Hi, good morning, everybody. My name's James Vayne Tempest. I'm Jefferies' European Specialty Pharma Analyst. Welcome to the first day of our Global Healthcare Conference. Now it's our time to have a chat with Indivior, a leading specialty pharma company based in the U.S., joined on stage here by Joe Ciaffoni, who's a relatively new CEO of Indivior, which is great, and also Ryan Preblick, CFO of Indivior. Thank you both for joining us today. Maybe to start with, Joe, I guess you've moved from board to management. What attracted you to the opportunity of being CEO for Indivior? Yeah, so first off, James, I want to thank you and your colleagues at Jefferies for giving us the opportunity to participate in the conference. In terms of the things that attracted me to the opportunity at Indivior, first and foremost, I would say it's the important work that the company does. The opioid crisis is one of the largest and most urgent U.S. public health emergencies of our time, and Indivior is on the right side of it. It's a company that exists every day to try to make a positive difference in the lives of people living with opioid use disorder. The second factor is the business and the profile of the company itself. The company has significant revenue. It's profitable. It has robust cash flow and a strong balance sheet. The third factor is Sublocade. Sublocade is an outstanding product. It has a long, durable runway in front of it, and it represents a great growth opportunity for the organization. The fourth and final factor that I would highlight is the fact that I think the company is undervalued. I think there is a disconnect between the intrinsic value of the company and where it is that our shares have been and continue to trade. It is an organization I'm excited to be a part of and to serve the company in this capacity. Thank you. Joe, this is actually the first opportunity we've had to get to know each other, which is great since you've taken on the role. Obviously, you joined the board and now obviously you're sort of CEO. It'd be really good if you could just share with us what your initial observations are, having been in the role literally one month. Yeah, so yeah, this is actually my fourth official week in the role, but by the nature of the transition, I've had the opportunity to engage the company for the past several months. What I would say to you, my initial observations are, one, the company is really comprised of talented professionals that are very passionate about the work that Indivior does. As part of the transition, I had a chance to participate in 51 roundtable discussions with over 1,100 of my Indivior colleagues. An interesting thing that emerged from that is for over 85% of our people, when you ask them why are they at Indivior, it's because the opioid crisis, opioid use disorder, is personal to them. What I would say to you is that passion, I believe, is the special sauce of the organization. That's what has enabled it to be as successful and as resilient as it's been. The second thing I've observed is we have outstanding products, and I think that's really important. It's one thing to have aspiration and passion to make a difference. It's really important, though, when you have products that can deliver for people living with opioid use disorder, and we certainly have that. I would also say to you, we are a relatively simplistic business, and we are an exceptionally complex, I might go as far to say unfathomably complex organization relative to the business opportunity. With that comes a lot of activity and a lot of things when you look at, we're doing so many things that almost can be challenging to figure out what it is that we're committed to and focused on doing exceptionally well. The final observation I would share with you, and I think this is an exciting one, is when you look at the US Commercial Organization, there is a significant opportunity. It is very tangible to improve the operational execution. As we do that, I expect to see immediate results. I will add one final thing along those lines. You may have seen, I am sure you know, we announced a week ago that Patrick Barry would be joining our organization. Patrick is somebody who I have worked with multiple times over the course of my career, and he is one of the finest commercial leaders that I have ever had the opportunity to work with. His first official day was Monday. We left him back in Richmond so he can get immediately focused on the important work the commercial team is doing, but he will have an immediate positive impact on the organization. Thanks for sharing that. I guess those are your kind of your observations, but what would you say are your top three priorities in terms of looking at? Yeah, I think our priorities for 2025, which is really a transition year for the organization, are clear. Number one, we need to deliver the 2025 guidance and our operating plan. We're encouraged with the start that we're off to for the year. I think it was great that we were able to affirm our guidance for the rest of the year. We need to build back trust and credibility. The second priority for us is the development of our Indivior action agenda, which I believe we'll be in position to share on our Q2 call at the end of June. That is something the management team and board are working very closely on. Once we define the path forward, we'll be in implementation mode. Our goal and our third priority is to be lock-loaded and ready to go in our operating posture when we hit the fourth quarter so that we can finish 2025 strong and get off to a fast start in 2026. Every leader, I guess, has their own style, but I guess how at the moment are you finding your spending or how are you spending your time? I guess related to that, is there, well, how much of a need is there to spend time in Washington? We do understand policy is quite a big factor in this indication. Where do you think this administration is headed on Medicaid? A few questions kind of blended in there in terms of how you're spending time and then thinking about Washington. I'll try to remember them all, but if I don't, help me through it. First off, from a time perspective, as I said, I was fortunate with how this transition played out because I've had a chance to hear every single voice in the company. I think it's really important when you're new not to come in with preconceived notions, but to take the time to understand every perspective. Since I've joined, I've been spending my time with the leadership team, really digging into the business and starting to develop what will emerge as our Indivior action agenda. I've also spent a fair amount of time out with customers and getting their perspective on our product, on our company, and how it is that we're interacting with them. From a public policy or government perspective, I think overall, when you look at what's happening, I view the opioid epidemic, the opioid use disorder, as really maybe one of the few bipartisan topics that there is. If you start with the administration's drug pricing priorities, I would say three of the six are directly aligned to the work that we do at Indivior. When you look at the bill that's working its way through from a Medicaid perspective, I would say it's going to be either neutral to positive. The core funding and support of opioid use disorder, substance use disorder, is built into that. If you look at, for example, the work requirement, people with chronic substance use disorder, opioid use disorder, are exempt from it. I think we're in a very good position and we're very confident of how things will go as we proceed. Thank you. You mentioned, I guess, as part of your three initial observations, the products, obviously kind of one thing, but perhaps specifically if we can ask on Sublocade, the observations you've got on that, given it is quite a competitive environment. Yeah, so it's interesting. When I look at Sublocade, we have a first-in-class product that is the number one prescribed product. Has been 350,000 patients have been treated. Physicians know what to expect. They believe in its efficacy. There's a high intent to prescribe more. We have broad payer coverage. We have a durable runway in front of us, and we've been able to bolster our label. So I'm exceptionally confident. I spend 100% of my time at this point focusing in on what Indivior does and how we maximize the Sublocade opportunity, along with we're the only player in the space with the expertise, along with the resources to do the thing that's critically important, which is to drive long-acting injectable utilization. The space, when I think of it, the real competition is physician apathy. It's the stigma of treating patients with opioid use disorder. It's changing the process of using transmucosal buprenorphine products to a different approach with long-acting injectables. I don't necessarily view competition beyond that. We certainly welcome innovation to the space. We're very confident in our product, and we believe anybody that's out there that wants to talk about long-acting injectable buprenorphine treatment, that's a good thing. We're glad and confident in Sublocade. When we compare yours to Braeburn's performance, are they doing anything spectacular or is it Braeburn winning over doctors? Yeah, look, at the end of the day, I would just reinforce that our focus is Sublocade. We're very confident in the profile of the product. It is differentiated. We have great access, and we're very encouraged that what we've seen over the past several quarters, which is that Sublocade share from a new patient start and total share perspective has been relatively stable. We are confident in our product, and we welcome anybody else coming into the space that wants to talk about long-acting injectable buprenorphine treatment. That is our view. Thank you. I think one of the things which caught a lot of investors off guard is sort of the changing dynamics of the criminal justice system. What dynamically changed there? Because it went from going sort of the fastest growing segment of the business to essentially being one of the reasons why you had to update the market? Right. Yeah. What happened there was simple. Unfortunately, at the end of the year, the Federal Bureau of Prisons, which was our largest account, was tasked to treat more patients, which is great for society, great for community, but unfortunately, they were asked to do that with the same budget. They had to make the decision to stop treating with our long-acting injectable and make the direct switch over to the film product. That occurred in Q1. That is the drop in our net revenue primarily from Q1- Q4. It is still a strong channel for us. We are going to support that channel, but it comes back to the focus of funding now in that category. Thanks. I guess still on the opioid addiction, I guess Suboxone Film continues to kind of be resilient. I guess we're all waiting maybe like you for this sort of fifth generic, but I guess what are the people on the ground telling you about that product? Yeah, so that film product, I believe we've managed that business quite well for the last five or six years. I'm not sure you can ever find another performance when there's four generics in the marketplace for us to maintain over 14 share points. The cash generated from that product helps support Sublocade resources, helps support our four share repurchases. Certainly tremendous. What we did see for the first time was some price erosion. The fourth entrants did take some pricing into 2024. We took the appropriate reaction to maintain strong formulary position in Q1. As of now, year to date, the pricing activity has been relatively quiet, but it is something that we will have to monitor. Thank you. I guess outside of Sublocade and Suboxone, the company acquired Opiant and it has got Opvee. How should we think about the longer-term potential of that franchise? Yeah, look, I think that's one of many things right now as we build our action agenda that we have to dig in on and really come up with a position of how we're going to handle Opvee moving forward. On the one hand, the profile of the product is exceptional, and it really seems like a brand that is fit for purpose in terms of where the opioid epidemic is and where it's heading with regards to fentanyl and other synthetic derivatives. The profile of the product really is a strong one. That being said, the product has been met with significant resistance. It has had nominal commercial uptake, and we have to really step back and see what it is we need to do in the way of evidence and real-world evidence, data generation, perhaps advocacy and determine what is the pathway forward with Opvee, but that's something we're digging in on right now. Thank you. I'd like to ask a few questions on financials, so perhaps this for you, Ryan, as well. Joe, in your initial kind of remarks in terms of observations, you talked about a relatively complex kind of organization, and I guess I inferred from that perhaps thinking about potential for margin upside over time. One pushback we do get from investors is around SG&A because this has remained really high over time. I think it's something like 50% of revenues, and I guess even admin is 25% of revenues. What can be done to get this lower to demonstrate the earnings power of the company? I think that is something investors have really been sort of yearning for, to kind of see this come through with the earnings power that you have. Yeah, I think investors are correct to challenge it. The company has significant earnings power. I think at the end of the day, when you think of the organization, it's about making every investment necessary to maximize the Sublocade opportunity in the US market, and then making sure any other dollar we invest is aligned to essential activities to unlocking value for patients and, importantly, maximizing the earning power of the company to unlock value for our shareholders. That's something we will be working very hard on. I'm very confident in what it is that we'll be able to do in terms of demonstrating the earnings power of the organization. As we get to our July call, talk about our Indivior action agenda, and then as we get into implementation for the remainder of the year, I think that will speak for itself. Excellent. We look forward to hearing about the action agenda then at the first half results. I guess outside of the SG&A kind of moving down the P&L a little bit, the R&D sort of aspect which you have, there were some programs that kind of reined in last year as the company looked to protect the business at the time of the warnings. How are you thinking about investing in innovation whilst at the same time protecting the P&L and kind of what assets or programs would you point us towards where it sort of selectively makes sense to invest those dollars? Yeah. Look, we're focused on investing in Sublocade growth in the US market and maximizing that opportunity. We have the two programs that are currently in phase II. They're well along the way of enrollment, so we'll see how it is that reads out. From there, I think we have to earn the right through our execution around the business, Sublocade in particular in the U.S., to determine how it is we want to allocate capital on a going forward basis. I think when you look at the business, both with the two pipeline programs we have and the durable runway of Sublocade, one of the things we really are probably, when we earn the right to think about it, we'll focus on are commercial stage assets, not necessarily R&D or pipeline type opportunities. I guess with the focus on the commercial execution of Sublocade in the U.S., how should we think about the ex-U.S. business? I mean, there are relatively limited profits there. It does consume kind of resources. Is the focus very much the U.S., or how should we think about the international business? Yeah. I think we're focused on US Sublocade, and one of the many things we need to think through is what is our approach anywhere else in the world in support of the business and what is the actual opportunity. Thank you. You mentioned about sort of Suboxone in terms of how it isn't promoted and it's been doing relatively better this year, so we haven't seen that kind of pricing erosion happen. Let's just say that does happen. I know there's going to be this action agenda coming in kind of first half, but when we think about the levers at the disposal of the business to help maintain profitability, if you did see some kind of price erosion, how much offset capability do you have or are the costs kind of relatively fixed? It'd be quite helpful to understand the dynamics there. With the film business, again, going back to the earlier comment, it's amazing what we're doing with very limited resources. There's really no headcount supporting the product. In regards to levers available to us, very small, quite profitable business for us. At this point, we're focused on maintaining access and keeping a pulse on the pricing by the generics. Thank you. When we think about the capital returns, which the company does, there isn't a dividend, but the company's done a number of share buybacks. At least what are your initial thoughts, Joe, thinking about free cash flow and capital allocation priorities? Yeah. I think right now what we have to focus on is driving Sublocade in the U.S., the development of our action agenda, and then the rapid implementation of our going forward posture so that we then have a full understanding of what cash flows will look like as we move forward and what is the earnings potential of the business. I think, as you said, James, the organization has a history. I believe we've executed about $400 million in repurchases. The business right now, there is a disconnect in our view between the intrinsic value of the company and where the shares are trading. I think that's always an option and something the company has demonstrated very clearly that it is willing to return capital to shareholders in that manner. Right now, we need to work through the process and get to what the organization will look like on a going forward basis so we can fully appreciate, as can the market, the cash flow generation and earnings potential of the business. I guess kind of related to that, the company has historically had to maintain a relatively high cash balance given litigation payments and sort of general liquidity. Again, how are you viewing that sort of going forward? I guess not to kind of go through the details of kind of all the litigations, but I guess what are the major payments potentially kind of upcoming we should be mindful of as we think about the overall kind of cash profile of the company? Having a strong balance sheet has been and will continue to be very important to us. We ended Q1 with close to $400 million of cash. I would say in the near term, the two priorities are the following. One is to make sure that we can pay all the settlements that are still outstanding for us, which is much lower than it used to be. Even before that, let me say, going back to Joe's point, make sure we fully resource Sublocade would be the top priority. After that, make sure we meet all of our financial obligations, which would include paying off the settlements as well as any debt obligations. I would say after that, that sets us up to take a look at the work we're doing over the next couple of months, and the results on cash flow will be determined. Once you add up the requirements of what we need, plus the results of the operational review we're doing over the summer, will give us that platform to start taking a look at optionality for capital allocation. Thinking about other drivers sort of over the midterm, yes, the focus very much on commercial execution of Sublocade today, sort of maximizing the value which you have from that. The company has been able to make acquisitions like with kind of Opiant, but we do not have another version of Sublocade in development down the line. A lot of investors sort of ask us when the Sublocade patent goes, what steps potentially can happen today to prepare the company for the mid-2030s. Balancing that internal demands versus potential kind of external products coming in, other new areas within addiction or anything else. How are you thinking about at this stage preparing the company for the longer-term sustainability? First off, in addition to the long runway and the opportunity for growth of Sublocade in the U.S., we have two assets in the pipeline, one of which is a buprenorphine-based long-acting injectable at a three-month interval, which to the degree that we were able to bring that product to the market, we think would provide significant value for patients with opioid use disorder. The other asset is our orexin-1 receptor antagonist. We'll see how it is that those products pan out in phase II. As I said, we have to right now earn the right to think about what it is that we're going to do beyond Sublocade. That starts with our execution around Sublocade in the U.S. The second thing is getting to the going forward posture and really understanding how we're going to maximize the earnings potential of the company. When we do that, and I think that will happen relatively quick, we're then going to be in a position where we can think about what is next. The thing I would highlight is if you think of the profile you set up, that is likely to be focused on commercial stage acquisitions, not pipeline-related programs, because we would want to have assets that contribute to the growth profile prior to any of the things that may emerge from our pipeline. Thank you. Not that long ago, Indivior purchased a manufacturing site. That was obviously to improve the COGS of Sublocade, but I guess also Perseris was mentioned as part of that. Given Perseris has been discontinued, does that change the business plan of that site at all? No. The primary focus of getting that facility was to secure the supply of Sublocade. That is paramount. We do not want to put that at risk. The focus was going to be on Sublocade at all times. Being able to incorporate Perseris into that was a nice to have, but right now we are still on track to have that finished by the end of 2026 and have product out in the marketplace by 2027. Thank you. This is the first chance I think we've had also the opportunity to chat since the release of exiting the LSE. I just wondered if you wanted to share any thoughts behind the decision for that? First, quite excited about it. It's something that we've talked about for the last couple of years. It's something that makes sense for us. 75% of our shareholders are based in the U.S. 80% of our net revenue comes from the U.S. Then since last year when we became dual-listed, almost 70% of our volume is traded in NASDAQ. It just makes sense. To Joe's comment earlier about trying to make our business simple. We're excited about it, and it becomes effective July 25th. Thank you. Coming up to the last few minutes. I know it takes some time to get between meetings, so we can close maybe a few minutes early, but perhaps in closing, Joe, if there's any other points we haven't spoken about in terms of what your agenda looks like in the near term to share with us, and then we can close the session. Yeah. No, look, I want to thank you for the opportunity to participate in the conference. As I said, right now we are maniacally focused on ensuring that we can deliver the operating plan, that we can deliver the guidance that we put into the marketplace. We understand the importance of earning back trust and the confidence of our various stakeholders. We're working very hard on the development of the Indivior action agenda. Once we finish that, we'll then be in implementation mode with a laser focus on finishing 2025 strong and perhaps even more importantly, to be in a position right out of the gate in 2026 to have a fast start. We are excited about the opportunity in front of us and really look forward to executing around our plan. Thank you. Joe and Ryan from Indivior, thank you very much for the discussion.