Welcome to our First Half Results Presentation at Indivior. My name is Shaun Thaxter. I'm the CEO and I look forward to hosting today's presentation. I will take it as read that you've read the forward-looking statements. We'd just like to walk you through the agenda for today's presentation. I will give an overview of the performance in the first half and then take a deep dive into some of the SUBLOCADE, our KPIs and then appreciate the good progress that we're making there and also take a look at the launch of PERSERIS and how that's progressing. Then Mark Crossley, our Chief Financial and Operations Officer will take a deeper look into the financials. And that will be followed by a legal update from our Chief Legal Officer, Javier Rodriguez. So I will warn you that under the advice of Legal Counsel, all we're able to say on the DOJ matter is that we are preparing for trial and we're not able to disclose any additional details. Christian will share some of the progress that's been made in R&D this year and there's some really exciting new science that has come out. So I think we'll all look forward to that. So starting with the financial performance in the first half, we saw declining revenues. It wasn't a surprise that revenues would come down of course because of the launch of the generics in the first quarter. What is the surprise however is just how well the SUBOXONE Film share has held up and the strong performance of the authorized generic. So this led to sort of better-than-expected revenues during the first half. Although declining, we exercised strong discipline over our cost base and through our savings programs that you know all about. We're able to deliver profit in…

Thanks, Shaun, and good morning everyone. Overall, second quarter financial performance mirrored that of the first quarter, resulting in half year results that were ahead of our expectations. The slower-than-expected erosion of SUBOXONE Film versus analogs, along with continued benefits from operating cost reductions, resulted in a small increase in operating profit and net income versus the comparable period a year ago. Now as we think to the second half of 2019, the cost savings benefits will start to wash through year-on-year comparisons. In addition, given we're just five months into the launch of generic film and the market is not stabilized, we're prudently assuming an accelerated rate of share erosion for SUBOXONE Film toward observed analogs in Q4 and therefore further net revenue decline. We confirm our OpEx guidance for which there will be some incremental phasing, primarily planned legal activity and marketing investments in the back half of the year. Please consider these factors in your modeling. Taking a closer look at the income statement. There were no real surprises. Starting with net revenue. The overall decline in both periods largely reflects the decline in U.S. net revenue from SUBOXONE Film. In Q2, we had a full quarter of generic impact, resulting in a 24% decline in U.S. net revenue. SUBOXONE Film share declined a further 13 points from 40% at the end of the first quarter to 27% at the end of the second quarter and Film share now stands at 27%. The decline in the U.S. Film business was partially offset by SUBLOCADE net revenue of $17 million in the quarter and by a good contribution from the authorized film generic marketed by Sandoz, which continued to lead the generic category with an exit share of 49%. Additionally, the quarter results were flat at approximately five…

Thank you, Mark. Good day and welcome everyone. With respect to the Department of Justice matter, Indivior filed a motion to dismiss the indictment with the court on July 19. Subject to change pending the outcome of this motion, trial is set for seven weeks scheduled to begin on May 11, 2020. As Shaun has previously stated the company is diligently preparing for trial. However as the DOJ received the protective order from the court that limits our ability to discuss this case publicly, we direct you to the public docket for any other information regarding this matter. Turning now to ANDA litigation, On July 12 the Court of Appeals for the Federal Circuit affirmed the earlier judgments of the District Court for the District of Delaware involving Dr. Reddy's Alvogen and Actavis. Specifically in a 2:1 majority ruling, the CAFC held that the asserted claims of the '514 and 150 patents are valid that DRL and Alvogen do not infringe the asserted claims of those patents, and that Actavis doesn't fringe the asserted claims of the '514 patent. This CAFC ruling maintains the status quo in the market as both DRL and Alvogen have previously launched the generic products at risk pending resolution of the outstanding district court litigation in the District of New Jersey on the 305 and 454 patents. Importantly, this ruling by the CAFC has affirmed the enjoinment of launch by Actavis until the expiry of the '514 patent in April 2024. As to DRL and Alvogen, Indivior is currently assessing with external counsel possible evidence to appeal the CAFC's ruling. Finally turning to Braeburn, on April 9, Braeburn sued the FDA in the U.S. District Court for the District of Columbia and asked the court to vacate the FDA's decision that SUBLOCADE's three-year exclusivity, bars…

Thank you, Javier, and good morning, everyone. Let me start with highlighting some of the strategic pillars and strategic priorities in the R&D organization true to our vision and mission. There are basically six main pillars in that strategy. The first one is what I would refer to as the business continuity. It is important to us to make sure that we have the appropriate resources allocated to maintaining valid licenses for all marketed products globally support all the supply activities, and of course managing our risk evaluation and management strategy. The second one is to now expand the treatment with SUBLOCADE beyond the marketed product that is in the U.S., Australia and Malaysia. We have filed a series of regulatory dossier, and we are currently responding to queries from the wide range of regulatory agencies in Canada, Europe, Israel and New Zealand. And with respect to SUBOXONE tablet in China, we are currently working on the technical transfer to Pukang Pharmaceuticals. The third pillar, and of course one of the main focus right now is what can we do in the R&D organization to support SUBLOCADE in the U.S. As you know, we have a series of post-marketing requirement studies. All these are currently on track. We have post-marketing commitments as well. These are on track. Life cycle evidence generation and optimization studies, I will give you an update on all these studies in a few minutes. The RECOVER study, we had our last patient in the 24-month time point in March this year, and we are expecting the final report on that study in December. We are performing some additional drug optimization work. And of course, we are sharing the science of SUBLOCADE in a wide range of peer-reviewed publications and conference presentations. The fourth pillar is with…

So, thank you Christian. So, what I think is very clear at Indivior is that we're making good strategic progress on our commitments to patients to the disease space and of course to you our shareholders. We see that the innovation the commitment to leadership and scientific advancement and understanding is really progressing at a very impressive rate. The number of publications and new scientific understanding and discovery is something that makes me incredibly proud as CEO of this company. We're seeing that our go-to-market capability that so many people have valued and invested in over the years is really starting to deliver on SUBLOCADE with the improvements in all the payor the logistics. We've really started to make some good progress there. Still we have to continue to work on the trial and the induction so that we can start to accelerate our growth rate to make sure that the financial profile of the company rewards those of you who've invested in our strategy and have confidence in our team. So, we continue to focus on that and look forward to updating you in the future. So, on the back of that I'll be happy to take any questions.

Hi, it's Harry Sephton from Jefferies. I just have a few questions please. I'll start with two on SUBLOCADE. Firstly, you've reiterated guidance $50 million to $70 million despite some quite strong sequential growth in the second quarter of $6 million. Does that mean that you expect sequential growth to slow into the second half of the year? And if so why? Secondly, are you currently occurring any SUBLOCADE rebates? What I really want to understand is if any of those SUBLOCADE rebates can potentially offset some of the maturing rebates that you're getting from the drop-off in SUBOXONE Film share? Thank you.

So, I'll answer the first one and give the second question to Mark. No, we're very pleased with the continued progress on SUBLOCADE and we don't expect things to slow down in the second half. And as we've said previously that we are very comfortable that we are tracking within our guidance.

And Harry as it pertains to the discounting with the Film versus SUBLOCADE, obviously, the Film is in a very mature cycle as it pertains to the rebates as we move towards SUBLOCADE it's had its infancy. So, we kind of have had the mandatory 23.1% government rebate that's out there with anything that flows through the government accounts. And then we've talked about while we don't disclose our gross to net on these assets we have talked about some minimal rebating as we look to take down the arduous sort of prior us that were affecting SUBLOCADE in year one. So, there's some minimal rebating there but so different sort of quantification. It will offset but relatively small.

I also had just two questions on the legal front. On the SUBLOCADE exclusivity if you were to appeal the decision from the court, would that delay any FDA decision on the potential approval or the final approval if that were the case of a Brixadi launch?

Yes, believe so. Although it's not clear what impact FDA's decision to appeal or not would have on that.

Okay. Thank you. And just a quick clarification question. Can you remind us what the timing around the 305 and 454 patent appeal is?

So, we don't have an appeal on the 305, 454. Those are district court cases. So, we don't have a trial date set yet, but the claims constructions -- hearing on claims construction is scheduled for October. But we don't have a trial date set yet. We expect it will be sometime in second half of 2020.

Great. Thank you.

It's Max Herrmann from Stifel. Three questions if I may. Firstly, just on SUBLOCADE. I guess, a similar question I've asked before, just in terms of the inflection point that you've talked about in the past. How do you see that now going forward? Do you still expect at some point that the momentum and the understanding of the product will get to a level where you'll start to see acceleration in the adoption? Secondly, just on PERSERIS, just I know it's early days, but wondered whether you're getting patients who are switching from risperidone tablets dailies or you're getting patients, new patients or is it coming from patients from Risperdal Consta? And then finally, just I know there's some ongoing discussion about whether SUBLOCADE enjoys orphan drug designation and may get exclusivity based on Subutex and back of that get an orphan drug status.

So yes, obviously we're pleased with the progress on SUBLOCADE. And we continue to expect that at some point there will be an inflection in the future. I don't know when that will be but clearly we feel confident that we continue to make good progress as demonstrated by the KPIs. With respect to PERSERIS, we don't have a great deal of information on where those scripts are coming from or I don't have it to hand right now. So we'd be glad to come back to you on that. And the third question just remind me Max.

It was orphan drug...

The orphan drug status yes. Yes at the moment once orphan drug status is granted then it remains with the molecule. So buprenorphine does have and our products do have orphan drug status. But at the moment, we don't have a period of exclusivity that's confirmed. That's something the FDA are looking at, at the moment.

Hi, it's Christian Glennie with Stifel as well. Just on SUBOXONE and the Film and the slower-than-expected erosion. Have you've been able to identify any particular reasons for that slower-than-expected decline and therefore any reasons why it would -- could go to that accelerate as you'd say would go to more dramatic erosion rates towards the end of this year. Any reason why particularly it would then change?

Yes. So we haven't been able to identify any sort of strategically sustainable reason as to why we are seeing this sort of outperformance of industry analogs. So in the absence of any reason why it would be different, our belief is that it will actually return to the analog. So this is really a sort of discussion about the area under the curve or the area above the curve depending which line you're looking at. We think that we will end up with that 90% erosion that we will migrate back towards then. We're very grateful and appreciative for the overperformance that we're seeing in the near term. But no evidence that suggests that this is going to be sustainable. So you form your own view as to how many weeks or months we think this phenomenon might continue for. We don't know obviously. There will be some momentum moving forward from here but we expect to be back at analogs around before the end of the year.

Thank you. And then just a follow-up on the SUBLOCADE retention rates that chart with the movement by month. I don't know what the sort of background data in terms of patient numbers is behind that? Is that do you think a fair reflection of the current retention rate? Or any reason why as you get more patient data in there that it might deviate from those sort of levels?

No, I think obviously the data is robust. So yes, it does reflect reality. We're not 100% sure exactly what the majority of the patient profile looks like in that population. So we'll have to wait and see as the data comes in as to how that evolves and how it impacts the retention rates. But certainly, I think that these are good retention rates than what we expected. That's what we saw in the Phase III studies. So we're encouraged with the results that we're seeing.

Okay. Well there being no further questions, thank you very much indeed for your attention. And we look forward to seeing you in all the usual places at conferences and our quarterly presentations moving forward. Thank you.