speaker
Nadia
Operator

Good day and thank you for standing by. Welcome to the Indivio 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 then hear an automatic message advising your hand is raised. To withdraw a question, please press star, one, and one again. Please be advised that this conference is being recorded. I would now like to hand the conference over to our speaker today, Jason Thompson. Please go ahead.

speaker
Jason Thompson
Head of Investor Relations

Thanks, Nadia, and welcome to Indivia's first quarter 2026 results conference call. I'm joined today by Joe Schifoni, Chief Executive Officer, Pat Berry, Chief Commercial Officer, Ryan Preba, 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 endivere.com. I'll now turn the call over to Joe Schifoni, our CEO.

speaker
Joe Schifoni
Chief Executive Officer

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 2 Accelerate of the Indivior Action Agenda. Pat will discuss sublocate performance, Christian will provide an update on the pipeline, and Ryan will review the financials. In the first quarter, we made significant progress in phase two of the Indivier Action Agenda and 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. sublocate performance. We grew total sublocate net revenue 32% year over year to $232 million, reflecting strong year-over-year dispense unit growth of 20%. The acceleration in sublocate 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, sublocate 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 return value to our shareholders by repurchasing $125 million of our shares at an average price of $31.45. Our strong first quarter performance and the underlying strength of sublocate across key metrics, along with a more favorable outlook for Suboxone, enabled us to meaningfully raise our 2026 financial guidance. I want to 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 2 Accelerate, we are focused on accelerating U.S. sublocate dispense unit growth in 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 Sublicate since its launch in 2018. Nearly one quarter of those patients were added in the last five quarters, underscoring Sublicate's strong growth trajectory. Sublicate 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. sublocate dispense unit growth to the mid-teens in 2026 up from 7% in 2025. We now expect total sublocated 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 1 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. 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 three of the Indivior Action Agenda breakout in the second half of this year. Next, I want to briefly touch on the decisions we made on the INDV 6001 and 2000 programs. We do not intend to pursue phase three 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. Indivier will maintain commercial rights in the U.S. Regarding INDV 2000, it did not meet the primary endpoint in the phase two 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 6001 and 2000 programs. 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 2 Accelerate and to enter Phase 3 Breakout in the second half of 2026. I'll now turn the call over to Pat.

Disclaimer

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