speaker
Jason
Investor Relations

Good morning, everyone. I am joined today by Joe Schifoni, Chief Executive Officer, Pat Berry, Chief Commercial Officer, and Ryan Previn, Chief Financial Officer. We're also joined by Christian Heidretter, 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 to this presentation that is now posted on our website at Endeavor.com. I'll now turn the call over to Joe Schifone, our CEO.

speaker
Joe Schifone
Chief Executive Officer

Thanks, Jason, and good morning and thank you for joining us on today's call to review our fourth quarter and full year 2025 results. I will begin with an overview of our business performance in 2025 and summarize our progress against the Indivior Action Agenda. Pat will then provide a commercial update and discuss our priorities for sublocate. Finally, Ryan will review our financial performance, 2026 guidance, and then detail our capital deployment strategy. 2025 was a transition year for the company. Last July, we rolled out the Indivia Action Agenda to maximize the potential of our business, make a positive difference in the lives of people living with opioid use disorder, and to create value for our shareholders. We've made significant progress, including successfully completing phase one, generate momentum, and delivering against our financial commitments for 2025. Specifically, We improved our commercial execution and generated momentum for Sublocate, delivering record net revenue in 2025 of $856 million, a 13% increase versus 2024, and total net revenue of $1.24 billion, representing a 4% increase compared to the prior year. We took several actions to simplify our organization and establish Indivior's go-forward operating model. Operating expenses will not exceed $450 million in 2026. We grew adjusted EBITDA 20% year-over-year to $428 million in 2025, along with notable margin improvement. We launched a new direct-to-consumer campaign, Move Forward in Recovery, on October 1, 2025, to drive awareness of sublocate among people living with opioid use disorder. Although early, we are encouraged by the engagement we are seeing and all key leading indicators are trending ahead of expectations. Finally, we strengthened our financial profile, including paying the outstanding $295 million obligation related to the legacy DOJ matter, thereby eliminating a significant future liability for our company. I want to thank the Indivior team for their contributions to our progress against the Indivior Action Agenda and their unwavering dedication to people living with opioid use disorder in the communities we serve. Our strong financial performance and the momentum we generated in 2025 position us to accelerate in 2026. Our confidence in the business is reinforced by our new $400 million share repurchase program authorized by our Board that we announced this morning. With Phase 1 of the Indivior Action Agenda completed and our go-forward operating model firmly established, we are now executing on Phase 2 of the Indivior Action Agenda, Accelerate. During this phase, we expect to accelerate sublocated dispense unit growth and net revenue throughout 2026 and immediately grow adjusted EBITDA and cash flow at a faster rate. Sublocate 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 and has been prescribed to over 475,000 people. We believe that Sublocate is a durable growth driver with 12 orange book listed patents that range from 2031 to 2038. We are committed to investing at sustained levels to maximize the potential sublocate and grow the long-acting injectable market. Although we are making progress, we believe long-acting injectables remain underutilized. We expect our laser focus on improving commercial execution, our sustained investments in patient education and activation, and efforts to advance state and federal policies that support greater treatment access will drive the acceleration of sublocate. I am encouraged by the trends we are seeing across all key metrics thus far in the first quarter. In 2026, we expect to deliver sublocate dispense unit growth in the mid-teens and acceleration compared to the 7% dispense unit growth we achieved in 2025. This will result in sublocated net revenue growth of 8% at the midpoint of our guidance range. The leverage generated by our go-forward operating model will immediately accelerate adjusted EBITDA and cash flow at a faster rate. We expect to generate 30% adjusted EBITDA growth in 2026, representing a 13 percentage point improvement in our adjusted EBITDA margin compared to 2025, and we expect to generate approximately $300 million in cash flow from operations. Our increased cash flow and strong financial position will enable us to strategically deploy capital to create value for our shareholders. Our capital deployment priorities are threefold. Manage our debt, opportunistically deploy our newly authorized $400 million share repurchase program, and evaluate potential business development opportunities to acquire the next commercial stage growth drivers as we earn our way to phase three of the Indivia Action Agenda breakout. We are encouraged by but not satisfied with the progress we made in 2025. The actions we took and the foundation we established strongly position us to achieve our financial and operational objectives in phase two accelerate in 2026. I'll now turn the call over to Pat.

speaker
Pat Berry
Chief Commercial Officer

Thanks, Joe, and good morning, everyone. As part of phase one of the Endeavor Action Agenda, Generate Momentum, we have been focused on improving commercial execution for Sublocade. Our commercial team is dedicated to helping people living with OUD, and they have a strong belief in Sublocade as the first and number one prescribed long-acting injectable in the category. We have made progress on our commercial execution initiatives, which are reflected in our fourth quarter and full year results. In the fourth quarter, we delivered strong dispense unit growth of 12% versus the prior year and 6% versus the third quarter. New patient starts in the fourth quarter were up 25% year over year, and over the course of the last 10 weeks of the year, weekly new patient starts achieved all-time highs on three separate occasions. Total category share of LAIs and new patient share in the U.S. for supplicate continued to stabilize in the mid-'70s. We exited 2025 with a record number of active sublocate prescribers, including those treating five or more patients. In the fourth quarter, both total active sublocate prescribers and prescribers treating five or more patients grew 14% year over year and approximately 6% sequentially. We believe this progress represents a combination of the fundamental strengths of sublocate along with our improving commercial execution. We are encouraged by the momentum we generated exiting 2025 and are well positioned to accelerate in 2026. We remain focused on continuous improvement in commercial execution to accelerate sublocated prescribing volume for the benefit of people living with OUD. Our efforts are centered on driving excellence in field force messaging, improving commercial channel productivity, growing patient activation and new starts, and unlocking treatment access through proactive engagement with policy leaders. We have seen improvements across each of these areas. Our field force messaging acumen that is focused on Supplegate's differentiated label is driving growth in the number of physicians utilizing the accelerated second dose. Approximately 7% of new patients receive the accelerated second dose, and 17% of active HCPs prescribed a second dose in line with this expanded sublocated label. On commercial dispense yield productivity, we remain in the early stages of improving yields towards our non-commercial channel average of approximately 80%. We are seeing steady progress with our targeted commercial specialty pharmacies and expect steady yield improvement as we move through 2026. In addition to these commercial improvement initiatives, we are investing to expand patient awareness and engagement. Last October, we launched our direct-to-consumer campaign, Move Forward in Recovery, which is designed to emotionally and authentically connect with people living with OUD and drive awareness of Sublocade as a treatment option for those struggling with moderate to severe opioid addiction. Recall this campaign has an omnichannel approach, including national television, digital and social media, and in-office point-of-care materials, along with a newly designed Sublocade patient website. We are seeing early indicators of success following the launch of the campaign. For example, prompted awareness among patients has increased versus the first quarter of 2025. Branded online search volume increased 60% in the fourth quarter compared to the months immediately prior to the launch of the campaign, driving high-quality engagement on the Sublocade website, including a 70% increase in usage of the Find a Sublocade treatment provider tool. We also saw an average of around 1,400 new CRM enrollments per month in the fourth quarter versus around 60 per month immediately prior to the new campaign, reflecting meaningful intent-driven patient action. We are also actively pursuing opportunities to expand patient access through our proactive public policy initiatives. For example, in several states, long-acting injectables are only available under a medical benefit. This creates logistical complexity, upfront cost, and administrative burden for providers. Expanding coverage under a pharmacy benefit would reduce these barriers, lower financial risk, and improve provider adoption. In parallel, we are engaging on bundled payment structures to help ensure that long-acting injectables are appropriately recognized, whether through potential carve-outs or a more accurate reflection in overall payment levels. This would strengthen the financial viability of treating people with OUD. Taken together, our improving commercial execution, patient activation efforts, and policy initiatives are laying the foundation for sublocated acceleration and give us confidence in our ability to deliver mid-teens dispensed unit growth in 2026. I will now turn the call over to Ryan.

Disclaimer

This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.

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