Okay. Good morning everybody. And welcome to the Full Year Results for 2018 for Indivior. My name is Shaun Thaxter, I'm the Chief Executive Officer. And I'm looking forward today with my colleagues Mark Crossley, Chief Financial Officer; Javier Rodriguez, Chief Legal Officer; and Christian Heidbreder; Chief Scientific Officer to sharing with you the results from last year. Our plans for this year as we continue to pursue our journey towards our vision to ensure that patients all around the world have unrestricted access to evidence based treatments for the chronic relapsing conditions and the co-occurring disorders of addiction. I will assume that you've read the forward-looking statements and our agenda today is I will give an overview then Mark will give a financial report. We'll have a legal update and then we'll look at some new exciting scientific data and progress that's been made in our R&D and medical function last year. Well, clearly, 2018 was a challenging year with net revenues dropping from the prior year. This is reflecting two key drivers. First of all, the intensity of pressure on our SUBOXONE Film franchise in the U.S. from both the tablet sector which had a very downward effect on pricing and rebasing and from the film sector where we had a pulse of entry of generic product from Dr. Reddy's in the middle of last year. The second impact was obviously the SUBLOCADE got off to a slower than expected start, and I look forward to sharing with you the progress and the momentum that we're building on the SUBLOCADE. It is a tragedy that so many people continue to die from opioid overdose. The opioid epidemic continues to rage in America, but the silver lining for the cloud is that the environment, society's attitude, government legislation, regulation,…

Thanks, Shaun, and good morning everyone. I'll take you through the results for 2018 and then outline our guidance for 2019. So on the income statement, we're providing an overview of the fourth quarter and full year on an adjusted basis. As always, we’ve provided the full reconciliation in the appendix. Starting with the headline numbers, net revenue of a 1,005 million was in line with revised 2018 guidance of 990 to 1,020. With net income of 272 was up modestly from 2017 and ahead of our revised guidance of 230 to 250 million. Given the challenges to the top line, the net income line shows the interventions made in relations to our cost structure, reduced finance expense, and 10 point year-over-year improvement on our tax rate. Turning first to the top line. The overall dynamics for the ones we've been discussing throughout the year in short benefits from double digit volume growth in the U.S. our largest market were more than offset by a four percentage point decline in SUBOXONE Film show, mix impact of disproportionate growth in lower margin government channels and tactical rebating. Meanwhile, in the Rest of World, modest growth in Australia and Canada was essentially offset by austerity impacts and increasing competitive pressure in certain EU markets. If we look a little more in detail at the U.S., the strong overall market for us we're seeing is largely being driven by increased federal funding to address the opioid prices in the U.S. So the year-over-year growth in state and federal Medicaid programs was disproportionately higher in 2018 versus the total market growth rate. This funding has driven increase treatment capacity, which sets the stage for continued good growth in the U.S. be in that market moving forward. Within our U.S. performance, SUBLOCADE net revenue for…

Thank you Mark and good morning everyone. By way of update on legal matters, government investigations continue as do negotiations to resolve them and we continue in advanced discussions with the Department of Justice. Last week, certain Kentucky public health agencies filed suit against Indivior and several opioid pain product manufacturers, alleging misleading marketing practices in connection with the sale of opioid products in the U.S. This is the first of the national class-action opioid claims made against Indivior as part of a manufacturer group of dependence. We have not been served with the complaint, and it served we intend to vigorously defend ourselves. However, these coins if pursued, present civil liability risks for Indivior. Now, as you all know, on November 20th, the CAFC issued a decision vacating the preliminary injunction against the DRL. On December 20th, Indivior filed a petition for rehearing and rehearing en banc of the decision of the CFAC. And on February 4th, the CAFC denied the petition and ordered that the mandate issue on February 11th. The issuance of the mandate would allow DRL to enter the market on an at risk basis. In response to that decision on February 5th, Indivior filed an emerging or emergency motion to save a mandate, pending a decision on the appeal, the 514 patent and a decision by the Supreme Court on Indivior's forthcoming petition for certiorari. On February 11th, the CAFC denied that motion. So we immediately responded by filing with the CFAC and emergency motion to save a mandate pending resolution of the forthcoming application for an administrative state to the Supreme Court. Now that motion was also denied and the CFAC ordered that the mandate will issue on February 19. We believe and continue to believe in the validity and enforceability of our patents.…

Thank you, Javier, and good morning everyone. So, I will give you an update on the R&D activities starting with the early stage of development assets, and then of course, an update on where we are with R&D activities to support SUBLOCADE. So early stage asset development first an update on Arbaclofen Placarbil, over the last couple of years, it is very clear that we significantly improved the overall profile of Arbaclofen Placarbil through our clinical development and reformulation plans. That said there are some risks related to two main challenges either molecule, the variability and absorption on the one hand and then the enzyme converting Arbaclofen Placarbil into R-baclofen is probably more a freak in nature and these risks must be addressed before any further development. The development of Arbaclofen Placarbil for the indication of alcohol liver disease and cirrhosis has additional development hurdles. For example, extremely challenging patient recruitment for those who also a very high level of, not only morbidity in this very sick patients but mortality during the conduction of the trials. So together, if you look at risks and at the same time the need to refocus our R&D priorities, we've made the final recommendation to stop any further development of Arbaclofen Placarbil and rather we focus our skills towards the GABAB positive allosteric modulator family of molecules in the context of our collaboration with Addex Therapeutics. Talking about Addex Therapeutics collaboration and the lead molecule ADX71441, we unraveled some new risks directly linked to that particular molecule. So, we do not believe that this is a so-called class or issue. So we have no doubt about the validity of the molecular target that is the GABAB receptor. So the risk here is some seizure risks in a particular species that is the dog. That…

Thank you very much, Christian. Just tantalizingly teasing and whetting our appetites with some high level data and there's a tremendous amount of more data to come. So just to wrap things up, then where are we, we continue to invest in the same strategies and focus in the same areas as we have. Our vision remains unchanged. Our strategy remains the same, yes, because of some financial constraints we're having to narrow that strategy in some instances, but still focusing on the big growth drivers we've always believe and we see that we're starting to see some momentum in SUBLOCADE still not at the point of inflection but good progress being made. So we continue to build the resilience of our franchise, build the resilience of our assets, build the resilience of our capability as an organization. And in order to drive that through all the short term and medium term challenges that we have the resilience of our culture. And I'm very proud of a commitment, the agility and the passion that our employees still continue to show for our vision and how that translates into value creation for you as shareholders. We continue to develop our innovative pipeline by innovative pipeline of course we're really referring to the evidence space of the medicines. Our vision is to ensure that patients all around the world have unrestricted access to evidence based treatment. And it's that new evidence it's the new science that delivers on our commitment to pioneer treatment to help transform the lives of patients and that's what we do and we're going to see a lot more focus in SUBLOCADE study development. We continue to expand our global treatment. We've now against your patient for the first time opportunity to receive segments in China, which we're very proud I, our Rest of World business outside of the U.S. continues to be very resilient. We have very talented people out there advocating for patients every day and we see that this is still generating very good cash flow for us. We will selectively invest in target markets with SUBLOCADE and PERSERIS as we evaluate the opportunities and things that prudent to do so. And we continue to develop and fortify our business. We've maintained a very strong discipline across based business, our cash flows and our capital structure to ensure that whilst we protect from the downside scenarios, we do maintain and retain sufficient investments to deliver on the growth drivers that we've always been committed to. So thank you very much for participating. I'll thank my colleagues for their presentations and very happy to take questions.

It's Graham Parry from Bank of America Merrill Lynch. And a few probably more for Mark, actually, just trying to get, dig into the numbers a little bit here. So, on the cost allocation between the 414 million and 460 million for the year, could you help us understand the split between SG&A and R&D and potentially, if you can display the U.S. versus ex-U.S.? How much about cost is allocated specifically to SUBLOCADE? And essentially, I'm trying to do is help us workout what's the breakeven on SUBLOCADE? Should it not make your $1 billion target? And secondly, could you add a bit more color to the comment you made on the sales returns and rebate, the potential gross margin impacts from a generic launch on Monday, shouldn't come any mix differential you can help us with on SUBOXONE Film versus SUBLOCADE? And then thirdly, you have $721 million of trade payables and at the end of the year. Could you just help us understand the terms of those and the risk that they may post to cash?

I think that might have been more than three Graham. So let's talk through the 440 to 460. We don't break that out with regards to the U.S. Rest of World or how much is on SUBLOCADE versus the other portions of the business. So I respect to why you want to know that, but it's just not some level of granularity that we give at this time in way. I can say is that with the interventions we've made, and on both on the refi of debt, the pay down of the debt and these interventions, we feel we feel comfortable with regards to making it through the transition period with 250 million of cash and an ability to few SUBLOCADE and PERSERIS to drive growth in the out years. As it relates to sales, rebates and returns and move forward basis on the brand, I wouldn't see any real change with regards to those, the generics will come in. But the rebates will stay in place to keep our place on formulary. There has been a bit of a trend of tactical rebates moving forward, there could be some pressure there but nothing more we think than what we've experienced in recent years. Gross margin is a great question. I think what you'll see moving forward is that there is mix impact as we launched an authorized generic, which will be at a discount to brand but your absolute dollars per film will be the same so you can see a contraction there, it's a mix of there and our Rest of World business will be larger, we're pricing is at a discount. So I think, if you'd expect somewhere between depending on where that mix stands up. You could see high-single-digits erosion potentially in the gross margin five to high digits somewhere in that range. And I think the last one I had, and this is an answer more than three Graham, is the 724 of trade payables. And I think the key one in there that I would really draw your attention to is really the 510 that's on there in the rebates and the returns, that's the piece that will really potentially negatively impact working capital moving forward. And I think the way the way to think about that in your models is we will have a certain amount of net revenue erosion on the film business. I think a proportional amount of draw dropped in those tables associated with film because most of those our films as a small portion that's Rest of World 30 to 40 million or so. And then, you'll have a pickup of additional sort of working capital associated with SUBLOCADE and PERSERIS that would partially offset that. So I think if you work through where your revenue drop off is and think of it as generally proportional, I think you can get to a good spot.

Max Herrmann from Stifel. I've got four questions as well. Just one SUBLOCADE interested in understanding how many physicians that are doing the book-to-bill and whether that's an increasing element? How you mean encouragement just trying to understand whether doctors are putting in fridge is in the practices and you're seeing a change in, in that based on making themselves more accessible to SUBLOCADE? Secondly just on the target physicians. I know you were looking at about 6,000 high subscribers. I think 2430 and then you say have now prescribed, I'm just trying to understand, there's still a lot that happens from high prescribers is hard to understand given them high unmet medical needs in this area, why they haven't? And third question is just in terms of retention rates. I mean they're obviously continuing to decline from your study -- the RECOVER study, sort of implying that patients have been taken off treatment rather than that they're relaxing on to back into abuse habits. So just trying to understand, why that number is now I think 35% after six months? And then finally just RECOVER study going on to that again. It seems kind of my understanding was a patient's place to stay on treatment and those boundaries in the short length of time. Are they most likely to relapse into that sort of abuse treatment service sort of self-evident, sort of part of that study?

So, first of all, the fine bill segments of the market, yes, we do see this is something that is growing, the Q codes came in halfway through this year, and we see the development of that sector progressing. Clearly it's not something we can do is to go in and persuade doctors that they should buy and build and teach them how to do it. That's a very much a no go areas for us for compliance reasons, but nevertheless, it is a sector that red is growing. So, we are saying that building. We haven't broken it out or application specific numbers publically, but we see that improving. With respect to the target physicians, there's a number of things going on here. One of the challenges is, you know, the number of many physicians with a part of these IDN networks that we talked about earlier. So, there is quality development work to do there. Also our clinical specialist or clinical liaison have in spending a lot of time, helping doctors as they learn how to do this. And those doctors get up -- the current doctors get up to speed that will give them more time available to go and target the doctors who have not yet come into this disease space. And we do know that you get early adopters and people who kind of like a bit to see what everybody else is doing. And as they start to gather momentum, so there's doctor say more comfortable coming in. So we continue to work through the publications that we generate the advocacy of the new science or clinical conferences, and this will create some more supportive environment. We've also learned, as we've gone through the year, the more persuasive way to tell the story, we've…

No, just in addition to abstinence, which is, obviously, the focus here, I think, it's very important to look at all the other measurements that we took into account. That directly related to the quality of life but very importantly the employment tree for example, it becomes very clear that all the data converge to the same point. That is, if you have the chance to remain in treatment for longer periods of time, you basically recover your life. You are better participants in your community, you pay taxes, because you are employed, and there is a cascade of events. And this is why we call that study. It's all about recovering your life

It's Paul Cuddon from Numis. Just two questions for me, firstly building on sort of Max's question for the number of active prescribers. And kind of getting into sales force effectiveness here, there is a big pool of potential prescribers here. I'm asking myself questions as to what proportion of your sales force have previously sold more scientific, long acting sort of medications. Is that part of an issue here for clinical liaisons and for the reps and perhaps you can help me with that? Secondly, on the dynamics of the potential imminent generic film launch with tablets with likely SUBOXONE brand having kind of longer term value, I mean, how do you think about that the potential cannibalization and in light of Dr. Reddy’s kind of reported issues with the manufacturing film kind of presentation. Could it be a bit more resilient than we might fear?

Okay. So with respect to sales force effectiveness, we've had a very thoughtful, very careful, diligent approach to evaluating all of our sales people across the year last year. And yes, it is true that some of our people, salespeople, prove to be more effective in this new reality than others, where it’s the different prioritization of skills, it is a more specialist job, but it demands a slightly different approach. And you have some people that are very agile and they just figure out what's required and they kept their themselves and then you have the middle group of people that need a little bit of coaching and support and then they get there and then you've got the group of people who just really haven't made the transition and not likely to make the transition. So, we've evaluated all of our sales people and we did have a group of people that we have you know unfortunately had to say to those people that we’re really sorry. We really like you as people, you've done a great job, you’re being very passionate and committed to the vision. We're grateful for everything that you did. And you're one of the people that helped us get to where we are. And we don't believe that you're one of the people that's going to help us to get to where we need to be. So we have reengineered our sales force and thanked the people that we don't believe are going to be sufficiently effective in the future to deliver on the vision and for every employee in the Company, it's a great privilege to serve this vision and you stay and you do it for as long as you're able to help further the agenda and just for some people,…

It's Nick Nieland from Citi. Just on a couple of questions on PERSERIS please. So can you apply any of the learnings from the SUBLOCADE launch to smooth rollout with PERSERIS? And give that there's an existing long-acting antipsychotic market, we do expect the launch of a product to be faster than SUBLOCADE has been this year? And then I asked you to give us a bit of guidance for that product for 2019?

So first question what learning did we have. Well I think that the two markets are very different. And the SUBLOCADE, we are teaching doctors to do a whole new thing. And we know how difficult that can be. So, it makes sense without PERSERIS salesforce rather than to go out and try and recreate that experience in schizophrenia. Let's go to the doctors who are already very familiar with long-acting injectable technologies, doctor who know the processes that they already have the capability they've learned all the billing. We didn't have that choice and addiction, but we do in PERSERIS. So, we do have a salesforce with 50 people. So we don't have full national coverage with sales people. We have to exercise choices. We're very happy with the people that we've chosen. And so we will launch with that level of capability. You can ask me about the guidance, we haven't given guidance for PERSERIS. But what's different about the PERSERIS and SUBLOCADE is approaching we will be able to track the progress through IMS data. That IMS data is not available to SUBLOCADE and so why we want to show you KPIs, that's why we want to give you, it's not transparency as we're able to do. To help you because you do need to measure how things are going, but you can do that with PERSERIS through IMS sales data.

It's James Vane-Tempest from Jefferies. Just one question if I can please. And that is as you've given SUBLOCADE guidance. And I'm just curious what your assumption is for writing in the value proposition, if there is a contraction in the film price. How payers might view the relative differential between SUBLOCADE versus the film in your assumptions?

I mean, we obviously anticipated that, these pricing dynamics will come, when we set the price for SUBLOCADE. So it's not something we think about material impact. It's another reason why it's important to generate the health economic data, right, because we're not trying to justify the increase price versus film. We're trying to show that an absolute terms, this is tremendous economic value. And if we do this, right. No-one else will have comparable data. So you've made the decisions based off the data that we have.

I think schizophrenia is a great analog where there's been generics there a long time on the oral side, but yet the LAI side is growing at 25% on the value about half of that as volume, about half of that is price increases on per annum basis, so just one analog for you.

Just one follow-up, Graham Parry from Bank of America. And we touched a little bit more about the shift to the pharmacy benefit for the medical benefits as you've touched on PERSERIS, and how far through that are you was the perspective in pharmacy and healthcare practitioner administration to overcome a lot of teething issues that you've had around Specialty Pharmacy distribution, is this going to go all the way that way? And is it going to help drive inflection in the future do you think?

Yes, we've got a number of accounts that have expressed an interest in moving to the pharmacy benefit. We're working through that at the moment. And that's something that as we move through the year, we think that you know, coverage on the pharmacy benefit will start to build we haven't given any specific numbers around that. But, you know, that's together with the other measures we think will continue to filter yield, and we're very pleased with how the yield is progressing. We would obviously like it to be higher, but being realistic, we, you know, we're progressing well on that on that measure.

Max Herrmann from Stifel, again just in terms of patient retention is going back on to this issue about whether retention on SUBLOCADE and the film and the tablets. How much of that is from a physician trying to say, well, now you should abstain and try and get your life together with abstinence rather than buprenorphine or whether they're, these patients that are actually just stopping treatment entirely and just going back onto opioids? So I just, I mean, obviously…

I think it's largely driven by the patient or the patient's not coming back. But if you think of the pressure the patient is under, the patient is living in an environment where the expectation is you will stop taking your drugs as soon as you can, right. Well, okay, your street drugs to fill not necessarily your medicine, but in order to be able to advocate to the patient that you ought to stay on your medicine for a given period of time. You need the science and the evidence base to support that decision and to suggest that the right thing to do. So, I think as a broader holistic sort of environmental education and transition that needs to take place, because if you're at home and the people you're with are expecting you to stop taking your medicine, right. That's all putting pressure on you to say, okay, I think I can do this now without my medication. So, we need to really bottom out what the science is really telling us because we haven't absolutely got conclusive or anything we can really claim or say at the moment, but the indications are that there is a sort of 12 to 18 month time period that patients benefit from being in treatment. Once we can scientifically prove that then we can go out and share it with people and doctors have a basis for thinking all right, I lived most of my patients after two or three months. How can I as a physician now what can I do to try and keep them into treatment for longer because I know because of all this new science that if I keep them in for treatment for longer, I'm going to get better outcomes and that gives you…