Okay. Good morning, everyone, and I wish you all a warm welcome to our 2016 results presentation as we continue on our journey towards our vision of ensuring that all patients around the world receive high-quality treatment for the chronic relapsing disease of addiction. My name is Shaun Thaxter, I’m the CEO of Indivior, and very pleased to have the opportunity to take you through our business today. I’ll assume that you’ve read the forward-looking statement. And I will just take you through the agenda for the day. I’m going to make some opening remarks commenting on the performance of the business last year. Then Mark Crossley, our new Chief Financial Officer will introduce himself and take us through the financials. That will be followed by Javier and Christian who will take us through the litigation and the pipeline. And then, I will come back and close out talking about the future and share our thoughts on our guidance. So, obviously, a very positive year; very pleased to see all those pluses down the financial profile. I will make few comments about the operational performance as we delivered our first year of growth in quite some time. Market growth continues in single-digit percentage. So, we’re very pleased that the underlying market continues to be strong with more patients coming forward to access treatment. Our market share held up very well. And we’re very pleased with our litigation performance with respect to the generic film, and we have positive progress in our court cases across the year. We continued to enhance our compliance programs to make sure that we keep pace with the growth in the market. Not only that but we made tremendous progress on our pipeline, positive efficacy and safety results on our buprenorphine once-a-month depot and good progress…

Thanks, Shaun. Good afternoon. I’m Mark Crossley and I’m delighted to be here today to present Indivior’s financial results for 2016. Shortly, I’ll provide the financial review focusing on the key drivers of our performance, which, as anticipated, parallel very nicely with Shaun’s review of results in the market. But, before I do, given this is my first set of results, I wanted to take a moment to provide you a little bit more color on my experience and my background. I’ve been with Indivior for about five years, initially joining the Company as the FD prior to the demerger, after a 13-year career at Procter & Gamble. I headed up the demerger from RB. So, I have a very good understanding of the systems, the processes, the people across the Company, and more importantly, the finance function. In addition to which in 2014 at the time of the demerger, I took on the role of Chief Strategy Officer and was focused on developing, setting and operationalizing the strategy for the standalone company. So with that, let’s turn to the financials, and we’ll start with the profit and loss statement. As we do each time, we show the profit and loss statement on two bases, the first is reported with exceptional items and second shows the adjusted P&L, which removes the exceptional items on both 2016 and the base period. I’m going to come back to the exceptional items in a moment, but as you’ll see noted, the exceptional cost in 2016 in both cost of sales at about $11 million, and SD&A of $227 million and the $19 million credit in the tax line. Taking a look at the revenues, we recorded a 4% increase in revenues to 1,058 million, which resulted in an operating profit all in of…

Thank you, Mark, and good afternoon, everyone. My name is Javier Rodriguez, Chief Legal Officer for Indivior PLC. The next series of slides are excerpts taken from our year-end results press release. And if you haven’t done so yet, I encourage you all to read the press release for a full description of these matters and associated disclosures. For purpose of this presentation, what I’m going to do is walk you through developments that have transpired since our Q3 results press release in November. So, starting with the Department of Justice investigation. The federal criminal grand jury investigation of Indivior is continuing, as are our discussions with the Department of Justice about a possible resolution of the investigation. As Shaun discussed previously, we don’t know if we will reach a resolution with the Department of Justice or what the ultimate cost of a resolution with the Department of Justice might be on this and other matters with other parties. While these discussions are taking place, we are continuing to cooperate fully with the investigation. With respect to the two state subpoenas that we received last fall from the states of Connecticut and California, we’re responding to the subpoena requests and continuing to cooperate in these investigations. With respect to the Federal Trade Commission investigation, on February 3rd of this year, the Special Master was appointed by the judge to evaluate issues related to legal privilege, release the report and recommendation in connection with the description of documents in our privilege log. We are evaluating the report and we’ll be submitting a response to the Special Master’s findings on February 24th. Thereafter, the judge will issue his ruling whether and to what extent to adopt the Special Master’s recommendations. With respect to the antitrust litigation, discovery in that matter is continuing.…

Thank you, Javier. Good morning, everyone. My name is Christian Heidbreder, Chief Scientific Officer at Indivior. And I will take 10-15 minutes now to give you the various updates on the pipeline. First, opioid use disorder. There were two main clusters of activities in 2016, first, geographical expansion of the SUBOXONE tablet, with two main filings, one to file a supplemental NDS to Health Canada for two additional dosage strengths of 12 and 16 milligram in addition to the existing 2 and 8 milligram; and then of course as planned, the NDA submission to the Chinese FDA for the SUBOXONE tablet that was achieved on the 27th of December. The NDA has been accepted by the Chinese FDA and the review started immediately after the Chinese holidays, the first week of February. Second big series of activities is of course directly related to our monthly buprenorphine RBP-6000 with the series of activities in preparation of the NDA submission. First, as you know, we released the top line results of the Phase 3 pivotal clinical safety and efficacy trial in the middle of August. As we speak, we are going over additional data analysis and interpretation. You may remember that in the context of the trial, we collected a significant amount of pharmacokinetic samples in order to prepare a very thorough pharmacokinetic, pharmacodynamic receptor occupancy model to link the pharmacokinetics to the clinical efficacy and safety. This work is currently ongoing. The second Phase 3 trial is the long-term safety extension study to really assess the clinical efficacy and safety of RBP-6000 over a 12-month period. The database for that trial was locked at the end of October. And again, we are going through a very thorough data analysis as we speak. There were also two trials that are not required…

Well, thank you very much, Christian. And congratulations to you and your team on the tremendous progress that you made with our core potential assets in the pipeline mix shift. So, as always, we look forward to future with enthusiasm. And I just want to take you through what the key priorities are now for the year ahead. Clearly, we have two big risks that we are working through at the moment, and we’d like to get to the other side of those and sort of secure long-term certainty for the business. Our first priority of course is to maintain the resilience in the performance of our core business and on top of that to then progress towards NDA submission and hopefully approval of our two key once-a-month injectible potential pipeline assets. We’ll continue our work to reach out to and expand access to treatment around the world, focusing predominantly in the U.S. of course to help optimize the opportunity -- the new opportunity for treatment for patients following the regulatory and legislative changes in the U.S. Elsewhere, we’ll continue our good work in Europe and progress the NDA submission in China. We will also continue to prepare for business development and M&A beyond our core business. And obviously, we’ll have much greater opportunity on this, once we’ve got the other side of our two key risks. So, that leads us to our guidance for 2017. So, our guidance is at constant exchange and excludes exceptional items. You can see the net revenue is $1,050 million to a $1,080 million with net income $200 million to $220 million. As we would expect, this is assuming no material change in the current market conditions, so it does include an assumption that we will win the ANDA litigation; there won’t be any…

Max Herrmann from Stifel, just a couple of questions. Firstly on RBP-6000, just trying to get a little bit more detail on where the IP for that is held, and trying to get a feel for the potential longer term tax consequences of that; and also patent expiry and sort of what time horizon we can expect for the product? And then also you alluded to the ex-U.S. filing; you’ve had discussions with regulators around the globe. You’ve talked about, I believe, or Christian mentioned a filing outside the U.S. before the end of 2017, just wanted confirmation what territories that was? And then just in terms of your expectations on RBP-6000, I wondered how you’ve factored in potential competitive threats for that particularly with the Camurus 2038 product is well out there. And then finally just in terms of -- I know that these are preliminary results and you haven’t had the formal audit, but understanding the way the process works, they’ve obviously reviewed -- the auditors have obviously reviewed your provision for the litigation charges and deemed that adequate. Otherwise, they would have increased that necessary provision. So, I was just trying to understand what the reason is for the clear emphasis on the litigation potentially being a higher than the 220? Thanks.

Okay. So, shall we take those in sequence? Mark, would you like to address the first question, please?

Sure. With regards to RBP-6000, the IP will be held in the UK. So, a little bit of tax out there with regards to the planning. I think the ex-U.S. filings, you’ve heard correctly from Christian. We’re looking to engage and build off of positive results with the U.S. filing and are rushing towards the completion of that by the end of the year. I think about that is as the EU-5 and Australia is how we think about it, and Canada. And then, with regards to the guidance on RBP-6000, yes, we have built into that the competition in the market that we’re expecting through into the peak sales. Shaun, do you want to handle the provision?

Yes, on the legal. Why emphasize the legal, we just want to be transparent and balanced to make sure that we give you a presentation that has that balance of the positive elements for the future as well as the risk. This is the latest language that will be given by our lawyers to give you as much transparency as possible. So, that’s why we wanted to share it with you today.

Hi. Matthew Cook, Bank of America Merrill Lynch. Thanks for the questions. Just on U.S. Suboxone pricing. You mentioned that it’s kind of stable in the generic side of the market, but branded compared to reduced discounting. Within your guidance, how much is baked into potentially more aggressive tactics into 2017 as they’ve not been able to gain any market share there? And then secondly on RBP-6000 guidance, you gave -- you’ve updated the peak sales, but you’ve given that you expect a slower launch trajectory. And could you just give us a feeling of when you are expecting to reach peak sales and how that ties in with the potential generic SUBOXONE Film patent expiry, if that comes to the market? And then, just a final on the China opportunity, the tablets, and the 6000 opportunity in Europe, how much infrastructure will you need to build that, and should we think of a similar cost that you’ve put into the U.S. that you just announced? Thanks.

Do you want to take the first question?

Sure. So, with regards to the pricing environment, we think through 2017 what we talked about is not having mass pricing with regards to the generic tablets in the U.S. but continuing to see some downward pressure on those requiring some tactical rebates on our side. Shaun mentioned during his discussion on the market dynamics that in 2016, we had some wins on some formularies to offset some of the losses. What we’re expecting kind of in the year ahead is we don’t see the wins out there because we have very, very good access. And what we see is another branded competitor that’s starting to ramp up on probuphine. And we see this a little bit more pricing pressure with the addition of two more generic competitors, Sun and Lannett who’ve been approved in Q4 and should launch within a year. So that’s the way we’ve looked at the dynamic. With regards to the 6000 guidance, the slower launch should pick up we said. And if the generic of SUBOXONE Film comes in, the label for RBP-6000 will be based on new starts. So, the way the label’s constructed, we don’t see that as a major impact with regards to the share. It’s a new transformational asset with regards to the treatment, new science and we’re expecting to get a fair share of the market, regardless of what the component is of the generic film. And then, 6000 in Europe, obviously, it’ll be a little bit a smaller market. There will be some go-to-market investment. We’ve got a little of that built in to the RBP-6000 spend this year, and we’ll be getting more clarification on that in the year ahead as we look through that.

Hi, thanks. It’s James Vane-Tempest from Jefferies, just three questions if I can, please. Firstly, just on your R&D budget, clearly went down 10% last year. How should we think about the evolution of that over the next years, given some of your projects? And secondly, in the presentation, Mark, you alluded to capital allocation, wanting to have some of the litigation kind of resolved. There is a number of issues outstanding which need to be resolved. So, are there sort of 1 or 2, which I guess you’d like to have resolved first before starting work? [Ph] And press release clearly says no intention for dividends for the foreseeable future. So, how should we think about capital allocation? And then my final question is, I guess I was interested in the timing to change the guidance for the depot today, given the Dr. Reddy’s trial results seem to be in next couple of months possibly. So, if that was to go against you in terms of thinking about potential pricing impact to the overall franchise and then the value proposition of the film, could we see that more than $1 billion number be resolved or how should we think about that? Thank you.

So, I think from an R&D budget standpoint, next from the guidance in 2017, we think of that as about flat. We’ve got some completion payments on the big assets and some investments that are happening on AT and some of the exploratory work that we’re doing from a guidance beyond there. We’re going to be investing in our pipeline and looking to fill some of the vacancy on the early assets. Capital allocation, I think Shaun explained kind of our key overhangs. We’ve got an ANDA and we’ve got the DOJ work that’s going on. And those are kind of the two that we view as the key. And we’ll be looking at the capital allocation as we get through each of those and resolve and the circumstances that they’re resolved in and then looking at the short and the medium and the long term sort of capital allocation as I talked in the presentation. The timing with regards to the guidance on Dr. Reddy’s, I think I covered, one, it’s a transformative treatment. If you look at any sort of analog with regards to schizophrenia, there is a bifurcation in the pricing model between the oral and the analog acting, because of the value that’s recognized there. And so, the deal is that as I said, it’s for new starts, this asset, that’s what would be in the label. And so, we view it as it’s a different decision than a conversion which you would have seen on the tablet to film launch.

Paul Cuddon from Numis. On the revenue guidance for 2017, I think Shaun mentioned, you hadn’t started to see the impact from CARA Act and potentially 21st Century Cures Act yet. So, what are you kind of receiving for the benefit of the federal efforts for 2017? And how much flex do you have on your cost base on various levels of litigation provision? And then, $1 billion guidance, you must have an assumed pricing level and what might that be having had out of these set of those [ph] questions?

Okay, all good questions. So, with regards to our revenue guidance in 2017 CARA and Cures, those have been built-in from a high-single-digit, very low-double-digit sort of market growth, which is a little bit ahead of what we saw in 2016. The cost base on litigation, we don’t disclose that separately. You see the pace of the litigation and you can assume how much I think is within the SD&A. And on the $1 billion guidance, we’re not breaking up our various assumptions and filling up models for you. What we’ve done is given the top-line and updated the guidance we think to an appropriate level moving forward.

Hi. Sarah Thomas from Deutsche Bank. Firstly, just on the risperidone, you referenced in the press release 200 to 300, because the specific niche market that is invested. What is that niche market given potentially risperidone is potentially quite broad an achievement in schizophrenia? And then, on cocaine, what are the timelines from here to starting Phase 3, now that you’re running with the new formulation? And then perhaps on the litigation, what is your level of confidence as we head into the litigation ruling today versus where we were 12 months ago, heading into a similar litigation ruling, albeit the slight nuance in dried versus drying? [Ph] Thank you.

Okay. So first of all for the risperidone product, clearly this is once-a-month injectible. So, the niche here is for patients for whom a doctor once who gave risperidone would like to stay the patient on a monthly dosing interval. Clearly, we recognize there are some big players with good products in the schizophrenia market. We don’t anticipate to go up and take a leadership position in schizophrenia should we launch it ourselves. We are just clear. But there is a very real, very compelling group of doctors and patients for whom this technology and our market research is showing that there is a very strong level of appeal. Christian, do you want to…

RBP-8000, as I mentioned, we focus really on the development of lyophilized product in order to move to the next clinical development stages. The plan is then to meet again with the FDA, once this is done sometime in 2017 for a third type B meeting in order to define the remaining part of the clinical development plan. And we will then update the community at that point.

Okay. On the litigation front, we’ve always said that we believe that our patents are valid and forcible. And we have the track record of the first trial going in our favor. There was a change in claims construction in the Dr. Reddy’s case, given the limitation definition of dried and drying. That has since gone through further clarification in the Mylan Markman hearing. And while technically that only applies to the Markman case, a lot of those same arguments that resulted in that claims construction were before the judge at trial and will be reiterated in the post-trial briefing. So, I’d say our confidence level hasn’t really changed. We still think our patents are valid in forcible, but obviously, there is always inherent risk in litigation and difficult for us to predict outcomes.