Welcome to the Jefferies Healthcare Conference. My name is Dennis Ding, biotech and spec pharma analyst here at Jefferies. I have the wonderful pleasure of having Indivior Pharmaceuticals here. We have the CEO, Joe Ciaffoni, as well as the CFO, Ryan Preblick, here with us. Welcome. Thank you, Dennis. Before we go into the Q&A, would love to give you the opportunity to make some opening comments around Indivior, what you guys are trying to do tremendous progress you guys have made over the last year. First off, I want to thank you and the Jefferies team for the opportunity to be at the conference. We're certainly excited to be here to tell the Indivior story. I do want to give the disclaimer that we will be making forward-looking statements, and I would encourage people to look at our financial disclosures for a description of the company and associated risk factors. Right now, at Indivior, we're head down in the execution of the Indivior Action Agenda. 2025 for the organization was a year in which we accomplished a lot in what was phase I, generate momentum, which was first and foremost about getting SUBLOCADE moving in a strong direction, while concurrently making sure we were making all of the necessary investments to drive SUBLOCADE and to grow long-acting injectable penetration while simplifying the organization and making sure we're only investing in that of which is essential. We had a strong year. It gave us a great setup as we entered phase two accelerate of our Indivior Action Agenda, where we expect to see SUBLOCADE accelerate throughout 2026 from a dispense unit perspective. We expect to see an immediate acceleration of the bottom line at a much faster rate. That's exactly what we saw in the first quarter. We had a very strong quarter, which resulted in us raising our full year guidance in a material manner on our Q2 call. I would say in the second quarter, we're seeing very strong trends, so we're very confident in how the business is trending relative to our revised guidance. Nearly every metric in support of SUBLOCADE is trending strongly, and as an organization, we're continuing to get better from an execution perspective, which is important for us. We have a lot of work to do to get to where we ultimately want to be, and we anticipate that we're going to be in position as we make the turn to the back half of the year to enter phase III of our Indivior Action Agenda, which we refer to as the breakout phase, where we will then focus on enhancing and diversifying the growth profile of the company through commercial stage acquisitions. The one comment there that I want to make is we're very confident in the durability and the growth trajectory of SUBLOCADE. We're also in a position where we'll be leveraging, not growing our cost structure. When we think about transitioning to the breakout phase, we will assess opportunities with urgency, but we will execute in a very disciplined and methodical manner because the reality is we don't have to do anything. We have a strong and growing business and a cost structure that isn't. We want to do the right deal at the right time. Yeah. Thanks for that. Obviously, SUBLOCADE is the biggest driver of the business and of valuation. You had a very strong Q1, not much seasonality with SUBLOCADE relative to what you see with many of your peers. Q2, you just mentioned very strong and encouraging trends, which is fantastic. As you go through 2026, the year-over-year comps do get a little bit tougher, yet you guys are still reiterating mid-teens dispense unit growth. I guess, what is driving that confidence? What is getting physicians using SUBLOCADE more to reach for SUBLOCADE more? Yeah. Look, when you look at our revised guidance and what it is that we believe is happening in support of SUBLOCADE, first and foremost, we've put a lot of effort into doing better and pulling through the commercial opportunity. Relative to what we were anticipating coming in the year based off what we saw in the Q1, we believe commercial will contribute more to the overall business. The second thing is us dispense unit growth has been very strong, but in particular, our new patient starts. In the Q1, people really follow the year-on-year new patients being up 29%. In my view, the more interesting part is coming off a very strong Q4 sequentially, new patient starts were up 10%, and that gives us a lot of confidence moving forward from a dispense unit perspective. What we believe are the drivers there is, one, we are getting better every day in terms of our commercial execution with our customer interfacing teams, whether it's sales professional to physician, whether it's management of our specialty distribution network. We're also very clearly now seeing signs that our consumer, which is the biggest bet we're making, which is around educating and activating the patient to go have discussions with their prescribers, is having an impact, and we believe that will continue as the year goes on. Maybe talk a little bit more about that last point around activating consumer. You guys have been investing in DTC in December, January, February. You guys have commented on positive trends. It seems like you are seeing that pull through. You're driving more patients at the top of the funnel, it seems like. Yeah. Look, when you look at the consumer, interestingly, in the Q1, not only was the LAI market up 23%, but there was also an interesting dynamic. LAI penetration did not improve sequentially. That's because the overall market, the orals grew faster than what it had historically been growing, which is a positive in our view, because consumer, all boats should rise with the high tide. Remember, we source over 95% of long-acting injectable starts off of transmucosal buprenorphine. When you look at impact of consumer, we've talked a lot about metrics like what we would call quality metrics, people going to our physician locator. With SUBLOCADE, a physician has to be authorized to do the injection. In the first quarter, we had 30,000 visits to our SUBLOCADE physician locator site. Our search activity is at an extremely high level. If you look at our CRM, where prior to initiating our consumer in October of 2025, we were enrolling about 60 people a month. We've been averaging over 1,200 a month. Importantly, a key indicator is driving awareness. Awareness of SUBLOCADE amongst patients who had been on or were currently taking transmucosal buprenorphine was very low, and we've seen a significant increase in patient awareness of SUBLOCADE. That awareness drives action conversation, which leads to the patients getting on product. Our new patient numbers continue to be very strong as we're in the second quarter through May. Okay. If I can summarize that really quickly. You're seeing market growth. You're also seeing orals growing faster than long-actings. New patients, they start on SUBOXONE. Right? Before at some point they transition over to SUBLOCADE. Is that a fair assessment? I would say, yeah. The summary should be the consumer we believe is having impact because we're seeing the overall market, the LAI market grows, and we're seeing SUBLOCADE new patient starts continuing to strongly progress off of really strong quarters since we've started the consumer. What is the typical patient journey to get on SUBLOCADE? Is it historically to go through SUBOXONE or some of the orals? Like I said, I don't think there is a typical journey for somebody who's struggling with opioid use disorder. What I can tell you is very few people start first treatment out of the gate with a long-acting injectable. Over 95% of patient starts are people transitioning from an oral over to a long-acting injectable. Usually, it's after an up and down journey, and they've hit a point of, I'd say, a different level of commitment to their recovery. Remember, when you're on a long-acting injectable, you're going to have control for an extended period of time versus taking an oral. You could choose to stop taking it if you wanted to continue with that behavior. I'd say it's a more committed patient that is very serious about t heir recovery when they choose to go on a long-acting injectable. Okay. One of the other things that you called out was just around improving the dynamics at the specialty pharmacy level. Can you just elaborate that in terms of where you guys were last year and the sort of incremental improvements that you're seeing? Yeah. There were five specialty pharmacies we identified where we were only converting four out of 10 patients. A start form would come in, our dispense yield, we call it. We were converting four out of 10 to a start. That's in comparison to our overall network where we convert eight out of 10. What's interesting in those five, their business skews to commercial, which is an area where I think SUBLOCADE is under indexed, meaning the commercial payer. We've put a lot of focus last year for six months, trying to understand what was happening, what's getting in the way of the conversion. Interestingly, prior to implementing what we would refer to as bona fide enhanced services in the first quarter, just with that operational focus, we saw the commercial performing better than what we were expecting. Now, to give your perspective, on a full year basis, a one-point improvement in commercial is worth $8 million. You don't have to move it a lot for it to have a meaningful benefit. We now have just implemented in all five of those specialty pharmacies, the enhanced bona fide services, which we expect for the remainder of this year and as we go forward, will ultimately bring those SPs in line to our overall network. We're excited about it. Okay. Historically, I believe Medicaid has been around 65% of SUBLOCADE in terms of dispensed units. Is that right? Commercial is the balance? It was, I'd say Medicaid's higher, maybe closer to 70%. Commercial was about 25%. I think it's important to note, Medicaid will always be the dominant payer for SUBLOCADE. At 25%, we're clearly under indexing relative to where we believe commercial should be. Yeah. Okay. You're seeing improvements on the commercial side. which is fantastic. Can you comment on just sort of where pricing is between those two channels, I think Medicaid typically has the lowest price. As there's a mix shift in the business more towards commercial, could there just be a natural pricing tailwind? Right. Exactly. That's when Joe mentioned for every one percentage point g ain in the channel mix, it's about $8 million on a full year. Medicaid definitely typically has a higher level of rebates compared to commercial. There is a difference in the net price per unit. Can you comment on how much of a difference on net price? No. No? You miss 100% of the shots you don't take. Okay. Well, you're seeing improvements in that part of the business, right? Their net price will be a tailwind as that eventually grows. Maybe it's 20% now, maybe 30%, 40% is where it should be, Medicaid's still going to be a big portion of that business. In terms of actual volume, right? When you talk with the prescriber, what's been the feedback from them last year, and how has that changed this year? Yeah. I don't think the prescriber feedback is changing. I think the behavior that has changed is the ability of our sales professionals to consistently articulate and educate the prescriber on the SUBLOCADE story, inclusive of the enhanced label. Physicians who have prescribed SUBLOCADE, their experience has been positive, and it distinguishes itself on its efficacy and the impact that it can make in the life of somebody struggling with OUD and their recovery journey. If you look at market research, one of the things we're encouraged by when we ask physicians what their future intent is, they see themselves prescribing 30% more SUBLOCADE. The physician aspect, I think we're in a very strong position. We're seeing a pickup, more physicians are utilizing the accelerated second dose, which was one of the label enhancements. They're seeing positive impact with that's encouraging. The rapid initiation is clearly a differentiator in the eyes of the prescriber. The key thing I come back to is the patient awareness was low. We are seeing, and our belief was in driving awareness and educating the patient and activating them to go have that conversation with a prescriber who understands SUBLOCADE and has had a positive experience with it is really what's starting to have impact. I am curious because there is another competitor in the market, right? You are spending a lot on DTC, on raising awareness. At the same time, you're also using SUBLOCADE as a brand, right? Presumably that would be a little bit stickier, right? As you're driving more patients into the funnel, there would be a preference towards SUBLOCADE. Is that what you are seeing? How should we think about that? Yes, the long-acting category should grow with all these DTC efforts, but should there actually be a preferential shift towards SUBLOCADE versus BRIXADI? With SUBLOCADE, you have the first and number one prescribed product that for now seven quarters has seen stabilizing market share on the mid 70%. Obviously as we make those investments, number one, we're a patient-centric company. We want patients to be treated, whether it's an oral, whether it's SUBLOCADE, which we believe is a differentiated long-acting injectable or the other LAI. Our first focus is to the patient, but obviously at the level we're investing, and I've been clear, we're investing beyond what our models suggest we should, and we're committed to doing that for the next many years. That's how strongly we believe in the importance of that. That yes, we, as the market leader, are going to get a disproportionate benefit in terms of the branded LAI, and that's what we're seeing. Understood. Okay. As you guys make progress on that front, right, what about SUBOXONE? That's another big portion of the business. It sounds to me like there is a benefit in terms of keeping that around as a way to eventually funnel patients into SUBLOCADE. Should we expect, I guess, in terms of revenue on SUBOXONE this year for it to be flattish relative to last year, appreciating that there are generics out there as well? I'll let Ryan comment on that, the one point I want to make. SUBOXONE and transmucosal buprenorphine, of which it's predominantly genericized, is an important resource for physicians in the treatment of patients. My commentary is that's the source of long-acting injectable starts. SUBOXONE was the leading branded product. It serves as a tail product within our portfolio at this point, and I'll let Ryan talk a little bit about how to think of its performance for the year. Yeah. The branded film product does compete against four generics. It comes down to the net price, to maintain that access with the payers. What I would say there is that the pricing has been constructive and reasonable since 2025 and even into the Q1 of 2026. What we said is that our current projection is moderated share erosion on film and a stable pricing for the balance of the year. Okay. Typically, when a generic player wants to erode price a little bit, are there specific time points through the year where it would be logical for them to do it? Or they could just cut price whenever they want at their discretion? They can do it anytime they want. Anytime? Okay. So far it seems. We're assuming, to be clear, stable price in 2026. Understood. Okay. Would love to talk a little bit about Medicaid. Some of this Medicaid funding and the expansion and all that stuff that's starting in 2027. There was a ruling that was disclosed yesterday or a draft or whatever you want to call it. It does seem like there were some incremental additions to what's classified as substance use disorder relative to the earlier draft. Can you just share some of your thoughts on that and maybe opine on some of the nuances around early recovery, active recovery, stable recovery and the potential impact to SUBLOCADE, if any? Yeah. Look, big picture, we have felt the political environment, inclusive of the Big Beautiful Bill, was very supportive of opioid use disorder, of substance use disorder. To be candid, with regards to the interim final rule, it was much more positive than what we would've anticipated, in particular, around continuity of care. It has obviously maintained the frailty exemption, which applies to people with opioid use disorder, substance use disorder. In the initial phase of 2027, it's a patient attestation that will enable them to continue their therapy. We were not anticipating that. When you look at from an administration and claims data, we believe that's going to result in more continuity. Big picture, we think SUBLOCADE is well-positioned. We were very encouraged by that ruling. We expect SUBLOCADE to be a durable growth driver for the foreseeable future. Okay. It does depend on how this gets implemented, right? How much each individual states will have a say in this or how they would implement it. There was some language around, if you are considered in stable recovery, meaning more than five years on treatment, you wouldn't be considered medically frail, so there wouldn't be an exclusion in terms of the workers' requirement. What do you think about that specific part of the language? Do you think that that could be an issue at all? Look, I hope and pray every day that patients will get to five years and not be struggling with opioid use disorder. The reality of SUBLOCADE, as an example, the average patient gets five injections. The data strongly suggests benefit at 12 months. I think overall, when you look at the big picture, you have an accommodative, both at a federal and state level, and compassion to people who are living with opioid use disorder. Corporately, we advocate, we certainly hope everyone who should get coverage with Medicaid gets that. If you take a big picture of the landscape in the United States, eight million people are misusing opioids, five million people are diagnosed with opioid use disorder, two million are being treated with buprenorphine. There is abundant opportunity for us in doing the right thing by patients to have a durable growth driver. The ebb and flow of Medicaid really, minus the humanistic perspective of wanting everyone to have coverage, is not going to impact our ability to realize what we're setting out to do with SUBLOCADE. Understood. You guys recently on Q1 raised guidance just almost across the board. Now we're looking at EBITDA in the GBP 600s. I guess, as you look at the business, if SUBLOCADE does accelerate, and it seems like there's a scenario where it could accelerate faster than what you're saying, which is mid-teens%. How much of that benefit would flow to the bottom line versus get reinvested in additional DTC and maybe even pipeline or BD? Yeah. We raised our revenue, we held our OPEX. The simple way to think of our OPEX, remember, post the pipeline decisions, we're currently winding down our R&D organization. We're continuing to do work from a G&A perspective. We're not where we need to be from a cost structure perspective. In 2026, the way to think of our OPEX guidance is if we identify things with the money that we're saving, that we believe would drive SUBLOCADE in 2026 or 2027, we will come to the high end of the guide. To the degree that there aren't things that are worthy of investing in, we'll let those dollars drop and come to the low end of the guide. What I can tell people sitting here today, we are leveraging, not growing our cost structure on a going forward basis. In 2027, we certainly aren't going to be above GBP 450 million on the high end of the 2027 guide, and we could potentially be lower. The big picture is SUBLOCADE will continue to accelerate. We will be leveraging, not growing our cost structure, and we will have additional margin improvements. Sure. When you're talking about reinvesting in SUBLOCADE and identifying opportunities, I guess, what is exactly on the, so to speak, menu, right, of things that you could continue to invest in? Yeah. Well, because there's another product in the category, I'm not going to get into what's on the menu specifically, but what I would say the likely area that we would be dialing up investment further would be around the consumer. Mm-hmm. Okay. That would be incremental to the magnitude of DTC that is already accounted for in your OPEX guidance. Yeah. If we opted to do that. Okay. In terms of that level of DTC spend, how committed are you in terms of doing this for the next several years, or would you do DTC for 12 - 18 months and then just kind of reevaluate? How are you thinking about that level of spend? We're committed for the next many years. In my experience with DTC, you have to be committed, one, to a relevant level of spend, and then two, a sustained level of spend. It's not something that you pulse up and down. We're committed to it for the long haul. What is that relevant amount of spend, in your eyes? Excuse me? What is that relevant amount of spend, in your eyes? Yeah, I'm not going to get into spending and how much we're putting behind it. The only comment I'll make there is we are over-investing relative to what our models suggest, because what we're not going to do when you have a wonderful growth driver like SUBLOCADE that has the ability to transform people's lives, and the cool part, and create value for the shareholders of Indivior, we're not going to look back five years from now and be disappointed in either where SUBLOCADE is or long-acting injectable penetration, and the reason that we're not happy about where it is, is because the leader in the space didn't make the investments to educate and drive awareness of long-acting injectables. That's our commitment. Sure. In the last three minutes, maybe we can talk about BD. As you guys enter phase III, Joe, you mentioned there's this urgency, right? There's this urgency, I think, at Indivior to go out and look at assets. I guess that high level, what is on your radar? How are you going to best leverage the cost structure that you guys have developed? First off, I want to emphasize, we will urgently assess, we will methodically and systematically execute, because the reality is we don't have to do anything. We have a strong, durable business and a great growth driver in SUBLOCADE. We also have a meaningful, in our view, disconnect between the intrinsic value of the company and where our shares are currently trading. As part of capital allocation, we will continue, to the degree that persists, to buy back our shares, and I think you know we just did a GBP 175 million accelerated share repurchase program. From a BD perspective, we are looking to enhance and diversify the growth profile of our business. We're focused on commercial stage assets only. We will be establishing a new strategic beachhead, so it won't be OUD. Because of that, we're generally therapeutically agnostic. We wouldn't go into oncology, gene therapy, or things like that, but we have a lot of flexibility. We want differentiated brands. We think that's critical to get reimbursement, which is critical to commercial success. We want runway in front of these assets. The only comment I would make is, the final comment is, once we establish that new beachhead, we want to make sure post-integration that there are then assets to buy that we could leverage what would be a new commercial infrastructure. Understood. It sounds to me like it could be something outside of substance use disorder, right? It will definitely be something outside of substance use. Okay. When you say diversify, it's not necessarily diversified away from SUBLOCADE, but away from OUD and substance use. Okay. Yeah. Yeah. SUBLOCADE will be an anchor for this company for a long time. It's a long and durable growth driver. Part of our thesis is that as we enhance and diversify the growth profile of the company, not only will we find an economically good deal for our shareholders, but there's also the potential for multiple expansion as we diversify the revenue beyond just the SUBLOCADE and OUD revenue that we have which will also create value for the shareholders. What would you view as meaningful in terms of the revenue contribution, either when you guys buy it at the time that you buy it, or perhaps at the time of peak sales? Yeah. Look, we factor in it has to be over GBP 200 million peak sales potential. More so than targeting specificity around revenue, look, we have a strong balance sheet. We've been clear we'd be comfortable going up to three times leverage on the balance sheet. I would add any deal we do would need to be accretive the year we did it, if not year one, the following year. I think one of the things that we prioritize is not just the additive impact to the top line, but we want to make sure that there's meaningful synergy when you're bringing the two organizations together as another way to create value for our shareholders. Sure. All right. Well, I think that's all the time that we have today. Thank you so much, Joe and Ryan, for being here, and hope you have a great conference. Okay. Thanks, Dennis. Thank you. Appreciate it.
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