Indivior Pharmaceuticals, Inc.

Good day and thank you for standing by. Welcome to the Indivia plc third quarter 2024 conference call. At this time all participants are in a listen only mode. After the speaker's presentation there'll be a question and answer session. To ask a question during the session you will need to press star 1 1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question please press star 1 1 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your host for today's call, Jason Thompson, Head of Investor Relations. Please go ahead.

Thanks, Sonia, and hello, everyone. 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 on slide two of this presentation. These statements are based on current information and beliefs, and we disclaim any obligation to update them except where required by law. We may also 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 www.indivir.com. I'll now turn the call over to Mark Crossley, our CEO.

Thank you, Jason and good morning and good afternoon everyone thanks for joining us joining me today or Ryan public our chief financial officer and Dr Christian hybrid or our chief scientific officer. i'll quickly highlight our results and some updates from our release earlier in the month and then Ryan will detail the financials and our full year 2024 outlook Christian is with us to answer any questions on the pipeline. Since we announced a business update just two weeks ago, I'm going to keep my formal remarks relatively brief, but I do want to provide a few updates. First, our results for the third quarter continued to show solid double-digit year-over-year growth and were in line with the expectations that we pre-announced earlier this month. Sublicate third quarter net revenue of $191 million increased 14% and primarily drove the 13% increase in total third quarter net revenue to $307 million. Our underlying profitability and gross cash position also remained strong. Adjusted operating profit through the quarter increased 62% to $97 million, and our cash position at the end of the third quarter was $344 million. In terms of the sequential net revenue trend for Sublocade, despite 2% dispensed growth quarter over quarter, we saw a modest decline in the third quarter from the second quarter. As previously discussed, Sublocade's growth is being impacted by a combination of intensified initial trial and adoption of the competing product, variability in funding timing in certain justice system accounts, and further destocking. Ryan will share more detail on the financial performance drivers in a moment. Second, as we navigate through the near term, our commercial teams remain intensely focused on our critical mission to help patients with opioid use disorder. We're generating increases in overall organized health system and CGS activation, which we believe will continue to grow the market for opioid use disorder over the long term. This resulted in Sublocade US patients and dispense growth on both a year-over-year and sequential basis in the quarter. Further, as we have now been in a competitive market for a year, we want to continue to reinforce that Sublocade remains the long-acting injectable of choice for opioid use disorder treatment over this time. First, Sublocade's share of new patients was 72% at the end of the third quarter. In addition, in analyzing multiple co-prescribing cohorts outside of CGS since the competitor's launch, we currently see Sublocade maintaining its leadership position at share levels consistently in the mid-60s percent range across these cohorts. Third, we're actively pursuing targeted streamlining actions, including cost reductions against the group's expense base. Our actions will mainly be focused on reducing G&A costs and reprioritizing our R&D pipeline. Ryan will have more details on this item, but these actions are expected to sharpen our strategic focus on fueling Sublocade's growth while advancing our two late-stage OUD-related pipeline assets and helping protect margins. Lastly, we've continued to work hard to secure our future and create greater certainty for Indivier stakeholders. As you'll have seen, we reached a preliminary agreement for a settlement of $40 million to resolve the last remaining legacy antitrust cases. Material terms and conditions of the final settlement agreement must still be negotiated, but our expectation is to resolve these shortly. If the settlement is completed, all of the antitrust litigation will be behind the group. Turning to our strategic priorities report card, starting with sublocate. Expanding on my previous commentary, U.S. patients and treatment grew 37% year over year to 166,600 at the end of the third quarter. On a sequential basis, this represents a 4% increase with over 6,200 patients gained in the quarter. Recall, we're targeting greater than 270,000 patients to deliver our peak net revenue goal of greater than a billion and a half dollars. In terms of continuing to lay the foundation for Sublocade's future growth, the number of active dispensing HCPs increased to more than 7,700 in the third quarter, representing a 15% increase from approximately 6,700 at the end of fiscal year 2023. We've also continued to make good progress activating justice system accounts, reaching over 800 accounts at the end of the third quarter. We've made progress in our goal to establish a nationwide network of alternate sites of injection for sublocate. In the third quarter, we added one new partner, bringing the total number of alternate injection sites to approximately 1,220 locations. The number of sublocated injections at these sites increased 60% in the third quarter compared to the previous quarter. We're also pleased to see that the DEA has extended telehealth for buprenorphine. This underscores the ongoing bipartisan efforts in the U.S. to increase patient access to medically assisted treatment. Looking at diversification and starting with Otvi, as you saw in our October 10th business update, we booked net revenue for two orders as part of our 10-year contract with BARDA. Outside of those orders, we believe we are building both a strong funding as well as trial and experience environment for OPVI. At the end of the third quarter, we had established approximately 180 experience programs and 32 states now have standing orders in place. In our rest of world business, we continue to see good growth and contribution from our new products, Sublocade and Suboxone Film. Their solid progression is helping us offset the ongoing challenges to our legacy tablet products. Ex-US sales of Sublocade grew 30% year-over-year to $13 million. Turning to our pipeline, a few highlights to mention starting with Sublocade. We previously announced that we submitted important label updates to the FDA for Sublocade, including rapid induction and alternate sites of injection on the body. We received priority review designation with a PDUFA date of February 7, 2025. If approved, We believe these label updates will help us directly address feedback we've received from HCPs on how we can improve the patient experience for sublocate. Turning to the pipeline, the most material development during the quarter was that the ALS Phase IIb study did not meet its endpoints in reducing voluntary cannabis usage among cannabis use disorder patients. While disappointing, we made the decision not to move forward with the asset. Additionally, as part of the reprioritization of our pipeline, we've announced today we made the decision to discontinue INDV-1000, a preclinical asset targeting alcohol use disorder. As a result, we're narrowing our pipeline to opioid use disorder with INDV-6001, a potential three-monthly long-acting buprenorphine injectable, and INDV-2000, a selective orexin-1 receptor antagonist. The phase two studies for both assets have been committed with study sites activated and development activities for both assets proceeding on track. For INDV 6001, in the quarter, we initiated a multiple dose PK study that will inform any potential future phase three study. The first subject, first visit, was achieved in September. The completion of this study with last subject, last visit, is currently scheduled for Q4 of 2025. The INDB 2000 phase two proof of concept study is underway. The first subject was dosed in June and through mid-October, 55 patients have been dosed. Our excitement about this asset reflects our belief in the significant unmet need for non-opioid, as a non-opioid option for patients as part of the OUD treatment continuum. The completion of this proof of concept study with last subject last visit is currently scheduled for Q4 2025. In line with normal practice, we'll assess the out-term from both of these studies at completion of the Phase 2 before making any decision on future investment. Moving to capital allocation, we're more than halfway through the $100 million buyback we announced in late July. We also continue to progress in resolving legacy litigation matters included in the announced settlement that I referenced earlier. With that short intro, I'll hand over to Ryan.