Good day and thank you for standing by. Welcome to the Indivior PLC Third Quarter 2024 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 host for today's call, Jason Thompson, Head of Investor Relations. Please go ahead.

Thanks Sonya, and hello 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 on Slide 2 of this presentation. These statements are based on current information and beliefs, and we disclaim any obligation to update them except where required by law. We may also refer to non-GAAP measures, the reconciliations for which may also be found in the appendix to this presentation that is now posted on our website@indivia.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. Joining me today are Ryan Preblick, our Chief Financial Officer; and Dr. Christian Heidbreder, our Chief Scientific Officer. I'll quickly highlight our results, and some updates from our release earlier in the month, and then Ryan will detail the financials, and our full year 2024 outlook. Christian is with us to answer any questions on the pipeline. Since, we announced the business update just two weeks ago. I'm going to keep my formal remarks relatively brief, but I do want to provide a few updates. First, our results for the third quarter continued to show solid double-digit year-over-year growth, and were in line with the expectations that we preannounced earlier this month. SUBLOCADE third quarter net revenue of $191 million increased 14%, and primarily drove the 13% increase in total third quarter net revenue to $307 million. Our underlying profitability and gross cash position also remained strong. Adjusted operating profit through the quarter increased 62% to $97 million, and our cash position at the end of the third quarter was $344 million. In terms of the sequential net revenue trend for SUBLOCADE, despite 2% dispense growth quarter-over-quarter, we saw a modest decline in the third quarter from the second quarter. As previously discussed, SUBLOCADE's growth is being impacted by a combination of intensified initial trial and adoption of the competing product, variability in funding, timing in certain justice system accounts and further destocking. Ryan will share more detail on the financial performance drivers in a moment. Second, as we navigate through the near term, our commercial teams remain intensely focused on our critical mission to help patients with opioid use disorder. We're generating increases in overall organized health system and CGS activation, which we believe will…

Thanks Mark, and good morning, and good afternoon to everyone. Despite the market dynamics that led to our recent update, I do want to highlight the strong underlying profitability of our business. In the third quarter we generated 13% year-over-year top line growth, and saw an increase in adjusted operating profit of 52%. And by continuing to actively manage our resources, we were also able to lower SG&A by 11% in the third quarter. I'll now walk you through our third quarter performance, and then discuss the dynamics behind our recently revised full year 2024 guidance. Finally, I will provide some more color on the streamlining actions Mark mentioned earlier. Starting with the top line, total net revenue of $307 million for the quarter, reflected growth of 13% versus the year ago quarter, both on a reported and on a constant currency basis. By geography, total U.S. net revenue grew by 15% while the rest of the world business grew by 5% at actual currency, and by 2% on a constant currency basis. SUBLOCADE remained the primary driver of our year-over-year net revenue growth in the U.S., from increased volumes in organized health systems, including justice system accounts. U.S. net revenue in the third quarter also benefited from the fulfillment of two OPVEE orders from BARDA. In the rest of the world as Mark noted, growth was driven by continued positive contributions from our new products, mainly SUBLOCADE. Total SUBLOCADE net revenue for the quarter was $191 million up 14% versus last year. U.S. SUBLOCADE expenses of $158,500 in the third quarter increased 19% versus last year and 2% versus the prior quarter. The difference between the sequential dispense growth of 2% and the modest 1% decline in net revenue, is due to trade destocking in the third quarter. Breaking…

Thank you, Ryan. Despite a more challenging market backdrop for SUBLOCADE in the near term, I hope we have demonstrated we remain highly confident that the underlying fundamentals of our business and strategy, remain intact and that we're on a path to help patients in this undertreated market, while generating substantial shareholder value through our actions. We're happy to take your questions now.

Thank you. [Operator Instructions] And the first question comes from the line of David Amsellem from Piper Sandler. Please go ahead. Your line is now open.

Thanks. So I just have a couple. First on the competitive landscape. Can you just talk about how you're thinking about, your share of new starts longer term, and what you think ultimately the market will shake out as you think you'll be getting half of new starts? Is it something higher? Is it something lower? I know what you've been saying recently, but help us better understand, where you think things are going to evolve in the context of a two player LAIB buprenorphine market. So that's number one. And then number two, is just in terms of capital deployment. I mean, you bought back shares, it looks like you're going to continue to do that. How aggressive are you going to be, through next year in terms of buybacks, and how do you balance that versus other business development priorities? You bought Opiant and that gave you OPVEE that was a sizable acquisition. Is that something that you're thinking about in terms of deal size going forward, or are you thinking more conservatively? Just help us understand your thought process there? Thank you.

Thanks, David. I think when we think about the competitive landscape, the early data certainly is encouraging. When you look at new patient share continuing to be above 70%, you look at the cohorts from the early adopters stabilizing out in the mid-60% range. And we see that as incredibly indicative, of the very unique profile that SUBLOCADE offers in this space. With early onset of therapeutic levels in four to eight hours, and maintaining those the entire month long, in a market that's been riddled by synthetic opioids. And we think that's very important, that efficacy based messaging. As we look forward, I think the key here, David, is more along the lines of this market has such a huge unmet need. There's less than of our two in 10 patients that are actually in treatment. LAIs are still 7%. Plenty of room for two players, plenty of room to get to greater than $1.5 billion. And then, when you look at some of the additional interventions that the team has made, including the label work that's been done by Christian and the R&D team, that certainly takes away some of the short-term feedback we've gotten from doctors, with regards to alternate sites of injection and the rapid induction. So, we see very positive trends moving forward. On the capital deployment side, I think as we've consistently applied our principles on capital deployment over the last three to four years, and in partnership with the Board who ultimately owns capital allocation, we'll continue to do so moving forward. And just to remind you of those, David, I think the first one is that we well fuel SUBLOCADE. We'll continue to advance our assets to the next stage gates, and then ensure we have the appropriate financial flexibility moving forward. And there are a number of items on our balance sheet that we need to make certain we can, we can fulfill moving forward. After that, if there's excess cash, the Board will work on prioritizing that for capital allocation. In the short-term, we have an ongoing buyback. In the short to medium term, we do not see business development. And the Board will have to assess, uses of excess cash after that, when the time's appropriate.

Okay. That's helpful. Thanks, guys.

Thank you.

Thank you. We will now take our next question. And the next question comes from the line of Chase Knickerbocker from Craig-Hallum. Please go ahead. Your line is now open.

Good morning, guys. Thanks for taking the questions. Just first from me, assuming kind of approval in Q1 Mark, for your label updates for SUBLOCADE. Can you help us with kind of the strategy to drive awareness, within your commercial organization with clinicians on these changes? Obviously once they're approved, and then kind of also with patients to kind of help reeducate them, on kind of the new profile for SUBLOCADE and how it compares to Bricsadi? Thanks.

I think these are important updates, and we think are important moving forward. As we think about our incremental investments. Obviously, some of those are on HCP and patient awareness of not only SUBLOCADE, but of the new developments with regards to its label and the improvements in the patient and doctor experience. So, we'll anticipate that utilizing both awareness, trial and adoption of SUBLOCADE efforts in investments, and that will include the label as well as SUBLOCADE overall. And those will begin on expected approval on February 7, with the PDUFA date.

Got it. Maybe just digging in a little bit on those cohorts that you mentioned. Can you kind of help us quantify, with how big that sample size is and kind of how confident you are that that, kind of continues through as we see kind of that, I guess, data set mature. And then second on that as well. What did you see from a cadence perspective, as kind of how that sampling of your competitor, kind of impacted usage? Did it kind of progressively go to that kind of mid-60s range, or did it go farther than that and then kind of rebound? Just kind of help us out with, with what you kind of saw in that data set maybe a little bit more color?

Yes, certainly. I think as we look over the first - four months or so, the cohorts are about 500 physicians in nature in that ballpark, which we think is pretty material when you're starting to look at trends, and where the market settles out. And I think, the key element here Chase, is that we are seeing that settle out in that approximately mid-60% range, with regards to the market. And for us, it just reinforces efficacy is the number one choice in making decisions. And that unique product profile that SUBLOCADE brings to the market. So very encouraging, early cohort data one year after competitor launch.

On average Mark, is it kind of the lowest it went in that mid-60s range? Because that would insinuate, obviously, with new patient kind of share of 72%, that there's not a whole long - more ways to go as far as kind of new patient share loss. And then second and last from me, and I'll hop back into queue, is just on price for SUBLOCADE, Mark. I mean, your commentary notes that kind of the difference sequentially from dispensed growth to revenue, is mainly the stocking. Do you expect any kind of price headwind as we kind of enter into Q4, and then kind of '25? Thanks.

Certainly in some of the cohorts it went beyond, and then came back, but it wasn't consistently in every single one. So I think but again, I think the key is where we're seeing the stabilization, and share leadership as well as - just the huge opportunity in the market as LAIs, which are still in the early stages of growth at 7%. Remember, market research from physicians says it should be 30%. So, there's a huge opportunity. Even if it was 50%, there's a huge opportunity for two players. But we see the early cohort data indicating share leadership. When it comes to price Chase, I'm glad you brought that up. I want to be very clear in my pricing commentary. When we look at the overall market, pricing is very stable. When you look at pharmacy benefit managers across both commercial, as well as government payers, we see very, very stable markets. We see open access, across all of the options in treatment. It's what you hear from doctors and patients that they want, based on where they are in their journey. They want the options of, which medication they choose rather than one-of-one. And when we make our bids for access on all of these plans, we never make a one-of-one bid. We always make open access, because we think that's best for the therapy area. My commentary on pricing was in a few CGS accounts, where you have to remember here that the funding is issued by a government agency, sometimes supplemented by grants. Pricing is a bit more sensitive there, and we have seen in an account that the competitor, used pricing to gain access to an account. We don't see that as a long-term issue. Again, we think of in criminal justice that we want open access to all options, and we think SUBLOCADE, will win out in the experience based on its overall efficacy.

Thanks, Mark.

Thank you, Chase.

Thank you. We will now take our next question. And the next question comes from the line of Paul Cudden from Deutsche Numis. Please go ahead. Your line is now open.

Yes, thank you very much for taking my questions. I have two, please. Just firstly on the Q4 visibility over SUBLOCADE, and the kind of implicit range that your $725 million to $745 million guidance gives. I mean how can, that '25 [ph] possibly be viable given the sort of stable patient trends, and as you just said, the sort of stable pricing. If you could just help me understand how that's, even in play that would be useful?

Yes. When we look at SUBLOCADE, and we look at the trends going into 2025, and we look at the top end of guidance to the bottom end of guidance. What we taken into account Paul, is continuation of the accelerated adoption of the competitor product, as we go through this transition period. The continuation of CGS kind of in year funding fluctuations, and then the continued destocking through Q4, is what we've built into that forecast. And when you think about the top to the bottom end of the guidance, it's just a more intensity of each of those factors. On average, when you look at the - the new guidance, we had about $20 million associated with the increased competitive adoption, $20 million associated with the CGS funding, and then $10 million of additional stocking.

Okay. Thank you. And then secondly from me, you talk about the mature 65%, but I'm pretty sure Ryan mentioned actually losing an account altogether. If you could clarify that as to whether that was losing an account, or actually kind of more having a competitor kind of take a minority share?

No, I think it's a good clarification Paul, and really I think it's two separate things. The cohort data is data from organized health systems outside CGS, which is 78% or so of the business in Q3. The lost account was the [West Coast] justice system account that we have referenced at the pre-release of guidance, where we had a competitor come in utilizing pricing and the alternate sites of injection. So, I think two separate areas, two separate sort of forces and that's the competitive, and the funding fluctuations in year on the CGS that are putting pressure there in the short-term. Again, not something we see into the medium and long-term.

Okay. Superb. Thank you very much.

Thank you, Paul.

Thank you. We will now take our next question. And the next question comes from the line of Christian Glennie from Stifel. Please go ahead. Your line is now open.

Hi guys. Thanks for taking the question maybe just to a bit more on the cohort data, just to make sure we're understanding it right. Is it a case that certainly in the OHS, or the sort of regular market, if you like, that effectively most systems end up with co-prescribers, obviously as and when the competitor comes into those systems? But so it's not an either or, so largely that is the sort of typical state of play that docs will have free choices effectively. And obviously select for their patients, whereas obviously in CGS it's exclusive to one, or the other. Just to make sure we got that right?

Good clarification, Christian. I think with the cohort data, what we've done very specifically is looked in each of those months, of early adoption on doctors that prescribed both products in that initial month. And then, we followed them through the first 12 months, 11 months, 10 months, nine months. If you were to look at the first four months that I referred to the 500 or so HCPs. And what we're talking about, when we talk about the mid-65% share, that's where those doctors that are co-prescribing, where we see the share settling out. So I think that's an important item, what we believe. And see, when you think of efficacy as the number one choice, when you think of SUBLOCADE's unique profile, we think with free choice that SUBLOCADE will be the market leader moving out. But obviously there's such a tremendous opportunity in the market, for two players. Within CGS, I think historically we've seen SUBLOCADE as the only player there. And as competition's coming in, for example, in this account on the West Coast, what we've seen is what started as a shift to the competitor now has shifted to where they're prescribing both products. And so, you could have that. We know in some markets there are trials, where they're using the competitor for lower BMI sort of patients, and things like that. So you're seeing some dual usage, but predominantly right now it's one-of-one.

Sorry, just. Yes, thank you. But it was more just to clarify that there's any scenarios in, which maybe a large OHS is going for one over the other, or is it that you should assume that the market will be open to both players?

I apologize, I missed the question there, Christian. I think the way to think about this is typically the OHS are open and they're open, they're going to be open for both products and it's going to be a physician choice, both for which long-acting. But do they utilize orals, which are still a significant portion of the prescribing decision, based on where the patient is in their very unique journey.

Okay. Thank you. Maybe one just to get maybe a bit more sense around, when you talk about rebalancing on OpEx, but then redeploying some savings into renewed efforts behind SUBLOCADE next year. Obviously you've got the label and things like that, but anything to else to point to whether it might be, an increase in sales force, or some other part of the strategy that is beyond kind of what we know around the label, and things like that?

Yes, I think for us as we look at where we are in in SUBLOCADE's journey, we're now opening up access across all the channels, have opened organized health systems, CGS. We now have alternate sites of care coming. We have a sales force that's covering the first 14,000 physicians that are out there for opioid use disorder. We think now is the time to focus on patient and HCP awareness, as well as activation and full adoption. And so that that for us, is going to be a key element of that spend back. And we'll give incremental details, with regards to that when we have our fiscal year and 2024, results in February.

Thank you. And then, maybe one final one just on OPVEE. I know it's still in relatively early innings, but nevertheless some expectation from your side around, when you should see that you've got open in ordering available in lots of states now. But maybe we'll see some material traction, beyond the sort of BARDA contracts?

Yes, I think no real new updates, since we last talked at the update a few weeks ago. We're continuing with our experience program and our real world evidence programs, to help document what's happening with regards to precipitated withdrawal, and with the lives we've saved. That's over 150. We are not seeing any feedback to our medical line, nor from first responders with regards to precipitated withdrawal, which we see as the number one objection and fear associated with both higher doses of naloxone, as well as with nalmefene. And with that and that evidence generation, we expect green shoots, with regards to increases in orders with first responders, and the public interest market moving forward.

Okay. Thank you.

Thank you Christian.

Thank you. As there are no further questions, I would now like to hand back to CEO, Mark Crossley for any closing remarks.

Thank you Sonya. With no more questions, this will conclude our third quarter results presentation. I'd like to thank everyone for their continued interest in Indivior, and we look forward the updating the market as we progress.

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