Great. Good morning, everyone. Welcome to the 36th Annual Piper Sandler Healthcare Conference. Our next company, Fireside Chat, is Indivior. With us, the CEO, Mark Crossley, CFO, Ryan Preblick. Thanks, gentlemen, for joining us. So, lots to talk about. I wanted to turn it over to you, Mark, for some opening remarks on SUBLOCADE and the overall business, and then we can go right into questions. Go ahead, Mark. Sure. Thank you for that. And listen, just to acknowledge, it's been a challenging year with a confluence of a number of external factors and competition on the business that have led to us re-guiding the Street on our flagship product, SUBLOCADE, as well as discontinuing our long-acting injectable for schizophrenia, Perseris, as we start to manage that category. But we've been very proactive in how we're managing the business, trying to really get out in front of where we are. And what we've done is made interventions to narrow our strategic focus so that we're focused solely on the execution of SUBLOCADE commercially, really driving that product to its potential because there is such a tremendous unmet need, and it's really at the start of its journey. Second, we've narrowed our pipeline down to OUD assets only. We have two phase II assets, a three-monthly injectable, and an Orexin-1 non-opioid opioid use disorder medication that are in phase II right now. Third, we have Opvee, which is a nasal rescue drug for overdose that's out there that we're in the second year of launch and excited about its potential and still believe in $150 million-$250 million at the top line. We've made interventions on cost. We just went through a streamlining exercise. As we've narrowed our strategy, we're able to focus on getting OpEx out of the system. Year- over- year, we're going to be down $10 million-$20 million on OpEx, including offsets of inflation, higher phase II studies for the two drugs that we have in phase II, and of course, further investment behind SUBLOCADE and Opvee. So making proactively the number of initiatives. SUBLOCADE, still believe in where this is. We shared at our Q3 results that we're seeing continued strong leadership potential in new patient share as well as cohorts following the early adopters and where those are stabilizing out with SUBLOCADE in a leadership position, so the future we believe is bright. We have a few new things coming along this year with potential label enhancements on alternate sites of injection on the body, as well as rapid induction that are coming, and I'm sure we'll talk about those a bit later, as well as that incremental investment that we think will drive SUBLOCADE growth in the short, medium, and long term, and then, of course, we've de-risked the franchise. We've settled the legacy legal items that were out there, the antitrust that have been around since 2013. We've settled that, and we've now papered that deal. That is final, and we're in engagement with the states on the OUD to do that. And then lastly, we have refinanced the company, taken out and have a $400 million debt facility, $50 million revolver, which has not been drawn, and $350 million of term loan. In 2025, we were scheduled to have that move into short-term liability. And so getting out in front of that to provide the financial flexibility moving forward, we thought was shareholders' best interest. So to summarize, proactively taking steps to streamline our focus, proactively drive the key value driver on SUBLOCADE, focusing OUD at our core. The future is bright with SUBLOCADE, and we're certainly at the start of that journey, which is increasingly with more and more data, getting more and more bright. Yep. That's a helpful start. So let's dive right into questions. So obviously, there's competitive dynamics between SUBLOCADE and your competitor, Brixadi, to consider. So I wanted to jump to sort of a question about near-term dynamics. Obviously, you lowered the guidance in recent months on the back of the competitive dynamics. What are you seeing right now? What can you say about dynamics in the fourth quarter regarding SUBLOCADE? I believe you said the word stabilization. So I'd love to drill down into what the near-term commercial dynamics look like. Yeah, and I think the stabilization is certainly in the cohorts that we're seeing from the early adopters where we see that share stabilize out at 65%. What we're seeing in Q4 is how we've guided to our guidance for the fiscal year 2024, which we have a lot of confidence in that range. Continued funding pressures a bit in criminal justice systems where, oddly, the success of having high adoption in these systems has them going through their budgets and having budget constraints in the short term, which we believe will be alleviated in the medium term and including next year and onward. So that's created some pressures in our forecast of them bumping up against those funding. Competition has gained access to one of our large accounts on the West Coast. That has continued. We've gotten back some of that, but not all of that account. And we've seen, again, continued low levels of stocking in the system where they're taking advantage of what's become an incredibly efficient delivery system that we've put in place with our SPs and our SDs, and customers are taking down those inventory levels. So we're seeing those pressure points as well as the accelerated adoption of the competition, their trial in Q4 as we've guided. But we have confidence in the numbers we've got out there. Yep. When you say 65%, is that your share of new starts, or is that your overall LAI share? Yeah. So at our third quarter, we shared we get about 72% in the third quarter of new starts. And what we see as we look a year for the first three months of cohorts where doctors prescribed both SUBLOCADE and Brixadi, the earliest adopters who were having conviction of starting Brixadi early on, what we're seeing is as we look at those at the end of Q3, we're seeing cohorts where we're at about a mid-share for SUBLOCADE stabilizing out with about. Got it. Okay. That's helpful. Can you talk to overall long-acting injectable buprenorphine market dynamics just in terms of the penetration of the LAIs and where that stands? Such a continued huge opportunity for us as we move forward and certainly room for multiple players. We've talked about stats a lot. There's over 10 million people that abuse opioids. And then depending on which data source you use, there's between three to 6 million people that have been diagnosed with opioid use disorder. And what we have right now is long-actings in the space that are still only 7% of the patient share. So it is tremendously low penetration for LAIs and even tremendously low treatment penetration even from a B-MAT. So we see with only 20% of people getting treatment, we see continued growth in the market moving forward, more patients coming into treatment, and we see LAIs getting to a higher share. Our data, our research with physicians says that they think about 30% of patients should be on LAIs. So there's a tremendous opportunity for growth moving forward as we continue to focus on the competitive environment, but also focus on expanding that market so that more patients have availability for these LAIs, especially SUBLOCADE, which we believe has a profile that really can help patients get and stay in recovery. So just going back to share versus Brixadi, to your point on the third quarter call where you mentioned 72% of new starts going to SUBLOCADE, I guess my question here is, where do you see that shaking out over time? I mean, is this going to be a 50/50 split between Brixadi and SUBLOCADE in terms of new starts? Do you think you can do better than that? Just help us better understand longer term how you envision a mix between the two in terms of new starts. Yeah. It's a great question, and it's one that we think over the next 12, 18 months, we think we're going to learn a lot about where this stabilizes out as we come through the transition period where they're initiating trial with the physicians that are in here, and we start to grow that out. I think the cohort data is one of the best short-term sort of data sources we have where it seems to be stabilizing out at this 35, 65, but for me, even if you didn't think SUBLOCADE was the better medication in this space and would stabilize out in leadership, if there was no first mover advantage and you're at 50/50, all it takes is about 20% share of patients to get to $2.5 billion products. Now, I believe SUBLOCADE's profile is suited well for opioid use disorder, getting people in and staying in recovery, and expect us to maintain a leadership. Okay. So let's talk about SUBLOCADE performance in various channels. So, particularly alternative types of care, also the criminal justice system. So wanted to drill down on those two channels in particular and what you're seeing Brixadi. I think to your point, David, we only have a 7% penetration with LAIs in the category. These are huge avenues for us of expanding the footprint across these channels. We have the large regional sort of medical centers that are still in growth mode, but these are two great avenues to meet patients where they are. Let's start with the criminal justice system. It's about 22% of our business in the third quarter despite some of the funding issues we talked about and the competitive pressure. It is very fast growing, much faster than the rest of the business. It is because what we're seeing is we're seeing a tendency of them wanting to treat these patients when they're at a time where they can intervene and get them into recovery. Because once they go through their time where they're incarcerated and they leave, about 75%-80% of patients typically relapse in the first three months, and then they're back in the revolving door. So we're seeing these folks want to treat. We're seeing that with a long-acting, they think that is a better vehicle. It's a better vehicle because, one, it's less resources in their prison systems, less guards, and less nurses to do daily treatment, whether they go cell to cell or whether they take the patients to the dispensary. That's huge resources. So only doing that once a month is very important. And they also like it because it can't be diverted. I can't put pressure on you to try and cup it, cheek it, bring that medicine out so it can be sold in the prison system because it's been injected in. So we're seeing a huge increase in that. We have over 600 justice systems activated there. Still very early days. We're focused on the first 5,000 of those as we move forward. So we expect continued growth there and then starting to work on the transition of care out and making that smooth so patients stay in treatment and come out, which is also part of the journey. Just to be clear, 600 justice systems that are activated that are current SUBLOCADE customers. Have prescribed and administered SUBLOCADE. Out of roughly 5,000. There's over 10,000. There's 5,000 we're focused on. 5,000 you're focused on. Okay. That's a helpful data point. Yeah. It is, and then alternate sites of care, which is even more in its infancy. We've focused on these large organized health systems that have the infrastructure for a specialty pharmacy controlled substance, but in the meantime, we've left behind a number of patients that are with independent physicians that don't have it, and the burden of prescribing SUBLOCADE has been tough, and as the law changed where DATA 2000 was removed, suddenly what it opens up is you can open up alternate sites of care where a doctor, say me, I'm in a small practice, and I want my patient to be on SUBLOCADE, but I don't want to have the medicine on my site. I can now send them to a partner who can do the injections like you would for a vaccine or other things or in the antipsychotics we see a lot. And so we're in the process of building out a nationwide network. We have about 1,200 sites with six partners. We have a portfolio of additional partners that we're working with to try and activate. The goal, albeit very aspirational, is to have it be almost as seamless as retail pharmacy so that people don't have to travel very far to get these injections, and it can open up SUBLOCADE as an avenue. We're still very early stages, 1,200 sites. We had about 600 dispenses in the third quarter, which was about 50% growth over Q2. Yep. So additional competitive dynamics that I wanted to touch on. You filed a prior approval supplement regarding alternative injection sites and also the rapid induction protocol. So I wanted you to walk us through both parts of the filing and also walk us through the competitive significance of each. Certainly. And I think it is significant, and it's something that's been in the making for quite some time. This was done as part of a PMR study we had with the FDA, and the team, I think, put together a very compelling package which got us the priority review. So kudos to our R&D team that enabled that with February 7th as the date. I think both of these certainly take away perceived gaps versus competition that allows folks to focus on efficacy more, right? And what we get to is with a rapid induction on SUBLOCADE, if it's approved by the FDA on February 7th, which we expect it to be, what you get is you can take a 4 mg transmucosal buprenorphine, and you can immediately, an hour later, put them right on a monthly SUBLOCADE. That not only closes the gap, but it creates an advantage versus the competition who only has that in their label on their weekly product. So it becomes an advantage to be able to do that on a monthly basis. And imagine prison systems, resource utilization, suddenly they're only having to, right from day one, do one injection, and they don't have to visit that inmate or patient for another month. So that's an advantage that's there. The other is the alternate sites of care or alternate injection sites on the body where we have submitted for the thighs, the buttocks, and the back of the arms similar to the competition. And for us, I think that does two things. It allows for those multiple injection sites, but it also takes you away from having your injection in the abdomen where, I don't know about you, but when I get an injection in my arm, I end up watching it, and it takes away that experience and makes it less invasive for both the patient, but also in prison systems for the nurses or the guards that are administering in front of a patient. Now they can do it from behind, and it's less invasive with regards to that experience with someone who is an inmate, right, even though they're a patient. So we see both of those very important in closing those gaps and creating advantages even on the alternate sites of injections. We'll have induction across all of those sites where the competition doesn't have induction on the back of the arm. Combine those with the out-of-fridge expansion that we got at the beginning of last year that we ran through the inventory at the half year where you have 12 weeks out of stock, and you've removed most of those perceived advantages. They don't play as much into efficacy, but they're important. Got it. So one thing that we've been hearing about Brixadi relative to SUBLOCADE is the needle size, the smaller needle size. So how much of a headwind has that been for SUBLOCADE, and can you talk to what you're doing to address this? Yeah. I think if you like the profile of SUBLOCADE, which I think most doctors, when they see how their patients react to SUBLOCADE, the fact that it covers the entire month long at both 2-3 nanograms per mL and 5-7 nanograms per mL with the 300 maintenance dose when the people that choose to be there, and that's over 45% of our patients stay on that 300 mg dose. You're going to like SUBLOCADE, but you're going to have a more viscous product, which requires the larger needle size. So with SUBLOCADE, we will not be able to reduce the needle size. We will continue to be a 19 gauge. We have not seen that as a major barrier, and it has an offset efficacy. I think it is a feature that is when you hear about the competition, it allows trial, and it's something that stands out with patients to enlist trial, but then when you get to efficacy, efficacy plays out. Oddly, a small needle sounds like less pain in the injection experience, but when you look at the phase III studies, both products had similar AEs due to pain. And we know that the buprenorphine causes most of the pain when it hits the subQ. It causes burning. So for us, yes, needle size will continue to be there, but we don't see it as a major issue. The number one driver of prescription for physicians is efficacy. Let's move on to net pricing. I wanted to ask about pricing dynamics, particularly the extent to which we could see pricing pressure with the availability of a competitor. So talk to what you're seeing lately and what we should think about regarding 2025 and later on. I think the best thing here is this should be about patients giving them options based on where they are in their treatment journey. And that's how we see it playing out predominantly in almost every channel. Your major payers are providing access to both products. There isn't pricing pressure. You're not seeing leverage in one-on-one pricing bids. This is about open access, very similar to antipsychotics. So it's about having many tools in the kit and letting the doctors choose based on patients. That's very positive and constructive in this therapy area where you still only have 20% of people in treatment. There has been some pricing pressure in criminal justice. We're talking about low single digits where they're very price sensitive because of their budgets that we talked about earlier. But that hasn't been an ongoing pressure. Once that was equalized, we haven't seen ongoing pressure there, so we're. Okay. That's helpful. So earlier this year, you had talked about Medicaid disenrollments as a major headwind, and that was a reason for, I guess, the first downward guidance revision. So with that in mind, can you talk through the extent to which that's still a headwind? And I'm more interested, actually, in how we should think about the impact of disenrollments as we move to 2025? It's a great question. It's one we get from a lot of investors. I think the really positive thing here is that what has been a very tough year for people on Medicaid having to re-enroll, having to the emergency measures got lifted. We had 25 million out of 94 million people on Medicaid who got disrupted in their coverage and got disenrolled. We've ended up with 13 million less people covered. We've moved from 94 million to 81 million. And if you think about 80% of our patients on Medicaid, that's a significant number of our patients that could have been disrupted because of their coverage. And that's what we saw last year that accelerated with our patients impacted at the end of that renewal cycle. These aren't people who day-to-day are worried about their healthcare and are out of touch with the renewal. So it happened at the end and accelerated and caused the messes. I think the good thing is all but three states are done right now. North Carolina finished in November. So we have Alaska, Washington, D.C., very small numbers of patients, and we have New York who's still negotiating their dates. So we see this no longer as a headwind as we enter 2025. We're going to get into more normal market dynamics where you have an OUD treatment market, and LAIs are trying to get awareness and grow that so that the rising tide raises all ships, albeit we think SUBLOCADE will. So just to be clear, the three states now that you're still are not past these emergency measures are which ones again? Alaska, Washington, D.C. Okay. Okay. And do you expect that? I mean, New York's a big state, obviously. It is. And so you've made it clear from your comments just now that you don't expect it to be a headwind, but how confident are you, just given that it kind of snuck up on you early in the year and drove a downward revision? So I just want to make sure. What's your view on what's your level of confidence that this is not going to come back and bite you guys here? We will build in our numbers items for those states. It's just going to be a much lower impact than what you've seen this year where all of the states came to the end of their renewal cycle. So there will still be a small headwind, but it'll be small, and we'll build it in with guidance. Okay. And this brings me to a broader question about just guidance in general, not about 25 guidance, but in terms of how you organize your assumptions. Is it fair to say, in addition to building in that small headwind for disenrollments, that your guide for 25 is going to appropriately reflect the competitive dynamics with SUBLOCADE because that was the reason for the other downward revision? So just help me understand how you're thinking about that. Yeah. I think it's been a year of a confluence of a number of events that were very tough to measure. And we will build all of those learnings into our guidance, including those competitive pressures where we're seeing that transition period will continue into 2025 where they're eliciting new trial with new physicians. So we'll see that happen. They're calling on doctors that prescribe SUBLOCADE, and we know that they will elicit trial, but we know also from the early cohort data that it stabilizes out in a range where SUBLOCADE is the clear. We expect that period to continue, and we'll build that competitive environment, continued insights on stocking levels, as well as these states that are less guided. Just to be clear, when you say early cohort data, these are your sort of early adopters that are trialing new product, but those early adopters are now in a stable place with those customers. Correct. It's the first three months of doctors who prescribed both SUBLOCADE and the competitor's product, and it looks at their share here later at the end of third quarter. So that's about 500 HCP. Not a small number of doctors. In the minute or so we have left, can you talk about the cost structure? And I'm specifically interested in how we should think about the commercial organization going forward and whether it's right-sized. And then the second part of the question is the extent to which you can drive operating leverage just with this growing LAI market. Maybe I'll handle it on a high level since we're at a minute. I think what we've done is we've really, with the narrowing of our strategies, we've taken the opportunity to streamline the organization and take costs out of G&A. We're reinvesting some of those costs, offsetting inflation, and then we have the increase in the pipeline. So that narrower focus is still resulting in costs down year- over- year despite those increases. So the gross amount is down. As you look to the future, and if you believe like I do in the greater than $1.5 billion, that leads to a very leverageable platform that will have margin expansion as you get through that growth. Now, we have this transition period next year where you have the competitor still here, and you have the potential pressure of a fifth entrant in the film that could disrupt that, but if you look to the short to medium term, you'll see margin expansion as the growth comes. And then one quick question on the R&D spend. I mean, are the levels that we're seeing lately a good way to think about spend going forward? Yeah. I think it really, and you know this better than me, David, with your over 20 years in the space, it depends on what phase you are with your assets and how the cards turn. So the way I think about this is we have two OUD assets. The intensity of the phase II next year will be heavier than it was this year. So the costs on those two assets will be up, but then it will depend on how the cards turn and the commercial opportunity versus the data readout and whether you take those into phase. Okay. Well, I wish we had more time, lots to talk about, but I'll leave it there. Thanks, guys. Thanks for having me, David.