Indivior Q1 2026 Earnings Report

Indivior EPS Results

• Actual EPS: $0.96
• Consensus EPS: $0.64
• Beat/Miss: Beat by +$0.32
• One Year Ago EPS: N/A

Indivior Revenue Results

• Actual Revenue: $317.00 million
• Expected Revenue: $272.84 million
• Beat/Miss: Beat by +$44.16 million
• YoY Revenue Growth: N/A

Indivior Announcement Details

• Quarter: Q1 2026
• Date: 4/30/2026
• Time: Before Market Opens
• Conference Call Date: Thursday, April 30, 2026
• Conference Call Time: 8:00AM ET

Indivior (NASDAQ:INDV) (NASDAQ: INDV) is a specialty pharmaceutical company focused on developing and commercializing treatments for substance use disorders and serious mental health conditions. The company’s primary focus is opioid use disorder, with products designed to support patients through medication-assisted treatment and recovery.

Indivior’s portfolio includes Sublocade, an extended-release injectable formulation of buprenorphine; Suboxone, a buprenorphine and naloxone product available in sublingual formulations; and Perseris, an extended-release injectable formulation of risperidone for schizophrenia. The company also markets Opvee, a nalmefene nasal spray intended for the emergency treatment of opioid overdose in adults and pediatric patients.

The company was established as an independent business in 2014 following its separation from Reckitt Benckiser. Indivior is headquartered in Richmond, Virginia, and serves patients and healthcare providers primarily in the United States, as well as in selected international markets. Its products are distributed through healthcare providers, pharmacies and other treatment channels.

Indivior is led by Chief Executive Officer Mark Crossley. The company continues to focus its research, development and commercial activities on expanding access to treatments for opioid use disorder and addressing other conditions associated with addiction and mental health.

Indivior Q1 2026 Earnings Call Transcript

Key Takeaways

• Positive Sentiment: Strong commercial momentum — Q1 total net revenue was $317M (+19% YoY) driven by SUBLOCADE net revenue of $232M (+32% YoY), 20% dispense unit growth, record ~31,800 new patient starts, and over 500,000 U.S. patients prescribed since launch.
• Positive Sentiment: Raised full‑year outlook and margin expansion — management increased 2026 guidance with expected SUBLOCADE revenue $950–990M and Adjusted EBITDA $620–660M (midpoint $640M), targeting a ~51% EBITDA margin driven by unit acceleration and favorable mix.
• Positive Sentiment: Improved balance sheet and capital allocation optionality — completed a $500M convertible note refinancing (reducing interest to 0.625%), repurchased $125M of shares and has roughly $275M remaining on the buyback, while signaling pursuit of commercial‑stage M&A opportunities.
• Negative Sentiment: Pipeline reprioritization and setbacks — INDV‑6001 will not advance to Phase III (rights amended with Alar; Indivior retains U.S. commercial rights) and INDV‑2000 failed its Phase II primary endpoint, so both programs will be de‑emphasized internally and positioned for external business development.

Presentation

[Operator]

Good day, and thank you for standing by. Welcome to the Indivior Pharmaceuticals Q1 2026 financial results conference call and webcast. At this time, all participants are in listen only mode. After the speaker's presentation, there will be the question-and-answer session. To ask a question during the session, you need to press star one one on your telephone keypad. You will hear an automatic message advising your hand is raised. To withdraw your question, please press star one and one again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to our first speaker today, Jason Thompson. Please go ahead.

[Jason Thompson, VP of Investor Relations at Indivior Pharmaceuticals]

Thanks, Nadia, welcome to Indivior's first quarter 2026 results conference call. I'm joined today by Joe Ciaffoni, Chief Executive Officer, Patrick Barry, Chief Commercial Officer, Ryan Preblick, Chief Financial Officer, and Christian Heidbreder, our Chief Scientific 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 two of this presentation. We also may refer to non-GAAP measures, the reconciliations for which may also be found in the appendix of this presentation that is now posted on our website at indivior.com. I'll now turn the call over to Joe Ciaffoni, our CEO.

[Joe Ciaffoni, CEO at Indivior Pharmaceuticals]

Thanks, Jason. Good morning, and thank you for joining us on today's call to review our first quarter results. I will begin with an overview of our performance and summarize our progress against phase II accelerate of the Indivior Action Agenda. Pat will discuss SUBLOCADE performance, Christian will provide an update on the pipeline, Ryan will review the financials. In the first quarter, we made significant progress in phase II of the Indivior Action Agenda executed key elements of our capital deployment strategy. Specifically, in the quarter, we grew total net revenue 19% year-over-year to $317 million, primarily driven by strong U.S. SUBLOCADE performance. We grew total SUBLOCADE net revenue 32% year-over-year to $232 million, reflecting strong year-over-year dispense unit growth of 20%.

[Joe Ciaffoni, CEO at Indivior Pharmaceuticals]

The acceleration in SUBLOCADE dispense unit growth was driven by improved commercial execution and the early impact that our new consumer campaign, Move Forward in Recovery, is having on patient activation. Importantly, SUBLOCADE category share was stable in the quarter, and we had record new patient starts. We delivered adjusted EBITDA of $164 million, up 112% year-over-year and margin improvement of 23 percentage points. We successfully executed our capital deployment strategy, improving our debt profile through the issuance of $500 million of convertible notes and returned value to our shareholders by repurchasing $125 million of our shares at an average price of $31.45.

[Joe Ciaffoni, CEO at Indivior Pharmaceuticals]

Our strong first quarter performance and the underlying strength of SUBLOCADE across key metrics, along with a more favorable outlook for SUBOXONE, enabled us to meaningfully raise our 2026 financial guidance. I wanna thank the Indivior team for their contributions to our progress against the Indivior Action Agenda and for their commitment to making a positive difference in the lives of people living with opioid use disorder and the communities we serve. In phase two accelerate, we are focused on accelerating U.S. SUBLOCADE dispense unit growth and net revenue throughout 2026 and growing adjusted EBITDA and cash flow at an even faster rate. In the first quarter, we achieved a major milestone. Over 500,000 patients in the U.S. have been prescribed SUBLOCADE since its launch in 2018. Nearly 1/4 of those patients were added in the last five quarters, underscoring SUBLOCADE's strong growth trajectory.

[Joe Ciaffoni, CEO at Indivior Pharmaceuticals]

SUBLOCADE is the first and number one prescribed long-acting injectable for the treatment of moderate to severe opioid use disorder. It is the only monthly long-acting injectable with an indication for rapid initiation. Looking forward, we believe continuous improvement in commercial execution and our commitment to significant and sustained investment in our new direct-to-consumer campaign will accelerate U.S. SUBLOCADE dispense unit growth to the mid-teens in 2026, up from 7% in 2025. We now expect total SUBLOCADE net revenue to grow 13% year-over-year to $970 million at the midpoint of our guidance. As expected, our new operating model established in phase I generate momentum of the Indivior Action Agenda is accelerating the growth of adjusted EBITDA and cash flow at a significantly faster rate than net revenue.

[Joe Ciaffoni, CEO at Indivior Pharmaceuticals]

We now expect to generate $640 million of adjusted EBITDA in 2026 at the midpoint of our guidance, up 50% versus the previous year, which equates to a 51% margin, up 16 percentage points versus 2025. Our increased cash flow and improved financial flexibility position us to strategically deploy capital to create value for our shareholders. With the completion of our debt refinancing, our capital deployment priorities are focused on opportunistically utilizing the remaining $270 million of our share repurchase program and evaluating commercial stage business development opportunities to enhance and diversify Indivior's growth profile. We are on track to enter phase III of the Indivior Action Agenda breakout in the second half of this year. Next, I wanna briefly touch on the decisions we made on the INDV-6001 and INDV-2000 programs.

[Joe Ciaffoni, CEO at Indivior Pharmaceuticals]

We do not intend to pursue phase III development of INDV-6001, and have amended our license agreement with Alar Pharmaceuticals. Pursuant to these amendments, Alar will regain development rights to the asset and commercialization rights outside of the U.S. Indivior will maintain commercial rights in the U.S. Regarding INDV-2000, it did not meet the primary endpoint in the phase II trial, and additional work is needed to further explore the initial signals we observed. We will not be progressing the program internally for opioid use disorder, and we will pursue external business development opportunities for this asset. Christian will provide more detail. I want to recognize and thank our R&D colleagues for leading with science and for the hard work they put into the INDV-6001 and INDV-2000 programs.

[Joe Ciaffoni, CEO at Indivior Pharmaceuticals]

Their efforts greatly advanced our understanding of these assets, and their work was high quality and conducted with integrity. To conclude, we are encouraged by our progress so far in 2026. Our results strongly position us to achieve our financial and operational objectives in phase II Accelerate and to enter phase III Breakout in the second half of 2026. I'll now turn the call over to Pat.

[Patrick Barry, Chief Commercial Officer at Indivior Pharmaceuticals]

Thanks, Joe. Our commercial teams are executing well against phase II of the Indivior Action Agenda, Accelerate. This acceleration is being driven by our commercial execution initiatives and our consumer activation investments, notably our successful DTC campaign, Move Forward in Recovery. We achieved record new patient starts in the first quarter of approximately 31,800, a year-over-year increase of 29%. This brought our total U.S. SUBLOCADE patients treated over the last 12 months to 191,600 at the end of the first quarter. Dispense unit growth in the first quarter was up 20% versus the prior year, reflecting acceleration in U.S. SUBLOCADE versus 2025. Total category share of LAIs in the U.S. for SUBLOCADE remained stable at 76%.

[Patrick Barry, Chief Commercial Officer at Indivior Pharmaceuticals]

We continued our track record of growing the number of SUBLOCADE prescribers, which is an important leading indicator for overall LAI category and SUBLOCADE growth. We exited the first quarter with a record number of active SUBLOCADE prescribers and those treating five or more patients. Total active SUBLOCADE prescribers grew 19% year-over-year, and HCPs treating five or more patients grew 20% year-over-year. While we are encouraged by the progress in U.S. SUBLOCADE, we see continued opportunity to drive further acceleration through our commercial improvement, consumer activation, and public policy initiatives. First, SUBLOCADE is the only monthly long-acting injectable with an indication for rapid initiation on day one and a second dosing as early as day eight. Our focus on delivering the second dose as early as day eight is driving increased adoption.

[Patrick Barry, Chief Commercial Officer at Indivior Pharmaceuticals]

Providers' recognition of SUBLOCADE's differentiated label continues to grow, particularly as synthetic opioids remain prevalent in the U.S. Approximately 9% of new patients are receiving the accelerated second dose, and 23% of active HCPs have begun prescribing a second dose in line with the expanded SUBLOCADE label. Second, our commercial channel productivity initiative is generating results. We executed five enhanced service agreements with key specialty pharmacies and have started to see steady improvement in commercial dispense yields. Third, consumer activation remains strong. We continue to invest behind SUBLOCADE through our DTC campaign, Move Forward in Recovery. Patient engagement stayed elevated throughout the quarter, with more than 1,200 new CRM enrollments each month, bringing total engaged consumers to over 8,300 since launch. Paid search volumes remain above pre-campaign levels, with category-leading share of voice across core search terms.

[Patrick Barry, Chief Commercial Officer at Indivior Pharmaceuticals]

Additionally, over 30,000 people searched for a SUBLOCADE provider with the Find a SUBLOCADE Treatment Provider tool on the SUBLOCADE website in the first quarter. To close, we are encouraged by our start to 2026. We believe that our improved commercial execution focused on sharpened message delivery with higher utilization of SUBLOCADE's core promotional materials on every call, along with our efforts directed at improving specialty pharmacy performance and consumer activation are having impact on new patient starts, mix, and acceleration in SUBLOCADE dispense units. We are confident that as we continue to get better, SUBLOCADE will do better and that we are on track to achieve our raised 2026 guidance for SUBLOCADE. I will now turn the call over to Christian.

[Christian Heidbreder, Chief Scientific Officer at Indivior Pharmaceuticals]

Thank you, Pat. I will now provide an update on our R&D pipeline starting with INDV-6001. INDV-6001 delivered meaningful scientific and regulatory progress during the year, achieving its principal phase II objectives, including a supportive safety profile, predictable pharmacokinetics consistent with modeling, and constructive engagement with the FDA. As part of our portfolio review, we evaluated INDV-6001 in the context of the evolving long-acting injectable buprenorphine landscape. In our review, SUBLOCADE is the only once-monthly long-acting injectable buprenorphine with a rapid initiation pathway in the approved label, continues to set the clinical and commercial standard in this category. SUBLOCADE's ability to achieve and maintain differentiated plasma concentrations without a complex induction regimen represents an important benchmark for future products.

[Christian Heidbreder, Chief Scientific Officer at Indivior Pharmaceuticals]

While INDV-6001 successfully demonstrated extended dosing intervals, including exploration of dosing up to three months, further analysis identified challenges, specifically, achieving clinically meaningful plasma concentration profiles, particularly in a treatment environment shaped by high-potency synthetic opioids, was anticipated to require more complex induction protocol relative to SUBLOCADE's established approach, introducing additional development and implementation considerations. In addition, a comprehensive review of late-stage development and commercialization factors highlighted some remaining challenges, including, one, manufacturing scalability, and two, limited anticipated clinical and commercial differentiation in the payer and prescriber landscape, and the resulting impact on pricing and reimbursement dynamics. As a result, we have decided not to advance INDV-6001 into phase III clinical development and have amended our license agreement with Alar Pharmaceuticals. Pursuant to these amendments, Alar will regain development rights to the asset and commercialization rights outside of the U.S.

[Christian Heidbreder, Chief Scientific Officer at Indivior Pharmaceuticals]

Indivior will maintain commercial rights in the U.S. Turning to INDV-2000. In a phase II proof of concept study, our selective orexin-1 receptor antagonist under evaluation as a novel, non-opioid treatment for opioid use disorder did not meet the pre-specified primary endpoint of no treatment failure over 12 weeks when evaluated across the full dose range, 100, 200, and 400 mg versus placebo. Interpretation of the overall dose response was confounded by unanticipated underperformance at the 400 mg dose and a higher than anticipated placebo response. While this phase II study does not support advancing INDV-2000 internally in opioid use disorder, we are encouraged by the broader body of data that emerged from the trial. Importantly, prospectively planned sensitivity analysis, together with converging supportive findings, identified a credible and biologically coherent signal at the 200 mg dose.

[Christian Heidbreder, Chief Scientific Officer at Indivior Pharmaceuticals]

At that dose, we observed higher abstinence rates over time versus placebo across cocaine and broader polysubstance use, including cocaine, methamphetamine, amphetamine, benzodiazepine, and opioid in combination. While these findings are exploratory, they are directionally consistent with the underlying orexin-1 mechanism and its potential role in cue-driven drug seeking, stress reactivity, and relapse vulnerability. We also saw supportive directional improvements in anxiety symptoms, as well as exploratory functional MRI findings that aligned with the clinical observations and further supported the biological activity of INDV-2000. Taken together, these results strengthen our confidence that the molecule is engaging relevant relapse-related pathways. Importantly, INDV-2000 demonstrated a favorable safety and tolerability profile with no major drug-related safety signal identified.

[Christian Heidbreder, Chief Scientific Officer at Indivior Pharmaceuticals]

While we do not plan to pursue development internally in opioid use disorder, we believe these findings support continued evaluation of 200 mg as the lead dose and position INDV-2000 as a credible business development opportunity while we continue to strengthen the data package through additional analysis, including exposure-response work and further evaluation of supportive clinical and mechanistic findings. These decisions are expected to have a significant impact on the R&D organization. However, it does not reflect the quality of the underlying science or the team's execution. We are grateful for the rigor, dedication, and high-quality work of our R&D team, whose efforts advanced these programs and generated valuable scientific and regulatory insights that will inform future innovation. I will now turn the call over to Ryan.

[Ryan Preblick, CFO at Indivior Pharmaceuticals]

Thanks, Christian. We are encouraged by our overall financial performance this quarter, which includes strong year-over-year total SUBLOCADE net revenue growth and even stronger adjusted EBITDA growth. Looking at our results in more detail, starting with the top line, total net revenue of $317 million for the first quarter increased 19% versus the prior year period. The increase was driven by strong SUBLOCADE net revenue growth in the U.S. Total SUBLOCADE net revenue of $232 million for the quarter increased 32% versus the prior year period. U.S. SUBLOCADE net revenue increased 33% versus the prior year to $218 million. Q1 net revenue growth was primarily driven by dispensed unit volume growth of 20% and favorable price mix.

[Ryan Preblick, CFO at Indivior Pharmaceuticals]

The first quarter included a gross-to-net benefit of $14 million. Turning to SUBOXONE Film net revenue, in the first quarter, we benefited from continued generic price stability in the U.S., moderated share decline, and favorable gross-to-net adjustments. As we said in February, we expect gross-to-net adjustments to serve as a headwind in 2026 for both SUBLOCADE and SUBOXONE. Total non-GAAP operating expenses were $116 million for the first quarter, down 21% versus the prior year. The decrease was primarily driven by reductions in headcount, the restructuring of the R&D and Medical Affairs Organizations, and footprint consolidations as part of phase I of the Indivior Action Agenda generate momentum.

[Ryan Preblick, CFO at Indivior Pharmaceuticals]

Looking at the bottom line, we generated record adjusted EBITDA of $164 million, an increase of 112% year-over-year, representing margin improvement of 23 percentage points. Our strong first quarter results and performance trends year-to-date led us to raise our 2026 financial guidance. We now expect total net revenue in the range of $1.215 billion-$1.285 billion, an increase of 1% compared to 2025 at the midpoint of our guidance range. This is primarily driven by stronger SUBLOCADE net revenue, which we now expect to be in the range of $950 million-$990 million, up 13% year-over-year at the midpoint.

[Ryan Preblick, CFO at Indivior Pharmaceuticals]

The increase in SUBLOCADE guidance reflects an improved outlook from an acceleration in dispense units based on strong trends year-to-date and favorable mix related to our progress on increasing commercial dispense yields. Our total net revenue guidance also reflects higher U.S. SUBOXONE Film net revenue based on year-to-date results, where we saw stable pricing and moderation in share decline. Our outlook for operating expenses remains unchanged at $430 million-$450 million. We now expect adjusted EBITDA for 2026 to be in the range of $620 million-$660 million, a year-over-year increase of 50% at the midpoint. This would represent an improvement of 16 percentage points in our adjusted EBITDA margin to 51% compared to 2025.

[Ryan Preblick, CFO at Indivior Pharmaceuticals]

We ended the quarter with gross cash investments of $201 million, and we are projecting forward leverage of 0.8 times based on the midpoint of our 2026 adjusted EBITDA guidance. In 2026, we expect to generate approximately $340 million in cash flow from operations, enabling us to strategically deploy capital. Our capital deployment priorities include managing our debt, returning value to shareholders through opportunistic share repurchases, and evaluating business development opportunities as we earn our way to phase III of the Indivior Action Agenda breakout. In the first quarter, we managed our debt by completing an upsized $500 million senior convertible notes offering due in 2031. Most of the proceeds were used to repay the remaining $333 million balance on the previous term loan.

[Ryan Preblick, CFO at Indivior Pharmaceuticals]

This both increases our financial flexibility and significantly reduces our interest rate to 0.625% from 9.5%. We also returned capital to our shareholders through opportunistic share repurchases in the first quarter. We repurchased 4 million shares at an average price of $31.45 for a total of $125 million. We have $275 million remaining on the $400 million program through mid-2027. In total, over the past five years, we have bought back $525 million of our shares at an average price of $16.74. As we earn our way to phase III Breakout, we will evaluate business development opportunities specifically focused on commercial stage assets that have the potential to enhance and diversify our growth profile. I'll now turn the call back to Joe for concluding remarks.

[Joe Ciaffoni, CEO at Indivior Pharmaceuticals]

Thanks, Ryan. The first quarter reflects our significant progress against phase II of the Indivior Action Agenda, accelerate. We delivered strong top and bottom line growth driven by SUBLOCADE's performance in the U.S. and leverage from our simplified operating model, enabling us to meaningfully raise our 2026 financial guidance. We also executed on our capital deployment strategy by successfully managing our debt and opportunistically utilizing our share repurchase program. We are on track to accelerate SUBLOCADE throughout 2026 and adjusted EBITDA and cash flow at an even faster rate as we earn our way to phase III of the Indivior Action Agenda breakout in the second half of 2026. We will now open the call for questions. Operator?

[Operator]

Thank you so much. Dear participants, as a reminder, if you wish to ask a question, please press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. Now we're going to take our first question, and it comes from the line of David Amsellem, Piper Sandler. Your line is open, please ask your question.

[David Amsellem, Analyst at Piper Sandler]

Thanks. I have a few. First, on the gross margins, there's some improvement here and with the manufacturing transition, should we take that to mean that you could see manufacturing at even better gross margins going forward? Help us just understand how to think about gross margins going forward. That's number one. Number two, business development and M&A. I know, Joe, you've talked about a beachhead in another therapeutic category. I was wondering if you could elaborate on that and what therapeutic categories, broadly speaking, are of interest?

[David Amsellem, Analyst at Piper Sandler]

Lastly, on the accelerated second dosing, can you talk about how getting patients to receive that accelerated second dose is correlated with this overall persistence, and how important that is? If you had color on that earlier in your prepared remarks, sorry, I missed that. Love to get your thoughts on how that accelerated second dose plays a role in patient persistence. Thanks.

[Joe Ciaffoni, CEO at Indivior Pharmaceuticals]

Okay. Thanks, David. We'll let Ryan kick it off with the gross margins.

[Ryan Preblick, CFO at Indivior Pharmaceuticals]

Hey, David. Good morning. Thanks for the question. For the gross margins, I would still guide you to the full mid-80% guide. Q1 did benefit from a couple of things. One, we had the prior year releases, and two, we had positive manufacturing variances built in there as well. In regards to the plan, the primary focus on the manufacturing facility is to secure product security. Again, I would guide you to the mid-80s for margins for the year.

[Joe Ciaffoni, CEO at Indivior Pharmaceuticals]

Okay. Pat, on the accelerated second dose?

[Patrick Barry, Chief Commercial Officer at Indivior Pharmaceuticals]

Yeah. Thank you for the question, David. On the accelerated second dose, that's an important differentiator for us because with the only LAI with that accelerated second dose, the benefit there is that you're achieving peak plasma levels early, as early as day eight. That's an important component to be able to get the patient doing well in the very early of treatment. Peak plasma levels is particularly important in the era of synthetic opioids. If they're doing better early and they're stabilized early, we believe that over time, that could help with persistency, but that's certainly something we'll continue to look at.

[Joe Ciaffoni, CEO at Indivior Pharmaceuticals]

Okay. From a BD perspective, David, as we earn our way to the breakout phase, which we believe we're on track to do in the second half of this year, we're, I would say, therapeutically agnostic, although there are certainly areas we don't think we would go into, for example, like oncology, and we're more focused on the fundamentals of what we would acquire. We are focused commercial stage only. We're looking for assets that have greater than $200 million peak sales potential. We think that's relevant relative to the size of our revenue base as we seek to enhance and diversify our growth profile. Differentiated assets are important from our perspective, both from a patient value perspective and importantly from a reimbursement perspective, which we think is critical to commercial success.

[Joe Ciaffoni, CEO at Indivior Pharmaceuticals]

The final thing I would highlight, because I think it's one of the real strong parts of the Indivior story, is that with SUBLOCADE, we have a durable growth driver. The third thing that will be important in anything we acquire is that those assets also have runway. From there, post-integration of an acquisition, we then would be looking to identify individual products that could leverage the new commercial infrastructure that we have in place.

[David Amsellem, Analyst at Piper Sandler]

Okay, helpful. Thanks.

[Joe Ciaffoni, CEO at Indivior Pharmaceuticals]

All right. Thank you, David.

[Operator]

Thank you. Now we're going to take our next question. It comes to line of Chase Knickerbocker from Craig-Hallum. Your line is open, please ask a question.

[Chase Knickerbocker, Analyst at Craig-Hallum]

Good morning. Thanks for taking the questions and congrats on another nice quarter here. Maybe just first for Ryan, you know, there's been some continued gross-to-net benefit on a year-over-year basis. I mean, maybe just focusing on SUBLOCADE, can you just give us a sense for how you kinda characterize that gross-to-net benefit a little bit more and then give us a sense for how you expect it to kinda roll off through the year? Thanks.

[Ryan Preblick, CFO at Indivior Pharmaceuticals]

Yeah, Chase, good morning. Thanks for the question. Yes, in Q1, we did book $14 million of a prior year release as we continue to true up our accruals. As we mentioned earlier, in totality, we still expect the prior year releases to serve as a headwind for the balance of 2026. The plan is to continue to provide you an update each quarter.

[Chase Knickerbocker, Analyst at Craig-Hallum]

Could you just maybe give us a sense for kinda the cadence of kinda that headwind through the year, and if there's any kinda benefit you expect in Q2 as well? Just second from me, guys, maybe just taking a step back, for Joe. If you look at kinda INDV-6001 here, again, maybe just taking a step back with the potential for BRIXADI generics, you know, before SUBLOCADE LOE, you know, how do you see this market, I guess, developing? How are you thinking about franchise expansion and kinda life cycle management, as you think about your long-acting buprenorphine franchise, and just kinda how you see the market kind of developing, Joe?

[Joe Ciaffoni, CEO at Indivior Pharmaceuticals]

Sure. Ryan?

[Ryan Preblick, CFO at Indivior Pharmaceuticals]

Chase, yeah, at this point, there will be adjustments for the balance of the year. I don't know the phasing at this point, I will continue to tell you in the aggregate, the prior year releases will serve as a headwind in 2026.

[Chase Knickerbocker, Analyst at Craig-Hallum]

Sure.

[Joe Ciaffoni, CEO at Indivior Pharmaceuticals]

Chase, with regards to your question around the evolution of the marketplace, look, we're very confident in SUBLOCADE's differentiated profile. Importantly, when you look at SUBLOCADE, the 300 mg dose continues to grow. It's now 63% of overall SUBLOCADE utilization. We're very confident that SUBLOCADE has a durable growth profile, and it's an asset that we're committed to for the long term. As it pertains to further opportunity within the space, we're obviously always looking and are aware of what's out there. There's nothing candidly that we're interested in that we don't have, and to the degree that Alar is successful in the development and manufacturing of INDV-6001 to a level that meets what we believe would make it commercially viable, we retain 100% of the commercial rights to that asset in the U.S. We certainly wish them well in their pursuit.

[Chase Knickerbocker, Analyst at Craig-Hallum]

Understood, thank you.

[Joe Ciaffoni, CEO at Indivior Pharmaceuticals]

You got it.

[Operator]

Thank you. Now we're going to take our next question. The question comes line of Dennis Ding from Jefferies. Your line is open, please ask your question.

[Dennis Ding, Analyst at Jefferies]

Hi, good morning. Thanks for taking our questions, and congrats on a very good quarter.

[Joe Ciaffoni, CEO at Indivior Pharmaceuticals]

Thank you.

[Dennis Ding, Analyst at Jefferies]

If I can ask on Lilly's brenipatide. I mean, they sound fairly excited about it and its potential in substance use disorders, and they started phase II in OUD on a background of buprenorphine, which I'm assuming is SUBOXONE. I'm curious how you're thinking about the design of that study, the readout in 2028, and importantly, if that impacts durability of SUBLOCADE growth through the long term, which I'm assuming goes off patent in the 2035 to 2038 time frame. Thank you.

[Joe Ciaffoni, CEO at Indivior Pharmaceuticals]

Okay. Dennis, before I hand it off to Christian to comment, the one thing I want to emphasize is we very strongly believe that SUBLOCADE has a long and durable runway in front of it with 12 Orange Book listed patents that go from 2031 to 2038. We also are in the process of trying to pull through additional patent applications that have the potential to extend out to 2044 to 2046. Christian, on any comments on?

[Christian Heidbreder, Chief Scientific Officer at Indivior Pharmaceuticals]

Yes, certainly. There are several trials that are currently ongoing, using GLP-1 for substance use disorder. The one that you mentioned in opioid use disorder, this is actually as an add-on therapy to transmucosal buprenorphine. There are a couple of other trials in alcohol use disorder. I must say that so far the evidence has been primarily anecdotal, it's the first time that there will be more formal clinical trials and we shall see what the outcome is. Please do remember that these trials so far for opioid use disorder have been designed as add-on therapy to buprenorphine.

[Dennis Ding, Analyst at Jefferies]

Perfect, thanks. If I can ask a follow-up on DTC. I mean, the campaign is, you know, obviously trying to increase category growth, which, you know, we're seeing in the numbers, but I'm also surprised that SUBLOCADE share continues to be generally stable. My question is, do you expect to pick up incremental share this year as DTC continues? If there's any sort of leading indicators that you can disclose around initial share capture? Thanks.

[Joe Ciaffoni, CEO at Indivior Pharmaceuticals]

Yeah. Dennis, I'll take that one. I appreciate the question. As we've been clear, our focus is on net revenue, new patient starts, and driving long-acting injectable market growth. We're very proud of the fact that share is stable at 76%. Whether it goes up a little bit, down a little bit in terms of the overall performance of SUBLOCADE both in this year and as we go forward, in our view is really not material. It's more about just the competitiveness within the space. We're very confident in our commercial team. We're very confident in the differentiated profile that SUBLOCADE brings to the market as the first and number one prescribed long-acting injectable.

[Dennis Ding, Analyst at Jefferies]

Perfect. Thanks so much.

[Joe Ciaffoni, CEO at Indivior Pharmaceuticals]

You got it.

[Operator]

Thank you. Now we're going to take our next question. The question comes line of Christian Glennie from Stifel. Your line is open, please ask your question.

[Christian Glennie, Analyst at Stifel]

Yeah. Thanks, guys. Thanks for taking the questions. Just starting, I guess on the outlook for SUBLOCADE. And particularly on the dispense growth. You did 20% in the first quarter, the guidance for the full-year seems to be still around the mid-teens level. Just trying to, yeah, just trying to understand initially around that. Is it just a prudence thing, is there some reason why that dispense growth might, you know, imply a slowdown through the rest of the year? That's my first question. Thanks.

[Joe Ciaffoni, CEO at Indivior Pharmaceuticals]

Yeah. Christian, thanks for the question. Remember, in the first quarter of 2025, that serves as a really low bar from a comparable perspective. What we're confident in is on a full-year basis, that we're gonna be able to achieve mid-teen dispense unit growth, which is double what it is that we achieved in 2025. Importantly, what I would focus you to, is the 13% increase in revenue, which is driven by the strong dispense unit growth, also now the favorable outlook that we have in terms of mix. What I mean by that is the percent that commercial will account for versus what we planned. Realize even incremental movement on a brand of this size, you know, 1 point improvement of commercial mix relative to what we had planned is worth about $8 million.

[Joe Ciaffoni, CEO at Indivior Pharmaceuticals]

That's certainly a key driver of the positive outlook that we have moving forward. We've put a lot of effort, which is a real tribute to Pat and his team, Susan Neff, who heads up trade and our work with specialty pharmacy and trying to improve the dispense yield, in particular with the SPs that skew to commercial.

[Christian Glennie, Analyst at Stifel]

Thanks, that's helpful. Second would be just any comment around the overall growth in LAI category overall and the share of LAI as a percentage of the overall buprenorphine market? Thanks.

[Joe Ciaffoni, CEO at Indivior Pharmaceuticals]

Yeah. Pat?

[Patrick Barry, Chief Commercial Officer at Indivior Pharmaceuticals]

Yeah, thanks for the question. We saw a really nice growth, approaching 23% on LAI category. We feel like our efforts, from a direct-to-consumer perspective are fueling that. Again, we continue to maintain that category share dominance at +76%.

[Joe Ciaffoni, CEO at Indivior Pharmaceuticals]

Yeah. Christian, the only thing that I would add, I think it's another interesting thing that gets to the impact that our we believe the consumer campaign is having. In the first quarter, the oral buprenorphine market grew significantly relative to the rate it had consistently been growing. The reason that's important is the start point of long-acting injectable patients are predominantly people that transition from a transmucosal buprenorphine. From a big picture, as a company that has a long-term commitment to this space that first and foremost is focused on patients getting treatment to improve the outcome in their recovery journey, we're very encouraged by that also is a positive over time in our view to long-acting injectable utilization.

[Christian Glennie, Analyst at Stifel]

Thanks. Sorry, just follow on the percentage, the rough percentage share of LAIs overall as a percentage of orals.

[Patrick Barry, Chief Commercial Officer at Indivior Pharmaceuticals]

Yeah. We're right at about 8.5% from an overall LAI category share perspective. Sorry, I missed on that.

[Christian Glennie, Analyst at Stifel]

Okay. Thank you. Thanks. No worries. Sorry, finally, just on guidance on OpEx, you unchanged there, but at the same time, not progressing the phase II, two phase II assets. I think previously you had implied that the guidance assumed, those would roll on. Just trying to understand, you know, on OpEx and whether there's something I'm missing there, why potentially the OpEx wouldn't be a bit lower, given you implied a bit of restructuring of R&D and the impact that that would have. Thanks.

[Joe Ciaffoni, CEO at Indivior Pharmaceuticals]

Yeah. I'll take that one. I appreciate the question. Look, we're focused and have been clear on making every possible investment to maximize the SUBLOCADE opportunity in the U.S. market. The way to think of our guidance in 2026 is, as we derive savings from the restructuring in R&D, as we continue to relentlessly focus on making sure we're only investing in things that are essential, if there are opportunities for us to invest in SUBLOCADE that would have impact this year or in 2027, we would make those investments and come in at the high end of the guidance range. To the degree that there aren't areas for us to invest those resources, we would let them drop to the bottom line.

[Joe Ciaffoni, CEO at Indivior Pharmaceuticals]

The other point I wanna emphasize is, as you think about the exciting phase we're in of the acceleration of SUBLOCADE, we're also leveraging, not growing our cost structure on a going-forward basis. When you think about it moving forward, you should expect to see us staying under that $450 million level, which will result in additional margin improvement.

[Christian Glennie, Analyst at Stifel]

That's great. Thanks, guys.

[Joe Ciaffoni, CEO at Indivior Pharmaceuticals]

You got it.

[Operator]

Thank you. Now we're going to take our next question. The question comes to line of Brandon Folkes from H.C. Wainwright. Your line is open, please ask your question.

[Brandon Folkes, Analyst at H.C. Wainwright]

Hi, thanks for taking my questions. Congrats on the quarter.

[Joe Ciaffoni, CEO at Indivior Pharmaceuticals]

Thank you.

[Brandon Folkes, Analyst at H.C. Wainwright]

Maybe just following up on business development. You know, can you just talk about the size of the transaction you would consider? You know, hearing your criteria earlier around minimum peak sales, you know, that sets one end of the range. Just trying to think about how large of a transaction, you know, you feel comfortable with? Can you just talk about where you feel comfortable taking leverage up to? Then along the same lines, you know, you talked about a commercial asset, but would you also consider a commercial-ready asset or company which also has a pipeline? Can you just talk about your willingness to bring in or minimize development risk altogether here in business development? Thank you.

[Joe Ciaffoni, CEO at Indivior Pharmaceuticals]

Thanks, Brandon. I'll let Ryan take the first question, and I'll take the second.

[Ryan Preblick, CFO at Indivior Pharmaceuticals]

Yeah. Thanks for the question. When it comes to the amount of leverage that we would feel comfortable with our strong balance sheet, we would be okay going up to three times, but that is assuming that we are going after a commercial stage asset.

[Joe Ciaffoni, CEO at Indivior Pharmaceuticals]

Okay. Brandon, when you think about our focus from an M&A perspective, we're clearly focused on commercial stage. We want to enhance and diversify the growth profile of the company. We are not anti-pipeline. In fact, we believe the financial strength of the company would enable us, if we acquire a company that has pipeline that we believe is worth investing in, we would be positioned to do so, but that is not the primary focus as we're assessing opportunities when we ultimately get to phase III Breakout and start to try to action around them.

[Brandon Folkes, Analyst at H.C. Wainwright]

Great. Thanks very much, congrats again on the quarter.

[Joe Ciaffoni, CEO at Indivior Pharmaceuticals]

You got it. Thank you.

[Operator]

Thank you. The speakers are now further questions for today. I would now like to hand the conference over to your speaker, Joe Ciaffoni, for any closing remarks.

[Joe Ciaffoni, CEO at Indivior Pharmaceuticals]

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 Indivior Action Agenda. Have a great day.

[Operator]

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

Participants

Executives

• Jason Thompson, VP of Investor Relations
• Joe Ciaffoni, CEO
• Patrick Barry, Chief Commercial Officer
• Ryan Preblick, CFO

Analysts

• Brandon Folkes, Analyst at H.C. Wainwright
• Chase Knickerbocker, Analyst at Craig-Hallum
• Christian Glennie, Analyst at Stifel
• Christian Heidbreder, Chief Scientific Officer at Indivior Pharmaceuticals
• David Amsellem, Analyst at Piper Sandler
• Dennis Ding, Analyst at Jefferies