Indivior Q3 2024 Earnings Call Transcript

Quartr
Provided by Quartr
October 24, 2024

There are 8 speakers on the call.

Operator

Good day, and thank you for standing by. Welcome to the Indivior Plc Third Quarter 20 24 Conference Call. At this time, all participants are in a listen only mode. After the speakers' presentation, there will be a question and answer session. Please be advised that today's conference is being recorded.

Operator

I would now like to hand the conference over to your host for today's call, Jason Thompson, Head of Investor Relations. Please go ahead.

Speaker 1

Thanks, Sonia, and hello, 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. These statements are based on current information and beliefs, and we disclaim any obligation to update them except where required by law. We may also refer to non GAAP measures, the reconciliations for which may also be found in the appendix to this presentation that is now posted on our website at www.endivior.com.

Speaker 1

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 Ryan Preblec, our Chief Financial Officer and Doctor. Christian Heiberter, our Chief Scientific 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

Christian is with us to answer any questions on the pipeline. Since we announced the business update just 2 weeks ago, I'm going to keep my formal remarks relatively brief, but I do want to provide a few updates. First, our results for the Q3 continued to show solid double digit year over year growth and were in line with the expectations that we pre announced earlier this month. SUBLOCADE 3rd quarter net revenue of $191,000,000 increased 14% and primarily drove the 13% increase in total Q3 net revenue to $307,000,000 Our underlying profitability and gross cash position also remained strong. Adjusted operating profit through the quarter increased 62% to 97,000,000 dollars and our cash position at the end of the Q3 was $344,000,000 In terms of the sequential net revenue trend for SUBLOCADE, despite 2% dispense growth quarter over quarter, we saw a modest decline in the 3rd quarter from the 2nd quarter.

Speaker 2

As previously discussed, SUBLOCADE's growth is being impacted by a combination of intensified initial trialed adoption of the competing product, variability in funding timing in certain justice system accounts and further destocking. Ryan will share more detail on the financial performance drivers in a moment. 2nd, as we navigate through the near term, our commercial teams remain intensely focused on our critical mission to help patients with opioid use disorder. We're generating increases in overall organized health system and CGS activation, which we believe will continue to grow the market for opioid use disorder over the long term. This resulted in SUBLOCADE U.

Speaker 2

S. Patients and dispense growth on both a year over year and sequential basis in the quarter. Further, as we have now been in a competitive market for a year, we want to continue to reinforce that SUBLOCADE remains the long acting injectable of choice for opioid use disorder treatment over this time. 1st, SUBLOCADE share of new patients was 72% at the end of the 3rd quarter. In addition, in analyzing multiple co prescribing cohorts outside of CGS since the competitors launch, we currently see SUBLOCADE maintaining its leadership position at share levels consistently in the mid-60s percent range across these cohorts.

Speaker 2

3rd, we're actively pursuing targeted streamlining actions including cost reductions against the group's expense base. Our actions will mainly be focused on reducing G and A costs and reprioritizing our R and D pipeline. Ryan will have more details on this item, but these actions are expected to sharpen our strategic focus on fueling SUBLOCADE's growth while advancing our 2 late stage OUD related pipeline assets and helping protect margins. Lastly, we continue to work hard to secure our future and create greater certainty for Indivior stakeholders. As you will have seen, we reached a preliminary agreement for a settlement of $40,000,000 to resolve the last remaining legacy antitrust cases.

Speaker 2

Material terms and conditions of the final settlement agreement must still be negotiated, but our expectation is to resolve these shortly. If the settlement is completed, all of the antitrust litigation will be behind the group. Turning to our strategic priorities report cards starting with SUBLOCADE. Expanding on my previous commentary, U. S.

Speaker 2

Patients in treatment grew 37% year over year to 166,600 at the end of the 3rd quarter. On a sequential basis, this represents a 4% increase with over 6,200 patients gained in the quarter. Recall, we're targeting greater than 270,000 patients to deliver our peak net revenue goal of greater than $1,500,000,000 In terms of continuing to lay the foundation for SUBLOCADE's future growth, the number of active dispensing HCPs increased to more than 7,700 in the 3rd quarter, representing a 15% increase from approximately 6,700 at the end of fiscal year 2023. We've also continued to make good progress activating Justice System accounts reaching over 800 accounts at the end of the 3rd quarter. We've made progress in our goal to establish a nationwide network of alternate sites of injection for SUBLOCADE.

Speaker 2

In the Q3, we added one new partner bringing the total number of alternate injection sites to approximately 12 20 locations. The number of SUBLOCADE injections at these sites increased 60% in the 3rd quarter compared to the previous quarter. We're also pleased to see that the DEA has extended telehealth for buprenorphine. This underscores the ongoing bipartisan efforts in the U. S.

Speaker 2

To increase patient access to medically assisted treatment. Looking at diversification and starting with OpV, as you saw in our October 10 business update, we booked net revenue for 2 orders as part of our 10 year contract with BARDA. Outside of those orders, we believe we are building both a strong funding as well as trial and experience environment for OpV. At the end of the Q3, we have established approximately 180 experience programs and 32 states now have standing orders in place. In our Rest of World business, we continue to see good growth and contribution from our new products SUBLOCADE and SUBOXONE Film.

Speaker 2

Their solid progression is helping us offset the ongoing challenges to our legacy tablet products. Ex U. S. Sales of SUBLOCADE grew 30% year over year to $13,000,000 Turning to our pipeline, a few highlights to mention starting with SUBLOCADE. We previously announced that we submitted important label updates to the FDA for SUBLOCADE, including rapid induction and alternate sites of injection on the body.

Speaker 2

We received priority review designation with a PDUFA date of February 7, 2025. If approved, we believe these label updates will help us directly address feedback we've received from HCPs on how we can improve the patient experience for SUBLOCADE. Turning to the pipeline, the most material development during the quarter was that the A List Phase 2b study did not meet its endpoints in reducing voluntary cannabis usage among cannabis use disorder patients. While disappointing, we made the decision not to move forward with the asset. Additionally, as part of the reprioritization of our pipeline, we've announced today, we've made the decision to discontinue INDV1000, a preclinical asset targeting alcohol use disorder.

Speaker 2

As a result, we're narrowing our pipeline to opioid use disorder with INDV6000 and 1, a potential 3 monthly long acting buprenorphine injectable and INDV-two thousand, a selective orexin-one receptor antagonist. The Phase 2 studies for both assets have been committed with study sites activated and development activities for both assets proceeding on track. For INDV-six thousand and one, in the quarter we initiated a multiple dose PK study that will inform any potential future Phase 3 study. The first subject first visit was achieved in September. The completion of this study will last with last subject last visit is currently scheduled for Q4, 2025.

Speaker 2

The INGV-two thousand Phase 2 proof of concept study is underway. The first subject was dosed in June and through mid October, 55 patients have been dosed. Our excitement about this asset reflects our belief in the significant unmet need for non opioid as a non opioid option for patients as part of the OUD treatment continuum. The completion of this proof of concept study with last subject last visit is currently scheduled for Q4, 2025. In line with normal practice, we'll assess the out turn from both of these studies at completion of the Phase 2 before making any decision on future investment.

Speaker 2

Moving to capital allocation, we're more than halfway through the $100,000,000 buyback we announced in late July. We also continue to progress in resolving legacy litigation matters included in the announced settlement that I referenced earlier. With that short intro, I'll hand over to Ryan.

Speaker 3

Thanks, Mark, and good morning and good afternoon to everyone. Despite the market dynamics that led to our recent update, I do want to highlight the strong underlying profitability of our business. In the Q3, we generated 13% year over year top line growth and saw an increase in adjusted operating profit of 62%. And by continuing to actively manage our resources, we were also able to lower SG and A by 11% in the 3rd quarter. I'll now walk you through our Q3 performance and then discuss the dynamics behind our recently revised full year 2024 guidance.

Speaker 3

Finally, I will provide some more color on the streamlining actions Mark mentioned earlier. Starting with the top line, total net revenue of $307,000,000 for the quarter reflected growth of 13% versus a year ago quarter, both on a reported and on a constant currency basis. By geography, total U. S. Net revenue grew by 15%, while

Speaker 2

the

Speaker 3

rest of the world business grew by 5% at actual currency and by 2% on a constant currency basis. SUBLOCADE remained the primary driver of our year over year net revenue growth in the U. S. From increased volumes in organized health systems, including justice system accounts. U.

Speaker 3

S. Net revenue in the 3rd quarter also benefited from the fulfillment of 2 Opdiv orders from BARDA. In the rest of the world, as Mark noted, growth was driven by continued positive contributions from our new products, mainly SUBLOCADE. Total SUBLOCADE net revenue for the quarter was $191,000,000 up 14% versus last year. U.

Speaker 3

S. SUBLOCADE expenses of $158,500 in the 3rd quarter increased 19% versus last year and 2% versus the prior quarter. The difference between the sequential dispense growth of 2% and the modest 1% decline in net revenue is due to trades destocking in the 3rd quarter. Breaking down our sequential dispense growth by channel, we saw solid low single digit growth in the base non CGS business. This was largely offset in the 3rd quarter by high single digit decline in dispenses in the Justice System.

Speaker 3

This reflected the loss of a significant account due to intensified competition as well as short term funding fluctuations in certain higher adopter accounts. For Opsbee, net revenue in the quarter of $15,000,000 reflected the two orders I referenced already, which are part of our 10 year agreement with BARDA. For SUBOXONE Film, share averaged approximately 15% in the quarter, which was down compared with both the prior year ago quarter. Net revenue in the quarter did, however, benefit from a non recurring trade spend accrual update as claims data from Change Healthcare has normalized since the cyber attack event. This catch up resulted in a benefit in the low double digit millions range in the quarter.

Speaker 3

As a reminder, we do not promote SUBOXONE Film in the U. S. Moving down to the P and L. Our 3rd quarter adjusted gross margin of 82% was down sequentially and versus the prior year quarter. The decrease in the gross margin percent primarily reflects favorable pricing on specific production batches in the year ago quarter that did not repeat this quarter as well as continued impacts from cost inflation, mainly wages, raw materials and services.

Speaker 3

Adjusted SG and A expenses were $133,000,000 in the quarter, a decrease of 11% versus Q3 of last year, reflecting the discontinuation of VECERIS as well as lower legal and other administrative expenses. These benefits were partially offset by Op Feed launch expenses and incremental growth investments behind SUBLOCADE. R and D expenses were $22,000,000 in the quarter, an increase of 22% versus the year ago quarter. The expected increase in R and D reflects the phasing of pipeline advancement activities that we indicated would accelerate in the second half of the year as INDV-six thousand and one and INDV-two thousand commenced Phase 2 studies. Adjusted operating income of $97,000,000 in the 3rd quarter was up 62% versus the prior year, mainly benefiting from solid growth in the U.

Speaker 3

S. Net revenue and lower overall operating expenses. Moving down the income statement, our 3rd quarter net finance expense was $5,000,000 versus net finance income of $2,000,000 in the year ago quarter. The net finance expense in the current year primarily reflects our lowered cash and investment balances. Our adjusted tax rate was 22 percent or $20,000,000 Taken together, this resulted in our adjusted net income growth of 47% to $72,000,000 in the quarter.

Speaker 3

Quickly touching on the balance sheet and our capital allocation or excuse me, our capital position. We ended the Q3 with gross cash and investments of $344,000,000 Year to date, positive cash flow from operations was offset by litigation related payments and by the $122,000,000 we spent on share buybacks through Q3. As Mark mentioned, we reached a preliminary settlement of $39,000,000 to resolve the remaining antitrust cases with certain end payers. The provision reflects the net present value of the expected payment amounts over the next 2 years. This follows last quarter's settlement agreement with certain parties in the opioid MDL, for which we recorded a $70,000,000 provision with the settlement amount due to be paid over 5 years.

Speaker 3

Material terms and conditions of both settlement agreements must still be finalized. On my final slide, I want to highlight a few key items from our 2024 guidance that we updated October 10. Our revised total net revenue guidance of $1,125,000,000

Speaker 2

to

Speaker 3

$1,165,000,000 reflects the headwinds we articulated in early October and at the midpoint represents 5% year over year growth. For SUBLOCADE, our guidance of $725,000,000 to $745,000,000 represents a 17% year over year growth at the midpoint. As we previously discussed, SUBLOCADE's growth is being impacted by a combination of competition and other factors, which we will expect will continue through Q4. For

Speaker 2

For OpV, we refined our net revenue expectations to approximately $15,000,000

Speaker 3

for the year based on receipt of the 2nd BARDA order. We expect net revenue excluding BARDA to be immaterial as we are still building trial and adoption among targeted users. Our guidance for film is unchanged. Our guidance for SG and A expense was narrowed to $555,000,000 to $560,000,000 For R and D, we reduced our outlook to $115,000,000 to $120,000,000 Taken together, we have reduced expected overall operating expense by $5,000,000 in the remaining 2 months of the year as we look to drive additional efficiencies. Given the elements I just discussed, we now expect adjusted operating income to be between $260,000,000 $280,000,000 which at the midpoint would be comparable to last year.

Speaker 3

Before I close, I want to provide some additional color on the streamlining actions we are announcing today, which are intended to fuel SUBLOCADE growth, fund our Phase 2 OUD assets and support group margins. In aggregate, Indivior anticipates reducing total operating expense by $10,000,000 to $20,000,000 in full year 2025 versus the 2024 midpoint of our guidance of $675,000,000 Recall, we define operating expense as a combination of our SG and A and R and D expenses. This year on year reduction includes savings from the launch of a new cost reduction program focused on G and A and R and D reprioritization, including discontinuing INDV1000 for alcohol use disorder. It also includes savings from the discontinuation of PERSERIS. The combined gross savings from these initiatives will allow us to fund planned investments behind SUBLOCADE in 2025 as well as our Phase 2 assets targeting opioid use disorder.

Speaker 3

These savings will also allow us to absorb expected inflationary impacts. Considering these offsetting factors, we still expect to show a year over year net reduction in operating expense in 2025, as I noted. We believe the result of these actions will be a more streamlined group with a clear focus on our strategic priorities, principally driving SUBLOCADE towards our peak net revenue goal of greater than $1,500,000,000 and strengthening our portfolio of OUD treatments to address unmet patient needs, while also helping protect our margins. We will share the final details of our actions no later than February when we report our Q4 and full year 2024 results. I will now turn the call back over to Mark.

Speaker 2

Thank you, Ryan. Despite a more challenging market backdrop for SUBLOCADE in the near term, I hope we've demonstrated 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 undertreated market while generating substantial shareholder value through our actions. We're happy to take your questions now.

Operator

Thank you. We will now take our first question. Please stand by. And the first question comes from the line of David Amsellem from Piper Sandler. Please go ahead.

Operator

Your line is now open.

Speaker 4

Thanks. So I just have a couple. First on the competitive landscape, Can you just talk about how you're thinking about your share of new starts longer term? And what you think ultimately the market will shake out at? Do you think you'll be getting half of new starts?

Speaker 4

Is it something higher? Is it something lower? I know what you've been saying recently, but help us better understand where you think things are going to evolve in the context of a 2 player LAI buprenorphine market. So that's number 1. And then number 2 is just in terms of capital deployment, I mean, you bought back shares.

Speaker 4

It looks like you're going to continue to do that. How aggressive are you going to be through next year in terms of buybacks and how do you balance that versus other business development priorities? You bought Opiant and that gave you Opdiv, that was a sizable acquisition. Is that something that you're thinking about in terms of deal size going forward or are you thinking more conservatively? Just help us understand your thought process there.

Speaker 4

Thank you.

Speaker 2

Thanks, David. I think when we think about the competitive landscape, the early data certainly is encouraging when you look at new patient share continuing to be above 70%. You look at the cohorts from the early adopters stabilizing out in the mid-sixty percent range and we see that as incredibly indicative of the very unique profile that SUBLOCADE offers in this space with early onset of therapeutic levels in 4 to 8 hours and maintaining those the entire month long in a market that's been riddled by synthetic opioids. And we think that's very important that efficacy based messaging. As we look forward, I think the key here, David, is more along the lines of this market has such a huge unmet need.

Speaker 2

There's less than 2 in 10 patients that are actually in treatment, LAIs are still 7%, plenty of room for 2 players, plenty of room to get to greater than $1,500,000,000 And then when you look at some of the additional interventions that the team has made, including the label work that's been done by Christian and the R and D team, that certainly takes away some of the short term feedback we've gotten from doctors with regards to alternate sites of injection and the rapid induction. So we see very positive trends moving forward. On the capital deployment side, I think as we've consistently applied our principles on capital deployment over the last 3 to 4 years and in partnership with the Board, who ultimately owns capital allocation, we'll continue to do so moving forward. And just to remind you of those, David, I think the first one is that we well fuel SUBLOCADE, We'll continue to advance our assets to the next stage gates and then ensure we have the appropriate financial flexibility moving forward. And there are a number of items on our balance sheet that we need to make certain we can fulfill moving forward.

Speaker 2

After that, if there's excess cash, the Board will work on prioritizing that for capital allocation. In the short term, we have an ongoing buyback. In the short to medium term, we do not see business development and the Board will have to assess uses of excess cash after that when the time is appropriate.

Speaker 4

Okay. That's helpful. Thanks guys.

Speaker 2

Thank you.

Operator

Thank you. We will now take our next question. And the next question comes from the line of Chase Knickerbocker from Craig Hallum. Please go ahead. Your line is now open.

Speaker 5

Good morning, guys. Thanks for taking the questions. Just first for me. Assuming kind of approval in Q1, Mark, for your label updates for SUBLOCADE, can you help us with kind of the strategy to drive awareness within your commercial organization with clinicians on these changes, obviously once they're approved? And then kind of also with patients to kind of help reeducate them on kind of the new profile for SUBLOCADE and how it compares to BRXADE?

Speaker 5

Thanks.

Speaker 2

I think these are important updates and we think are important moving forward. As we think about our incremental investments, obviously some of those are on HCP and patient awareness of not only SUBLOCADE, but of the new developments with regards to its label and the improvements in the patient and doctor experience. So we'll anticipate, that utilizing both awareness, trial and adoption of SUBLOCADE efforts in investments and that will include the label as well as SUBLOCADE overall. And those will begin on expected approval, on February 7 with the PDUFA date.

Speaker 5

Got it. Maybe just digging in a little bit on those cohorts that you mentioned, can you kind of help us quantify with how big that sample size is and kind of how confident you are that that kind of continues through as we see kind of that, I guess, data set mature? And then second on that as well, what did you see from a cadence perspective is kind of how that sampling of your competitor kind of impacted usage? Did it kind of progressively go to that kind of mid-60s range? Or did it go farther than that and then kind of rebound?

Speaker 5

Just kind of help us out with what you kind of saw in that data set, maybe a little bit more color.

Speaker 2

Yes, certainly. I think as we look over the 1st 4 months or so, the cohorts are about 500 physicians in nature in that ballpark, which is we think is pretty material when you're starting to look at trends and where the market settles out. And I think the key element here Chase is that we are seeing that settle out in that approximately mid-sixty percent range with regards to the market. And for us, it just reinforces efficacy is the number one choice in making decisions and that unique product profile that SUBLOCADE brings to the market. So very encouraging early cohort data 1 year after competitor launch.

Speaker 5

On average Mark, is it kind of the lowest it went in that mid-60s range because that would insinuate obviously with new patient kind of share of 72% that there's not kind of a whole long way more ways to go as far as kind of new patient share loss? And then second and last for me and I'll hop back in the queue. It's just on price for SUBLOCADE, Mark. I mean your commentary notes that kind of the difference sequentially from dispense growth to revenue was mainly about stocking. Do you expect any kind of price headwind as we kind of enter into Q4 and then kind of 2025?

Speaker 5

Thanks.

Speaker 2

Certainly. In some of the cohorts, it went beyond and then came back, but it wasn't consistently in every single one. So I think but again, I think the key is where we're seeing the stabilization and share leadership as well as just the huge opportunity in the market as LAIs, which are still in the early stages of growth at 7 percent, remember market research from physicians says it should be 30%. So there's a huge opportunity. Even if it was 50%, there's a huge opportunity for 2 players, but we see the early cohort data indicating share leadership.

Speaker 2

When it comes to price, Jason, I'm glad you brought that up. And I want to be very clear in my pricing commentary. When we look at the overall market, pricing is very stable. When you look at pharmacy benefit managers across both commercial as well as government payers, we see very, very stable markets. We see open access across all of the options in treatment.

Speaker 2

It's what you hear from doctors and patients that they want based on where they are in their journey. They want the options of which medication they choose rather than 1 of 1. And when we make our bids for access on all of these plans, we never make a 1 of 1 bid. We always make open access because we think that's best for the therapy area. Area.

Speaker 2

My commentary on pricing was in a few CJS accounts where you have to remember here that the funding is issued by a government agency, sometimes supplemented by grants. Pricing is a bit more sensitive there and we have seen in an account that the competitor use pricing to gain access to an account. We don't see that as a long term issue. Again, we think of in criminal justice that we want open access to all options and we think SUBLOCADE will win out in the experience based on its overall efficacy. Thanks Mark.

Speaker 2

Thank you, Chase.

Operator

Thank you. We will now take our next question. And the next question comes from the line of Paul Cuddon from Deutsche Namis. Please go ahead. Your line is now open.

Speaker 6

Yes. Thank you very much for taking my questions. I have 2, please. Just firstly on the Q4 visibility over SUBLOCADE and the kind of implicit range that your $725,000,000 to $745,000,000 guidance gives. I mean, how can that $725,000,000 possibly be viable given the sort of favorable patient trends?

Speaker 6

And as you've just said, the sort of stable pricing, if you could just help me understand how that's even in play, that would be useful.

Speaker 2

Yes. When we look at SUBLOCADE and we look at the trends going into 2025 and we look at the top end of guidance to the bottom end of guidance, what we've taken into account, Paul, is continuation of the accelerated adoption of the competitor product, as we go through this transition period, the continuation of CGS kind of in year funding fluctuations. And then the continued destocking through Q4 is what we've built into that forecast. And when you think about the top to the bottom end of the guidance, it's just a more intensity of each of those factors. On average, when you look at the new guidance, we had about $20,000,000 associated with the increased competitive adoption, dollars 20,000,000 associated with the CGS funding and then $10,000,000 of additional stocking.

Speaker 6

Okay. Thank you. And then secondly for me, you talk about the mature 65%, but I'm pretty sure Ryan mentioned actually losing an account altogether. If you could clarify that as to whether that was losing an account or actually kind of more having a competitor kind of take a kind of minority share?

Speaker 2

No, I think it's a good clarification, Paul. And really, I think it's 2 separate things. The cohort data is data from organized health systems outside CJS, which is 78% or so of the business in Q3. The lost account was the West Coast Justice System account that we have referenced at the pre release of guidance where we had a competitor come in utilizing pricing and the alternate sites of injection. So I think 2 separate areas, 2 separate sort of forces and that's the competitive and the funding fluctuations in year on the CGS that are putting pressure there in the short term, again not something we see into the medium and long term.

Speaker 6

Okay. Superb. Thank you very much.

Speaker 5

Thank you, Paul.

Operator

We will now take our next question. And the next question comes from the line of Christian Glenny from Stifel.

Speaker 7

Maybe just a bit more on the cohort data just to make sure we're understanding it right. Is it a case that certainly in the OHS or the sort of regular market, if you like, that effectively most systems end up with co prescribers, obviously, as and when the competitor comes into those systems. But so it's not an either or. So largely, that is the sort of typical state of play that docs will have free choices effectively and obviously select for their patients, whereas obviously in CJS it's exclusive to 1 or the other, just to make sure we've got that right.

Speaker 2

Good clarification, Christian. I think with the cohort data, what we've done very specifically is looked in each of those months of early adoption on doctors that prescribed both products in that initial month. And then we followed them through the 1st 12 months, 11 months, 10 months, 9 months, if you were to look at the 1st 4 months that I refer to the 500 or so HCPs. And what we're talking about when we talk about the mid-sixty 5 percent share, that's where those doctors that are co prescribing where we see the share settling out. So I think that's an important item.

Speaker 2

What we believe and see when you think of efficacy as the number one choice, when you think of SUBLOCADE's unique profile, we think with free choice that SUBLOCADE will be the market leader moving out. But obviously there's such a tremendous opportunity in the market for 2 players. Within CJS, I think historically we've seen SUBLOCADE as the only player there and as competition is coming in, for example, in this account on the West Coast, what we've seen is what started as a shift to the competitor now has shifted to where they're prescribing both products. And so you could have that. We know in some markets there are trials where they're using the competitor for lower BMI sort of patients and things like that.

Speaker 2

So you're seeing some dual usage. But predominantly right now it's 1 of 1.

Speaker 7

Sorry. Just yes, thank you. But it was more just to clarify that there's any scenarios in which maybe a large OHS is going for 1 over the other or is it that you should assume that the market will be open to both players?

Speaker 2

I apologize. I missed the question there, Christian. I think the way to think about this is typically the OHSs are open and they're open. They're going to be open for both products and it's going to be a physician choice, both for which long acting, but do they utilize orals, which are still a significant portion of the prescribing decision based on where the patient is in their very unique journey.

Speaker 7

Okay, thank you. Maybe one just to get maybe a bit more sense around when you talk about rebalancing on OpEx, but then redeploying some savings into renewed efforts behind SUBLOCADE next year. Obviously, you've got the label and things like that. But anything to else to point to whether it might be an increase in sales force or some other part of the strategy that is beyond kind of what we know around the label and things like that?

Speaker 2

Yes. I think for us as we look at where we are in SUBLOCADE's journey, we're now opening up access across all the channels, have opened organized health systems, CJS. We now have alternate sites of care coming. We have a sales force that's covering the first 14,000 physicians that are out there for opioid use disorder. We think now is the time to focus on patient and HCP awareness as well as activation and full adoption.

Speaker 2

And so that for us is going to be a key element of that spend back, and we'll give incremental details with regards to that when we have our fiscal year end 2024 results in February.

Speaker 7

Thank you. And then maybe one final one, just on Opdiv, I know it's still in relatively early innings, but nevertheless some expectation from your side around when you should see that you've got it open and ordering available in lots of states now, but maybe we'll see some material traction beyond the sort of BARDA contracts?

Speaker 2

Yes, I think no real new update since we last talked this at the update a few weeks ago. We're continuing with our experience program and our real world evidence programs to help document what's happening with regards to precipitated withdrawal. And with the lives we've saved that's over 150, we are not seeing any feedback to our medical line nor from first responders with regards to precipitated withdrawal, which we see as the number one objection in fear associated with both higher doses of naloxone as well as with nalmefene. And with that and that evidence generation, we expect green shoots with regards to increases in orders with first responders in the public interest market moving forward.

Speaker 7

Okay. Thank

Speaker 2

you. Thank you, Christian.

Operator

Thank you. As there are no further questions, I would now like to hand back to CEO, Mark Crossley for any closing remarks.

Speaker 2

Thank you, Sonya. With no more questions, this will conclude our Q3 results presentation. I'd like to thank everyone for their continued interest in Indivior and we look forward to updating the market as we progress.

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Key Takeaways

  • Strong Q3 financials: Total net revenue rose 13% year-over-year to $307 M, driven by SUBLOCADE’s 14% growth to $191 M, while adjusted operating profit jumped 62% to $97 M and cash reached $344 M.
  • SUBLOCADE maintains leadership: US new-patient share was 72% in Q3, with co-prescribing cohorts stabilizing in the mid-60% range despite competitive pressure, funding timing variability in justice accounts, and destocking.
  • Cost-reduction and pipeline focus: Indivior plans to cut G&A expenses and reprioritize R&D, discontinuing its cannabis asset and INDV1000 in favor of two late-stage opioid use disorder programs to support SUBLOCADE’s growth and margins.
  • Pipeline and label updates: SUBLOCADE’s rapid-induction and alternate-injection-site label updates received FDA priority review with a Feb 7 2025 PDUFA date; Phase 2 studies of INDV6001 (3-month buprenorphine) and INDV2000 (orexin-1 antagonist) remain on track for Q4 2025 readouts.
  • Litigation resolution nearing: The company reached a preliminary $40 M settlement to resolve its last legacy antitrust cases, which, upon finalization, will eliminate all remaining opioid-related litigation.
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Earnings Conference Call
Indivior Q3 2024
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