available in the second half of next year for that as well. As far as for the commercial plans, the iovera product and our view of how big it could be and when it could be and what we need to do to get it there. It is being reviewed again as part of the many different pieces of the business that's going through active review at this point. So in the meantime, ZILRETTA is chugging along. It's going to be mid-single-digit volume growth with a couple of points of price. Iovera° just got a much greater growth rate, but it's a much smaller project, so -- that's to be expected. Yes.
Gregory Renza
analystGreat. And I think we've all noticed an acknowledged that we're hearing more about PCRX-201, the intra-articular gene therapy. Maybe just for some context, what was the impetus behind the move into gene therapy in the osteoarthritis? And maybe just remind us why we're actually talking about this for, because there's been some cards turning over?
Charles Reinhart
executiveSo it's probably not fair to say that we made a decision to move into it as we acquired it, and it came with ZILRETTA. It was part of the Flexion acquisition. As often happens, you focus on one aspect of the company you acquire, you don't necessarily always appreciate what the other things that come with it. We -- at the acquisition, we didn't -- it was in a Phase I. We didn't have any idea what the output would be. But subsequently, the [ deal ] looks really interesting. Right now, we've presented 1 year data. So it shows clinical efficacy in reduction of pain for -- at the 1-year time frame. And at this point, we have 2-year data, which we're hoping that gets into a medical meeting by the end of this year. We've initiated conversations with kind of experts in the field to see what they thought about it. And the bottom line seemed to be that the other products out there or potential products out there are good for the 3- to 6-month time frame. And the clinicians told us basically that -- and I think this is their words, it'd be transformative to get out to a year. And at this point, we've got 2 year. So we think, wow, we really may have just looked into something. It's really amazing. And so we're trying to figure out where do we go next to develop what's the clinical time line. We definitely need to get and talk to the agency about what their views are. We're not gene therapy experts, and we acknowledge that this is a very different area. But you can't -- if you see something that really looks like it has potential and can really impact patients' lives. And it is in knee OA. Knee OA is one of our areas of expertise. EXPAREL is in knee OA, particularly in the post-surgical sets. And ZILRETTA and iovera° are both there. So from that perspective, it's a nice fit.
Gregory Renza
analystYes. Yes. No, that's really complementary. It's intuitive. And as you're saying, you're stewarding the asset based on the data and laying that drive the way. And maybe to that, when it comes to your resource allocation, just remind us of the allocations of R&D and spend. That's something that folks certainly ask on, I just want to ensure as you're already reiterating that your focus is squarely on EXPAREL
Charles Reinhart
executiveYes. If I look forward based on what I know with both the shoulder OA in ZILRETTA and the spasticity for iovera° and PCRX-201, I don't think there's a big bolus of R&D about to happen. But really, we have to figure out what is the next stage for 201. And we'll have to make a decision when we get there.
Gregory Renza
analystGreat. Great. I just want to pitch it to the audience. Any questions in the room for Charlie. Great. We covered a great deal, Charlie. Anything else we missed or anything else you wanted to focus on before we break?
Charles Reinhart
executiveI think we have covered the high points. I would say that the level of activity and the interest level and the passion of the company, it remains really high. Pacira, a lot of employees at Pacira have some personal experience related to the opioid epidemic. So honestly, I've never been in a company that everybody has a mission, but really people get up in the morning and they're focused on the reduction of the use of opioids. And we think we have 3 products to get us there. We think EXPAREL with the reimbursement is going to be a major improvement and that we really do have the ability to change patients' lives and prevent people who're getting access to opioids that therefore have a really negative impact on their future.
Gregory Renza
analystYes. That's an important reminder. And with that, it's a good place to stop. Charlie, thank you very much.
Charles Reinhart
executiveThank you, very much.
Gregory Renza
analystGood to see you, thank you.
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