Good morning and good afternoon, everyone. Thanks for joining us. With me today to discuss our Half Year 2021 Results and our progress against our strategic priorities are Ryan Preblick, our Chief Financial Officer; Dr. Christian Heidbreder, our Chief Scientific Officer; and Jon Wasserman, our Interim General Counsel. Looking at the agenda, I will provide an overview of our strategic progress, after which Ryan will detail our financial performance, and Christian will then walk you through our R&D advancements, after which we will move to a question-and-answer session. Turning to our second quarter performance on Slide 5, in short, the key takeaways for the quarter are as follows: one, the team has executed well and they have made clear progress against all of our strategic priorities; two, our strategy behind expanding treatment access in organized health systems, or OHS for short, is delivering a fourth consecutive quarter of double-digit quarter-over-quarter growth. This paradigm shifting treatment continues to gain traction with physicians and patients giving us continued confidence in achieving our long-term $1 billion plus net revenue goal. Third, we are moving forward with confidence in our growth strategy and outlook for the future. We are backing this by initiating a share repurchase program of up to $100 million, which I will speak to in more detail a bit later. Now, turning to our report card on Slide 6 for a more detailed discussion of how we are progressing against our commitments to shareholders. Starting with SUBLOCADE, which delivered revenue of $61 million in the quarter, with continued solid underlying growth and a large $7 million criminal justice system order. The strong Q2 performance drove net revenue for the first half of 2021 to $104 million, a growth rate of 79% versus year ago. Our second quarter underlying net revenue, excluding…

Thanks, Mark and good morning and good afternoon, everyone. We had another quarter of good execution that was driven by continued strength in the U.S. addiction franchise. Our progress with SUBLOCADE with year-over-year growth in Q2 of over 100%, along with SUBOXONE Film strength resulted in overall net revenue growth of 34% in the second quarter. This top line performance drove our strong adjusted operating profit growth in the same period. Our strong Q2 resulted in overall first half performance that allowed us to raise our full year financial guidance. As we outlined on June 30 and confirmed this morning, we expect total net revenue to be in the range of $705 million to $740 million, which at the midpoint would represent a 12% increase versus 2020, and pre-tax income to be significantly higher than our previous expectations. In sum, we entered the back half of 2021 from a position of strength and remain confident that our growth strategies and resources, including cash of $1 billion position us to deliver profitable growth for the full year. Now, turning to the quarter, starting with the top line, the increase in total net revenue was largely performance driven, but did include a 4% benefit from FX. The increase in net revenue was mainly a function of 110% year-over-year increase in SUBLOCADE net revenue and continued SUBOXONE Film share resilience in the U.S., which had double-digit year-over-year growth in the second quarter. U.S. net revenue grew by 44% as a consequence. Rest of world, on the other hand, was down 2% year-over-year if we strip out the FX benefit. The slight underlying decline was driven by the ongoing austerity measures and competitive pressure in Western Europe and Canada. Our focus in rest of the world markets however remains on net revenue diversification with…

Thank you so much, Ryan. Good morning, good afternoon, everyone. My update today is twofold. First, I will briefly review some salient data on the epidemiology of the disease, including opioid use disorder, alcohol use disorder and cannabis use disorder. And second, I will give you a brief overview of our pipeline activities. You will also find a summary of our peer-reviewed publications and conference presentations in 2021 in the appendix. Let me start with the disease state. As you can see on Slide 15 drug overdose death rose, unfortunately, nearly 30% in 2020 to a record 93,000 according to provisional statistics released on July 4 by the CDC. It is actually the largest single year increase ever recorded. Synthetic opioids are the primary driver of the increases in all those deaths and accounted for more than 56,000 deaths as of December 2020. And I would say that state and the local health department reports clearly indicated the increasing synthetic opioid-induced overdose is primarily linked to illicitly manufactured fentanyl. Let’s not forget however the devastating effects of alcohol use disorder. The prevalence of alcohol use disorder in the U.S. was about 6% corresponding to 14.5 million people. And among individuals with alcohol use disorder, only about 1.1 million people actually received any treatment for alcohol use disorder during the same period. Use of medications for alcohol use disorder, were reported by 223,000 individuals. On the next slide, let me elaborate a little bit more on cannabis use. In 2018, the United Nations estimated that 192 million people worldwide had used cannabis in the previous year. And in the U.S. alone, we are talking about 4.8 million people with the past-year cannabis use disorder. So I would like to highlight a couple of facts. First, the amount of THC, the active…

Thanks, Christian. Before turning to Q&A, let me just take a moment to thank our employees and other key stakeholders for their continued support and dedication to our patient-focused vision. Through hard work and adhering to our guiding principles we have placed Indivior on a solid strategic and financial path during a challenging period. We have the right products, the right teams and the resources to not only endure through the dynamic and challenging operating environment we are currently experiencing, but to thrive beyond. With that, I will turn it over to the operator for Q&A.

[Operator Instructions] So, your first question comes from the line of Max Herrmann from Stifel. Please go ahead Max. Your line is now open.

Hi guys. Great. Thanks for taking my question. Three, if I may. Firstly, just wanted to try and understand a little bit about the SUBOXONE Film underlying sales and margin guidance. I appreciate that you have had a – maybe a one-off revenue recognition from the sending of the Sandoz AG authorized generic agreement that you had, but you also mentioned a little benefit from product mix from I think more cash pay patients. And therefore I am trying to square that with your margin guidance, which is for a negative impact or lower margins as the product is generally trending towards the Medicare kind of lower or Medicaid lower sort of payment contracts or business. So, that’s the first question. Second question is just on the TEMGESIC sale ex-U.S. analgesics and just what the sort of revenues were for last year, so we can understand exactly what that will strip out. And then finally, just to get a better idea of the criminal justice system market, what do you estimate is the opportunity in that market? And other than the one contract that you have mentioned so far have you had other business in that market already or that channel already? Those are my questions. Thank you.

Thank you, Max. Appreciate the questions, and I will maybe handle the latter two, and then I will hand over to Ryan to talk you through the dynamics on the Film business. With regards to the TEMGESIC sale I mean, obviously, this is a historic business not promoted, non-strategic that is outside the U.S. About $10 million in sales and so we took the opportunity to leverage the asset, get some cash. And the way the business thinks about it is it basically funded the opportunity and the option value that we have on the Aelis assets, so for us, a good trade-off there. With regards to the criminal justice system market listen, I think with regards to that market there really is momentum picking up in the criminal justice system arena. You see it’s a beneficiary of Federal funding. There is some legislation that’s in Congress with regards to the Medicaid Reentry Act to try and help fund treatment in transition out of prisons. And President Biden has continued to keep it in his commentary even at his most recent town hall in Cincinnati, Ohio. In our view SUBLOCADE, it’s a perfect vehicle for providing medically-assisted treatment during incarceration and upon release. I mean, it addresses the complexity and safety issues for daily treatment in the incarceration. And in addition, it provides a full month of treatment upon release to protect the patients at they are – when they are most vulnerable to both relapse and the highest risk of overdose. So, our ecosystem teams have been making some progress. We continue to take bigger steps with the $7 million order and shifting to a dedicated team now with this momentum we think is spot on and strategically exactly where we should go. So with that, maybe Ryan, I will hand over to talk through what’s going on with the dynamics of the Film.

And I will break it down into three buckets for you. So first, when we did provide guidance going into the year, we said our gross margin would decline in the high-single digits from the mid-80s down to the high-70s. And that was because as we went from 2020 to 2021, the majority of our Film business was going to be on the state Medicaid channel, which is the less profitable channel. And so that’s why when we provided that guidance, we were assuming that our gross margin would erode. And with Film still being a large contributor of our business that’s why it had that impact. But what we are seeing so far in Q2 and the reason why we updated our guidance to just in the low-80s is because we are able to maintain more of our commercial, highly profitable channel because it’s non-contracted. So, that’s what’s helping us on that front. And then thirdly, the reason why it was quite strong and it was stronger than expected in Q2 in the mid-80s is it included a one-time benefit because of that $7 million tied to the finalization of the Sandoz product. So net-net, still looking forward to our gross margin this year being in low-80s, still lower than last year because the Film continues to have a strong presence in our portfolio and then look forward to 2022 where it continues to improve again.

Do you expect that – the non-contracted business though to continue to be stronger than you expected at the beginning?

I think – so at this point it would be great if it does, but we no longer promote the Film, and that’s up to the payers to make that decision. But as of now, we haven’t heard anything differently.

Okay. Thanks. And just maybe just to follow-up on the question about how big an opportunity is the criminal justice system opportunity, is there any more color you can provide on that?

Sure, Max, maybe a little bit more. About 65% of patients that suffer with OUD travel through the criminal justice system at one point in their journey. I think because of that dynamic and because they re-enter society, it is a great opportunity to catch patients where they are. And just even the absolute revenue in criminal justice is probably the least attractive part because what it does is it provides a launching pad for people to enter recovery. There is probably about 5,000 prisons – different prison system entities across the U.S., of which we are primarily focused on the top 1,500. They capture the vast majority of the volume, and there is just a really high prevalence of substance use disorder among this population. So as we move forward, activating those accounts, each one is quite complex, and it – really there isn’t a bolus of a parent in which you open up and you have momentum in the children. For the most part, these are [indiscernible] on that. So, it’s block and tackling, it’s account to account to account, and that’s why we have made the shift from keeping it as part of our ecosystem team, a portion of the business to a dedicated team to deal with the complexity of opening these up and help meet the patients where they are in their journey on recovery.

Okay, great. Thanks very much.

Thank you, Max for the questions.

Thank you. Your next question comes from the line of Harry Sephton from Jefferies. Please go ahead Harry. Your line is now open.

Great. And then thank you for taking my questions. I have three, please. So, maybe just to start with the SUBLOCADE fentanyl label extension, just want to get a sense of how much interest you are seeing from that recent label extension whether you are seeing a meaningful step-up in sales from that? My second question is on the costs. So, first half costs looked at around $100 million – sorry, $200 million versus your full year guidance of $470 million to $480 million. I just wanted to get a sense of what’s going to be driving the ramp-up, you have mentioned the $25 million investment for the LAI products, but the phasing of any other costs would be helpful? And then just finally, you mentioned on the refinancing, the strategic flexibility, just wanted to get a bit more clarification around that. Clearly, you have got a very healthy cash balance, just want to get a sense of why you need to maintain the debt position? Thanks.

Alright, Harry. I will handle the first one and then give it to Ryan for the second two on the costs and the refi. I think, first and foremost, this sort of fentanyl label change, it’s the sort of work that Christian and his entire team and our medical team, it really demonstrates Indivior’s leadership position in addiction. I – this is breakthrough sort of science. It’s really – if you think about the updated data from the CDC regarding overdose deaths, the label is pertinent and timely. And that data in case folks haven’t seen it from Christian’s – it was in Christian’s slides, but you are talking about 69,710 opioid overdoses a day. That’s 190 people each day that pass due to overdose, of which 75% of them are synthetic opioids such as fentanyl. So for us, this updated label it indicates sustained buprenorphine plasma concentrations reduced the occurrence of fentanyl-induced apnea. So for us, it’s early days to see momentum behind scripts with regards to this. But in the third quarter this is a scientific message that our medical team will be able to share because of the new science. And it’s something that when the peer-reviewed publication comes out, it will further aid in dissemination of the message. But breakthrough science, very pertinent for this disease space with over 69,000 deaths a year. So Ryan, could you maybe talk through the costs and then the thoughts on the capital structure with keeping the debt…

Yes. I will start off with the debt. And yes, our goal, as we mentioned, is to keep a very balanced capital position. And with the $1 billion on the balance sheet, one, it does give us that financial flexibility to continue to look at making sure that we are putting the right investments behind our current business, make sure we have the fuel in case we need to pull the trigger on any potential small to mid-term M&A. And also, we have to keep in mind that we have an account payable balance of over $400 million that’s tied to Film accruals. So, even though those are not coming due just yet as we mentioned to you, the Film erosion uncertainty. And if the Film does revert to what analogs say it should, because of having three or four generic players in the marketplace, there would be a large unwind of that accounts payable that we would need to be able to fund and then also just making sure that if you take a look at the next 2 years or 3 years that we can cover all of our large requirements, such as the DOJ and RB settlement. So net-net, we feel good with our current balance and it does leave us with the financial flexibility for the balance of the year. Second, in regards to the OpEx, you are certainly correct that the second half operating expense balance will go up versus the first half. But we are excited about that. We are excited about the marketplace starting to open up. We are excited about our field-facing teams having more in-person activity. And so with that, there is going to be three tactical areas of spend that you will see increase. One is in sales and marketing, certainly see some more T&E, conferences expenses, cost tied to lunch and learns. So again, that’s exciting for us, which allows us to get our presence out there. And then alongside that to make sure that we are supporting our field sales we have scaled up our second half digital marketing efforts to make sure that we can get our message out there at the same time. So, you will see that increase as well. The second area is in R&D. We are looking forward to our R&D trials to continue to ramp back up after the COVID. I think Christian mentioned some of the work that’s being done there. So, you will see those expenses in Q3 and Q4 as well as we are looking at some production capacity projects that we are going to unlock in the second half. And then finally, as you mentioned, it’s the $25 million of investment, which will primarily be focused around building out the CJS teams, medical teams as well as obtaining additional real-world data to help support our studies.

Those are the three areas of what’s going to be driving the second half uptick.

Great. That’s it for me. Thanks.

Thank you, Harry.

Thank you. The next question comes from the line of Paul Cuddon from Numis Securities. Please go ahead Paul. The line is now open.

Thanks for taking my questions. I also have three. Just kind of taking a step back on the sort of U.S. market dynamics with a range of buprenorphine-based products and sort of new prescribers coming in, I am just wondering if you could talk about any changing trends of new patient starts, what are people typically starting on treatment, are there any major changes there? Secondly, with the new products coming in rest of the world, Film, SUBLOCADE, SUBUTEX extended release do you need to put a bit more investments behind those as well? And finally, from me in an era where medical injections are looking like they are going to become mandated, do you kind of think there is some potential for SUBLOCADE to become part of a sort of more kind of committed treatment, particularly within the criminal justice system? Thank you.

Thanks for the questions, Paul. First, on the U.S. market dynamics, I think the last year has really changed some of those dynamics with kind of normalizing telemedicine and physicians being able to initiate treatment outside the office really, which is a new paradigm in this area. And that initiation tends to be on orals. But for us, getting patients into treatment is absolutely the right thing. And we know it’s a chronic relapsing disease, and we know the benefits of SUBLOCADE are bringing more and more patients to that kind of paradigm-shifting option for treatment. So, we welcome it and are excited about helping more patients throughout the journey whether it’s on Sublingual or on again, SUBLOCADE. As I look to the rest of the world with regards to investment we have been quite targeted with regards to shifting of investment from the heritage products over to the launch. It’s – for us it’s a detailed sensitive sort of effort here. And the hospital systems and the socialized medicine systems there haven’t required quite the degree of go-to-market investment that you have seen in the U.S. due to the unique call patterns that we had and distribution systems that we have there. So, we don’t see major step changes in investment in those areas. With regards to SUBLOCADE and a parallel to vaccines and potential mandating, what I would say is the virtues of SUBLOCADE for me stand on their own and we continue to see those be recognized more and more, right. We have a large market for opioid use disorder with a relatively low treatment penetration. SUBLOCADE is a breakthrough asset, right, with regards to it changes the paradigm. It hits 2 nanograms per ml with 70% to 80% receptor occupancy, which blocks the euphoric effects of opioids and helps disrupt the major causes of addiction which are withdrawals, cravings and that feeling of euphoria. We don’t see any other product that delivers that sort of PK profile, that sort of benefits, and so we are excited about continuing to push forward. Post-COVID, as we shift from COVID which is the near-term sort of pandemic, we see a shift of momentum into dealing with the epidemic. You have seen – we talked the data on CDC, but we see even more of a shift within the U.S. to deal with this epidemic and hopefully help more patients. In turn this treatment paradigm, which really you have only got about a very low penetration of treatment hopefully you have turned it on its head and get more normalized treatment in the 80% penetration range, which is what I think we should all aspire to.

Excellent. Presumably SUBLOCADE continues working beyond two months as well.

Yes. Yes, it does. Thanks Paul.

Thank you.

And no further question at this time. Please continue, sir. Closing remarks.

Alright. Just a quick thank you to everyone on the call and to all of our stakeholders for their continued support and interest in Indivior and we look forward to the one-to-ones and the conferences coming ahead to meet with you in more detail. Thank you so much.