Good afternoon, ladies and gentlemen, and thank you for standing by, welcome to today's Indivior PLC First Quarter Results 2019. At this time, all participants are in listen-only mode. There will be a presentation followed by a question-and-answer session. [Operator Instructions] I must also advise you, meeting is being recorded today on Thursday the 2nd May of 2019. And I would now like to turn the call over to your host and the presenter, Mr. Shaun Thaxter, the Company's CEO. Please go ahead, sir.

Thank you. Good afternoon, good morning everyone, and thank you for joining us to discuss our Q1 results. My name is Sean Thaxter. I'm the CEO of Indivior and I'm joined by our CFO, Mark Crossley; Chief Legal Officer, Javier Rodriguez and Chief Scientific Officer, Christian Heidbreder. I will make some opening remarks and then Mark will provide you with more details on the financials. And after that, as usual, we will take your questions. First off, let me begin by expressing our sincere and deeply held disappointment that our shareholders now face additional uncertainty as a result of the recent DOJ action. We've tried to be as helpful as possible by including additional background details in our press release today. However, the matter is with our External Counsel and we will not be able to answer any questions you may have on this topic beyond referencing today's press release and the press release of the 9th of April. What I would like to emphasize though are the following key points. First, as a management team and as an organization, we are fully committed to remaining our focus and energy on executing our strategy to return Indivior to sustained long-term growth. Second, we remain pilots in the pursuit of our vision to help patients and communities struggling with Opioid addiction. And third, through our business transition, we will continue to invest in our employees, our capabilities and our compliance. With that focus in mind let me now move on to the first quarter results. In summary, Indivior delivered a solid performance in what was a challenging and complex quarter, based on strong execution and on the resilience of our longstanding leadership position in Opioid Use Disorder. Most important, we made progress on the top and the bottom line drivers that…

Thank you, Shaun, and good morning and good afternoon to everyone on the call. Overall financial performance in the quarter was ahead of our expectations and we continued to execute on the key elements of our contingency plan designed to maximize cash and return Indivior to long-term growth. Taking a closer look at our financial performance in the quarter, starting with net revenue; overall, we saw a 5% decline versus the previous year at constant currency, despite facing generic film entry in mid-February. While we had some transitory items exaggerating the pressure on our rest of world net revenue, the US business reported 2% growth versus the prior year. As Sean highlighted, the US performance reflects three main factors, namely the lower than expected share loss in SUBOXONE Film, the strong launch of the authorized generic and continued growth in SUBLOCADE. Focusing on the U.S. market dynamics for a moment, SUBOXONE Film share has declined from 53% at the end of 2018 to 36% at the end of the quarter and 30% in the week of April 19th. We believe SUBOXONE Film's resilience in the short term is being driven by our patient base and their success on film. In short, we believe the switch to a generic product is certainly been carefully considered by payers and HCPs. Additionally, given SUBOXONE's rebating overtime, the treatment remains competitive at a net pricing level with some payers. Ultimately, however, we do not expect this to be sustainable and believe it's likely that the branded SUBOXONE Film will arrive at the share position suggested by industry analogs. This dynamic is reflected in the full-year guidance we have provided today. Turning to the performance of our authorized generic film, Sandoz has proved to be a great provider for our authorized generic offering and they've…

[Operator Instructions] And we have a question from the line of Harry Sephton of Jefferies. Please go ahead.

Firstly, could I just quickly clarify what you're now expecting to be the ceiling rate -- sorry the ceiling conversion rates for SUBOXONE Film now that you've got to that 50% conversion rate? And also, clearly the SUBOXONE film share has held up relatively well compared to what we normally expect of a generic. Given that a generic would normally just be simply substitutable, what have really been the drivers as to retaining this higher share of SUBOXONE film? Thank you.

Thank you, Harry. First of all, with respect to the yield, I think that we've always been clear that we don't consider the job done by hitting 50%. That's the analog. That's what everyone else does. We are going to -- we aspire to have the yield within the 60% to 70% range. So, whilst we think it's worth commenting that we've sort of hit the analog benchmark, our ambition is to strive higher than that. I can't really give you a celling, but the sort of normal rate on SUBOXONE Film which is exclusively a pharmacy benefit is around 65%, 67%. So it'd be very difficult to imagine getting beyond 70% and we're striving towards that at the moment. Of course, we'll have to see the progress we make.

With respect to the SUBOXONE Film?

Yes, I think Harry, the SUBOXONE Film has exceeded analogs at this time. We think it probably has to do with being a chaotic patient base you now and doctors really liking the SUBOXONE Film, hesitating to change in the short term you know. As well as the fact that it is a -- it is a mature product that has some discounting associated with it. As you know, in Government channels, we have been -- have been having mandatory discounts for some time associated with CPI protection. So for some payers, it just doesn't make sense to switch over in the short term. Again, we think that the competitive pressures with the number of generics that we have in the market with Mylan, Alvogen and Dr. Reddy's, we'll continue to drop that price. We see some payers that are instituting MAC pricing, putting further pressure on the pricing. So we think that in the short term, we're going to revert to the analogs which would have kind of 70% at this point in time with 90% by the end of the fiscal year.

That's really helpful and thank you guys.

[Operator Instructions] And your next question is from Max Herrmann of Stifel. Please go ahead.

Hi, thanks for taking my questions. Just a couple; just on SUBLOCADE, obviously you've presented new data from the RECOVER study and I wondered what the sort of impact you're seeing in terms of -- from physicians to that. I think you've also presented now I think up to eight months of sort of patient retention data in your presentation. I'm just trying to understand in terms of compliance, what you're seeing because obviously whilst the one -- the every month data that you're providing shows there is one element of compliance. You also have how many days-free patients are during the month. Is there any anecdotal data you can give that demonstrates compliance difference between SUBLOCADE and SUBOXONE Film? And then any more light you can share on discussions with the DOJ would be helpful.

So, this is Christian. We got some very positive feedback from the ASAM presentations. Just to let you know, also, the Lancet paper that we published earlier today was the center of a lot of attention during the ASAM meeting and was actually among some of the publications highly rated. Just for everyone, the ASAM of course is the American Society of Addiction Medicine, so all the key players in de-addiction medicine typically attend the meeting. There was a lot of attention around two main presentations, we did there. Altogether, we made four presentations, but two of them were high in demand. The first one was of course the RECOVER study. For the first time we present it beyond the baseline characteristics, the 12 month data, clearly indicating that the longer patients have an opportunity to be in treatment, the higher the probability of recovery as measured by numerous factors. Secondly, we presented for the first time the fentanyl blockade study. This is not a SUBLOCADE study per se. But what we did there was to basically expose opioid retardant patients to plasma concentrations of buprenorphine that's very similar to do, as that are delivered by SUBLOCADE and we basically managed to see that ex these unique plasma concentrations that we deliver with SUBLOCADE, we in fact have an opportunity to block the respiratory depression triggered by fentanyl, so lot of attention there. Another presentation that gained a lot of attention was a post stroke [ph] analysis that we did on the Phase III trials and that we are currently further analyzing in the context of post-marketing requirement study is to understand better the patients who actually may deserve higher SUBLOCADE maintenance dose, that is the 300 milligram. And we have gathered preliminary data suggesting that opioid injector users may actually benefit from the higher maintenance dose of SUBLOCADE. So, these were the key highlights of the ASAM meeting, so a lot of very positive feedback from that meeting.

Hi Max, in response to your question on the DOJ, as you know, we have ongoing litigation now with the DOJ and we're limited in what we can say and as Shaun mentioned in his opening. We tried to provide as much detail as possible in the press release. What I can say is that, we're diligently preparing for trial. We're confident in our case based on the assessment of the law and the facts by our external counsel. That said, we have been willing and continue to explore all options for resolution short of trial in an attempt and that's our goal to achieve certainty for all of our stakeholders.

Thank you. Is there any sort of feedback you have on, basically on SUBLOCADE on compliance, because obviously one of the key aspects of it is the compliance advantage over -- or potential advantage over other therapies. Is there anything, because just the month to month retention of patients doesn't seem to be significantly different to what we've seen or you've shown before for the film?

Yes, I mean we are getting very positive anecdotal feedback from physicians. One thing that seems to come up quite often is that patients like waking up in the morning and not having that need to reach for their medication because they've got the very stable plasma concentrations and they're not experiencing the up and down. So I think that with the retention rates that we're seeing are consistent with what we expected from the clinical trial. And it's early days. We'll continue to see how this plays out moving forward. I think one of the key things that's interesting that, as the new science is emerging, it's highly suggestive that you know staying in treatment longer, right, is providing more data. And if you ask most physicians, most physicians will say staying in treatment is a very good thing being retained in treatment. You well I know that, that's why I asked the question, right. But the data, there is some new scientific data and the pattern that's emerging is providing that data to support what physicians believe. So we think that as that dialog starts to open up with the data that we are investing in and so that will provide the opportunity to -- for doctors to push patients harder in terms of keeping them retained in treatment, because it's providing the evidence that says that this is therapeutically the right thing to do.

Great, thank you.

Thank you. Your next question is from the line of Nick Nieland with Citi. Please go ahead.

Hi, thanks for the questions. So, Firstly, can I ask how much of your SUBLOCADE revenues come from government programs currently. And then secondly, would any exclusion from federal programs that you talked about and DOJ indictment, would that apply to SUBLOCADE and other products? And then, can you talk to us about the realized pricing on SUBLOCADE and how that compares to one year ago. Thank you.

Thanks, Nick, for the question. As we've said in the release, it is a material portion of our programs. I think historically, we've talked about, on the film business, while we don't break thing and we've talked about the government accounts being upwards of 50% of the business. So quite a -- quite a material amount moving forward, with regards to exclusion -- could exclusion be for everything? We'd have to leave that to the actual pronouncement from HHS but the belief is it could be, it could be for all products. And lastly on pricing with SUBLOCADE, as we look through that kind of in the current quarter versus last year, we're seeing relatively similar sort of net pricing dynamics versus our expectations.

Thank you. [Operator Instructions] And currently, we have no further questions, please continue.

Okay, well, thank you everybody for joining us today. We appreciate your continued support and interest, as always, in our Company. We look forward to seeing you at all the usual places, at the investor conferences as we move through the next quarter. And really look forward to being able to share our progress at the half year results. So, thank you.

Thank you. That concludes the presentation. Thank you for participating. You may disconnect.