Good morning, good afternoon and thanks for joining us. With me today to discuss our Second Quarter and Half Year Results are Ryan Preblick, our Chief Financial Officer; and Dr. Christian Heidbreder, our Chief Scientific Officer. Looking at the agenda, I'll provide an overview of our financial results as well as the progress we're making against our strategic priorities, after which Ryan will take you through the results and guidance in more detail. Christian will then walk you through our R&D priorities and pipeline updates, and then we'll move to the question-and-answer session. Before I move on to my overview, I'll assume everyone's read the forward-looking statements. Turning to the second quarter, key messages on Slide 5, the company executed well and delivered stronger top and bottom-line performance than we expected. Importantly, we also made excellent progress against the strategic priorities that form the foundation for creating long-term value for all Indivior stakeholders and which we -- will enable us to deliver a better future for patients. Our focus on organized health systems continues to drive strong growth for SUBLOCADE. As you saw, net revenue in the second quarter was $98 million. Excluding the large one-time order in the year ago period, SUBLOCADE net revenue grew by over 80% year-over-year and increased 15% versus the previous quarter. This sequential growth performance represents the eighth consecutive quarter of double-digit underlying growth for SUBLOCADE. Based on this strong momentum, we now expect SUBLOCADE net revenue for the full year to be in the range of $390 million to $420 million. At the midpoint, this would be an increase of $25 million over our previous guidance and represents a 66% increase over SUBLOCADE's fiscal year 2021 net revenue mark. At the total company level, we're maintaining our full year 2022 guidance for net…

Thanks, Mark, and good morning and good afternoon to everyone. I'm pleased to report another good quarter of execution and business momentum. We again delivered double-digit top-line growth driven by the strong performance of SUBLOCADE. As expected, adjusted operating income decreased versus the prior year, reflecting the growth investments we have made to extend the success of SUBLOCADE and PERSERIS. We also maintained our disciplined approach to capital allocation, balancing reinvestment in the business, with shareholder returns in the form of a second share buyback program. Including our stepped-up level of investment, and share repurchases, we still exited the quarter, with over $1 billion in gross cash and investments. I'll now provide some more detail on the performance drivers in the quarter, and discuss our outlook for the rest of the year. Starting with top line, total net revenue growth up 10% versus the year ago quarter and by 12% at constant exchange rates. Looking at the first half, total net revenue grew 12% versus the same period last year, and by 14% at constant exchange rates. As I mentioned, the increase in total net revenue was mainly a function of strong SUBLOCADE growth in the US, but we also are seeing strong contributions from PERSERIS and from SUBLOCADE in markets outside the US. By geography, total US net revenue grew by 22% versus the prior year quarter, if we again exclude the large CGS order we had in the second quarter of last year. Net revenue in rest of world was down 2% year-over-year, excluding unfavorable FX impact. The pressure in the rest of the world continues to be from ongoing generic competition and austerity measures, which are impacting overall pricing. The divestiture of the TEMGESIC franchise also impacted second quarter net revenue by $2 million, or about four…

Thank you, Ryan and good morning, good afternoon, everyone. Let me start with an update on our current pipeline activities. First Aelis Farma achieved a major milestone on the development of AEF0117 with the start of a clinical Phase IIb proof-of-concept study and a first subject, first visit that occurred on May 23. The primary objective of this study is to demonstrate that AEF0117 induces a greater proportion of subjects with a response of less or equal to one day of cannabis use per week compared to placebo. The number of subjects will be up to 330 treatment-seeking individuals with a mean cannabis use of more or equal to five days per week within the last four weeks at the screening and baseline visit of the study. Other work streams including chemistry, manufacturing and controls and non-clinical toxicology are progressing in parallel as planned. Second our selective orexin one receptor antagonist program completed Phase I single ascending dose study with the characterization of eight doses and no events of clinical concern. The second Phase I multiple ascending dose however was put on clinical hold by the FDA in September last year based on non-clinical reproduction toxicology findings from another similar development program not sponsored by Indivior. We submitted a complete response of the clinical holds to the FDA on June 27 and I am very pleased to announce that yesterday July 27 the FDA removed the full clinical hold and confirmed the multiple ascending dose study can now be initiated. The study is expected to start in September. In parallel, major progress has been made on the formulation and clinical development front as well as non-clinical. Lastly our GABAB positive allosteric modulator program for alcohol use disorder has identified two lead molecules and backups that are going through primary and…

Thanks, Christian for those updates and for the insights on cannabis use disorder. To summarize, the team delivered strong second quarter performance behind focus on execution which has led to progress across all of our strategic priorities and an upgrade on our fiscal year 2022 SUBLOCADE top-line guidance to $390 million to $420 million. We've completed our consultation with shareholders, seek their approval for a second listing on a major US exchange. With that, I'll turn over to the Q&A to Dennis.

Thank you. [Operator Instructions] And our first question comes from the line of Max Herrmann from Stifel. Please go ahead. Your line is open.

Thanks very much for taking my questions. I've got a few, if I may. Firstly, just in terms of a bit of housekeeping on SUBLOCADE, where do you see the stocking position currently in the US with SUBLOCADE? Do you think wholesaler stocking specialty pharma stocking has kind of normalized? Is there anything we should be aware of in the quarter? And then I know you, kind of, guided that you expected a sort of acceleration of the growth of SUBLOCADE in the second half I think earlier this year when Omicron was taking -- or having an impact. I wonder if that's still the case. So that's the first kind of question. Second one just on the OHS, kind of, now you obviously targeted all of -- well you've opened access to all 500 targeted accounts. I wonder if there's any rationale behind expansion of your sales force there perhaps on the ground now in the US given the opening up of the market as well as that stage in the evolution of its commercialization. And then finally, just a question on the SUBLOCADE margin or the impact that SUBLOCADE is having on the gross margin. Obviously, we're seeing that the Medicare Medicaid channel on SUBOXONE is impacting it negatively, but I would have thought given the very strong growth you're seeing from SUBLOCADE that that would have a positive impact as well that would counterbalance that. So just trying to understand that a bit better. Thanks.

Thanks for the question, Max. I'll take the first three and then I'll ask Ryan to talk you through the margin with regards to the relatively modest shift in mix. From a stocking standpoint on SUBLOCADE, we see it as relatively normalized for a growing asset. So those -- while the absolute value increases the weeks of cover remain relatively normalized so no material impacts with regards to that. When I think about the first half, second half acceleration as I mentioned in my remarks, I think the first half growth was higher than our expectations. The impacts of the different variants of COVID were less impactful early on and the team has really executed with excellence. And I think when you look at the guidance, we expect to see continued momentum in the second half and that's why we've raised that guidance by $25 million at the midpoint and are confident of the momentum we have and being able to deliver on that. When it comes to the access to parents and the potential for expansion of the sales force, I think we made -- if I remind the callers, last year we made a number of pointed investments focused on accelerating the growth of SUBLOCADE. We added account access directors. We added medical science liaisons and added key account managers to increase that footprint and continue to deliver access. At this time, we don't see a need to increase the sales force. The key here is to focus on continued engagement at the child level to both activate those child accounts as well as engage with the HCPs in there to pull through SUBLOCADE adoption. So that's where we see that Max. And Ryan do you want to talk to the gross margin?

Hi, Max good morning. On the gross margin, so we certainly still stand by the guidance that we provided low to mid-80s going into the year and maintain that. You did see a nice step-up of a percentage point from Q1 to Q2, which does highlight the progress we are making as SUBLOCADE becomes a larger contributor to our business. There are two aspects to that. One, the film mix and the film strength in the first half did keep it down slightly. And as typical I think you're hearing across all different industries there is some inflation that we are dealing with quite -- it's manageable today, but that is an impact that we are seeing. But certainly looking forward to growing margins as we progress on the journey with SUBLOCADE and its higher margins.

Great. Thanks very much. I’ll get back in the queue. Thanks very much.

Thanks Max.

Thank you. There are no further hands raised at this time. [Operator Instructions] And we have -- just had two more hands raised. One moment while I bring the next person on. And our next question comes from Peter Testa of One Investments. Your line is open. Please go ahead.

Hi. Yes, two questions please. One, just to understand when you talk about the phasing of R&D and costs in H2, would you expect that to be starting now, or is that going to be more -- will some of these programs be launched during -- after summer into Q4, just so I understand the cadence please?

Certainly Peter. I'll hand that off to Ryan just to talk about the phasing of that spend and activity.

Yeah, so we are certainly committed to the programs that we communicated going into the beginning of the year. The work was definitely started in Q2, and is currently ramping up as we get into Q3. I don't want to get into specific timings around the quarters, but certainly we'll be endured in Q3 and Q4.

Right. Okay. And then just on the Ryan, guidance point when you're absorbing SUBOXONE potential risk, is it basically to say you're absorbing more or less the upgrade in SUBLOCADE and SUBOXONE at the gross margin and that's basically what you're absorbing in Q4?

Yes at this point. Again we try to make a reasonable assumption with the limited data we have in intel. And as we committed in our scripts, we will keep the market abreast based on what we learn.

Okay. And then last thing was just on -- I'm going to try this one see if you want to answer. You gave the view on the high-prescribing doctors, five or more patients as they increased. I was wondering if you had any sense of what proportion of new prescriptions in the quarter they were.

We just don't carve the data out at that level. I think there's a number of folks that are coming through in specialty distributors so to share that data and that trend could provide a bit of a murky picture. I think the momentum in the business speaks for itself. When you look at both the year-over-year growth on an underlying basis in the 80s the quarter-over-quarter growth at 15% versus Q1 and the momentum that goes into the second half based on the execution and delivering on access to those top 500 organized health system parents, I think we've got strong momentum and plenty of room for growth moving forward.

Okay. And maybe just one other associated. If you look at the regulation around allowing doctors to prescribe with different levels of education required, there's been some talk about allowing more to be done without having to go through the same degree of education even if it's online. Is there anything happening you see in your coming forward from that?

Yes, that's a good question Peter. I think opioid use disorder I think is one of the truly bipartisan issues that are in front of this administration. And there are a number of efforts that are I think in the Congress and have been passed previously with regards to trying to break down barriers and increase access to treatment and I think that's one of those. It is in the Congress has not been passed at this time. But we support broad access to multiple sort of treatment modalities to help take the treatment penetration in this disease space which is at 20% which is quite woeful given the epidemic we face and try and turn that upside down to 80%. So, we're fully supportive of any way to increase access to treatment.

Yes, let's see if the latest breakthrough in Congress contains -- what it contains for you guys, maybe something there. Thank you

Thank you, Peter.

Thank you very much. [Operator Instructions] And our next question comes from Max Herrmann from Stifel again. Please go ahead.

Great. Just a couple of follow-up questions. Firstly, just on PERSERIS, I mean clearly you reiterated the long-term guidance there for the product. Obviously, the sales force expansions had some great impact on its prescription trends, so that's excellent. Just wondered what your thoughts were on the Teva/MedinCell long-acting risperidone if that gets to market, what impact that might have and what the characteristics are between the two PERSERIS and MedinCell products? That's the first question. And then the second just how are you doing in the channel -- the criminal justice system channel? Obviously, you excluded the $7 million sort of large lumpy order from some of your competitors for the second quarter 2021 where there was that big order. But I just wondered how you're getting on in that channel.

Thanks for the additional questions Max. I think with PERSERIS, I think you've really hit the nail on the head here with regards to great progress by the team. This expanded national launch has only been in place since the start of the year and you can see they're really starting to make great progress with 40% growth quarter-over-quarter, great year-over-year growth. And we're seeing requests from physicians for samples and interest in what's a differentiated product profile. When I start to look at the competitive landscape, I think this very much like addiction is quite an underserved patient population. Adherence is the number one unmet need in this space according to physicians. And with only about 18% to 20% of patients in long-actings, we think that space for multiple provider -- multiple options for treatment [Technical Difficulty] treatment here whether it's the existing ones or future people entering the space. So, that's where we are on PERSERIS. When it comes to the justice system channel, we continue to make great progress there. Again, this is an investment we made in the back half of last year. I spoke to its strategic importance given that 65% of our patients at some point in their journey with addiction come in contact with this channel. And we've staged up and ramped up and launched at the beginning of the year a 20-person dedicated sales force here because of the importance of this channel and are really starting to make good progress. We've had more sales in the year-to-date than we had the entire previous year. We've got access in over 30 states at over 100 facilities and the momentum continues to build there. So, very proud of the entire team the general sort of ecosystem team who've carried the criminal justice system to-date and then their nice handoff and partnership with these justice system access directors. So, very good progress Max. thank you.

Great. Thanks very much.

Okay. Thanks Max. And that concludes the questions and I will hand back to Mark Crossley.

Thank you, Dennis and thank you everyone for participating in the first half results and the continued interest in Indivior. I look forward to continuing the dialogue moving forward at conferences and at our Capital Markets Day in December. I hope everyone has a great day. Thank you.