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JPMorgan Healthcare Conference

Jan 9, 2023

Tessa Romero
Senior Biotech Analyst, J.P. Morgan

Welcome everyone to the 41st annual JPMorgan Healthcare Conference. My name is Tessa Romero. I'm one of the senior biotech analysts here at JPMorgan. I'm joined by Taylor Hanley and Adhiraj Chauhan from the team. Our next presenting company is Pacira BioSciences. Speaking on behalf of the company, we have CEO David Stack.

Before I turn it over to David, I just wanted to highlight to those listeners that we do have an ask a question button where you can submit your question and I will try and get it in our discussion in 20 minutes or so here. You can raise your hand and ask it free form. With that, David, over to you.

David Stack
Former CEO and Chairman, Pacira BioSciences

Thank you, Tessa, thanks to JPMorgan for having the opportunity to spend a few minutes with you folks today. Pacira is the leading company in non-opioid pain management, and our mission is to provide an opioid alternative to as many patients as p ossible. To achieve that objective. Boy, this thing is sensitive. To achieve that objective, we have a portfolio of non-opioid pain medicines that act across the neural pathway.

I think it's important for everybody to understand that as we go forward here, we'll be talking about opportunities for the sensory pathway to block pain signals from the body to the brain. As we work with KOLs in the marketplace, we also understand that there is an equally large opportunity to block, recalcitrant or unnecessary brain signals to the body.

I'm speaking specifically here about stellate ganglion blockade for cardiac dysrhythmia as well as for spasticity. One of the things we like about this portfolio is we focus on the same customers across this neural pathway experience.

Our focus here is on surgeons, anesthesiologists, including CRNAs, as well as sports medicine and spine physicians and pain management and regenerative medicine folks. That gives us the opportunity actually to go deep with our strategic relationships, both on clinical as well as commercial development.

The portfolio of commercial products as it exists today, really we have a portfolio of safe and unique products that we think provide the opportunity to work across the spectrum of patients for sensory blockade of pain. First, EXPAREL is the only long-acting local analgesic that's approved for post-surgical pain control.

ZILRETTA is the only product that's approved by the FDA for extended-release intra-articular injections of OA knee pain. iovera is the only novel handheld product that can provide immediate pain control as a drug-free nerve block. We have 9 years of consecutive Adjusted EBITDA positive experience on sales of $657.7 million last year. We announced in our press release last week that we expect to have earnings per share of at least $2.50 for full year 2022. To dig down a little bit into the durability of our cash flow, this provides a look at quarterly revenue and Adjusted EBITDA.

You can see that we have a consistent pattern here of reliable cash management, which allows us to be comfortable that we can take care of all of our debt services as well as fund all of the clinical programs that we'll talk today out of operating cash flow.

Again, looking now specifically at EXPAREL, this is our crown jewel, if you will. This is the only long-acting analgesic approved for infiltration, field blocks, nerve blocks, and pediatric medicine. A very significant differentiator from any potential competitors in the marketplace. In 2007, our average daily sales increased by a little over 7%. Part of the durable cash flow strategy is that we have intellectual property and a number of Orange Book-listed patents that take us out till January of 2041.

We have treated 12 upward on the verge of treating our 12th millionth patient in the United States in a very large market with 34 million patients in our TAM and a number of opportunities to address this expansive marketplace.

To slow down for a minute and provide some information on what's going on in the procedure marketplace, you know, there's been a lot of discussion about labor and inflation and all of other things that are putting pressure on hospitals in the United States, and I'll talk more about that in the next slide as well.

To give you a sense of what's going on in the market for procedures, I would ask you to, well, first of all, look at the far left, and that would give you a sense of surgical procedures in our TAM during the pandemic, and you see what you would expect.

If you go over to the straight line that is approximately in the middle of this slide, that is the pre-pandemic elective surgery profile. That would be the standard of what the marketplace was like before the pandemic. Then if you look at the. Or maybe I can point to it. Can you guys see that? No. Okay. The purple line is, Yeah, the purple line is orthopedics, and the greenish line is soft tissue.

Surprisingly, what we see here is that the peak of the surgical rebound from the pandemic period was actually week 14 of 2022. This is totally inconsistent with anything that we've seen before. For the first 10 years this product was on the market, our quarterly cadence of procedures on an annual basis was 21%, 24%, 25%, and 31%. Then we see 2022 when that whole marketplace is essentially turned upside down, and the biggest procedure quarter of 2022 actually turns out to be Q1.

You see a consistent decay of the marketplace until the orthopedic procedures start to normalize and stabilize as we got into Q3, and the soft tissue procedures continued to decay as we went into Q4, and we still don't know what the data was for that as we get into the end of the year.

That's important because in context, we wanna show you what this marketplace looks like in terms of where the growth is and where the market is stagnant. The first thing for inpatient procedures, you would see that this is June of 2022 over June of 2021, just to set the context, right? This is that 12 months rolling. Hospital procedures decreased by 6.4% over that timeframe where EXPAREL was flat.

The outpatient procedures, on the other hand, 4.3% growth of the market, 13.7% for EXPAREL, that overall, you have a market that grew by 1.5% in total and 7.4% for EXPAREL. Essentially the message here that in a flat market, EXPAREL grew by 7%.

If we draw down on that and go to the right of this same slide, what we're showing you is the market for the major procedures that drive the revenue growth of EXPAREL and, you know, the first are spine, shoulder, and joint. You'll see dramatic growth in spine and shoulder. Joint is the biggest single procedure indication for the use of EXPAREL.

The soft tissue surgeries were general surgery, 0.1% for the market and nearly 10% for EXPAREL, breast and gyn onc. You can see why we're confident in the long-term growth profile of our product, because the market on an annual basis is moving roughly at 0.1% per month out of the hospital to the outpatient environment.

Much of that has been enabled by the ability to treat post-surgical pain control without having to use an opioid. A couple of initiatives that we're endeavoring as we move through 2023. The first, just to set the context, is that we have increased the capacity of EXPAREL to the point where today we can produce way more than $1 billion worth at the current price.

We see our margins growing, our gross margins approaching 85% over the next couple three years. We looking for big growth opportunities, major growth opportunities. In October, we started to participate in the 340B Program, which is a 24% statutory discount, but allows us to be true to our mission and be able to treat low and disadvantaged marketplaces with non-opioid treatment therapies.

This is especially important when we get into the low margin hospital outpatient environment for soft tissue and colorectal procedures, where the margins are nearly the cost of EXPAREL. We need some help in order to afford the opportunity to have non-opioid pain control in that patient population.

All in, you see 340B as being an opportunity to address 10 million patients in total, and the mandatory discount ends up being about a 5% discount to our net margins. We went from roughly 93% to roughly 88% as in terms of margins, still very healthy by pharmaceutical company standards.

As we move the gross margins from something in the mid-70s to something in the mid-80s, we see that we're quite easily in a position to be able to offset that opportunity to increase the size of the addressable market without having doing any gross harm to the gross margins. Equally exciting or even more exciting is in the last week of December, we were these primary sponsors of the NOPAIN Act. This was approved by the Congress as part of the Reconciliation Act.

This is not an EXPAREL or a Pacira specific opportunity. This is actually for all post-surgical pain control, and it will require CMS to pay for non-opioid post-surgical pain control for 3 years. By the way, we had a congressional budget score.

The Congressional Budget Office scored EXPAREL as zero for participation in this, meaning that we offset all of the cost of the product by savings in treating these patients with non-opioid alternatives. The way the statute was written is that it initiates in 1/1/2025. That was not our intention, as you might expect.

We right now are working with the heads of the different Congressional committees and our law firms and our lobbyists to effort that moving forward to 1/1/2024, based largely on the fact that there were 109,000 drug overdoses in the United States last year, and more than two-thirds of them involved opioids.

We're trying to put an effort forward here on behalf of patients. All in, you see an additional 20 million patients who would become available for EXPAREL therapy based on NO PAIN. With the institution of the NOPAIN Act, 72% today of our total TAM would be reimbursed in the outpatient environment. This is really important, not only to Pacira, but to patients.

Specifically, what we're doing with EXPAREL and the way we grow in the very short term is next week we will file a supplemental NDA for a lower extremity nerve block. This is based on two studies. One is an adductor canal of the femoral nerve with a p-value of 0.007 for both pain control and opioid reduction at 96 hours at four days with a 10 ml dose.

The second is a foot and ankle study, where we have a p-value of 0.0001 for opioid reduction and pain control, again with a 10 ml dose for 96 hours. We've also agreed with the FDA on what the pathway is for a pediatric claim in the package insert from zero to six years. Currently, we're approved for 6 years and above.

As a true statement of the efficacy of this delivery technology, we have a phase 1 data set for subarachnoid use. Basically, it's a spinal, with EXPAREL, and we expect to move that program into phase 2 in early 2023. We've secured ASC funding for C9290 for 2023, and we move forward here in terms of how we intend to expand the opportunity for patients to receive EXPAREL.

For ZILRETTA, we, this is a product that we acquired from Flexion in November of 2021. We finished last year. This is the only product that's FDA-approved for OA of the knee, the only corticosteroid that's approved for extended duration for OA of the knee.

There are 7 million patients that are appropriate for the use of EXPAREL or of, I'm sorry, of ZILRETTA. It has a product-specific J code of J3304, so we have reimbursement covered in the office. As we move into 2023, and right now, in fact, we have our national meeting ongoing in Florida, and we are training up the sales organization on the use of ZILRETTA in diabetic patients.

Flexion actually had a data set that shows that over a million patients are currently in front of glycemic spikes when they use generic triamcinolone acetonide, and we believe that there's a material opportunity here for these 20+% of patients who are currently being treated for osteoarthritis of the knee to avoid those safety issues and stay in control with a long-acting product.

At the same time, we are combining our sales forces. Previously, we had a separate sales force that called on physicians in the office, both for ZILRETTA and iovera, and we had a separate sales force, a larger sales force for EXPAREL that primarily worked in the hospital setting.

In the post-pandemic environment, our reps really don't have a chance to work in the hospital nearly as much as we did before and rarely get into the operating room now. When that became apparent that those folks were gonna be calling on physicians in their offices, it made sense to put these two groups together and have now a sales force of over 200 that will call on the office setting for all three products.

As a result of that, the territories become smaller, and we will increase our reach and frequency around ZILRETTA and iovera by over 300%. For ZILRETTA, we have a Phase 4 diabetic safety study where we will look at time under control.

We'll also look at the glycemic spikes and look at the cost of those safety issues in the marketplace. In the second quarter, we will start a shoulder study. There is no steroid currently approved for shoulder for any use. You know, we see that as another 1,000,000 patients and expect to have data in the middle of Q4.

Based on our discussions with the FDA, if we have two comparative trials here, we will look for a superiority claim versus generic triamcinolone in any of these indications. Our third product is Iovera, quite an interesting product for us. This is basically using cold for a drug-free nerve block. This procedure takes 15 minutes. I've had it several times myself. This is the only local opportunity, handheld opportunity to be able to provide a patient with a immediate action.

When you freeze the nerve, it's called Wallerian degeneration. It is not an ablation. The nerve grows back over several months. We can provide immediate action and several months of pain control basically using ice, something that patients understand. We are getting a lot of traction in the marketplace as a cash pay opportunity for people who wanna relieve pain, is going on vacation.

We hear a lot about, "I belong to the golf club, but I'm not playing because I have pain." You know, we see patients who are not surgical candidates, patients, a number of reasons why patients are willing to pay for a lifestyle that will give them several months of pain control with a very short procedure and not involve any drugs. Did $50 million last year, a lot of growth to come.

Our primary understanding of how this product will grow rapidly in the short term, first, it's the same reach and frequency story that we just went through over ZILRETTA, we will increase our opportunity to be in front of customers by threefold.

Really gets interesting when we start to look at spasticity. There's 10 million patients in the United States that are diagnosed with spasticity. 2.6 million of those folks have had a treatment for spasticity. If you look at the numbers, only 150,000 of them are currently receiving treatment. We understand that to mean that the marketplace alternatives for appropriate treatments for spasticity just don't work very well.

We have a lot of evidence from Paul Winston and the group in Vancouver, and there's dozens of videos up on YouTube if anybody wants to look at it, where lives and the entire family infrastructure is completely changed when we're able to treat these patients.

I've got all kinds of weird stuff on my computer that you guys aren't seeing, thank God. It changes the entire dynamics when somebody who's a quad, who's in a wheelchair can do the simple things like feed themselves and dress themselves. This is actually a very emotional experience for the organization, and I would tell you to look these videos up if you want to, but they will make you cry. Just know that that's the sidebar of being involved with this.

We will start a spasticity treatment trial in the second quarter of 2023. We expect that we'll have that data before the end of the year. Because this is a device, and it'll be a 510(k) approval, we believe that we can be on the market in three to six months.

Sometime in the third or in the second or third quarter of 2024, you can expect us to be on the market for the treatment of spasticity, and then to follow that up with an active comparator trial to demonstrate the advantages of non-drug nerve blocks for the treatment of spasticity. All right, I give up. Oh. Okay. When you roll all that together, this is what this looks like in terms of 13 clinical trials that we're involved in as we go through 2023.

Not all of them are for the commercial pipeline. This is up on the web, so I don't expect that anybody is gonna study this in any detail in this short transition. We have a useful and exciting pipeline. PCRX-201 is a product that also came to us through the Flexion acquisition.

This is a gene therapy product with a promoter on the gene. We have a Phase 1 data set that is compelling, especially so since the most efficacy was actually seen at the lowest dose. The promoter aspect of this is interesting because this will only provide the receptor antagonist in the presence of IL-1. This gene actually turns on and off depending on whether your immune system and your inflammation around IL-1 is actually present.

We also have the same delivery technology that we use for EXPAREL, multivesicular liposomes. We have a dexamethasone product that's being developed for low back pain. We have a bupivacaine product that is a high dose EXPAREL, if you will.

It won't be EXPAREL, of course, because it's a different dose of bupivacaine, and it's planned to last 7 days or more. Externally, we have external innovation where we have board seats, and we're participating in the development of Spine BioPharma's Remedisc. This is a Phase 3 asset that we expect will read out next year. This is 7 amino acid peptide.

If you think about the delivery of healthcare, if you're doing a facet joint or if you're doing an epidural, we will have the opportunity to also provide a product to slow down the progression of disease in this patient population.

GeneSense is another IL-1Ra product. GeneQuine is actually the product the company that owns the initiation of PCRX-201 and the IP around that, as well as Keltrix, which is an anti-inflammatory company that we think adds a lot to our ability to work in this patient population. Wrapping up, significant durable cash flow. We can pay for everything that we're doing with operating cash. EXPAREL has patent protection that takes us out to January 22nd of 2041. We're in good spot there.

We expect to be able to pay down our debt. Just as a point of reference, we paid $50 million down on the Term Loan B in December, and we expect to continue that as we go through this year. We have a number of commercial assets, and we have significant value creation opportunities for each of those assets as we just went through and follow up with a exciting pipeline of products that we think all go after these same opportunities along the neural pathway. I look forward to telling you more about it as we go through the next couple of quarters. With that, Tessa, we'll turn it over to Q&A.

Tessa Romero
Senior Biotech Analyst, J.P. Morgan

Great. Well, let's proceed here and bring Charlie in up on stage here to join me. Just as a reminder, please just wave your hand if you have a question, and we'll get you in here. All right.

David Stack
Former CEO and Chairman, Pacira BioSciences

Oh, sure. The question is: Can we talk about the Paragraph IV challenge? Yes. You know, it's in discovery. It's in early discovery still, so I can't give you a lot of information, other than to tell you that according to the FDA, Dicta te relative to generic EXPAREL, and they wrote a points to consider just for generic EXPAREL.

They would have to be able to address every point and every one of our patents in order to have a generic. Well, the biggest part of that is that based on some previous experiences in this same space, you have to do your bioequivalence with commercial material.

Tessa Romero
Senior Biotech Analyst, J.P. Morgan

Mm-hmm.

David Stack
Former CEO and Chairman, Pacira BioSciences

Just as a point of reference, it cost us $110 million to build our newest plant in Swindon, just outside of London. Somebody's gonna have to be in a position to spend a lot of money to see whether that works or not. We don't have any evidence that they have access to multivesicular liposomes.

They have some multilamellar liposome technology that has been recently approved in China, that will never pass muster as a generic opportunity against EXPAREL in the United States. They have until April next year. This, the 30-month stay would go till April of next year. We don't believe that they have anything approaching a generic EXPAREL.

Tessa Romero
Senior Biotech Analyst, J.P. Morgan

Okay, great. Great. Well, maybe I'll chime in here. A question on EXPAREL. How should we think about the sales trajectory for the product here for the year? I think current consensus estimates for the street are sitting around $609 million. Are you comfortable with where consensus is sitting and kinda can you give us a sense of kind of how you're thinking about growth for the year?

David Stack
Former CEO and Chairman, Pacira BioSciences

Yeah, I don't think consensus has not benefited from the data slide that we showed that talks about the market being flat. One of the things that we're trying to do here is reset that expectation. We will provide guidance and no longer participate in the monthlies that we've been putting out, starting now. As part of the Q4 call, we will provide guidance.

We're not a million miles away from that, but I think we want to reset this around the 2022 experiences and take charge of our own narrative around where this product is going. That's a 2023 answer to your question. As we go forward and we get NOPAIN, you can expect...

What we see here is 340B is the opportunity to treat several thousand additional patients and have several hundred additional healthcare providers using EXPAREL. If you think about the dynamic of being able to do that with very modest cost, if any, to the margin, then when we get NOPAIN Act approved, we've actually had the market has been seeded then with people who have experience with the product and we're trying to limit the timeframe it would take for people to get up and running as a result of NOPAIN Act.

Tessa Romero
Senior Biotech Analyst, J.P. Morgan

Okay. Okay. you know, any other additional color you'd provide, Dave, on kind of the latest status of the surgical market? Specifically, how would you characterize the kind of the pandemic-related operational challenges that still persist?

David Stack
Former CEO and Chairman, Pacira BioSciences

Yeah. I'll go back to the graph I showed. Okay, this is treacherous, guys, 'cause... Oh, yeah.

Tessa Romero
Senior Biotech Analyst, J.P. Morgan

I think it was.

David Stack
Former CEO and Chairman, Pacira BioSciences

Yeah.

Tessa Romero
Senior Biotech Analyst, J.P. Morgan

Let's see.

David Stack
Former CEO and Chairman, Pacira BioSciences

All right.

Tessa Romero
Senior Biotech Analyst, J.P. Morgan

Forty-eight.

David Stack
Former CEO and Chairman, Pacira BioSciences

There we go. We've talked a lot about labor shortages, and that's what we heard from our customers, especially in the ambulatory surgery centers, especially as we were looking for nursing teams to work a 12 or a 14-hour day on a Saturday or on a weekend.

We've come to the conclusion that our ability to attract labor to be able to work, especially on weekends, is absolutely correlated with whether the kids are in school or not. You can see very directly how the labor opportunity has had an impact. The problem with that statement is that does not support what we saw in this graph at all.

Tessa Romero
Senior Biotech Analyst, J.P. Morgan

Yeah.

David Stack
Former CEO and Chairman, Pacira BioSciences

Right? Because if we had that peak in week 14 of 2022, we had the labor obviously then to be able to do that, and then we see the decay that took place past that appears to still be ongoing with soft tissue. What we think is happening here is that this is inflation, this is food, fuel, and healthcare in a very large way.

The insurance carriers, especially commercial insurance, has taken up most of the capacity in the ambulatory surgery market, believing that they can save 30%-35% of the cost of care by moving the expensive high-margin procedures into that environment.

What's left behind, as you see pretty graphically here in this, is the low-margin procedures that hospitals would have to do, and I'm talking about, you know, taking a half an hour of an OR and making $300,000, $350,000 in... or $350 net. That segment of the market is having trouble finding a place where they can actually have these pr

ocedures done, especially in an environment where many of our big hospital customers are losing, as you guys have seen, you know, $100 million, $1 billion. What we think here is that... Well, there's only two possibilities, right?

One is that we've been operating on patients that don't need surgery for a very long time, or these patients are gonna come back to the marketplace because they require surgery, and because of the inflationary nature of the market that we're in right now, they're willing to do that for very painful, high acuity orthopedics procedures and spine procedures, but people are living with colorectal and abdominal procedures, much the way we saw the same exact thing in 2008.

Tessa Romero
Senior Biotech Analyst, J.P. Morgan

Yeah.

David Stack
Former CEO and Chairman, Pacira BioSciences

As we go forward with 2023, we two things, I guess. We're projecting off of 2022, which I think is the only sensible thing to do, but also understanding that if we're going, you know, 7% in a 1% growth environment...

Mm-hmm.

We're very well-positioned if this marketplace normalizes and comes back to anything like the pre-pandemic level.

Speaker 3

Okay. Do you have a hunch on kind of when we could see more normalization in the market?

David Stack
Former CEO and Chairman, Pacira BioSciences

The NOPAIN Act will do it for sure. We think that, you know, the 340B Program takes us a ways there. It opens up an additional 10 million patients at a reduced price. It doesn't take you all the way to reimbursement, but where price is a major issue, we think we can take segments of that where opioids are known to be most problematic.

If we're successful in moving the NOPAIN forward to 2024, yeah, to 2024, that would be my time point. You know, we're gonna grow the brand and, you know, lower extremity nerve block and pediatrics. There are a number of procedures that we're training our field force and focusing them on that don't have the same inflationary pressure that we see here. OBGYN, oncology, C-section, pediatric deformities.

There's a number of procedures where, you know, you're gonna get a child's scoliosis operated on no matter what the scenario is, right? Shriners and St. Jude's are both big customers of ours. It's more the man in the street kind of hernia and colorectal surgery that we need to take care of, and we think the NOPAIN Act does that. 2025 in that scenario.

Tessa Romero
Senior Biotech Analyst, J.P. Morgan

Okay. Okay. Any questions from the audience?

David Stack
Former CEO and Chairman, Pacira BioSciences

Yeah.

Tessa Romero
Senior Biotech Analyst, J.P. Morgan

Thanks. You talked about the 340B Program pricing program. I was just wondering, how should we be thinking about gross to net in 2023 and how it compares to 2022? I guess beyond that, just wondering if you could give a little more color on the pricing and reimbursement landscape evolving over the near term with the pricing program as well as the NOPAIN Act.

David Stack
Former CEO and Chairman, Pacira BioSciences

Yeah. Two quite different things, right? 340B Program is and this is complicated, so I appreciate you asking the question, actually. The gross to net difference... A little less than 20% of our of our 2022 business were also participants in 340B Program.

When we track that down to the gross to net on revenue, it ends up being about 5.5% of our total net was at risk. Go back to my comment about moving from 75% to 85% gross margin as we build these larger facilities and take down the smaller facilities.

That 10% margin allows us to participate in this program, offer the opportunity to low income and indigent patient populations, and share the benefit of that 10% gross margin increases as we go forward. We did have a price increase on January 3rd that also will help us offset that. As we go through the year, the 10 million patients that were referenced come from accounts who while there are some current accounts that crossed over.

We also have a very significant number of procedures that are being done in 340B eligible hospitals that have never ordered EXPAREL. The assumption there being that cost is largely the driver of that. Indeed, we have started to see those patients or those hospitals order EXPAREL.

As we go through the year, 85% margins or 80+% margins against the 24% statutory discount, these things come together, and we expect that over the year, 340B Program will be neutral to slightly accretive, if that's the answer to your question.

The pricing question is a little bit different. Our biggest customer in terms of vials is still the federal government, Department of Defense and Federal Supply Schedule. They accept your price increases 1 year in arrears. Oddly, you wanna have a price increase because you want to actually pick up last year's price increase and have one coming next year for these people who are already in the statutory discounted landscape.

We intend to have a thoughtful price increase on an annual basis, and then where it's required to be able to discount so that we can be appropriate to providing the standard of our mission, which is to provide an opioid alternative to as many patients as possible. Generally have a price increase and then discount where it's required to make sure patients are being provided low or no opioid treatment therapies. Is that okay?

Tessa Romero
Senior Biotech Analyst, J.P. Morgan

Yep.

David Stack
Former CEO and Chairman, Pacira BioSciences

You got it? Okay, good.

Tessa Romero
Senior Biotech Analyst, J.P. Morgan

Yeah. One more from me, if I could. I mean, as you kinda take all these factors together, Dave, I guess, how do you think about the peak sales opportunity now? You know, are there any sort of competitive landscape factors or dynamics you'd point out in sort of thinking about kinda what your peak sales could look like here?

David Stack
Former CEO and Chairman, Pacira BioSciences

No. We still believe that EXPAREL is a billion-dollar product inside the current 5-year plan. You know, the high and the low of that or the rapidity with which that happens, again, goes back to the NOPAIN Act and our ability to gain reimbursement across these additional 10 million swath of procedures.

We will get there. In any case, your question about competitive, we are the only product that has a label, a broad label, and especially for nerve blocks and field blocks, which is the vast majority of our growth on an annual basis. We don't believe there's another useful commercial product in the marketplace.

Especially drawing on safety, where this product is safe enough that we're comfortable injecting it into subarachnoid spaces, and that's largely based on the safety of the product and dramatic differences between EXPAREL and virtually any other product that is in the marketplace, for this use.

Tessa Romero
Senior Biotech Analyst, J.P. Morgan

Maybe you could talk a little bit about how an approval in lower extremity nerve block could contribute to sales growth here. I think it sounds like a launch is potentially on track for 2024. What is the size of that market opportunity?

David Stack
Former CEO and Chairman, Pacira BioSciences

Lower extremity total is a little over 3 million patients. We are very aggressive in the total, the arthroplasty market already. The only caution there would be that we're currently being used in 300,000 of those patients as it pertains to knee.

The delta is 2.7 million patients. Relatively nascent in foot and ankle, and so that is a real opportunity. That's why, you know, the half dose, if it wasn't clear as I went through the presentation, both of those trials was very significant. P- values were the 10 ml dose, and both had a p- value at 96 hours. You know, we think that both of these growth opportunities will be extreme.

Tessa Romero
Senior Biotech Analyst, J.P. Morgan

Okay. Any questions from the audience? Switching gears to ZILRETTA, I wonder if you could provide a little bit more color on the opportunity in diabetes and how that fits into the overall knee osteoarthritis market.

David Stack
Former CEO and Chairman, Pacira BioSciences

Yeah, it's a very significant patient care opportunity. What's really interesting is when we've had a number of ad boards with orthopedic folks and with pain management and regenerative medicine docs, they all will reference patients who ended up in the operating or in the emergency department or in the ICU and never had any real understanding of what was going on there.

It is interesting that the insurance companies, only 75% of the patients respond to triamcinolone acetonide. The insurance companies will force you through using the generic form for at least 1 dose to make sure that the patient is a responder. On the backside of that, you know, we believe that showing that these patients stay in control with the use of a long-acting product that doesn't have the spikes is really important.

We've got $5.8 million patients, and over $1 million of those patients are diabetics as treated today. We think this is an interesting opportunity, and then we will study that to be able to quantify it in terms of cost as well as time. The endocrinologists don't talk about A1C anymore. They talk about time in control. We wanna actually study the product against a different metric of time in control, and so we'll be able to do that.

Tessa Romero
Senior Biotech Analyst, J.P. Morgan

Great. Well, I think we're just about out of time here. I wanna just thank the Pacira team for being here, and thank you for all of our listeners for joining. I hope everyone has a great rest of the conference.

David Stack
Former CEO and Chairman, Pacira BioSciences

Thank you.

Tessa Romero
Senior Biotech Analyst, J.P. Morgan

Thank you.

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