Good morning everybody and welcome to the 2019 Full-Year Results for Indivior. I’ll take the forward looking statement as read and welcome you to join us for our presentation this morning. I will give a short overview and perspective on the performance of last year, then Mark Crossley, the Chief Financial Officer will take you through the detail of last year’s financials. We’re also joined by Javier Rodriguez, the Chief Legal Officer who will give us a legal update; and Christian Heidbreder, the Chief Scientific Officer who will take us through an R&D update and some of the scientific developments that we have. So, just a few thoughts on last year, clearly it was a very challenging year operationally for the business. We had some major challenges to deal with. With the arrival of the generic film and the federal indictment, and the streamlining of our organization that was necessary, but sometimes with strong teams and healthy cultures, adversity can be very unifying, and I think that we’re particularly proud of the resilience shown by the teams within our businesses across the year. So, a natural fact, we finished the year with having created a very strong foundation for the future. We made good progress on establishing the foundation for SUBLOCADE in the U.S. We met our financial targets. We put the foundation in place for growth and we began the development of our new promotional campaign to drive for the future. We were also in parallel able to launch PERSERIS, so we’re starting to deliver on our long-term strategy to diversify the net revenue streams. And while we were doing all of that of course, we continue to evaluate our compliance programs to make sure that our compliance management monitoring and training is appropriate for the evolving shape of…

Thank you Shaun and good morning everyone. Overall, we’re pleased with our 2019 financial results. The resilience of SUBOXONE Film along with the improvements we made to our cost structure put us in a position to raise our net revenue and net income guidance twice during the year. We’ve also maintained good capital stewardship with a cash balance of over $1 billion. As Shaun highlighted, we were able to use some of the benefit from our over performance to make incremental growth investments behind SUBLOCADE, notably our nationwide DTC campaign that you just saw an channel expansion behind organized health systems in the fourth quarter. Looking ahead, we will continue to maintain strong operational control over the business and make additional growth investments for SUBLOCADE, partially funded by the near-term resilience we continue to see in SUBOXONE Film, but before I get ahead of myself and into the details of 2020 guidance, let me first run down the results for the quarter and the year just past. Starting with net revenues, we saw a 22% decline in 2019 versus the prior year. While overall net revenue performance outperformed our expectations. It nevertheless declined versus the prior year, mainly due to unexpected, excuse me expected brand film share loss post the generic entry last February, albeit at rates in less than the analogues. The loss of share was partially offset by strong underlying BMAT market growth in the low double-digit range and by 72 million of net revenue from SUBLOCADE, as well as contribution from the authorized generic film product until its discontinuation in the fourth quarter. Looking at the fourth quarter, the 44% decline versus the prior year was steeper than in previous quarters largely driven by two one-off impacts. As discussed at the Q3 earnings, the impact of the…

Thanks Mark and good morning everyone. I’ll provide a few brief updates on legal matters since our last release in Q4. First in the Department of Justice case on November 14, the court denied Indivior's motion to dismiss the original indictment. Following that the DOJ filed a superseding indictment, which we have moved to dismiss on December 19 and that motion is still pending. And on January 29, the Department of Justice filed an application for post-indictment protective order seeking to prevent transactions in assets sought to be forfeited in the superseding indictment transactions not in the ordinary course of business and transactions of more than $1 million without prior court approval. The application also seeks to require Indivior to maintain $438 million in a financial account and other relief. Indivior will oppose that application by the Department of Justice. In the Van Dorp securities litigation, Indivior and the individual defendants have moved to dismiss the lawsuit that was filed on November 29. The motion is the spending and briefing is scheduled to be completed on February 27. Finally, regarding the ongoing SUBOXONE Film and the lawsuits, we’re pleased to announce that Indivior settled its case against Aveva Drug Delivery Systems on December 18. The terms of that settlement are confidential, and finally in light of the claim construction hearing on the 305 patent in the cases against Dr. Reddy's Laboratories and Alvogen Pine Brook Indivior entered into a stipulated order and judgment of non-infringement with the defendants, and so the lawsuits are proceeding on the basis that these defendants are infringing the 454 patent. That’s my summary and with that I will turn it over to Christian for an R&D update. Thank you.

Thank you Javier and good morning everyone. I will now spend a few minutes to update you on R&D activities starting with the strategic pillars to support SUBLOCADE in the U.S. The first two pillars are related to post-marketing requirements and post-marketing commitments following approval of SUBLOCADE in the U.S. back in November 2017. These requirements are mainly related to demonstrating the rapid induction of treatment with SUBLOCADE, as well as the characterization of patient subpopulations who may benefit from the highest maintenance dose of SUBLOCADE of 300 milligram. We also had few post-marketing requirements related to characterization of NMP safety and NMP is the solvent in our foundation. These are nonclinical studies. The clinical studies are on track and on their way. The nonclinical studies have already been submitted to the FDA back in 2018, and are currently under review. The commitments have all been approved by the FDA actually last Monday, February 10. So, we are currently working with the FDA to finalize a quality language in the U.S. labor. The third pillar is related to additional studies to demonstrate the clinical safety of SUBLOCADE. This is a study that we call the PK/UDS, Urine Drug Screen. It aims at determining the duration of the tactical levels of buprenorphine over extensive periods of time after association of treatment with SUBLOCADE which again with leads to a much better understanding for prescribers and patients. The fourth pillar is dedicated to evidence generation. So, of course we have our recover study. I’m very pleased to say that our recovery of 12 months data have been accepted for publication in the Journal of addiction medicine. So, keep an eye on this. It will probably be released over the next couple of months. To recover 24 months data where [quality control buyers]…

Okay. Thank you, Christian. I think a very compelling, you know, roll-out of new science and its new science that will drive this disease space and rightly so. I feel particularly proud as CEO that our vision and our strategies have remained unchanged for some time. Our ability to invest in our strategies of course has been impacted by external events, but our focus, our dedication and our commitment to the patient and to pioneer and innovate in this disease space remains very resilient and resolute. So, as we think about our business moving forwards, in the short-term, clearly the big challenge that we have to deal with is the current litigation overhangs, which we take very seriously and continue to work on through our legal advices. Internally and commercially, it's all about the depot technologies. These technologies really do transform treatments for patients as evidenced by all the new scientific data that is not only already emerged, but is in the pipeline to help drive further forwards. The U.S. will be the core market in the near term, and as we are successful, we will invest in the growth of our business, but we will also conserve the cash along the way. Our longer term aspiration remains unchanged. Our early-stage assets, we would like to bring into our pipeline as our affordability allows to continue to target the other addictions outside of opioid addiction. We will continue to diversify our business where possible, in the U.S. and outside of the U.S., and in the future, as our business starts to grow and SUBLOCADE picks up, so we will look to further M&A. So, that's it. Thank you very much for your participation and now we will take any Q&A.

It’s Max Herrmann from Stifel. Just a couple of questions to start, just trying to understand how – you’ve obviously had some positive experience in the fourth quarter from larger kind of contracts from your OHS customers. Just trying to understand the attitudes of the judiciary for kind of MAT therapy versus absence in kind of non-opioid rehab, which I think maybe preferred in the past, so just trying to understand how that’s being reflected.

Yes, there is an increasing willingness to embrace medication assisted treatment through the judicial systems, and this is something that is evolving as an area. I think that the injectable technologies give more permission because one of the great issues in the past is how do you manage the dosing; how do you manage – supervise, you know, daily dosing, whereas the injectable therapeutic class will give the opportunity to make progress there, and I think that is recognized. Although it’s not fully developed, it's a scenario that we are investing in and helping the policymakers think this through.

And then, just a question for Mark in terms the kind of I guess, COGS gross margin, can you kind of explain obviously your volumes went down significantly. I know there’s been some change in the accounting for revenues, but how did – how come the overall costs have gone up in 2019 and the gross margin, obviously guidance for 2020 is this kind of gross margin of low 80s [percent]?

Yes. So, I think there’s two things. One is like you're talking about the absolute value in Q4 being up over the period despite volumes being down. You have to recall, we had a significant number of shipments in the period associated with closing out our commitments, you know, to the authorized generics. So, volumes, period-over-period, you know, might not have changed as much as one might expect, Max, would be how I would think about that. And then, as we look to 2020, when we get into the actual going rate, you know, what we’re starting to see is we get share erosion. The share erosion is going to come in your most profitable channels, right. That’s where the broadest differences is in the discounts in the market, so we’ll have item – you know retention in more of the government channels with higher discounts and thus a gross margin so you’ve got both channel mix, and then, you’ve got, you know, your ex-U.S. businesses is a higher percentage of business and that comes with also a lower gross margin. So, it’s more of the mix within your revenue profile than it is any absolute major cost increases.

Alright, thanks.

Yes.

Hi, guys. It’s Paul Cuddon from Numis. Just wonder if you could elaborate on the resilience of SUBOXONE Film in 2019 and perhaps by private versus government channel share and any sort of anecdotes that you’re getting back from kind of major distributors over generic dosing and presentation of the Film?

So, as it goes to the resilience, you know, I think the thing to think about is the overall pricing environment with regards to the Film. When generics first came out, we were on a long-established sort of market, so the discounting that it had established through time in government channels and on just based on how the algorithm works year-to-year where anything above a cost-of-living adjustment sort of on that goes back into discounts, right. So, you have a heavily discounted product already. So, when the generics first hit the market, you know, the price differential isn't that large. And so, that adds to – when I talk about the pricing dynamic, that adds to the retention in the short-term for just economic reasons, right, for economic reasons. And then, you know, payers just didn't make decisions totally on economics in the period. We saw Alvogen head out of stock, you know, so there could be and we’re hearing there is a bit of continuity, but now that that’s stabilized out, we think the economics will eventually take on, on a going basis, and thus a reversion to the analogs is how we forecasted the business.

Okay. And then, secondly, before we lose the KPIs all together, if you could kind of talk through some of the healthcare professionals that are initiating treatment and just give us a sense of the mix of these uses of SUBLOCADE, have they been long-term data waved, are they kind of recent sort of waive physicians, and then extending that into the patients, the physician are treating more than five patients, is that a gain at the 275 waived physicians? Thank you.

Yes. We’re seeing a mix across all physicians who are both initiating and adopting. We are particularly pleased with the number of physicians who have adopted, and we’ve said previously that’s a number of physicians with five patients or more, and that’s up over 900 now. So, we’re pleased that as the positive experiences of the physician and the patient, you know, is encouraging more patients and more doctors to increase that penetration of use.

Thank you.

Hi, Harry Sephton from Jefferies. Just a few questions please. So, I appreciate you comment directly on the DOJ, but clearly, you’re preparing to go to trial in May. If you were to go to trial in May, would [indiscernible] for any new slow post that and also would that still be a possibility of you potentially reaching assessment even if you were to go to trial?

The case is scheduled to go for six or seven weeks, so, you know, I presume there would be a news flow on a regular basis leading up to the trial and during the course of it. And then, obviously, if we’ve gotten to a point where there was a ruling, there’d be news following that. And to your question on the potential for settlement, we’re always open to the settlement and are, you know, pursuing all avenues to try and resolve this case. So, that's always a possibility.

Okay, thank you. And then, on PERSERIS, it’s been in the market for a while now, so approximately or less waver here. What has been the feedback from the prescribing community on the product relative to some its competitors?

Yes. We have been very encouraged by the positive feedback we’ve had from those doctors that, you know, we’ve been able to do reach with our sort pilot [indiscernible] team. The feedback is positive. We’ve had recent market research data that shows that 34% of doctors who’ve experienced PERSERIS would use it as a first or second line treatment. We have had heavy demand for sampling, so we hope that, you know, as the sort of – as we move beyond the initial sampling trail and that will convert to net revenue and we’ll start to see net revenues build. What I think is important to recognize with PERSERIS is that we’ve been very successful in getting rapid penetration of parity coverage in over 80% of payer accounts. So, we have not seen any accounts sort of blocking us in favor of the competition. So, you know, as the prescriber experience build and patients share their experience, and so, we expect that we will see modest growth in PERSERIS across this year.

That’s really helpful, thank you. And then, just on SUBLOCADE, I know, you just said you got a 5% price increase on the list price earlier this year. Do you envisage a comparable increase in net price? Would you expect rebating is going to increase for that product over the year?

It's because of the significant portion that's associated with government channels that has the same price protection. So, you’d expect kind of 50% to 60% of that kind of flowing through.

Okay, thank you.

Yes.

Rohit [indiscernible], I’m a shareholder and I have few questions all based on how Indivior is doing this morning before start of this presentation in the stock market. It's again, you know, about 19% fall and it has made on to the Top 3 losers of the day so far. So, I'm just wondering like how you are or will be planning to build confidence among the shareholders? Second, I see you have quite a lot of cash at the moment and we, as a shareholder, I mean to say, look forward to having dividends being declared, but you like reported loss, and you are projected to make loss again in the next financial year as well, so I don’t know I mean I am just looking for few answer so that I can decide whether to stay as long term with Indivior or, you know, what I'm saying. So, other question is, do you see Indivior hitting like [EUR2] again in near future? Currently its [39p – about 39p] before start of this presentation, and I believe that you have kind of a amount if there’s any like legal cost or settlement cost, now do we have any kind of up in the air figure what settlement cost currently if any is being informally or formally whatever being told to Indivior, is any – that kind of information available for us, shareholders? So, there are like three, four questions I’m trying to get answer for.

Okay.

So, yes, that's about it. Thank you.

Okay. So, with respect to shareholder confidence, we always share very transparently what’s going on in the business. We have a clear vision. We have a clear strategy and we report regularly and take the opportunity such as this to answer questions from shareholders on how we’re progressing on the implementation of the strategy and what the financial progress is. So, that's what we can do and to deliver performance, deliver on our objectives and our commitments and we will continue to do that. With respect to what might the share price be in the future, of course, I can't possibly predict what the share price will be in the future. You know that’s something for the market to determine as we continue to make progress. With respect to the cash position and the cash holding, Mark, would you like to?

Sure. I think it ties in with regards to both your comments on the reported loss and the cash and the provision. Obviously, we’re in a transition period, right. The Film revenues are dropping off and SUBLOCADE and PERSERIS are up ticking and we’re securing investment, which are leading to a short-term period with a loss this year, but it's helping secure the growth to the billion dollar franchise and those investments, we believe, are necessary and will drive us towards that sustainable franchise. The cash and our capital structure of keeping the debt in place, we think is the appropriate balance of flexibility for the long-term interest of shareholders and other stakeholders and the provision, which we kept in place at 438 million, continues to be in line with IFRS kind of our best estimate, so thank you.

[Indiscernible] we are aware of like, you have about [400,000 or 600,000] I don’t remember the exact figure that…

That’s the provision of the [multiple speakers].

Yes, yes, yes. But anything we know like why [indiscernible] will be able to cover, I mean, I know it’s going to be…

There’s n o update to the [indiscernible] we can’t speak to ongoing discussions and the litigation coming up. We have a provision for 438 million.

Just a couple of follow-up questions, firstly just on the authorized generics, you obviously mentioned one of the reasons for the high costs and the – and cost of goods in the fourth quarter was larger shipments two Sandoz. Now just that they still have products and prescriptions going through in the market, you – do you have an idea of where their inventory is and how long – much longer we may see kind of them being able supply the full market? Because I’m surprised at how [indiscernible] last for. And then, the second question is on you mentioned some of the litigation that I think the DOJ, if I understood correctly was trying to prevent you from doing in ordinary course of business any sort of transaction over $1 million. Just wanted to get a little bit more understanding of how that restricts you in terms of, you know if you wanted to in-license something would that be prohibitive for that if it was more than $1 million things like that?

So, let me maybe take a first cut and then we can have Javier add in this as necessary. I think with regards to the authorized generics, obviously, we've done our best to help close out that relationship in a good fashion and help them meet their contractual arrangements with their customers. That will lead to some share or some inventory in stock that they have bleeding through throughout 2020. Exactly, how much that is that's for you to ask Sandoz about and how long they think that'll be, but you’ve seen the shares and where those are. Those are readily available in IMS so. As it relates to the motion, I think listen, the motion is just that a motion. You know, we will object to that motion in court and we’ll see where that comes out, so it's hard to speculate on that right now, Max, with regards to the impacts, the ranges, there will be a lot of details that come out as that get put before the judge.

But if the basic motion that they’re trying to get is even in the ordinary course of business, you wouldn’t be able to enter a contract that was over $1 million where let’s say you want to license something in for $2 million.

Yes, again, I think there's a lot of details on the specificity of the motion that will play out. I mean they’ve – you’ve seen the public where they’ve asked for I think a court approval on $1 million, right. So, we'll see where that goes.

Okay, thank you.

Hi, I’m just curious if there’s anything to learn both SUBLOCADE and I think the competition on the long-acting cameras are now approved in Australia, is that correct? But I'm not sure whether they are both being launched or like what states – states of commercialization wherein in Australia, and if they are, is there anything to learn from that market in the context obviously those guys coming in at the end of this year in the U.S.?

So, regarding, ready for market entry in Australia. So, I think what, as I think is through. I think what’s the big win here. The big win here is for public health and for patients. The big win is the 85% of patients who are not in treatment, particularly in the U.S. You asked about the impact in the U.S., I think the emergence of a new therapeutic class of injectable products has to be good for public health. It has to be in the best interest of patients. It has to be in best interests of evolving the disease space. so you'd hope that if there are two companies driving and advocating for expanding access for treatment, two companies out driving the medication as to a treatment agenda, there will be a lot of growth in the – you know and penetration of the untreated – the treated percentage of the total patient population. So, it should be good for public health and I would imagine that targeting the patients who are not in treatment would be the way to go.

Okay. Well thank you very much indeed for your time, attention, and support and we look forward to seeing you through the year. Thank you.