speaker
Operator
Conference Operator

Good day and thank you for standing by. Welcome to the IndiVS second quarter 2025 Results Conference call and webcast. At this time all participants are in a listen-only mode. After the speaker's presentation there will be a question and answer session. To ask a question during the session please press star 1 and 1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question please press star 1 and 1 again. Please note that today's conference is being recorded. I would now like to turn the conference over to Jason Thompson, your host for today's call. Please go ahead.

speaker
Jason Thompson
Host, Investor Relations

Thank you and good morning and welcome to the IndiVS second quarter 2025 earnings conference call. I'm joined today by Joe Schifone, Chief Executive Officer, Patrick Berry, Chief Commercial Officer, Christian Heidbreder, Chief Scientific Officer and Ryan Prebitt, our Chief Financial 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 2 of this presentation. We also may refer to non-GAB measures, the reconciliations for which may also be found in the appendix to this presentation that is now posted on our website IndiVir.com. I'll now turn the call over to Joe.

speaker
Joe Schifone
Chief Executive Officer

Thanks Jason. Good morning and thank you everyone for joining the call. Today I will start with an overview of our performance in the quarter and then introduce the IndiVir action agenda. Pat will discuss the actions we are taking to generate momentum with Sublicate in the U.S. and Ryan will review the financial results for the along with our upwardly revised financial guidance for 2025. And then we will open up the call for questions. Since joining the board in December 2024, being announced as CEO in late February and officially assuming the role on May 8th, I've had the opportunity to listen to and learn the perspectives of the IndiVir team, treatment providers and investors. IndiVir's greatest strengths include the committed professionals that make up the organization and its outstanding products, all of which have the potential to make a positive difference in people's lives. Having participated in more than 150 roundtable meetings with over 1,000 members of the IndiVir team, I learned that over 85% of our people have been impacted by OUD or addiction in some way and that this fight is personal to them. This is IndiVir's special sauce and what has driven the organization's success and resilience over the years. And this is what will fuel our success moving forward. Turning to the quarter, I'm pleased to report we delivered record Sublicate net revenue led by a solid performance in the U.S. Suboxone Film in the .S.L. performed our expectations as pricing remains stable through the second quarter. Our top line performance positions us well for the remainder of the year and enables us to raise our full year 2025 net revenue guidance and our profit expectations is now measured by adjusted EBITDA. I want to congratulate the IndiVir team on a solid performance and importantly thank them for their leadership. We are encouraged by our performance in the quarter, we are not satisfied as U.S. commercial execution represents an opportunity for improvement. Moving forward, we will be laser focused on improving commercial execution in the U.S. It will become a hallmark of the organization. 2025 is a transition year for IndiVir. We've strengthened our leadership team and refreshed our board with important additions including the appointment of Tony Kingsley to the board who brings deep commercial experience. You've also seen the announcements of Pat Berry as our new chief commercial officer and most recently Vanessa Proctor as our new executive vice president of corporate affairs. These key leaders will play critical roles in implementing the IndiVir action the majority of growth from a single country. Yet the operations to support the business are complex with an inordinate amount of nonessential activities inflating the cost structure and adversely impacting execution. There is an opportunity to strengthen the company, increase focus, reduce cost and improve execution through simplification. Over the past couple of months, the management team in partnership with the board have been developing the IndiVir action agenda. The IndiVir action agenda is a three-phase multi-year operational roadmap intended to maximize the potential of our business and make a positive difference in the lives of people living with OUD while creating value for our shareholders. Phase one of the IndiVir action agenda generate momentum kicked off in May and through the end of 2025. The key focus areas of phase one are growing sublicate in the U.S. through the remainder of the year by improving commercial execution. Pat will discuss this in more detail. Taking actions to simplify the organization by eliminating all nonessential activities. And determining the actions and investments necessary to accelerate long-acting injectable penetration in the U.S. market and to accelerate sublicate net revenue growth in 2026 and beyond. The overarching goal of phase one is to generate operational momentum and we already have multiple work streams underway. We are diligently working to simplify the organization with a focus on delisting from the London Stock Exchange, assessing the rest of world business and go forward operating model, determining the path forward for OPPE, consolidating our operating footprint and restructuring the R&D and medical affairs organizations. We anticipate making and implementing decisions in these and other areas in the weeks to come. We will establish our go forward operating model in the fourth quarter with the expectation that will finish 2025 with momentum and be positioned to accelerate in 2026. We look forward to providing an update on our third quarter results call. Phase two of the endive action agenda accelerate kicks off on January 1, 2026. The goal of phase two is to accelerate U.S. sublicate growth and immediately accelerate profitability and cash flow generation at a rate that exceeds revenue growth. By leveraging our go forward operating model, we expect to see immediate accretion to the bottom line and improve cash generation. Simultaneously, we will invest to accelerate sublicate growth in the U.S. in 2026 and beyond. I am confident that we can make every investment necessary to maximize the potential of sublicate in the U.S. and drop significant dollars to the bottom line right out of the gate in 2026. Through strong operational execution, we will earn our way to phase three of the endive action agenda breakout where we will leverage a stronger financial profile to acquire the next drivers of growth. Our focus will be on commercial stage acquisitions. We believe we will be able to enter the breakout phase in the second half of 2026. There is much work to do between now and then and I want to emphasize that we need to earn our way to phase three through strong execution of phase one and two of the endive action agenda. To conclude, we are encouraged by but not satisfied with our start to 2025. We are pleased to be in a position to raise our 2025 guidance and we have a clear path forward. For the remainder of 2025, we will be working diligently on phase one of the endive action agenda. We are committed to growing sublicate in the U.S., simplifying the organization and taking the necessary actions to make sure we are only investing in essential activities. Our go forward operating model will be locked down in January 1st, 2026. We will be able to accelerate sublicate in the U.S. in 2026 and immediately accelerate the bottom line at an even faster rate. I will now hand the call over to Pat to discuss the opportunities we see for generating momentum with sublicate for the remainder of the year. Thank you,

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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