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spk01: Good morning and good afternoon, everyone, and thanks for joining us. With me today to discuss our third quarter results are Ryan Preblek, our Chief Financial Officer, and Dr. Christian Heidrieder, our Chief Scientific Officer. For today's call, I'll provide an overview of the strategic progress, after which Ryan will detail our financial performance and our 2022 guidance, and then we'll move on to Q&A. Turning to slide three, I'm going to assume that everyone has read the forward-looking statements. Turning to slide four, in the third quarter, we continue to see strong year-over-year and sequential growth in Sublocade. This important treatment reached a new milestone in the quarter, crossing the $100 million mark for the first time in the third quarter to deliver $108 million in net revenue. Sublocade's strong performance was the main driver of our top and bottom line growth in the period. As in the past several quarters, This performance was driven by the growing presence in the organized health systems channel. We're very pleased with the progress of Preceris in the quarter, with net revenue up 14% sequentially and 60% versus last year. Importantly, we saw an encouraging uptick in unit volume and net revenue contribution from the new sales territories where we've expanded our presence. Based on our performance year to date, together with the progress we're making against our strategic priorities, We're confident we will deliver a strong finish to the year. We've now narrowed our fiscal year 2022 guidance for sublocate to the higher end of our previously communicated range, and we've increased our expectations for total net revenue and adjusted operating profit for the group. Ryan will provide a little more detail in a moment. Clearly, the macro environment remains challenging with the geopolitical climate, as well as decelerating economic growth and inflation across our markets. In this regard, our strong financial position with over a billion in cash and investments continues to provide us flexibility. Finally, on this slide, we're pleased to have received overwhelming shareholder support for the additional listing on a major U.S. exchange. We believe this important initiative will be beneficial in raising the group's profile in its highest value market and potentially attracting a broader group of biopharma-focused investors and analysts. In preparation, we executed a five-for-one share consolidation earlier in the month, and we're working at pace to affect the additional listings spring of 2023. Turning to our strategic priorities report card on slide five, our go-to-market strategy has now driven nine consecutive quarters of double-digit increases in Sublocade net revenue and patient dispenses. The organized health system channel continues to be the predominant driver for Sublocade, generating approximately 75% of the growth. As we highlighted on our last quarterly call, we've reached our goal of activating the top 500 key organized health system accounts earlier this year, and the primary focus of our strategy now is to increase prescribing depth within our activated organized health systems. Where we have clear line of sight, we're tracking our progress against a number of metrics, including the number of new prescribing physicians and those prescribing more than five patients, which in our experience signals treatment adoption. I'm pleased to report that both KPIs grew solidly versus the prior quarter, indicating we're making real inroads into prescribing depth. As you're aware, we've carefully targeted investment where we see the biggest opportunities to extend Sublocade's leadership position as a long-acting injectable for treating opioid use disorder. For example, we formed a dedicated team to access the criminal justice system. We bolstered our medical science team to educate physicians on the science of medically assisted treatment broadly and sublocate science more specifically. And we remain on schedule for a second manufacturing site to increase capacity for sublocate and perceris. If I turn to revenue diversification, I'm pleased to report continued progress for sublocate and suboxone film outside the U.S., Net revenues for Sublocate in international markets was $7 million in the quarter. And we're pleased with the initial Sublocate Suboxone film net revenue in Europe. The combined impact of these launches is helping us to largely offset the declines we see in the legacy tablet business. Over time, we continue to expect this dynamic to return us to net revenue growth outside of the US. For Preceris, as I alluded to earlier, we're seeing sequential pickup in performance driven by our investment in national sales coverage and strong quarter-over-quarter and year-over-year growth. We did see a short-term disruption in sample supply leading to allocation of samples in the third quarter, which will be alleviated in November. However, based on the significant patient need, the differentiated product profile that Preceris offers, we remain convinced of its net revenue potential of $200 to $300 million. Regarding the pipeline, Here, our focus is on strengthening the evidence base for sublocate and progressing our innovative early stage approaches to a range of substance use disorders. On the latter, we continue to be very excited by the potential of AEF-0117 to transform the lives of people with cannabis use disorder. As you're aware, the Phase 2B clinical trial of this important asset is now underway, and we are very much looking forward to the full result readout in 2024. Finally, on our operating model, we've maintained our focus on prudent cash management and asset optimization so that we're able to both fully invest in our number one strategic priority, sublocate, as well as continue to execute on our second 100 million share buyback, which is about two-thirds of the way complete. On that, during the quarter, we bought back over 10.2 million shares on a pre-consolidation basis as part of our second 100 million share repurchase program. This brings the total on the second buyback program to 66 million at the end of September. Even after this outflow, we ended the quarter with a healthy gross cash and investment position of over a billion dollars and net cash and investments of close to 800 million. To summarize, this was another strong quarter of execution and delivery against our strategic priorities. As we look to the remainder of 2022 and beyond, we're confident we have the right strategy, the right products, and the right team to deliver on our mission and our long-term growth objectives. We look forward to sharing more detail on our long-term shareholder value creation plans as part of our upcoming investor day on December 7th in New York City. With that, I'd like to hand over to Ryan to take you through the financials for the quarter in more detail.
spk00: Thanks, Mark, and good morning and good afternoon to everyone. I'm pleased to report another good quarter of financial execution and business momentum. We delivered excellent top-line growth driven by the strong performance of Sublocade. Our adjusted operating profit also increased versus the prior year, reflecting results from the growth investments we made to support the success of Sublocade and Paceras. We also maintained our disciplined approach to capital allocation, balancing reinvestment in the business with shareholder returns as we progressed with the share buyback program we announced in April. We once again exited the quarter with over a billion dollars in gross cash and investments, providing us tremendous flexibility. I'll now provide some more detail on the performance drivers in the quarter and discuss our outlook for the remainder of the year. Starting with top line, total net revenue growth was up 24% versus the year-ago quarter and by 27% at constant exchange rates. For year-to-date results, total net revenue grew 16% versus the same period last year, and by 18% at constant exchange rate. The increase in total net revenue throughout 2022 was mainly a function of strong sublocated growth in the U.S., but we also continue to see growing contributions from Becerras and from sublocated markets outside the U.S. By geography, total U.S. net revenue grew by 32%. versus the prior year quarter. Net revenue for the rest of the world returned to growth this quarter and was up 9% year-over-year, excluding unfavorable FX impact. Sublocated net revenue outside of the US grew 75% year-over-year to $7 million, continuing to help offset the ongoing pressure from generic competition in the legacy tablet business. While the rest of the world net revenue results continues to be impacted by the strong U.S. dollar relative to other currencies, the overall bottom line income impact is mostly mitigated by corresponding expenses which carry a similar negative FX adjustment. Total sublocated net revenue of $108 million and $290 million for the third quarter and year-to-date Q3 2022 respectively. puts us on track to be at the upper half of our previously revised guidance, or $405 to $420 million, as we noted in our press release. Sequential net revenue growth for Sublocade was 10% and generally aligned with dispenses when you exclude the impact of FX. Moving to Paceras, net revenue of $8 million was up 60% versus Q3 of last year, largely driven by the rollout of our new national sales team earlier this year. Sequential net revenue was up 14% and was impacted by some sample limitations Mark had mentioned earlier. We recognize that Perseverance net revenue continues to be off a small base, but nonetheless are encouraged by the growth in Perseverance on a number of internal demand metrics and positive prescriber feedback. Turning to Suboxone film, the average share of approximately 19% in the third quarter was essentially flat from the prior quarter's average share of 19. As a reminder, we do not promote Suboxone film in the US. I will discuss film share guidance for the remainder of the year in a moment. Moving down to P&L, our third quarter adjusted gross margin was 83%, flat from the prior quarter and down from 86% in Q3 of last year, reflecting a higher mix of less profitable government channels for Suboxone film in the US and some cost impacts from inflation. Like other companies in this environment, we have seen elevated costs for labor, logistics, and services in our COGS as well as our OPEX. However, the overall impact for us has been manageable this year and has not required a change in guidance in these impacted areas. We are, however, closely monitoring these inflationary impacts and are actively making offsets where possible without disrupting the business. Our adjusted overall operating expenses were $133 million in the quarter, an increase of 8% versus Q3 of last year, reflecting the growth investments behind the LAIs and the phasing of our R&D initiatives to the back half of the year. As you all have noted, Q3 R&D increased 42% versus Q2 as expected. Moving to adjusted operating profit, we saw solid results versus the prior year, with operating profit of 58 million in the third quarter, up 53% versus Q3 of last year. For year-to-date through Q3 2022, adjusted operating profit of 172 million was up 11% versus the same period in the prior year. Lastly on the P&L, our adjusted net income of 43 million increased 59% in the third quarter versus Q3 of last year. For year-to-date through Q3 2022, our adjusted net income of $130 million increased 14% versus last year, reflecting the dynamics I just highlighted. Quickly touching on the balance sheet and our capital position. As I mentioned, we ended the third quarter with gross cash and investments of $1.35 billion. Included in that balance is $64 million of collateral returned to us from the settlement we reached with Dr. Reddy's last quarter. Year-to-date cash generation from operations excluding the $64 million return of collateral in Q3 and the $108 million in litigation settlement payments in first half was at $107 million. I will now discuss the adjustments we are making to guidance for full year 2022. For Subacade, we are narrowing the net revenue range to $405 to $420 million. This represents the upper half of our previous net revenue range of 390 to 420 and is based on a strong year-to-date momentum and our continued strong progress in the OHS channel expected in fourth quarter. On Suboxone film, as you are aware, the FDA approved a fourth generic film competitor in June, which increased the level of uncertainty in what has been a relatively stable market over the last 18 to 24 months. At this point in the quarter, a fourth generic has not launched. As a consequence, we now assume that any potential launch impact is considered in our upwardly revised total net revenue guidance for the current year. We will continue to assess the competitive environment and will update the market accordingly. Turning to the total operating expenses, we are maintaining our guidance of $520 to $540 million. We have, however, chosen to reallocate some new anticipated underspend in R&D towards incremental marketing behind Sublicate. As a result, we are raising our SG&A guidance range by $5 million to $445 million to $460 million. These incremental commercial efforts will continue to support and expand Sublicate's leadership and position us for further growth as we move into 2023. to $80 million still anticipates a sequential uplift in expense in fourth quarter for sublocate, post-marketing requirement and lifecycle management studies, sublocate manufacturing capacity expansion, and early stage asset advancement. However, some components of these important studies will now phase into 2023. Taking these factors together and considering continued FX pressure we are narrowing and increasing our overall net revenue guidance range to 890 to 915 million. We also now expect adjusted operating profit to be modestly higher than our prior guidance given the resultant impacts on our P&L. Let me close by saying we are pleased with our execution and our financial results for the quarter. We believe our year-to-date performance puts us solidly on track to deliver strong full-year 2022 results. We are confident that we can deliver our full-year revised guidance and look forward to seeing investors at our Capital Markets Day on December 7th in New York City. I will now turn the call back over to Mark for some closing comments.
spk01: Thank you, Ryan. Once again, I'm extremely pleased with the team's execution against our strategic priorities. Our go-to market strategy on Sublocate is working and 75% of our growth is coming from that channel, and our current midpoint of fiscal year guidance is marking just over 40% progress towards the billion dollars in sales. We continue towards adding an additional U.S. listing next year and are extremely excited for our Capital Markets Day in New York in December, where we'll provide more detail on our roadmap to delivering sustainable shareholder value. With that, I'll turn the call over to Sarah to manage questions and answers.
spk03: Thank you. As a reminder, if you would like to ask a question, please press star 1-1 on your telephone and wait for your name to be announced. We'll now take our first question. Please stand by. This is from the line of Thibault Boutaran from Morgan Stanley. Please go ahead.
spk02: Thank you for taking my questions. I have a couple on sublocate. First question, could you give us a rough idea of the market share of sublocate right now in terms of patients within the BMAT category? And second question, when we think of the different components of growth for sublocate going forward from a top-down perspective, there is an unfortunate increase in the pool of patients due to the acceleration of the pandemic. There is potentially the increase in the proportion of patients treated and then the market share of sublocate. So just if you, you know, when you talk about the mid to high single digit growth in the BMAT market, you know, could you just help us understand how much is just patient growth and how much is potential increase in the treatment penetration? Thank you.
spk01: Thibault, thanks for that. I think on Sublocate, you know, there's such a tremendous unmet need here, and I think it really combines kind of both of your questions. The first is the market share now, we're still in such an early days of the launch of our organized health system strategy. Remember, we just pivoted to that two years ago with a reorganization to the ecosystem model. We've seen tremendous growth with double digit quarter over quarter growth over the last nine quarters, and despite that, we still only have about a three percent patient share of the market. So it's early days. There's tremendous opportunity for this asset to continue to help patients in their journey towards recovery. The market side of this disease space is hugely unfortunate and really represents, you know, how the opioid epidemic has just continued, you know, to propagate here in the U.S. You know, if you think about it, there are over 10 million people that abuse opioids here in the U.S., You know, over 3 million have been diagnosed with opioid use disorder, and less than 20% of people are in treatment. So I think as you think about the growth of sublocade, the market will continue to grow, you know, and there's a huge, huge ability for that to grow from more patients entering in treatment, even if the disease doesn't grow specifically because of that low treatment penetration, you know, of less than 20%. And then I think when you think about the market share of Sublocade, absolutely, you know, as we continue to bring this paradigm shifting treatment into the market, build more awareness, we expect growth to come through more patients utilizing it on their recovery journey. So we expect kind of growth on both sides of the market as well as Sublocade awareness and penetration. Thanks, Thibault.
spk02: Thank you.
spk03: Thank you. We'll now take our next question. Please stand by. This is from the line of James Bain Tempest from Jefferies. Please go ahead.
spk04: Hi, thanks for taking my questions. Two if I can please. Firstly, just looking at the trend quarter on quarter growth for sublocate and looking to what I guess is the upper end of your guidance. That implies a pretty big step up in Q4. So I'm just kind of wondering if the businesses, you know, historically done, you know, plus or minus 10 million sequentially a quarter, you know, what gives you the confidence potentially, you know, looking at full year, we could maybe nearly double that on a full year, but on a Q4 basis to, you know, roughly 20 million. My second question is, again, just around market dynamics. I appreciate we've got to wait till probably next year to get guidance for 2023. But when you look at sort of the momentum of growth that you're seeing, Are there any sort of low-hanging fruit, which you've kind of been able to get this year, where we should expect slower growth next year? Or given the market dynamics you've kind of laid out, is the level of growth you're seeing potentially sustainable as we get into next year? Thank you.
spk01: Thanks for that, James. And listen, I think we are extremely pleased with regards to the continued strong quarter-over-quarter growth. Have a lot of confidence in the guidance range that we've given for the full year. and carrying that momentum into Q4. So we expect to deliver on that guidance. When I start to think about the market dynamics, well, we'll guide on 2023 in February. We will talk about, at a capital markets day, a little bit more in depth with regards to sublocated, the go-to-market model, the bipartisan nature of this disease space, which we expect all of those things coming together to continue to drive that growth moving forward. So it's those dynamics all combined that just continue to give us conviction behind the billion-dollar-plus of peak net revenue guidance we have for sublocated.
spk04: Thank you. If I can just ask a follow-up just on the first point. I completely understand the confidence in meeting guidance, but is there anything which would suggest there could be a potential inflection in Q4 or kind of higher sequential growth in Q4? Just wondering if there's any potential new contracts coming up or anything like that which could suggest a larger sort of sequential Q4 improvement specifically?
spk01: James, I think it's just continued delivery on the operating model. And there's normally some Q4 dynamics ahead of the year end and ahead of price increases that sometimes has modest impacts on stocking. But we have confidence, again, in delivery on the yearly numbers that we've given.
spk04: Thank you.
spk03: Thank you. Well, now I'll take our next question. Please stand by. This is from the line of Max Herman from Stiefel. Please go ahead.
spk06: Thanks for taking my questions and congratulations on another strong quarter. A number of questions, if I may. Firstly, just trying to understand a little bit on the gross margin. I appreciate that suboxone in the Medicare and Medicaid channel is low gross margin, but I was expecting given the strength of sublocate and the high gross margin nature of that product that you might have seen a bit of an improvement so just trying to understand that uh um i'll leave the status the first question and follow up with the others okay um i'm going to go ahead and ask ryan to to take you through kind of the the gross margin expectations yep so no that's a fair question and we were in line with where we expected the gross margin uh to
spk00: to play out for the quarter. We certainly do expect, as Subicade becomes a larger contributor of the business, for the margins to expand. It's just right now you're still seeing the impact of the large contribution coming from the less profitable film. And on the back end of that, we are seeing some cost pressures as well due to inflation. But net-net, we're right in a position where we thought we'd be at this point.
spk06: Right. Then just a couple of more finance questions and then focusing on sub-decades. So just I wonder in terms of the tax situation for 2023, have you got an idea there? I know you don't want to give guidance for the full year, but I just wondered on the tax situation that seems to be picking up in the group and what the likely potential benefits are from the patent box on sub-decade. the tax side and then just um on sublocate itself a couple of questions one is um get a bit more color on your ohs experience so obviously appreciate the dispensing benefits within the large hospital which may be the center of that ohs but i wonder how the trickle down into the clinics that uh operate within the OHSs, how you found your experience with Sublocade in those networks. And finally, just on SublocadeXUS, could you update us on the launches? I know you obviously launched in Canada, Australia, and Israel. I know you were planning to launch over the coming months in other European territories now. I wondered whether you had an update on that. Thank you.
spk01: Okay. So, Max, I think I'll start with the sublocate and then hand over to Ryan to give a little bit of color on tax without guiding in 2023, which, of course, as you mentioned, we'll do in February. The color on the organized health system, I think, remains as we've been talking. We've gotten access at the parent level, and now it's about depth. It's about opening up these children accounts within the parents now that the parents have authorized this controlled substance specialty pharmacy sort of product in. And that sell-in cycle, that acquisition sort of model is not as long as the parents that we talked about, which was nine to 15 months, but is actually probably more sort of quarters and not months. So that takes time, but what that does is it starts to open up more doctors and more patients. And as we've talked about before, the majority of doctors and patients you know, that treat opioid use disorder are in these organized health systems. So we're getting deeper access. And as I mentioned in my script, what we're seeing as we follow cohorts is, you know, we're getting deeper adoption through time with people that have started to prescribe the medication. So a very positive experience, but it certainly isn't a faucet that when something's open, you know, you get to max prescription. There is an acquisition process on those children organized health systems. Outside the U.S., we are in Canada, Australia, and Israel, as you mentioned. We continue to work at a country level with regards to reimbursement and launch plans. Still expecting here in the balance of the year to go to launch in the Nordics and looking towards Germany and other markets in Europe in 2023. And we'll be able to provide a lot more color on that in February. Ryan, would you like to handle the tax question?
spk00: Yep. So on the tax situation, certainly the first point I would highlight is it's been relatively stable over the last two or three years. Our tax rate is mainly dependent on the mix of business or tax locale in regards to where we're generating the net revenue. But that's something that we certainly monitor closely and plan accordingly, and the patent box benefit that you did mention certainly factors into our strategy as we go into every year. And one of the things we pride ourselves on is definitely keeping a loop in regards to what's going on with the tax changes both here in the US and the UK. So those are all the factors that we will build into our tax plan as we get into next year.
spk06: Thank you. If you don't mind, a follow-up question just to try and understand how the OHS systems are working within the clinics. I understand that obviously when you first launched, there were some challenges with getting opioid use disorder physicians to hold inventory and or to prescribe given they may have been in sort of like general psychiatry clinics. When you go to the hospital, you obviously have the pharmacy unit there, and that makes life easier for dispensing through a specialty pharmacy. I wonder when you get into the clinics within those OHSs, is that still the case, or are they then starting to come across that more challenging dispensing situation? issue that you had early on in the launch.
spk01: No, it's a great clarification question, Max. And I think you're right. At the big regional sort of parent centers, they obviously have pharmacies on site. They've got all the things to manage. And when you go out to the more satellite sort of children campuses, you still have the back office that helps with billings. They help with scheduling. They help with all these things. And then it can vary a bit within the various units. Some of them have pharmacies on site. Some of them are smaller and maybe don't. And so it can vary children to children with regards to those. Now, what we know is the experience from the network of specialty pharmacies and specialty distributors that we put together is extremely strong. You know, the days to getting medication, the prior odds, And the yield that comes through that, we've built a network that is extremely efficient. But there will always be, for smaller clinics that don't have pharmacies on site, there will always be a bit of friction just associated with a specialty product. And that's just a nature of this sort of drug. But when you're in the organized health system, predominantly, a lot of the friction points are removed. And what we see are people adopt sooner and adopt deeper with more patients per HCP than you see in other areas. So we're excited. It is still very early days in these organized health systems. Again, we're only two years into this. We've only got a 3% patient share. And so we look forward to continuing to partner with those organized health systems moving forward.
spk06: Great. Thanks very much, Monk. Thank you.
spk01: Thank you, Max.
spk03: Thank you. As a reminder, if you would like to ask a question, you can press star 1 1 on your keypad. We'll now take our next question. This is from the line of Paul Cudden from Numis. Please go ahead.
spk05: Hello, guys. Thank you. I have three questions, please. Just focusing on the depth of prescribing, I mean, do you think sustaining double-digit sequential growth that is possible into kind of 2023, quarter and quarter, Secondly, I mean, any stocking issues for the rest of the world business or do we think that's started to turn? And then sort of just a final question on sort of cash and the prevailing interest rate environment.
spk01: Certainly, Paul. I'll handle the first two if that's okay. I think you're talking about depth of HCPs prescribing. Listen, I can tell you I continue to expect there to be both additional new prescribers and additional depth. How that translates into the guidance for 2023, I think that's a great question when we get together in February with the fiscal year-end results and give our formal guidance for next year. But you can tell we have very strong momentum with regards to how we're moving forward. I think as you look to the rest of the world, and I think what you're getting to is Is, you know, obviously the underlying non-FX sort of growth this year is quite, this quarter is quite strong. Is there some one-off sort of items? You know, I think there's always a little bit of fluctuation quarter to quarter. And I think here, you know, we have to look towards our medium-term sort of guidance where we expect this to return to growth. There are heavy generic presence in the heritage business, significant austerity measures that many governments imply on this. in these markets, and what we look to is in the medium term to return this business to growth. So I think quarter to quarter there will be some fluctuations. Maybe what I'll do is hand over to Ryan to answer the questions you had with regards to cash and prevailing interest rates.
spk00: Yeah, so again, quite happy with the cash position we have. What it does is it gives us a lot of flexibility and optionality. to make quick business decisions as we move forward. Cash, at this point, as the environment is quite dynamic in the markets, it's something that gives us some protection that we feel good about. And in regards to the debt facility, again, that's just another way for us to keep the optionality open, provide maximum capacity. So we feel good where we are between our cash position and our debt facility going through these uncertain times.
spk05: Okay, thank you. With regards to the success that you're having with kind of now with the National Field Force, do you think that you'll always be committed to substance use disorder or do you see potential to deploy some of that capital into kind of more adjacent clinical indications?
spk01: Yeah, it's a good question, Paul, and I think one with regards to capital allocation that we continue to get. And I think, you know, we just remain incredibly consistent on how we think about capital allocation. you know, for Indivior. And the first priority is to reinvest in Sublocade to achieve the billion dollars plus. And then after that, you know, the board and management, you know, sit back and think about how do we create value for shareholders. And in the short term, you've seen we've done a couple returns of capital via buybacks. We're in the midst of our second $100 million buyback. And then we think about business development obviously items in addiction you know are the highest priority you know but we continue to continue to look you know with regards to those opportunities on a value sort of basis for shareholders super thanks very much thank you Paul thank you I'd now like to hand back to the speakers for closing remarks Thank you, Sarah, and my thanks to everyone for their time today and continued support of the Indivior team. I look forward to seeing everyone in New York City on December 7th. Thank you.
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