Hey, good morning, everyone. This is David Amsellem from the pharma team at Piper Sandler, and welcome to the Piper Sandler Healthcare Conference. We're gonna kick things off with Indivior. Lots to talk about. We have CEO Mark Crossley with us. Thanks so much for joining us, Mark, and let's just go right into questions. Absolutely. There's much to cover. So I'll start off with a question on the recent settlement for the SUBOXONE antitrust litigation. I know that's something that has been top of mind. So just give us an overview of that settlement and what that means for your cash position and your capital structure. Yeah. Thank you, David, and thanks to the Piper Sandler team for having us at the conference again this year. Great to be here. It's a perfect way to start because I think what happened, you know, as that multi-district litigation continued, and we got closer to trial, is it put in a going concern on the business. And so that resolution for us brings a lot of certainty for our shareholders, and it has, as we settled with the last remaining class, the direct purchasers, so that entire multi-district litigation is finished. You know, we now have some certainty for shareholders. We've removed the going concern from the business Mm-hmm. which means that the rest of the legal matters that the company has are quite manageable and we think, you know, more customary as we, as we move forward. Mm-hmm. So for us, it's the right deal on behalf of our stakeholders. And then in terms of the cap structure, cash position, net debt, EBITDA, at this point, can you just give us a quick lay of the land of where things are post-settlement? Yeah. You know, we have a very strong balance sheet at Q3, you know, almost $800 million in cash. And so when you take the final resolution, the net cash position, you know, when you get to their minus settlement, is about $400 million. So it's still a very strong balance sheet. It's one that we saw lots of flexibility moving forward, and so much so that as we went through the consideration of our capital allocation strategy at our November board, you know, we went ahead and started a $100 million share buyback Great because we felt we had enough flexibility to do that. So I wanted to move into a broader discussion about capital deployment, and talk about how you're thinking about capital deployment more broadly. So there's the buyback Mm-hmm. But there's also potential in licensing, business development, M&A. So give us your your thinking on how you balance those two competing initiatives, if you will. Yeah. And David, we've been extremely boring and consistent in our capital allocation strategy in the three and a half years that I've been CEO, and it starts for us on the organic side of the business. Fueling SUBLOCADE, it has tremendous sort of potential, greater than $1.5 billion in sales. We also have a pipeline that we're looking to advance, and potentially inbound some addiction assets. Once we get through that and we have the flexibility to meet the commitments of the business, we really have two options: it's business development and it's shareholder returns. Mm-hmm. As we've looked in the past, we've executed on both as ways to drive value for shareholders. We expect that moving forward. In the short term, as we saw with the return of capital to shareholders, we're focused on launching OPVEE, continuing Mm-hmm. to integrate Opiant, and we've just bought a plant, you know, for continuity of supply for SUBLOCADE to support that greater than a $1.5 billion product. We're gonna integrate those. So in the short term, you know, we thought this, the capital return was the way to go Yeah to drive value for shareholders. So I'm particularly interested in how you're thinking about further building out your psychiatry-focused business, because you do have a bit of a foothold here with PERSERIS and your LAI form of risperidone, and you do have some sales infrastructure here. So obviously, you're a leader in addiction science. We know that. In psychiatry, I wanted to get your thoughts on how you're looking to build out that vertical. Yeah. I think as the leader in addiction, we look to treat the whole patient. And so as you look at where we've gone, we've gone from medically assisted treatment. Now we have rescue. And many people wonder: Why does a Schizophrenia product fit with this company? But when you look at people that suffer from Schizophrenia, over 60% of them have a substance use disorder. They're self-medicating, they're having issues, and they need support also. Mm-hmm. That's been the natural toehold into Schizophrenia. What we would look at is where we look to treat the whole patient. Mm-hmm. Those are natural areas of diversification. So typically, substance use disorder right at the core, and then you can get out into those psychiatric sort of comorbidities to Yeah to help these patients. Mm-hmm. That's where we'll look to be, moving forward when we get back to business development. Yeah. Okay. When you say get back to business development, do you have, I guess, a timeline on that? And I guess help me understand the, you know, the extent to which it's a near-term priority versus a longer-term priority. No, it's a great question, David, because in the near term, I would say we're focused on launching OPVEE with success Yeah SUBLOCADE, as well as integrating the recent plant we've gotten. So we don't see major, you know, business development like an Opiant or larger Sure -in the short term. We could inbound assets as we have, you know, in areas of addiction that are, you know, mid to late stage. Okay. Those could happen at any time. Okay. So let's talk about SUBLOCADE. Yeah. Lots to talk about here. So, let's talk about just commercial dynamics on SUBLOCADE, and particularly interested in how you're pulling in new patients. I mean, this is a growing asset. It's clear that it's a major growth driver for the business. Are you getting patients mainly transitioning from oral SUBOXONE? Are you getting totally new starts? Just help us understand that dynamic there. Three and a half years ago, we pivoted our entire go-to-market model to organize health systems. Yep. These are large regional medical centers, government health centers, and prison systems. Mm-hmm. What we've seen as we've pivoted there is a willingness of physicians to move to long-actings faster Mm-hmm. and with more patients. They don't have to have, They have a support network around them to deal with a specialty pharmacy product. And what we're seeing is as we do that, as a patient either falls out of treatment and comes back in Mm-hmm. or is new to treatment, you know, long-actings are of the highest order of consideration. In addition, you do get some physicians and patients who make a decision that they've been on orals for a period of time, and they're looking to break the daily habit and the daily ritual of a daily medication. And they think by going to once monthly dosing and stopping what often has been a six and a half year to seven year journey before they enter treatment, of pursuing their drug to take care of withdrawals Mm-hmm. You know, it breaks that habit. So we get some of those, too, that are people that are stable on orals, that are moving over. Okay, that's helpful. What about the payer landscape for SUBLOCADE? How is that these days? And, also talk about the mix between government Mm-hmm. mainly Medicaid and commercial coverage. Yeah, well, I think we're very lucky that this is a focus, you know, in the U.S. where it's been so disproportionately hit by the opioid epidemic. Yep. With less than two in ten people in treatment that actually suffer from the disease, you're seeing good access and people trying to break down barriers of treatment. They think that patients in treatment are cheaper than patients out of treatment in regards to that, and that leads to very good payer access. About 90% of the lives covered- Mm-hmm with very, very good access, good quality access with regards to prior auth or anything like that. So that's good. We also offer a co-pay program Mm-hmm that takes away, you know, any sort of, any sort of price from a patient standpoint at the, at when they get their medication. And when you look at the business, because of where the patient is in their life cycle, upwards of 65%-70% of these patients are actually on government, government payer accounts. Yep. It's just because of the nature of where they are in the disease and how it's impacted their lives. A very, very strong portion of it is in government accounts. Okay. And in terms of Medicaid coverage, on state plans, the coverage is broad, and I hesitate to use the term hassle-free. Yeah. But what's the extent to which it's hassle-free? I would say as hassle-free as you can be for a specialty- Sure pharmacy medication. Yeah. It's one of the first medications I've seen that actually, when you tested the payers, you had a higher willingness to cover it Mm-hmm than you did on the commercial side because they saw the huge value with these patients. Okay, that's helpful. So, Very, very strong access. So now just going down the list of different topics on SUBLOCADE. Commercial support. Just give us a quick refresher on the prescriber audience, how many docs you're calling on, how many centers you're calling on, sales force sizing, and where you are in terms of the extent to which you're right-sized on the sales organization. Mm-hmm. Just help us better understand those dynamics. Yeah. So I think starting up at the high level, over 10 million people abuse opioids- Yep every million in treatment, so it's larger than that Schizophrenia patient base we talked earlier. Mm-hmm. We pivoted to this organized health system because a controlled substance specialty pharmacy product adds a lot of administrative burden to the historic people that we're prescribing for opioid use disorder. The other dynamic is, many of those smaller doctor's offices have moved into these large, organized health systems. So you're getting more doctors, more patients in organized health systems. It's the predominant place, you know, where you're getting probably 70%-75% of the patients- Yep and physicians are in there. So we focused on that organized health system. When you look, we focus on the top 500 on the regional healthcare center. Mm-hmm. There's subsidiary accounts that are somewhere between 10-16,000 that we'll look to activate- Mm-hmm to be able to have our product on site. That covers about 20,000-30,000 physicians- Mm-hmm who are certified for opioid use disorder Okay and most of the high-decile prescribers. You know, about 12,000 or so prescribers account for about 75% of the medication that gets prescribed here. So we'll have coverage of all of those doctors with our sales force, which is now with the expansion that we recently did Mm-hmm with the intervention by the U.S. government to remove DATA 2000. Mm-hmm. It allows for alternate sites of care, so we had to expand our sales force to be able to get where we can get to the independent physicians. Yep. Which is about 500,000-600,000 patients, we believe. So now we've got full there, and we're over 300 customer-facing people. Okay. So in terms of where you are now, do you feel like you're right-sized, or do you feel like there's further expansion coming? Yeah. And I think we were right-sized for organized health systems- Yeah before this expansion. Then with the removal of DATA 2000, those patients that were there, you know, 500,000-600,000 patients, we see a great opportunity for them to now be able to get SUBLOCADE. Where previously, the administrative burden on the practice made it very tough for them to be able to prescribe. Is there at all, This might be an ignorant question, but is there at all a DTC component here that we should be mindful of? And, you know, I when I think of, you know, addiction medicine, there's the patient, but there's also caregivers and family members. And so how do you think about those dynamics as you think about DTC? Yeah. What, what we see is that when both the patient or the caregiver is thinking about this, the first place they're going to is the Internet. Sure. Right? So search engine marketing, targeting that towards those people as well as the physicians, just to have it front of mind with regards to SUBLOCADE as an option, has been a focus. We ran a broader DTC campaign just before COVID hit. So the readout on that was a tough one because suddenly, you know, patients weren't getting into physicians' offices and things of that nature. You know, but we see high, high efficiency on our search engine marketing and our digital campaigns on the internet, 'cause that's the first place they go. Right. But no broadcast media component- No. In regards? Not that we're seeing now. Got it. Got it. Okay, so on the competitive front, so there's BRIXADI. Mm-hmm. And I wanted to ask you how market dynamics are playing out with the launch of that product. You know, one of the things that we hear about BRIXADI is, you know, more flexible dosing. Mm-hmm. I'm wondering how that's playing out in practice, and if that's having any impact on SUBLOCADE? Yeah, I think first, if you look at this larger market we talked about earlier- Yeah SUBLOCADE itself has been growing, growing very strongly and, and penetrating the market, but we're still only about a 4%-4.5% share of the overall buprenorphine medication-assisted treatment. So it's still early days. Yeah. You saw this in Schizophrenia, where one LAI sort of manufacturer came in, made good headway, but as you added incremental share of voice, the whole category grew. Sure. Now, we expect that dynamic to potentially happen here, but we also believe that with our paradigm of treatment that we have, we just don't see it from any other long-acting. It's immediate 4-8 hours, you're up to therapeutic levels. Mm-hmm. Those therapeutic levels are maintained the entire 28 days. Mm-hmm. No on-top dosing, no rescue dosing, you know, that we see with other LAIs. And when you could overdose, that's very important. Mm-hmm. The therapeutic levels we have block the Mu receptors. Mm-hmm at a rate that the drugs of abuse can't get to them. So it protects those patients in their moments of weakness, and we just don't see that sort of therapeutic dose or that paradigm of treatment from the competitor. We do see the features and the benefits Yep of some of their assets, but we just don't see that paradigm. And where the market over the last six years or seven years has really transitioned from pain pills and heroin over to these synthetic opioids, which are 40x-100x more powerful. Yeah. 80,000, almost 80,000 deaths a year because of that. So we see, you know, this therapeutic sort of level being a key intervention and a paradigm of treatment that we just don't see any other one, anyone having. I do wanna get to overdose. Yeah with OPVEE. But one other question on SUBLOCADE versus BRIXADI, and then just to your point here. If I'm hearing you correctly, the penetration of LAIs in addiction treatment is quite low. Quite low. Is it fair to say that, you know, this is not a zero-sum game between SUBLOCADE and BRIXADI? I mean, is that, is that how you're thinking about it? That, that's exactly how we're thinking of it, David, is, Listen, we've seen nothing in the early days, and it is early days, right? Sure. It's only been out since the beginning of September. Yep. But we've seen nothing in the early days that puts any sort of doubt with regards to our greater than $1.5 billion of sales into only 10% of patients that would have to be on SUBLOCADE to get there, or exiting 2025 on a billion-dollar run rate. So we don't see anything that's happened in the early days of launch that would preclude, you know, our previous guidance on those items. Got it. So let's talk about OPVEE and the Opiant acquisition. But so you've, you know, this is, you know, I guess, early days here. Mm-hmm. So just talk about what you're seeing and hearing in the field on the product. And, you know, one question I had as we're talking about the launch is, you know, there's OTC-available Narcan. And, but dynamics in the market have changed. You know, synthetic opioids, fentanyl, I mean, much, much more potent, much more dangerous. You have a much more potent, you know, product here. So all of those moving parts, how's the launch going? Yeah. So maybe I'll start with why we partnered with Opiant to Yeah to bring them into Indivior to expand that continuum of care is because of OPVEE, that Nalmefene based molecule, which is extremely fast-acting. It has a long half-life Mm-hmm longer than the synthetic opioids, which are seven to eight hours. You know, you've got Nalmefene, which is at about 11. Mm-hmm. It has a very high affinity to the Mu receptor, and that's led to the label being the only label for rescue products that specifically mentions synthetic opioids. Yeah. And with that being, you know, the largest portion of the supply chain for illicit opioids now, and often intermixed with other drugs of abuse. So think, think people that go and think they're getting cannabis Yeah and you've got drug dealers who are lacing it with opioids, hoping to get people addicted, and that's where you're getting a lot of overdoses. So having a very strong active that's long-acting, we believe is quite an important choice out in the market. Now, the early days, because we've guided to de minimis revenue this year Mm-hmm it's because we have to set up the foundation so there's an equal playing field. Mm-hmm. That requires standing orders in every state- Mm-hmm that are for FDA-approved rescue devices rather than Naloxone based. Yep. Getting to where grants, because 90% of the volume is in public interest groups, you know, first responders Mm-hmm charity groups that are, that are providing this for, like, harm reduction and stuff. We need to make it so that the funding can get down for all FDA-approved medications. Mm-hmm. And then the last one is, while we work with those first responders, is changing their protocols to allow how they're gonna deal with a Nalmefene based product such as OPVEE. So once those are changed, then you've got a very open market where it's easier to, easier to activate. And so that's what we're focused on right now, is opening that up. So if I'm thinking about this correctly, a lot of your initial demand is really gonna be coming from those first responders, not, This is not gonna be, necessarily, a retail product. It's where 90% of the volume is today. Yeah. Now, I'm not saying, David, that we're not gonna focus on retail, 'cause we will Yeah because we think that's a differentiated product. If I had a daughter in college, I would want her to have this in her backpack in case she ever got exposed, right? Because I think what she's probably gonna get exposed to is gonna be a synthetic opioid. Yeah. Now, one of the great developments we had recently that we talked about in our Q3 earnings, is a partnership with BARDA. Mm-hmm. In which two sides to that partnership, the first is they've agreed to fund all the follow-on R&D, about $23 million worth of R&D funding, to continue the studies and the knowledge behind the Naloxone rescue. The other is they've committed to 100,000 units in the first year of the deal, about $8.5 million-$9 million of revenue that we're expecting there. We're gonna be their product in case there's ever a weaponization of fentanyl. Yeah as a terrorist event, and that's what BARDA is there for. And the fact that they've chosen OPVEE Mm-hmm We think is a great external validation of the asset we brought in, you know, in the first quarter. But as you think about, you know, usage in communities, though, you know, Naloxone is cheap, and there's, you know, from the opioid settlements, there's a lot of free Mm-hmm Naloxone sloshing around in the, in the channel, and, you know, you can get it over the counter. So here comes OPVEE, you know, different price point. So is that something you're getting pushback on in terms of, you know, this is a, you know, yeah, maybe a better mousetrap, maybe a, you know, a better modality, but, you know, it's expensive? Yeah. I think when you look at the profile- Mm-hmm with regards to the asset, that fast acting, the strong affinity, and the long half-life Mm-hmm We're not seeing the pushback on the price, 'cause the price is still... When you're in those public interest groups, you're talking about, you know, $75 for two doses, you know? So divide that by two for one dose and, you know Mm-hmm Because of the profile, we're not seeing a pushback on that at all. Okay. And let's switch gears to PERSERIS. And I think you had tweaked down your guide, and now, of course, we have Teva in the market with UZEDY. So could you just help us understand, you know, the market dynamics with PERSERIS? Is UZEDY's presence, you know, causing any pressure? Just help us understand, just broadly, what the dynamics in that marketplace look like. Yeah. Really good momentum on PERSERIS Mm-hmm in the first half of the year. Almost 60% growth, you know, on that, on that asset. Really strong momentum. And then, yes, we had a competitor enter, and the competitor Yeah enters with almost 4 x the number of salespeople we have in the market. It's caused, I would call, a share of voice and a bit of confusion in the market because they're also risperidone-based and SubQ. Yeah. We believe that's a short-term sort of impact on the market with regards to that Mm-hmm as the physicians start to figure out who they're talking to, and we can get back to the differentiated profile of PERSERIS. It's impacted this year's guidance to take us down to the lower end of our range Mm-hmm which is what we clarified at Q3, but we don't see it as anything that's a barrier, you know, as we look towards, you know, our long-term guidance of peak revenue between $200 million-$300 million. How do you position PERSERIS versus UZEDY? Yeah. For us, we still see a differentiated profile versus UZEDY, right? Mm-hmm. We have a very fast onset, also 4-8 hours to these therapeutic levels. Mm-hmm. Maintain the full month-long. Very, very solid a adverse event profile- Mm-hmm and still see that as differentiated. In physicians that are using PERSERIS, we see it as a drug that they have built into their profile. Okay. Can you just walk us through your commercial infrastructure on PERSERIS? You said Teva had 4 x the number of reps, and, you know, this is a promotion-sensitive Mm-hmm So you know, it sort of begs the question: Do you devote more resources commercially to PERSERIS? Yeah. We've got between 125 and 130 reps on PERSERIS. Mm-hmm. You know, part for us is we've been about really highlighting this differentiated profile- Yep to drive uptake of this in depth with the prescribers who adopt it. It's our revenue guidance is $200 million-$300 million. So we're looking at being a niche product, you know, within Schizophrenia. So we don't anticipate, you know, flooding the market and trying to equal on reps, and there's, I think, over 1,800 reps in this space when you take into account all the other competitors Mm-hmm because we talk about Teva and UZEDY, but, you know, Janssen and the other players Yeah I mean, it's, it's significant. But, but it is a $4 billion-$5 billion market. Yeah So just carving out a very small share can provide a nice diversification play. The market, I mean, just knowing this from, you know, other companies that Mm-hmm I cover, the market is growing. The LAI footprint is growing. Is that what, is that what you're seeing? I mean, this is sort of a steady grind Mm-hmm higher in terms of penetration of the LAIs, LAI antipsychotics? Absolutely. Absolutely. Yeah. Listen, we launched in a unique time. We launched three quarters before COVID came, and we were- Yeah Seeing great long, great, great pickup, and then things kind of went sideways for a bit. So we'll stick to our guns, continue the good detailing the team's doing. Yeah. Why don't we switch gears in the couple minutes we have left to pipeline? Particularly interested in 117 in cannabis use disorder. I kind of look at that as a pretty unique indication, and of course, with legalization and decriminalization, there's a lot of cannabis use and misuse. So just give us an overview of the development program for 117, and just walk us through briefly mechanistically why you think it could work. Yeah, and if I start at the highest order Yeah You're right, this is not your mother's cannabis that people are getting. You know- Yeah there's over 50 million people using it, 14 million have been diagnosed with cannabis use disorder in the U.S., and these are high-THC products Mm-hmm in tons of different mediums: gummies, vapes, you know, tinctures in between. Sure. It is a different market and different impacts with over 20% THC on average, that is much more addictive Mm-hmm and impactful. The partnership with Ailis, when we brought this in, we're very excited about this asset. It came in as a phase IIb asset. Mm-hmm. We made a modest upfront payment, and they continued the phase II study. When we come out of that study, you know, we'll make a call. We'll partner with the FDA with regards to how the phase III will be studied. Mm-hmm. A big thing will have to be more of a harm reduction mentality, more like where the WHO is Sure with regards to substance use disorder. So that'll be a key tenet, but we'll figure that out when we meet with the FDA with regards to this. Now, the mechanism of action is what's so attractive about this thing. Yeah. 'Cause right now, for cannabis use disorder, they're really, It's psychotherapy Mm-hmm and then there's treating symptoms. Sure. But there isn't a good mechanism of action. This acts on the CB1- Mm-hmm And it is a specific signaling, so it's not on all the time, and so you don't get the side effects of other drugs that have tried to act on the CB1, which is drowsiness, sleepiness, you know, all the side effects. It only comes on when there's an intoxication sort of level. Mm-hmm of cannabis. And so it pops on when it's needed, and then Mm-hmm It turns off, so you don't get the side effects. Our hypothesis is it'll make for a great phase III asset and hopefully something that can be the first to market to help with cannabis use disorder. Just real quick, 'cause we're out of time, phase IIb data, when do you expect that? Yeah, we're expecting last patient, last visit, end of Q1. Mm-hmm Beginning of Q2 next year. So hopefully, we're engaged with the FDA by the end of next year. Got it. Okay, well, we're out of time. Thanks so much, Mark- David, thanks so much. and thank you to the audience. Yeah, really enjoyed it.