... Being Specialty Pharma Analyst. I'm delighted to be here with you all this afternoon with the Indivior team. We've got Mark Crossley, our CEO, we've got Ryan Preblich, our CFO, and we've also got, you know, the full IR team as well. So thank you all very much, you know, for your time this afternoon. Lots of questions, interesting kind of Q3, and we're getting a lot of, you know, incoming, so really good opportunity to have a discussion, which we're looking forward to. Perhaps, Mark, if I can hand over to you to give a brief introduction in terms of the highlights you wanted to have at Q3, and then we'll get straight into Q&A. People on the line, if you do want to ask a question, probably the easiest thing is to either send me an email at jvane-tempest@jefferies.com, or Bloomberg IB message, and we'll make sure we can put that to management. So with that, Mark, over to you. Sounds great, James. And listen, thanks for hosting the session. Good morning and good afternoon to everyone, you know, on the call today. I appreciate the continued interest in Indivior. Before we begin, I just have to point out the legal side of things, which is that, you know, comments today may include forward-looking statements. Actual results may differ materially. You know, we list some of the factors that may cause actual results to differ in our third quarter materials, which are available on indivior.com. So, you know, I think for me, we just had our Q3 results. Let me summarize a few bits that have come out from one-to-ones and from our engagement, you know, with the brokers. I think probably the first thing that came across was litigation as a topic where people were looking. Just from a high level standpoint, I think we are pleased to have settled the antitrust multidistrict litigation with the resolution with the direct purchasers. As the settlement was reached, you know, you'll have seen in the third quarter that with those results, the going concern language has been removed that came in in July. So we're happy to have the certainty that the settlement provides for stakeholders. With regards to the remaining litigation, you know, as indicated by the removal of the going concern, we believe it's manageable. You'll also have seen that we initiated a $100 million share buyback that we announced just this past Friday after our board meeting. We hope that that continues to give confidence in the good remaining flexibility, and that we expect to continue to generate strong cash flow moving forward off the backs of our medium-term profitable growth thesis that we shared last December. The buyback is also really pretty fulsomely aligned with our capital allocation strategy that we've been sharing over the last three years. It balances investments in the business, financial flexibility, meeting our commitments, as well as the potential for business development and/or capital returns. And I think we've had a demonstrated track record at the management and board level of delivering against that allocation. So, you know, where the shares are currently trading, it also offers, you know, an attractive return for shareholders with regards to the buyback itself. The second comments we've heard, you know, and again, at a high level, is with regards to SUBLOCADE momentum. I do wanna just start with, you know, that we remain extremely confident in our peak net revenue goal for SUBLOCADE of greater than $1.5 billion. I continue to be pleased with SUBLOCADE's net revenue progression this year. You know, at the midpoint of our 2023 guidance, we expect to deliver greater than 50% year-over-year growth. Understand that some investors are concerned about the sequential net revenue growth, but we believe it's part of some seasonality that we've seen and observed over the last couple of years. And when you look, you know, while quarter-over-quarter in the third quarter, it may have dropped to 8%, year-over-year, it's still at 55% growth. So that seasonality is there, but the strong momentum continues. We believe the commercial investments that we're making in SUBLOCADE will pay off, you know, by providing access to SUBLOCADE for HCPs and patients who just previously weren't able to use SUBLOCADE due to the administrative burden in these small independent practices. And given that this was enabled by the recent change, kind of from a macro sort of impact of removing DATA 2000, you know, the incremental revenue that we see from this opportunity, you know, was not part of our initial greater than $1.5 billion peak net revenue guide. So this is incremental to the foundation we'd already built and the guidance we'd already given. And then lastly, while we haven't guided for next year, we do expect to have strong momentum exiting the year and entering for year-over-year, strong year-over-year growth in SUBLOCADE. The third comment we've had from the Q3 results is margin expansion. And, you know, I think we continue to expect ultimately, you know, to show demonstrable operating leverage in our P&L that we committed to at last year's Capital Market Day. I think a great example of this is, you know, even after acquiring the Opiant business and the costs associated with that earlier this year, we still expect to generate year-over-year adjusted operating profit growth this year. And just as a reminder, with regards to Opiant, you know, strategically, it fits squarely in our expertise, our disease space. It's financially attractive, but the acquisition came with some short-term sort of costs that came in without revenue of $40 million-$50 million of costs in 2023. Represents about 400 basis points of adjusted operating margin, you know, at the midpoint of our 2023 net revenue guidance. And so for me, the, the clarity here is, is on driving value via different vehicles. One is the base business, the margin expansion, which we would have had significant margin, and the other is by bringing in assets which drive value on a cash flow sort of basis. So, so very exciting there. And I think the last piece that we've, we've kind of heard about a bit is that we've kind of altered from our virtual sort of manufacturing strategy and went and acquired a manufacturing site. You know, just really at its essence, really simply put, we believe this is an extremely prudent move, and it's in the best interest of shareholders as we look to secure the long-term production of SUBLOCADE, and it's greater than $1.5 billion peak net revenue. You know, we expect to complete the tech transfer go live, you know, in 2026, and when we have a full year of manufacturing in 2027, we expect savings of $20 million, you know, from production at that site. So not only does it provide BCP, but it's better and cheaper with having this site in-house, with, you know, under our control. So just a quick kind of conclusion. Major antitrust behind us. We believe the rest of the matters are manageable. Great confidence in SUBLOCADE's trajectory, towards our peak net revenue goal of greater than $1.5 billion, and we expect to, to demonstrate the inherent leverage in our operating model, that absent, the acquisition of Opiant this year, you would have seen that, that over 400 basis points of margin expansion. So with that, I'll hand over to James. I know, I know, you know, he's got some questions, and I'm sure some questions will come in virtually. That's great, Mark. Thanks very much. Quite a few things for us to kind of unpack there. I guess to start off, you know, let's talk a little bit about the MDL. You mentioned, you know, there's those three main tranches, you know, that's kind of, you know, behind the company now, which is a great step forward. But one of the questions, you know, we've kind of been getting is it doesn't seem to be, you know, at the end of it, because I guess when you do look in the Q3 release, you know, there does seem to be some other new plaintiffs or where the losses cannot be estimated. And so can you help us sort of understand essentially what's left? And can you help us essentially understand what the settlement of that, you know, means? I think the key here is, you know, we're trying to control the controllables we can, and bringing resolution on these things, certainty at the right value. And, you know, bringing the antitrust classes, the states, the end payers that were the certified class, as well as the direct purchasers to conclusion, you know, we think is in the best interest of shareholders. It also removes that going concern issue. Now, there are some counterparties that have strategically, you know, gone and broken off from the class. We do have some N payers there. And probably the other one that's mentioned the most from a legacy issue is our inclusion in the opioid pain sort of MDL. And we recognize that those are there. Those aren't at conclusion yet, but these are long-term legacy issues that we're continuing to actively manage to bring to conclusion. Obviously, the end payers, you know, are a carve-out of a class that we settled for about $30 million, and while we can't guide to that, you know, we know that the end payers, you know, do have some issues with their damages model. You know, the film was cheaper, you know, during the time it's out there. So we don't have provisions against each of these because, again, we just don't see, you know, from a legal standpoint, you know, the merits in the counterparty's case or potentially any sort of damages sort of model. So we continue to believe these are manageable. We'll look to actively manage them to bring them to conclusion and provide certainty to shareholders. Thank you. Sorry to push the point, but I guess, just to make sure I understand, you said it's a subset of the class of $30 million. So would, again, this is not a guidance, but would a reasonable assumption to be what's kind of left is less than $30 million? I think where, you know, I guess a lot of the discussions I've had with investors have been is, you know, you've made such good progress settling three MDLs, but in terms of what's left, you know, simplistically, people are trying to understand if that's $1 million, $10 million, $100 million, $300 million. I mean, literally, because it's sort of where losses are unable to be estimated, any kind of directional steer would just kind of be useful on a best efforts basis, even if, you know, there's no kind of specific guidance. I appreciate there might be a lot you can say, but that's kind of one of the main areas we've been getting some feedback. Yeah, and I respect the question. I think all we can do is we've provided note 13, which is very robust in its disclosures, have provided a bit of context and perspective. You know, but I think the key here is for us to focus on bringing these to resolution moving forward, and unfortunately, we can't provide this level of sort of numbers that folks are looking for with regards to that, James. Understood. Then I guess, you know, the process will take its time. I guess, do you reckon this could be finally kind of behind you with these outstanding things in 6 months, 12 months, 18 months, three years? You know, just to give us a feel in terms of where the way the U.S. legal system works, how long you would expect before we can hopefully get some kind of resolution. Yeah, I think from a time duration, it's also tough to guide. Obviously, I think you've got a management team who's been really focused on bringing these legacy matters to conclusion. I think we have a good track record to date and have been focused on the larger ones first, and we'll continue to actively manage these moving forward, and with a focus on bringing them to resolution, you know, as soon as we can. Okay. Thank you. Switching gears then to, I guess, the market and and SUBLOCADE, it would be helpful if you could give us a little bit more color on market trends, where you can, either in terms of volumes and pricing, and where you see some volume changes. Because certainly, you mentioned sort of seasonality in your kind of opening remarks, but some people are wondering that in terms of the competitive environment, they're either seeing greater use of generics, you're obviously seeing a new entrant to kind of SUBLOCADE, with kind of BRIXADI. Is there any, you know, kind of, changes since September would kind of be helpful to sort of understand those moving parts? ... Sure, James, and let's just start with the overall market first. I think, you know, I mean, addiction continues to have a huge unmet need. Self-reported, over 10 million people that have used opioids, you know, just over 3 million that are diagnosed and, and a small number, less than two in 10, actually in treatment at any one time. So there is a huge unmet need. We expect the market to continue to grow. It's kind of growing in kind of the mid-single digits sort of range at this time, and we continue to see good tailwinds from the administration with funding and making interventions to help with access, increasing access and breaking down barriers, a la Data 2000 removal. So that, I think from an overall market, continues to be incredibly attractive. And as you look towards SUBLOCADE and LAIs as a subset of the broader buprenorphine medically assisted treatment, you know, I think there's a huge opportunity here, you know, to really help patients. You know, and certainly plenty of room for multiple players to be in here. As we look to where things have been in the short term, again, quarter-over-quarter, you know, when we look at the front half and the back half, we were obviously in mid-teens quarter-over-quarter growth in Q1 and Q2. People had seen that slow to 8%, but again, this it is seasonality that's in the back half of the year. We had 55% year-over-year growth in Q3, all right? And when you look at the top end of our SUBLOCADE guidance in Q4, you know, it's a 50% growth rate that we're seeing there, too. So, you know, people quarter-over-quarter, I think, are saying, "Hey, is it slowing? Is this going to be the new normal? Mm. Again, when you look back to last year, we saw similar rates of slowdown in the back half on a quarter-over-quarter, and trying to figure out exactly what that certainty is about has been a bit tough for us in market research. But we don't see the same seasonality with the orals, and we seem to think that it's as we look at the data, when you're going from, you know, abusing opioids into treatment and you're doing daily medication, it's less of a transformation than going to a long-acting, you know, with once a month sort of injectable. So we think that has some of the seasonality in it. Okay, I've had a question which I'll kind of throw in here as part of my follow-up question to that. And that is, I guess when we look at sort of the second half of this year versus last year, one of the kind of the understanding from someone dialed in is Medicaid ending the automatic enrollment on July the first. And so if patients kind of have to enroll annually, you know, if people aren't either on the drug for kind of the whole year, how disruptive has that been? And I guess the second part, the second half... The second part of the question is, you know, Q4 this year, we've obviously got the ramp of kind of BRIXADI. So I guess, what are you seeing in either in terms of the scale of the launch or the areas of the market where you're kind of stronger, just to kind of—I don't, you know, talk about other companies, but I guess just in terms of, you know, the market impact that is having, either it's creating the market kind of a life in patients or whatever that kind of might be, what setting is used. A few things thrown in there, but— Yeah, no, it's okay. I can ask them. Let me, let me handle both of those, James. And I think the first one is, if there is an impact with regards to this Medicaid renewal, the fact that the COVID emergency sort of renewal, you know, has ended, and the muscle memory at renewing your plans has led to some people dropping out. If there's somewhere around 94 million, 95 million lives covered, you know, we've seen over 5 million sort of folks fall out of treatment. You know, by the time you take a portion of those are children, you know, a portion of those, you know, aren't, aren't potentially OUD patients. You know, we think the net impact, it might be a point or two of growth, but it's, it is not what's driving it's the seasonality that's driving kind of the quarter-over-quarter. So there is an impact. Tough to really isolate it, you know, but it might be a point or two with regards to that, and we'll continue to assess that. I think most of the people on the call know that just due to the nature of the journey that our patients have been through, we do have a disproportionate share of our patients on government payer programs, so we are disproportionately impacted this, versus maybe other medications out there. So I think the second part of the question is Q4, and when we look to, you know, the impact of having a competitor in the market, and what I can say is, listen, let's just drop back. There's such a huge opportunity for both players. Their launch is in such early stages. I think you need to really talk to Braeburn and to Camurus with regards to how they're doing. You know, we're not seeing anything in the early stages of this, you know, that is different than we expected, that is impacting anything to do, you know, with our guidance this year. You know, our interim guidance of exiting 2025 at a, like, a $1 billion, or a billion-dollar run rate or our peak revenue guidance. There's nothing, nothing that's surprising with regards to the launch or any disproportionate impact in the early days. I've had a clarification question come in. When you mentioned there was an aspect of SUBLOCADE, which wasn't included in your north of $1.5 billion, peak sales target. Can you just remind, just for the benefit of the person and everyone else, what that is, to help us understand how that may have shifted? Yeah, certainly. We upped our guidance at our capital markets day, early December last year, to greater than $1.5 billion, and that included sort of the market dynamics that were in place at that time. And before that, we've always talked about, listen, if something major were to change in the landscape, such as, you know, enabling alternate sites of care, you know, that could change, you know, our footprint, and it could potentially lead to incremental revenue. And it's exactly what happened just before Christmas last year. You know, the U.S. government eliminated Data 2000. And Data 2000, it was put in place, James, back in 2002 to shift buprenorphine from a restricted class similar to methadone, that had to have individual dosing, to actual take-home medication. Now, Data 2000 never envisioned anything other than an oral daily dose take-home medication. It didn't envision the fact that there would be long-actings in the market, and the inadvertent side of it is that it prevented alternate sites of care for small, independent doctor's offices. They didn't want the administrative burden of a specialty product that's controlled substance, that put a real burden on their practice. And in other spaces, they typically could set up and send their patient to someone else to inject the medication. But Data 2000 eliminated that. The interpretation of the law was that you weren't allowed to. So by taking that away in December, suddenly it opens up so that these independent physicians' offices, remember, our strategy is in organized health systems, large systems that have the administration and back office to manage this product. It suddenly opens this back up, and the early signal of that was having our first alternate site of care provider up in June. That's Albertsons. They're on the front end of this. They see it as their role in helping with the opioid epidemic, and they now have 1,000 storefronts where they can inject long-acting buprenorphine SUBLOCADE. And for us, these are patients that we hadn't built in to our revenue projections when we built up to the greater than $1.5 billion. So it's incremental revenue and thus incremental value for shareholders. So a really great development in the space. Thank you for that. That's very helpful. I guess the time when you gave your guidance, you gave a sense in terms of what the number of patients could be. Are you able to give us a number in terms of what the patient number you expect that would increase the opportunity by? No, we haven't, we haven't gotten down to that level of granularity, James. What we have said is- Worth a try. Well, it was a great try, but this will take quarters and years. We have to build up a full national sort of network here. So Albertsons is great, but it's 1,000 storefronts. We want to get as close as we can to a retail experience, which means the proximity of going for these injections needs to be close to the patients, and we'll be looking for additional partners to add on. And the beauty of that is, as we've done our sales force expansion, you know- Mm-hmm ... adding this incremental 40, you know, customer-facing people out there, in addition to eight in criminal justice, we'll be able to have now the increased capacity to reach these independent physicians, who at SUBLOCADE, can be in there. We'll be able to pull through as the network builds out. The other question which we get quite a bit of, at least covering the comparison to BRIXADI is, you know, the headline price is lower, I think 17% lower. So with cash-conscious payers, is there a risk that some contracts don't get renewed or we have to be lower to be competitive? Yeah. What I'd say, James, is we believe that from a net price and from a usage, you know, we're more than competitive with any other long-acting out there. And so for us, we've not seen pricing pressure in the category and continue to retain... We have almost 90% of lives that are covered. We have a co-pay card, you know, that for commercial patients, albeit a smaller percentage of our patients, it does, you know, take their co-pay down to zero. So there isn't kind of an elasticity issue, you know, when you get at a patient level from a walk away. So still great lives covered, you know, almost 90%, and from a patient standpoint, there shouldn't be a price issue. Understood. We've also had some feedback that a smaller needle size and I guess the weekly option from BRIXADI is a real kind of differentiator. So again, you know, some investors are kind of, you know, we get sort of pushback why the volume growth won't slow down. So I guess I'd be curious to get your thoughts on that. Yeah. Rather than getting into, into features, right? I think which, which I kind of see those as features. I'd say, I'd say, I think with SUBLOCADE, what you're getting is a paradigm shift in treatment. One that we just don't see from other long-actings in this space, and in an adherence-based sort of area with synthetic opioids that are, you know, ending up causing overdoses of about almost 80,000 a year, of which 90% of them are synthetic opioids. We think our paradigm of treatment is a huge differentiator in this space. So, you know, we just don't see other long-actings that are up to therapeutic levels in four hours-eight hours, right? We just don't see that with other long-actings. We don't see that therapeutic level being maintained for the full 28 days. You know, payers are paying for a medication. Patients expect that therapeutic dose to last for a full month. We just don't see that. And then the uniqueness of our therapeutic dose that we maintain the entire month, we believe is quite differentiated also. The maintenance dose of our medication, dose 2 ng/mL-3 ng/mL, which occupies the receptors in the Mu receptor where the opioids work, with a higher affinity buprenorphine at a level that they're saturated. So there's no room for those full agonist opioids that cause the euphoria and the respiratory depression to be able to gain access. So it protects those patients in a moment of weakness. Yeah. And we also see that for our 300 mg dose, which is an option for people that, you know, physicians feel there's a benefit in maintaining the 300, it has about a 5 ng/mL-6 ng/mL concentration, and we see about 40% of the volume, you know, remaining on that. So it's a very unique therapeutic sort of paradigm of treatment that we have, that we just don't see differentiated. Listen, I think some of these features that get talked about, you know, are interesting, but I think in the market, with the performance for the patient, I think they are important, and we haven't seen any of those be a barrier to treatment, in the years they've been out there in driving the year-over-year growth we've been seeing. Thank you. And switching gears into manufacturing, I guess you talked a little bit about that in your kind of opening remarks. I mean, you successfully used contract manufacturers, you know, for many time. At least as far as I can remember, acquiring a facility was never really kind of part of the roadmap, so it was a surprise to me as well when that was kind of announced. So I guess, not what are the issues with the contract manufacturer, but I guess what are the kind of the drivers which kind of essentially led to this decision? Because it is a material investment for you. ... No, it is an investment, and I think strategically, it's one that's in, certainly in the best interest of shareholders. To have the supply of this built up, secured, you know, just well beyond the greater than $1.5 billion, we think is key. And currently we have one partner, you know, with two sites, and we think the diversity of this in the BCP is a key investment. And with that, as a given, you know, we had to look at our strategy with regards to this product. You know, do you find another partner or do you, you know, bring this in-house? Given the nature of this product, this is a hard to manufacture, very unique product, and it leads to a great product profile and a great paradigm shift in treatment, but the manufacturing is tougher. So we think by bringing this in-house, given there's so few parties that have the capabilities to do this, by bringing this in-house, it shores up the capability and it's worth the investment. The capital would have been spent if we'd gone to any third party, so it really is about the upfront and the $30 million that we would have had. And so we kind of looked at that investment versus a greenfield, you know, to have this sort of flexibility, and getting and acquiring an FDA-approved sterile manufacturing with a team extremely capable and have had good inspection sort of history, we think it gives us a nice, fast head start on getting that additional site. Okay, so it's a risk kind of mitigation measure. Because I think you, you say we hear the kind of conspiracy theorists, you know, in terms of when we have sort of conversations with investors. You know, some people have tried to understand, you know, I guess previously you've cited supplier issues in Australia, and I think some people are looking at this thinking, are there potentially sort of supply issues in the U.S.? Is there a potential contract canceled contract on CDMO? Are you worried you're not going to have CDMO capacity, you know, to kind of deliver your kind of peak sales? So I think it's those sort of types of things where I think there have been a little bit more caution in some of the discussions we had more recently. I'd love to have any thoughts on that, if you can. Yeah. So, so let me be very clear. This is not an issue with regards to the supply of the business, you know, over the next few years. This is looking to the future. When you're, when you're doing supply in pharma and even more in sterile manufacturing, you're not navigating a speedboat that you can turn on demand. This takes years to build up your sites and be ready to go. And so you have to think, you know, three years in advance. And as we said, we're not going to be up and running at the site until 2026. So I think for me, that is a key element. And I respect folks remembering, you know, our issue in Australia. That was not about capacity of supply or, or our partners, you know, issues with our partner that we currently have. That was a very specific. There's a different spec product in Australia, you know, with regards to that, and we had a batch failure, and that's what caused the disruption in supply over in Australia for three months. It doesn't have anything to do with capacity or the capabilities of our current partners. So this is truly a product we have greater than $1.5 billion, and we want to make certain that we're able to provide it moving forward. Thank you for providing that reassuring commentary. I guess another question is, you know, you obviously announced this investment, and I guess we'll tackle the cash impact separately. You know, you talk potentially about $20 million worth of operational savings by 2027, but there's kind of like a ramp-up phase in order to get there. So can you help us think about what the investments are, either starting this year, going into next year, and then, you know, thinking about kind of like the net benefit? I mean, as you know, the largely kind of, you know, fixed cost operating model, you know, can be quite sensitive to changes in spend. So can you help us think about when that's likely then gonna be, you know, fully rationalized or you can get the full operational benefits from being scaled up? You see what I mean? Yeah. Over that kind of period, those new investments to help us understand that would be really helpful. But on the P&L level, then we'll talk about cash. Yeah, I think Ryan did a really good job outlining this in our third quarter results. Obviously, $5 million cash upfront, some contracts that had losses with current partners that we take to the balance sheet, and some very modest kind of losses over the next couple of years, just operationally, that don't go to the balance sheet. You know, so I think when you think of that, you know, it's a very little impact in the adjusted P&L moving forward, and we'll continue to look at that team and operationalize it. Now, the investments we'll make in tech transfer, you know, getting the line in there, we can do all of that while the team continues to function and continues to keep their muscle memory on the sterile manufacturing with the current customers. And then what we'll look to is go live in 2026. And as we start to have a full year sort of impact, we start to see $20 million of savings over a year. So you know, if I was to kind of summarize this, we're doing it for BCP. We would do it even if there weren't cost savings to make certain you had supply of this, but we're gonna get, you know, at least $20 million a year in savings. So it's not just better, but it's also cheaper, and there's a huge NPV on this project. Just to peel back one more layer on the onion, if I may, and that is, you know, modest, you know, costs, are we talking low single digit, low double digit, you know, to help us sort of understand that. And I guess you're talking about adjusted, so are there actual larger kind of costs which will maybe be, you know, reported kind of over that period? And I guess if it's $20 million when that's sort of ramped up, you know, at what point do you expect that to be breakeven, you know, in terms of the net cost to—on the path to $20 million? So let me kind of tease it out. We'll put $30 million of contracts onto the balance sheet. As the costs that relate to that come through the channel, those will go against the balance sheet. The impact from a margin standpoint is, you know, mid- to low-single digits, is what I would say over those couple of years. So we're very modest when we say that. And listen, as you look at $20 million a year of cost savings, you know, in 2027, you know, those are net savings to the bottom line on the site. You'll twilight the current contracts, as SUBLOCADE comes up, and so it will be just producing for our demands. Okay. Listening breaks even pretty quickly. ... Okay, so it'll be $20 million in 2027. And then I guess you say how it's very ROIC accretive. I guess when you consider the cost sort of upfront, so I'm just kind of curious what are the return hurdle you had or when you expect the payback period over X number of years to help us understand the, you know, the value accretion from the site as well? Yeah, listen, we've not talked through all that, but I think it's pretty easy if you're getting $20 million a year of savings starting in 2027. I mean, you can back into the payback period with regards to the site. Okay. Thank you. Switching gears a bit to PERSERIS and Opiant. I guess you cited, you know, some near-term challenges of PERSERIS with a competitor. So I guess how much spend is required to address this? Yeah, I don't see incremental spend on this, James. I think what we've got is the competitor has entered, the competitor, you know, has, you know, more than tripled the amount of reps out in the field that we do, with well over 400. And what we're seeing is a bit of share of voice and a bit of, you know, noise in the system, in that they've come to market also with a risperidone subQ injectable. And you know, as we look at our product, we look at the experience that the physicians continue to have, we see these as short-term headwinds, you know, with regards to SUBLOCADE. You know, once the noise settles and folks see the difference between their asset and PERSERIS, we expect to continue to return to growth. You know, even if you look at the front half of the year, we were growing at nearly 60% year-over-year, so physicians like this product. It was at a very good growth trajectory. If we hit the low end of our guidance, which is what we guided to, you know, we're at a kind of a break-even run rate, exiting 2023, entering 2024. So from a cost standpoint, you know, this is truly about winning in the physician's offices. There isn't a lot of ancillary spend, you know, supporting this asset. How long do you think it could take to get to, you know, the low end of your peak sales of $200-$300? Because I guess when you look at the ramp, obviously it was launched during a tricky time, anyway, but it has been kind of quite slow. You know, some people also ask us the question that, you know, Rovi potentially has a competitor on the market in February, if Risvan gets approved, and we don't know if they're gonna partner that or what that means. So there's gonna be another competitor in that space, but I guess potentially. So I guess with, you know, the kind of the progress that you've got, can you help us understand the inflection of this, of this product? Because, you know, some people sort of wonder why you keep it. I mean, obviously, it's good from a diversification perspective, but, you know, if you continue to not see the inflection that I guess you and I- we all sort of expect, you know, I think people just look at it from a value creation perspective as well. Yeah, yeah, we do also, right? And so exiting this year, kind of at a break even, and then everything else is accretive to this asset, you know, with a relatively modest sort of investment of the sales force. You know, we see that as in the interest of shareholders from a diversification play, from a return on investment sort of play. When it hits, you know, the $200 million-$300 million of revenue, we've not guided to that timing. You know, but when as it starts to return back to growth with the teams, you know, call platform being totally up to s- up to the. We had some vacancies in Q3, back up to full complement. You know, we'll guide on 2024, which will be a nice interim step, you know, for investors to kind of make their own trajectory up to the 200. Okay, um- We haven't seen anything. Maybe the last thing is, we haven't seen anything really from Uzedy. We knew they were out there when we gave our $200 million-$300 million peak revenue. We kind of had a feel for their product profile. We haven't seen anything that, that precludes that. Obviously, you know, the competitor has a, a bit different aspirations as they, as they go into the market. But we're looking to carve out $200 million-$300 million of sales in a $4 billion-$5 billion market. Thank you. One of the things which probably didn't get the light of day at the results, which it probably should have done actually, is you signed a really good long-term contract for OPVEE. So perhaps kind of, you know, for the benefit of everyone here, just remind everyone, you know, the scale of that, the cadence in terms of delivering the revenues, the materiality of that, because there are a lot of other things kind of going on. You know, this is a nice little beacon. You know, it'd be lovely to know more about, you know, where the kind of the value prospects of that could be also following this contract. Yeah, I think before I get to the contract, maybe I'll talk a little bit more about OPVEE, right, James? Because I think for folks, when we bought Opiant, OPVEE was the crown jewel. And there are a few other elements in the pipeline, but we saw those as extra. The whole value of that acquisition was on OPVEE, which is a nalmefene nasal injection, very fast acting, very long acting, and a very strong affinity to the mu receptors, and we believe perfect for dealing with the synthetic opioid sort of supply chain. It's the only asset in here that specifically mentions, you know, it works within synthetic opioids. So we believe in this asset. We had talked about a Q4 launch, and because of the nature of the launch and having to do a lot of foundational sort of government affairs work, we talked about de minimis revenue this year. The work and the foundational efforts have been ongoing. You know, we've got 26 standing orders that now have been shifted over to FDA-approved rescue medications. You know, we're working on, you know, going to the people that provide the grants or apply for them to have those be also for all FDA-approved medications. So you get your standing orders, you get your funding, and then as we engage with first responders, you know, we're able to engage with them on what their, what their protocols are as they start to shift over potentially to nalmefene. So those are kind of the three efforts that have to be done to open up this market and really gain the potential, which is because that has to happen, you know, over the coming year. You know, we've guided to de minimis revenue in Q4. Now, that said, we are making progress. There are shipments going out, you know, we'll talk about that at fiscal year-end, and BARDA is a great external affirmation of what we believe about OPVEE. You know, I think their contract is a continued partnership, that they and NIDA partially funded the phase three study, and the BARDA contract has two components of it. I think the first one is what you said, James. There is a volume commitment for their fiscal year 2024, which runs kind of, you know, October first through into next year for 100,000 units, which is about $8.5 million-$9 million of revenue. So a very nice commitment from a revenue standpoint for next year. And then they have options for the next 9 years, you know, for 100,000 units a year, nine, you know, $8.5 million-$9 million of revenue. So a really nice sort of baseline there. Again, those are options in the out years because that's how they do their budgeting. The other thing they've done is they've committed resources for all the follow-on studies, you know, that we engage with the FDA on and have commitments to, you know, from how does this work, you know, with adolescents, shelf life stability, et cetera, that are about $23 million worth, that are also funded in this contract. So for me, their belief, I mean, this is the agency, BARDA is the agency that deals with terrorist activities, and if you weaponize synthetic opioids, and the fact that they've chosen, you know, Opiant as their partner of choice, I think is just a great outward signal. I appreciate their options, right? But I guess, yeah, there's $8 million-$9 million, you know, in revenue. So I guess, under what parameters would that not be renewed the following year? I mean, for all intents and purposes, should we really think that this is a contract that's going to be delivered, or in what instances would it not be renewed next year? I think it's very tough for me to talk about, you know, a government agency and their budgeting and their choice on whether they exercise an option. You know, we believe that in preparedness, we think our asset is the right one. We're happy that they've chosen us, but I think that's one that gets me stepping out of bounds with regards to the subject. No, that's fine. No, that's fine. Maybe about the international business, I guess it's in all, I think probably has disappointed in constant currency terms. So I, I guess, so taking a step back, obviously, you know, you've got a global business and you do really only have one bigger competitor, and I think people look at the success the kind of Camurus has had ex-U.S., and I guess versus your success, those people will ask the question, why? And now that essentially they're going into the U.S., you know, we do kind of get the question, well, this is gonna be more, you know, kind of competitive in your, your kind of home market. So there's two questions put in there as well. Yeah, and I respect the question. I think, listen, I mean, our ex-U.S. business has had a heritage sort of tablet business, and only recently have we brought our new technologies over there with the film, with SUBLOCADE. And it has taken a trend, which over the last five years has been 3%-5% kind of erosion each year due to austerity measures, which happened across Europe in the socialized medicine and due to, you know, sort of generic and competitive pressures, you know, in those markets. And it's returned back to, you know, in the quarter flat. You know, in the previous quarters, we had growth, and on the full year, we expect to have growth in our rest of world business. So we've seen that new technology enable that growth. And SUBLOCADE, for us, is a major part of that. Now, our go-to-market, our approval process from R&D focused on the U.S., and I think that's really benefited us. It's the largest, you know, market. It's been disproportionately impacted by, by the opioid epidemic, and so we're second to the market and entering... You know, we've just entered in Germany. Beginning of 2023, we entered in the Nordics, and we were a follower, you know, in Australia, and we've been in Canada. And so we're seeing good, strong growth, $30 million year to date in those markets. But we are a follower and, and having to enter after the physicians have built muscle memory, you know, on the competitor. And what we're seeing is growth in line with expectations, coming into the market. I guess another question we sometimes get is the incremental return of $1 invested in the U.S., potentially is gonna get a greater return than kind of international. You know, the question being, why keep the international business to some extent, right? If you can basically get greater monetization in the U.S. Yeah, listen, I think the U.S. or the ex-U.S. business is an extremely... First of all, we help a lot of global patients, right, with the medications we have that are suffering from opioid use disorder. And that sets up a very, very profitable business model over there that spins off a lot of cash, you know, for shareholders. And so, you know, given that high cash generation from that business, you know, we think it's right to maintain that. It has optionality, you know, as the pipeline comes to market, for potential expansion globally for other areas of substance use disorder, you know, that we see other areas. Now, the U.S. is, again, it's just disproportionate with OUD, the impact of it, you know, the fact that it's, it and Canada are about the only markets that have really been flooded with synthetic opioids. So the epidemic has disproportionately hit there, but we see, we see that platform for growth moving forward in other areas of substance use disorder. And I guess the other observation is, you know, the market is a lot more mature in the U.S., I think both in terms of access and I guess market understanding, treatment facilities, stigma, you know, in terms of actually kind of getting treatment, right? And so with a kind of a more challenged reimbursement outlook also in Europe, perhaps because there isn't as great a kind of understanding of the overall kind of condition, we sometimes sort of get the question, you know, what scope is there for kind of SUBLOCADE? Why is Suboxone Film kind of really underrepresented? And is there a market for those products, or is it initially a case of, you know, you really need to have that kind of generic tablet, and it's unlikely to get great attraction on the other products? ... Yeah, again, I think we've had our heritage tablet business, and those new products have been in there a relatively short period, are in launch. They're, they're on, on board paper, and we believe doing a good job and have returned that from eroding year-over-year to growth on the year. So, respect the question, but I think, you know, this is, this is a significant portion of revenue. When you look at it, it's about 20% of our overall revenue for the company, and it spins off a lot of cash and provides a lot of flexibility for shareholders. So, we see it, we see it as, while it's not the same potential margins as in the U.S., we see it as a highly profitable portion of our franchise, where we're able to help a lot of patients. For a long period of time, we were the only people, you know, in those markets helping these patients suffering from opioid use disorder. Thank you. Switching gears to outlook. So we talked to a lot of sort of different moving pieces of things going on in Indivior, you know, kind of this year. I know you're going to give 2024 guidance in February, and I'm not expecting you to give that now. But I guess there are a lot of moving pieces to help people sort of understand what's happening, whether that's, you know, the momentum in SUBLOCADE, the step up in the annualization of the investments in SG&A, thinking about the investments in the new facility, any other kind of mix or inflationary changes. You've got a bigger pipeline, thinking about kind of R&D. And so given that, again, the fixed cost nature of the business, you know, the operations can be relatively sensitive to relatively small changes in kind of input. So at this stage of the year, what, you know, how can you sort of guide us appropriately in sort of the directional of those kind of different impacts to help us get a feel as to where it kind of approximately could be? I appreciate budgeting is ongoing at the moment, but just to kind of help us post kind of Q3 to see where things should land, you know, vaguely in 2024. Yeah, listen, I think we'll guide 2024 in February, kind of on our normal cadence. But I think if you rewind the clock to last December, you know, we committed to this medium-term profitable growth framework, right? Strong top line growth, driven by SUBLOCADE, driven by PERSERIS, you know, and potentially in the short term, offset, you know, by potential film erosion if that should return to analogs. And we've seen a fourth generic come in, you know, and we know there's two other parties out there between Par and Teva. So you'd think, you know, in the future, as we do that, the continued strength of SUBLOCADE, partially offset by, by the film. We've continued to invest with a bit of sales force expansion to take that opportunity for these patients that weren't included in our peak net revenue guidance of greater than $1.5 billion, to help those independent physician offices have SUBLOCADE as an option. So there's some incremental costs there. Our pipeline continues to advance. We haven't talked about the inbound and the partnerships with the ALR, having a potential longer-term acting injectable, you know, that's able to help with unmet patient needs. The Orexin-1, which we had a positive end of phase one, that will go into phase two. You know, this is a swallowable tablet that's a non-opioid, that we think will, from a hypothesis standpoint, reacts a lot like buprenorphine but isn't addictive. And so from a trend and the normalization of treatment, we think that's a huge opportunity. So we'll see some uptick in R&D as those assets are in and continue to move forward. But we do, despite those investments, despite that, we continue to see progress and margin expansion moving forward. And so I think as people think through their models, they just have to model in kind of each of those components, but we believe we still have good, strong operating leverage moving forward. Okay. So the visibility today, it wouldn't be, you know, crazy to assume margins could go up next year despite the annualization of all these, you know, kind of effects. Is that, is that a fair comment? Yeah, we'll guide- What could go wrong? Specifically on that in February, but I... Listen, I could see that if I was modeling, I could see some margin expansion. How much of the benefit is lower litigation? So I guess also you made some settlements, right? So I guess, is there an element of spend which you could have had next year? I guess we always get requests in terms of, you know, trying to figure out incrementally what goes more into the SG&A budget. But I guess I don't need to sort of go down to that level of granularity, but, you know, what, what are the, you know, potential kind of benefits to SG&A from lower legal costs as we go into next year, if, if- Ryan, Ryan covered this off at the Q3 results, that there's, you know, high single digits potentially that could come down, and it depends on what the pace of litigation is next year, you know, given Note 13. You know, so, you know, I know some people have said, "Oh, you must be spending, you know, $60 million or $70 million on legal expenses with everything that's going on." It certainly isn't that amount. You know, you know, we're talking about low tens of millions that are on legal. So it isn't, it isn't like there's gonna be, you know, next year, potentially 400 basis points of margin expansion due to, due to a, a slower pace of legal. Thank you. That's, that's really helpful. I guess coming back to the SG&A point, I guess we talked a little about this earlier, but I guess it's probably worth reiterating the point, and that is, you've got this kind of incremental spend. I guess, you know, the other kind of question we get is, is this sort of offensive or defensive, right? Are you having to spend this because there's a new competitor in the market to maintain their share, or are you actually sort of spending this and you're finding this is kind of contributory to, to the overall top line? Yeah, again, this is about patients who currently aren't able to get access to SUBLOCADE because their physician is one of these small independent practitioners. The administrative burden of a controlled substance specialty product that would have to be stored on site, the REMS, the local federal laws that are required to get that, just have not allowed it to be in their decision set. So this is about helping those patients. It's about, you know, enabling them to have that, and it brings incredible shareholder value to the shareholders. You know, whether there's a competitor in the market, we would be doing this anyways to get this opportunity. We've signaled for-... Since I've been CEO, you know, that we had a good footprint for getting the reach and frequency to drive the organized health systems, and the only time we'd probably need to increase, is if there was a material change in the landscape, you know, that opened up access, à la the elimination of Data 2000, that allowed alternate sites of care. Well, that happened, you know, we've messaged kind of each of the quarters and quite firmly at the half year that we were considering how to best take advantage of that and help those patients, and now we're acting on it. Thank you. Another kind of point just thinking about over the midterm is, you know, there is inherent operating leverage within the model, right? But then when kind of the revenues kind of increase and saying, okay, we're not going to see a whole bunch of margin expansion, we then sort of see more SG&A, right? And so to some extent, if you've got that kind of underlying earnings power, then the investments, obviously, you are kind of wanting to invest in sort of the overall growth. But when we just sort of take a sort of step back and think how the margins could phase over the next few years. Don't put words in your mouth, but it sounds as if the manufacturing is gonna be a big piece of that. So would a fair way to think about it is, if there is this sort of gradual kind of progress, hopefully, you know, you start to see maybe more of a kind of inflection from 27, if that's when you're gonna start to see the real benefits from this $20 million net savings from manufacturing. Or given the investments you've got today, is that sufficiently scaled up? We could potentially see that kind of earlier, just given, you know, you've got, you know, well-established kind of sales force and the incremental contribution margin from the SUBLOCADE is quite good. Yeah, what I, what I'd say is similar, similar to the investment decision with regards to the expansion to the independent physicians. We obviously hadn't made the, the decision with regards to the model, you know, for the SUBLOCADE expansion when we gave our guidance. So we see in that medium term, good margin expansion, you know, and operating leverage that, you know, increases our cash flow generation as we have this strong top line growth. We don't see any disconnect in that model, and the choices we've made, we believe, actually could enhance that moving forward. I would also highlight, you know, there are different ways to drive value that can, that can potentially cause the optics in the short term to be a little different. And, and I think we're coming all the way back to how I opened in the comments. You know, folks are forgetting that we bought Opiant in the early part of this year, increased our guidance on costs at $40 million-$50 million, you know, with no increase in revenue. And if you took those out, that operating model that we talked about in December would be producing, you know, upwards of kind of 400 basis points of margin expansion. So while we're there, I think, I think there's different ways. There's the current P&L leverage, and then there's the cash flow generation. And if you believe in OPVEE the way we believe in OPVEE, you know there's tremendous value there, not just strategic fit, but tremendous value. So there's different ways to do that, and we have to remember that when we start to look at the current P&L and start to look back, we have to remember the things that have been added in as a value creator also. That's a great reminder. Ex opinion is over 400 basis points of margin expansion, despite the kind of the higher investments which you're making in the underlying business this year. Yeah, because I definitely think in some of the conversations, that message is kind of a lost, you know, in terms of the underlying earnings power, because you bolted on this sort of loss, loss-making business initially until that gets better. Mind if we got only about 8 minutes left. Anyone on the line, if you do want to ask more questions, feel free to ping me a Bloomberg IB, or also an email. I guess in the time remaining, maybe we can focus on capital allocation, because obviously that's, you know, a big driver, of the business, I guess, particularly thinking about beyond sort of SUBLOCADE. Maybe to start off with is, at least in terms of the other pipeline, which you've got, you obviously talked about investing more kind of in R&D, but what are kind of like the key assets we should think about? Because some people, you know, wonder what's gonna happen to the business beyond SUBLOCADE. We'll tackle M&A separately, but I guess at least in terms of the existing business, that would be great. So maybe, maybe two pieces on that. One is the existing pipeline, which is, you know, we've been expanding through time and we're very happy with, and then a little bit on the capital allocation moving forward. You know, listen, we've started to really bolster out, and if you're, you know, one of the leaders in addiction, you know, it can't just be about opioid use disorder, it has to be about other substance use disorders also. And, you know, we have a partnership with Aelis, and we're in two B, you know, on that cannabis use disorder asset. Expect last patient, last visit, kind of end of Q1, beginning of Q2, you know, readout and the engagement with the FDA, you know, kind of Q4 next year. So we're at a good inflection node with regards to that, on whether we take that into phase three. And just a reminder, James, I mean, the U.S. has gotten to this very unique spot where with the medicalization, the legalization of cannabis, with high THC products, you're starting to see, you know, more, more addiction happening there and impacting people's lives. You know, we've talked about earlier the ALR asset with the, you know, potentially a three-monthly sort of product, you know, that we're doing some phase two like studies, a tox study, and some multiple ascending dose to try and look at the optimal duration and doses. With regards to that, we think there's a huge unmet need with longer duration, you know, especially great examples in prison systems where LAIs, based on their resources, increase the number of patients they can treat. You know, I was in a prison system in August, and they had a ceiling on how many patients they could treat with orals. The fact that we had long-actings, they could treat 4-5 times the number of patients based on the same number of resources that were going in. So a tremendous development. If you could take it from monthly to three monthly, it's another huge benefit there. So we like that ALR product. That's phase two, that we're gonna be doing those studies, you know, in preparation for what should be a single phase three. Then you start to look, we've got a phase two readout on a nasal spray for alcohol. This was inherited from the Opiant acquisition. We'll see where this comes out. I just will remind you, listen, we bought Opiant for OPVEE, and we'll see where this reads out, but it's a phase two alcohol use disorder asset. And then we've got an early stage. We've just done the lead candidate with a GABA B for alcohol use disorder also, and then there's the OX1, which is going into phase two. So we've got a nice pipeline across the existing business, you know, for unmet needs across, you know, alcohol use disorder, cannabis use disorder, that we think, you know, will provide shareholder value, and we'll be entering markets and helping patients that similar to how we did with opioid use disorder back in 2002. Mm. So really attractive there. Now, how does that... That's the pipeline, that's future value that we'll continue to invest in, you know, with the P&L. When we think about capital allocation, we're gonna remain incredibly boring, James, with regards to this. We're gonna continue to invest in SUBLOCADE and that pipeline. You know, we will continue to maintain financial flexibility and meet our commitments. And once that's done, we'll look at potential business development towards diversification. That could be tuck-ins, that could be something like Opiant, or shareholder returns. And I think- Okay. You know, if you look at the short-term decision we've made, we've just done a $100 million buyback. I think we're focused on making the OPVEE launch, the integration of that site, a success. And so what we're signaling is there won't be business development for a period of time, and we think this buyback is in the best interest of shareholders with our excess cash. Okay. So no real M&A for the next couple of years is probably a prudent sort of point to think about at the moment. Yeah, certainly, certainly as we think towards 2024, and our focus is on SUBLOCADE- Okay ... OPVEE, and integration of Okay You know, of that plan. Okay. I think a number of investors we speak to are kind of happy that this is a business that is net cash, just given there's a lot of moving pieces and kind of dynamics and stuff which is going on. I guess the timing of the announcement of the buyback, you know, we did get, you know, some kind of questions on that. And I guess, A, the rationale behind that. B, I guess there's a lot of outgoings in kind of Q4, you know, in terms of some of the settlements which you've been able to kind of get. Mm-hmm. I guess just kind of curious in terms of the headroom, which, you know, you feel the business needs, given kind of all the investments from a cash perspective, to give you that confidence to announce the buyback now. Yeah, listen. It was interesting, we have had a call on that, and I kind of said: Well, you know, listen, we're on a cadence, and we do every board meeting, you know, we do a review of our capital allocation. And, you know, our board meeting was Wednesday, Thursday last week, and we came out Friday with that. You know, maybe there were some shareholders who wish we'd deviated from talking at the board and tried to accelerate the discussion to, you know, put it out at the same time as Q3 earnings. But we wanted to keep the same cadence, the same diligence in reviewing that, and came to that conclusion as we looked at where we were, post-settlements, post-Q3 results, that we had the confidence, and that was the best use of capital after consideration by the board. So we announced that on Friday. And maybe just to ask a follow-up question to that, and that is, you know, is there a certain amount of operational cash which you need, certain minimum kind of levels? And I guess, if I can come back to a minimum headroom, 'cause we do sort of get, you know... Just to also kind of help us sort of anticipate if the business is kind of tracking ahead of that. You know, you did sort of mention that, you know, you could look to maybe do something like that in the future if the business so, you know, so allows. Just kind of wondering if there is like a, a kind of like a minimum level of cash you feel the business actually needs to have within the company. Yeah, listen, our debt covenants have a minimum cash level that we have to do, which is 50% of the outstanding debt. And then, you know, a certain amount of sort of operating protection there. But remember, I mean, listen, we've still got after this... If you take away the settlement, we've still got, you know, $400 million of cash on the balance sheet. We're extremely cash generative moving forward from our operations. And, you know, again, we believe we had the free cash flow to do this buyback, you know, the $100 million over about a 10-month period. Very similar to the previous programs that we've run. Excellent. Mindful of everyone's time, still very precious. We're coming up to the top of the hour. Really, Mark, just to hand the helmet back to you, just for any kind of closing remarks before we close the call, to make sure you've had the opportunity to give all the messages you'd like to give this afternoon. No, listen, I think in the opening, I covered most of the messages. You know, so I'm just thank people for their interest. Listen, I think, you know, we're at a great spot, you know, with Indivior and where we're headed moving forward for driving value for shareholders. You know, we've brought resolution to the antitrust MDL, believe the rest of our legal overhangs are manageable moving forward, and we'll look to bring certainty on those and actively manage those. You know, but the underlying business continues to have strong top-line growth, margin expansion, and the management team is looking at, you know, every way they can to drive value, à la acquiring Opiant or having a plant, you know, that both provides BCP as well as, you know, strong NPV moving forward and margin expansion. So, a great time to be investing in Indivior. That's great. Well, on behalf of Jefferies, thank you very much for your time. Thank you, everyone, for your questions and dialing in, and look forward to any other company things we get to the full year. All right. We do too, James, and thanks again for putting this session together. Really enjoyed it. Thanks. Thanks for the discussion. Bye-bye, see you.