Good day. And welcome to the Indivior’s First Quarter Results 2018 Conference Call. Today’s conference is being recorded. At this time, I would like to turn the conference over to Mr. Shaun Thaxter, CEO. Please go ahead, sir.

Good morning and good afternoon, everyone. I would like to welcome you to Indivior’s first quarter results call. My name is Shaun Thaxter, CEO and I am joined today by Mark Crossley, our CFO, Christian Heidbreder, our Chief Scientific Officer, as well as Javier Rodriguez, our Chief Legal Officer. As always, we appreciate your time and interest in Indivior. When we last reported in February, we were pleased to provide an outlook for another year of solid profitable growth in the business in 2018, together with the eminent launch of SUBLOCADE, our new treatment paradigm for opioid use disorder. Today, I'm pleased to confirm that our financial performance in the first quarter of 2018 leaves us on track to achieve our full year guidance and that our initial market reception to SUBLOCADE is very positive. I want to make three general comments about our performance and progress in the first quarter before handing it over to Mark to provide you with a few more details, after that as usual we will go to Q&A. My first comment is that our base of SUBOXONE business continues to be relatively resilient in a marketplace that continues to grow at a solid pace. Even in the phase of intensifying generic tablet competition and aggressive pricing from some branded competitors, our rapid share in the first quarter remained at 55%. And of course, we’ve continue to defend our intellectual property for this important product with the issuance and assertion of yet the third new patent, the 305 patents. This is an Orange Book listed patent which relates to certain polymer film compositions having a substantially uniform distribution of active drug. Secondly, while we're pleased with the SUBOXONE films performance because it fuels our company, we're very much focused on SUBLOCADE success. It's essentially been…

Thanks, John. I want to start up by highlighting that the market backdrop in our largest market the United States with 80% of net revenue remains very healthy with continued underlying growth in the low double-digit range. In addition to the regulatory measures that have taken effect to expand treatment capacity, overall public awareness of the epidemic in the U.S. has continued to grow. The number of health care providers are signing up to treat OUD, including physicians, nurse practitioners and physician assistants has continue to increase in the first quarter and thus far in the year the number of sign ups is outpacing 2017 levels. The dynamics we're experiencing in the US market continued in the first quarter, where positive market growth and low single digit net price improvements were more than offset by competitive pressures, channel mix impacts, as well as a one-off impact of higher destocking versus the base period. These dynamics in the U.S. are partially offset by the increase of the rest of world revenues which continue to benefit from strength in the Australian and Canadian markets, as well as FX benefits in the period. As a result, our total Q1 net revenues declined 4% to $255 million. As Shaun mentioned, we anticipated this topline performance for the quarter and are expecting the growth dynamic to reverse in the second half of the year, when SUBLOCADE uptake is expected to accelerate. Turning to SUBLOCADE. We had modest initial revenues in the quarter, primarily reflecting distributor stocking. While it remains early in the launch, when we look at the two months through April since SUBLOCADE is been available, it's fair to say that we're pleased with the initial physician and patient enthusiasm with which this exciting new treatment is being met. The volume of patients using…

Okay. Thank you, Mark. Well, given the progress we've made, I'm hopeful we're in the process of moving in Indivior to the next level from a commercial point of view. As we begin our fourth year as a standalone company, I'm proud of what's been accomplished in a relatively short space of time and I just like to remind everybody of some of the key milestones that we passed. First of all, we've maintained the resilience and profitability of our base SUBOXONE business and we continue to invent and defend our intellectual property. Secondly, with SUBLOCADE’s approval and launch, we are once again extending our global leadership position in addiction with what we believe is a breakthrough treatment for opioid use disorder. Shortly, we are hopeful that we will have created another growth avenue for Indivior with RBP-7000. If approved, we believe that RBP-7000 will be a successful new treatment that will address unmet patients needs in schizophrenia. We're also continuing to build our pipeline of early stage compounds based on the molecular pathways that have been identified as the most promising in potentially treating various substance use disorders. Development work is already underway with the Addex team on the lead molecule ADX71441for which we have an exclusive license. You will also know that we recently signed an exclusive licensing agreement with C4X Discovery for the most advanced molecule focused on the orexin-1 receptor. Finally, we continue to strengthen our unique patient focus and performance driven culture which is a key competitive advantage for Indivior. So that concludes our formal remarks and we now be very pleased to answer any questions you may have.

Thank you. [Operator Instructions] And so we will take our first question from Max Herrmann of Stifel. Please go ahead.

Good afternoon and good morning. Thanks very much for taking my questions. Three questions if I may. Firstly, just wanted to understand how the treatment of SUBLOCADE is a – has a medical benefit in some cases versus a prescription benefit, my - might alter the way in which the product is reimbursed. Secondly, just on the financials try and get an update, you mentioned that there's been destocking in the market. I wondered whether you are now at normal stocking levels or whether you think the stocking levels below or still above normal stocking? And then finally just again I was surprised in your first quarter numbers that your SG&A expense actually dipped on the fourth quarter, given that you are in the ramp up on launch of SUBLOCADE. So get some more insight the reasons behind that? Thank you.

Okay. Max, this is Mark. Thanks for your questions. So starting with the medical benefit versus the RX, I think for us that's a positive sort of development that's flowing through the medical side. Those - the costs associated with the disease space you know, entering emergency rooms and things of that nature which are quite costly on the medical side of the plan are now matched up very nicely, you know, with the cost of treatment. And so we like that those are - those are going to be on the same side with probably about 80%, 75%, 80% of the scripts running through that side. So we view that as a positive development when it comes from a reimbursement standpoint. And I think we need some of that in the access we have to date during the year with about 25% of life’s covered. As we get to the financials. With regards to the stocking, we are within the normal sort of range of stocking at this time. Not that there aren't occasionally up a point or two of fluctuations within a quarter, but we think we're in a good spot after the Q1 destocking that occurred. On the SG&A side. We are down versus Q4. I think you know, some of the things to think about is you know, within the company we are normally phased kind of Q1 to Q4. There was some lumpiness I would say in cost in Q4 associated with one-off costs on setup for the launch with the hub, and with some of the other services that are there. And then just to recall, that we also are awaiting our OPDP approval, which will launch many of our formal commercial efforts on the marketing side, the preparation of materials, online marketing et cetera, et cetera. And that you know, right now the clinical liaisons are working off of the PI, so that - that's led to some of that phasing that you may not have expected as you did your modeling.

Okay. Thanks. Just following up on the medical benefit, am I right understanding that you would - that would often just be included in the doctor's visit. So there wouldn't be a kind of additional copay, it would just be the same payment. So there's no incremental pool for having in SUBLOCADE injected as well as the visit?

So I think the way to think about the medicine itself is it would be injected at a doctor's office visit, but it would be covered under kind of a medical coinsurance. But as you know from our discussions at fiscal year end, you have a copay card that will take that cost from most patients down to about $5. So we don't see that as a barrier with that program in place and that program with such a high number of patients coming through the hub is also facilitated through that hub and makes it very seamless to the patient with easy application of the copay.

Great. Thank you.

Thank you. We will now take our next question from Mr. Graham Parry of Bank of America Merrill Lynch. Please go ahead.

Hey, thanks for taking my questions. Just the first one on SUBLOCADE, if you could actually give us a sales number and how much of that was stocking, whether you'd give us that number again in the second quarter. And can you give us some more detail around what achieving [ph] problems actually are that you referred to, so that your prices are getting through and what way you think you obviously head into 2Q. And secondly, your thoughts on the new FDA draft guidelines, so that's 505(b)(2) [ph] filings for long acting buprenorphine part of that pace referencing SUBLOCADE with just PK buyers availability data and it looks like that’s lowering the bar for sort of copycat type competition. So could you just give us a feel for the extent to which you think there's a risk of cheaper competition to SUBLOCADE before patent expiry? Thirdly, on cost saving, you discussed SG&A, if you could just help us understand R&D phasing through the air that’s bringing in the near term on antagonist's the fact you're phasing if R&D cost through the cost of the year? And then finally, if you could quantify this destocking number in the U.S. market in the quarter as well, that will be very helpful? Thank you.

Okay. Well, the easy ones to knock on the head is the FDA has not lowered the bar or competitor entry, but I’ll let Christian to explain further about that and try and take the questions in sequence. So first of all you asked about the SUBLOCADE, we haven't given any net revenue numbers. And I think that we've been very clear that was something we are going to be doing at first quarter, but equally have said that we’ll share SUBLOCADE net revenue at the half year. So that's clear. We're very pleased with the level of interest from doctors and the number of patients that are you know, starting the process with hubs are getting the SUBLOCADE product and we're also very encouraged with the feedback from those doctors and patients who actually experienced the product. So those are the two key things that we really need to focus on. Because if we know that those things are going well and the process in the middle is an efficiency process how quickly can we get from you know, the request in the product to having the product delivered. So we've seen a very high utilization of our patient hub, which again we're very pleased about because that provides a sort of concierge service to the patient and the doctor, so that the administrative processing burden is shifted out of the doctor's office and into the utilization of that has been higher than anticipated. So that did create a little bit of a backlog and some capacity issues in the first two weeks, which have now all been taken care of and we put some extra capacity in that to manage the demand going forward. So I think everything is very much in line with our expectation across all…

Comments on the draft guidance that the FDA has articulated recently. This is completely in line with the previous guidance from the agency with respect to ANDA and 505 B2 pathways, which is also completely consistent with the guidelines that we had received during the development of SUBLOCADE. If you read very carefully the draft guidance then you see that the FDA has clearly outlined that the proposed depot buprenorphine must be shown to be similar to SUBLOCADE with respect to several key parameters. So what FDA has done now is to take SUBLOCADE as a benchmark and needless to say if you go through the details of the parameters it must be matched. The hurdle is very high. I mean, I'm not going to a lot of details about the FDA is really focusing on the parameters of the unique profile of SUBLOCADE. On top of the PK profiles, we also need now to take into account the accumulation after multiple doses and the estimated time to complete clearance of the drug after the [indiscernible] has been reached. So all these key parameters go far beyond the normal bioequivalence standard for generic drugs. And we truly believe that the unique profile of SUBLOCADE and very tight variability profiles following SUBLOCADE administration will be very difficult for a competitor to achieve. On top of that now I remind you that we also have eight Orange Book listed patents that will – six excuse me, six patents. They will further increase the hurdle to any competitor.

Thank you.

Thank you. We will now take our next question from Paul Cuddon of Numis. Please go ahead.

Hey, guys. Just a few questions from me. I just wondered if you could elaborate on the SUBLOCADE rollouts by territory, I think you were initially focusing on areas of the high prescribers and early adopters and places where you’re going to get reinsurance – I am sorry reimbursement and coverage. So if you could sort of run us through the geographic rollout that would be great. And the federal briefing on the 4th of June, what do we expect to come out of that, is that sort of decision day on the appeal. And finally, owned the ATRIGEL, I guess this gets into both the bioequivalence and the launch of schizophrenia, where you've talked about 76% of patients having concurrent oral supplementation. So is there – so the months long release also going to be a key feature for RBP-7000? Thank you.

Okay. So the first question was on the SUBLOCADE rollout by territory. I mean, we do have national coverage in all territories. So we have prioritized - adjusted very thoughtfully, the physicians who we think are most likely to embrace the technology first, overlapped with where we think the early payout coverage will come from and other parameters to try and ensure that we've got an early uptick. As we've already said, the demand on our hub services you know, has been very pleasing and exceeded initial expectations. So we're very encouraged there.

So in terms of your question on the on the federal appeal, we don't have a hearing date scheduled yet, so that's pending, where we are in the process is, we are in briefings and in June our initial brief on those appeals will be due.

Okay. Thank you. And then finally on the positioning of RBP-7000 with ATRIGEL and the broader sort of market use of overmedication on top of the long acting?

Yeah. I think you're spot on Paul, I mean, the profile that ATRIGEL provides with the active will be a key differentiator as we go to market with that product.

Okay. Thank you.

Thank you. We will now take our next question from Nick Keher of RBC. Your line is open. Please go ahead.

Hi, guys. Thanks very much for taking the questions. Largely been asked already, but just on SUBLOCADE on the rollout. I'd be quite - I know this is early days, but if it's anecdotal, could you provide any input on what type of patients that the product is being used for by the physicians, now that they’ve got that in their hand, so are they going for the patients that have failed therapy previously? New patients, stabilized patients, et cetera? And then also be interested to hear if you could give us an idea, is this patient's who might been on filmed being switched overall? Are we seeing some sort of – are we seeing share taken from perhaps other products in the market as well?

Yeah, I think as you rightly said at the start of topic it's too early to really draw any firm conclusions on any trends. Clearly SUBLOCADE is indicated to be given on patients who've already been initiated on other forms of buprenorphine in a tablet or the film and clearly that doctors are falling in line with that. So the feedback that we're getting is that patients are doing well on that. We know that those of you who will - who are ace have probably picked up the buzz among the doctors who have tried the product and you know, it's anecdotally reporting that they're pleased with the results and so are their patients. So you know, it's really hard to over interpret, a very small amount of data so early in the processes, as much as we would love to be able to sort of lay it all out. I mean, it's just - it's just too soon. We just don't have that much you know hard data to go on, but we will be very pleased to share what we have at the half year.

Okay. Thank you.

Thank you. We will take our next question from Nick Nieland of Citi. Your line is open. Please go ahead.

Hi. It's Nieland. I’ve just got a couple of questions please. First one is do you expect the launch of RBP-7000 to be a similarly slow rollout like SUBLOCADE or do you think that prescribers will adopt this medication quicker given their familiarity with injectable antipsychotics or will it be more of substitution? And then do you have anything further you can report on your negotiations with any FDA, ANDA filers on a potential for a settlement on SUBOXONE film? Thanks.

Okay. So with the RBP-7000 we are actually launching into a very different type of market. So it's difficult to draw comparisons. I think you're absolutely right, say surely this is a physician population, they're comfortable with the concept of the technology that we're already utilizing it to a high degree and an ever increasing degree and therefore they must be familiar with the distribution system. So some of those things that other doctors in the addiction space are learning these guys know how to do so absolutely. What I think is going to be different about the schizophrenia category, of course, that we're not the leader in schizophrenia and we don't have those you know, very strong long-term trusted advisor relationships, such as strong driver of success in the addiction field. So it will be a slow build for different reasons. And I think that's all perfectly sort of logical. And the second - just remind me the second question?

Just about whether - you think you are…

Yeah. There's nothing to add on the ANDA filers. I mean we've always said very consistently, we believe in our ability to generate and defend IP. I think our track record speaks for itself there. And at the same time you know, we're always ready to talk, you know, the settlement where we believe that the settlement terms reflect the strength of our position and the right thing to do for shareholders. So we've got no news on that front. Other than the fact that our position remains - the door is always open, but unless someone comes through the door we'll continue to assert our patents and you know, defend our intellectual property with great vigour.

Okay. Thank you.

Thank you. We will now take our next question from Stuart Goldberg of Capitol Hill Capital. Your line is open. Please go ahead.

Mark. I missed the question earlier about the destocking. You said, it was about 4 points of growth. I was wondering if there was anything else in there that would lead to a first quarter decline in discounting to your current base on the film? And then I have a question on SUBLOCADE.

Yea, Stuart, I think you're right in the recall with regards to the impact of the destocking. It is about 4 points, somewhere between about a half and three quarters of a week of - on hand. With regards to the balance of the dynamics, what we're seeing is a bit of continued tactical rebating that we've talked about. This is all about maintaining formulary, you know, as well as this managed Medicaid mix you know, that really picked up in the back half of last year where we're seeing that channel is growing in kind of the high teens at 18%, 18.5% or so versus the base business, the CMC that's growing you know, in mid single digits. So that's having that negative mix impact on the business. You know, we're excited that people are getting access to treatment, which is very key. It's just coming in an area where the rebates are a bit higher based on the dynamics with the government. So that's causing that other mix that's getting us to the underlying growth in the U.S. that we talked about earlier that's in the you know, 4%, minus 4% range.

Okay. And then when you were talking about the SUBLOCADE hub, is that more of an issue that you didn't have ready or is it demand issue. I mean, a little bit more if you could - clarification on the hub and what went - what was going wrong there?

Yeah, it's not so much that anything's going wrong. I mean, we had it organized and remain well-prepared. I think when we sort of use the term hub, it's really the whole process at doctor's office, sort of learning the processes of using the hub, we put field reimbursement specialists on the ground to go around and help doctors offices because there's so many they can get to in a day. We did have over utilization of the hub, which we see as a very positive thing because it means that you don't just trust Indivior and the services that we provide to help - you know, make things as smooth as possible to patients and unless they’ve relied on over the years to help you know, provide the best evidence based treatments that they can. So you know, they are good problems to have, problems with a small pay, but nevertheless they need – it need to continue to improve and develop that. And you know, we've looked at every thought, the technology that’s hub [ph] part of distribution and hub services and we are advised that just that sort of friction that we're experiencing is very normal and customary, just about everybody who's run this process has experienced these types of challenges. And you know, it's important not to get them out of context. So I think we've always been transparent and said look, we knew that it would take a few months to - for this to settle in and it's all within our sort of normal range of expectations. Overall we’re encouraged, it’s great.

Thank you.

That will conclude – apologies. That will conclude today's Q&A session. I would now like to turn the call back to Mr. Thaxter for any additional or closing remarks.

Yeah. Well, I'd just like to thank everybody for their continued interest and support. And we will look forward to seeing you in our one to ones - at our conferences and of course, at the half year. So thank you very much for being on our call today.

Thank you. Ladies and gentlemen, that concludes today's call. You may now disconnect.