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spk04: 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. We also may refer to non-GAAP measures, the reconciliations for which may also be found in the appendix to our presentation that is now posted on our website at endivere.com. I'll now turn the call over to Mark Crossley, our CEO.
spk07: Thank you, Jason, and good morning and good afternoon, everyone, and thanks for joining us at our first quarter results call today. Here with me are Ryan Preblek, our Chief Financial Officer, and Christian Heidbreder, our Chief Scientific Officer. I'll start the day with an overview of the Q1 results and a progress report against our strategic priorities, and then Ryan will then discuss the Q1 results and our fiscal year 2024 guidance. Following that, we'll provide an update on our primary listing initiative and conclude with questions and answers. Turning to the key messages, led by Sublocade, we delivered another quarter of solid double digit top line growth in the first quarter. Total net revenue grew 12% versus year-ago quarter to $284 million. First quarter adjusted operating profit of $70 million declined modestly versus last year due to commercial investments behind Sublocade and the acquisition of Opium, which closed in March last year. We expect to generate positive operating leverage on these investments as we move through the current year. Turning to Sublocade, we delivered year-over-year net revenue growth of 36% in the first quarter, which is in line with our full-year growth expectations. Sublocade's sequential net revenue growth of 2% was lower than we planned. We believe growth in dispenses were negatively impacted by two external forces, including a higher-than-expected rate of Medicaid patient disenrollments and the cyber attack at Change Healthcare. Let me provide more color on how each of these impacted Sublocade's growth in the quarter and why we remain confident in our full year 2024 net revenue guidance. First, the most recent data on Medicaid renewals indicates a higher than expected number of patient disenrollments of over 20 million. Recall at the peak during COVID, over 90 million patients were enrolled in Medicaid. This is particularly relevant in opioid use disorder treatment as the nature of the disease means that approximately 70% of our patients are covered by Medicaid. The impact of this disenrollment process will annualize at the end of June, and therefore this headwind should begin to subside as we move through the second half of the year. Although the impact on Sublicate's growth in the quarter was larger than expected, Medicaid disenrollment was a known dynamic. The cyber attack on Change Healthcare, by contrast, was a completely unexpected disruption. Change Healthcare is the largest claims processor in the US, responsible for one in three claims. Change is a crucial connection for healthcare systems, making clinical, administrative, and financial processes simpler and more efficient for payers, providers, and patients. The cyber attack on February 21st impacted new patient, and refill adjudication for Sublocade during the first quarter. Though difficult to isolate the financial impact of each of these items, we estimate that on a combined basis, they lowered Sublocade's sequential dispense growth in the U.S. by mid to high single-digit percentage rates. In addition, we saw abnormal destocking of $5 to $7 million during the same timeframe as this change cyber attack. we would expect stock levels to normalize in the coming months. With the cyber attack behind us and Medicaid renewal annualizing at the end of June, we look forward to subsiding impacts from these transitory items, which we believe are masking the strong underlying demand for sublocate. In fact, early dispense trends in April are tracking back to the growth levels we had expected in the first quarter. Additionally, we expect this strong underlying demand will be further bolstered over the remainder of the year by our expanded sales force, which is now fully deployed, and by our continued strong performance in the justice system channel. The justice system now accounts for approximately 25% of sublocated US net revenue, and in the first quarter we saw continued strong momentum in this channel with double digit dispense growth versus the prior quarter. For these reasons, we're confident the total net revenue and adjusted operating profit will accelerate through the year from the first quarter, particularly in the second half, and we reconfirm our fiscal year 2024 guidance. Finally, after receiving strong support from shareholders, we're confirming our intention to move forward with a shareholder vote to affect a primary U.S. listing. We and the board believe this is the right long-term move for shareholders and our business, and we appreciate the engagement and feedback we've received. Moving next to our report card for the first quarter, we continue to make good progress against our strategic priorities to drive value creation. I've described in detail the dynamics in the quarter related to Sublocade's growth. I'll briefly discuss some additional items here that highlight our continued strong year-over-year progress with Sublocade and that provide us with confidence in our future growth. First, The number of patients receiving Sublocade grew approximately 59% year over year to 150,000 at the quarter end. This is noteworthy as it is now more than halfway towards the estimated 270,000 patients we're targeting to achieve our 1.5 billion plus net revenue goal. While we're pleased with our progress, we're still only reaching a small portion of the 3.1 million diagnosed opioid use disorder patients in the U.S. and the over 10 million that report misusing opioids. Our strong underlying performance across key Sublocade metrics reflects continued successful penetration of organized health systems in the U.S. justice system. We're increasing Sublocade's prescribing depth across our existing OHS customers and gaining access to new ones. In total, Sublocade has access to over 1,000 distinct organized health systems We've also furthered Sublocade's access to an additional 50 justice system entities in the quarter. As a result, active healthcare practitioners prescribing Sublocade increased over 30% year over year to almost 7,000, and those prescribing to five or more patients, which we view as adopters, grew approximately 30% year over year to almost 3,000. As I previously mentioned, we expect to build on this momentum with the recent commercial investments behind Sublocade Our increased field force will allow more detailed frequency to organize health system-affiliated physicians, and we will also target non-OHS office-based practitioners as part of our alternate sites of care initiative. Our main partner in this effort today is Albertsons. We're still gaining experience here, but the signs continue to be promising. To share a couple of metrics, the number of Albertsons locations performing injections for patients has doubled since last quarter to almost 80%. and the number of patient injections at Albertsons grew by almost 50% sequentially. Based on this encouraging start, we're continuing to explore additional partnerships to help grow patient access with independent HCPs with a nationwide alternate site of care network. Moving next to diversification, starting with Sublocate outside the U.S., which is now in six markets, we again saw strong year-over-year growth of over 30%. In addition to solid progress in Canada, we saw an increase in uptake in the Nordics and Germany during the quarter. Our other new ex-US launch Suboxone film also showed growth from continued expansion across Canada and greater regional access across EU countries. Turning to Purseris, while competition has intensified in the risperidone LAI category, once monthly risperidone products are gaining share rapidly and the overall category is still growing. Against this backdrop, we continue to highlight Perceris' unique product profile, which continues to result in positive anecdotal prescriber feedback on product performance. Sequential dispense growth was 10%, not only underscoring the good underlying momentum we're seeing, but also representing an acceleration from previous quarters. We expect to augment our efforts with Perceris with the publication of real-world evidence studies in the second half of 2024. Taken together, we remain confident in our full-year net revenue guidance for Becerras and expect accelerating net revenue moving forward. Lastly, on diversification, OPV net revenue was modest, as expected. Our continued near-term focus is on laying the foundation for OPV's success by changing policy to enable the growth of Nalmophene Rescue and ensuring the availability of funding. To date, 31 states' standing orders include OPV. Furthermore, all SAMHSA grants have been updated to include all FDA-approved overdose rescue medications, and state and local abatement funds can also be used to purchase overdose rescue medications, including Otvi. This is important foundational work, which we expect to result in increased trial and adoption and accelerating net revenue growth as the year progresses. You should also note that we expect to fulfill the first $8 million requisition of Otvi from BARDA by the third quarter. As the only overdose rescue medication that is specifically indicated for synthetic opioids like fentanyl, the potential for Opvi to save lives is tremendous in light of the current wave of overdose deaths caused by powerful synthetic opioids. Turning to our pipeline, Christian is here to answer any specific questions. I would highlight that we expect the pace of development activity to pick up over the balance of the year. This quarter, we'll be initiating a phase two clinical proof of concept study for INDV2000 our Erexin-1-based non-opioid for opioid use disorder. In the third quarter, we expect to receive the top-line results of the clinical Phase IIb study for AEF0117, our partnered asset for cannabis use disorder. After analyzing the data and meeting with the FDA in the end of Phase II meeting, we will ultimately make a decision on whether to exercise our option for $100 million and to proceed to Phase III trials. Also in Q3, we expect to begin PK studies in support of future Phase III studies for INDV 6001, a potential three-month buprenorphine-based LAI targeting opioid use disorder. So a very busy year ahead for Christian and his team. Lastly, on our fourth strategic pillar, operating model and capital allocation, Ryan will walk you through the cash movements, but I'll quickly touch on a couple of items. The conversion of the Raleigh site for future production of Sublocade is proceeding well. Second, with regards to the potential primary U.S. listing of our shares, we're scheduling a shareholder vote on May 23rd. If approved by shareholders, we would expect to transition our primary listing in late June. Before concluding my remarks, I just wanted to remind you of the key elements of the medium-term profitable growth framework that we provided in December 2022 and how we are tracking toward this. As you've heard today, we delivered double digit net revenue growth in the first quarter and we expect the pace to accelerate over the balance of the year as we move beyond the transitory impacts on sublocated and see growing returns from our commercial investments. We expect this in turn to deliver positive operating leverage and accelerated growth in adjusted operating profit. Taken together, we remain confident that we're on track to meet both our fiscal year 2024 guidance and our medium term goals. With that, I'll hand it over to Ryan for review of the financials, and then we'll open it up to Q&A.
spk05: Thanks, Mark, and good morning and good afternoon to everyone. Overall, I'm pleased to report a solid quarter of execution considering the unexpected headwinds in the quarter that Mark referenced. Looking at the first quarter results in more detail, starting with the top line, total net revenue of $284 million grew 12% versus the year-ago quarter, on a reported and on a constant currency basis. By geography, total U.S. net revenue in the first quarter grew by 15% versus the year-ago quarter, driven by sublocating. The rest of the world was down 2% on a reported and on a constant currency basis. In the rest of the world, Q1 was slightly impacted by shipment timing. We did see good growth from sublocate outside the U.S. with net revenue up 33% to 12 million. And overall, we continue to expect the rest of the world to grow in full year 2024. For total sublocate, we delivered year-over-year net revenue growth of 36% in the first quarter. Although this was in line with the midpoint of our full-year guidance expectations, sublocate sequential net revenue growth of 2%, and U.S. dispense growth of 4% were both lower than expected. Both metrics were affected by the items Mark discussed, which I will expand on. First, as we just detailed, Medicaid disenrollment dynamics had a disproportionate impact on our company, as more than two-thirds of sublocated patients are covered by Medicaid. This impact accelerated in Q1 beyond the low single-digit headwind we had seen in prior quarters. Looking ahead, we expect this trend to begin subsiding in the second half of 2024, as Mark noted. Second, as a result of the change cyber attack, many sublocated treatment providers were unable to process claims and verify patient eligibility. This impacted our sublocated net revenue performance in the latter part of the quarter through two dynamics. First, we believe it resulted in a significant reduction in dispenses for new patients in March compared to the solid dispense rates we saw in the first two months of the year. Second, we believe it had an adverse impact on refill dispenses for existing patients where re-eligibility was required for treatment continuation. So a disconnect in our hysterical retention curves beginning with the onset of the late February cyber attack. Taking these two items together, we estimate the impact on U.S. sublocate dispense growth in the first quarter to have been in the mid to high single-digit percentage range. Turning to the difference between the sequential 4% dispense growth and the 2% net revenue growth, this primarily reflects unexpected destocking of sublocate in the U.S., which we estimate at between $5 and $7 million. This destock was atypical compared to historic inventory trends and occurred in the same time frame as the change attack. Moving to Becerras, reported net revenue of $11 million was up 38% versus the prior year and down 8% sequentially due to low single-digit million destocking in the quarter. Encouragingly, dispenses were up 10% sequentially, We remain confident in meeting our full-year net revenue guidance of $55 million to $65 million. OPFI net revenue was modest in the first quarter, as we continued to lay the foundational components for the launch, as Mark detailed. We continue to expect full-year net revenue of $15 million to $25 million, including an $8 million product order from BARDA. Turning to Suboxone film in the U.S., the average share of approximately 17% in the first quarter, was down about one percentage point versus the fourth quarter and two percentage points versus the year-ago quarter, all within expectations. As a reminder, we do not promote Suboxone film in the U.S. Moving down to P&L, our first quarter adjusted gross margin of 85% was flat versus the prior year quarter. The higher mix of Sublocate and favorable manufacturing variances, which also benefited Q1 last year, were largely offset by cost inflation. We continue to expect the full year gross margin to be within our guidance range of low to mid 80%. Adjusted SG&A expenses were $143 million in the quarter, up 22% versus Q1 of last year. This increase primarily reflects the incremental sublocated commercial investments which are now fully in place and the addition of the opium business, including launch expenses for OPFE. R&D expenses were $28 million in the quarter, an increase of 4% versus Q1 of last year. The increase primarily reflects work to advance early-stage assets and Phase IV studies for sublocating. Given the pace of development activity is expected to pick up, this will result in an uptick in R&D expense over the balance of 2024. Our adjusted operating profit of $70 million in Q1 was down 1% from Q1 of last year, due to a combination of the net revenue dynamics that I have highlighted and the commercial investments behind Sublocade and Opium. Lastly, on the P&L, our adjusted net income of $51 million decreased 9% versus Q1 of last year, reflecting the dynamics I just highlighted, in addition to modest net finance expenses. Quickly touching on the balance sheet and our capital position, we ended the first quarter with gross cash and investments of $356 million. Material cash outflows during the quarter included scheduled annual settlement payments of $70 million to the DOJ, RB, and DRL, and share repurchases of $36 million. Looking ahead, we expect to maintain good financial flexibility and to continue our disciplined capital allocation strategy. In the near term, this remains focused on reinvesting to fuel our base business towards our net revenue goals and meeting our stakeholder obligations. As always, if there is excess cash, we will examine opportunities for business development and potential shareholder returns. We have discussed a number of the external dynamics which impacted sublocated results in the quarter. Based on our expectations for a resolution of these transitory headwinds, and continued strong business execution, we remain comfortable with our guidance elements for full year 2024, including sublocated net revenue of $820 to $880 million and an expected increase in adjusted operating margin of around 300 basis points at the midpoint. I will now turn the call back over to Mark.
spk07: Thank you, Ryan. I want to close with some additional detail on our proposed transition to a primary U.S. listing. while maintaining our secondary listing in the UK. As I highlighted earlier, we've received strong support from shareholders and so it's our intention to move forward to a shareholder vote on May 23rd. If approved, we're targeting an effective date in late June. Subject to shareholder approval and as part of this effort, we're planning a number of investor awareness roadshow meetings as well as comprehensive analyst teach-in on May 23rd in New York City. the same day as the shareholder vote earlier that day. The virtual details of the analyst teach-in will be provided on our website. Assuming the U.S. primary listing proceeds, we intend to transition to reporting in U.S. GAAP beginning in January 1st, 2025 and thereafter. We plan to provide an update later in 2024 regarding this process, during which we will set out the key reconciling items compared with our current IFRS reporting. With that, I'll turn it over to Evan to facilitate Q&A.
spk08: Thank you. As a reminder, to ask a question, you will need to press star 1-1 on your telephone and wait for your name to be announced. Please stand by as we compile a Q&A roster. Our first question comes from the line of James Vane Tempest from Jefferies. Please go ahead. Your line is open.
spk03: Thanks very much for taking my questions. I have three if I can, please. Firstly, just on Sublocade XUS, I think you mentioned six countries, just wondering where it's launched at XUS. The second question is just when I look at the Sublocade and the performance, at least versus consensus, seems to be around 15 million or so. So I guess when we look at the guidance, given Q4, from memory, is sort of seasonally weaker, is it fair to say you're more likely going to be at the lower end of your guidance? And then the third question is just around destocking you saw. Is that potentially related to the change attack? I mean, can you give us a sense in terms of what the customer visibility you have is, please? Thank you.
spk07: Thanks for those questions, James. Just to start with the first one on the ex-U.S. sublocated markets, we're in Finland, Germany, Sweden, Australia, Canada, and Israel. So those are the markets that we're currently in. With regards to your question on – I'm going to start with the destocking and then build to the consensus. What we saw was we saw destocking in the period, and we've reached out to our partners because we saw the weeks of stocking drop from 2.1 to 1.7, equating to the 5 to 7 that we talked about. And as we talked to the partners, they indicated broadly there were no plans to reduce their stocking. what we believe is with the disconnect in the data they use for their algorithms on inventory that that caused the decrease in days. So we believe there is a connection to the change cyber attack. As relates to consensus in the lower end, We've done a significant amount of work in this place. I'll start with first, there is such a tremendous unmet need in the space, less than two in 10 people in treatment. Sublocate is still early in growth with just under a 6% share. Strategically, our structure, the excellence of execution by the team, and the differentiated product profile that we have, we've looked at the building blocks in the balance to go. you know, as we regain and pass through the transitory items. Strong CGS growth, which is over 20% quarter-on-quarter, as well as the Salesforce expansion, which increases our reach and frequency and have comfort, you know, with the entire range of $820 to $880 million for Sublocate.
spk08: Thank you.
spk07: Thank you, James.
spk08: Thank you. We will now take our next question. Please stand by. Our next question comes from the line of Max Herman of Stifel. Please go ahead. Your line is open.
spk01: Great. Thanks very much for taking my questions. I've got a few. I'll limit it to three at the moment, maybe come back later. Just trying to, first of all, just touch on suboxone film and the volatility kind of month-on-month or quarter-on-quarter, what's driving that? Because obviously, you know, you have this odd quarter where the rebating impacts the reported number when you change the rebate provision. I wonder whether there was anything within the first quarter that led to that decline from the fourth quarter. So that's the kind of first question. Secondly, just in terms of the litigation on the tooth decay, I notice there's now 325 cases. Kind of interested to know if you have a view on how many of those are sort of single tooth, because I believe the judge is commenting that those will never get to a significant claim. So now the plaintiff lawyers are trying to exclude those from future cases. So I just wanted to understand that. And then in terms of Albertsons, you talked a bit about the growth. In terms of the sales force that's now effective, I'd be interested to know the exact timing of that and whether we're really just at the start of the growth potential there. So I'll leave it with that for now. Thank you.
spk07: Thank you for those, Max. Maybe what I'll do is I'll cover those in reverse order. I'll cover the Albertsons growth, the litigation, and then I'll hand over to Ryan to talk through, you know, the Suboxone film sort of dynamics. So let's start with Albertsons. I think you've kind of indicated where we are. This is the very early stages of reopening independent physician's ability to prescribe sublocate because of the administrative nature, these alternate sites of care alleviate that burden by being able to go there. Very pleased to be partnering with Albertsons, have some good coverage, but it is certainly not a seamless nationwide network that we're looking to create through time. So we are in very early days of this. spoke to an increased sales force to increase the reach and frequency in both our organized health systems, but have the capacity to start to call on these independent physicians. That sales force was just put in place in the first quarter, so they're just out there. In addition, the team in the home office, as you can imagine, is working a portfolio of partners to broaden that network so that it is nationwide coverage and as close to the retail network as we can get. We'll never get there, but that's our aspiration, is to have these as close to the patients as we can be. So very early days on that, and this will be quarters before we start to build out that nationwide network. On the litigation, absolutely right. We highlighted the 325 cases. I think for me, the disclosure's been updated, but the key here is it's the very early stages of the case. This has only recently become an NDL. There have only been a few status conferences with the judge. Most of those are procedural in nature. Given the statute of limitation expecting to expire in June, we're expecting to have more cases here. And, you know, throughout time, we'll understand, you know, one, the number, and then we'll start to work through what the cases look like as discovery begins. But, again, it's very early stages and unable to comment, you know, with regards to the quality of the individual cases. I will note one more thing with regards to that, and we've included an update in the disclosure, is we have alerted our insurers, our product liability insurers, with regards to the case. They've agreed to pay defense costs, but have filed a notice of reservation with regards to coverage on the product liability side, which our lawyers have indicated is customary for these sorts of matters.
spk05: So, Ryan, do you want to talk to the Suboxone Dynamics? Good morning, Max. So on Suboxone film, really there's two things at play here. One, knowing that there are now four generics in the marketplace since last year and to the point that we do not promote this product, it was not unexpected that we would lose some share points. And at the end of fourth quarter going into Q1, we did lose about a percentage. So that's one of the reasons why you saw the drop from Q4 to Q1. And then in addition to that, we just run our normal balance sheet reviews Every quarter, they take a look at our accrual provisions. These assumptions and adjustments are reviewed by PWC. And at the end of Q4 2023, we did have a positive trade spend update. And when you looked at Q1, there was no adjustment at that point. So those are the two main reasons of why you're seeing the step down in net revenue on film.
spk01: Great. Thank you.
spk05: Thank you, Max.
spk08: Thank you. We will now take our next question. Please stand by. Our next question comes from the line of Chase Knickerbocker from Craig Hallam. Please go ahead. Your line is open.
spk10: Good morning, guys. Thanks for taking the questions. So, first, I just want to make sure I understand, you know, kind of the cumulative effect of these headwinds on supplicate. So, mid to high single-digit kind of sequential growth headwind from change in Medicaid. And then the $5 to $7 million kind of destocking is on top of that. And then when we kind of think of that distributor destocking, should we think of that being a tailwind to Q2? And have you kind of seen that ordering already fill that shortfall so far in April?
spk07: So absolutely right on your interpretation on that, Chase. Those are additive. The stocking is in addition to, you know, the underlying dispense impacts that we're seeing for both new patients but also retention in treatment where we did see a disconnect from our historical retention slant refill rates that we believe in the quarter impacted us by about 6,000 units. So a significant impact where we saw that disconnect and associated with the two transitory items. On the stocking, we do expect that stocking to return as the data clarity cleans up. associated with the change cyber attack and would expect that, you know, whether that's Q2 or into Q3, but over the next coming months, absolutely, we expect that to come back.
spk10: Got it. Maybe just putting a finer point on kind of, you know, the midpoint of sublocate guidance would indicate kind of stronger than seasonal, you know, sequential growth in the last three quarters of the year here. So just to kind of put a fine point on maybe how these headwinds abate and then, you know, some of these patients come back and get those you know, this quarter and next. So basically kind of mid-delayed March, there were patients that, you know, were not able to get verified for redosing kind of at that three-month renewal time point. And then there were also patients not able to clear the prior off that were kind of new to therapy. So kind of both those patient groups, you know, would likely come on to drug, you know, in the April and May timeframe if systems are kind of back to normal and things are able to get adjudicated. Is that kind of, we should think of that as kind of a bolster to growth in the midway, midpoint of the year here?
spk07: I think that's what I would call one factor to the growth. I think we have a continuing headwind of the Medicaid renewal continuing through to the half year where then we'll annualize that and that headwind will go away in the back half. But I think the other elements with regards to the cyber attack and things like that, you're thinking of it correctly. The patients should return to treatment either by re-adjudicating with the insurance they're Or if it's Medicaid reentry, they'll go somewhere else to get the insurance coverage. So that will be a tailwind. But also, I can't understate our belief in the proven strategy, structure, and operational excellence of the team that's just been proven over the last three years as we've worked towards penetrating organized health systems. You know, the differentiated asset that we have with unprecedented evidence and real-world evidence, you know, especially in a space with synthetic opioids. And when you look to those, you know, CGS, which was not impacted by either change or the Medicaid reentry, grew it over 20%, quarter over quarter. And we have a Salesforce expansion, which increases our capacity over 50%. So we've got a few additional tailwinds to the ones you highlighted with just patient reentry or re-adjudications.
spk10: Got it. And just last for me, and I'll hop back in queue. Just on CGS, it's, you know, it's fair to say that, you know, that beat your expectations in the quarter, correct? And then, you know, maybe speak to in that channel, if you're hearing about any customers in the criminal justice system doing any sort of competitive sampling, or is that a space where, you know, you kind of still have that to yourself?
spk07: Yeah, I would say in line with expectations. I think we've, you know, this is earlier on in its journey. We just two years ago put in a dedicated sales force for CGS and have done that. So activation, you know, is still early days here. You know, I think when it comes to competition, you know, we expect them to turn to criminal justice. But I think you know, with our unique profile of a product in which you get to therapeutic levels in four to eight hours, that therapeutic level is two to three nanograms for the 100 milligram dose. It's, you know, five to six nanograms per mil, you know, on the 300 milligram dose that lasts the entire month long. We think we have a unique offering in the criminal justice system channel versus competition.
spk08: Great. Thanks, guys. Thank you, Jason. We'll now take our next question. Please stand by. Our next question comes from the line of Thibault Bouterin from Morgan Stanley. Please go ahead. Your line is open.
spk00: Thank you very much. First question on the chance therapeutic hack and the timeline. If you could give us a little bit more details, when did the disruption started exactly? When was it resolved? And just confirming that there is no lingering disruption today. Second question on sublocate product improvement. You recently, I think, had an approval for a longer shelf life at home temperature. So, you know, how much of an impact do you expect this to make? And are you working through any other, you know, new improvement or feature for sublocate or label enhancement that could continue to improve the product profile? And just a last question on the pipeline. the timeline for the three-month formulation license from Allard Pharmaceuticals. Just wondering if we are thinking about traditional development timeline for a new innovative product, which would suggest that it would probably not hit the market before end of this decade, or could this actually go earlier, and could there be a way to accelerate development here given its formulation? Thank you.
spk07: Thanks for the question, Steve. I'll handle the first two, and then I'll hand off to Christian, who's with us, to talk about that very attractive asset. So with regards to change, listen, I think as you look at the timeline, they were impacted by the cyber attacks starting on February 21st. We became aware of it with various press releases that started to hit the wire March 5th. with regards to that and have been tracking that quite diligently, hearing subjectively from the field, seeing some of the impacts on data, which is on a one and a half to two week delay. Everything that we're hearing and seeing is that they have put in place the necessary interventions to free that up. I think some of that is indicated by us in the early days of April, returning to, you know, the dispense growth that we were seeing in the early days of Q1. So I think that's a positive sign that that headwind is being resolved and the market has adjusted to it, albeit after, you know, about a five-week disruption. With regards to the sublocate product improvements, you know, I'll provide some color and we'll invite Christian to add anything he has on those, as well as talk to the three-monthly You're absolutely right, Thibault. We have received improvement for a 12-week out-of-fridge indication. We're currently in the process of trading out that stock, and once we are solely in the 12-week, that will be something we can talk to doctors about. I think that's exciting at the doctor level. Because for them, they can only hold product if the patient doesn't show up for a period of 10 weeks or less. So this covers that entire period. And so a physician wouldn't have to have a fridge when working with a specialty pharmacy. So that should help that, albeit we haven't seen a fridge as a barrier in the launch to date. And there's fridges out there. So this is probably more of a new physician sort of dynamic. We are also working on a bolus of other sort of items, some for the label and some real-world evidence. I'll speak to the label items. We're working on, as part of our 401 study, alternate injection sites so that we can move away from the abdomen to back of the arm and the buttocks. And we're also working on rapid induction on our monthly product. And that would be, from what we can see for competitors, the only monthly product with rapid induction. We expect those submissions to go to the FDA in Q3. If we get an accelerated review, we could hear back in Q1. If it's a normal review, it looks like Q3 2025. So with that, I'll hand over to Christian for any additional color on those, but also to talk about the ALAR asset that we inbounded last year.
spk02: Thank you, Mark. No addition to the label updates. Clearly, in addition to the more formal label update studies, we continue to perform real-world evidence studies, especially to support sublocade in different subpopulations, including those suffering from psychiatric comorbidities, but also additional evidence in the criminal justice system. With respect to INDV 6001, the partnership with ALR Pharmaceuticals, we are going to launch a series of multiple pharmacokinetics studies in the third quarter of this year. We are going through a pretty heavy technical transfer from HeLa to Invivior as we speak, and preparing everything that is going to be required to launch these multiple dose PK studies. That should give us a pretty good understanding on the pharmacokinetics profile of this product by the end of 2025. At which point, we will certainly organize an end of phase two meeting with the DFDA in order to determine the next steps, whether or not we can accelerate the pivotal phase three trials. That is something that we will discuss with the agency at that time.
spk08: Thank you. Thank you. We will now take our next question. Please stand by. Our next question comes from the line of Carl Burns of Northland Capital Markets Incorporated. Please go ahead. Your line is open.
spk09: Thanks for the question. Most of my questions have been answered. But I'm wondering what you can comment in terms of what you're seeing from competition, specifically from Brixati. And do you see Brixati's entry as broadening the demand for long-acting BMAT therapies? Thanks.
spk07: Thanks for the question, Carl. And listen, when it comes to launch plans and dynamics, I think I'll leave those to the competition and their partners to speak to those. I think from my standpoint, nothing has changed based on what we're seeing based on our perception of the market. There's such a huge unmet need in addiction with less than 2 in 10 patients in treatment. Adherence is such an unmet need. There certainly is room For two players in an LAI segment, I think we see in schizophrenia another space with even less patients diagnosed that there's multiple players and there's a $4 billion market there with people playing. That said, we remain, based on the dynamics we're seeing, based on where the market is, we still believe in our differentiated profile that Sublocate provides. You know, it's well suited in this US market where the illicit supply chain has been overtaken by synthetic opioids, backed by five years of HCP patient experience. And it has that differentiated profile that I spoke to later that we think is especially important, you know, given where the supply chain is. So we have, you know, even with competition, we have conviction behind our guidance for 2024. our peak revenue guidance of greater than a billion and a half, and then of course our interim guidance where we expect to exit 2025 at a billion dollar run rate.
spk09: Great. Thanks again.
spk07: Thank you, Carl.
spk08: Thank you. We will now take our next question. Please stand by. Our next question comes from the line of Max Herman of Stifel. Please go ahead. Your line is open.
spk01: Great. Thanks for taking my supplemental questions. Three of them are two on R&D. Just wanted to understand the next steps, obviously, with AEF 117 for cannabis use disorder. Obviously, you're going to get the data in the third quarter and then, I guess, end of Phase 2 meeting with the FDA before the end of the year. Assuming it's positive, are you able at this point to have a a view on what the phase 3 would look like and what the timing would be. That's the first question. Secondly, just on a bit more detail in terms of the proof of concept study for INDV2000, the Ericsson 1 antagonist, what's the phase 2 trial design? And then finally, just trying to understand, it sounds like you're underlying if I get it correctly, with stocking and the headwinds from the, you know, from the change healthcare as well as the Medicaid disenrollment, that you're around 10% sort of growth quarter on quarter, which is kind of in line with what your new patient or patient start data suggested, quarter on quarter growth in terms of patients on treatment. Is that correct? what that's an indicator of as well, trying to understand the difference between dispensed units and new patients. Thank you.
spk07: Well, maybe I'll start with the third question and then I'll hand over to Christian who's here to, you know, handle those two R&D. I think what we've tried to indicate is we do believe the one-off sort of impacts associated with these transitory items is mid to high single digits. When you look at the dispenses, you know, we were at 4%, and we talked to, you know, the fact that historical planning and our planning had us in double-digit sort of growth in the first quarter. So I think, you know, your interpretation is accurate, Max, that, you know, the underlying business we'd expect to be double-digit quarter-over-quarter growth. So thank you for that question. Christian, do you want to talk through AEF 117 and the Ox 1?
spk02: Absolutely, Mark. So AES-0117, as you mentioned, we are currently waiting to see the results of the Phase IIb trial. This is going to happen in the third quarter this year, after which clearly we will request an end-of-Phase II meeting with the FDA. We hope that the agency will grant us the meeting in the fourth quarter of this year. This meeting, as you know, is going to be really critical for us to understand first the FDA's perspective on the Phase IIb data because this is going to determine the type of Phase III trial that we may want to propose to the agency. but also clearly a major discussion as to the clinical endpoints for that periodical phase three trial, not only the primary endpoints, but also the secondary endpoints. So really, I cannot comment on the design of a phase three trial at this stage, especially since I haven't seen the data. So again, a critical meeting with the FDA hopefully before the end of the year. and then we will have to make a decision as a corporation as to whether or not we exercise the option and then move forward to the remaining part of the clinical development plan. The INDV2000 clinical proof of concept design, I will not comment on the design per se. We submitted a protocol to the agency in the first quarter this year, We had a couple of back and forth with the agency to finalize the protocol. In a nutshell, basically, for a proof of concept, we are going to try to understand how we can transition patients from a buprenorphine initiation of treatment onto this completely new mechanism of action that, as you know, is a non-opioid-based medication for the maintenance of treatment of opioid use disorder. So more on this one as we initiate the trial in the second quarter of 2024.
spk01: Great. Thank you. I mean, are you able to say how many patients will be in the study?
spk02: We will have about 330 patients in that clinical proof of concept.
spk08: Great. Thank you.
spk02: Thanks, Max.
spk08: Thank you. There are no further questions at this time. Speakers, please continue.
spk07: Thanks, Evan. With no more questions, this will conclude our Q1 results presentation. I'd like to thank everyone for their continued interest in Indivior, and we look forward to seeing everyone at the upcoming healthcare conferences. Thank you.
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