Indivior PLC

Good day and thank you for standing by. Welcome to the IndiVS second quarter 2025 Results Conference call and webcast. At this time all participants are in a listen-only mode. After the speaker's presentation there will be a question and answer session. To ask a question during the session please press star 1 and 1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question please press star 1 and 1 again. Please note that today's conference is being recorded. I would now like to turn the conference over to Jason Thompson, your host for today's call. Please go ahead.

Thank you and good morning and welcome to the IndiVS second quarter 2025 earnings conference call. I'm joined today by Joe Schifone, Chief Executive Officer, Patrick Berry, Chief Commercial Officer, Christian Heidbreder, Chief Scientific Officer and Ryan Prebitt, our Chief Financial Officer. 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 of this presentation. We also may refer to non-GAB measures, the reconciliations for which may also be found in the appendix to this presentation that is now posted on our website IndiVir.com. I'll now turn the call over to Joe.

Thanks Jason. Good morning and thank you everyone for joining the call. Today I will start with an overview of our performance in the quarter and then introduce the IndiVir action agenda. Pat will discuss the actions we are taking to generate momentum with Sublicate in the U.S. and Ryan will review the financial results for the along with our upwardly revised financial guidance for 2025. And then we will open up the call for questions. Since joining the board in December 2024, being announced as CEO in late February and officially assuming the role on May 8th, I've had the opportunity to listen to and learn the perspectives of the IndiVir team, treatment providers and investors. IndiVir's greatest strengths include the committed professionals that make up the organization and its outstanding products, all of which have the potential to make a positive difference in people's lives. Having participated in more than 150 roundtable meetings with over 1,000 members of the IndiVir team, I learned that over 85% of our people have been impacted by OUD or addiction in some way and that this fight is personal to them. This is IndiVir's special sauce and what has driven the organization's success and resilience over the years. And this is what will fuel our success moving forward. Turning to the quarter, I'm pleased to report we delivered record Sublicate net revenue led by a solid performance in the U.S. Suboxone Film in the .S.L. performed our expectations as pricing remains stable through the second quarter. Our top line performance positions us well for the remainder of the year and enables us to raise our full year 2025 net revenue guidance and our profit expectations is now measured by adjusted EBITDA. I want to congratulate the IndiVir team on a solid performance and importantly thank them for their leadership. We are encouraged by our performance in the quarter, we are not satisfied as U.S. commercial execution represents an opportunity for improvement. Moving forward, we will be laser focused on improving commercial execution in the U.S. It will become a hallmark of the organization. 2025 is a transition year for IndiVir. We've strengthened our leadership team and refreshed our board with important additions including the appointment of Tony Kingsley to the board who brings deep commercial experience. You've also seen the announcements of Pat Berry as our new chief commercial officer and most recently Vanessa Proctor as our new executive vice president of corporate affairs. These key leaders will play critical roles in implementing the IndiVir action the majority of growth from a single country. Yet the operations to support the business are complex with an inordinate amount of nonessential activities inflating the cost structure and adversely impacting execution. There is an opportunity to strengthen the company, increase focus, reduce cost and improve execution through simplification. Over the past couple of months, the management team in partnership with the board have been developing the IndiVir action agenda. The IndiVir action agenda is a three-phase multi-year operational roadmap intended to maximize the potential of our business and make a positive difference in the lives of people living with OUD while creating value for our shareholders. Phase one of the IndiVir action agenda generate momentum kicked off in May and through the end of 2025. The key focus areas of phase one are growing sublicate in the U.S. through the remainder of the year by improving commercial execution. Pat will discuss this in more detail. Taking actions to simplify the organization by eliminating all nonessential activities. And determining the actions and investments necessary to accelerate long-acting injectable penetration in the U.S. market and to accelerate sublicate net revenue growth in 2026 and beyond. The overarching goal of phase one is to generate operational momentum and we already have multiple work streams underway. We are diligently working to simplify the organization with a focus on delisting from the London Stock Exchange, assessing the rest of world business and go forward operating model, determining the path forward for OPPE, consolidating our operating footprint and restructuring the R&D and medical affairs organizations. We anticipate making and implementing decisions in these and other areas in the weeks to come. We will establish our go forward operating model in the fourth quarter with the expectation that will finish 2025 with momentum and be positioned to accelerate in 2026. We look forward to providing an update on our third quarter results call. Phase two of the endive action agenda accelerate kicks off on January 1, 2026. The goal of phase two is to accelerate U.S. sublicate growth and immediately accelerate profitability and cash flow generation at a rate that exceeds revenue growth. By leveraging our go forward operating model, we expect to see immediate accretion to the bottom line and improve cash generation. Simultaneously, we will invest to accelerate sublicate growth in the U.S. in 2026 and beyond. I am confident that we can make every investment necessary to maximize the potential of sublicate in the U.S. and drop significant dollars to the bottom line right out of the gate in 2026. Through strong operational execution, we will earn our way to phase three of the endive action agenda breakout where we will leverage a stronger financial profile to acquire the next drivers of growth. Our focus will be on commercial stage acquisitions. We believe we will be able to enter the breakout phase in the second half of 2026. There is much work to do between now and then and I want to emphasize that we need to earn our way to phase three through strong execution of phase one and two of the endive action agenda. To conclude, we are encouraged by but not satisfied with our start to 2025. We are pleased to be in a position to raise our 2025 guidance and we have a clear path forward. For the remainder of 2025, we will be working diligently on phase one of the endive action agenda. We are committed to growing sublicate in the U.S., simplifying the organization and taking the necessary actions to make sure we are only investing in essential activities. Our go forward operating model will be locked down in January 1st, 2026. We will be able to accelerate sublicate in the U.S. in 2026 and immediately accelerate the bottom line at an even faster rate. I will now hand the call over to Pat to discuss the opportunities we see for generating momentum with sublicate for the remainder of the year. Thank you,

Joe. We are encouraged by but not satisfied with our start to 2025. We are pleased by but not satisfied with the performance of sublicate in the quarter. We are focused on generating momentum with sublicate for the remainder of the year by improving commercial execution. Success here will position us for the acceleration phase of the endive action agenda entering 2026. I have been impressed by the passion our commercial teammates have for OUD patients and the confidence they possess in sublicate. Sublicate is fundamentally strong and poised for I believe this because sublicate is the first and number one prescribed LAI treatment that has been taken by over 350,000 people living with OUD. The breadth of the prescriber base is growing and the depth is improving. Sublicate has broad label-aligned access among Medicaid and commercial payers and market research indicates that healthcare providers have a high intent to increase prescribing and see sublicates top attribute. These strong fundamentals translated into solid results in the quarter for sublicate. Record second quarter net revenue performance for sublicate was driven by year over year dispense growth of 6% versus the prior year and 9% versus the first quarter. Importantly, during the first half of 2025, market share in the U.S. for sublicate remained stable at approximately 75%. I was also pleased to see in the quarter year over year growth in the number of active sublicate prescribers and those prescribing for five or more patients. The 14% increase in the number of active sublicate prescribers and the 9% increase in five plus prescribers are important leading indicators for the sublicate franchise and represent a solid base from which to grow. The number of sublicate patients over the trailing 12 months also grew increasing 7% year over year. Our focus in the second half of the year is delivering on phase one of the endive action agenda for sublicate, improving commercial execution to generate momentum. Success will position the commercial team to be able to accelerate sublicate in 2026. Our first priority with regards to strengthening commercial execution is sharpening the field force's messaging acumen with higher utilization of sublicate's core promotional materials on every call. In conjunction with sharpened messaging, we are also improving field force productivity to enable better reach and frequency on healthcare providers. We are also working on reinforcing sublicate's treatment benefits with prescribers. This includes driving broad HCP awareness of the updated sublicate label. These label updates include alternate sites of injection and rapid patient induction. In particular, we believe the ability to accelerate the second dose of sublicate provides better outcomes for our patients and is among the drivers of increased HCP utilization. Payor response has been positive with coverage of the new dosing approach reaching approximately 80% of covered lives. We believe these label updates have great potential to demonstrate sublicate as a -for-purpose LAI for today's opioid crisis, which continues to be driven by powerful synthetic opioids. We are also focused on pulling through sublicate's broad access across Medicaid and commercial payers. The commercial channel represents a large opportunity for patient activation given that sublicate volume in the commercial channel only represents 25% of the total patient volume. We are confident that this is an area where we can improve. Related to the opportunity we see in greater commercial patient penetration is ensuring better performance within the specialty pharmacy channel. At present, dispense yield rates within our commercial channel are notably trailing our national average dispense rates. It is critical to address treatment yield to help our patients obtain the treatment they and their HCPs have chosen by improving the efficiency of our overall distribution model to ensure delivery of their chosen treatment to our commercial patients. We will be working on an -by-account basis to improve the performance of our distribution network. Finally, we are augmenting our field efforts by investing in omnichannel digital media targeting HCPs. This surround sound opportunity will complement our field force's individual selling efforts. We also believe there is a large opportunity to activate patients through direct to consumer efforts. Recall sublicate has an 80% plus prescription pull-through rate after patient request. I'm confident that these table stakes activities will generate momentum in the second half of 2025 and put us in a position to accelerate in 2026. I look forward to updating you on our progress as we move through the remainder of 2025. I will now turn the call over to Ryan who will take you through the financial results for the quarter and our upwardly revised guidance for 2025.

Thanks, Pat. Overall, this quarter's financial performance was solid. For the remainder of the year, we are focused on delivering on our financial commitments and implementing phase one of the Endivior action agenda, Generate Momentum. Looking at the second quarter results in more detail, starting with the top line, total net revenue of $302 million increased 1% versus the prior year. As record sublicate net revenue offset, expected pricing pressure on Suboxone film and the continued wind down of Paceras. Total sublicate net revenue of $209 million increased 9% versus Q2 2024. On a sequential basis, total sublicate net revenue increased 19%, reflecting a 9% increase in the previous quarter. On a dollarized demand basis, total sublicate net revenue in the second quarter would have been 194 million. Turning to Suboxone film, we outperformed expectations in the second quarter due to price stability in the U.S. along with a modestly higher than expected market share of 14%. Suboxone film net revenue also benefited from favorable growth to net dynamics of $10 million. Overall, while pricing has remained relatively stable throughout the first half of 2025, our 2025 financial guidance continues to forecast pricing pressure in the second half of the year. Total non-GAAP operating expenses were $167 million in the second quarter, up 2% versus the same quarter last year. Selling and marketing expenses in the quarter were higher, as expected, from increased marketing behind U.S. sublicate. Non-GAAP G&A expenses were down 7% versus the year-ago quarter. R&D expenses were $21 million in the quarter, a decrease of 20% versus the second quarter of last year. The decrease was due to the reprioritization of pipeline activities to focus solely on our two Phase II OUD assets and the related cost savings. As noted in the press release, we have adopted adjusted EBITDA as our primary profitability measure, replacing non-GAAP operating income. On this basis, adjusted EBITDA was $88 million in the second quarter, which was slightly down versus last year, as modestly higher net revenue was more than offset by increased marketing behind U.S. sublicate. Touching on the balance sheet, we ended the second quarter with gross cash and investments of $538 million, up from $347 million at year end. The second quarter benefited by approximately $120 million from the timing of Medicaid rebate invoices, which we expect to unwind in the third quarter. At the end of the second quarter, our adjusted leverage ratio was 1.0, excluding legal settlement obligations. As we have mentioned, we are committed to maintaining financial flexibility through Phase I, generate momentum of the endevior action agenda. To best reflect our operations, we are introducing adjusted EBITDA into our 2025 financial guidance as our primary profitability measure. This impacts our non-GAAP operating expense guidance, which will now exclude full-year 2025 stock-based compensation expense of approximately $25 million. Reconciliation from the non-GAAP operating profit guidance we provided on our first call in April to adjusted EBITDA excludes the $25 million in stock-based compensation and our full-year 2025 depreciation and amortization expense assumptions of approximately $10 million. Adjusted EBITDA, had it been part of our April financial guidance, would have been $220 to $260 million for 2025. Based on our solid performance in the first half of 2025, we are raising our guidance for the year. Our total net revenue guidance range is increasing to $1.030 billion to $1.080 billion, reflecting the solid -to-date performance of Subicade and Suboxone film pricing stability in the U.S. For Subicade, we are raising our full-year 2025 net revenue guidance to the range of $765 to $785 million. This represents -over-year growth of 3% at the midpoint versus full-year 2024. We see improving fundamentals for Subicade and expect to see growth on a demand basis for the remainder of this year. Our gross margin and operating expense expectations are unchanged. We are raising our adjusted EBITDA guidance to $275 to $300 million, which is an increase of 20% at the midpoint versus our previous expectations. Lastly, I did want to mention that we now expect our effective corporate tax rate for full-year 2025 to be between 19 and 22%. Before concluding, I want to briefly mention corporate updates that further align with our increased U.S. focus. First, effective last week, Indivior canceled its secondary listing on the London Stock Exchange. This action reduces cost and complexity associated with the dual listing. Second, Indivior was added to the U.S. Russell indexes on June 30th, which are well-known benchmarks for U.S. investors. I'll turn the call back over to Joe for closing remarks. Thanks,

Ryan. We are encouraged by our performance in the first half of the year, but we have a lot of work ahead of us to maximize the full potential of Indivior. We are confident we will deliver on our increased financial guidance for this year and be able to update you on the progress against the Indivior action agenda on our third quarter call. We will now open the call for questions. Operator?

Thank you, sir. As a reminder to ask a question, please press star 1 and 1 on your telephone and wait for your name to be announced. To wait for your question, please press star 1 and 1 again. Once again, please press star 1 and 1 on your telephone and wait for your name to be announced. To wait for your question, please press star 1 and 1 again. We are now going to proceed with our first question. And the questions come from the line of David Amselum from Piper Sandler. Please ask your question.

Thanks. Just got a couple from me. First, Joe, you talked in the past about prioritizing gaining traction in patients who are commercially covered. Can you talk about that opportunity and how you're thinking about balancing that versus the core Medicaid population that comprises the bulk of the sublicate business? That's number one. Number two is, can you talk about the criminal justice system channel? I didn't see it in the slides. Your predecessor talked about it a lot. Where does that fit in in terms of overall strategy? Lastly, I wanted to ask you about your thoughts on R&D spend going forward. I know there's some strategic decisions to think about, but this is a commercial stage business and there is quite a bit of R&D spend. So how are you thinking about prioritizing or not prioritizing R&D in the context of all the other priorities that you've outlined commercially? Thank you.

David, thanks for the question. I'm going to do it in reverse order because I'm going to hand the commercial question off to Pat. So first off, with regards to R&D and our medical affairs organization, we're going to be working through what will be a significant reorganization of those functions. Importantly, I'm pleased to be able to report by the end of this year, both in Divya year 6,001 and 2000, we believe we'll be fully enrolled and we'll have the opportunity to hopefully read out that data by the end of the first quarter of 2026. When we think about R&D organization moving forward, we want to make sure we're maintaining the capabilities from a development perspective to be able, if successful, to transition those programs into phase three. As it pertains to the criminal justice system, what I would say is the criminal justice system is an opportunity in our view of which we'll continue to be focused on. As you know, in the quarter, as a result of coming off the formula in the federal bureau of prison, we absorbed pressure, all of which manifested in the first quarter. We've seen stability, so we view that as a new start point within the criminal justice system upon which we will focus on growing. I think the important thing when people think about sublicate is that they focus on the overall opportunity that we have, whether it be in commercial, Medicaid, criminal justice system, and it's really abundant in keeping in mind that LAI penetration is just under 8%. We're very excited about the potential growth opportunity for sublicate and we view it as an enduring growth asset for us. I'll hand it off to Pat to talk about commercial.

Thanks, Joe. We're certainly not de-emphasizing the Medicaid channel. The Medicaid patients deserve an OUD treatment and essentially we have demonstrated success in terms of converting those patients and getting them activated to treatment. However, when we look at the commercial opportunity in our covered lives, there's about 60% of our covered lives are commercial patients and yet when you look at the sublicate volume, it only represents 25%. We want to continue to focus on Medicaid as a channel, but those commercial patients also deserve sublicates, those who are suffering from OUD. Our focus is going to be on capitalizing on that as well. That's a Salesforce focus in terms of messaging, making sure our customers are fully educated on coverage and it also is an opportunity for us to make sure that that specialty pharmacy channel is effective and efficient so those patients once prescribed can be activated.

Okay, helpful. Thank you. Thanks, David.

We are now going to proceed with our next question and the questions come from the line of Chase Nicobocca from Craig Hallam. Please ask question.

Good morning. Congrats on the excellent quarter guys and thanks for the questions. Maybe just first on guidance. Have we seen anything so far in July that points to further kind of price compression on Suboxone kind of backing into the second half? You'd need to model a pretty decent volume or price decline and then just on sublicate along the same lines. Is there any reason kind of with all the strategic programs you put in place that sublicate would not kind of grow sequentially? Again, second half of the year, it looks like guidance assumes that there's probably a little bit of a sequential decline in Q3. I mean, just some thoughts on kind of product drivers there as it relates to top line guidance.

Sure. So, Chase, I appreciate the question. With regards to our guidance, what I would say to you is we haven't seen any signs of additional price erosion with Suboxone film, although we are factoring that into the guidance right now. To the degree that doesn't manifest, that would be a positive. And when you think about sublicate, what I would focus you on is on a demand basis, the sublicate guidance does incorporate growth in the back half of the year. We are very encouraged by what we're seeing from a fundamental perspective inclusive of demand in July, but we have a lot of work to do in front of us to achieve it, but it does assume sequential growth on a demand basis.

Got it. And then just two more if I could, Joe. First on the action agenda, any thoughts on kind of the magnitude of what the bottom line kind of cost savings benefit would be from kind of streamlining the business? And then along those same lines, should we expect that any changes from streamlining the business would be in effect by year end 2025 and so there would kind of be a full year of benefit from either being able to reshift those costs or drop them the bottom line in 2026?

Yeah, so Chase, appreciate that question. With regards to the action agenda, I'm not going to give any color at this point in terms of giving a number or a target. That's not how we've approached it. We're focused first and foremost on making sure we're making every investment necessary to maximize the potential of sublicate in the U.S. And then we are focusing diligently on simplifying the organization and removing all nonessential spend. I believe when we get to our third quarter, Carl will be able to give a perspective of what that looks like and then it will be fully captured in our guidance. What I do want to address head on in the question you're asking, we are not dabbling around the fringes. We are addressing the core of the cost structure. So people should have an expectation that it is a meaningful and significant reduction to the overall cost structure and we will have everything or near everything implemented where we will have a full year effect and what people should expect is growth of sublicate but right out of the gate, those dollars dropping to the bottom line in January of 2026.

Understood. And then just lastly, Joe, your predecessor gave some thoughts around kind of where they think market share would stabilize out with your competitor with sublicate. I mean, do you have any thoughts as you've kind of become familiar with this market as far as kind of how you think kind of long-term market share shakes out and kind of over how long of a period we kind of get there?

Yeah, so I appreciate that question. From my perspective, the single most important thing when you think of sublicate on a going forward basis is long-acting injectable penetration. The answer to what the peak sales of sublicate will be will not come down to what the market share of sublicate is. Now in saying that, what I will emphasize that we're very encouraged by, because certainly from a competitiveness perspective, in particular with our commercial team, it's a very important metric. We have now seen for multiple quarters stabilization of market share from a total perspective and we've also seen that from a new patient share perspective and we're seeing it at a total in the mid-70s, which we're very encouraged by. And the final comment I would make is we are very confident in the profile of sublicate along with physicians' knowledge and empirical experience that its market position is going to pan out just fine.

Thank you, Jeff.

We are now going to proceed with our next question and the questions come from the line of Dennis Sting from Jeffries. Please ask a question.

Hi, good morning and congrats on a very solid quarter. Just one question for me on cost cuts. Is it reasonable to assume that you like to align your SG&A spend as a percentage of revenue to be more in line with industry peers, which is I think around 30% of revenue? Is that a fair way to think about it and how you're thinking about it too, which if so would imply about $200 million cut in op-bacs just from SG&A over time? Thank you.

So Dennis, I'm going to hand

that one off to Ryan. Hey, Dennis. Thanks for the question. So first, there's no doubt that our number one priority is generating the momentum behind sublicate, but our organization is too complex and our cost structure is too high for a company of our size. So we are currently assessing the entire organization from top to bottom as we speak with two focus areas. One is to make sure that we are fully resourcing sublicate to generate that momentum behind it. And then second, to only fund programs and activities that are essential. All non-essential spend will be dropped to the bottom line. In regards to what exact number we want to get to, listen, let us work through this over the next couple of months. We will be in a better position over the next couple of quarters or so to start sharing some of that. But we do believe that as we get into 2026, we will see the benefit from this work.

Okay, great. Thank you. Thanks, Dennis.

As a reminder to ask a question, please press star one and one on your telephone and wait for your name to be announced. To withdraw your question, please press star one and one again. Once again, it's star one and one for any question. Thank you. We are now going to proceed with our next question. And the questions come from the line of Thibaut Boutre from Morgan Stanley. Please ask your question.

Thank you. First question is just a clarification on stocking and the gross net dynamic for sublocating the quarter. On stocking, is it a normalization towards normal level after the previous stocking or do you expect a reversal of this in the second half of the year? And gross net, if you can explain to us a bit in more detail the dynamics here, is it a mixed effect? Is it sustainable? Is it going to reverse? That's the first question. And the second one is just if you could elaborate a bit on the previous market headwinds we saw during 2024. You know, CJ's budget, I think it's clear, but the Medicaid enrollment and any headwind in terms of the Medicaid, is it something that's over and you should assume that the environment is now more favorable and now it's just sort of execution and organic growth? Or do you still see any sort of headwind in the Medicaid enrollment or the total number of patients on Medicaid? Thank you.

Thank you, Thibaut. I'm going to hand the first question on stocking over to Ryan and then come back and I'll address the Medicaid question.

Hi, Thibaut. Yeah, so in tier two, the stocking impact was minimal. There's always going to be some ups and downs through the year, but at this point we project it to remain relatively stable for the balance of the year.

And

then with regards to your question on headwinds, I really can't speak fully to the past. What I can tell you is that we see opportunity and tailwind in front of us. Certainly there are dynamics within Medicaid in the U.S. that are taking place, but from a big picture perspective, we're encouraged that the opioid epidemic, opioid use disorder seems to be a bipartisan topic. We certainly advocate for coverage for everyone who is qualified along with access to treatments and appropriate care for OUD. I would be mindful that when you think of Medicaid, the changes being proposed don't start to be implemented until 2027 and there's consideration as it pertains to people who have OUD and substance use disorder as an example where they're not going to be held to the work requirement. So the big picture when you think of Public Aid is it's about the abundant opportunity in front of it. There's an 8% LAI penetration. Whether you're talking Medicaid, whether you're talking commercial, whether you're talking the opportunity and criminal justice system, we are confident this year through operational execution of our commercial team that we will generate momentum. We will be doing the assessment and making the decisions of where we're going to invest to drive LAI penetration to accelerate the brand on a going forward basis.

We are now going

to proceed with our next question. And the questions come from the line of Carl Burns from Northland Capital Markets. Please ask your question.

Thanks for the question and congratulations on the quarter. I'm wondering going back to the commercial opportunity and considering that you're around 25% and you have 60% in terms of BMAT therapies and 80% patient outreach conversion with the DTC initiatives that are going to come into place. What do you think is a realistic expectation long term in terms of getting closer to that 60% number? Where do you think it may ultimately land?

So Carl, I appreciate the question. First to be clear, we have 60% of covered lives within commercial. We do not expect to set expectations commercial ever to be the contributor that Medicaid is. But we do believe that we certainly should be getting more than 25% contribution from the book of business. So we want to see that number moving upwards. But I wouldn't have an expectation that it's ever on par or anywhere near the level of what we're deriving from Medicaid. But it should be meaningfully higher than it is.

Excellent.

Thanks.

As a reminder to ask a question, please press star 1 and 1 on your telephone and wait for your name to be announced. Till we've got your question, please press

star 1 and 1 again. We have no further questions at this time. I will now hand back to you

for closing remarks.

Thank you, operator. And thank you to everyone for joining the call today. We look forward to updating you on our progress as we execute the Endivier Action Agenda.

This concludes today's conference call. Thank you all for participating. You may now disconnect your lines. Thank you and have a good day.