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spk00: Good day, 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 our presentation. We also may refer to non-GAAP measures, the reconciliations for which may be found in the appendix of this presentation and also at the back of our published press release. These items are now posted on our website at endivere.com. I'll now turn the call over to Mark Crossley, our CEO.
spk03: Thank you, Jason, and good morning and good afternoon, everyone, and thanks for joining to discuss our half-year results. I'll start with some opening remarks, review our progress against our strategic priorities. Christian will then provide a scientific update, and then Ryan will wrap it up with details on our financial performance and our updated guidance before heading on to Q&A session. Turning to the key messages, it was another strong quarter of execution by the entire Indivior team, which keeps us on track to deliver the attractive medium-term growth profile we set out at our Capital Markets Day last December. Recall, this framework contemplates double-digit net revenue CAGR and positive operating leverage. Looking first at the financials, our second quarter results were above our expectations, powered by another very good performance by Sublocade. Total second quarter net revenue of $276 million and adjusted operating profit of $71 million grew by 25% and 18% respectively versus the same period last year. On a half-year basis, we were able to maintain our adjusted operating margin despite the incremental operating expenses from the Opium acquisition. What stood out most to me about our performance was the solid contribution from all of the growth levers of our business. Sublocade year-over-year growth of 58% in the quarter is certainly the headliner, but we also saw an encouraging acceleration in net revenue from Preceris. And on a constant currency basis, we delivered a fourth consecutive quarter of year-over-year growth in the rest of the world, driven by new products, including Sublocate, which is now delivering double-digit quarterly net revenue outside the United States. Our strong half-year performance, along with the outlook of the remainder of 2023, now lead us to raise our full-year guidance for Sublocate and total company net revenue, as well as our adjusted operating profit. On top of our strong business performance, we achieved key strategic milestones in the quarter, which we expect will help secure our future growth potential. These included the successful integration of Opium and the approval of its key asset, Opvi, which we're projecting to launch in the fourth quarter of this year. We also have integrated Opium's pipeline of assets for substance use disorders, which you'll hear a little more about from Christian during his scientific update. We also took a step forward in clearing the backlog of legacy litigation through partial settlement of the antitrust MDL litigation, something I will come back to in just a moment. And then lastly, we successfully affected the additional U.S. listing of our shares in the NASDAQ Global Select market. Turning to our report card and looking at our performance in a bit more detail, Sublocade had a strong quarter with net revenue of $155 million. This represented growth of 58% year over year and 17% versus the prior quarter. Given this sustained strong performance through the first half of the year, we now expect sublocate to deliver net revenue in the range of 590 to 630 million. At the midpoint, this 30 million increase would represent growth of 50% versus fiscal year 2022. This performance continues to be driven by the success of our strategy to focus on and invest behind our organized health systems. In the quarter, we saw increased breadth and depth of prescribing in each of our targeted organized health system subsegments, including large private health systems, federal health care systems, and the U.S. justice system. Focusing for a moment on the U.S. justice system, it's still early days for us in this important subcategory. To date, we've accessed approximately 275 of the top 1,000 priority justice facilities we've targeted in the U.S. However, the justice system is our fastest growing subsegment and now represents 10% of total sublocated net revenue. Encouragingly, we're seeing growth across all three major justice system customer groups, federal, state, and local systems. The success of our OHS strategy has taken the number of sublocated patients above the 100,000 milestone for the first time. This is an important milestone, but still only represents about 3.5% of the 3.1 million people diagnosed with opioid use disorder in the US, showing just how much more work there is still to be done. Finally, The elimination of data 2000 waiver as part of the mainstreaming addiction treatment act now offers the potential to administer sublocate at alternate sites of care. In other words, outside the prescriber's office at qualified off-site locations. In response, we're working with Albertson's companies, one of the largest food and drug retailers in the U.S. with over 1,700 in-store U.S. pharmacies. 700 of which are now involved in this program across 15 states. If this proves beneficial for patients and healthcare providers alike, we would assess targeted incremental investment to accelerated growth, as this initiative should make prescribing Sublocade an option for offices that are smaller or have less resources. It's just another step in allowing for treatment choice based solely on scientific merits. To conclude on sublocate, our strong second quarter performance speaks to the continued successful execution against our strategy with this groundbreaking treatment for patients with moderate to severe opioid use disorder. When we then layer on top the favorable funding and legislative backdrop, this supports our expectation of delivering a $1 billion net revenue run rate for sublocate as we exit 2025 and ultimately our $1.5 billion plus net revenue goal. Turning to diversification and starting with Braceras, we're seeing benefits from our expanded national field force in terms of increasing awareness of Braceras among behavioral health treatment providers. Second quarter net revenue growth was strong year over year, but importantly, and as expected, we saw healthy, renewed sequential growth in the quarter after some destocking in the first quarter. Looking at the rest of world business, it's encouraging to report another quarter of growth, We continue to face challenges in Europe to our legacy tablet business, but this has been more than offset by the introduction of our new differentiated products, Sublocade and Suboxone film. Most recently, we've launched Sublocade in Germany, and we're pleased to gain UK approval earlier this month. We expect these contrasting overall dynamics to continue, and as a reminder, our expected double-digit growth kegger for the medium term includes modest growth in the rest of the world. Of course, the new news in the quarter, in terms of diversification, was the approval of Opvi, our new opioid overdose rescue medication. We're pleased with the FDA-approved label, given it specifically mentions synthetic opioids, which, as you know, are now the main cause of opioid-related overdoses. Our launch plans are underway. The Opvi.com splash page is live. Our digital marketing strategy has kicked off, and we're making outreach across public and private entities to help ensure maximum access, all in anticipation of going into the market with product in the fourth quarter. We've not yet announced pricing yet, but we recognize the innovation OPV brings to the market while also considering the broad access that we will seek for this important new product. We continue to expect modest net revenue in 2023, given the Q4 launch timing, with peak net revenue of $150 to $250 million. Looking at the pipeline, Christian will provide a more fulsome update at the conclusion of my remarks. That said, I must say I'm pleased to report that the timelines for our key assets and post-marketing studies are all on track. Finally, turning to our fourth strategic pillar, optimizing our operating model, we achieved important milestones in the quarter that we expect will enhance both value and create greater certainty for shareholders. First, we successfully delivered the additional listing of our shares on NASDAQ. We expect the listing to generate significant benefits for Indivior, including increased awareness among US investors and securities analysts, and most importantly, increasing awareness of OUD treatment overall. Second, We remain on track for final validation and commencement of commercial supply at our second long-acting injectable manufacturing site in the second half of 2023. Before turning over to Christian, I want to update you on the status of our antitrust multi-district litigation, where we've been actively pursuing our strategy of seeking resolution at the right value through mediation. As you know, we were able to reach settlement agreement with the states and the District of Columbia, and we've paid the $102.5 million settlement amount last month, which is in line with the existing provision. To date, we've been unable to reach settlement agreements with the remaining two classes of plaintiffs, but we remain open to settlement at the right value, and the trial has now been scheduled to start in late October. We've updated our disclosures to reflect this progress as well as the proximity of the trial. Our adjusted provision of $187.5 million continues to be our best estimate for settlement purposes with the remaining claimants. As a reminder, our overriding goal is to continue to create greater certainty for Indivia's stakeholders. While clear progress has been made, these matters are ongoing and we cannot predict with any certainty whether we'll be able to reach settlement with the remaining classes, and continue to caution that the final aggregate costs could be materially different. Before handing over to Christian, let me close out this section by saying the team continues to execute well and deliver strong financial results, and we're making good progress in advancing each of our strategic priorities. With that as an opening, I'll turn over to Christian for his scientific update.
spk11: Thank you, Mark, and good morning, good afternoon, everyone. Our contribution to sublocate success has focused and will continue to focus on breaking barriers to treatment access by creating new evidence through four strategic pillars. First, we have initiated five phase four studies aiming at addressing knowledge gaps in the area of sublocate rapid induction, patient subpopulations that may benefit from the 300 milligram maintenance dose, alternate injection sites, long-term recovery outcomes, treatment cessation guidance, and comparative effectiveness with other medications for the treatment of opioid use disorder. We also launched a platform called ROAD for data integration and sharing with the scientific and medical communities. Second, we are pursuing four long-term collaboration studies to understand the long-term outcomes of sublocated treatment its differentiation versus current standard of care, and the journey towards recovery. Third, we have launched a broad range of real-world evidence studies with 21 work streams along three themes, health disparity, recovery, and harm reduction. Fourth, nine externally sponsored studies are supporting research areas of interest, including high-risk opioid overdose patients, patients in the criminal justice system, rapid initiation in different treatment settings, comorbidities, and the long-term efficacy and safety. Our intranasal nalmophene product, OBVI, as you know, was approved by the FDA on May 22nd this year for the emergency treatment of known or suspected overdose induced by natural or synthetic opioids in adults and pediatric patients aged 12 years and older. We are currently planning the implementation of post-marketing studies, including pediatric studies, as well as development reproductive toxicity studies on DDM, the nasal absorption enhancer in the formulation. An enhanced pharmacovigilance request is also being implemented. On the next slide, you can see that we are making significant progress with our pipeline in opioid use disorder, alcohol use disorder, cannabis use disorder, and acute cannabinoid overdose. First, our selective orexin-1 receptor antagonist for the treatment of opioid use disorder, INDV2000, is on track to complete the multiple ascending dose study with the last subject, the last visit at the end of the third quarter of this year. and the preparation of an end of phase one meeting with the FDA in the fourth quarter this year. Supportive clinical and non-clinical studies as well as stablet formulation development and manufacturing are currently ongoing. In the alcohol use disorder space, we are expecting preliminary data from a phase two trial on our intranasal naltrexone INDV4002 towards the end of the third quarter this year. Our GABA-B positive allosteric modulator program, INDV1000, has led to the characterization of two new lead molecules. A decision for lead selection is on track for the end of the third quarter this year. In the cannabis use disorder space, our strategic collaboration with ALICE Pharma for the development of AEF0117 is progressing as planned. The estimated last subject last visit for the face-to-be trial is in the first quarter of next year, with a final clinical study report in the third quarter of next year. In the meantime, other CMC, chemistry manufacturing controls, non-clinical toxicology, and clinical work streams are progressing as planned. Finally, the development of Drenabant for the treatment of acute cannabinoid overdose is on track towards IND enabling activities. with a support from a grant from NIH NCATS. On the last slide, I would like to draw your attention to a seminal paper that was published by Ailis Pharma in the journal Nature Medicine, which summarizes the entire development of AEF0117 from its inception all the way to the data generated in clinical phase one and phase two trials. Thank you, and let me hand it over to Ryan for the financials update.
spk01: Thanks, Christian, and good morning and good afternoon to everyone. Overall, I'm pleased to report another good quarter of execution and business momentum. We delivered very strong top-line growth driven by sublocate, and we grew our adjusted operating income versus the prior year, despite absorbing a full quarter's worth of open expenses. I'll now provide some more detail on the performance drivers in the quarter. Starting with top line, total net revenue of $276 million reflected growth of 25% versus the year-ago quarter, both on a reported basis and at constant exchange rates. By geography, total U.S. net revenue grew by 26% versus the prior year quarter, while the rest of the world was up 19% year-over-year and 20%, excluding FX. The rest of the world is benefiting from the launch of Sublocade and Suboxone film in new markets, as Mark discussed, as well as strong performance in more established markets, particularly Canada. Sublocade net revenue outside of the U.S. grew 67% year over year to $10 million in the quarter. Total Sublocade net revenue of $155 million for the second quarter of 2023 was stronger than what we had expected. Sequential net revenue growth for sublocate was 17%. I would note that based on the timing of the July 4th US holiday, there was stocking in the low single digits late in the quarter that we expect to gradually unwind in Q3. US dispenses were up 16% sequentially in the quarter and aligned with net revenue adjusting for the stocking impact. Moving to PSERIS, net revenue of $11 million was up 57% versus the prior year. Sequential growth of 38% was positively impacted by the destocking we highlighted in the first quarter of 2023. We continue to be encouraged by the performance we are seeing in PSERIS on a number of internal metrics and are confident of reaching our net revenue guide of $45 million to $55 million for the full year. Turning to Suboxone film, the average share of approximately 19% in the second quarter was flat compared with both the first quarter and the year ago quarter. I'll come back to the outlook for this product in a moment with my guidance discussion. But as a reminder, we do not promote Suboxone film in the US. Moving down the P&L, our second quarter adjusted gross margin of 83% was similar to the prior year quarter, mainly reflecting improved product mix offset by inflationary impact. Adjusted SG&A expenses were $125 million in the quarter, an increase of 17% versus Q2 of last year, reflecting the full quarter of added opium expenses, together with increased legal costs and inflationary impacts. R&D expenses were $32 million in the quarter. The expected increase in R&D was primarily driven by the progression of sublocate studies and pipeline assets, as well as activities relating to our additional contract manufacturing site. As Mark mentioned, we expect startup of this site in the second half of 2023 and are pleased with this extra supply and risk mitigation initiative. Our strong net revenue performance helped to absorb the opium and OPV pre-launch expenses that were added when we closed the transaction in early March. As a result, adjusted operating income of $71 million in the second quarter was up 18% versus the prior year's $60 million. You should note that we continue to expect OPN transaction to be accretive to earnings after the second full year of the OPV launch. Lastly, on the P&L, our adjusted net income of $56 million grew 24% in the second quarter versus last year, reflecting the dynamics I just highlighted. Quickly touching on the balance sheet and our capital position, we ended the second quarter with gross cash and investments of $782 million. During the first half, positive operating earnings were offset by litigation-related payments, including the antitrust MDL settlement of $102.5 million in June. Lastly, taking a closer look at guidance. we are increasing total company full year 2023 net revenue guidance to $1.3 billion to $1.9 billion from $970 million to $140 million, primarily due to the strong performance of Sublicate in the first half of 2023. For Sublicate, based on current performance trends, we are raising the full year 2023 net revenue guidance to a range of 590 to 630 million, which represents a growth rate of 50% at the midpoint compared to full year 2022. With our gross margin and OPEX expectations unchanged with the open expenses added in the last guidance revision in Q1 2023, we now expect adjusted operating income to be higher than last year's performance of 212 million. For film, our guidance now assumes commercial availability of a fourth film generic in the U.S. at the start of the fourth quarter, whereas our previous guidance assumed this entry more in the mid 2023 timeframe. As we have stated previously, we have no specific market intelligence as to exactly when or even if this generic will launch. In the event that the additional generic does not launch by the start of the fourth quarter, we may choose to reinvest some of the net revenue upside in tactical commercial initiatives to accelerate the uptake and adoption of sublocating. Let me close by saying we are pleased with our execution and our financial results for the quarter. We believe our first half performance puts us solidly on track to deliver strong results in 2023. Importantly, we are confident that we can deliver our increased full year guidance. I will now turn the call back over to Mark.
spk03: Thank you, Ryan. Sharon, I think we're now ready to take questions from the audience.
spk05: Thank you. To ask a question, you will need to press star 1 and 1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1 and 1 again. We will now go to your first question. One moment, please. And your first question comes from the line of James Vain-Tempest from Jefferies. Please go ahead.
spk09: Hi, good afternoon. Thanks for taking my questions. I have three, if I may, please. Firstly, just curious, the underlying earnings power of the business. If we were to kind of exclude Opiant and all the kind of the costs that are integrated, what would the EBIT growth be in 2Q? My second question is, we've obviously seen Bricsardi US approval. I was just kind of curious how you're viewing that product in the market as we get towards later in the year. You've obviously taken the decision to raise sublocate guidance, but I guess anything around how that could impact pricing or your strategy would be useful. And then the third question is just regarding the ongoing disclosures, I guess, which you've made from a risk perspective. I was wondering how frequently is the risk language updated around going concern on a rolling 18-month view? And I was just wondering if either direct or end payers settle, and does that remove essentially the going concern risk language? And if so, you know, when could we see that? Thank you.
spk03: Thanks for the questions, James. We don't carve out on a quarterly basis the impact of opiate. What I would say is I think we did highlight an incremental cost within the year of about $50 million that would ramp up through the year and into launch. So we just don't carve out at that level of detail. On Brixati, listen, obviously we do note that they have been approved and are expected to be in the market in the fourth quarter. I think questions with regards to their launch strategy and items of that matter are best left to the Braeburn team. as well as their partner cameras. From our standpoint, I continue to kind of highlight there is such a huge unmet need in this disease space where only about 20% of patients actually get treatment that LAIs in this space are a huge opportunity. And even at, you know, our current updated guidance, we're still only talking about 3.5% of patients having access to Sublocate. So there's plenty of room for multiple players. But what I will say is we remain extremely proud of the differentiated profile that Sublocate provides. It's one that's backed by five years of HCP and patient experience. Sublocate has an immediate boost to therapeutic levels. unique therapeutic levels that on the maintenance dose of 100 milligrams is over two nanograms per mil at the 300 milligram maintenance dose is about five nanograms per mil which we believe really protects patients in their moments of weakness especially with a market that fentanyl has taken over the illicit supply chain so so for us we're focused on our asset which we think is differentiated versus other lais and we'll continue on our organized health system strategy so As relates to the disclosure, I think it's really, really important that the facts of this case haven't changed. And really, we review our language. We review our going concern every quarter when we come to the market. And this cautionary language update is more due to the passage of time and the potentially simpler trial with less classes involved in it. We're continuing, you know, on our strategies to get resolution at the right value via mediation. And I think a good first step of that was the resolution we had with the states, which was in line with the reserve. So we'll continue to pursue the strategy through the updated trial date of October 30th. Thank you. Thank you, James.
spk05: Thank you. We will now go to our next question. And your next question comes from the line of Max Herman from Stiefel. Please go ahead. Your line is open.
spk04: Great. Thanks for taking my questions. Three, if I may. So firstly, just on the R&D spend phasing, I notice you've left the Guidance range unchanged there with $100 million at the top end, although you've spent, I think, $59 million in the first half. Historically, the last few years, it's definitely been second-half weighted. I wondered if you can explain a little bit. Do you expect a lighter spend in R&D and what would be the reasons for that tailing off in spend against historical norms? Secondly, just in terms of profitability, I know now you're guiding to greater profit than in 2022. I wondered if you could give us a little bit of an indicator of how you think that will be phased. Are you expecting a lower profitability operating profit terms in the second half of the year than the first half because of the launch costs on opium? Just a little bit more detail there. And then just maybe in the litigation, is there any more color you can give in terms of, I know you talked about in the first quarter results, you talked about having interactive discussions with the state's payer at the time. I wondered if you've had any more kind of, you know, interactive discussions with either of the two other plaintiff classes. Thank you.
spk03: What we'll do, Max, I'll start with the last question, then I'll hand over to Ryan to talk about the R&D spend phasing and then the profitability. I think just due to the ongoing nature of the matters, they're before the court. There are many elements which remain confidential. I think we have to let my previous comments on the call as well as the updates to the disclosures stand as they are. And again, it's just because of the nature of the proceedings. Um, so with that as kind of an answer to the, to the litigation side, I'll go ahead and hand over to Ryan to talk through, you know, the, uh, the R and D spend and the profitability profile.
spk01: Good morning, Max. Um, on the R and D spend what you're seeing there. Well, first of all, it's our R and D. Priorities are still the same, right? It's, it's the, um, studies and trials that we continue on sublocate that Christian walked through it to continue work on building out that second manufacturing site with the tech transfer. And then third, it's the continued progress on some of our new early stage assets with CUD and ALIS. And what you saw starting at Q3 of last year was us really getting scaled up on the sublocate trials. And then you saw that increase in Q3 and Q4. You're really seeing us at full run rates in the first half. So I would say some of that should decline a little bit in the back half in regards to those activities tied to sublocate. but still feel very confident in the number that we put forth for the full year. In regards to your second question around profitability, first thing I would just call out is we are quite excited about raising the operating income number for the year, even after layering in, as Mark said, $40 to $50 million of expenses tied to opv and opium. Around Q3 and Q4, we tend not to provide guidance on a quarterly basis because there's a couple of pulls and pushes there As you inferred, R&D could come down a little bit, but on the back end of that, in the second half, we're going to have some more commercial programs as well as some support costs for the launch of OPPE. So still feel really good about the full year number.
spk04: Great. Thank you.
spk03: Thank you, Max.
spk05: Thank you. We'll now go to your next question. And your next question comes from the line of Paul Cudden from Numis. Please go ahead.
spk10: Thank you very much, guys. I've got two questions, please. Firstly, just probing the range you've provided for kind of sublocate for the full year. Still quite wide. And I mean, the upper end, I'm just wondering what your assumption would be quarter to quarter kind of growth in dispense rates, whether there's anything in Q1 and Q2 that led to that elevated quarter and quarter growth rate that wouldn't necessarily continue into Q3. And then secondly, just on Subutex, Exxon, rest of the world, were there any stocking dynamics in the first half of the year that may not recur into the second half, or is that something that's now on a much more sustainable growth plane? Thank you.
spk03: Good afternoon, Paul, and thanks for the questions. With regards to the range on sublocators, I think the strong first half results really demonstrate the team's execution against the strategy. Being over 100,000 patients in route, the 270,000 patients required to get to the billion and a half waypoint, because we've always said a billion and a half plus, all very key. And that's allowed us also in the short term within the year to raise our guidance to the by $30 million at the midpoint, which gets to the year-over-year at 50%. Now, when I look at the quarter-over-quarter, I think Ryan mentioned a bit of stocking in the second quarter that's flattered the Q2 results a bit, but we expect continued strong growth in the back half and continued momentum. With regards to Subutex XR, I would say that with regards to those results, we haven't seen material stocking in those markets. This is continued structural progress across all the markets we're in that have led to the kind of year-over-year growth and achieving kind of a nice milestone of $10 million of net revenue within the quarter.
spk10: excellent thank you and just the final one if i may just on this kind of pilot program that you're launching with kind of potentially smaller clinics is this something that perhaps in the future you'll have to materially sort of scale up um kind of resource for is it something that the partner could could handle more of the um the opex that will be required
spk03: It's a great question, Paul. And just for a bit of color, I mentioned it a bit in my opening remarks, but Albertsons is the second largest supermarket chain in the U.S. They have 2,200 stores. Of those stores, there's 1,700 that have pharmacies on site. And what we're really excited about is that the leadership of Albertsons has recognized the instrumental role they could play in helping fight the opioid epidemic in the U.S., So the elimination of data 2000 allows for these alternate sites of care where the administration of sublocate can be done at an alternate treatment space and allow physicians who just don't have the infrastructure in their office to manage a controlled specialty pharmacy product. It allows them to prescribe based on patient's needs. And for us, it also allows patients to have the medication administered in a more normalized fashion. Similar to vaccines or in schizophrenia, they can go to these pharmacies to have the medication administered. From engagement with HCPs, that is a responsibility of Indivior's, and that's where I've talked about potential targeted investments you know, to come back to some of these smaller doctor's offices moving forward. But for us, this is about accelerating growth, having sublocade help more patients on their journey to recovery.
spk10: Superb. Thank you very much, and I hope that goes well.
spk03: Thank you, Paul.
spk05: Thank you. We will now go to your next question. And your next question comes from the line of Thank you.
spk06: Just a couple of questions. The first one, just to follow up on the strategy to decouple prescription and administration. So you're making sublocade available in potentially more places for administration, but is it addressing one of the key obstacles for the uptake, which historically has been the difficulty for some physicians to treat this patient population and access this patient. So is it an initiative that's going to address this specific issue? So just if you could give some details on this. And then second question on capital allocation. You could have any cash deployment either towards M&A or returning cash to shareholders until the litigation situation is resolved, or is it an option that you maintain in the short term until you have more clarity on the litigation situation? Thank you.
spk03: Thanks for the question. I think you're hitting the nail right on the head with regards to having alternate sites of care. It does address a tremendous need out there in doctors' offices. Recall, when we pivoted our strategy to organize health systems. We were pivoting to large systems with infrastructure, with the back offices to support physicians in procuring and arranging for administration of a controlled specialty pharmacy product. That infrastructure and those demands in these smaller doctor's offices, which historically have treated a significant number of patients, was just too much in there. That's why we made the pivot to the organized health systems, which has driven our growth. What this is doing is addressing those physicians who have remained in these small offices who just don't have the infrastructure. They can now meet with their patients, prescribe Sublocade, and have this script either be written or electronically delivered to the Albertsons Pharmacy where they can go and get this administered. I think of it just like if you went and got a vaccine, you could go and get your shot for the vaccine at the front of one of these pharmacies. So it does address some need. It addresses an area where physicians are unable to prescribe because of the burden. And I think this is a great action by the Congress to pass this act, which eliminates this barrier and normalizes the treatment space. So really good stuff here. On the capital allocation, it's a great question. Listen, I think for us, You know, we're very consistent in our capital allocation policy. You know, we review this as a management team and with a board on a regular basis as we actively manage it. And the priorities, you know, remain extremely consistent with our previous discussions. We're reinvesting in growth, including the current products. We're maintaining financial flexibility and to meet our obligations. And then... If there's excess cash, we look to either diversify the business via business development or return excess cash to shareholders, as we've shown that we're doing. In the short term, we're focused on reinvesting in the business, delivering on sublocate, delivering on integration and launch of Otvi, and we'll continue to actively manage our capital allocation moving forward. Thank you.
spk05: Thank you. We will take your next question. And your next question comes from the line of Carl Burns from Nordland Capital Markets. Please go ahead.
spk08: Thanks for the question, and congratulations on your progress and results. I was just wondering if you might be able to provide a little bit on the specifics and detailing of OPFI, particularly to the public sector and first responders. And do you see the label, which is inclusive, of synthetic opioid language for overdose treatment that OPV would be positioned to emerge as a standard of care among first responders. How do you see that sort of, you know, transpiring? Thanks.
spk03: Thanks for the questions, Carl, and great to have you covering in Divior. You know, with regards to the detailing of OPV, this is a much different sort of call platform. you know, than Sublocate or Preceris where you're not calling, 90% of the volume runs through the public interest sort of markets, first responders, community action groups. And so you're calling more on decision makers and purchasing sort of groups. So the call platform is much more focused. And so it's a much smaller sales team focused in this space, much more focused. I think when you think about Opvi and this new and differentiated sort of option for overdose rescue, we're pleased with the label we've gotten. We're pleased with 90% of opioid overdose deaths caused by synthetic opioid census fentanyl. Opvi is the first and only nasal opioid rescue medicine that's specifically indicated for synthetic opioids like fentanyl. So for me, during an opioid overdose, every second matters with regards to the quality of the recovery to minimize long-term damage or death. So really critical. And for us, with the Nalmophene Nasal Rescue, OPVI, being fast-acting and having a long half-life, about 11 1⁄2 hours, which is longer than fentanyl's, you know, we're excited about the opportunity it has to help more patients. Yeah. We'll let the first responders and the people in the market decide if it's going to be the new standard of care, but we're excited to have it as an option out there to help save people's lives.
spk08: Great. Thank you, and congratulations again.
spk03: Thank you, Carl.
spk05: Thank you. Once again, as a reminder, if you would like to ask a question, please press star 1 and 1 on your telephone keypads. We will now go to your next question, and it comes from the line of Edward Thomason from Liberum. Please go ahead. Your line is open.
spk07: Hello. Thank you for taking my question. I had two, if I may. Firstly, just on Sublocade, particularly in markets where you have launched it in the rest of the world, in the same market as Brixaldi, such as Finland and Australia, What has been your learnings from those specific markets? And then I'll follow up with the second question after that.
spk03: We're in the rest of the world. We're in Canada where we don't have competition, Australia where there is competition, as well as in the Nordics and more recently the Nordics in Germany. So the primary market where there's been competition for a period of time is in Australia. Because of our registration strategy, which was focused on the U.S., we were second to market in Australia during a period of COVID. And I think what we're seeing is a tale of different geographies and health payers within Australia in Australia. One area, you know, we see that, you know, the standards have been written for Brixati and Sublocate in those markets have a much lower market share. And in the other areas where it's more open access, where they're letting physicians make the choices, we're seeing a much more sort of normalized competitive environment and Sublocate's benefits are able to be better utilized by physicians and in those markets. You know, we're seeing higher share, you know, in the, you know, 35% to kind of 45%, you know, region, which is important. Now, of course, these are markets with a socialized payer scheme. You know, in Australia, fentanyl has not yet hit the shores, so it is a very different competitive market than I think what you would see, you know, here in the U.S., which is, you know, it's disproportionately been hit by the opioid crisis than other countries.
spk07: Okay, thank you. The second question I had was just on the updated risk factors, and particularly that worst-case scenario that you illustrated that exceeded the existing cash resources. In that scenario, what price erosion are you factoring in to suboxone film if a fourth generic entered into the market in that working scenario?
spk03: Edward, I think as we look to suboxone film, we've always planned the business as it will eventually return to analogs with additional entrance. That's the way typically, you know, generic markets works, and we factored that in the short term. you know, the stock or the film has been, you know, much stickier in its share. And despite an approval, you know, of a fourth generic, we haven't seen them enter the market. And so we think having that film out there is good for patients and for shareholders, you know, it's a nice incremental cash in the short term.
spk07: Okay, but sorry, that doesn't really answer the question, which is related to the erosion of price if that fourth generic enters the market. I can understand you can see volume switching to the generic, but particularly on the price. Do you have an answer to that specific part of the question?
spk03: Apologies. I'm not trying to dodge it. It's just the share drop is so significant when you go to analogs that in those sort of plannings, you drop off from a revenue standpoint. But the pricing... The pricing we have, we're already at pricing in government entities, which tends to be the lower in the market. So we wouldn't see incremental pricing impacting us. It just could be that the generic pricing might lower and take share. So from an individual standpoint, we wouldn't see much of an impact to price or mix because we're already in the lowest price accounts. But for the generics, we would expect that their prices to drop.
spk07: Okay. All right. Thank you for taking my questions.
spk03: Thank you, Everett.
spk05: Thank you. We'll now go to our next question. And your next question comes from the line of Peter Tester from One Investment. Please go ahead.
spk02: Hi. Thank you for taking the question. It's just one question on how the OHS systems are adjusting to the opportunities they now have with the legal changes. I mean, you talked a bit about how you're using Albertsons, but how they may be organizing themselves also to handle patients and train doctors given the different limits and so on. If you could give any words of what you're seeing there, please.
spk03: It's a good question, Peter. The Albertsons opportunity is so new that you're not really seeing adjustments. I mean, it just went into place at the end of the quarter. Now, the good thing is it's gone in and it's been activated in those 700 systems and we have already had a number of administrations. But recall, in the organized health systems, whether it's justice systems, large government, or large health systems, they tend to have the infrastructure around these physicians from a pharmacy on site, a back office to manage reimbursement and scheduling. They have the infrastructure to support the physician. It's not that they might not use an alternate set of care for a reason now and then, but the reason we've had the growth is because they have the infrastructure to support both the physician and the patient, you know, in the administration of Sublocate.
spk02: I was also wondering about the training rules and doctor prescribing limits and other factors which have changed in legislation. Do you see whether you see them working with their doctors or handling, you know, penetration through the systems differently or other things they can do?
spk03: No, it's another great question and another aspect, you know, that we haven't addressed on the call with regards to the data 2000 elimination. And I think this is one where this is gonna be a journey through time as this disease space through that legislation continues to normalize. This means that any doctor can administer buprenorphine. We're not seeing a rush of new physicians to do that. It's still remaining highly concentrated with the physicians that are there. When we are seeing some physicians, increase their number of patients. But again, this isn't something that's a light switch or a faucet where you turn it on and everything's migrating over. This is happening through time, bit by bit, with regards to the overall treatment for opioid use disorder. That's great. Now, thank you for the help. No, thank you, Peter. Appreciate it.
spk05: Thank you. We now have a follow-up question. And your follow-up question comes from the line of Max Herman from Sievel. Please go ahead.
spk04: Great. Thanks for taking my additional questions. A couple. One is just discussions on ARPV. Obviously, the product's now approved. I wondered whether you've been able to have many of these discussions ahead of the fourth quarter launch with the first responder payers. So that's the first question. And the second one is just in terms of just trying to understand the Albertson opportunity here. In terms of your calls currently on non-OHS psychiatrists and opioid use disorder treatment physicians, And since you've been so focused on the OHS and the criminal justice system, are you currently calling on non-OHS doctors and criminal justice system doctors?
spk03: Thanks for both questions, Max. On the OTV side, you know, since it's been approved, we've not set price. People have had initial discussions with regards to OTV, its profile. But the discussions will really start to increase over the next two to three weeks when we set our final pricing. With regards to Albertsons, we do have a percentage of calls, a small percentage of calls, probably 10% or so, that are outside of organized health systems in physicians who have continued to prescribe sublocate and shown a willingness to manage the complexity. But that's one of the things I highlighted in my comments is because this reopens up that historic call platform, we're going to have to take a look at resource allocation on this. We don't see this as a doubling of the sales force. It's a more targeted sort of look, but we want to make certain that we're able to help those physicians get sublocated to the patients to help them enter recovery with this new channel or new administration route for the medication.
spk04: No, great. Thanks very much.
spk03: Thanks again, Max.
spk05: Thank you. I will now hand the call back to Mark Crossley for closing remarks.
spk03: Thank you, Sharon, and thanks to everyone for your continued interest in Indivior. In closing, I just want to thank our teams again for their continued hard work and the dedication to patients. It's been another quarter of strong financial results, delivery against our strategic priorities, and entering the second half of the year, we have good momentum across our key growth drivers and are working hard to create greater certainty for all of our stakeholders. We look forward to reporting our progress in the coming months. Thank you very much.
spk05: Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect.
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