Morning, everybody. Welcome to the Stifel Healthcare Conference once more. I'm Christian Glenney, Healthcare Analyst based out of our London Office. Delighted to be joined in the session by Joe Ciaffoni, CEO, Ryan Preblick, CFO of Indivior, a $4 billion Market cap company, Annual Turnover about $1.2 billion. I'm sure many of you know a Global Leader in the opioid use disorder market. Lots to discuss, guys. Let's get into it. I guess the obvious part is your starting point is your Q3 results. We saw a strong beat in raise. That's your second quarterly beat in raise, Joe, since you came in. Stock's now hitting pretty much a seven-year high, pretty much almost an all-time high since listing in 2014. I guess from my perspective, the beat was kind of three components, maybe more, but primarily SUBLOCADE coming in higher, to about 10% higher. You upgrade your four-year guidance higher. Suboxone erosion not being as more modest than guided. I guess the big reveal more was your $150 million Sost Savings to come next year, which was probably at the top end of most people's expectations. Obvious place to start, SUBLOCADE. I guess first of all, get your views, perspective on where you are today with the product maybe versus when you came into the business, and the actions fundamentally that you've been taking to get this momentum back, the 10% growth you're guiding to this year. We started the year at flat growth. Some of the specific actions you've been taking. Sure. So, look, first off, I want to thank you and the Stifel Team for the opportunity to participate in the conference. We're certainly excited to be here. When I joined Indivior, and you can kind of understand it from the outside, but the first thing to ground yourself in is just the unmet need within this market and the size of the market. You have 9 million Patients or People who are misusing opioids. You have 6 million that are diagnosed with opioids use disorder. Only 2 million are being treated with a buprenorphine medication-assisted treatment, and less than 10% are getting a long-acting injectable. There's clearly a need. There's a significant opportunity to grow Long-Acting Injectable Penetration. We're fortunate at Indivior to really have a special asset in SUBLOCADE. It's a first-in-class long-acting injectable. It's the number one prescribed. It's been used in over 350,000 Patients. Physicians know what to expect, and it has a durable runway in front of it. Great growth opportunity for the company. To your question directly, this year, what we believe is driving the performance and we announced our Indivior Action Agenda, and we talked about phase I, generate momentum. We believe that first and foremost, through improved Commercial Execution, we could generate momentum and growth in support of SUBLOCADE. The fact is we are executing at a higher level as we're getting better. We're doing better. The second thing is the Label Enhancements, which are an important part of the SUBLOCADE story. Those things never have an immediate impact because you have to drive Awareness, and they start to have effect over time. I think that's contributing to the momentum we're seeing. The organization made a significant Investment in Sales and Marketing at the beginning of the year, which also I think is playing through and having impact. That has us in the position we're in. I would say that we are very encouraged by what we're seeing in the data in October. All indicators in support of SUBLOCADE are pointing in the right direction, and we're confident that we're on track to achieve our revised 2025 Guidance. Thanks. Maybe that's good to follow up maybe on that Induction, the ability to Induce Therapy with a monthly is unique to SUBLOCADE. Are there any kind of particular data points maybe that you can share? Are there any maybe significant patient numbers that are coming via that route? Is there a particular profile of that kind of patient that's more appropriate for that monthly Induction? Look, when you look at the Rapid Initiation, which really differentiates SUBLOCADE, it's the only monthly long-Acting Injectable that has Rapid Initiation in the label. It's very hard. We don't have great data on the patient doing a trial of buprenorphine and then starting on SUBLOCADE. The important part of the indication is the ability to inject the Second Dose as early as day eight. There we do have data. Right now, that's about 8%, and that's growing from where it's been as Awareness Rises. We expect that to continue to grow as we go forward. In terms of patient type, opioids use disorder, if you talk to one practitioner, you've essentially talked to one practitioner because it's such an individualized patient experience and the journey that they're on. The beautiful thing of SUBLOCADE with the indication for moderate to severe opioid use disorder, it really is an appropriate consideration for a broad range of patients. Right. I mean, maybe on a related, you talked about greater investment behind the product this year. You've kicked off a bit more of a substantial, as I understand it, sort of more nationwide DTC campaign that started in early October. I guess, again, any initial Assessment, Evaluation of maybe the, I know it's early days, but the impact that that's maybe having. Yeah. Maybe where I'll start is with regards to SUBLOCADE. We've been very clear we are going to make every possible Investment in support of SUBLOCADE and in support of driving Long-Acting Injectable Penetration. In fact, we will be moving forward Over-Investing relative to what models would suggest that we should, in particular from a Consumer Campaign perspective. The reason we're doing that, that ultimately we believe Educating and Activa ting the Consumer is the path to unlock the growth in the Marketplace. I'll share with you an interesting Statistic on a product that's been in the market as long as SUBLOCADE. Unprompted Patient Awareness of SUBLOCADE is 4%. That tells you the opportunity and what it is we're seeing and why we're making that Investment. With regards to the Campaign, what I can tell you is it tested exceptionally well in Market Research. It's too early to give you any meaningful Feedback. What I would say is we're encouraged by the Early Indicators that we look at both Qualitatively and Quantitatively. It's something that we're committed to on a going forward basis where we will continue to Over-Invest relative to the models at a sustained level. That's a big bet that we're placing in terms of unlocking the potential of both LAI Penetration and SUBLOCADE. I think the stat that had been quoted previously, something like if a patient comes in and is aware and requests SUBLOCADE, it's like almost 90% fulfillment of that. Is that? I think that's indicative of almost any category in the U.S. because it's such a collaborative, you have such a well-informed Patient Population when they're then engaging with the HCP that they generally, unless there's a specific reason a physician can't accommodate or wouldn't accommodate that request, the patient at a very high rate will get the product that they request. That's also why, as the leader in the category, it's important that when you look at it in the data, we've now seen four quarters of Stabilization from a share perspective of SUBLOCADE at 75%. It's really the role of the leader to drive the category, and that's what we're committed to do. Maybe just on, I mean, does the DTC sort of play into going more after the, so maybe just explain the sort of breakdown in terms of Insurance to Profile Typical, and then this opportunity that you've talked about in terms of more the sort of Commercial Part of the Market. Does that, the intention there presumably to drive, and how do you get more of that Commercial Side of the Market? The Consumer Work we do is geared to all patients, to anybody that cares about somebody who has opioid use disorder. That is about educating, driving awareness that drives the Market, and then having the number one Prescribed Product, we are in a very good position as LAI Penetration grows. The payer question is a little bit different. We are very fortunate. Our teams have done a great job of securing broad access for SUBLOCADE. It is about 88% in both Medicare and Commercial. The simple way to think of it is Medicare in terms of covered lives accounts for about 30%, but it accounts for over 60% of SUBLOCADE Prescriptions. Commercial, conversely, accounts for over 60% of covered lives, but only 25% of SUBLOCADE Utilization. The opportunity is to grow both because overall LAI Penetration is low, but that mix Commercial should be a higher Contributor than what it is to SUBLOCADE. I do want to be clear, it will never be a bigger Contributor than Medicare, but we definitely should be executing and pulling through that access more effectively than we have to this point. Maybe just touch on maybe two particular markets. I think at least the company used to call out criminal justice system and in-store pharmacies. There was the Albertsons Collaboration. I guess just your perspective on those particular Markets, are they still opportunities or how do you see that? Yeah. My perspective is first and foremost, the opportunity, what we should be judged on is SUBLOCADE net revenue, and the big opportunity is LAI Penetration. There are ample places and ways of which we will focus to drive it. Criminal Justice System, the way I think of it, it's an opportunity. It's a space we're committed to. That business has been rebased this year. Now we're focused on bringing it back to growth. When you think of alternative site of care or Albertsons, as you refer to it, think of that more as a pilot and really is immaterial and a nominal contributor, but it's something that is worth exploring to see if you can provide other ways in which patients can have access to an Injection Network. Okay. So, come to your Action Agenda. So, phase I was Generate the Momentum. You're starting to see that, the 10% growth this year. In fact, more in the teens applied for Q4. Phase II is then an acceleration of that growth. So, if we were to say sort of 10% is then the baseline for this year, I know you're not going to guide to next year to 2026, but I guess what do you think is achievable in this sort of Acceleration phase? Yeah. Look, when we're head down right now in phase I, Generate Momentum, we need to finish the year, deliver on our Financial Commitments, achieve our Operating Objectives, and concurrently position the business to enter phase II A ccelerate on January 1st, 2026. What I would say is we do expect to see throughout 2026 a pickup in the Growth Rate of SUBLOCADE, especially from a dispense unit perspective. We expect to see revenue growth in 2026. We expect to see an immediate Acceleration at a far faster rate right out of the gate as it pertains to the bottom line. Okay. Good. They also should cover off a previous sort of target in terms of the company previously had a sort of $1 billion, at least an exit rate by the end of 2025. Actually, funnily enough, given your guidance at the moment, you may not actually be that far off as an exit rate, at least in the fourth quarter. We have you at about just below a billion in 2027. To my mind, that looks breachable, but I guess just your thoughts on, are you hungry, is this something that could be a new target that you introduce to the Market on the billion dollar or not? Yeah. So, look, as a practice, we will never give Peak Sales Projections or prognosticate out on what Peak Sales Potential of any of our products are. That being said, this year our Revised Guidance is $825 million-$845 million. We're confident that we're on track to achieve that. I would say that we certainly expect if you define a blockbuster product as a billion dollar plus for SUBLOCADE to surpass that. Our focus and the way we'll approach the business is we confront the reality of where we are today. We want to stay head down from an execution perspective. The ultimate answer to the question of what will SUBLOCADE's peak sales be will come down to what Long-Acting Injectable Penetration ultimately becomes. That's where I emphasize, that's what we're trying to unlock. That's where we'll continue to make, as the Market Leader, the investments necessary to drive Long-Acting Injectable Penetration. Okay. And then maybe just finally then on SUBLOCADE, and is the Market Share you talked about that stabilizing out recently? You call out a 75% share. The competitors call out a 30% share. Obviously, the math does not quite add up. So, maybe just to clarify, maybe when you talk about 75%, the sort of data you are referencing there, and then more broadly, how do you see Market Share evolving? Is it just about growing the categories there or can you gain Market Share? Yeah. I think an important thing to put into context, we have perfect data on the number one Prescribed Product in the category that accounts for a vast majority of the share. Then we're triangulating data through External Data Sources on a competitor. We have applied a consistent methodology for a long period of time, and we have seen for four quarters SUBLOCADE share stabilizing in the mid 75%. That is our position based off of the data that we have consistently applied to the market. At the end of the day, we welcome anybody to the space because there's such a high unmet need, and there's a need for more voice around Long-Acting Injectable Penetration. The reality is at the end of the day, if there was somebody that was able to invest at the levels we are, I would gladly give up Market Share points because the story here isn't going to be whether SUBLOCADE is a 75% or 70% market share product. At the end of the day, it's going to be what is Long-Acting Injectable Penetration. I bring you back to if you have 2 million people out of 6 million diagnosed getting a buprenorphine Medication-Assisted Treatment, I think we could all concur that LAI should have a bigger role than 8%. That's really the name of the game, but that's our perspective on Market Share. The 8% in a three, four-year, five-year view, any thoughts on where that could be getting to? It is definitely going to go up. I think, look, again, I'm not into prognostication. I could give you analogs to look at. You could look at Schizophrenia. You could look at HIV. It would suggest 30%. We have reams of data internally that would suggest 20-30% is reasonable. The reality is we're at eight. We're going to be working hard to drive it as Long-Acting Injectable Penetration increases. We believe that's a really good thing for people who are living with opioid use disorder, which is our focus and our Primary Driver. The cool part of this category is if you do the right thing for patients, if you lead with science and educate prescribers, you can also have a growth business. Okay. Great. Maybe just quick word touch on Suboxone, obviously not, maybe Ryan on this. I mean, we don't, obviously not a key growth driver, but the tail has been quite remarkable on the product. You still got about a 25% share of that film market seven years on. You do kind of $200 million this year in revenues, presumably profitable revenues. I guess just your thoughts on how that might evolve over the next year. We haven't had the fifth generic. Are there any others in the wing? Is there anything that could disrupt this market particularly next year? Thanks. Christian, first, I do want to say good morning to you and thanks for hosting us. It is amazing that we're still talking about the film net revenue at this level with four generics in the marketplace at this time. What it really comes down to is the Generic Pricing. Over the last couple of quarters, it has remained stable, relatively quiet, and that's why you're seeing us benefit from it. It's been a nice contributor to our profile this year, no doubt. What we put into our guide for the balance of the year was assuming that it would remain stable for now, but then we're going to have to take a look at this as we get into 2026. What I would say is even if a fifth generic did come in, I think with the four generic players in the market at this point, those dynamics are going to continue in terms of what we have to watch. Okay. Perfect. Okay. Let's go into the Action Agenda on the sort of cost saving side. Again, maybe for Ryan initially, the big reveal was $150 million. You say if it's roughly $600 million this year, that will be, in your words, no more than $450 million on OpEx for next year. I guess maybe just quantify the mix of where that $150 million is coming from. Yeah. If you don't mind, the first thing I just want to say about this $150 million, it did not come from a Cost Savings Initiative. The first thing we did was take a look at what investments and resources we needed to put behind SUBLOCADE. That was the focus. We took a look at the cost structure. We took a look at the structure of the organization, and we were able to take out $150 million. The major components are first headcount. We reduced our headcount by over 30%. We took a look at all spend that was non-essential to support our action agenda, and that was dropped to the bottom line. Two other items. One was we discontinued the sales and marketing of OPVEE, and we closed down some of the sales and marketing in the rest of the world. Maybe just quick touch on that rest of the world. Maybe looked at maybe was a potential track of looking to maybe divest or sell that rest of the world business or not, or is that something maybe you'd consider in the future, or is it now this is just kind of you're resetting around these Key Markets? We explored every strategic option with the exception of the status quo with the rest of world business. We landed on what we believe is the best option to move forward with for Indivior, and now we're going to bring operational stability to the organization. We will be focused on maximizing the potential of our portfolio in Canada and Australia, and then we'll be optimizing what is essentially legacy tablet business in France and Germany. Very clear. Okay. Maybe then the implications of this, the cost that's coming or savings at the $150 million next year, SG&A will be about 35% of sales. We'll see EBITDA Margins go from roughly sort of the mid-30s this year to the mid-40s this year, at least on our forecast. Just your sense for, A, what is the right level of investment behind SUBLOCADE to drive that growth in terms of that percentage end, or where do you think EBITDA Margins could, should be going, at least for the business as it stands today? Yeah. Look, our focus is what's right for Indivior, and that means what is the necessary Investment for SUBLOCADE. We will make every Investment that we possibly can that we feel will maximize the opportunity for SUBLOCADE and drive Long-Acting Injectable Penetration. Our commitment moving forward is we will remain maniacal in removing non-essential spend from the Organization, and wherever that nets out, we're not targeting a percentage. We're not looking at peer groups. The interesting part is we're able to make all of the investments necessary and remove at least $150 million from the cost structure, which obviously moves all of those percentages up dramatically, but that's really the start point. From there, we will continue to focus on removing any non-essential spend and refining the organization as a matter of practice, just like we will always be looking for Investments to make in support of SUBLOCADE. Okay. That leads then on to the other question that sort of looks then into phase III, and you'll generate some meaningful Cash Flows. Obviously, that will, as you said, it'll drop through the bottom line. You have some remaining commitments around DOJ settlements and so forth, but phase III is looking at bringing new growth drivers into the business. You talked about that being a second half next year. Is this something that sort of generally waits until you get to that point, or is it something you're already sort of prepping today? In terms of those assets, a bit more flavor for the sort of things you're looking at. We definitely are going to have a lot of Capital Allocation optionality, and we have a lot of things to think through both from an Economic and Strategic perspective. There is a saying that the killer of the present is the past and the future. We are really head down on execution of phase I of the Indivior Action Agenda, Generate Momentum, and really preparing the Organization to enter phase II, Accelerate. That being said, we do have a business development function, and we are certainly staying in tune with what is going on. I think we also always have to have an opportunistic posture as we are committed first and foremost to doing what is right for patients and unlocking value for our Shareholders. We will always be opportunistic. We do have to earn our way to Allocate Capital to acquire additional Assets or Company, both from an internal perspective in terms of our confidence that we're in a position and capable of taking on more, and externally from a Shareholder Perspective where they trust us to Allocate Capital in that manner. Now, to the last part of your question, we will be focused on Commercial Stage assets only. I don't believe there is anything in the addiction space. I think we have the assets that one would want to have. What we will focus on are things both from a Size Perspective. If you think of our revenue base, Assets that we believe have potential of at least $200 million. I think the runway of those assets from an LOE Perspective is important. We don't want to acquire something that then puts an overhang on the business from an LOE Perspective. Because it will be a different Therapeutic Area, the other thing we will do is map out what are other assets that you could then acquire to then Leverage, at least from a Commercial Perspective, what would be new infrastructure. Makes sense. Maybe Ryan, also on the topic of Capital Allocation, previously done buybacks, that sort of thing. What's you, the board's view on that potential for something like a buyback? Yeah. So. Shadow return. Yeah. No, at this point, we're going to continue to focus for the balance of 2025. We want to get through Q4, continue that Momentum. We're currently going through our planning process as we speak right now to see how 2026 is going to play out. That's something that we're going to get back to you in early 2026. Certainly have options, but yeah. I would add the company has a history of doing buybacks. I think over the past several years, the Organization's bought back $400 million worth of its shares, I think at an Average Price of about $14.60. Again, I'll put that in a bucket of opportunistic, and there's a history of the Organization being willing to return capital or value to shareholders through buybacks. Okay. Maybe related topic, obviously on Capital Allocation is finally then on pipeline. You've got a couple of phase II. You've got this longer acting three-monthly. You've got an Orexin 1 antagonist. I guess the three-monthly from the discussions we've had with KL, it seems like that has real merit behind it. I guess what do you need to see in terms of that data to take that forward? On the Orexin, non-opioid-based approach, to my mind, maybe that sort of was desirable a few years ago. Now we have buprenorphine used widely in criminal justice and things like that. Maybe that Market Demand or rationale for a non-opioid-based approach is maybe dwindling a bit, but that's my interpretation. Maybe your thoughts. Yeah. For me, first and foremost, we're excited to see the data. I think ultimately you need to be a data-driven organization. We expect to see that sometime early in the second quarter. If you look at 6001, I think it's important that we see that it's a true three-month product. I think that has the potential to be a meaningful differentiator and something that really can make a positive difference in the treatment of patients and their recovery journey. There's a big difference in the outcome of patients who are staying on product for over a year versus those who are dropping off sooner. I think you also, we're going to have to work through the manufacturing. These products are not necessarily easy. There's a lot of work to do from a CMC Perspective. Then making sure that when you look at the landscape on a going forward basis, that it's an asset with the profile that we believe it can have that will get the reimbursement that enables it to be successful. We're certainly encouraged and looking forward to seeing the data. We have a lot of work to do as it pertains to 6001. Indivior 2000 will be interesting because buprenorphine is well established. It's highly effective. That's a high bar. I think one of the things that will be interesting, and I will remind people, is the Orexin 1 mechanism has been studied in a lot of other indications. Hopefully, we're going to have an asset. Others have been derailed primarily for safety or side effect-related reasons, and we're hopeful that won't be the case with this Orexin 1. Whether it will have utility in OUD is TBD, but we also may have an asset that creates optionality. We'll see. At the end of the day, the data will answer that. The good news is someone coming in new, the phase II were fully funded. It's kind of an option to see what the data says. Your budget and the plans on OpEx at the moment at least stands on assumption that you take those both programs forward. Our $450 million max OpEx next year contemplates, and we've maintained the capability to execute phase III, and if successful, would also incorporate the associated phase III work. Perfect. I think we are counting down time here. Thank you very much, Joe, Ryan. Look forward to seeing how the year turns out, of course. You enter that acceleration phase and then look to build a bigger business as well. Thank you very much for coming. Thank you, Christian. We appreciate the opportunity.