Good morning and good afternoon, everyone. And thank you for joining us today and your interest in Indivior. I’m Shaun Thaxter, CEO. And I’m also joined by Mark Crossley, CFO; as well as by our Chief Scientific Officer, Christian Heidbreder; and our Chief Legal Officer, Javier Rodriguez. We will have about 15 minutes of commentary. I will make some opening comments, and Mark Crossley will follow with a rundown of the key financials. And then we will, of course, turn to your questions. The big picture is that our daily medication businesses around the world are under pressure from well documented and anticipated market challenges, resulting in the current downward net revenue trend. Our big opportunity and immediate priority is to drive new net revenue growth from our recently approved injectable products, SUBLOCADE and PERSERIS, to mitigate these downward pressures and to create new, sustainable, long-term top and bottom line growth for Indivior. In the third quarter, we faced a combination of downward forces on our base business. First of all, we faced increased generic competition, most notably the at-risk launch by Dr. Reddy’s of a generic version of SUBOXONE Film in the U.S. Secondly, the concentration of U.S. market growth focused in the less-profitable government channels. And there was further erosion in generic tablet pricing in the U.S. and continued government-mandated price cuts in the Rest of World segment. Looking forward, the revenue pressures we face in our U.S. Film-based business are likely to continue. The momentum on volume expansion and growth will continue in government channels, and this will be fueled by increased state-level funding to address the opioid crisis. Furthermore, generic buprenorphine and naloxone tablet pricing is now at commodity floor price levels of around 80% below list price. This level of pricing has the greatest impact…

Thanks, Shaun. Overall, our results are -- on an adjusted basis, were consistent with the expectations we had when we updated guidance in late September, and they reflect the competitive and environmental dynamics we are experiencing. As well, they also reflect our progress on making our internal cost-savings initiatives announced in July. As a consequence, we remain on track to achieve our revised fiscal year 2018 guidance of net revenues between $990 million and $1.20 billion, and net income between $230 million to $255 million, as we communicated on September 26. This assumes the U.S. market conditions remain unchanged, chiefly that the Court of Appeals upholds the preliminary injunction that Indivior was awarded against Dr. Reddy’s. Now turning to our performance, starting with the top line. Year-to-date revenues declined 7% to $768 million, but by 11% to $245 million in the quarter. On the quarter, the step down in net revenue reflects the low double-digit market growth, primarily in the less-profitable government channels, more than offset by the net revenue loss from Dr. Reddy’s generic at-risk launch in the quarter. And this consisted of both share loss and a bit of destocking activity. In addition, there is continued price pressure from continued lower generics pricing in the U.S. that Shaun spoke to earlier. SUBLOCADE net revenue in the U.S. on the quarter was $3 million, bringing year-to-date net revenue to $5 million, and we are on track for our $8 million to $10 million of net revenue guidance in fiscal year 2018. The Rest of World revenue declined in the quarter by 15% at constant FX, primarily due to government austerity measures on price and increased competitive pressure in certain EU markets that we guided to earlier in the year. This is further impacted by phasing of shipments and onetime…

Thank you, Mark. So that completes our sort of commentary, and now we’d be very pleased to take your questions.

[Operator Instructions] We will now take our first question from Max Herrmann from Stifel.

It’s Max Herrmann from Stifel. Firstly, just to try and understand a little bit more about the treatment adherence and how that’s -- the experience you’re seeing with SUBLOCADE in the market, how that compares with the SUBOXONE Film and whether the compliance advantages are bearing out with the once-monthly formulation. Secondly, just wanted to get an update from you regarding the European filing for SUBLOCADE. And then also I see you’re now planning to resubmit the film for filing in Europe. So I want to just try and understand what had changed there in terms of bringing that back on to the market.

Okay. Thank you, Max. Yes, we are pleased with the compliance rates. When you look at the chart, you see that the fourth injection of 45%, it -- what’s not clear from the chart is that, actually, if you’ve had your fourth injection, you’ve probably been in treatment for 6 months. Because if you imagine the time frame when these patients were receiving their first injection, they were probably been on treatment with SUBOXONE Film for one or two months before they received their first injection. So when we think about the fourth injection here, we’re probably looking -- and we can’t be unequivocal about this, of course, but we’re probably looking at patients who have been really in treatment for five or six months rather than only four months. So it’s very difficult to make a direct comparison with SUBOXONE Film in absolute terms. But we should think that -- how long has this patient been on SUBLOCADE or injections? How long they’ve been in treatment? Probably six months. So the retention rates tend to correlate to that extra time frame. So I think this is a very encouraging statistic because what we’re starting to learn is that getting to six months is quite an important milestone in terms of duration in treatment for patients starting to sort of -- to be seem to be having a significant impact in progressing the management of their disease. So we are pleased with that. With respect to the EU filing of SUBLOCADE and film, Christian, would you like to comment on that?

Yes, absolutely. So SUBLOCADE in Europe, we are targeting the fourth quarter 2018 to make the filing according to a decentralized procedure because this will be an extension on Subutex. We are going to basically target EU whole, that is France, UK, Germany, Italy as well as the Nordic countries. That is Denmark, Norway, Sweden and Finland. With respect to the SUBOXONE Film, there has been, in fact, a lot of changes. As you may know, we have addressed several questions from the European regulatory agencies from the past. We are now in a position to really file the film dossier, following a very important meeting we had with BfArM, the German regulatory agency. That was the rapporteur of our filings. And we are currently targeting the first quarter of 2019 in order to make the appropriate filing according there to a centralized procedure.

We will now take our next question from Paul Cuddon from Numis. Your line is open. Please go ahead.

Just a question on the attrition rates between the prescription and dispensing, in light of the 82% payer coverage. Because I mean, for me, the number of prescriptions initiated is very encouraging. The number of physicians attempting treatment is also very encouraging. But it’s that conversion that that 35% from 29% doesn’t appear to be moving. So it’s the balance of where the 65% is falling away, if you could explain.

Yes. I mean, we were very quick to gain formulary access. And I think, as we’ve talked before, the sort of implementation of the medical benefit takes time. The more people we talk to, the industry experts are saying, "Well, you’re making very good progress against industry analogues about the time it takes from going on formulary to having medical benefits policies written, drafted, implemented and then systematized." So I think what we’re seeing is we are seeing improvements. We’re hearing it in from the field. The doctor’s offices are finding it easier to get patients through the system. Fewer percentages. We talked before. We had a lot of inconsistencies between plans and patients getting rejected from the same plan with different rules. That’s all kind of sort of working its way out now. So I think we are seeing, people say that normally takes six to nine months. So I think that’s pretty much on track and making good progress. Although we’re, by no means, happy with it, of course. But the issues that have held it back are working their way out. Admittedly, it’s not yet as visible in the performance indicators as we would like it to be, but we are confident we’re doing all the right things. Reimbursement team, strengthening their relationships with office practices. And that’s giving them greater access and better quality of trust and relationships with the practices so that they now embrace the education that they’re being given on how to do this. And so all these things are having a cumulative effect.

But you would say it is the medical benefits analysis that is the primary part of that 65% attrition?

That’s a major contributor. Another contributor is, obviously, we have had taken a long time for patients to wait to get their treatments. So some doctors and patients have given up. That’s improving all the time. So we would expect, subconsequently, that to improve the yield rates as well.

I think the thing to remember also, Paul, is you do have new physicians coming in, doing this for the first time. And so if you go back to the example Shaun used with whether it’s a passport or one of these things, they’re going through that learning cycle, potentially making errors in paperwork and things like that along the way, and that impacts this somewhat also. So you’ve got some that are starting to become functional with regards to this new go-to-market model, and then you’ve got new people coming that are still naïve and still learning. So it’s a combination of those things.

I think there’s also -- I was just saying, we’re also looking out for opportunities in selected plans where we might be able to move this from the medical benefit to the pharmacy benefit, which will also sort of systematize some of these out-of-the-manual process. But that’s not something that’s universally available, but we’re exploring opportunities there to make it. I think the benefits there are twofold. Not only is it about the time that it takes for this to work through the system and the inefficiencies within it, it’s also about how much work and effort is it for the doctor’s practice. So what you’re really seeing here, in terms of who are the early adopters, these are the doctors who are most patient-oriented. These are the patients that -- the doctors that really, really, really care about this particular patient population, and they’re willing to go the extra mile, right, for their patients. So if it has been a little bit of hard work in the 6 months, they don’t care because they really want to help their patients. Now of course, there’s a limit to how many patients they got time to do, so that’s not being helpful. But the doctors who just say, "I don’t really have the infrastructure to spend too much time on that." That will build as the simplicity and the ease and the time all comes down so that will help us improve our penetration. So all these things sort of work cumulatively, and we see good progress.

We will now take our next question from Nick Keher from RBC.

Just wanted to talk through the launch for PERSERIS. But also, you discussed the fact that you would think again, as the PI decision goes your way for Dr. Reddy’s. I’m just quite keen to understand what you’re thinking would you also be on an Alvogen risk launch beyond Dr. Reddy’s as well. And if you can just talk through the potential scenarios there.

Gladly. So the first thing we have to recognize is that Alvogen don’t have a product approved yet. But I think if we’re realistic, it probably will get a product approved at some point. But certainly, it’s not available yet. Now I am aware they talk a good story about looking up a launch, but their fate would be pretty much the same as Dr. Reddy’s . The minute we got word of an approval in any distribution, we’d be straight in through the courtroom door within -- literally within minutes and hours. And we would be issuing -- asking the court for a Temporary Restraining Order. And we would go after that with as much passion and enthusiasm as we did with Dr. Reddy’s, and then follow that through with the same level of ruthlessness and determination about getting a preliminary injunction on Alvogen. It would be going to the same judge. It’s unlikely that he would welcome all of this nonsense from Alvogen when it’s very clear what his ruling is on this subject that he’s already made very public with Dr. Reddy’s. So -- I mean, we would expect to follow the same path. While we’re talking Dr. Reddy’s, just to remind everybody, we had a ruling on the 4th of October. We are optimistic about the ruling there. But nevertheless, it wouldn’t be wise to make business decisions on the assumption of something that you feel good about until it’s actually happened. When it -- clearly, it would have so much impact on the business. So that’s why we need that confirmation before we can go ahead and activate the PERSERIS launch. So we have done good work on recruiting. And we’ve identified some good talent. So we’re ready to move very quickly and effectively once that ruling comes. Next question will probably be when will it come. The answer is we don’t know. We hope to have it sometime this month. But again, it’s up to the court and the judge when they issue their ruling. And it’s not good news or bad news if it comes quickly or takes longer or if they just take as long as they take to work these things through as we all know. What specifically would you like to know about the PERSERIS launch?

No, sorry. It’s really just in terms of -- you did answer the question. But the key thing I suppose probably from that is, would we be fair to say then if Alvogen did launch at risk, this wouldn’t impact your PERSERIS launch? You wouldn’t change your profile of that launch at all? Is what you said there, you’d be quite confident going the same way.

Assuming that the judge -- well, yes. I mean, we can’t guarantee anything that happens. And clearly, we have these binary risk events in our business, and we run our business on the expectation of a positive outcome. So our expectation would be, or I hope or however you would like to characterize it, that if Alvogen did launch, then there’s no reason to believe that we would not get a restraining order because we did with Dr. Reddy’s and the arguments are the same, very similar. The preliminary injunction, similarly. So we don’t really have any reason to change our position on that. Therefore, our position in court remains the same.

Okay. And then just referring back to one of the questions from earlier on Slide 7 of the presentation on the treatment adherence rates. Are there any other -- I mean, you talked about 6 months -- the fourth injection suggests that somebody’s been on treatment for 6 months. With that 45% rate, it all seems a little bit low against the analogue of the film, for instance, at 6-month treatment rates. A benefit, but not perhaps as much as what we had expected from prior presentations and results. Are there any other reasons why the injection rates are dropping off the way they are for the patient from what you’ve seen today?

Yes. I’m not sure which data you have in mind when you think these don’t have significant variation from the film. The data I think we’re most familiar with is that you tend to see about 50% drop off in the film in the first sort of couple of months of treatment, though if you could remind me of the data point you’re thinking.

It’s actually from your prospectus from the -- when you came to market the presentation at the time. So you put against the film against the tablet for 6 months. At six months, 33% on therapy on the film. I think you’re -- yes.

All right. Okay. So you’re comparing the 45% with the 33%. So yes, I mean, I think if you ask a lot of opinion leaders and experts, they would see -- if you -- that’s nearly a 50% improvement. They would see that as a significant benefit then there’s a significant improvement. I think they would try and think that’s very valuable and clinically relevant. If you think what’s likely to be happening for those patients if they’re not in treatment, potential for relapse, overdose and all the negative things and costs that the payer incurs when patients are not in treatment, those are quite significant. And we also have to recognize the sample size is relatively small. We’ve only had 2,500 sort of patients through this year. So it’s still early days to draw too many substantial conclusions.

We will now take our next question from Nick Nieland from Citi.

A couple of questions just on PERSERIS. The price looks to be in line with the lower end of competitors in that market. I wonder if you could just comment on whether that is the case. And about your pricing strategy.

Yes. I mean, the -- we tend to find that a lot of these products are all on a fairly similar sort of net price. And we certainly don’t have any intention to sort of disrupt the market at a pricing level. So we expect that we will be in the sort of normal range of most of the market.

And then secondly on PERSERIS. I seem to recall the price for the SUBLOCADE launch, you did the market evaluation and you increased your peak sales guidance based off the back of that. And I wonder if you’ll be doing the same for PERSERIS and whether the chance you might change your guide based on the market analysis prices to your first commercial launch next year.

Yes. I think that we don’t have any change basis at the moment to change our PERSERIS forecast. However, when we do recognize that this is a rapidly growing sector and the sort of the segment is growing quite healthily. But at the moment, based off our research, we don’t have a basis to make any changes.

Okay. And then lastly, just on SUBLOCADE. You’re putting aside all of the logistical issues that you’ve documented. Just talking about actual demand for the product from patients described it. I was just wondering how that compares to the expectations you had before you launched.

Yes. Well, I think -- I mean, one thing that is the big difference in terms of our sort of expectation on the demand front is that we clearly had anticipated we’d have a full promotional mix, and we would have the resources and the materials. And we’ve only really had those in full -- a full suite of those in September. So this is a very complex message. We’re trying to transform the treatment of addiction. We’ve got a lot of new science. It’s very technical, and it needs careful explanation. It’s not the sort of thing you can get done in three minutes in the product label. But the product label is all our field force have had for the first six months. So we don’t want to make excuses because we’re not -- we’re accountable for delivering what we said what we were going to do. But nevertheless, the fact is that we did have to wait an extra four months for those resources. So I think that we will be in a better place to judge how well physicians are really responding to the message when we’ve had three or four months with all the support materials that the physicians need. Because the physicians find themselves, "Well, I’d like to talk to my patients about this. What have you got to help me." Well, haven’t got anything. "Well, what can you give to me?" Well, I haven’t got anything. I’ve only got my label. Now we’ve got the patient labels. The physician can give something to the patient. The patient can read what they should expect on the treatment. And all the reassurance that’s required. Because that emotional level, when you’re asking people to do something different, they believe it, and they want to do it,…

We will now take our next question from Harry Sephton from Jefferies.

Just had a quick question going back to the adherence rates. So looking at that fourth injection, does that count for any patients that might have missed like an injection cycle, as it were? And if not, do you have any indication as to how many patients who do potentially lapse an injection cycle might potentially come back further down the line?

Yes. I think it’s too early to have any real data on that. We haven’t picked that up as something that we have observed. But it’s an interesting question, and we’ll look for it moving forward.

So that fourth injection is someone who has had consistently those four injections over and not potentially missed the cycle?

Yes.

Yes. Okay. That’s clear.

Yes, that’s correct. Yes. That’s correct.

And then on conversion rate, how many of those -- I guess, the 65% which have been rejected is from prior authorizations? And it would just also be helpful to know why they’re getting rejected for those prior authorizations.

Yes. I mean, we don’t have specific data to share on the exact numbers. But what we do know with the prior authorization, a lot of it is being driven by a lot of the health plans haven’t had enough patients through yet while the policies have all been embedded in place. Where we are finding doctors who sent patients to the same health plan, they’re kind of getting systematized. They’re getting used to it and things let down. We’re seeing the inconsistencies starting to flush out of the system. And I think it’s the inconsistencies, the poor training, the inexperience of the people who are adjudicating the claims, that is an important issue here. And that’s what we are hearing predominantly. We’re not hearing generally that all the health plans are systematically rejecting this because they don’t want patients on it. The vast majority -- and this is a very important point, the vast majority of the prior authorizations only require that the patient is confirmed, has a diagnosis of opioid use dependence. So what does that mean? So well, it means, the payer -- you could argue the payer’s being responsible. There’s an opioid crisis. Everybody who is in the opioid business is being scrutinized rightly so by the government, and they need to demonstrate they’re doing the right thing. If you were an insurance company and you want to show you’re doing the right thing, you say, Well, we do double check. Anyone who gets this medication is actually appropriately treated and diagnosed as a non-label patient. That’s all they’re asking us to do. If they didn’t want to pay for it, they’d put multiple step edits and all sorts of other criteria in addition to that diagnosis. But they’re not doing that. They’ve also rapidly put this on the formulary, right? We’ve got 82% of the U.S. lives covered, which is an incredible achievement at this moment in time. There are lots of things that you can quite rightly say, "Well, we’re disappointed with this and disappointed with that." But we can’t possibly be disappointed with how payers have embraced this and put onto formulary. We also know -- the whole environment around the opioid crisis is positive. And nobody wants to be seen to be working against the opioid crisis. So we think these efficiencies will improve, that the environmental support and encouragement is there. The experience and the learning of the administrators and the engine room of these health plans is improving.

And just one final question. It’s clear there are actual growth and the number of prescription journeys has been positive. But it’d be useful to get an indication as to how many physicians your clinical liaisons have actually been directly in contact with in that time and what sort of percentage conversion that ‘18, ‘17 number is of the total number of physicians you’ve been in contact with?

We’re in contact, obviously, with most physicians. But I think the sort of priority focus has sort of been targeted on the top sort of 5,000 to 6,000 physicians in the first phase.

This concludes today’s question-and-answer session. Mr. Thaxter, I’d like to turn the conference back to you for any additional or closing remarks.