Indivior PLC

LSE:INDV

Earnings Call Transcript 2023-Q2

[Operator]

Good day and thank you for standing by. Welcome to the Indivior PLC half year results 2023 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. [Operator Instructions]I would now like to turn the conference over to your host today Jason Thompson. Please go ahead.

[Jason Thompson, executive]

Sharon. 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 indivior.com. I'll now turn the call over to Mark Crossley, our CEO.

[Mark Crossley, executive]

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 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 market's day last December. We call this framework contemplates double digit net revenue kegger 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're able to maintain our adjusted operating margin despite the incremental operating expenses from the Opiant acquisition. What stood out most to me about our performance was a 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 PERSERIS.And on a constant currency basis, we delivered at fourth consecutive quarter of year-over-year growth in the rest of the world driven by new products including SUBLOCADE 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 SUBLOCADE 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 Opiant and the approval of its key asset OPVEE which we're projecting the launch in the fourth quarter of this year.We also have integrated Opiant's pipeline of assets for substance use disorders which you'll hear a little more about from Christian during a 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 the sustained strong performance through the first half of the year, we now expect SUBLOCADE to deliver net revenue in the range of $590 million 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 sub segments 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 1000 priority justice facilities we've targeted in the U.S. However, the justice system is our fastest growing sub segment and now represents 10% of total SUBLOCADE 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 SUBLOCADE 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 U.S. showing just how much more work there is still to be done.Finally, the elimination of data 2000 waiver as part of our -- as part of the Mainstreaming Addiction Treatment Act now offers the potential to administer SUBLOCADE at alternate sites of care. In other words outside the prescribers office at qualified off site locations. In response, we're working with Albertsons 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 accelerating 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 SUBLOCADE, 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 SUBLOCADE as we exit 2025 and ultimately, our one and a half billion dollar plus net revenue goal.Turning to diversification and starting with PERSERIS, we're seeing benefits from our expanded national field force in terms of increasing awareness of PERSERIS 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 U.K. 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 world.Of course, the new news in the quarter in terms of diversification was the approval of OPVEE, our new opioid overdose rescue medication. We're pleased with the FDA approved label given it specifically mentioned synthetic opioids which is, you know, are now the main cause of opioid related overdoses.Our launch plans are underway. The opvee.com/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 OPVEE 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 million 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 U.S. 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 multidistrict 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 in the District of Columbia, and we paid the $102.5 million settlement amount last month which is in line with the existing provision. Today, 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 Indivior 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 the 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 it over to Christian for his scientific update.

[Christian Heidbreder, executive]

Thank you, Mark. And good morning, good afternoon, everyone. Our contribution to SUBLOCADE 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 4 studies aiming at addressing knowledge gaps in the area of SUBLOCADE rapid induction patient sub populations that may benefit from the 300 milligram maintenance. Those 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 the 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 SUBLOCADE treatments, each 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, co-morbidities and the long-term efficacy and safety.Our intranasal nalmefene product, OPVEE, as you know was approved by the FDA on May 22, 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. INDV-2000 is on track to complete the multiple ascending dose study with the last subject last visit at the end of the third quarter this year and the preparation of an end of Phase 1 meeting with the FDA in the fourth quarter this year. Supportive clinical and non-clinical studies as well as established formulation development and manufacturing are currently ongoing.In the alcohol use disorder space, we are expecting preliminary data from a Phase 2 trial on our intranasal naltrexone, INDV-4002 towards the end of the third quarter this year. Our GABAB B positive allosteric modulator program, INDV-1000 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 of this year.In the cannabis use disorder space, our strategic collaboration with Aelis Farma for the development of AEF0117 is progressing as planned. The estimated last subject last visit for the Phase 2B 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 and controls, non clinical toxicology and clinical work streams are progressing as planned. Finally, the development of Drinabant 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 Aelis Farma 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 1 and Phase 2A trials. Thank you and let me hand it over to Ryan for the financials update.

[Ryan Preblick, executive]

Thanks, Christian. And good morning, 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 SUBLOCADE, and we grew our adjusted operating income versus the prior year despite absorbing a full quarters worth of Opiant 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 SUBLOCADE was 17%. I would know that based on the timing of the July 4 'U.S. holiday, there was stocking in the low single digits late in the quarter that we expect to gradually unwind in Q3. U.S. dispenses were up 16% sequentially in the quarter and aligned with net revenue adjusting for the stocking impact.Moving into PERSERIS, 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 continued to be encouraged by the performance we are seeing in PERSERIS on a number of internal metrics and are confident of reaching our net revenue guide of $45 million to $55 million to the full year.Turning to SUBOXONE Film, the average share of approximate 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 U.S.Moving down to P&L, our second quarter adjusted gross margin of 83% was similar to the prior year quarter mainly reflecting improved product mixed offset by inflationary impact. Adjusted SG&A expenses were $125 million in the quarter, an increase to 17% versus Q2 of last year reflecting the full quarter of added Opiant 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 SUBLOCADE studies and pipeline assets as well as activities relating to our additional contract manufacturing site. As Mark mentioned, we expect startup of the 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 Opiant and OPVEE prelaunch expenses that were added when we close 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 Opiant transaction to be accretive to earnings after the second full year of the OPVEE launch.Lastly, on the P&L, our adjusted net income of $56 million grew 24% in a second quarter versus last year reflecting the dynamics I just highlighted. Quickly touching on the balance sheet in our capital position, we ended the second quarter with gross cash and investments of $782 million. During the first half, positive operating earnings were all set 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 of 2023 net revenue guidance to $30 billion to $90 billion from $970 million to $140 million primarily due to the strong performance of SUBLOCADE in the first half of 2023. For SUBLOCADE based on current performance trends, we are raising the full year 2023 net revenue guidance to a range of $590 million 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 Opiant 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 in adoption of SUBLOCADE.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.

[Mark Crossley, executive]

Thank you, Ryan. Sharon, I think we're now ready to take questions from the audience.

[Operator]

[Operator Instructions]. We will now go to your first question. One moment, please. And your first question comes from the line of James Vane-Tempest from Jefferies.

[James Vane-Tempest, analyst]

I have three if I may, please. Firstly, just curious if 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 Brixadi U.S. 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 SUBLOCADE 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 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, when could we see that?

[Mark Crossley, executive]

Thanks for the questions, James. We don't carve out on a quarterly basis, the impact of Opiant. What I would say is I think we did highlight an incremental cost factor 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 Brixadi, 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, Camurus. 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 if our current updated guidance, we're still only talking about 3.5% of patients having access to SUBLOCADE. So, there's plenty of room for multiple players.But what I will say is we remain extremely proud of the differentiated profile that SUBLOCADE provides. It's one that backed by 5 years of HCP and patient experience. It has -- the SUBLOCADE has an immediate boost to therapeutic levels. Their unique therapeutic levels that on the maintenance dose of 100 milligrams is over 2 nanograms per mi. The 300 milligram maintenance dose is about 5 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 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 it 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 potentially simpler trial with less classes involved in it. We're continuing 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 30. Thank you, James.

[Operator]

We will now go to our next question. And your next question comes from the line of Max Herrmann from Stifel.

[Max Herrmann, analyst]

I have three if I may. So, firstly, just on the R&D spend phasing. I noticed 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. And historically, last few years, it's definitely been second half weighted. So, 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 spends 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 Opiant 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 States payer at the time. I wondered if you had any more kind of interactive discussions with either of the two other Plaintiff classes?

[Mark Crossley, executive]

What we'll do, Max. I'll start with the last question and 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, 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. So, with that as kind of an answer to the litigation side.I'll go ahead and hand over to Ryan to talk through the R&D spend and the profitability profile.

[Ryan Preblick, executive]

Good morning, Max. On the R&D spend, what you're seeing there. Well, first of all, it's -- our R&D priorities are still the same, right? It's the studies and trials that we continue on SUBLOCADE that Christian walked through. It's continued 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 ALS. What you saw starting at Q3 of last year was us really getting scaled up on the SUBLOCADE 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 SUBLOCADE, 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 million to $50 million of expenses tied to OPVEE and Opiant. 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 OPVEE. So, we still feel really good about the full year number.

[Mark Crossley, executive]

Thank you, Max.

[Operator]

We'll now go to your next question. And your next question comes from the line of Paul Cuddon from Numis.

[Paul Cuddon, analyst]

I've got two questions, please. Firstly, just probing the range you've provided for kind of SUBLOCADE 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 the elevated quarter-on-quarter growth rate that wouldn't necessarily continue into Q3?And then secondly, just on SUBUTEX XR and 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 plan?

[Mark Crossley, executive]

Good afternoon, Paul, and thanks for the questions. With regards to the range on SUBLOCADE, 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 $1.5 billion waypoint because we've always said $1.5 billion plus all very key. And that's allowed us also in the short term within the year to raise our guidance to -- 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.

[Paul Cuddon, analyst]

And just a 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 will have to materially sort of scale up kind of resource for? Is it something that the partner could handle more of the OpEx that will be required?

[Mark Crossley, executive]

It's a great question, Paul. And just for a bit of color, I mentioned it a bit in my opening remarks. But Albertsons, it's the second largest supermarket chain in the U.S. They have 20,200 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 SUBLOCADE can be done at an alternate treatment space and allow physicians who just don't have the infrastructure in their office to managed a controlled specialty pharmacy product. It allows them to prescribe based on patients' 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 an engagement with HCPs, that is a responsibility of Indiviors. And that's where I've talked about potential targeted investments to come back to some of these smaller doctors' offices moving forward. But for us, this is about accelerating growth, having SUBLOCADE help more patients on their journey to recovery. Thank you, Paul.

[Operator]

We will now go to our next question. And your next question comes from the line of Thibault Boutherin from Morgan Stanley.

[Thibault Boutherin, analyst]

Just a couple of questions. The first one, just a follow-up on the strategy to the couple prescription and administration. So, you're making SUBLOCADE available in potentially more places for this situation, but is it addressing one of the key uptake for the uptake which historically has been the difficulty for some physicians to treat this patient population and access these patients? 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 still one question on capital allocation, should we -- 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 litigation situation?

[Mark Crossley, executive]

Thibault, thanks for the questions. 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 are 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 doctors' 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 the script either be written or electronically delivered to with just the Albertsons pharmacy where they can go and get this administered. I think of it just like if you went and get a vaccine, you could go and get your shot for the vaccine at the front of one of these pharmacy. 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, we're very consistent in our capital allocation policy. We review this as a management team and with the board on a regular basis as we actively manage it. And the priorities 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 SUBLOCADE, delivering on integration and launch of OPVEE, and we'll continue to actively manage our capital allocation moving forward.

[Operator]

Who will take your next question. And your next question comes from the line of Carl Byrnes from Northland Capital Markets.

[Carl Byrnes, analyst]

I was just wondering if you might be able to provide a little bit on the specifics of detailing of OPVEE particularly to the public sector and first responders. And do you see the label which is inclusive of synthetic opioid language for overdose treatments that OPVEE would be positioned to emerge as a standard of care among first responders. How do you see that sort of transpiring?

[Mark Crossley, executive]

Thanks for the questions, Carl, and great to have you covering Indivior. With regards to the detailing of OPVEE, this is a much different sort of call platform than SUBLOCADE or PERSERIS, where you're not calling -- 90% of the volume runs through the public interest order markets, first responders, community, 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 the space, much more focused.I think when you think about OPVEE 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. OPVEE 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 nalmefene nasal rescue OPVEE having been fast-acting and having a long half-life about 11.5 hours which is longer than fentanyls, we're excited about the opportunity it has to help more patients. So, 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. Thank you, Carl.

[Operator]

[Operator Instructions]. We will now go to your next question, and it comes from the line of Edward Thomason from Liberum.

[Edward Thomason, analyst]

I had two if I may. Firstly, just on SUBLOCADE, particularly in markets where you have launched it in the rest of world in the same market as Brixadi such as Finland and Australia. What have been your learnings from those specific markets? And then I'll follow up with the second question after that.

[Mark Crossley, executive]

Yeah, we're in the rest of world. We're in Canada, where we don't have competition in 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 the tail of different geographies and health payers within Australia.In one area, we see that the standards have been written for Brixadi, and SUBLOCADE 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 SUBLOCADE's benefits are able to be better utilized by physicians. And in those markets, we are seeing higher share in the 35% to kind of 45% region which is important.Now of course, these are markets with a socialized payer scheme. In Australia, fentanyl has not yet hit the shore. So, it is a very different competitive market than I think what you would see here in the U.S., which is, it's just disproportionately been hit by the opioid crisis than other countries.

[Edward Thomason, analyst]

The second question I had was just on the updated risk factors, and particularly that worst-case scenario where that you illustrated 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?

[Mark Crossley, executive]

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 generic markets works and we factored that in the short term. The stock -- the film has been much stickier in its share. And despite an approval 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. It's a nice incremental cash in the short term.

[Edward Thomason, analyst]

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 switch into the generic, but particularly on the price. And do you have an answer to that specific part of the question?

[Mark Crossley, executive]

Yeah, apologies. I'm not trying to dodge it. It's just the share drop, it's so significant when you go to analogs that in those sort of plannings, you drop off from a revenue standpoint. But 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 shares. So, from an Indivior standpoint, we wouldn't see much of an impact to price or mix because we're already in the lowest priced accounts. But for the generics, we would expect their prices to drop. Thank you Edward.

[Operator]

We will now go to our next question. And your next question comes from the line of Peter Testa from One Investments.

[Peter Testa, analyst]

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 on what you're seeing there, please?

[Mark Crossley, executive]

It's a good question, Peter. And 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 going 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 site 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 in the administration of SUBLOCADE.

[Peter Testa, analyst]

I was also wondering about the training rules and doctor prescribing limits and other factors which have changed in legislation whether you see them working with the doctors or handling penetration through the systems differently or other things they can do?

[Mark Crossley, executive]

No, it's another great question and another aspect that we haven't addressed on the call with regards to the data 2000 elimination. And I think this is one where it's going to -- this is going to 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 is migrating over. This is happening through time, bit by bit with regards to the overall treatment for opioid use disorder. Thank you, Peter. Appreciate it.

[Operator]

We now have a follow up question, and your follow up question comes from the line of Max Herrmann from Stifel.

[Max Herrmann, analyst]

A couple. One is just discussions on OPVEE. Obviously, the product is now approved. I wondered whether you've been able to have many of these discussions ahead of the fourth quarter launched 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 on -- currently on non-OHS psychiatrists and opioid use disorder treatment physicians. Since, you've been so focused on the OHS and the criminal adjusting system, are you currently calling on non-OHS doctors and criminal justice system doctors?

[Mark Crossley, executive]

Thanks for both questions, Max. On the OPVEE side, since it's been approved, we've not set price. People have had initial discussions with regards to OPVEE, 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 call, probably 10% or so that are outside of organized health systems and physicians who have continued to prescribe SUBLOCADE 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 SUBLOCADE to the patients to help them into recovery with this new channel or new administration route for the medication. Thanks again, Max.

[Operator]

Thank you. I will now hand the call back to Mark Crossley for closing remarks.

[Mark Crossley, executive]

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.

[Operator]

Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect.