Indivior Pharmaceuticals Inc Q4 FY2025 earnings call

业务进展概述

2025年是公司的转型年，推进Indivior Action Agenda，成功完成第一阶段“Generate Momentum”，实现财务目标。改善商业执行，Sublocate净收入创纪录；推出直接面向消费者活动“Move Forward in Recovery”；加强财务状况，支付2.95亿美元解决遗留司法部事项。

2026年计划

执行Indivior Action Agenda第二阶段“Accelerate”，期望加速Sublocate配药单位增长和净收入，提升调整后EBITDA和现金流。

商业更新

Pat介绍，第四季度Sublocate配药单位同比增长12%，环比增长6%，新患者启动同比增长25%，活跃处方医生数量增加；持续改进商业执行，包括优化现场团队信息传递、提升商业渠道生产力、促进患者激活和新启动、推动政策以扩大治疗获取；启动直接面向消费者活动，看到早期成功迹象，如患者提示知名度提升、品牌在线搜索量增加等。

2025年，Sublocate净收入达856百万美元，较2024年增长13%，总净收入为1.24亿美元，较上年增长4%。调整后EBITDA较2024年增长20%至428百万美元，且利润率显著改善。2026年运营费用将不超过450百万美元。Sublocate是治疗中重度阿片使用障碍的首要长效注射剂，为每月一次的长效注射剂，已为超47.5万人开具处方，拥有12项2031至2038年的橙色书列表专利。

2026年期望Sublocate配药单位实现中高个位数增长，净收入中点增长8%；调整后EBITDA中点增长30%；总净收入预期在11.25亿至11.95亿美元之间，Sublocate净收入预期在9.05亿至9.45亿美元之间；公司宣布董事会授权4亿美元股票回购计划。

Q: Joe, I wanted to get your thoughts, just taking a step back, on where you think penetration of LAI buprenorphine modalities ultimately could go to, or what you think would be a reasonable way to think about peak penetration of the category in the OUD space. And then secondly, how should we think about share versus your competitor. Obviously, the goal is growing volumes here. And that's been the focus. But there's a lot of, I think, investor focus on your share, even though the pie, so to speak, continues to grow. So I'm wondering if you can give us some thoughts on share. That would be helpful. And then lastly, You mentioned capital deployment in your prepared remarks. I wanted to get some more detailed thoughts on business development. What kind of therapeutic adjacencies or other therapeutic areas are you looking at? My assumption is that you're looking at commercial stage assets, but wanted to get more details on your thought process regarding this.

A: Thanks, David. So, look, I appreciate your questions. First off, with regards to LAI penetration, we're now embarking upon 9%. So we have to confront the reality of where we are, and we believe there is significant opportunity to continue to grow LAI penetration. We believe that long-acting injectables are underutilized. I'm not going to get into peak penetration projections. However, I will share with you some analogs and data we look at that will give a sense of what is possible. So if you look at categories, Like schizophrenia, as an example, from a long-acting injectable perspective, you would see penetration at 30%. I can assure you we have a lot of market research here at Indivier that would support LAI penetration in the range of 20% to 30%. My final comment on LAI penetration is we are committed, as the long-standing leader in the space, to doing everything that we can to educate and activate consumers with regards to the important role that long-acting injectables can play. As it pertains to your question on share, what I would emphasize on share, and you're correct, our focus is really first and foremost about driving the market. From a share perspective, we have seen over many quarters our market share stabilizing in the mid-70%. I would emphasize that we're the only entity in the world that has perfect data on the vast majority of the market, and we've been applying a consistent methodology. Importantly, what we are most focused on is new patient share, which has been very strong, as has the absolute number of new patients. We're pretty routinely now achieving all-time highs in new patient starts. And then to your final question on capital deployment, look, there's nothing, our start point is there are no commercial assets in the space of opioid use disorder that we believe are there that would enhance our portfolio. Once we made that determination, we'll be establishing a new strategic beachhead in a new therapeutic area. I won't say we're agnostic. There are certainly some areas we wouldn't go into, like cancer gene therapy. But what we're focused on are business fundamentals. So we're looking at commercial stage only. We're looking for assets that have peak sales potential of greater than $200 million. It's important to us that the products have a long runway. One of the strengths of the Indivior story is we have a great growth driver with a durable runway and sublocate. So we want to acquire assets that have runway that goes towards the mid to end of 2030 at a minimum. And then, of course, we want differentiated assets. We're not interested in being an aggregator of commoditized brands. We feel that's important from a patient value perspective. But also, when you look at it from a reimbursement perspective, we believe to get the coverage necessary to be successful commercially, that you have to have meaningfully differentiated products.

Q: Good morning, guys. Congrats on the results here, and thanks for taking the questions. Maybe just first digging in a little bit more to guide. Can you just kind of delineate what your guidance assumes from an LAA market growth perspective in 26? And then, you know, to ask Dave's question just a little bit differently on the share, what does it assume for share in 2026? Just kind of zooming in on the guide specifically, Joe.

A: Yeah, Chase, thanks for the question. On the sublocate guide, I'm not going to get into an LAI penetration assumption. We're assuming mid-teen sublocate growth, which is a significant step up from where it is that sublocate was in 2025. And I will comment on a market share perspective. We do expect to see continued stabilization of sublocate market share. And just as we wrap up 2025, you know, like you had mentioned, you guys kind of have perfect data. Can you just kind of update us on what LAI market growth was in 2025? And then my last question, Joe, is just a little bit more, you know, I'd appreciate some more thoughts on kind of buyback versus M&A. It's just kind of where they are on the priority list. Is this something where you'll kind of be opportunistic on M&A and in the meantime, you know, you guys will be, you know, fairly aggressive on the buyback as far as that being kind of the primary capital allocation after you service your debt, of course.

A: Yeah, in LAI category growth for Q4, we were approaching 18%. And so, again, really strong category growth. Hey, Chase, good morning. So when it comes to capital allocation, you know, due to our financial strengths and the strong cash flow from the business, we have options here. And it's not about or, it's about and. And if you start with the debt, you know, right now we do have expensive debt, but it's part of our normal cadence. It is something that we are looking at and it is something that, you know, we will take care of in the near future. If you look at the share repurchase, This is another option we have to deliver value to our shareholders. We authorized the $400 million program to be ready to be prepared to buy back shares and be opportunistic. That decision will be made in the context of what else is going on in the business at that point in regards to the debt conversation, BD, making sure we have the right capacity for investments behind sublocates. And then also, You know, we need to evaluate if there's still a gap between the share price and what we believe the value of the company is. And then finally, when it gets to the business development, you know, we're still earning our way to phase three, the breakout, where, as Joe just said, you know, we're going to look at BD, including buying commercial assets. So overall, we are definitely focused on driving shareholder value.

Q: Hi, good morning. Thanks for taking our questions. I have two. So number one, what are your thoughts on the overall Medicaid funding landscape and the potential impact on sublocates from less funding in 2027, and how confident are you around maintaining that mid-teens unit growth in the U.S. in 2027 and after. And then number two, on SG&A, I'm just curious about the shape of SG&A in 2026, given it was 148 in Q4. And if you can comment on how much you are spending on DTC in 26, and, you know, at what point would you reevaluate that DTC spend in terms of growing or shrinking that?

A: Dennis, thanks for the question. First off, with regards to DTC, we're not going to get into how much we're spending for competitive reasons. What I will assure you is we're making every investment in support of it, and we're actually over-investing beyond what our models would suggest that we should. We're also committed to investing behind DC at those levels. for a multi-year period, because at the end of the day, the most important thing that we can do is educate and drive long-acting injectable penetration. As it pertains to Medicaid, I'm not going to get into, we're just starting 2026, what we think growth would look like in 2027. What I can tell you is, one, we advocate for and are hopeful from a humanistic perspective, that everybody who should be supported by Medicaid is supported. We believe that overall, if you look at the various legislation, it's generally supportive, and we view that as a bipartisan support to helping people with substance use and opioid use disorder. And then the final point I would make at eight, nine percent long-acting injectable penetration, there is so much opportunity for growth with sublocate across the board inclusive of Medicaid, it will not be impacted whether Medicaid population is plus or minus a certain percentage. And then I'll give Ryan the opportunity to comment on SG&A.

A: Yeah, good morning. In regards to the step up in Q4, that was simply us taking advantage of our DTC campaign tested really well, and we had the opportunity to start it early. So that's the expense you're seeing in Q4. And around phasing for 2026, our quarters are relatively flat. You may see some skew to the first three quarters just due to the campaign we have in place.

Q: Hi. Thanks, guys. Thanks for taking the questions. First one would be on the sublocate and the guide. Just so, I guess, to understand it properly, obviously, you had meaningful gross to net benefits. So is the idea that we adjust for that, take that off in terms of the underlying, I guess, base for sublocate that gets you, if you're doing mid-teens, that gets you to the range that you've guided to? As in, I'm trying to compare the 8% net revenue guide versus your mid-teens guidance in dispensed growth.

A: Thanks for the question, Christian. So look, in 2025, gross to net served as a tailwind. In 2026, gross to net will serve as a headwind to the business. So the key component of the guide is the following we're going to grow and accelerate the spent unit growth to the mid-teens and we're assuming that we're going to continue to see a stabilization of market share Q: and then on the um i i guess just obviously you know funny enough you go if we're going back to the capital markets day 2022 the you talked about an exit rate to, you know, billion-dollar exit rate by the end of 25. You've actually gone and actually done that. So I guess any observations about, you know, the potential to breach that billion-dollar number?

A: Yeah, so look, I appreciate the question. We're not going to get into any peak sales projections, any – forward-looking when we're going to hit certain thresholds. What we're focused on is delivering on the financial commitments that we made to everyone for 2026. And the final comment I would make there is we are very confident with Sublocade that we have a durable growth driver. And I think we're just scratching the surface on the potential of this asset, both from a business perspective, but candidly, more importantly, and the potential it has to make a difference in a positive way in the lives of people living with opioid use disorder in the communities that we serve.

Q: And my final one, if I can, maybe just to clarify a previous comment around new assets. And he talks about being well served, obviously, in OUD. But in terms of, and they seem to apply other therapeutic areas, but would that include other addiction areas? or is it outside addiction?

A: Yeah, so look, I appreciate the question. First thing我 want to emphasize, we're head down in phase two accelerate, and we've been clear we need to earn our way to phase three breakout. I would not have an expectation that anything we do from an acquisition perspective would be focused on opioid use disorder or substance use disorder. So I would think of different therapeutic areas than that, but I would bring you back to the business fundamentals that will really drive what it is that we're looking to achieve. Commercial stage, peak sales potential greater than $200 million, a long and durable runway in front of it, and a differentiated asset that would deliver both patient value and enable us to get the reimbursement we feel is necessary to be successful commercially.

Q: Hi, thanks very much for taking my question. Maybe just a quick one for me. Can you just talk about the contribution from the criminal justice system opportunity in your 2026 sublocate guidance?

A: Yeah. Thanks Brandon. I'm going to give that one to Pat. I appreciate the question Brandon. We see the criminal justice segment as a strong opportunity for us. We see it as a rebase business and from there we believe we can grow. Also, Sublocate is a differentiated asset. It's the only monthly with a long-acting injectable monthly with the rapid induction and you have prescribers that are familiar and comfortable with it. So in that context, we do believe it can contribute to the growth that we're guiding to on mid-teens. But obviously, we're looking at the broader opportunity while CJS is a part of it. We're looking at the opportunity as the category leader to continue to fuel and grow the overall LAI category.

Q: Yes, thank you. And thank you for the clarification on sublocate guidance between the 15% and the 8%. There's also another element. It's small, but sublocate XUS, how should we think about that line of revenues given the organization changes they've made? You've made, sorry. So should we expect this to To stabilize, could it decline next year? Just if you could help us on that. And then just on R&D, obviously you're going to have two phase three go-no-go decisions in the next few weeks. And how should we think about the impact of the different scenarios on your OPEX guidance if you take zero, one, or two assets to phase three?

A: Sure. I'll let Ryan take the first question, and then Christian and I will split the second.

A: Good morning. So on sublocating the rest of the world, It's going to be relatively flat year over year. We will see growth in Australia and Canada, but we will lose some of the volume coming out of the Nordics.

A: Okay. And then with regards to R&D, I'll let Christian comment on the programs and timing of the Phase 2 readouts. What I would tell you is our budget for 2026 contemplates if we have the opportunity to advance those programs that is built into the operating budget that we're working towards. Christian?

A: Yes, so based on what Joe just said, the two phase two trials were completed at the end of the fourth quarter last year. We are now going through the traditional process of data cleaning, data closeout, and statistical programming. This will be followed by a database log by the end of the first quarter. this year with the final tables, figures, and listings available in the second quarter of this year for preparation of top-line results on both concepts. Now, I must add that in addition for IMDb 6001, in addition to the Phase II data, the decision to proceed to late-stage clinical development, that is the Phase III, hinges on three additional factors. First, the manufacturing feasibility and the availability of the drug product for the actual phase three. Second, we are currently running a payer validated differentiation and evidence that is going to be required for coverage based on the target product profile research. And then three, the impact of that research. on the clinical phase three trial design if indeed this is what the business decides to do.