Ladies and gentlemen, and thank you for standing by. Welcome to the Indivior First Quarter Results Conference Call. At this time, all participants are in a listen-only mode. After the speakers' presentation, there will be a question-and-answer session. [Operator Instructions] I must advise that this conference is being recorded today, Thursday, 14th of May 2020. I would now like to hand the conference over to your first speaker today, Mr. Shaun Thaxter, Chief Executive Officer. Thank you. Please go ahead, sir.

Good morning, everyone, and thank you for joining us today. I'm Shaun Thaxter, CEO, and I'm joined today by my colleagues, Mark Crossley, Chief Financial and Operations Officer; Christian Heidbreder, the Chief Scientific Officer; and Javier Rodriguez, Chief Legal Officer. I will make some brief opening remarks, then Mark will provide a rundown of our Q1 performance and current business trends and, of course, review our financial position. As you've seen from the press release, we delivered first quarter results, which were in line with our plan and on track to meet our 2020 financial guidance. Then the emergence of the COVID-19 lockdowns in March interrupted these plans, and we have since been refocusing our efforts on remaining strong, resilient and well positioned to support our workforce, patients, partners and other key stakeholders. We obviously do not know when the pandemic will end, but our expectation is that it will pass eventually. Our challenge is to ensure that Indivior emerges in the strongest possible position to deliver on our long-term strategy and vision in the post-COVID environment. As a reminder of our vision, we strive for all patients around the world to have access to evidence-based treatment for the chronic conditions and co-occurring disorders of addiction. This vision obviously drives our business and also guides our response to the current crisis. This is, of course, an extremely challenging time for many patients suffering with conditions such as Opioid Use Disorder and schizophrenia. Securing access to treatments when many countries have been in states of lockdown has presented real issues. Consistent with our vision, we have responded by allocating additional resources to ensure supply of patients while maintaining our focus on improving access. Access to treatment is driven through the support and passion of our more than 800 employees around the…

Thank you, Shaun. Good morning, and good afternoon, everyone. I hope you and your families are staying safe and healthy through these very unique times. First, echoing Shaun's comments, we are incredibly grateful to our 800-plus employees that have quickly adapted to the challenging environment, demonstrating tremendous agility and working tirelessly for our patients. As you saw, our first quarter results were in line with our expectations and tracking well towards our original fiscal year 2020 guidance. However, as we entered March and the effects of COVID-19 began to impact the business, it became clear we are entering a potentially prolonged period of uncertainty. Shaun has already set out the organizational impacts on Indivior. In terms of the financial impacts, recall that around 80% of our net revenue is generated from the U.S. Here, the stay-at-home orders across the states are having unforeseen impacts on prescribers and patients for PERSERIS and SUBLOCADE. Based on the latest market research data from IQVIA, total interactions with health care practitioners are down approximately 70% and new-to-brand prescriptions are down around 40% compared with pre-COVID levels. New product launches, as I'm sure you've heard from other pharma companies, as well as medicines requiring direct HCP administration, have been especially impacted. Given the unknown duration and extent to these impacts, we're obligated to withdraw our fiscal year 2020 net revenue and net income guidance in April. Moving forward, our goal is clear: we manage the acute near-term impacts of the epidemic and mitigate enterprise risk, while also preserving the resources and capabilities that we believe will allow us to emerge successfully once the environment begins to normalize. Now turning to Q1 results where we saw a minimal impact from COVID. First quarter total net revenue was $153 million. The 36% decline versus Q1 last year…

Okay. Thank you, Mark. So in summary, we had a good quarter 1, which gives us confidence not only in our strategies but our ability to execute against them. We're proud of our organization's resilience and determination to serve patients' best interest in the short term through the crisis. And from a management and leadership point of view, obviously, we're very focused on understanding the macro trends out there in the environment and understanding what the sort of nuanced impact will be on our treatment service provision as we start to migrate towards a new normal. And we're very open-minded to the fact that we may need to fine-tune and make adjustments to our sort of operating model and resource allocation to ensure that we are best positioned for growth in the new reality. So with that, we will open up for questions.

[Operator Instructions] And your first question comes from the line of Harry Sephton from Jefferies.

I hope you're staying safe through this pandemic. To start with on SUBLOCADE, do you have an estimate of how much impact the drop from mid-March had on your 1Q performance? And also, how should we be thinking about the disruption through this pandemic? Is it more of a reduced growth rate or a stagnation in the growth rather than potentially seeing an actual decline in the number of SUBLOCADE patients? I also have a question on your selling costs. I noted an increase of around $30 million on last year. What was the -- was the material difference here primarily from the direct-to-consumer campaign? And -- or were there any other drivers there? And also, do you have any plans to recommend the direct-to-consumer campaign in the future as we come out of this pandemic?

Okay. So thank you, Harry. First of all, we haven't observed any measurable, quantifiable impact on the Q1 performance. Obviously, enrollments were down at the end of the quarter. So there was an impact. We haven't traced that through to net revenue. So I think that that's our sort of best estimate there. In terms of the drop-off, we did see, whereas we were seeing an acceleration in quarter 1 across most of our -- well, all of our metrics that we consider important, we were seeing an acceleration and an uptick. I think for some period of time, we had been in a sort of linear growth mode, and everyone was waiting for when do we get to the inflection and start to see some of these KPIs accelerating. That means that there's a new growth trajectory. So we did see early part of that in quarter one. It was then a very dramatic drop-off of the rate of new patient enrollment as soon as all the social distancing and lockdown measures went into place. In fact, you can trace the day of the announcements, and then the next day, we started seeing enrollments dropping off. So as we have sought to identify industry analogs and comparisons, you get a drop-off, you always want to know, are we doing better than everyone else, the same as everyone else, or worse than everyone else to try and understand what's caused by the generic environment and what are the things we can do to influence that. We see that we're pretty much in line with analogs for the types of products that patients have to go to the doctor's office to have administered. And this is sort of ballpark 40%. Then in the last two weeks, we have seen that what…

Certainly. Harry, on the selling costs. The increase versus the base period is a combination really of 2 things. Part of it is the direct-to-consumer sort of advertising that you're talking about. But then recall, as we talk through the Q4 results from 2019 or the fiscal year-end results from 2019, we have increased investments throughout the period as our strategy has expanded into channels, opening up OHSs, the IDNs, the criminal justice system, things of that nature. So there has been also an increased investment there. I would think of it as it's probably 50% to 60% DTC and the balance is these other investments to expand into these channels.

And your next question comes from the line of Max Herrmann from Stifel.

Firstly, just in terms of SUBLOCADE outside the U.S. Obviously, you've got Swedish approval. Just wondered if you could update us seeing Camurus' program do relatively well outside the U.S. And I wonder what your thoughts were on the opportunity outside the U.S. for SUBLOCADE.

Yes. Well, obviously, we do see a material opportunity for SUBLOCADE out the U.S. We've got product approval in Canada and Australia, and we've sort of started shipping product recently. So patients there will start to benefit from SUBLOCADE. The recent approval in Sweden, and we -- other -- obviously have other European countries where we are working through the registrations at the moment. So it's very hard to predict when those registrations will come out. It's very dependent on the questions that they ask and the volume of questions and whether the regulatory agencies work at their usual speed through this crisis. But we're certainly very comfortable with the nature of the dialogue that we're having, and those are all progressing. I think what's positive about the Camurus situation is, of course, that they are demonstrating that there is a need for some long-term injectable medication. So we're obviously very encouraged by that. We're also very confident in the science of SUBLOCADE. We know it to be unique. We know that the 2 nanograms per mil across the whole month providing 70% and above receptor occupancy is turning out to actually generate very meaningful new clinical outcomes. And you know that because if they weren't new and they weren't different and they weren't scientifically robust, they wouldn't be published in the quality of the journals that we're getting. So we're very much in a sort of situation of being very excited about the equity that we have. We're jumping up a bit to be able to turn that into meaningful benefits on a day-to-day level for the jobbing physician who is presented with patients. I think it's also worth recognizing in other countries, around the world, there's a heavy emphasis on supervised dosing. So for many patients, they have to go to the pharmacy every day and receive daily medication. So to have a once-a-month treatment really liberates that patient from sort of daily routine of all that goes with reinforcing and treatment. And if we can provide the receptor occupancy and the clinical impact that the studies show really provide those patients with a new opportunity to work towards recovery. We haven't given any financial view as to what that might quantifiably look like. Obviously, the regulatory and pricing environment evolves all the time. And when we have our products approved, we'll be able to look at the label, look at the pricing, and then we'll be able to make an informed view when we have that information.

And then just maybe a follow-up question on SUBLOCADE in the U.S. Obviously, you've put into this quite some detail in terms of new patient enrollment. Just the data we see is showing, obviously, growth of SUBLOCADE, maybe impacted, stalling a little bit given the impact of COVID-19. But given that we saw previously the rapid turnover that you see with patients going off treatment, if you didn't enroll new patients, wouldn't you not expect to see a much more rapid decline in total prescriptions, which is not something that we have been seeing? So I'm just trying to square that.

Yes. I'm not sure I quite am aligned with the idea that there's sort of rapid decline in turnover. I think that the retention in SUBLOCADE was at least as good as what we saw with other dosage forms. Maybe Christian can make a comment on the data. And as of now, we are seeing good retention rates in the SUBLOCADE population. So yes, over time, clearly, if you're not getting the new patients, you're not benefiting from the repeat prescriptions, and patients in treatment will eventually stop taking medication, hopefully, because we would wish that they're able to live an abstinent lifestyle and return to a more normal fulfilled life and hence, focus on recovery. But Christian, would you like to just make a comment on the retention rates and what we're seeing in the studies?

Yes. What we are seeing actually in the long-term safety and efficacy studies is actually a very good retention rate. And very importantly, what we are looking at far beyond abstinence is really these patient-centered outcomes and all the determinants that define what recovery is all about, that is, are you getting back to employment, for example, which is highly relevant, especially during this period. Are you, in other words, recovering your life. So I totally agree with Shaun on the retention here.

Has that changed then? Because you were obviously publishing the sort of retention rates by month during the first period of the launch. And I wonder whether maybe you're seeing better retention rates then than you were seeing when you were first presenting data on this?

I think the retention rates that we're seeing are still consistent with those data.

And your next question comes from the line of Paul Cuddon from Numis.

I've got two, probably handle them one by one, actually. The first one, digging into the mid-teens growth in the MAT market. And given we know the sort of indirect impact of this pandemic could well last a lot longer than the pandemic itself. But I sort of wonder to what extent you're seeing new physicians gain waivers. And to what extent are you able to support them?

Thanks for the question, Paul. We have seen the increase in growth in the sublingual market. We think it's due to the efforts that the government has put in place to help with continuity of treatment and moving to telemedicine. And so we think via telemedicine where there aren't actual HCPs don't have to directly impact or administer the medication, the sublingual is obviously a preferred medication. So we think that's there. As it pertains to supporting physicians with regards to the film market, our sales force does not promote the film any longer. So with regards to getting their day to 2,000 waver, stuff like that, that's all handled via the various societies and getting the certifications. We continue to see those rates increase, albeit not at the kind of, not at the same rates as we saw in Q4 and prior to the pandemic.

Okay. And that kind of brings me on to the sort of next question, which is given the opportunities in telemedicine and the difficulties in initiating new HCPs or kind of patient starts with SUBLOCADE, are you missing a bit of a trick to put a bit more effort into your own kind of branded generic SUBOXONE as a kind of anchor? But I can imagine your generic competitors won't be offering much support remotely to physicians at this time. And to what extent that could actually be used in the future to move towards SUBLOCADE?

Just on that sort of technical point, we don't have a branded generic SUBOXONE Film. There was one last year, but that was discontinued. We believe that the future lies in being able to give patients the best treatment option available, which, based on the available evidence, we believe that the scientific evidence base is building in favor of SUBLOCADE. So we're putting our resources behind the long-term strategic growth of that very sustainable franchise and that we are very confident based on where we were at just before COVID that we have good strategies and we have the capability to execute effectively against those strategies. Obviously, my expectation would be that as we go along the nuance and the fine-tuning of the strategy and the improved more experience you get and the capability to execute against it will accelerate the growth of the business. But do not believe it would be either in patients' or shareholders' best interest to distract ourselves from that key task because we've set out an expectation of $1 billion of net revenue for SUBLOCADE, and we are very much focused on making sure that we get there as soon as we can irrespective of whatever challenges may come along the way. And we're taking a long-term strategic approach to our business. And we will have to deal with the short term to the best of our ability.

And just finally, are you able to break out sort of how long the long-term liabilities are on those provisions, I think in the past you've...

Paul, I'm not allowed to talk anymore with regards to it other than what's in the financials with the $138 million in the short-term and the $495 million in the long term. So I can't speak to the particulars, so I apologize for that.

And there are no further questions at this time. Sir, you may continue.

Okay. Well, if there are no further questions, then I'd like to thank everybody for their continued interest, active participation and support for this very important disease area and your continued interest in Indivior. And we will look forward to seeing you in the future and maybe online at conferences and meetings, but we will be there to talk to you and answer your questions. So thank you very much.

Thank you. And that does conclude our conference for today. Thank you all for participating. You may all disconnect.