Indivior PLC

LSE:INDV

Earnings Call Transcript 2022-Q2

[Mark Crossley, Chief Executive Officer]

Good morning, good afternoon and thanks for joining us. With me today to discuss our Second Quarter and Half Year Results are Ryan Preblick, our Chief Financial Officer; and Dr. Christian Heidbreder, our Chief Scientific Officer.

Looking at the agenda, I'll provide an overview of our financial results as well as the progress we're making against our strategic priorities, after which Ryan will take you through the results and guidance in more detail. Christian will then walk you through our R&D priorities and pipeline updates, and then we'll move to the question-and-answer session. Before I move on to my overview, I'll assume everyone's read the forward-looking statements.

Turning to the second quarter, key messages on Slide 5, the company executed well and delivered stronger top and bottom-line performance than we expected. Importantly, we also made excellent progress against the strategic priorities that form the foundation for creating long-term value for all Indivior stakeholders and which we -- will enable us to deliver a better future for patients. Our focus on organized health systems continues to drive strong growth for SUBLOCADE.

As you saw, net revenue in the second quarter was $98 million. Excluding the large one-time order in the year ago period, SUBLOCADE net revenue grew by over 80% year-over-year and increased 15% versus the previous quarter. This sequential growth performance represents the eighth consecutive quarter of double-digit underlying growth for SUBLOCADE.

Based on this strong momentum, we now expect SUBLOCADE net revenue for the full year to be in the range of $390 million to $420 million. At the midpoint, this would be an increase of $25 million over our previous guidance and represents a 66% increase over SUBLOCADE's fiscal year 2021 net revenue mark.

At the total company level, we're maintaining our full year 2022 guidance for net revenue and adjusted operating profit. This guidance reflects the increased strength of SUBLOCADE mostly offset by the assumption that recent FDA approval of a fourth generic will result in a launch early in the fourth quarter.

Consequently, we expect SUBOXONE market share will begin eroding at an accelerated rate versus our previous guidance. If the timing and/or impact of the launch is different, we'll update guidance accordingly. Ryan will provide more color on our fiscal year 2022 guidance momentarily.

Next, we've maintained our strong balance sheet and financial flexibility. We exited the quarter with over $1 billion in cash and investments, including cash outflows related to our second $100 million share repurchase program. We continue to take a disciplined approach to capital allocation, opportunistically investing behind our strategic priorities and at the same time returning value to shareholders in the near term, while in parallel exploring diversification opportunities via potential business development.

Finally, based on positive feedback following extensive consultation with shareholders and input from our advisers, we're moving forward with a formal proposal to seek shareholder approval for an additional listing of Indivior shares on a major US exchange.

Turning now to our report card, which benchmarks the progress we're making against our strategic priorities, SUBLOCADE net revenue of $98 million for the quarter resulted in first half net revenue of $183 million. Excluding adjustments for trade spend and stocking, underlying SUBLOCADE net revenue for the second quarter increased approximately 18% versus the first quarter, which is generally in line with the defense growth. At the end of the quarter approximately 65,000 patients were being treated with SUBLOCADE, up from 57,000 at the end of the first quarter.

As a reminder, our peak net revenue guidance for SUBLOCADE of more than $1 billion is based on delivering a target of 180,000 patients under treatment and we feel we're well on our way. 70% of SUBLOCADE's net revenue and growth are now being driven by organized health systems where I'm pleased to report we have achieved our access goal for the 500-plus priority organized health system parent accounts.

Looking ahead, while we'll continue to bring in new organized health system customers, the main focus of our strategy is towards generating greater depth of prescribing within the accounts we have accessed. I'll expand on this in a moment. Taking a step back the SUBLOCADE treatment paradigm has never been more relevant with drug overdoses resulting in more than 108,000 deaths in the latest 12 months, with almost 82,000 of those deaths related to opioids. At this rate more than 12 people in the US are dying every hour from substance overdose.

Moving next to diversification, PERSERIS delivered net revenue that increased 75% in the second quarter compared to the last year and 40% increase versus the first quarter. The national PERSERIS sales force has been in the market for six months and is making good progress as evidenced by strong recent prescription trends and sample metrics.

Taken together with the increasing recognition among prescribers of PERSERIS' differentiated product profile, we're confident that we will deliver our net revenue target for 2022 as well as our long-term net revenue goal of $200 million to $300 million.

Turning to the ex-US business, underlying second quarter net revenue, excluding currency impacts was down 2% versus the prior year, as our legacy tablet business continues to face pricing pressure from both branded and generic competitors. We are however very pleased with SUBLOCADE's steady progress outside the US with net revenue showing steady growth to $6 million in the most recent quarter to reach $12 million in the first half of 2022.

Overall, we remain focused on returning the rest-of-world business to sustainable long-term growth and continue to believe this is achievable based on the long-term potential we see for both SUBLOCADE and branded SUBOXONE Film.

Christian will take you through the details of our pipeline progress in a moment, but you will have seen in May that Aelis commenced the Phase 2b study for AEF0117, targeting cannabis use disorders. This is a large proof-of-concept study expected to contain over 300 participants and run out of Columbia University in New York City.

We're expecting initial data from the study in late 2023 with conclusive analysis to be completed first half of 2024. We remain very optimistic about the potential for this asset given the real and growing need for cannabis-related treatment.

Only last month the New York Times carried a major article highlighting the growing evidence that chronic cannabis use can cause psychosis and addiction along with chronic health issues. These conditions are thought to be caused by the significantly higher concentration of THC present in today's cannabis products.

Yet despite the growing scientific recognition of the risk, a number of US states are expected to legalize recreational use of cannabis in the coming years which in turn is likely to result in a growing number of afflicted individuals.

In terms of optimizing our operating model and capital allocation, I'll touch quickly on a few items. First with regards to our second $100 million share repurchase program since initiating it at the beginning of May, we've repurchased approximately eight million shares at a cost of $29 million.

Next we took the opportunity to settle the legacy and the litigation with Dr. Reddy's for amounts that we had previously provisioned. This removes another legal uncertainty for the group.

Finally, as I said upfront, we'll now be moving towards a shareholder vote on the potential for an additional listing in the US. We believe this will elevate our profile in our largest market and potentially attract a broader group of US-based biopharma investors.

In terms of the mechanics, we expect the Shareholder Circular to be made available to shareholders in early September with an extraordinary shareholder meeting to take place in late September. The exact details will be included in the Circular.

Before turning the call over to Ryan, I want to take a moment to expand on my comments about focusing our organized health system strategy towards increased depth of prescribing in our priority accounts. For those of you who may be less familiar with the US healthcare landscape Organized Health Systems or OHS's is a collective term for large private health care systems, government systems such as the Veterans Administration hospitals, and last but not least the justice system.

These institutions contain the majority of wavered buprenorphine medically assisted treatment, prescribers and patients and they have an embedded administrative infrastructure that aligns well with SUBLOCADE's product and treatment administration profile.

As you've seen we've gained access to our targeted 500 priority organized health system parent accounts. And while we continue to open new accounts, our focus is shifting to achieving greater prescribing depth across the OHS's we have opened access to.

Achieving depth in these accounts is not a simple nor a quick process, and involves collaborative efforts across our entire commercial organization. Over the past year, we've further invested in our field force, and in developing a range of core capabilities covering account activation, reimbursement, and ongoing medical education. Having been formed in the fourth quarter of 2020, our ecosystem teams continue to increase their effectiveness and are driving the strong growth we're sharing today.

We're seeing evidence in our success in the growing number of child facilities, we're accessing with individual organized health systems, as well as the numbers of prescribing physicians and patients associated with each organized health system. To give just one success metric, we're seeing a steady increase in the number of prescribers, with five or more patients. Those have grown 60% year-over-year.

You can expect to hear more about our OHS strategy, and the road map to delivering our long-term objectives for SUBLOCADE at a Capital Markets Day we're scheduling for the 7th of December in New York City.

To conclude my opening remarks, the team remains relentlessly focused on our strategic priorities and has delivered strong first-half performance. In the second half of the year, we expect to build our momentum and extend our leadership position in treating substance use disorders and their comorbidities. We believe our success will continue to create value for shareholders and patients alike.

With that, I'll hand over to Ryan.

[Ryan Preblick, Chief Financial Officer]

Thanks, Mark, and good morning and good afternoon to everyone. I'm pleased to report another good quarter of execution and business momentum. We again delivered double-digit top-line growth driven by the strong performance of SUBLOCADE. As expected, adjusted operating income decreased versus the prior year, reflecting the growth investments we have made to extend the success of SUBLOCADE and PERSERIS.

We also maintained our disciplined approach to capital allocation, balancing reinvestment in the business, with shareholder returns in the form of a second share buyback program.

Including our stepped-up level of investment, and share repurchases, we still exited the quarter, with over $1 billion in gross cash and investments. I'll now provide some more detail on the performance drivers in the quarter, and discuss our outlook for the rest of the year.

Starting with top line, total net revenue growth up 10% versus the year ago quarter and by 12% at constant exchange rates. Looking at the first half, total net revenue grew 12% versus the same period last year, and by 14% at constant exchange rates.

As I mentioned, the increase in total net revenue was mainly a function of strong SUBLOCADE growth in the US, but we also are seeing strong contributions from PERSERIS and from SUBLOCADE in markets outside the US.

By geography, total US net revenue grew by 22% versus the prior year quarter, if we again exclude the large CGS order we had in the second quarter of last year. Net revenue in rest of world was down 2% year-over-year, excluding unfavorable FX impact. The pressure in the rest of the world continues to be from ongoing generic competition and austerity measures, which are impacting overall pricing.

The divestiture of the TEMGESIC franchise also impacted second quarter net revenue by $2 million, or about four percentage points. On the positive side, SUBLOCADE net revenue outside of the US grew 50% year-over-year to $6 million, helping us partially offset the decline in the legacy tablet business.

Total SUBLOCADE net revenue of $98 million, and $183 million for the second quarter and first half of 2022 respectively, was stronger than we had expected. Compared with the first quarter sequential net revenue growth for SUBLOCADE was 15%. Based on current patient and prescription trends, we remain confident that SUBLOCADE net revenue in the second half will be higher compared to the first half. Therefore, we are raising SUBLOCADE's full year 2022 net revenue guidance to a range of $390 million to $420 million.

Moving to PERSERIS, net revenue of $7 million, was up 75% versus the prior year and 40% versus the prior quarter. We recognize that, this is off a small base, but nonetheless we are encouraged by the acceleration we are seeing in PERSERIS on a number of internal metrics. This reflects the impact of our new national sales team, as well as the easing of coped restrictions, which have improved our ability to promote the benefits of this important schizophrenia medicine on an in-person basis. We are now reaching 85% of our call platform on an in-person basis, which is an improvement over the last quarter.

Turning to SUBOXONE Film, the average share of approximately 19% in the second quarter was down from the prior quarter's exit rate of 20%. 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 was 83%, up slightly from the prior quarter, but down from 85% in the prior year, reflecting a higher mix in the less profitable government channels for SUBOXONE Film in the US.

We have been closely monitoring inflation, which is impacting some of our labor and logistics costs. However, the overall impact has been manageable and relatively immaterial thus far. As such, we continue to expect our full year gross margin to be in the low to mid-80s range as SUBLOCADE continues to grow as our largest product.

Our adjusted overall operating expenses were $121 million in the quarter, an increase of 16% versus Q2 of last year, reflecting the strategic investments we made in the business to accelerate growth and diversify our revenue.

We are expecting overall OpEx to increase in the second half of 2022, particularly with the scheduled phasing of R&D for life cycle management and post-marketing studies for SUBLOCADE as well as for our supply expansion efforts for SUBLOCADE. We are not changing the overall OpEx guidance for the full year of $520 million to $540 million.

Continuing to adjusted operating income, as a result of our increased growth investments, adjusted operating income was $60 million in the second quarter, was down 9% versus the prior year. For the first half, adjusted operating income was down modestly at about 3%.

Lastly on the P&L, our adjusted net income of $45 million declined 8% in the second quarter versus last year. For the half year, our adjusted net income of $86 million declined 1% 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 just over $1 billion. During the first half, positive cash flow generated from our underlying operations of $117 million, was largely offset by settlement payments of $108 million as well as by some timing differences on government rebates.

I note the settlement with Dr. Reddy's does not impact our overall balance sheet strength as these amounts were fully provisioned for. The cash paid in the second quarter for this settlement has been more than covered by the return of collateral to Indivior from surety bondholders in July.

Lastly, taking a closer look at guidance, while I have already touched on a number of the key elements, we are leaving unchanged total company full year 2022 net revenue guidance at $840 million to $900 million and adjusted operating income at approximately the same level as last year's performance of $187 million.

This reflects a stronger than expected net revenue performance of SUBLOCADE in the year-to-date period, together with the risk of a potential for the generic competitor during the second half of 2022 and the FX impacts of a stronger US dollar.

Specifically, on SUBOXONE Film, as you are aware, the FDA approved the fourth generic film competitor in June. While this additional generic has not yet been launched, it nevertheless introduces an increased level of uncertainty going forward in what has for some time been a relatively stable market since generic entry in early 2019.

To reflect the risk of potential SUBOXONE Film share loss in the second half, we have assumed this new generic will be launched at the start of the fourth quarter and that the film will subsequently trend towards historical analogs.

I want to stress, however, that while we consider these assumptions to be reasonable, we have no visibility when or if the fourth generic will launch. Consequently, we plan on updating the market when we have further clarity and information and certainly no later than our Q3 results in October.

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 full year 2022 results. Importantly, we remain confident at this point that we can deliver our full year guidance, even with the assumption of increased film competition we have made due to the stronger than expected performance of SUBLOCADE.

I will now turn the call over to Christian to discuss our pipeline.

[Christian Heidbreder, Chief Scientific Officer]

Thank you, Ryan and good morning, good afternoon, everyone. Let me start with an update on our current pipeline activities. First Aelis Farma achieved a major milestone on the development of AEF0117 with the start of a clinical Phase IIb proof-of-concept study and a first subject, first visit that occurred on May 23. The primary objective of this study is to demonstrate that AEF0117 induces a greater proportion of subjects with a response of less or equal to one day of cannabis use per week compared to placebo.

The number of subjects will be up to 330 treatment-seeking individuals with a mean cannabis use of more or equal to five days per week within the last four weeks at the screening and baseline visit of the study. Other work streams including chemistry, manufacturing and controls and non-clinical toxicology are progressing in parallel as planned.

Second our selective orexin one receptor antagonist program completed Phase I single ascending dose study with the characterization of eight doses and no events of clinical concern. The second Phase I multiple ascending dose however was put on clinical hold by the FDA in September last year based on non-clinical reproduction toxicology findings from another similar development program not sponsored by Indivior.

We submitted a complete response of the clinical holds to the FDA on June 27 and I am very pleased to announce that yesterday July 27 the FDA removed the full clinical hold and confirmed the multiple ascending dose study can now be initiated. The study is expected to start in September. In parallel, major progress has been made on the formulation and clinical development front as well as non-clinical.

Lastly our GABAB positive allosteric modulator program for alcohol use disorder has identified two lead molecules and backups that are going through primary and secondary in vivo profiling studies as well as synthesis to enable non-clinical studies for candidate selection, currently expected by the end of the first quarter 2023.

Moving to the next slide and giving you more background information on cannabis use in worldwide, you can see that cannabis remains the most widely used drug worldwide. In 2020, more than 4% of the global population aged between 15 and 64, which translates into 209 million people had used cannabis in the past year. The prevalence of past-year cannabis use has increased by 8% since 2010, while the number of people who used cannabis in the past year increased by 23% since 2010.

The increase in cannabis users goes in parallel with a long-term trend of increased THC content and decrease the CBD content in seized cannabis in Europe and the United States. In the states that have legalized cannabis in the US and Canada, there has been a diversification of cannabis products, different methods of use and changes in the potency of THC content in the available products. For example, the potency of seized cannabis flower in the United States has more than doubled since 2000 to around an average of 14% in 2019 but there are products with levels of THC of 20% or higher in some states that legalized the drug. And more recently cannabis concentrates are showing much higher potency of up to 70%.

Taking a deeper dive into the situation in the US on the next slide indicates that nearly 50 million of people aged 12 or older used cannabis over the past year and 14.2 million developed a cannabis use disorder over the past year. So one must now recognize that there is a simultaneous quadruple confluence of factors leading to cannabis use disorder including: one, increasing prevalence of use; two, increasing intensity of use, in terms of both frequency and quantities; three, increasing THC content of cannabis products; and four, age of cannabis use initiation.

On the next slide you can see a few examples of the recent scientific literature emphasizing the results of that quadruple confluence of factors. One, the relationship between cannabis use during adolescence and neurodevelopment alterations; two, the increased odds -- ratio of psychopathology with age of cannabis use initiation and increased cannabis potency and frequency of use; three, the increased prevalence of what we call the cannabinoid hyperemesis syndrome also referred to as scromiting, a portmanteau for scream and vomiting and its impact on emergency departments since legalization of recreational cannabis; four, the association of persistent cannabis use with vascular inflammation and oxidative stress; and five, the danger of new ultra-potent synthetic cannabinoids of more than 70% of THC content.

Research has also shown that perceptions of cannabis harm have decreased in areas where the drug has been legalized, but at the same time, the proportion of people with cannabis use disorder and associated comorbidities has increased. So there can be no effective treatment without recognition of the problem and the necessary information to develop the resilience to make good choices and have access to science-based treatment and services.

Thank you. And let me hand it over to Mark for final conclusions.

[Mark Crossley, Chief Executive Officer]

Thanks, Christian for those updates and for the insights on cannabis use disorder.

To summarize, the team delivered strong second quarter performance behind focus on execution which has led to progress across all of our strategic priorities and an upgrade on our fiscal year 2022 SUBLOCADE top-line guidance to $390 million to $420 million. We've completed our consultation with shareholders, seek their approval for a second listing on a major US exchange.

With that, I'll turn over to the Q&A to Dennis.

[Operator]

Thank you. [Operator Instructions] And our first question comes from the line of Max Herrmann from Stifel. Please go ahead. Your line is open.

[Max Herrmann, Stifel]

Thanks very much for taking my questions. I've got a few, if I may. Firstly, just in terms of a bit of housekeeping on SUBLOCADE, where do you see the stocking position currently in the US with SUBLOCADE? Do you think wholesaler stocking specialty pharma stocking has kind of normalized? Is there anything we should be aware of in the quarter?

And then I know you, kind of, guided that you expected a sort of acceleration of the growth of SUBLOCADE in the second half I think earlier this year when Omicron was taking -- or having an impact. I wonder if that's still the case. So that's the first kind of question.

Second one just on the OHS, kind of, now you obviously targeted all of -- well you've opened access to all 500 targeted accounts. I wonder if there's any rationale behind expansion of your sales force there perhaps on the ground now in the US given the opening up of the market as well as that stage in the evolution of its commercialization.

And then finally, just a question on the SUBLOCADE margin or the impact that SUBLOCADE is having on the gross margin. Obviously, we're seeing that the Medicare Medicaid channel on SUBOXONE is impacting it negatively, but I would have thought given the very strong growth you're seeing from SUBLOCADE that that would have a positive impact as well that would counterbalance that. So just trying to understand that a bit better. Thanks.

[Mark Crossley, Chief Executive Officer]

Thanks for the question, Max. I'll take the first three and then I'll ask Ryan to talk you through the margin with regards to the relatively modest shift in mix. From a stocking standpoint on SUBLOCADE, we see it as relatively normalized for a growing asset. So those -- while the absolute value increases the weeks of cover remain relatively normalized so no material impacts with regards to that.

When I think about the first half, second half acceleration as I mentioned in my remarks, I think the first half growth was higher than our expectations. The impacts of the different variants of COVID were less impactful early on and the team has really executed with excellence. And I think when you look at the guidance, we expect to see continued momentum in the second half and that's why we've raised that guidance by $25 million at the midpoint and are confident of the momentum we have and being able to deliver on that.

When it comes to the access to parents and the potential for expansion of the sales force, I think we made -- if I remind the callers, last year we made a number of pointed investments focused on accelerating the growth of SUBLOCADE. We added account access directors. We added medical science liaisons and added key account managers to increase that footprint and continue to deliver access.

At this time, we don't see a need to increase the sales force. The key here is to focus on continued engagement at the child level to both activate those child accounts as well as engage with the HCPs in there to pull through SUBLOCADE adoption. So that's where we see that Max.

And Ryan do you want to talk to the gross margin?

[Ryan Preblick, Chief Financial Officer]

Hi, Max good morning. On the gross margin, so we certainly still stand by the guidance that we provided low to mid-80s going into the year and maintain that. You did see a nice step-up of a percentage point from Q1 to Q2, which does highlight the progress we are making as SUBLOCADE becomes a larger contributor to our business. There are two aspects to that. One, the film mix and the film strength in the first half did keep it down slightly. And as typical I think you're hearing across all different industries there is some inflation that we are dealing with quite -- it's manageable today, but that is an impact that we are seeing. But certainly looking forward to growing margins as we progress on the journey with SUBLOCADE and its higher margins.

[Max Herrmann, Stifel]

Great. Thanks very much. I’ll get back in the queue. Thanks very much.

[Mark Crossley, Chief Executive Officer]

Thanks Max.

[Operator]

Thank you. There are no further hands raised at this time. [Operator Instructions] And we have -- just had two more hands raised. One moment while I bring the next person on. And our next question comes from Peter Testa of One Investments. Your line is open. Please go ahead.

[Peter Testa, One Investments]

Hi. Yes, two questions please. One, just to understand when you talk about the phasing of R&D and costs in H2, would you expect that to be starting now, or is that going to be more -- will some of these programs be launched during -- after summer into Q4, just so I understand the cadence please?

[Mark Crossley, Chief Executive Officer]

Certainly Peter. I'll hand that off to Ryan just to talk about the phasing of that spend and activity.

[Ryan Preblick, Chief Financial Officer]

Yeah, so we are certainly committed to the programs that we communicated going into the beginning of the year. The work was definitely started in Q2, and is currently ramping up as we get into Q3. I don't want to get into specific timings around the quarters, but certainly we'll be endured in Q3 and Q4.

[Peter Testa, One Investments]

Right. Okay. And then just on the Ryan, guidance point when you're absorbing SUBOXONE potential risk, is it basically to say you're absorbing more or less the upgrade in SUBLOCADE and SUBOXONE at the gross margin and that's basically what you're absorbing in Q4?

[Ryan Preblick, Chief Financial Officer]

Yes at this point. Again we try to make a reasonable assumption with the limited data we have in intel. And as we committed in our scripts, we will keep the market abreast based on what we learn.

[Peter Testa, One Investments]

Okay. And then last thing was just on -- I'm going to try this one see if you want to answer. You gave the view on the high-prescribing doctors, five or more patients as they increased. I was wondering if you had any sense of what proportion of new prescriptions in the quarter they were.

[Ryan Preblick, Chief Financial Officer]

We just don't carve the data out at that level. I think there's a number of folks that are coming through in specialty distributors so to share that data and that trend could provide a bit of a murky picture. I think the momentum in the business speaks for itself. When you look at both the year-over-year growth on an underlying basis in the 80s the quarter-over-quarter growth at 15% versus Q1 and the momentum that goes into the second half based on the execution and delivering on access to those top 500 organized health system parents, I think we've got strong momentum and plenty of room for growth moving forward.

[Peter Testa, One Investments]

Okay. And maybe just one other associated. If you look at the regulation around allowing doctors to prescribe with different levels of education required, there's been some talk about allowing more to be done without having to go through the same degree of education even if it's online. Is there anything happening you see in your coming forward from that?

[Ryan Preblick, Chief Financial Officer]

Yes, that's a good question Peter. I think opioid use disorder I think is one of the truly bipartisan issues that are in front of this administration. And there are a number of efforts that are I think in the Congress and have been passed previously with regards to trying to break down barriers and increase access to treatment and I think that's one of those.

It is in the Congress has not been passed at this time. But we support broad access to multiple sort of treatment modalities to help take the treatment penetration in this disease space which is at 20% which is quite woeful given the epidemic we face and try and turn that upside down to 80%. So, we're fully supportive of any way to increase access to treatment.

[Peter Testa, One Investments]

Yes, let's see if the latest breakthrough in Congress contains -- what it contains for you guys, maybe something there. Thank you

[Ryan Preblick, Chief Financial Officer]

Thank you, Peter.

[Operator]

Thank you very much. [Operator Instructions] And our next question comes from Max Herrmann from Stifel again. Please go ahead.

[Max Herrmann, Stifel]

Great. Just a couple of follow-up questions. Firstly, just on PERSERIS, I mean clearly you reiterated the long-term guidance there for the product. Obviously, the sales force expansions had some great impact on its prescription trends, so that's excellent. Just wondered what your thoughts were on the Teva/MedinCell long-acting risperidone if that gets to market, what impact that might have and what the characteristics are between the two PERSERIS and MedinCell products? That's the first question.

And then the second just how are you doing in the channel -- the criminal justice system channel? Obviously, you excluded the $7 million sort of large lumpy order from some of your competitors for the second quarter 2021 where there was that big order. But I just wondered how you're getting on in that channel.

[Ryan Preblick, Chief Financial Officer]

Thanks for the additional questions Max. I think with PERSERIS, I think you've really hit the nail on the head here with regards to great progress by the team. This expanded national launch has only been in place since the start of the year and you can see they're really starting to make great progress with 40% growth quarter-over-quarter, great year-over-year growth. And we're seeing requests from physicians for samples and interest in what's a differentiated product profile.

When I start to look at the competitive landscape, I think this very much like addiction is quite an underserved patient population. Adherence is the number one unmet need in this space according to physicians. And with only about 18% to 20% of patients in long-actings, we think that space for multiple provider -- multiple options for treatment [Technical Difficulty] treatment here whether it's the existing ones or future people entering the space. So, that's where we are on PERSERIS.

When it comes to the justice system channel, we continue to make great progress there. Again, this is an investment we made in the back half of last year. I spoke to its strategic importance given that 65% of our patients at some point in their journey with addiction come in contact with this channel.

And we've staged up and ramped up and launched at the beginning of the year a 20-person dedicated sales force here because of the importance of this channel and are really starting to make good progress. We've had more sales in the year-to-date than we had the entire previous year. We've got access in over 30 states at over 100 facilities and the momentum continues to build there. So, very proud of the entire team the general sort of ecosystem team who've carried the criminal justice system to-date and then their nice handoff and partnership with these justice system access directors. So, very good progress Max. thank you.

[Max Herrmann, Stifel]

Great. Thanks very much.

[Operator]

Okay. Thanks Max. And that concludes the questions and I will hand back to Mark Crossley.

[Mark Crossley, Chief Executive Officer]

Thank you, Dennis and thank you everyone for participating in the first half results and the continued interest in Indivior. I look forward to continuing the dialogue moving forward at conferences and at our Capital Markets Day in December. I hope everyone has a great day. Thank you.