All right, good afternoon, everyone. Welcome again to the 37th Annual Piper Sandler Healthcare Conference. This is David Amsellem from the Piper Biopharma Research Team, so our next company fireside chat is Indivior, and we're delighted to have Joe Ciaffoni, CEO, and Ryan Preblick, CFO. Thanks, gentlemen, for joining us, and this is still very new and a lot of changes, and you've been articulating your vision for the company over the last few months since you got into the seat, so maybe just at a high level, Joe, just talk through your overall vision for Indivior, and then particularly in the context of the recent changes in the organization. Yeah, so look, David, first off, on behalf of Ryan, Jason, and myself, we want to thank you and the Piper team for the opportunity to participate in the conference. We're certainly excited to be here and excited to talk about what it is that's happening at Indivior. Look, in terms of the vision for the organization, I would start with the Indivior Action Agenda, which is our three-phased multi-year operational roadmap intended to maximize the value of our business, to make a positive difference in the lives of people living with opioid use disorder, and to create value for our shareholders. And we're heads down in execution of the agenda as we continue to progress. I think it will propel us to realizing our vision, which is to become a leading diversified specialty pharmaceutical company committed to making a positive difference in the lives of people through the commercialization of differentiated medicines. Okay, so I wanted to dive into the changes in the organization and really get your thoughts on the cost structure, and I know this has been a big topic. Just give us a refresher on, as you came in, the various redundancies and inefficiencies that you saw when you became the CEO. Yeah. So look, the first thing I'll emphasize, because I think the exciting part of the Indivior story and what I saw when I became the CEO and have even greater resolve is the SUBLOCADE growth opportunity. We have a fantastic asset with a durable runway in front of it, and it's a product that we believe deeply in. And our first priority was ensuring we were making every single investment necessary as we go forward to maximize the potential of SUBLOCADE and to drive long-acting injectable penetration. And we had a belief, and what we saw was a very complicated organization, I would say unnecessarily complicated relative to the simplistic view one could have on the business. And over the past several months, we've been working very hard to simplify the organization, to remove all nonessential activities and associated costs from the company. And in doing so, we were able to remove $150 million of OPEX. Going forward, what we've said is, as you think of 2026, our OPEX will not exceed $450 million. Now, how we went about doing that, one, we addressed a lot from a G&A perspective. Our R&D and medical affairs organizations, relative to the opportunity within the pipeline and the commercial opportunity, really needed to be correctly sized. We stopped, and it was a difficult decision to do so, the commercial support of OPVEE. The reason it was difficult is it's a product with a profile that is easy to be enamored by, but the reality of the commercial situation was such that it wasn't one that made sense for us to continue to invest in. Then we recently announced, from a Rest of World perspective, we would be optimizing that business, which means we will be moving from being in 41 countries to four countries. We're committed to maximizing our business in Canada and Australia and optimizing the opportunity in France and Germany. Got it. Okay. So wanted to ask a few follow-ups on the cost, the different action items. R&D, in covering the company the last few years, that was one item that struck me as a large number, given what the mission of the organization is and was. So how are you thinking about R&D going forward? You do have a couple of phase two programs that are ongoing, but beyond those readouts, what will be your general approach to spend? Yeah. So look, when you think of the organization, one, the company has led with science in this category for a long time and brought meaningful innovation to the market. Indivior 6001 is a program we're excited about. That would be a three-month formulation of buprenorphine. That will be fully enrolled and fully funded, the phase two, by the end of the year, along with Indivior 2000. We expect to have data readouts in the early second quarter of 2026. And the commitment there is if we have programs that are worthy of advancing, we have the capabilities and the resources built into our budget to advance them. Beyond that, when you look at the organization, as we focus to diversify and enhance the growth profile of the company, we will be focused on commercial stage acquisitions when we earn our way to it, in what we refer to as phase three, the breakout phase of the Indivior Action Agenda. And I do want to come back to BizDev and M&A, but I wanted to ask a follow-up question about XUS commercial support. So you've mentioned four countries, down from over 40. What does that mean for overall profitability? In other words, when you think about what the organization was earning, if it was profitable at all in its XUS business, where were margins pre-changes, and what does it mean now that you have scaled back your commercial support XUS? Yeah. So what I would say around the rest of the world optimization is two things. It's on two fronts. One, it certainly allows us to take some complexity out of the business. It allows us to focus on the U.S. Sublocade business. In regards to the profitability conversation, we're sticking with four countries that currently represent 77% of the forecasted net revenue and 94% of the forecasted EBITDA. So we went from 41 countries down to 37. And so when you look at the overall profitability, the overall impact to what we're going to produce for the whole company, it is immaterial, but we are still focused on maximizing Australia and Canada and still having a strong business in Germany and France. If I'm hearing you correctly, it sounds like those other countries that you disengaged from, it sounds like you were losing money in those markets, or at least some of those markets. Is that fair? It is. It was a mixture, and we just weren't at scale. Yeah. And another backward-looking question, but I think it's important just in terms of understanding the direction of the company going forward. You mentioned moving on from OPVEE, but how was OPVEE not synergizing with your SUBLOCADE business? Yeah. So look, when you think about OPVEE, one, we were supporting it with a totally separate infrastructure. So we weren't leveraging our addiction sciences team. The hard part of the OPVEE decision is the profile of the product is one the organization was passionate about and is one that's easy to believe in, and that's the only rescue medication, as an example, with an indication for synthetic opioids inclusive of fentanyl. The reality of the situation, the market dynamics were such, whether it be the high cost of goods, whether it be the market becoming genericized, the saturation of Narcan, so on and so forth, that it just wasn't viable for us to continue to be investing at the level we were in support of it. Now, we will be fulfilling orders, and we're committed to meeting all of our contractual and regulatory obligations, but it just wasn't the right product for us to be focusing on as we think about Indivior moving forward. Okay. All right. Now let's look forward. So 2026, you talked about overall spend or where spend will not go to. Can you talk about, if you can, overall operating margin targets? Or how are you thinking about that? I mean, pretty clear, margins will expand next year. I think that's pretty obvious. The question is, can you give us a range? Yeah. So we're not going to give a range today. We will be issuing guidance the week before JP Morgan, which will give people a sense of the impact. You're correct. We'll have significant margin improvement. The important part, and it's interesting because we get asked this a lot, what we focused on first and foremost was making sure we're making every investment in support of SUBLOCADE. We weren't setting any targets. And then once we were confident on a going-forward basis, we were equipped to do that. We then simply looked at all activities that were nonessential, not aligned to what it is we're prioritizing on a going-forward basis versus really targeting a specific margin target. Now, the output of that is you're going to see pretty dramatic margin improvement as we move into 2026. Okay. So now we can talk about SUBLOCADE. And we've spent most of the rest of the conversation talking about Sublocade. So I wanted to start with payer access. And one of the things that struck me when you took the seat is you talked about the opportunity in commercially covered patients, with the caveat that Medicaid is still going to be the predominant part of your business, but you talked about commercially covered patients, and that's a real opportunity. So two questions here. One is, can you talk to overall payer access right now? And then secondly, can you talk about the opportunity in specifically commercially covered patients? Yeah. So look, we're very fortunate with SUBLOCADE that we have great access in both Medicaid and commercial at about 88% availability. So that's the real positive for us, and there's significant opportunity in both of those books of business with LAI penetration at 8% to continue to improve it. When you look at Medicaid, Medicaid represents about 30% of our covered lives. It represents over 65% of SUBLOCADE prescriptions. Conversely, commercial represents about 60% of our covered lives and only 25% of SUBLOCADE prescriptions. So the interesting thing there is we're at an intersection between payer pull-through with our customer interfacing teams, making sure they're educated, are able to equip physicians and their staff with an understanding of how to navigate that commercial landscape, and then the work that we do from a specialty pharmacy perspective in ensuring that we're supporting offices and patients as they're seeking to get put on to SUBLOCADE on the commercial side. So it seems like there's a disconnect here with commercially covered patients, and that's a real untapped opportunity. So maybe to sort of set the scene, if you will, what were the major or what have been the major issues in terms of pull-through, in terms of getting commercially covered patients on board, which, for lack of a better way of putting it, are going to be more profitable patients compared to Medicaid. So what have been the major issues, major bottlenecks? Yeah. So the first one comes down to focus. So in commercial, there's a saying, "Water flows to the path of least resistance." The Medicaid process is an easier one. Our field forces disproportionately were focusing to the Medicaid opportunity and didn't have the focus to the pull-through opportunity. And then the second piece is execution. And the execution is both within the physician offices and equipping them with the information that they need. And then importantly, as we're working with specialty pharmacies in support of those commercial patients, ensuring that they're getting the information and are able to convert to a patient start. And that's really, forget the importance to the business, that's the right thing for the patient. As you can imagine, when patients are at that point in the treatment journey where the physician and patients have agreed that they want to go on SUBLOCADE or any therapy, it's really important that you're able to have the system work to get them started on the product. Sure. Can you talk about where the criminal justice system opportunity fits into your overall Sublocade strategy in the U.S., at least relative to your predecessor? I mean, I know that previous leadership really talked about this as a big opportunity, but also cited budgetary issues and other headwinds. So how do you think about the prioritization, or not, of the CJS? Yeah. So what I think the big and exciting opportunity for Sublocade is that there are 9 million people that are misusing opioids in the United States. There are 6 million that are diagnosed with opioid use disorder. Of that, only 2 million are being treated with a buprenorphine medication-assisted treatment. And of that, only 8% are getting a long-acting injectable. So whether you're looking anywhere, organized health system, key accounts, federal accounts, criminal justice system, they all represent opportunities. To your question specifically, the criminal justice system this year has been rebased. It has been stable for the past several quarters, and it's now in a position where it's a part of the market we're committed to. We believe Sublocade has the potential to make a difference and in many respects is fit for purpose for the criminal justice system. We are focused on trying to grow it now from a state and local perspective, and we're also working hard, no commitment to try to find our way back onto the Federal Bureau of Prisons, so I would say opportunity, but the bigger picture is there's abundant growth opportunity for Sublocade, and we're committed to maximizing the asset, and the key to doing that is driving long-acting injectable penetration. Let's talk about, at a higher level, how you're targeting and how you're thinking about the different type of account opportunities. Not just CJS, but organized health systems, etc., etc. What type of accounts are you having the most success with regarding SUBLOCADE, and what kind of accounts do you need to improve with? Yeah, so it's a great question. We're having the greatest traction within organized health systems, specifically what we refer to as key accounts, which essentially are addiction treatment centers. Federal accounts are within that group. Integrated delivery networks, candidly, have been a disappointment because we're working, and we need to find a way to enhance their focus, to operationally ensure they're equipped to be able to use a treatment like Sublocade. So that's how I would answer the organized health system. We talked about the criminal justice system. And then you have the independent physicians who have experience using buprenorphine that are treating a meaningful amount of patients who are dealing with opioid use disorder, where we think there's an opportunity for them to be using Sublocade with appropriate patients. Got it. So let's move on to the competitive landscape. Obviously, it's now a two-player market. It's been that way for some time. Can you talk to the Sublocade share of new LAI buprenorphine starts and just overall LAI share? Yeah. So look, that's something that we're very encouraged by. We have seen now for over a year Sublocade market share stabilizing in the mid-70%. For the first time since the other long-acting injectable came to the market in October, we actually saw our new patient share crisscross or leapfrog our total patient share, which we view as an indicator of brand health. If your new patient share is ahead of your total share, it at a minimum reinforces our belief that we're seeing stabilization in market share. Candidly, I know the importance in how people lock in on share. The more important thing, from my perspective, in maximizing the Sublocade market opportunity is driving the long-acting injectable market. In the learning of having a second entrant come to the market, we're the only ones that are equipped, and therefore we need to step up to the challenge to make the investments to drive long-acting injectable penetration. We're committed to doing that, and we're going to do that by investing a lot of resources in support of our consumer effort. In fact, we will be over-investing relative to what our models would suggest that we should. So before I come back to investment and your DTC campaign, I did want to ask about the overall penetration of LAI buprenorphine medication-assisted therapy. So it's been in the single digits for quite some time. And I guess a question that kind of gnaws at me is, why is it not higher? Is it because Suboxone just has multiple generics? Are there other factors, access factors at play here? You would think this would be a market that would be uniquely suited to an LAI modality. So why is that penetration not higher? Look, it's a great question, and I think it's the most important question that we've been thinking about. I'll share with you an interesting statistic, which will bring you back to the focus we have on consumer and why it is that we're going to be investing so aggressively there. In the development of our new consumer campaign, we did quantitative research with patients who were diagnosed with opioid use disorder, who either were on transmucosal buprenorphine or who had been on transmucosal buprenorphine. Their unprompted or unaided recall of Sublocade was less than 4%. So the reality, and this is really when you talk about being a leader in the category, and as I already commented, we have to step up to the challenge in a way we never have to educate and to drive and motivate patients to seek treatment for long-acting injectables and to have that conversation with their physician. So I really strongly believe that the consumer is the lever to pull, and it's one that we're absolutely committed to doing for the next several years because we're not going to look back three years from now, and if we're disappointed in the long-acting injectable penetration, it won't be because Indivior didn't step up to educate, drive awareness, and activate patients. So with that in mind, and you kind of answered, or at least partially answered, my next question, which is about DTC. I mean, there's broadcast media component here, which I did not expect. So how big of that, of the overall DTC pie, is going to be broadcast media driven? And in terms of patient activation and driving awareness, I mean, this is, I would think about this as a multi-pronged approach. You have not just the patient, but you also have their families, caregivers, etc. So how are you thinking about different points of activation? Yeah. So we're taking a total omnichannel approach. So we will be aggressively investing in all channels. Obviously, TV is an expensive channel, which we're committed to. And we're going to be communicating to patients where it is that they and people who care about them seek information. I think the key thing is Indivior has dabbled around the consumer. The two challenges were we haven't done it at a level of relevance. So you have to spend at a level that it breaks through, and then you have to be committed to it for the long haul, and it needs to be sustainable in order to really educate, activate, and get patients and physicians having that conversation. And that's what we're committed to doing. Can you just talk to sales force sizing, and is the commercial organization right-sized? Yeah. So I won't get into specifics on the size of our customer interfacing teams. What I will tell you is as part of our assessment of the investments we need to make in support of SUBLOCADE, we certainly assess that, and I can absolutely assure you that our field forces and customer interfacing teams are sized appropriately for the opportunity that we see upon us. As a matter of hygiene, that's an exercise that we will do every year as we do our annual planning. Okay. So in the couple of minutes we have left, I want to touch on a couple of non-Sublocade items. First, Suboxone, which is hung in there rather nicely. Can you talk to dynamics, both at present regarding pricing and what you're expecting in 2026, and how you're thinking about the potential for additional generic entrants down the road? Yeah. So when it comes to film, it's straightforward. The performance is simply based upon the generic pricing. And what we saw in 2025 was relatively stable generic pricing, which then benefited us over the last couple of quarters. When we built our guidance for the balance of 2025, we did make the assumption that the pricing would remain stable, and that's what we're seeing so far through the balance of fourth quarter. And 2026, what are your expectations? Yeah. When you get into 2026, assuming that the generics behave rationally, at this point in the product's life cycle, you would assume some share erosion, most likely at the levels that we've seen over the last two years, and then you look at pricing, you would probably see your normal pricing pressure in a state Medicaid channel. Yeah. Okay. So you touched on BizDev, M&A, and I realize this is more of a question that is further afield, but wanted to get your thoughts philosophically on this. Addiction medicine is a very specific audience. So what I struggle with here is how you can find assets that leverage that commercial infrastructure, or do you start thinking about other therapeutic areas, which, by the way, Indivior has done without success? So how are you thinking about that? Yeah. Well, the first thing I'm thinking about is that we're going to strive to be successful in whatever it is that we choose to do. If there was anything out there from an addiction perspective that would leverage the infrastructure that we have in place, obviously, that would be our top priority. I don't necessarily believe that is out there. So therefore, what I would say at this point, we will be focused on commercial stage assets when we earn our way to that opportunity. I think the more important thing than therapeutic area, although you would certainly want to do adjacent areas that would make sense, is one, the asset itself. So we would be looking for assets that we believe have $200 million plus peak sales potential. I think that's relevant relative to our revenue base. One of the things we're fortunate with Sublocade is we have a long runway in front of us. So we certainly would want to bring in an asset that has runway and wouldn't create an overhang from an LOE perspective. And then, obviously, as you're likely pivoting to a new therapeutic area, one of the things we'll be mapping out is once we make that acquisition, integrate it, what other assets are out there that we could then leverage that infrastructure. We wouldn't want to pivot from an area where we don't see additional opportunities to another area that would be devoid of other assets that you could leverage that new infrastructure. All right. Well, I'll leave it right there since we're out of time. Thanks, Joe. Thanks, Ryan. Thanks, everyone in the audience. Thank you, David. Thank you.
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