Ladies and gentlemen, thank you for standing by. And welcome to Indivior PLC Full Year Results 2021. At this time, all participants are in listen-only mode. After presentation, we will have a question-and-answer session. [Operator Instructions] I would now like to hand the conference over to your speaker today, Mark Crossley, Chief Executive Officer. Please go ahead, sir.

Thanks, Roberto. And good morning, good afternoon, everyone. Thanks for joining us. I'm Mark Crossley, CEO of Indivior. With me today to discuss our results and progress are Ryan Preblick, our Chief Financial Officer; and Dr. Christian Heidbreder, our Chief Scientific Officer. For today's call, I'll provide an overview of our strategic progress, after which Christian will provide a scientific update, and Ryan will conclude our formal remarks by detailing our financial performance and the full year 2022 guidance we published in our press release, we'll then move on to Q&A. Before I move on to my overview, I'll assume that everyone has read the forward-looking statements. I'm going to begin my formal remarks by first thanking our employees. The fact that Indivior has made such tremendous progress against the continuing backdrop of the pandemic speaks to the commitment of our people. Their passion for the focus on delivering for patients is truly humbling. Indeed, never has our purpose to deliver pioneering life-transforming treatments and our patient-centered vision, been more critical and relevant given that tragically, drug overdose deaths reached over 100,000 in the United States during the 12 month period for the first time ever. In short, the epidemic has gotten worse. And as you can see, the vast majority of these deaths are as a result of misuse of opioids, notably, synthetic opioids such as fentanyl. What makes these statistics even more tragic is the fact that 10 million people-plus self-report misusing opioids, and over 3 million people have been diagnosed, while only 1.2 million have received treatment. This phenomena, known as the treatment gap, is one which we must approve on. The treatment gap is one element that motivates the entire Indivior team to advance our vision that all patients around the world will have access to…

Thank you, Mark. And good morning, good afternoon, everyone. Let me first go back to the unprecedented number of drug overdose deaths in the 12 months time frame ending in June 2021 with synthetic opioids, including fentanyl accounting for approximately 65% of fatal overdoses. There are a couple of points I would like to make. First, the overdose crisis disproportionately affect individuals with criminal justice system involvement. Most individuals with opioid use disorder experienced at least one episode of incarceration, typically in a county jail. Most jails, unfortunately, do not provide widely accepted medication for opioid use disorder, which contributes to high rates of overdoses after release. And for those facilities offering medication for opioid use disorder, treatment retention after release remains a significant challenge. Second, emergency departments are a cornerstone of care to close the treatment gap. Unfortunately again, few emergency departments are offering medications for opioid use disorder, and only a third of patients seen in the emergency department for non-fatal overdose received medication for opioid use disorder in the following year. Moving to the next slide. Our response to this crisis is to continue to generate new real-world evidence in support of opioid use disorder treatment in general, the use of SUBLOCADE in particular. Our approach is fourfold, three of which are summarized on this slide. First, we continue to update our US label with new data. For example, our buprenorphine-fentanyl interaction data showing that the treatment-relevant plasma concentrations of buprenorphine significantly decreased respiratory depression and apnea induced by escalating doses of fentanyl, was approved by the FDA in June last year. Furthermore, the data has now been published in the Journal, PLOS ONE, a few weeks ago and a third peer reviewed manuscript is underway. Second, we established a series of collaborations including, for example, the…

Thanks, Christian. Good morning, and good afternoon, everyone. I will quickly touch on some highlights for 2021, but will devote most of my remarks to our 2022 guidance and drivers. Looking at 2021, our financial performance was very solid, and our results for the year overall were within or above our stated guidance ranges across all of our key metrics. Highlights include total 2021 net revenue growth of 22% driven by an 88% increase in SUBLOCADE net revenue to $244 million, continued SUBOXONE Film resiliency and steady progression of PERSERIS, albeit from a low base. SUBLOCADE reached net revenue of $75 million in Q4, increasing 92% versus the prior year period. You should note that this included approximately $4 million of year-end stocking. However, even if we adjust for the stocking, we would still have seen strong double-digit increase in net revenue versus the prior quarter. Turning to SUBOXONE. The US film business grew 10% for the full year with particularly strong growth in the fourth quarter. The performance in Q4 reflected an increase in market share to 22% as a result of being put back on the New York State formulary, as well as trade stocking of just over $10 million. As we have continually stated, we do not actively promote this product in the United States. Our full year 2021 adjusted operating expense, which, as a reminder is SG&A and R&D combined, was in line with our expectations at $477 million. We had a step-up in sales and marketing investments beginning in the second half of 2021, and R&D expense increased during the year due to higher activity levels versus 2020 when pandemic restrictions impacted planned activities. These investments, which will annualize in 2022, are intended to further our leadership position in OUD treatment, provide us increased manufacturing…

Thanks, Ryan. That concludes our formal remarks. And we'll open to Q&A at this time. I hand this over to Roberto.

[Operator Instructions] We have the first question from Christian Glennie from Stifel. Please go ahead.

Yeah, good morning, good afternoon, gentlemen. And congratulations on a very strong fourth quarter and full year results. I guess three questions and taking each one in turn. Just on SUBLOCADE and a couple of things here. One is I didn't catch the stocking contribution in the fourth quarter. And in terms of the scrip data we've seen so far, there's relatively modest growth in the first few weeks this quarter versus the prior quarter. Is that explained then really by what you're saying about a bit of Omicron impact and a bit of unwinding of that stocking?

Thanks for the question. I'll ask Ryan in a second to talk about the stocking. I think, listen, when it talks - when we start to get into Q1, we'll report out that data with our Q1 results. But listen, there is an impact, as we've said in our release and our comments, there is an impact from Omicron. It reduced our access a bit to physicians during the period, but we're starting to see that as we're seeing in the press starting to see that wane off. So Ryan, could you give a little bit more color on the stocking we saw at fiscal year end?

Yeah. On SUBLOCADE, we saw about - like I've mentioned in my release, about $4 million to $5 million of stocking. That's primarily what we would categorize as price increase speculation potentially or year end wholesale decisions. We did take a price increase at the beginning of 2022, so that may be the decision of the wholesalers. That's something that usually does unwind during the first month of the next quarter, but we'll see how that plays out.

Okay. Thank you. That's helpful. And then related to that, if I may, I mean, is it possible to break down a bit more where you're seeing the growth coming from, whether it's - is it new patient starts? Is it a longer duration of treatment with SUBLOCADE, price increases and the like? Just what's the mix there in terms of driving current growth then?

Yeah, it's a great question. And I think, listen, what we've really seen as we've pivoted our strategy and really aligned our organization behind the Organized Health Systems is recall, this is an area where physicians have support systems around them to support the nature of this product, the specialty pharmacy product has more complexity with getting prior authorizations, delivery of the product, handling a controlled product on the premises. And having the infrastructure around them in the Organized Health Systems allows them to take off their CEO hat of their practice and focus really on the best interest of the patients. And as we've continued to focus there, put in place the ecosystems, we've seen a disproportionate amount of our growth, you know, the majority of our growth coming there even though we're seeing continued growth in our heritage platforms. That growth, I would say, is multi-factorial, almost as you've mentioned it. We are driving both new HCPs in and depth of prescribing, which is getting us new patients. And we're seeing that patients are liking the medication and staying on treatment in line with our expectations. And as Ryan said, we took a gross kind of mid single digit 5% price increase on the product. So all of those things are going to be driving our progress moving forward. In addition, within Organized Health Systems is the criminal justice system. And we've talked a lot about this. It's a crucial area for meeting patients where they are. 60% of our patients at one point in time in their journey pass through the criminal justice system. And we think getting them treatment while incarcerated or upon release really will help them on their journey to recovery. So that's an area we invested quite significantly in, in the back half as we staffed up a dedicated sales force. I hope that's helpful.

Yeah. Thank you. That's helpful. Turning to deployment of capital, I guess, obviously, you did the buyback last year. You said you're still considering that, but obviously flagging potential inorganic or M&A opportunities. Just wonder if you could elaborate a little bit more, what more could you say around what sort of targets you might have in mind on the inorganic side, areas of - therapeutic areas and or stages of development, maybe something nearer market or on market today. Anything you could say around that?

Yeah. Capital allocation, obviously, we've got a very straightforward capital allocation strategy. It's fully aligned with our strategic priorities. The first thing - the first priority and top priority is that we invest behind SUBLOCADE to drive its growth to the $1 billion plus in net revenue. We invest behind diversification. We've seen that with PERSERIS as we've gone to the national sales force. And we're bringing products, the film and SUBLOCADE, to the Rest of World markets. Additionally, and you saw this last year, we're looking to both expand and progress our pipeline. We saw that with bringing inbound the Aelis cannabis use disorder asset and the work Christian and his team have done to advance the OX1 opioid use disorder asset, as well as the GABA-B asset, which is focused on alcohol use disorder. And after that, yes, you know, with $1 billion of cash, we're looking at other avenues to drive shareholder value, which could be inorganic options or potential returns of capital, and we saw that last year in 2021 as we did $100 million buyback. As we look towards inorganic opportunities, obviously, we are the global leaders in addiction, and so we look quite near to the core and then, of course, comorbidities in behavioral health and CNS areas.

Okay. Thank you. And finally, if I may, just on the US listing plans then, is there - obviously, you don't necessarily need the cash, but is there a prospect that it could be a straight lift or something around a capital raise given the perceived wisdom sometimes getting people involved in a raise could increase the levels of interest and uptake initially in the lift? And assuming that there's broad shareholder support, is this a potential 2022 event, I guess, as a follow-up?

Yeah. I think first and foremost, we don't want to get ahead of ourselves here. I think the key is we've had some inbound traffic from investors, both on the US and the UK side that have been asking for this, they think there's potential value. And what we need to do is continue with our consultation with all of our shareholders to gain their views and their insights on this potential strategic action. Once we've done that fulsome sort of engagement, only then can we make a decision with regards to the best way forward. So I don't want to put the cart before the horse here. I want to make certain that we gain our shareholders' views moving forward, and then we'll look to next steps.

Okay. Thank you. That's helpful.

Thank you for the questions. Appreciate it.

Thank you for your question. We have the next question from James Vane-Tempest from Jefferies. Please go ahead.

Yes, hi. Thanks for taking my questions. A few if I can, please. With the 49,000 patients of SUBLOCADE, just thinking about as we grow there, are there any states, regions or payer groups where we can see the most progress as we look through this year? The other question is just on SUBOXONE, as we saw last year, it seems as if the messaging was you didn't know whether there's going to be another competitor, we saw sort of raises sort of throughout the year. Whereas this year, it seems as if sort of the level of SUBOXONE you're expecting to continue to be stable this year. And I'm just wondering, what's changed on your outlook or assessment of that or is the risk profile of your guidance changed? And then the final question is just looking at the Brixadi second CRL in December, just wondering how we should think about your overall peak sales. I know you said more than $1 billion, but does that change anything directionally? Thank you.

Thanks, James, for the questions, and I'll just take them, I think, in order. I think you highlighted that 49,000 patients on SUBLOCADE, and that's well on our way to our $1 billion plus of revenue. And when it comes to where do we see concentrations of those, is there regional sort of preferences, a lot of that is based on where the epidemic is most pointed, and that tends to be in the coastal regions of the US. From a payer standpoint, really, it's almost agnostic. And really, the focus here for us is getting to the Organized Health Systems to really be able to pull through both HCPs and patients on this journey. And that includes the criminal justice system that I spoke to a little earlier in the question. So that will be the focus. Our strategy is proven, I think, now as we've seen the growth. And our capabilities are also proven 1.5 years into our restructuring behind the Organized Health Systems. As pertains to SUBOXONE, listen, I think this is an important one. When generics launched, this is a unique disease space. There are no analogs for opioid use disorder, and so you need to follow the data you have, which is the analogs across multiple disease spaces. And we use that to take our best estimate of what would happen in the market. There's nothing structurally different than we saw, and we didn't have experience in the market. As time has evolved, and now we're entering year three living in COVID and with generics, we do have a bit of data, right. The last 12 to 18 months has shown us that the current market forces in the sublingual market have stabilized out a bit. And with that, we think looking at the track…

That's great. Thank you.

Thank you, James.

Thank you for your question. We have the next question from Peter Testa. Please go ahead. Your line is open.

Hi. It's Peter Testa, One Investments. A couple of questions, please. Maybe just firstly, on SUBLOCADE. Can you give some sort of understanding about the OHS traction and criminal justice traction gained in the latter part of the year when you - on a channel basis, whether it's systems open, doctors access, criminal justice system related, just so I can kind of understand or follow the traction you're getting there?

Certainly, Peter. And thanks for the question. I think you saw a major step-up in the fourth quarter with regards to what we call access to our Organized Health Systems. And we've been targeting over the last few years the top 500 Organized Health Systems. And the team has access that's at least a script through those, in 400 of those. Now that's a huge strategic sort of evolution for the team to open those up to do all the hard work and heavy lifting to do that. And now that focus is on opening up the children of those parents. Those are Organized Health Systems. Now you have to go to the individual sites that many of these have, and you have to open up more HCPs and deeper penetration of treatment. So we're looking to continue that penetration within the HCPs and within the Organized Health Systems moving forward. As it relates to criminal justice systems, there is about 5,000 criminal justice systems across the US. We're focused on the top 1,000. And obviously, we made the decision to expand to a dedicated sales force in the back half of this year. And while we've made some good progress in the criminal justice, we had a large one-off order in the second quarter of about $7 million and we've seen continued uptick. We expect the primary strategic progress will be in the periods ahead. And that's - some of that is supported you know, by some of the legislation that we're seeing out in the market. I think a great example of that is New York, which passed the law in the first quarter - fourth quarter, excuse me, that said that you must treat patients suffering from substance use disorder while they're incarcerated. Now that goes into effect in February. Of course, the way these things work is those systems have to work through how that will work, work through the bureaucracy, work through that. So it's not something that instantaneously in February opens up the floodgates. But it certainly is a monumental sort of shift in how we think about treatment. I think we're also seeing some of that at the federal level, where the Medicaid Reentry Act is in Congress and being considered. And that would allow for people to get health care coverage 30 days before their release so that they can get opioid use disorder medications. And so if that were to pass, that's another significant hurdle in meeting patients where they're most able to start their recovery journey. Hope that helps.

Yes. No, indeed. And on the criminal justice, there's also been the DOJ money you set aside. Is that - when you think about in terms of a number of different programs to try to support the uptake of treatment, concepts of treatment through the justice system at that level as opposed to the incarceration level? Is that something which is you see as something you direct sales force towards helping and supporting or more just a background of contribution to you?

Now great question, Peter. I think, listen, there is more funding available in this space than ever before. And I think some of these settlements have been directed only towards treatment for addiction, whether that's evidence-based treatment, education, prevention, et cetera. And I think that's a critical element here. I think there are grants available in criminal justice systems to be able to get medications. And there are databases available for grant finders that folks are able to use and we're able to point them to with regards to gaining access to those. So we see that as a vital tool for folks to increase medically assisted treatment.

Okay. And then on the SUBOXONE side, you obviously have the Medicaid channel and you have the insurance channel. When you're assessing your - how that works out, have you seen any particular changes in the insurance channel in terms of payer position or co-pay or anything else which would be of relevance?

Peter, I'm going to hand that one over to Ryan to address.

Yeah, good morning. So no, not at this point. We have not heard of any significant formulary changes that would impact film. As we mentioned in the past, majority of our volume is on state Medicaid at this point. Those formulary meetings for the states happen between now and Q2, but we'll probably learn more during the next couple of months. And beyond that and since we don't promote the products, we leave the market dynamics aside at this point.

Okay. All right. And then just last question, on the R&D step-up when you think about the aspect supporting SUBLOCADE, can you give any sense as to what you would regard as the 2022 key, say, outcomes from some of those studies? Maybe detail which ones we should look for and maybe when you think you'll be able to get any further into the community on that? Or is it more going to be longer studies?

These will be longer studies. We expect to see the bulk of some of these studies in the period between 2023 to 2025.

Great. That’s super. Thanks very much for the answer.

Thanks, Peter.

Thank you for your question. There are no further questions. I will hand back the conference to Mr. Crossley.

Thanks, Roberto. And listen, that concludes our fiscal year end results. On behalf of the entire Indivior team, I'd like to thank all of you for your continued interest and support in the Indivior story. Hope everyone has a great day. Thank you.

That concludes the conference for today. Thank you for participating. You may all disconnect.