Indivior Q2 2024 Earnings Call Transcript

Quartr
Provided by Quartr
July 25, 2024

There are 11 speakers on the call.

Operator

Good day, and thank you for standing by. Welcome to the Indevia Plc Half Year Results 2024 Conference Call and Webcast. At this time, all participants are in listen only mode. After the speakers' presentation, there will be a question Please note that today's conference is being recorded. I would now like to turn the conference over to your first speaker, Mr.

Operator

Jason Thompson, Head of Investor Relations. Please go ahead.

Speaker 1

Thanks, Raz, and good morning, 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 2 of this presentation. We also may refer to non GAAP measures, the reconciliations for which may also be found in the appendix to the presentation that is now posted on our website at indivior.com. I'll now turn the call over to Mark Crossley, our CEO.

Speaker 2

Thank you, Jason, and good morning and good afternoon, everyone. Thanks for joining us. Joining me today are Doctor. Christian Heidbreder, our Chief Scientific Officer Jeff Burrus, our Chief Legal Officer and Ryan Preblec, our Chief Financial Officer. I'll quickly highlight our results and some updates from our release earlier in the month, and then Ryan will detail the financials and our full year 2024 outlook.

Speaker 2

We'll then open the line for questions. Our results for the Q2 were in line with the expectations we pre announced earlier this month. SUBLOCADE delivered year over year net revenue growth in the quarter of 24%. As we previously discussed, SUBLOCADE's growth continued to be impacted by transitory headwinds, which we expect to ease during the second half and especially as we look into 2025. There are 2 significant new items in today's announcement.

Speaker 2

The first is that we've taken a $75,000,000 provision for the agreed quantum of an expected settlement for opioid litigation brought by certain municipalities and tribal nations. This continues our path of proactively resolving legacy litigation items at the right value for shareholder certainty. The second item is the Board's decision to initiate a new $100,000,000 share repurchase program, which we will seek to execute in an accelerated timeframe given the attractive value the shares currently represent. This new buyback program is a strong indication of our confidence in delivering on our intermediate and long term objectives for SUBLOCADE, exiting 2025 at $1,000,000,000 net revenue run rate and achieving greater than $1,500,000,000 in peak annual net revenue. I'm not going to repeat everything we outlined in our July 9 release, but I do want to provide a few incremental updates since that announcement.

Speaker 2

First, we're starting to see the benefits of our increased commercial investments behind SUBLOCADE. Recall that over the past year, we've increased our field force by 50% and our Justice Systems team by 25% and we're seeing significant increases in customer engagement and activation as a result. In terms of key metrics, through the end of Q2, we've increased active SUBLOCADE dispensing HCPs to over 7,200 from approximately 6,700 at the end of fiscal year 2020 3. And we've activated approximately 120 new CGS facilities thus far in 2024 to reach over 700 total activated justice system accounts. 2nd, we've completed the actions related to the cessation of PERSERIS sales and marketing.

Speaker 2

We thank our former colleagues for their professionalism and past contributions to Indivior and we wish them the very best for the future. Additionally, we anticipate making product available to patients for up to a year to help manage treatment transition. 3rd, we expect fulfillment of the BARDA contract for Aphi to begin this quarter, which as a reminder will amount to approximately 8,000,000 dollars in net revenue in fiscal year 2024. Lastly, in terms of key items for the quarter, we're pleased to complete our U. S.

Speaker 2

Primary listing at the end of June with strong support from shareholders. Over time, we expect the benefits to be increased awareness of Indivior among the U. S. Investment community and U. S.

Speaker 2

Index inclusion. As part of this effort, we'll begin reporting in U. S. GAAP next year starting with our 1st Form 10 ks filing in March 2025. This is a key requirement for U.

Speaker 2

S. Index inclusion. Next, I want to call out some highlights from our regular quarterly reported card. Beginning with SUBLOCADE patients and treatment that which grew to 49% year over year to 160,400 at the end of the second quarter. On a sequential basis, this represents a 7% increase with over 10,000 patients gained in the quarter.

Speaker 2

Recall, we target greater than 270,000 patients to deliver our peak net revenue goal of greater than $1,500,000,000 SUBLOCADE dispenses of $155,700 increased 25% versus last year and 5% versus the prior quarter. The difference between the sequential dispense growth rate of 5% and the net revenue growth of 7% is primarily due to destocking activity in Q1. I'm also pleased to report that our alternate sites of care efforts are continuing to show good progress. The number of SUBLOCADE injections at these sites increased 55% in the 2nd quarter compared to the previous quarter and our network has now grown to over 1200 locations across 22 states with 5 partners. Looking at diversification, we continue to build a funding trial and experience environment for AbbVie, which we're confident will translate into paying customers over time.

Speaker 2

In the short term, we are facing some pushback to adoption from the views of certain harm reduction advocates. We'll continue to engage these voices with science and real world evidence to counteract them and accelerate adoption. As we believe the ultimate goal must be to save lives. Meanwhile, as I just highlighted, we expect delivery on the BARDA contract to begin this quarter, which will account for most of Opdiv's net revenue in fiscal year 2024. Turning to our Rest of World business, we continue to see good growth in contribution from our new products SUBLOCADE and SUBOXONE Film.

Speaker 2

Their solid progression is helping us to offset the ongoing challenges to our legacy tablet products. In particular, ex U. S. Sales of SUBLOCADE grew 25% year over year in the first half to $25,000,000 with growth led by Canada and an increasing contribution from the Nordics. You should note that our order timing and elevated stocking in the year ago quarter had an adverse impact on overall rest of world performance.

Speaker 2

As said, we continue to expect modest growth for the full year. Turning to our pipeline, a few highlights to mention starting with SUBLOCADE where we've completed the clinical studies supporting important label updates for rapid induction and alternate sites of injection and will be making regulatory submissions to the FDA this quarter. We announced that Indivior 2000 has commenced Phase 2 development with patient dosing starting last month. Our excitement about this asset reflects our belief in the significant unmet need for non opioid option for patients as part of the OUD treatment continuum. Turning to AEF-one hundred and seventeen for cannabis use disorder, we expect top line results from the clinical Phase 2b study this quarter, which we'll release when final.

Speaker 2

In terms of next steps, we would then expect to have an end of Phase 2 meeting with the FDA to discuss the Phase 2b data as well as clinical Phase 3 study design and clinical endpoints. We'll then evaluate the outcome from that meeting, the clinical results and our market research to form a view on commercial potential. This will inform our decision on whether to exercise our option on the asset and enter Phase 3 development. Finally, on clinical developments, I'll just quickly highlight that we discontinued INDV-five thousand and four, Drinabant for acute cannabinoid overdose based on our assessment of a limited market opportunity for the product. Moving to capital allocation.

Speaker 2

As I noted, we're today announcing a new $100,000,000 buyback based on our confidence in delivering against our medium term profitable growth framework. We're also making good progress in resolving legacy litigation matters. As we disclosed at the start of this month, we've agreed to pay $85,000,000 to certain end payers ending the antitrust trial that was scheduled to begin on July 15. In addition, we are today taking a $75,000,000 provision for an agreed settlement amount for certain opioid litigation including the opioid MDL matters related to municipalities and travel nations. While this quantum is agreed and payable over multiple years, the parties still must negotiate material terms and conditions of the final settlement agreement.

Speaker 2

We expect to make a further disclosure upon reaching that final settlement. With that, I'll hand over to Ryan.

Speaker 3

Thanks, Mark, and good morning and good afternoon to everyone. This was a challenging quarter as a result of the transitory headwinds affecting SUBLOCADE and the changed market outlook for PERSERIS. I nevertheless want to reiterate Mark's confidence that we are on track to deliver against our medium term profitable framework and to create significant shareholder value. For today, I will start my comments by summarizing the financial impacts of our decision to end the sales and marketing of PERSERIS before briefly walking you through the financials for the Q2 and closing on our full year guidance, which we revised on July 9. Our strategic decision to end the promotion of PERSERIS will result in a charge of approximately $65,000,000 with $42,000,000 recognized this quarter and the balance of approximately $23,000,000 in Q3.

Speaker 3

This charge includes severance costs, write offs for inventory, equipment and intangibles and other termination payments. The cash impact will be approximately 20,000,000 dollars and will largely be incurred in Q3. On an annualized basis, we expect this result in savings of approximately $50,000,000 with $20,000,000 included in the revised SG and A guidance for full year 2024. Turning to the performance drivers in the quarter, starting with the top line. Total net revenue of $299,000,000 reflected growth of 8% versus the year ago quarter, both on a reported basis and at constant exchange rates.

Speaker 3

By geography, total U. S. Net revenue grew by 12%. The Rest of the World business was down 10%, 8% when excluding FX. The quarter was negatively impacted by shipment timing in this quarter and elevated stocking in the comparable period last year.

Speaker 3

SUBLOCADE net revenue outside of the U. S. Grew 30% year over year to $13,000,000 in the quarter. Total SUBLOCADE net revenue was $192,000,000 up 24% versus Q2 of last year. As previously discussed, this was lower than we had expected due primarily to Medicaid disenrollment impacts, lower stocking levels and delays in some newer CJS account activations.

Speaker 3

On a sequential basis, subgrade net revenue grew 7%, slightly ahead of dispenses given the destocking activity in Q1. For OpVie, net revenue in the quarter was minimal. For SUBOXONE Film, the average share of approximately 16% in the quarter was down compared with both the Q1 and the year ago quarter as expected. As a reminder, we do not promote SUBOXONE Film in the U. S.

Speaker 3

Moving down to P and L. Our 2nd quarter adjusted gross margin of 84% was up slightly versus the prior year quarter, primarily reflecting favorable manufacturing variances and improved product mix from increased SUBLOCADE net revenue. Adjusted SG and A expenses were $144,000,000 in the quarter, an increase of 15% versus Q2 of last year, reflecting the incremental commercial investments we have made. R and D expenses were $27,000,000 in the quarter. The decrease in R and D reflected phasing of expenses related to post marketing studies for SUBLOCADE, partially offset by pipeline development efforts, which will accelerate into the second half of this year.

Speaker 3

Adjusted operating income of $79,000,000 in the second quarter was up 11% versus the prior year. Lastly, on the P and L, our adjusted net income of $60,000,000 grew 7% in the quarter, reflecting the dynamics I just highlighted. Quickly touching on the balance sheet and our capital position. We ended the 2nd quarter with gross cash and investments of 405,000,000 dollars During the first half, positive cash flow from operations was offset by litigation related payments and by our existing $100,000,000 stock repurchase plan, which we expect to finish by the end of this month. As Mark mentioned, today we announced a new $100,000,000 share repurchase program to reflect our confidence in the business and we are provisioning 75,000,000

Speaker 4

dollars for

Speaker 3

an agreed settlement for certain opioid litigation with the Quantum agreed and payable over multiple years. I would highlight that the $75,000,000 provision will be remeasured once we reach final settlement with all the parties. The provision would then be reclassified to a liability and the amount would be lowered to approximately $65,000,000 by using a risk adjusted rate versus a risk free rate when discounting to the net present value. Closing on our full year 2024 guidance, which we updated on July 9, I want to highlight a few key takeaways. Our revised total net revenue guidance of $1,150,000,000 to $1,215,000,000 reflects the transitory headwinds we are facing in full year 2024 and at the midpoint represents 8% year over year growth.

Speaker 3

As we noted on the investor call on July 9, we expect to move beyond these items as the year progresses and especially as we look into 2025. For SUBLOCADE, our guidance of 7 $65,000,000 to $805,000,000 represents 25% year over year growth at the midpoint and keeps us on track to exit 2025 at $1,000,000,000 run rate and on a path to exceed 1,500,000,000 dollars For Opdiv, based on a slower than anticipated ramp, we recalibrated our net revenue expectations for full year 2024 to $9,000,000 to $14,000,000 The majority of this reflects the BARDA order of approximately $8,000,000 that we expect in the 3rd quarter. Our guidance for film is unchanged. Our guidance for OpEx of $550,000,000 to $560,000,000 reflects a reduction of $25,000,000 to $30,000,000 versus prior expectations. This reduction includes the $20,000,000 of anticipated cost savings relating to PERSERIS as well as lower volume dependent expenses.

Speaker 3

Our guidance for R and D is unchanged. Taking all the pieces together, we now expect adjusted operating income to be between $285,000,000 320,000,000 dollars At the midpoint, this implies solid year over year growth of 12% and an approximately 100 basis point margin improvement. I will now turn the call back over to Mark.

Speaker 2

Thanks, Ryan. Despite a challenging first half, I hope we've demonstrated that we remain highly confident that the underlying fundamentals of our business and strategy remain intact and that we're on a path to help patients in this largely undertreated market while generating substantial shareholder value. We're happy to now take questions.

Operator

Thank you, sir. Thank you. We are now going to proceed with our first question. The questions come from the line of David Amsellem from Piper Sandler. Please ask your question.

Speaker 5

Hey, thanks. So just have a few. First, can you talk about what percent of new starts you're getting versus the competitor, BRXADE? And more importantly, how are you thinking about the mix between SUBLOCADE and Brixati as we move through the second half of the year and into '25? That's number 1.

Speaker 5

Number 2, looking at the guide for SUBLOCADE, can you talk about the extent to which it contemplates competitive headwinds related to BRXADE? In other words, is it just contemplate the disenrollments or does it contemplate competitive headwinds as well? And then lastly, just on the inventory, is that a statement on the competitive dynamics or is there something else going on there? Thank you.

Speaker 2

Thanks, David. Let's start with the Bursati question. And I think as we look to the market, we continue to see a market where nothing hinders our conviction behind our belief that SUBLOCADE is a paradigm shift in treatment and we don't see other products that match the offering, especially in a market where the opioid epidemic has transitioned to fentanyl in other highly powered synthetic opioids. This is further reinforced into your question, David, that we're seeing 4 out of 5 new patients are choosing SUBLOCADE. So a significant patient choice, as new patients are coming into treatment.

Speaker 2

With regards to the guide, the guide, we have extreme confidence with regards to what we've guided on SUBLOCADE and that includes all the factors we currently see in the market, the transitory issues as well as competitive pressures. And if you could repeat your third question, I missed it when you asked it.

Speaker 5

Yes, sure. On the inventory, just the lower stocking levels, is that a statement on the competitive dynamics or is there something else going on there?

Speaker 2

Thank you. I'll hand that to Ryan.

Speaker 3

Yes, no, that's a good question. At this point, we believe it's a one time reset, as we get through 2024, primarily driven by as we become more focused on these OHS larger networks, they tend to be able to streamline their order patterns. So the turns at the wholesalers have become lower, which then has the byproduct of requiring less stocking at this point.

Speaker 5

Okay. And if I may just sneak in one follow-up just on net pricing, net realized price over time. With a 2 player LAI market now. How do you think about the trajectory of net price, not just for this year, but also as we move through next year? Thanks.

Speaker 2

Yes. I think we'll probably guide on 25 in February. But what we see now is on an absolute pricing basis is it's incredibly stable. And any of the sort of variances I think that folks would be modeling are going to be more mix related as the channel sort of mix shifts through time. And David, let me just say a bit remiss.

Speaker 2

I probably should have started with this welcome to coverage, saw the initiate this week. Thanks for joining.

Speaker 5

All right. Happy to be here. I'll jump back in the queue. Thanks guys.

Operator

Thank you. We're now going to proceed with our next question. The questions come from the line of Paul Curdon from Deutsche and Numis. Please ask your question.

Speaker 6

Good morning, guys. Just two questions for me, please. Just noting the success in the ultimate sites of care between Q1 and Q2. I'm just wondering if you could elaborate on those 5 partners, what exactly is working well there and are they exclusive relationships? And there has been secondly just for me on uncertainty over the impact of Medicaid disenrollments.

Speaker 6

You had a peer with high Medicaid sales and site that they haven't seen any impact. So I'm just wondering if you could just help me quantify the impact that you have seen and why that might be different. Thank you.

Speaker 2

Certainly. So, with regards to ASOC, yes, we're really pleased with that and the progress that we've had and continue to have. And to remind everyone, this is something that's going to take quarters years to build out a nationwide network to open this up for these independent physicians who've previously been held out because of the administrative burden of a specialty pharmacy product. So we now have over 12,000 locations across 22 states with 5 partners and seeing injection growth grow over 55% as we're able to start calling on these independent physicians and be able to highlight that there are those local pharmacies there is very important. So very excited about over 1200 locations.

Speaker 2

With regards to the Medicaid reenrollment, I can't speak to other people's business. But what I can say is we spent an immense amount of time diagnosing our business and where we are. And what we've seen with the waves of both the change healthcare and the reenrollments is we've seen a major shift in our retention curves that have fluctuated three times that we believe have impacted our business of the $60,000,000 reduction on SUBLOCADE about $30,000,000 or about 5% growth year over year. I still do have to highlight, we're still forecasting that we're going to grow over 25% on SUBLOCADE year over year. So while a bit slower than we expected because of the transitory issues, we're still seeing significant growth and are excited about the fact that we are receiving 4 out of 5 new patients.

Speaker 6

Superb. Thank you very much.

Operator

Thank you. We are now going to proceed with our next question. The questions come from the line of Chase Knickerbocker from Craig Hallum. Please ask your question.

Speaker 7

Good morning, everyone. Thanks for taking the questions. So just starting on SUBLOCADE, just to kind of work off a question that David had asked. So you had said kind of when we were originally doing 2024 guidance that and with the update earlier this month that the competitive kind of headwind, so to say, was kind of in line with your expectations when you had originally guided. Can you kind of walk us through what it assumes from kind of new patient starts from your competitor in the second half of the year?

Speaker 7

Does your guide assume that those new patient starts for your competitor kind of ramp up further from the 21% that I think you referenced earlier? Just kind of benchmarking us on guidance for the second half there.

Speaker 2

Yes, Chase. Listen, we don't provide guidance on all kind of the leading and lagging KPIs. I the key part here is we've given a guidance range for the balance to go that we have extreme confidence in. We highlighted at the interim update that the transitory nature, the transitory items have made it more difficult to forecast what the move forward on a quarter to quarter basis. But we have confidence in the range on the year that we'll achieve that.

Speaker 7

Got it. And then maybe just one for Jeff, he's on the call here. On the new provision, so obviously quite a few plaintiffs kind of around the opioid MDL items. Can you just kind of help us clarify this preliminary settlement kind of what you would expect it to settle when it comes to the opioid litigation? Is this kind of a wholesome potential preliminary settlement or just kind

Speaker 4

of help us there?

Speaker 8

Yes, sure, Chase. Thanks for the question. So the settlement is potential settlement is with the municipalities and tribal nations, which if you look at our Note 13, when we talk about that, about onethree of the case are private plaintiffs and twothree of those 400 cases are municipalities and tribal nations. So we would expect to settle, put those cases with municipalities behind us.

Speaker 7

Got it. And then just last one. Abhi, we haven't really talked about it too much with kind of all the recent items. Maybe just speak to kind of how the reception has been from potential customers relative to what your original expectations were? And then kind of just the main drivers for kind of the revision and expectations that we've seen recently?

Speaker 7

And then a little bit more context, if you would, on kind of the pushback that you're receiving from some harm reduction advocates? Thanks for the questions. Yes.

Speaker 2

Thank you, Chase. What I'd say is maybe I'll start with your last point and then build that into what we're seeing. I think the pushback that we're seeing from certain harm reduction folks has been larger than we would expect it. We have a medication here that we believe is very suited for the synthetic opioids that have overtaken the drug supply that are causing poisonings of non addicted people as well as overdose of those that are choosing to recreationally use opioids. And we believe that nalmefene is a breakthrough paradigm shift for these folks.

Speaker 2

And it's the only one specifically called out for synthetic opioids on the label. So we've seen a stronger than expected voice from harm reduction who have a fear of precipitated withdrawal. And obviously that's not been studied, in market, which makes it tough. I think from our standpoint, what we're doing is helping drive experience through our experience program. As we mentioned, at the interim results, we have over 170 activations of new experience programs where people are able to get product and use it.

Speaker 2

I think for me, the extreme positives there is that as people are getting this product and using it, the average units used in our initial pilot up in Michigan was 1.2 units. So you're using less units. It's a simpler rescue, and it's acting exactly we with customers. But we expect through time that the experience program, the in market performance will translate into sales to customers and in line with our expectations.

Speaker 7

Thanks guys.

Speaker 2

Thank you, Chase.

Operator

Thank you. We are now going to proceed with our next question. The question comes from the line of Thibault Boutere from Morgan Stanley. Please ask your question.

Speaker 4

Yes, thank you very much. My first question is on the average number of dispensed per patient. So we see the number of patients increasing faster than the number of dispense. And if we do a very good math on the average dispense per patient, that number has been coming down for a number of quarters. Just wanted to know if you could help us understand what this means.

Speaker 4

I interpret this as a faster turnover of the patient population. So in average, lower duration of treatments. First of all, is this correct? And also is it related to the Medicaid disruption of your patient base? And so could we expect the average number of distance per patient coming back up as we get out of the Medicare disruption?

Speaker 4

So that's the first question. And second question on the share buyback. Could there be any potential technical constraints here because you're paying a large proportion of the outstanding shares over a relatively short amount of time. So just wanted to know if you could potentially run into any technical limitation. And then last question on the civil opioid agreement.

Speaker 4

So can you just clarify that all public entities have been dealt with and so the remaining ones are only the kind of private individual claims? And also if you could give us any insight into where you are in managing these remaining individual claims for the similar MDL? Is it possible to see potentially also a settlement dealing with all of these at the same time at some point? Thank you.

Speaker 2

If you could just repeat the end of your last question please Thibault. It broke up a little bit. I heard the portion on the opioid MDL public versus individual or what we would call more product related neonatals. What was the second part of that where you broke up?

Speaker 4

The second part was just if you could give us any insight on where you are managing these claims. So if you could also see a potential settlement at some point?

Speaker 2

Thank you for that. Sorry, you broke up. So I'll handle the first one. I'll ask Ryan to handle the share buyback and then just let Jeff talk through the nuances of the OCO-eight MDL, which is again a preliminary settlement agreement on Quantum with more to come on the exact details of the papering. So when it comes to the average number of dispensers, think you virtually have answered your own question, Thibault, is you are seeing a little bit of a disconnect on patient growth versus dispensers and you indicated a faster turnover.

Speaker 2

I think it is due to that retention curve shift that we saw associated with Change Health, associated with the Medicaid disenrollment where we're seeing patients out of treatment faster. Our expectation is that retention curve will shift back to what's been a very consistent retention curve for the past 4 years. So we expect that as the transitory issues ease to come back and reconnect, so to speak, moving forward. So with that on the SUBLOCADE dynamics, Ryan, you want to talk about the technical constraints that with regards to the buyback that Thibault was asking?

Speaker 5

Yes. So the

Speaker 3

plan is to first wrap up the current program as soon as possible. We anticipate that end of July, early August and then start this new program right after that. We have a plan of front loading that to certainly take advantage in the disconnecting the share price and have a structure in place to have it last over 6 months. In regards to any constraints, we certainly have to abide by more trading rules and the most common one is if the share price is 5% above the 5 day average, we do have to halt purchases at that point. That's something that's happened in the past and something that we will have to adhere to going forward.

Speaker 2

Thanks, Ryan. Jeff, do you want to talk to the opioid MDL? Yes.

Speaker 8

Let me move this microphone a little closer to me. I really appreciate the question. So first, I didn't say this to Chase, but I just want to make sure everybody understands. We are really pleased to have reached an agreement on the Quantum for the settlement because we do believe it will ultimately put the municipality litigation substantially behind us. Obviously, we still have to negotiate the final material terms, but we have reached that agreement with the plaintiff's executive committee and certain states' attorney general.

Speaker 8

I think you'd asked a question about the private plaintiffs. So, as it relates to the private plaintiffs, those cases are very early in their stage, right? They've all been stayed. There has been little to no activity on them. You should view those claims, I think, as Mark mentioned, more along the lines of a product liability claim.

Speaker 8

But because they're in the very early stage, we have only begun our evaluation of the claims. Obviously, we believe we have meritorious defenses, and we intend to vigorously defend ourselves in these private plan of actions. And then lastly, we do expect and would plan on fulsome participation from municipalities in the cases. So we would expect fulsome participation. But until we get to final settlement terms, we won't know how that's going to play out.

Speaker 2

Thanks, Jeff.

Speaker 4

Thank you.

Operator

Thank you. We're now going to proceed with our next question. The question comes from the line of Max Herman from Stifel. Please ask your question.

Speaker 9

Great. Thanks for taking my questions. I've got a couple, if I may. Firstly, just in terms of looking towards the cannabis use disorder AEF-one hundred and seventeen data in September. What should we be looking for in terms of where do you see success in terms of the clinical outcomes?

Speaker 9

Obviously, conscious that you then have to wait to the end of Phase 2 meeting with the FDA and make a decision on whether to exercise your options. That's the first question. The second is just a bit more clarity on the I guess a third of the cases, I think you talked about 400 cases in the opioid, MDL and the 3rd private cases. What is that case? Because obviously, I thought the basis of most of these cases was to do with use of opioids for treatment of pain in individuals.

Speaker 9

What are the cases that they've got against Indivior then?

Speaker 2

Thanks for those questions, Max. I'm going to go ahead and start with Christian to talk about the end of Phase 2 results and meeting with the FDA. And then I'll ask Jeff to talk a little bit more color on those remaining cases that aren't part of the settlement.

Speaker 10

Hi, Max. So as you know, I cannot comment clearly on the results at this stage. The study is complete. We are currently looking the database. And over the next several weeks and couple of months, we are going to thoroughly curate the data, analyze the data and interpret the data.

Speaker 10

So we are currently on track to lift top line results in September. Following these top line results, we will then prepare the submission to the FDA. This is a pretty substantial submission to the FDA in order to organize an end of Phase II meeting with the agency before the end of the year. And then it is, as Mark mentioned, the combination of the data of the Phase 2b study as well as the feedback from the FDA at the end of Phase 2 meeting that will help us to make the decision as to whether or not we exercise the option of this asset in the Q1 next year.

Speaker 2

Yes. I think the key on that one Max is it is truly like a lock and key. The results will come out and they'll be what they are versus the endpoint in the Phase 2, which was an 80% reduction. But that will then inform a dialogue with the FDA with regards to a potential Phase 3 and what those endpoints would be, which could differ from the Phase 2. So it truly you have to first see the results and then you have to have the discussion with the FDA and only the 2 of those when added with the market research on what it would mean commercially will inform the option.

Speaker 2

Jeff, could you please speak to the remaining cases?

Speaker 8

Yes, sure Mark and Max. So your question is what about the individual plaintiffs, the private plaintiffs? Most of them are asserting claims for what is called a neonatal abstinence syndrome. So these would be mothers or family members that have sued, alleging that a child was born with an addiction to opioids. And we have been named in a number of those lawsuits.

Speaker 9

So this would be individuals who were taking, I guess, Suboxone and as a result of their treatment, then they're in pregnancy, the child was born addicted to opioids?

Speaker 8

Yes, Max, I would maybe recharacterize it as they alleged they've take Suboxone. That's part of the issue, right? These are very early in their stages. So we don't really have a lot more information than they filed the claims. But yes, the allegations would be that they took some product that we had and that the child was born with neonatal absence syndrome.

Speaker 9

Okay. Thank you.

Speaker 2

Thank you, Max.

Operator

We are now going to proceed with our next question. The question comes from the line of Paul Caiden from Deutsche Niemid. Please ask your question.

Speaker 6

Yes. Thank you, guys. I just got a couple of follow-up questions, if I may. Just firstly, now there are 2 companies or at least companies out there promoting kind of long acting injectables for opioid use disorder. I mean, are you starting to see any new clients come on board then getting in contact with you to ask about the potential benefits of SUBLOCADE that you may not have activated yourself?

Speaker 6

And then secondly for me, a question for Christian on the start of the longer acting product. Once you've shown the 2 nanograms per ml for 90 days, I mean, what really would there be sort of needed to do to get that product through into kind of more kind of pivotal studies? Thank you.

Speaker 2

Maybe I'll handle the first one and then I'll ask Christian to talk through the longer acting. Listen, I think our belief has always been that when you look at this disease space, the high unmet need that's out there less than 2 in 10 participate. Our expectation is that the increased share of voice for long acting will actually drive market growth in the medium and long term as we continue to help more patients. And I think as I detailed in my prepared comments, what we are seeing is continued strong HCP end patient growth, that are active prescribers. So now we're over 7,000 active prescribers

Speaker 10

of SUBLOCADE.

Speaker 2

So we continue to see good growth and see it that we're in the early days because we only have about a 6% penetration of LAIs in the market. So excited about the bright future ahead. Christian, you want

Speaker 8

to speak to the ALR partnership?

Speaker 5

So, I mean,

Speaker 10

A pretty good on the pharmacokinetics of a 3 month LAI with buprenorphine using the ALAR drug drug delivery platform. This is based, however, on a single dose study. So the next step for us is to organize what we call a multiple dose pharmacokinetics study to really inform us and understanding the pharmacokinetics properties of this new product in order to then organize a meeting with the FDA before we embark on pivotal Phase III trials.

Operator

Thank you. We have no further questions at this time. I will now hand back to Mark for closing remarks. Thank you.

Speaker 2

Thank you, Roslyn. With no more questions, this will conclude our Q2 half one results presentation. I'd like to thank everyone for their continued interest in Indivior. We look forward to updating the market as we progress. Have a great day.

Operator

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

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Earnings Conference Call
Indivior Q2 2024
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