Good day. And thank you for standing by. Welcome to the Indivior PLC Q1 2022 Financial Results Conference Call. At this time, all participants are in a listen-only mode. After the speakers' presentation, there'll be a question-and-answer session. [Operator Instructions]. Please be advised that today's conference is being recorded. [Operator Instructions]. I would now like to hand the conference over to your speaker today, Mark Crossley, Chief Executive Officer. Please go ahead.

Thank you, Sharon. And good morning and good afternoon, everyone. Thanks for joining our first quarter results call. Here with me today are Ryan Preblick, our Chief Financial Officer, and Christian Heidbreder, our Chief Scientific Officer. I'll start with an overview of the results for the first quarter and a progress report against our strategic priorities. Ryan will then discuss the results in more detail, and we'll follow up and move on to Q&A. Before I move on to my overview, I'll assume that you've read the forward-looking statements. On slide 4, turning to the quarter, we delivered strong results which put us on track to meet our full-year 2022 guidance. This performance was driven by the team's successful execution against our strategy focused on growing SUBLOCADE in organized health systems. In summary, our first quarter net revenue grew 15% and operating profit improved modestly, even including the significant uplift in strategic growth investments we're making to grow SUBLOCADE and PERSERIS. Our financial position also remained extremely strong. I want to briefly call out a few highlights. First, SUBLOCADE net revenue of $85 million grew 13% versus the previous quarter and about doubled versus Q1 a year ago, with year-over-year growth of 98%. With this performance, SUBLOCADE has now surpassed SUBOXONE Film as our largest contributor to overall net revenue. Growth was driven by increased penetration of the organized health systems, which represented over 75% of SUBLOCADE's growth, fueled by the platform investments we made. The success of our SUBLOCADE strategy means this important therapy is becoming available to an increasing number of patients at a time when combating the US opioid epidemic has never been more urgent. The CDC now estimates that drug overdoses have caused more than 105,000 deaths in the latest 12-month period, with almost 80,000 of…

Thanks, Mark. And good morning and good afternoon to everyone. We had a strong first quarter to start full year of 2022. We are pleased with our execution, and we are on track to achieve the full-year 2022 guidance that we communicated in mid-February. During the quarter, double-digit top line growth was driven by the strong momentum behind SUBLOCADE, while SUBOXONE Film share remained relatively resilient. Our adjusted operating income increased modestly versus the prior year, reflecting our increased net revenue and the significant investments in sales and marketing we have made over the last year to accelerate the growth of our LAIs. We also maintained our financial flexibility, with more than $1 billion in cash and investments. As Mark mentioned, this has enabled us to return value to shareholders through the announcement of a new $100 million share repurchase program. We expect this program to begin May 3. Now I will provide some more detail on the drivers of our performance in the quarter. Starting with the top line, total net revenue grew 15% versus the year-ago quarter and by 17% at constant exchange rates. The increase in net revenue was mainly a function of the near doubling in SUBLOCADE net revenue. By geography, total US net revenue grew by 26%. In contrast to the strong performance, net revenue and rest of the world was down 10% year-over-year, excluding an unfavorable FX impact. This decline was driven by ongoing austerity measures, generic competition, and the divestiture of the Temgesic franchise, which contributed $2 million of net revenue in the year-ago period. On the positive side, SUBLOCADE net revenue outside of the US doubled to $6 million, putting us on track to offset the decline in a legacy tablet business over time. Total SUBLOCADE net revenue for the first quarter…

Thank you, Ryan. So, in summary, a strong start to the fiscal year by the entire Indivior team, with progress against our strategic priorities and strong financial results. Additionally, we've announced the return of capital to shareholders and continue to progress with shareholder consultation on a potential US listing. With that, I'll go ahead and open up to questions and answers.

[Operator Instructions]. Your first question comes from the line of Paul Cuddon from Numis Securities.

I've got two questions initially please. And firstly, on the sort of reconciliation between the patients sort of in treatment, growing around 16% from the end of 2021 to the revenue reported revenue growth, to what extent is that a sort of late Q1 increase in patients that are just starting out? So, essentially, new patient capture versus an average patient number? If you could start with that one first, and then I can pick up on the next question after?

Listen, I think that this is a small difference of a couple points between the two, and they're generally highly correlated, as you can see, between both patients, dispenses, and the revenue lines. So, we're really super pleased if you look at the strategic progress, as well as the execution that the team has delivered as they started off Q1 on SUBLOCADE.

Net revenue per dispense, those in the US seems to be holding up pretty well. But I don't want to over read this. Do you think there could be changes up or down as the year progresses that we should be aware of?

Listen, I think, Paul, as we look at the US market with regards to SUBLOCADE, it's a relatively stable pricing environment with regards to where we are. We have good coverage, good access, and have our continuous sort of patient program with regards to buying down copays in the market. We took a gross price increase of about 5% in January. So, that should be factored in on the year ago sort of metrics on a net basis, and continue to just drive and execute across the fundamentals of our organized health system strategy.

If you don't mind, just one quick one on the Aelis pharma assets. If I were looking at the Phase 2a data, the one thing I would say is that it does seem to be quite a sticky drug. So, the daily dosing regimen, do you think that's going to be the right approach kind of heading into later stage trials?

Yeah. I think, first of all, we are super excited about it, as I said in my comments and expect that first dosing here in Q1, but I'll hand over to Christian who's here to talk us through a bit of the scientific sort of endpoints and thoughts on the asset itself.

Aelis will embark on a Phase 2b. As you know, we are expecting first subject, first visit in the second quarter. Based on the preliminary data or the Phase 2a showing a decrease in the subjective effects of cannabis and a decrease in self administration, we are proposing to really test the three doses of the Aelis compounds once a day for 12 weeks. And we are going to look into the proportion of subjects with a response of less than one day of cannabis use per week compared to placebo. And then, as a secondary objective, we will investigate the proportion of subjects that reach various levels of reduction of use and, very importantly, how this influences their quality of life. And then, of course, on top of that, we will continue to monitor the safety and tolerability of AEF0117. So, quite exciting time for this progress with collaboration with the Department of Psychiatry at Columbia University.

Your next question comes from the line of Thibault Boutherin from Morgan Stanley.

Just a couple. The first one, what are the kind of next key pieces of legislation to watch in the US that could provide further support to your business and to kind of opioid addiction treatment in general? And maybe a second question, on the ANDA litigation, if you could give us a bit more color on the mediation process and what can be expected here in terms of potential resolution and just potential for resolution, in general.

I think the first question, Thibault, you broke up a little bit, but was what are the next keys in the overarching US market that will continue to drive…

Sorry, it was about potential legislation that could pass and that could provide support for the business in terms of if there's anything that you're watching in the pipeline of – in terms of potential legislation that could change the situation.

Legislation, okay. I apologize. So, I think in the overall US market, opioid epidemic is just a huge – there's a huge unmet need. There's a treatment gap of 80% where only 20% of people that suffer from OUD actually get any form of treatment. It's a truly bipartisan issue that we're seeing across both aisles in the administration, and we continue to see this get focus from a funding standpoint and there's legislation that's in Congress that has to do with addressing treatment where patients are most able to get it, specifically the Medicaid Reentry Act that's sitting in Congress and we're hoping will gain some momentum as we move into the second and third quarter of the cycle. Additionally, you've seen some things that have popped recently with the administration's position on addressing the opioid epidemic as well as with the increases in fentanyl use, over 80% of the deaths of fentanyl, we're having the first fentanyl day in the US to increase awareness and that is in May. And so, I think all of these things in a disease space where awareness of treatment, the stigma associated with the disease and this huge treatment gap that exists that we think will fuel treatment and the growth of treatment moving forward, we think these are all positive momentum that will hopefully decrease the stigma and open up treatment broader. With regards to litigation and the mediation in the ANDA, listen, I think nothing has really changed there. We're looking to have that – that gets scheduled and take place and we'll see where that takes us moving forward and will comply, of course, with the court order. But our legal team and our external advisors are working on that actively.

Your next question comes from the line of Max Herrmann from Stifel.

Three, if I may. Firstly, just on SUBLOCADE, obviously had a good quarter, can you give us a bit more color in terms of the underlying – I think you mentioned maybe there was a bit of stocking in the number. Can you quantify that? And then, just in terms of the ex-US kind of rollout of SUBLOCADE, how that's progressing and what new markets are you looking at this year? Secondly is PERSERIS and then I'll ask those later.

Listen, I think with SUBLOCADE, Ryan spoke to really two effects. There was stocking in Q4 and then there were some one off trade releases in Q1, that really those impacts offset each other, kind of $4 million to $5 million. So, the growth that's there is relatively clean, albeit both periods are elevated a bit with one-offs when you look at the actual underlying. So a very, again, strong quarter as you look at dispenses, you look at patient acquisition, and you look at growth quarter-over-quarter, which is which is clean, albeit bases on both side are inflated with one-offs. From an ex-US standpoint, we're really pleased with the continued growth and progress there. As you know, we're in our Australian, Israel and Canadian markets, and continue to see quarter-over-quarter and year-over-year growth. As we look to other markets in the back half of the year, Q4, and beginning of 2023, as we as we get reimbursement and approval and start to supply those markets, we'd look to enter those and offer patients, who are suffering from opioid use disorder, our kind of paradigm shifting treatments. So we're excited to get into those new markets as we move forward.

Secondly is on PERSERIS. Obviously, had expected that we might be seeing a little bit of acceleration in prescription trends, given the expansion of the sales force is pretty significant, doubling or more than the rep promotional effort. So what's holding it back? And do you still see this $200 million to $300 million opportunity, given the headwinds that you're experiencing?

Let me just start with – listen, I remain confident in both our fiscal year guidance of the $30 million, as well as our peak net revenue guidance of $200 million to $300 million that we've shared with folks. Our first quarter was in line with our planning assumptions. We have expanded the national launch, and they've been in the field since Q1, which is leading to signs of renewed growth as the Omicron sort of restrictions subside. But these are leading sort of indicators as the national team gets embedded with their optimal sort of reach and frequency in the platform to drive that growth. It's leading to both growth in unit volumes, as well as number of HCPs as we exit the quarter and enter Q2 and higher demand for HCP requested samples in both inpatient and acute care psychiatric facilities, as well as outpatient clinics. So, it's these things that along with the continued full national exposure throughout the year that we have confidence that the growth will start and we'll hit our target for the year as well as the peak net revenue guidance of $200 million to $300 million.

My final question is more strategic. Totally appreciate that – as you want to focus your attention on SUBLOCADE and, to a lesser extent, PERSERIS to make sure you achieve the objectives you've set for those products. You obviously still have and are generating significant amount of cash. From a strategic perspective, when do you think SUBLOCADE will be established enough so that you might be able to look at broadening the business perhaps through an M&A sort of type and maybe bringing some other assets on board?

Listen, I think here, I think we are focused on really driving the momentum on SUBLOCADE, not distracting the team from that. And while we don't expect to pursue material M&A this year, with that continued momentum, we do see it as a logical next step towards diversification and shareholder value creation and it's one that the Board and management are spending time as we move forward. So, we'll look to it. No time sort of guidepost on that because you know how M&A works in these spaces, but it's one that we're strategically turning to as we move ahead.

Your next question comes from the line of James Stein [ph] from Jefferies.

It's James Vane-Tempest from Jefferies. Couple of questions, please, just on SUBLOCADE. What is the average duration patients take SUBLOCADE for? And I guess, when people stop taking it, how much of it is just due to them relapsing or versus affordability issues? And then, my second question is thinking about the opportunity of SUBLOCADE in the criminal justice system, how much potential also is there in drug courts? And how would you envisage the pricing dynamics evolving, given a potential uplift in volumes in that scenario?

I think, first, on average duration with SUBLOCADE, the average duration is in the five to five-and-a-half month range with regards to that. I see this as kind of a normal sort of exploration. I don't see it as an affordability issue. When you look at SUBLOCADE, we have excellent coverage approaching 90%. We have a very solid copay program that buys down copays to $0 for patients, which makes it quite competitive with even the orals on a patient affordability standpoint. So, we don't see affordability as a major barrier. And we think this is a transition with five to five-and-half months where you've seen Christian – science that he and the team have delivered with the RECOVER study that talks about the higher chances of staying in recovery when you stay in treatment for 12 months or more. And I think this is just an evolution that that will hopefully occur in the disease space as stigma drops off, as normalization of treatment occurs and people realize that given you typically abuse for six or more years before you enter treatment for the first time that getting off treatment should not be your first priority. So, that's a little bit with regards to the duration of treatment. As we look to the SUBLOCADE opportunity in criminal justice, I agree with you, we're focused on both facilities and expanding into drug courts. We think both of those are a great entry point where patients are motivated to enter treatment and get on their recovery journey. As we've talked, 60% to 65% of patients go through the criminal justice system at one point in their journey. So, we agree with that. As it relates to pricing, we built in the criminal justice system with regards to our guidance as we move forward, but, obviously, that that pricing is more like a government channel than it is a commercial sort of channel sort of pricing environment as relates to [indiscernible].

Just one more follow-up if I can. I know you've talked about a couple of times on this call, but just for clarification, so the destocking and the stocking seen in Q4 and Q1, you mentioned sort of $4 million to $5 million in Q4 and the same in Q1. Just wondering, the stocking in Q4, was that fully destocked in kind of Q1? And how should we think about that in terms of what the real kind of underlying growth is? Because I didn't quite completely understand the parameters you were saying in terms of where the underlying growth is versus the stocking/destocking elements.

Just to clarify, so in Q4, there was stocking of about $4 million worth, which we call is price speculation where the trade does increase your inventory. In Q1, the one-off was related to trade spent benefit of $4 million. So, when you back those two one-time events out of the base and also Q1, your underlying net revenue growth was up 14%, which is in line nicely with the US dispense growth, which was 14%. So, net-net, the volume – the underlying baseline that you should be focusing on is the 14% growth quarter-over-quarter. And the destocking that could have happened has not, but we think that's because the increase in demand is at the level now that they did not need to destock and needed the product to fulfill orders going on in the future.

Your next question comes from the line of Peter Testa from One Investments.

I have a couple of questions on marketing channel for SUBLOCADE. I was wondering if you could give a sense on the OHS traction. You talked about the numbers, you talked about increasing focus on depth. Is there any understanding you can help us with on how that depth progress is going, i.e. number of doctors prescribing, first time number, regular, these sorts of things to get some understanding how the OHS channel depth program is going?

Listen, organized health systems, we continue to make great progress. And they're driving over 75% of the growth and represent in excess of 60% of the revenue for SUBLOCADE. So, really, truly, this is a strategic channel in which we've really focused more is driving the vast majority of the growth and the increases you're seeing. So, the numbers that are represented when you talk dispenses and you talk patients are being driven by the organized health system. Now, as I think to depth in the organized health systems, we obviously are coming in on our 500 parent organized health system target to get access of a script in those. And the growth is really across three different vectors moving forward. Each of those parents have satellite sort of sites. We call those children. We need to gain access to those to get the full benefit of each of those organized health systems. Then we're looking to have more physicians get first time prescriptions. Obviously, those are growing through time. And we're looking for depth of prescribing with regards to prescribers moving forward. So, all three of those sort of dimensions of growth are what give us confidence in the short and the medium and the long term with regards to the $1 billion plus guidance that we have.

Are you able to provide any understanding on those three? Has there been any progress made, maybe just looking over past 12 months, or any period you'd like to give, so we can understand how that depth part is going?

We've not carved those out to date. I think the key metrics that we see that really show the progress because 90% of our platform is in the organized health systems are truly the dispenses and the patients as we move forward, but we can give some consideration to that, Peter.

Just a question on the justice system too, on the justice system. Can you give any sense on patients, how the patient numbers you've given, to the extent to which the patients have been originated in justice system during Q1?

We've not given out specific sort of patient sort of information, but what we are seeing is sequential growth in systems that are activated, which means that you're getting to the – with an activation, you're getting to a dispense in those channels. And obviously, we're focused on that top 1,000 criminal justice systems, unique criminal justice systems across the US, and we've got prescriptions in over 100 of those at this time. And I think one of the things that we're proud about is that the Q1 dispenses already to date are almost in the range already of what we had in all of 2021 combined, so absent the large one off order we had in Q2. So, you can see we're getting some accelerated growth in those channels. And for us, the key with criminal justice system, because these patients that are in there are typically in shorter term offenses, getting a patient in treatment there is also a patient who will then transition into potential organized health systems while they stay in recovery.

And the other question that you mentioned the pricing and justice system was sort of more government type pricing. When you think of total at an EBIT margin level, technically kind of different marketing and support requirements, is there much difference between a patient coming through the justice system versus coming through OHS?

Well, again, I think when you think of absolute pricing, it's more government channels. So, organized health systems have both commercial payers as well as government payers. So, there's a blended mix. Whereas the criminal justice system is predominantly a government mix. So, what you're talking about is lower overall net pricing. And really, then, when you look at criminal justice system, while there is some marketing activities on materials and those sorts of things, we have – I think we talked last year, we've increased to about a 20-person team that's focused on those areas. So, we don't disclose the actual product or the P&Ls by channel, but that's a little bit of insight to help you with your question.

I guess the question is, is it much different to NOC [ph] because you have all the educators and other factors that go through OHS that's quite sales force and support staff intensive. I didn't know whether there's much difference. But okay, fine.

Yeah, we don't break it out that sort of granular level because of…

Your next question comes from Paul Cuddon from Numis Securities.

Just a couple more for me. And I appreciate this is going to be difficult as the year progresses, but sort of current exchange rates with Sterling, you're getting a lot more kind of raw material for your dollar these days. I'm just wondering whether we should be thinking of sort of gross margin impacts for the year. And then whether you're starting to see any sort of inflationary wage inflation, given the sort of prevailing sort of economic climate that we should be factoring in.

We certainly have factored in those variables into the guidance that we did provide, and feel comfortable that we have appropriately managed that through the metrics. What I would say is majority of our cost base on the SG&A side is really personnel. And we manage those through your typical merit increases and have done fairly well in regards to headcount retainment, and so we're not seeing a lot of risk at that point. And then, when you look at our cost of goods sold line item around inflation there, we are lucky that the primary product in the cost of goods sold is the raw material from buprenorphine, which is quite manageable at this point in terms of the inflation on that item. We are certainly seeing inflation for power and for some supply costs, but those are small components of our overall costs. So, net-net, we feel that we're in a good position. We're going to continue to monitor it during the first half, and then see how it plays out as we get into the second half.

Your next question comes from the line of Max Herrmann from Stifel.

Just a single follow up question from me as well, which is just in terms of the physicians that are prescribing, SUBLOCADE, do you get a feel for kind of how many, let's say, patients are on their books and, let's say, on average, what sort of number of patients they see as suitable for SUBLOCADE versus the dailies? And so, just give us an idea of what sort of proportion you're getting to in accounts that are or doctors that are prescribing?

That's a great question, Max, and it's one that obviously when you're in the launch mode we're in is developing through time as physicians become more experienced in SUBLOCADE and continue to see the breadth of patients that are suitable for it. So, there is no end point with regards to that. What we do see is that, in the organized health systems, the physicians that start to prescribe, prescribe faster and with a deeper number of patients per HCP than in our original call platform, and we've seen a significant increase in the number of HCPs that have five or more patients and are more higher adopters over – since we've shifted into organized health systems. So, we're making good progress on the deeper adoption, but the percentage of patients suitable for this is tough to play out through the actual prescription. So, that's one that will play out through time.

And your next question comes from the line of Peter Testa from One Investments.

Just one quick question on R&D. Given the phasing is obviously lighter in Q1, I was wondering if you could just give us any sense as to how we think about R&D spend phasing in the rest of the year, but any particular high or low quarters we should think about?

No, that's a fair question. And we are certainly excited and look forward to the programs really ramping up starting in Q2 and then we're going to see the acceleration of those investments that we talked about last year. So, I would anticipate high activity Q2, Q3, and even into Q4 across the three categories. One are the other studies and trials on SUBLOCADE. The second are the investments we're putting behind the increased capacity to manufacture SUBLOCADE. And then the last is the continued support of the other assets that Mark did discuss in his script today.

Thank you. I will now hand the call back over to Mark.

Thanks again, Sharon. And that officially closes our first quarter results call. Appreciate the continued interest and support in Indivior and we look forward to seeing everyone at the upcoming conferences. Have a great day.

Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect.