Good day, and thank you for standing by. Welcome to the Indivior 2023 Full Year Results Conference Call. At this time, all participants are in a listen-only mode. After the speakers' presentation, there will be a question-and-answer session. [Operator Instructions] Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Jason Thompson. Please go ahead.

Thanks, Evan, and good morning, everyone. Before we begin, I need to remind everyone that on today's call, we may make forward-looking statements that are subject to risks and uncertainties and that actual results may differ materially. We list the factors that may cause our results to be materially different here on Slide 2. We also may refer to non-GAAP measures, the reconciliations for which may be found in the appendix to our presentation that is now posted on our website at indivior.com. I'll now turn the call over to Mark Crossley, our CEO.

Thank you, Jason, and good morning and good afternoon, everyone. Thanks for joining us to discuss Indivior's fourth quarter and full year results. I'll begin with some opening remarks and a review of our growth strategy. Christian will then provide an update on our R&D priorities, following which Ryan will detail our financial performance and our 2024 guidance. Lastly, I'll provide some preliminary thoughts on the process we're initiating to consult on a potential primary U.S. listing in the summer of 2024. 2023 was another year of strong execution and performance by our team. Led by SUBLOCADE, our total net revenue increased 21% to approximately $1.1 billion and adjusted operating profit increased 27% to $269 million. This was our third consecutive year of double-digit top line performance and even after absorbing the incremental costs of the Opiant business and strategic growth investments behind SUBLOCADE, adjusted operating margins increased for the full year. We also made excellent progress against our strategic priorities to create a durable, addiction-focused franchise capable of delivering consistent value-creation for shareholders. I'll highlight the key milestones we achieved in 2023 in a moment. Looking ahead to 2024, we expect another year of strong net revenue growth led by SUBLOCADE. Taking the midpoint of our guidance, $850 million of SUBLOCADE net revenue implies 35% year-over-year growth, marking another major step towards our target of greater than $1.5 million in peak net revenue. This in turn supports the Group's expectations of fiscal year 2024 of delivering 18% overall net revenue growth and approximately 300 basis points of operating margin expansion, again both taken from the midpoints of our guidance range. Importantly, both our performance in 2023 and our outlook for 2024 are in line with the medium-term profitable growth framework that we committed to at our Capital Markets Day…

Thank you, Mark, and good morning, good afternoon everyone. As you can see, over the last year, our pipeline has expanded with several projects expected to reach development milestones in 2024. You may also note that INDV-4002, the intranasal naltrexone product for alcohol use disorder that came with our acquisition of Opiant Pharmaceuticals last year, no longer appears in our pipeline. INDV-4002 failed to meet its primary endpoint in a clinical Phase II study that had been initiated by Opiant. We have therefore decided to discontinue its development and prioritize our most promising project. Let me start with an update on our activities in the opioid use disorder and opioid overdose rescue. Our support to SUBLOCADE is fourfold. First, label updates with a focus on rapid induction and alternate injection body sites. We are currently planning for preapproval submissions to the FDA in the third quarter of this year with estimated approval in the first quarter of 2025 if priority review is granted or third quarter 2025 under standard review. Second, evidence generation and peer-reviewed publications, including additional Phase IV studies, externally sponsored studies, and real world evidence studies. Third, product optimization with the implementation of our oxygen absorber desiccant for room temperature and shelf life extension in the U.S., Australia, and Canada, as well as additional regulatory submissions. And fourth, access expansion in most of the world. Unfortunately, fentanyl use continues to rise across the U.S., with now more than 90% of opioid overdose deaths involving fentanyl and other synthetic opioids. Synthetic opioids have a more rapid onset of action than, for example, morphine and heroine and delayed intervention can produce diffuse brain damage and cardiac arrest. Therefore, the ability to rapidly restore normal breathing has become essential for a successful overdose reversal. We are currently supporting our intranasal…

Thanks, Christian. Good morning and good afternoon to everyone. I'm pleased to report that we delivered a strong financial performance for Q4 and full year 2023. I plan to touch on some of the highlights before spending most of my time on our outlook for full year 2024. At a high level, we reported total net revenue growth of 21% in full-year 2023, driven primarily by the 54% increase in SUBLOCADE net revenue. Adjusted operating profit grew by 27%, faster than our top line, despite the absorption of close to $40 million of Opiant operating expenses and OPVEE launch expenses. From a liquidity standpoint, we exited the year with $451 million in gross cash and investments. Looking at our financial performance in more detail, starting with the top line. Fourth quarter SUBLOCADE net revenue of $176 million increased 49% versus the prior year and 5% versus the prior quarter. U.S. SUBLOCADE net revenue also increased 5% versus the prior quarter, with expenses growing slightly higher at 7%. During the quarter, there were modest increases in trade spend related to a higher mix of the Medicaid business. For the full year, SUBLOCADE net revenue reached $636 million, putting us at the top of our range that we increased with our half one results. Moving to PERSERIS, full year 2023 and Q4 net revenue of $42 million and $12 million, respectively, both increased by 50% versus the comparable year-ago periods, although full-year results did come in below our guidance. Overall growth in PERSERIS was primarily driven by the expansion of the sales team completed in late 2022. Turning to SUBOXONE Film, average share in the fourth quarter was approximately 18%, down roughly 2 points from full-year 2022 average. As a reminder, we do not promote SUBOXONE Film in the US. Net revenue…

Thank you, Ryan. In closing, we announced today that the group is exploring the potential to transition to a primary listing of its shares in the U.S. Consultations with shareholders will begin over the coming weeks. If these discussions are supportive, the Board intends to put forward a formal resolution to shareholders in the spring that would affect a U.S. primary listing in the summer of 2024. We, along with the Board, believe that the U.S. is Indivior's most logical primary trading venue based on our current and future business complexion and opportunities. As you see, the vast majority of our total net revenue is generated in the U.S. Further, the U.S. is expected to increase as a proportion of the group's total net revenue, driven by our proprietary products, SUBLOCADE, OPVEE and PERSERIS. The U.S. opioid epidemic unfortunately only continues to worsen and we believe Indivior's treatments are a huge part of the solution. We believe a primary listing in the U.S. will further elevate awareness of the group's profile in the U.S. capital markets and will attract more U.S. investors and U.S. analyst coverage. Also, we believe there is value in U.S. index inclusion over time. Finally, our U.S. shareholder base continues to grow. We currently estimate that cumulatively almost 50% of Indivior shares are owned by U.S. shareholders versus over 30% for U.K. shareholders. That said, I do want to be clear that our intention is not to leave the London market. We think it's important for our U.K. shareholders to continue to have a liquid trading venue that is convenient to them. Our organization is prepared to take this next step. We have investments in place for the required capabilities, including reporting controls and legal to make the transition successful. There will be no material incremental costs in effecting and maintaining a primary U.S. listing. So in summary, the teams delivered strong underlying financial and operating results in fiscal year 2023 with significant progress against each of our strategic priorities. Fiscal year 2024 is shaping up to be an exciting year with our pipeline initiatives and our listing evaluation. Our overall 2024 financial guidance is strong and supports our plans to deliver material operating leverage. We look forward to communicating our progress as we go through the year. With that, I'll go ahead and open up the call to questions and answers.

Thank you. [Operator Instructions] Our first question comes from the line of Thibault Boutherin of Morgan Stanley. Please go ahead. Your line is open.

Yes. Thank you very much. First question on OPVEE, please. So, $15 million to $25 million guided, of which $8 million on the BARDA contracts. Just wanted to know if you could comment on the initial kind of launch dynamic outside of BARDA. Any commercial challenge you're facing and you're seeing on the market, and if you could give us more on the strategy to overcome that? And just generally more color on the situation on the ground would be helpful. Second question on business development. So you reached a point where you probably are well advanced in the integration of Opiant. Just wanted to kind of assess your appetite for deals now and the kind of specific therapeutic areas you're looking at. If your thinking has changed at all here. And maybe just last one on the aseptic manufacturing facility. If you could remind us the kind of impact on P&L and cash flow this year, in the next couple of years, when will it breakeven and then be margin accretive would be helpful. Thank you.

Thanks, Thibault. I appreciate the questions and I think I'll answer the question on OPVEE and business development. Then I'll hand off to Ryan to talk through our new manufacturing site sort of implications. So let's talk about OPVEE. First off, I think, we're exactly where we thought we'd be in this launch. As we talked last year, the initial stages are much more on the policy side to prep the market for a new rescue medication with a new active because most of the laws, the funding, are all constructed based on the existing paradigm of treatment, which is naloxone. So the work has been going there. We have standing orders in place in 31 countries. We've been working with those that provide grants and funding to enable all FDA approved medications to be available for grants. And we're working on protocols at the local level. So those efforts are in line with our expectations. I would also say that we've had some early adopters and have been very pleased with how the medication has performed in actual market versus the theoretical science that drove the actual acquisition. So it's good to see those starting to really lined up that the hypothesis is coming true in early adoption. So very excited for OPVEE's potential, not only in 2024, but as a paradigm shift for helping those who've been subject to opioid overdose. On the business development side, listen, I think 2023 was a major step for us, acquiring Opiant, acquiring a plant, and bringing in a couple of assets into our pipeline. As we look forward for our capital allocation, we have a consistent framework moving forward, but from a material M&A, we see 2024 more digesting what we have. So we don't anticipate material M&A in 2024, but we could at any time, look to tuck in any early-stage assets of addiction that Christian finds to be good mechanisms of action. So, we'll look to further sort of business development end of '24 into 2025.

Ryan, could you speak to the manufacturing facility and its impacts?

So first, it is really exciting to bring this new facility under the Indivior umbrella. We considered it a low-risk capital investment for $5 million to secure long-term product supply. The plant is already operational. We have assumed some of the contracts they had. If the contracts are at a loss due to the way that we've structured the deal, that goes on the balance sheet. So what we're dealing with is we've communicated we're going to have to invest about $40 million of CapEx over the next two or three years to get that facility prepared for SUBLOCADE. But then we've also communicated we may incur some modest margin impact over the next year or so, but the plan is to become productive and profitable within two years by the end of 2026, 2027, which at that point, we would see significant savings to the margins at that point. So, overall, very excited about this. And all these costs and investments aren't built into our guidance that we provided.

Thanks, Ryan.

Thank you. We will now take our next question. Please stand by. Our next question comes from the line of Max Herrmann of Stifel. Please go ahead. Your line is open.

Great. Thanks for taking my questions, and congratulations on a strong end to 2023. I've got a number of questions, so please bear with me. Firstly just in terms of SUBLOCADE and the potential longer term in terms of market penetration, clearly, you've now got another competing product, longacting injectable on the market. I guess, where do you see the impediments now to that market share expanding maybe beyond the sort of likes that we see with the analogs in the schizophrenia market and closer to where we see in markets like Australia and Finland? I wondered how and specifically prior authorization is being used by the insurers as an impediment for its uptake. We've been speaking to a number of clinicians and that seems to be one of the things we need to work with before they can use a SUBLOCADE or BRIXADI. That's the first question.

Okay. So, Max, listen, I think you're right. Historically, in the U.S., when you're looking at the use of longacting injectables, the adoption in Europe and other markets tends to be a bit higher and that's just across most longacting solutions. When I look to the future growth for SUBLOCADE and broader longactings in opioid use disorder, I think there is such a huge unmet need in this space. We have less than two in 10 patients in treatment. Adherence is the number one unmet need here and longactings still have a very small share, but are growing quite fast. And so plenty of room for multiple players in here and certainly we're -- when you look at Indivior, the true paradigm shift in treatment that SUBLOCADE offers with getting to therapeutic levels in 4 to 8 hours, maintaining those therapeutic hours or those therapeutic levels the full 28 days with no on top or booster dosing required, and therapeutic levels that create blockade of the opioid receptors with 2 to 3 nanograms per mil therapeutic levels of the 100 milligram dose and 5 to 6 nanograms per mil of the 300 milligram maintenance dose that for us we think are perfectly suited for the synthetic opioids that are in the market. So we see continued strong growth as demonstrated with the guide we gave on SUBLOCADE this year. And certainly setting the stage for us to get to our greater than $1.5 billion peak net revenue guidance that we have out there.

Great. Thank you. In terms of SUBLOCADE, obviously, you've identified or highlighted that the IQVIA data is really not representative of the performance and it's pretty small sample now of the total. We've seen and you've talked about the seasonality of prescription trends. I wondered, if you look back at the historical growth, you seem to see a stronger first half than a second half in terms of growth. Is that what you'll expect again this year in 2024?

Yeah. Without getting into any sort of quarterly guidance, I mean, I think we have experienced over the last two years that there is a bit of seasonality in this sort of transformational sort of change to impact patients. That's impacting growth disproportionately in the first half on a year -- on a quarter-over-quarter basis, where people are a little bit less motivated at the end of the year to take a transformational sort of change to engage with the longacting. So we would expect based on the last few years for that trend to continue.

And then two final questions. One is on the community kind of setting. Albertsons, currently, I think you talk about overly 1,100 pharmacies now. What portion of scripts are currently going through that channel, and how do you see that channel responding to the, obviously, recent promotional efforts you've made there?

Thanks for the question on that, because I think it is an important sort of evolution in the market as we seek to continue to normalize addiction treatment and make it available in new locations. And I think the removal of DATA 2000 allows that. As we've talked, it is still incredibly early days here, Max. I mean, Albertsons just came online at the half year last year and we are just now having the sales force expansion we talked about with the Q3 results. They're just now entering the field. I think the key for here is the future aspirations of what this could become. We see it as an incremental revenue opportunity that wasn't included in our initial greater than $1.5 billion net revenue guidance because we didn't have access to these independent physicians. And what we want to do is make it as seamless as possible, which means building off of Albertsons' early move and finding other providers to create a national network that makes it so these independent doctors are able to prescribe SUBLOCADE for their patients. So this is going to be quarters before we see material growth in the sector, but we think it will certainly help these patients and it is incremental revenue.

And then final question, just to give a -- kind of have a call without some discussion of litigation. Where do you see what the current situation is in terms of the movement there, obviously, post the major settlements that you made last year, in particular, focus perhaps on where you see the tooth decay MDL and how you view the recent settlements on, let's say, by Hikma and others with regards to the opioid pain MDL?

Yeah. Thanks for the questions there, Max. And listen, we are pleased with the settlement of the antitrust MDL, and we expect that to become final when the fairness hearing happens in front of the judge, who, as everyone knows, acted as the mediator in this case. So we expect that to occur. When it comes to the rest of our litigation, obviously, we believe that these items are quite manageable. Do highlight that the tooth loss claims, which initiated last year and we disclosed have now become an MDL. But it's still incredibly early days in that litigation. And from an opioid MDL, again, we note that there are settlements going on, but as we look to enter into whether it's resolution via a mediation or whether it's defending our claims in court because of the strong defenses we have, we'll continue to move forward in our efforts to resolve that moving forward.

Great. Thank you very much.

Thank you.

[Operator Instructions] At this time, there are no further questions. I will now turn the call back over to Mark.

Thank you, Evan. And that officially closes our fiscal year 2023 results call. We appreciate the continued interest and support in Indivior, and we look forward to seeing everyone in the near future.

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