Indivior PLC (2IVB.F) Earnings Call Transcript & Summary

I think we start. Good morning, everyone. Thank you for joining this session of the Morgan Stanley Global Healthcare Conference. I'm Thibault Boutherin, I co-head the European Pharm Equity Research team based in London. Before we start, I would like to refer to some important disclosures, which can be found on the Morgan Stanley website at www.morganstanley.com/researchdisclosures. If you have any questions, please reach out to your Morgan Stanley sales representative. So for this session, I am delighted to welcome Joe Ciaffoni, CEO of Indivior and Ryan Preblick, CFO of Indivior. So thank you very much for taking the time to join us today. So we'll start with maybe some introductory remarks from you, and then we'll go on the Q&A.

Sure. Thank you, Thibault. And I want to thank you and the Morgan Stanley team for affording us the opportunity to participate in the conference. We're certainly excited to be here. We're excited to have the opportunity to talk about what's happening at Indivior. I would start by saying in terms of our performance in 2025, we're certainly encouraged by what it is that we're seeing. We're not satisfied in any way by our performance, and we'll continue to focus on driving execution for the remainder of the year, but we believe we're well positioned to deliver on our 2025 financial guidance. There's a long road in our revised guidance. There's a long road in front of us and a lot of work to do, but we're very optimistic. As it pertains to the work right now at Indivior, everyone's focused on executing the Indivior Action Agenda, which is our multiyear operational road map, which we believe will position the company first and foremost to make and maximize the potential of this portfolio to make a positive difference in the lives of people living with opioid-use disorder and to create value for our shareholders. We are in Phase 1 of the Indivior Action Agenda, which is generate momentum. During this phase, we're trying to generate momentum in support of SUBLOCADE through stronger commercial execution, while concurrently making the determinations as it pertains to the investments that we will make to accelerate SUBLOCADE to accelerate long-acting injectable penetration on a going-forward basis. We're also focused on simplifying the organization and ensuring on a going-forward basis that we are only investing in what are essential activities for the organization. I'm confident we'll be in a position to enter Phase II of our Action Agenda accelerate on January 1, 2026. And in the accelerate phase, we expect to see an acceleration of SUBLOCADE in particular, in the U.S. throughout 2026, but we do expect to see an immediate acceleration of the bottom line at a much higher rate right out of the gate. So with that, I'll hand it back to you.

Okay. Amazing. So before we go into the business, maybe we can start with some topical question on U.S. policy. Maybe Ryan, if you can start maybe about tariffs. If you could remind us Indivior's exposure to potential U.S. tariff and pharma, your supply chain for SUBLOCADE, SUBOXONE in the U.S. and any other factors relevant to investors regarding tariff?

Yes. Right now, Indivior has a very low exposure to tariffs. Our film product and SUBLOCADE are both manufactured here in the U.S. As a percentage of cost of goods sold, we import a very low percentage, and it's primarily raw material, buprenorphine. And at this point, that's exempt from the tariffs coming over from the U.K. So net-net, as it stands right now, we're in a good position.

And maybe another question on Medicaid. If you could remind us the share of revenues from Medicaid in your U.S. sales for SUBLOCADE, SUBOXONE? And if we see an impact on the funding for Medicaid, how could that potentially impact the business?

So sure, when you look at SUBOXONE film and SUBLOCADE, the majority, so over half of the business comes from Medicaid with SUBLOCADE right now, it's about 65%. We feel that we're very well positioned overall when you look at what's happening from a government and policy perspective, starting with the administration's drug policy priorities, 3 of 6 of those align directly to the work that we're doing at Indivior. If you look at the bill that recently passed through the Congress, there's a lot of exemption being made for people with substance use opioid use disorder, for example, around work requirements. So we're very confident that there's abundant opportunity to grow SUBLOCADE on a going-forward basis. We certainly advocate for and hope every person who is eligible and should receive Medicaid is able to do so. But at the end of the day, we're sitting at 7.8% long-acting injectable penetration, no matter where that nets out. there's abundant opportunity within Medicaid to grow SUBLOCADE as there is in the other portions of the business.

Amazing. Thank you very much. So turning on to the business. You've now been CEO for a few months. So maybe if we can start by your diagnostic of the organization. Where have you been surprised by the strength of the company? And where do you see much room for improvement?

So look, my diagnosis of the organization is, first and foremost, the work that the company does is so important. And it's relevant we're on the right side of the opioid epidemic. We're fortunate that we're a company that is generating significant revenue. We have a tremendous growth driver in SUBLOCADE, that's the first LAI, it's the #1 prescribed product. It has a durable runway and great coverage. We're a profitable company that's generating meaningful cash flow, and we have a strong balance sheet. On that side of the ledger, probably the thing that surprised me most, prior to joining the company, I participated in 151 roundtable meetings. So I had the chance to hear the voice of every employee of Indivior. And what struck me is when I ask people, why do they work at Indivior for over 85% of our people, they've been personally impacted by substance use disorder, opioid-use disorder. And I believe that's really the special sauce of the organization. Our people are passionate. They're committed. They believe in what we're doing. And I think that's why the company has been so resilient. On the other side of the diagnosis, Indivior is a relatively straightforward business. It's an unfathomably complex organization relative to the business opportunity. With that complexity, I think there's a lot of activity, much of which is nonessential. And on the biggest surprise, I guess, in terms of opportunities for improvement is just the level of commercial execution, in particular in the U.S. isn't at the level than it needs to be, but I can assure you that will become a hallmark of the organization. We will excel the commercial execution moving forward.

Okay. Great. And I just want to actually touch a bit on the organization. You mentioned that [RTD] complex when the mission of the business is straightforward. So what are concrete examples of the complexity? How are you planning to address them? And how will the go-forward operating model will differ structurally from what Indivior is today?

Yes. So look, if you start with what is the thing that creates the most value for patients that creates value for our shareholder, it's SUBLOCADE. And in particular, at SUBLOCADE in the U.S. market. So first and foremost, we are going to put a tremendous amount of effort and investment in support of SUBLOCADE, if anything, we may potentially overinvest in SUBLOCADE as we seek to accelerate the product and drive long-acting injectable penetration. We've been pretty clear in terms of where we're focused in terms of simplifying the organization and taking nonessential spend out. So we've talked about a restructuring of our research and development organization that we're currently assessing all options as it pertains to most of world and OPVEE. As an example, I can assure you, the only options that aren't in play is the status quo. And the net-net, we believe that we're fortunate to be in a position where we can make every investment, in fact, to overinvest in the support of SUBLOCADE and not or and drop meaningful dollars to the bottom line right out of the gate in 2026. And the other comment I would make, we are not dabbling around the fringe of this cost structure. We are hitting it head on. So the impact of that will be meaningful.

Okay. And if I sort of can push a little bit on quantifying. SG&A was 49% of sales in 2024. G&A within that was 27% of sales. So can you outline a bit the opportunity here? And in the midterm, what do you believe is an appropriate sort of ratio that we could see?

Yes. So we're not going to get into percentages and that sort of thing in response to your question. What I will say is the following. What we're looking at is meaningful. It will have an immediate impact in January of 2026. On our Q3 call, we will share with people where our head is at in terms of the amount of OpEx. So it will be a statement of we expect OpEx to be reduced by at least and then we're going to be issuing guidance in January and people will see the full extent of the OpEx that we're taking out. But I would just emphasize, it is going to be significant. It will have day 1 impact. But the key is we're going to do that not by setting a target, but by ensuring we're making every investment in support of SUBLOCADE in eliminating nonessential activity.

That's very clear. And just a bit of, I would say, clarification on the timing. So should we expect that planning of the organization will happen in the second half and you establish sort of new cost base end of this year? Or could we see this being a multiyear process?

Yes. So we'll have our going-forward operating structure in place by the end of this year, and Ryan can comment on how to think about the impact and how it will flow through from a cost structure perspective.

That's clear. On ex U.S., you mentioned that you are reviewing this part of the organization. It was 15% of sales in 2024. So how do you think about ex U.S. operation in that context? And what alternative models could you adopt? Could you go to a distributor model? And do you know at this stage if it's fair or not to expect growth ex U.S. going forward?

Yes. Ryan, do you want to start on that one?

Yes. I would say when we look at the Rest of the world business, it does drive a large level of net revenue and some op income for the business. But it's just not at sale compared to where we are in the U.S. The focus is in the U.S. market. We have SUBLOCADE, we have film, and we have tablets still performing well over there. But it's a stable business, grows modestly year-over-year. But at this point, as Joe said, the status quo is not acceptable at this point. So we are looking at all options when it comes to rest of the world in terms of generating value out of that.

Okay. That's clear. And maybe if you can turn to SUBLOCADE and to the long-acting injectable market. Maybe if you can go back on some of the dynamics in the U.S. So you had really good growth in the second quarter. If you could come back on the dynamics behind this performance. Are you already seeing an impact from the label update you had in the U.S. recently? Or do we have -- could we still see more impact from this going forward?

Yes. So I think it's a culmination of factors that are starting to have impact. So we had the label updates from early in the year. The organization made significant investment from a marketing perspective, inclusive of consumer. And also, I think we started the process of improving our execution. When you look at Phase 1 of our Action Agenda, which is generate momentum, that's really anchored to a belief that this year, by improving commercial execution, we should expect to continue to grow SUBLOCADE for the remainder of the year while we're thinking through what are the bigger investments that we can make to accelerate the product in the long-acting injectable market in 2026.

That's clear. And there were some market headwinds on the buprenorphine market and the long-acting injectable market through 2024. The Medicaid disenrollment was a headwind. There was some budget constraints in the criminal justice system. So where we in terms of these obstacles today? And what are the sort of key obstacles you're navigating right now in the U.S. market with SUBLOCADE?

Yes. So look, we're very fortunate. SUBLOCADE is poised and well positioned to grow. We're expanding the breadth of our prescribing base. We're improving the depth of prescribing. We have broad payer coverage. We have a differentiated asset. If you step back and think about SUBLOCADE, it's the first long-acting injectable, it's the #1 prescribed that's been used in over 350,000 patients. We have 88% coverage in both Medicare and Medicaid. And so our focus is really on what we can control, which is our execution from a commercial perspective, which I really think to be candid, is the biggest opportunity for improvement that positions us for when we make these other investments to drive the market to ensure that SUBLOCADE really is the beneficiary.

That's clear. I have to mention competition, right? So Braeburn launched a competitor product called Brixadi. It had quite some success taking market share in the U.S. through 2024. Are there particular segments of the market where you feel they've been successful? How are you pushing back against them? And do you see currently a market share stabilization? And do you expect this to continue?

Yes. So look, to be candid, we spend all of our time. I spend all of my him focused on our execution in support of SUBLOCADE. I'll reiterate it again. We have the first LAI. We have the #1 prescribed long-acting injectable product. It is a differentiated product and that it's the only once-monthly that has rapid initiation in its label. So we're most confident in the market position of SUBLOCADE. We welcome anybody to the space. And we believe that additional voice will be beneficial to patients and will better inform physicians in the community. And so we're not worried about or concerned about any competitor coming to the space. We embrace that. We've seen over multiple quarters now, share stabilization of SUBLOCADE in the mid-70%. And look when you look at any category, there are physicians that we would refer to as early adopters. In this case, these are buprenorphine proponents delivered in a long-acting injectable. And of course, they're going to trial a new product coming to the market. So I congratulate the other product on their share, welcome them to the market, but our focus is really Indivior execution in support of SUBLOCADE and the biggest learning of 2024 is that we're the only company with the resources and that is equipped to drive long-acting penetration because I think the bigger challenge of '24 wasn't the impact on share, it was with a second entrant that the market didn't grow in line to expectations. And that's where we now know we're the ones that have to drive that and make those investments.

That's clear. And I want to follow up on the long-acting injectable penetration. And you said clearly that the priority to drive this penetration within the buprenorphine market going forward. Right now, I think you mentioned in the past, it's around 8% penetration within upon buprenorphine. How high do you think this penetration rate could go? It's realistic to think that 25% or even 30% of buprenorphine could be an injectable in the mid to long term?

Yes. So I'm not going to prognosticate on where it could go. I'm going to confront the reality of where it is, which is 8%, which is far too low. So we're going to be working very hard and stepping into this with the appropriate investments anchored in particular, to educating and activating the consumer. So that's most important. Not to dodge your question, I think you could look at a lot of analogs and data. If you want to look from a long-acting injectable perspective, if you look in the HIV schizophrenia market, I could show you research that we have internally that would suggest 20% to 30% long-acting injectable penetration is reasonable.

That makes sense. And as we think about the sort of barriers to overcome to drive that penetration, can you come back a little bit on what are some of these key barriers. Is it clinical inertia? Is it logistical hurdles around shipping the products and logistics around the product? Is it training injectors, patient preference, payer dynamics? So what are the sort of key obstacles to overcome to drive penetration?

Yes. It's kind of everything that you said. So look, first and foremost, you have to appreciate the complexity of somebody who is struggling with addiction. And there's a difference when you make a determination that in your recovery journey, that you're going to go to a monthly, long-acting injectable that's going to take away the rewarding effects of drug use, it's a difference in terms of your readiness which can impact product choices. Some patients prefer the ability day-to-day to pick and choose what product they want to use. That's where education of the patient, the people who care about them trying to activate them and making sure they understand and are thinking through with their physicians, the pluses and minuses of long-acting injectable treatment is important. You have physicians that for many years have really supported and done well by patients using tablets than transmucosal film. So there's a change of behavior. That's a different approach to the product. This is a category that today is 92% generic. And so that's certainly something that we have to work through and make sure that we have broad access. But importantly, and this gets to our execution, are able to educate physicians on a plan-by-plan basis of the availability of SUBLOCADE inclusive of how to navigate the specialty distribution. So it's a culmination of all of those things. What we can control is how we execute, educate and help people who are motivated to use SUBLOCADE to navigate those dynamics, and that's what we're focused on.

Okay. That's very clear. One aspect of the commercial strategy I want to mention in particular is you mentioned your ambition to grow the share of SUBLOCADE sales coming from the commercial channel by a position to Medicaid. If you could give us a bit more insight into how you can drive this additional penetration in that specific patient population?

Yes. So there's a saying in the commercial world, water flows to the path of least resistance. The reality is it is easier -- it's an easier process to get a patient on Medicaid SUBLOCADE. It is not a challenging process, though, to get that patient commercial. We just haven't had the organizational focus and set clear expectations with our people around execution. So if there's 2 areas that really get to the blocking and tackling of execution where I know we can have impact, it's our commercial pull-through where we have 88% access that represents 60% of our covered lives, but only 25% of SUBLOCADE utilization. Now SUBLOCADE will -- it will always be skewed to Medicaid, but not as dramatically as it is. So that's the delta that we're trying to impact the other area is how it is we educate and our confidence in helping physicians understand the specialty pharmacy distribution network along with when they're in a buy-and-bill situation.

Very clear. I want to come back a bit on the guidance for this year for SUBLOCADE. You raised the guidance in the second quarter, but after the good performance you had in the first half, it still appears quite conservative. So if you could maybe come back on why we should expect more limited sequential growth in the second half? Or is it just that you want to make sure that your guidance is conservative basically?

Yes. I would say, first, taking a step back, we had a solid Q2, record SUBLOCADE at $209 million. But what we did say is if you look at that performance on a demand basis, it was more like $194 million. And so our guidance does project growth in the second half versus the first half. So that's what we have built into the guidance for the balance of the year.

And I would add, our view is the guidance is reasonable. Ryan gave a strong depiction there of the SUBLOCADE dynamic. With regards to SUBOXONE film, we continue to have to assume that there's the potential for price erosion. I guess I'll knock on wood that we haven't seen that. And to the degree we don't see that for the remainder of the year, that would represent upside relative to the revised guidance, too.

Okay. That's clear. And just maybe to finish on SUBLOCADE. One channel of growth in the past has been the criminal justice system. Then we faced some funding issues relatively recently. So how should we think about this specific channel going forward? Is it still a key priority for you? And how can you reignite growth here in the criminal justice channel?

Yes. So criminal justice system remains an opportunity that we're committed to and focused on. In many respects, we think long-acting injectables are really fit for purpose within the criminal justice system. We think the business has now been rebased, and we're focused on growing it from here, and that gets to strong commercial execution. It also gets to the work that we do from a public policy, government affairs perspective because a lot of that is associated with funding. And so we're very fortunate. We announced in the middle of the summer that Venessa Procter who is an exceptional professional has joined the organization as our Executive Vice President of Corporate Affairs, and that's under her remit, and I'm very confident in the job that she'll do.

Okay. That's correct. And just wanted to turn a bit on SUBOXONE now. So you mentioned the upside risk on the short-term should pricing hold up a little bit more. Can you talk a little bit about your view on SUBOXONE in the long term? How do you expect the dynamics to evolve? Could there be a change in strategy in this product? Or is it pretty much the same as we've seen so far? Yes, maybe...

Yes. So I think SUBOXONE film is a very straightforward story for us. It's a very mature product that is in a category now that is genericized and we'll manage it the way you would any late in the life cycle product. When you think of the story of Indivior in terms of growth and going forward, it's really a SUBLOCADE and SUBLOCADE in the U.S. market story. And for now, SUBOXONE film continues to be a nice contributor to the portfolio.

That's clear. And one product I want to mention, and you touched on it, is Opiant. When Indivior acquired OPVEE, there was a whole organization coming with it. Can you comment on the level of integration of OPVEE within Indivior today? Is there room for simplification here, maybe starting here?

Yes. So what I would say with regards to OPVEE is, on the one hand, it really is a product that has a profile that one could easily be enamored by. It's a differentiated rescue medication, and that's the only one with synthetic opioids in its label. It works fast, it is potent and it is long lasting. That being said, to this point, the commercial uptake has been de minimis. And we've been confronted with resistance that I don't think the organization anticipated. So where I'll leave it is OPVEE is something that we're thinking through how it is that we will handle that on a going-forward basis. What I can assure you is the status quo will not be one of those options.

And can we expect an update in the third quarter on Opiant, OPVEE?

Yes. So we expect when we have our Q3 call, if not sooner, that all of the organizational changes we've talked about will have been implemented, and we will end the year in our going-forward operating posture.

Okay. That's clear. And I just want to touch a bit on pipeline and R&D. You've narrowed the pipeline to now 2 Phase II assets, one ultra-long injectable version of buprenorphine and one nonopioid medicine for opioid-use disorder. So maybe if you could comment on your degree of confidence in the potential success of the Phase II, how committed you are in moving them to Phase III in case of success and how we should think about your long-term approach to R&D as well?

Yes. So the good news is I really don't have to opine too much because the Phase II studies will be fully enrolled by the end of the year. So they're fully funded and will be enrolled, and we're going to get data readouts in the first quarter or early second quarter of 2025. From there, if we're fortunate to have products or programs to advance the Phase III, we will maintain a development capability that will enable us to execute those Phase III programs. When you think about Indivior moving forward, if we earn our way and we need to earn our way both in terms of our internal confidence capabilities along with external trust and credibility to Phase III, which we refer as the breakout phase of the Action Agenda where we would seek through acquisition to diversify and enhance the growth profile of the company, we will focus on commercial stage acquisitions.

Okay. That's great. That was actually my following question. So very clear commercial stage assets. What kind of assets would be a good fit with Indivior in terms of therapeutic areas where you could go? Are you fully focused on opioid disorder? Could we see acquisition addition more generally? Could it be broader neurology?

So look, right now, we're so far from that, and we're head down in execution beyond saying that it would be commercial stage that would be our focus. I don't want to comment too much because it could give an impression that we're out further ahead of where we actually are. I think what you just talked through would be a traditional logic flow. Obviously, if there's something that was OUD specific that leverage the capabilities and infrastructure that we have in place, that would be the ideal scenario and then you're moving into adjacent areas. But right now, we're 100% focused on the generate momentum phase of the Action Agenda and trying to position the company to move into Phase 2 accelerate on January 1, 2026.

That's clear. And if we take a step back and we look at capital allocation in general and maybe also in the shorter term, if you can sort of frame your prioritization between M&A, returning cash to shareholders and how we navigate through that in the next couple of years through the Action Agenda?

What I would say there is we're going to come back at the beginning of 2026 with a better sense of what our capital allocation priorities are. We want to take 2025 and really execute this project momentum exercise to the highest level. That will give us a better chance to really realize what our top line is looking like. It will give us a chance to really put the resources behind SUBLOCADE to build that momentum. And also, as we work through this exercise of looking at our cost structure, the complexity, it will give us a chance to see what our bottom line looks like as well. So when you add all those up, by the end of '25, we'll have a better view of where we stand with those optionalities going into '26.

That's clear. Okay. So maybe one last question for you, Joe. You've delivered an earnings beat. You -- I mean, as a team, you raised guidance, you simplified the listing structure of the company. You announced the strategic plan and the market reacted very well to all of these initiatives. Share price has performed very well over the last few months. So do you still believe the stock is meaningfully undervalued from here? And what are the key areas of misunderstanding from the market?

Yes. So I appreciate the question. I do believe there continues to be a gap between the intrinsic value of the company and where it is that our shares are trading. I think that one, people get but maybe underestimate the durability and what a great growth driver SUBLOCADE is and the potential that it has on a going-forward basis. And then the second thing to be very candid, is I think people are underestimating just how inflated the cost structure is and how we have the ability to make every investment, in fact, overinvest in support of SUBLOCADE and driving long-acting injectable penetration and then meaningfully change the view of the earnings potential and cash generation of this business.

That's very clear. We're getting close to the end of the time. So thank you very much for your time today and for joining us at the conference.

Thank you.

Thanks, Thibault.