Indivior Pharmaceuticals Inc (INDV) Q3 2018 Earnings Report, Transcript and Summary

Good morning and good afternoon, everyone. And thank you for joining us today and your interest in Indivior. I’m Shaun Thaxter, CEO. And I’m also joined by Mark Crossley, CFO; as well as by our Chief Scientific Officer, Christian Heidbreder; and our Chief Legal Officer, Javier Rodriguez. We will have about 15 minutes of commentary. I will make some opening comments, and Mark Crossley will follow with a rundown of the key financials. And then we will, of course, turn to your questions. The big picture is that our daily medication businesses around the world are under pressure from well documented and anticipated market challenges, resulting in the current downward net revenue trend. Our big opportunity and immediate priority is to drive new net revenue growth from our recently approved injectable products, SUBLOCADE and PERSERIS, to mitigate these downward pressures and to create new, sustainable, long-term top and bottom line growth for Indivior. In the third quarter, we faced a combination of downward forces on our base business. First of all, we faced increased generic competition, most notably the at-risk launch by Dr. Reddy’s of a generic version of SUBOXONE Film in the U.S. Secondly, the concentration of U.S. market growth focused in the less-profitable government channels. And there was further erosion in generic tablet pricing in the U.S. and continued government-mandated price cuts in the Rest of World segment. Looking forward, the revenue pressures we face in our U.S. Film-based business are likely to continue. The momentum on volume expansion and growth will continue in government channels, and this will be fueled by increased state-level funding to address the opioid crisis. Furthermore, generic buprenorphine and naloxone tablet pricing is now at commodity floor price levels of around 80% below list price. This level of pricing has the greatest impact with the most price-sensitive payers, as we know, and also exerts downward price pressure across all channels. Because of these factors, Indivior expects continued pressure on its U.S. SUBOXONE Film net revenue base. In the near term, to mitigate the risk to the bottom line, we have streamlined the organization and are on track to deliver our previously announced cost savings of $80 million to $100 million by the end of full year 2019. I would like to say how pleased I am with how our team is responding to these challenges. We have maintained SUBOXONE Film’s market-leading position with our share backup to pro -- close to pre-Dr. Reddy’s entry levels, and we are continuing to generate strong profitability. Our streamlined business provides us the ability to move forward with confidence in driving the success of our future growth drivers, SUBLOCADE and PERSERIS. So let’s look to our future now, starting with SUBLOCADE. We continue to work diligently towards our primary strategic goal of unlocking the potential of this groundbreaking Opioid Use Disorder treatment, which we remain confident will meet the $1-billion-plus revenue goal we have set for ourselves. You’re all aware that we have faced a number of barriers in the launch phase, and that this has resulted in a slower initial revenue build than we had planned. But as you also see in the KPIs we released this morning, we have achieved significant improvements in the third quarter in the SUBLOCADE prescription journey key performance indicators. Access is now at target levels of 82% of covered lives. The prescription journey is in the target range of around 15 to 20 days, and we’re steadily improving the dispense conversion rate, which is at 35%, which is well over halfway towards industry standard for the long-acting injectable analogues. We won’t be satisfied with 50% as a target, of course, but it’s a benchmark. And we will continue to shoot to optimize once we achieve that goal. So we’re pleased with the progress against these logistical seething problems and now look to leverage the recent positive events that help accelerate new physician trial to further drive demand. Recognizing some of the key barriers to demand generation that we’ve experienced in the first six months. And these are: the physicians are often cautious about storing the product on site, and many are reluctant to actually inject patients. And this is something that we’ve seen mainly with psychiatrists. We’ve also found many physicians are in provider networks requiring policy change to allow specialty pharmacy distribution models, and so this is also taking time to work through. We’ve also had a lack of promotional and educational resources for physicians and patients, which has made, obviously, the conversation more challenging. However, key events have occurred that provide us with new opportunity to accelerate our ability to address these issues. First of all, we’re beginning to see the benefit of having a full promotional mix, enabled by the receipt of our approved messages from OPDP. These began to impact the market in September in the following areas: First of all, we have a full range of promotional and educational materials for physicians, enabling an improved quality of communication between our clinical liaisons and health professionals. This is particularly important as the science and the messaging is quite complex in bringing forward this transformational new technology. Secondly, we’ve been able to have a launch of our full treatment advocate program, where physicians talk to other physicians about treatment, particularly with SUBLOCADE. Patient educational materials are now available about SUBLOCADE. So patients, for the first time, have information in their hands that they can read about this medicine and the benefits that they can expect to receive from it. We’ve also launched our SUBLOCADE website, which provides education about treatment with SUBLOCADE for patients and also their families and caregivers. And this is being further stimulated by the launch of our search engine marketing and our digital campaign. In its first month of September, this generated 350,000 visits to the SUBLOCADE website. So those benefits have really all started to impact in September, following our OPD resources. The second big event is the recent legislative environment has changed, which has also unlocked further potential. Legislation H.R.6, the Patients and Communities Act, contained important changes across the board for addressing the opioid dependence, were the very specific changes that will positively impact SUBLOCADE. First of all, the legality of the distribution of Schedule III injectable products through specialty pharmacy is being enshrined into law, which gives greater clarity and will give many physicians greater confidence about using this distribution channel and storing medication on site. The second big thing this legislation now allows for is, for the first time, waived physicians will be able to write the prescription and have the patients receive the injection from another doctor, even if the injecting doctor does not have a waiver to treat opioid dependence. This will be particularly helpful for psychiatrists in our disease space, particularly many of them do not like to touch their patients. So this will be a new opportunity for that genre of physicians. The third big benefit is the board-certified physicians can now go immediately to 100 patients without having to work through the 30-patient initial trial period. So I think these are all very important structural changes in the market that will be supported. We continue to have belief in the transformational potential for SUBLOCADE because it’s continually reinforced by the anecdotal feedback we get from patients and physicians who have experienced SUBLOCADE. This is supported quantitatively by the movement of physicians from trial to adoption. We saw that the number of physicians treating more than 5 patients has more than traveled across the quarter to 108 physicians. We continue to see the positive experiences shared by patients in social media and are now hearing, for the first time, that patients are starting to ask their doctors about SUBLOCADE by name. So in summary, while it is still early in the launch, we are confident that we are doing the right things to drive success. New physician trials will be our primary focus as we layer these new opportunities on top of our existing program. Although the impact is not yet observable in the third quarter net revenue, we are starting to see early indications of the impact of the new promotional mix. The full momentum, however, and the benefit of the legislative changes will be experienced over quarters rather than weeks and months. So as we now turn our attention to PERSERIS, we’re look -- very much looking forward to making our PERSERIS available, which, as many of you know, is our long-approved, long-acting injectable for the treatment of schizophrenia. This is a competitive category. But we know that there are still unmet patient needs, and we firmly believe PERSERIS can deliver on these. In particular, PERSERIS leverages the same Atrigel platform used in SUBLOCADE, which means that not only does PERSERIS have a rapid onset of action, but it also maintains the plasma concentration of its active ingredients for a full month. Regarding the launch of PERSERIS, we are moving forward by making initial quantities of product available in the U.S. this quarter to respond to initial interest and to generate awareness. We will move forward on the full commercial launch with 40 to 60 representatives, contingent upon the issuing of the ruling that the preliminary injunction has been held -- upheld by the federal court. So we’re very keen to get moving on that, but we need to get the positive outcome from the preliminary injunction ruling before we actually take action. Once PERSERIS is established in the market, we will have delivered on an important strategic objective for Indivior. We will have a more diversified net revenue stream from products that leverage our strength in the closely linked disease spaces of addiction and schizophrenia. So to conclude my comments, we have faced many challenges, but we are moving forward and starting to gain momentum. We’ve shown through Indivior’s short history that we thrive on challenges and are ready to adapt when it is necessary. We all focused on the future and to put in place the road map that we believe will allow us to continue to deliver against our strategy of global leadership in the treatment of addiction and its co-occurrences. We are focusing on driving the success of SUBLOCADE and PERSERIS with a streamlined organization, and we know that the results ultimately are the true measure of our success. And we remain confident in our ability to deliver. We look forward to providing you with a further update and more detail at our Capital Markets Day on the 5th of December. I will now turn the call over to Mark for a more detailed rundown of our financial performance. Mark?

Thanks, Shaun. Overall, our results are -- on an adjusted basis, were consistent with the expectations we had when we updated guidance in late September, and they reflect the competitive and environmental dynamics we are experiencing. As well, they also reflect our progress on making our internal cost-savings initiatives announced in July. As a consequence, we remain on track to achieve our revised fiscal year 2018 guidance of net revenues between $990 million and $1.20 billion, and net income between $230 million to $255 million, as we communicated on September 26. This assumes the U.S. market conditions remain unchanged, chiefly that the Court of Appeals upholds the preliminary injunction that Indivior was awarded against Dr. Reddy’s. Now turning to our performance, starting with the top line. Year-to-date revenues declined 7% to $768 million, but by 11% to $245 million in the quarter. On the quarter, the step down in net revenue reflects the low double-digit market growth, primarily in the less-profitable government channels, more than offset by the net revenue loss from Dr. Reddy’s generic at-risk launch in the quarter. And this consisted of both share loss and a bit of destocking activity. In addition, there is continued price pressure from continued lower generics pricing in the U.S. that Shaun spoke to earlier. SUBLOCADE net revenue in the U.S. on the quarter was $3 million, bringing year-to-date net revenue to $5 million, and we are on track for our $8 million to $10 million of net revenue guidance in fiscal year 2018. The Rest of World revenue declined in the quarter by 15% at constant FX, primarily due to government austerity measures on price and increased competitive pressure in certain EU markets that we guided to earlier in the year. This is further impacted by phasing of shipments and onetime favorable items in the base period. Based on IMS, we expect the fiscal year 2018 net revenue impact of Dr. Reddy’s at-risk launch to be in the range of $12 million to $18 million. As evidenced by our share recovery during the quarter, it appears that Dr. Reddy’s share has stabilized below 1%, while their initial quantities of stock continue to sell through. While we’re still not certain of the absolute amount of stocks sold into the market ahead of the PI, their share has stabilized, thus making the revenue forecastable for the year. Continuing to gross profit. On the margin basis, we saw a contraction in the quarter of around 400 basis points, and this is primarily due to the ongoing contingency planning related to potential generic film entry in the U.S. Working further down the income statement, again on an adjusted basis, year-to-date operating profit declined 24% to $254 million, but increased 13% to $71 million in the quarter. Similar to what we’ve seen in the year’s numbers, lower revenue, along with the SUBLOCADE launch investments and establishment of the Behavioural Health unit to launch PERSERIS, were the main impacts. However, unlike the previous two quarters, we’ve more than compensated for these factors in the third quarter through a combination of lower legal and R&D expenses as well as initial realized cost saving benefits of $21 million. As you know, we’ve targeted cost savings this year of $55 million, with the continued expected benefits from our initiatives and the recently completed headcount reductions. The majority of targeted fiscal year 2018 savings will be realized in the fourth quarter. Adjusted net income in the year-to-date period declined 5% to $205 million, but increased 23% to $58 million in the third quarter. The increase in the quarter was driven by a number of factors, including the higher operating profit, a decrease in finance expense from the near -- from the term loan refinancing we executed in December as well as an uptick in interest income and a lower tax rate in the U.S. Turning to the balance sheet and cash flow. Cash and cash equivalents stood at $901 million at September 30. Net cash was $569 million, an improvement of $193 million versus the end of the year. To highlight, we’ve prepaid $150 million of outstanding principal on the term loans on September 10. As a result, the outstanding borrowing under the term loan facility is down to $329 million. We continue to preserve our strong financial position to protect against potential downside risks and litigation liabilities, while maintaining flexibility in a play-to-win strategy. With that, I’ll turn back to Shaun.

Thank you, Mark. So that completes our sort of commentary, and now we’d be very pleased to take your questions.

[Operator Instructions] We will now take our first question from Max Herrmann from Stifel.

It’s Max Herrmann from Stifel. Firstly, just to try and understand a little bit more about the treatment adherence and how that’s -- the experience you’re seeing with SUBLOCADE in the market, how that compares with the SUBOXONE Film and whether the compliance advantages are bearing out with the once-monthly formulation. Secondly, just wanted to get an update from you regarding the European filing for SUBLOCADE. And then also I see you’re now planning to resubmit the film for filing in Europe. So I want to just try and understand what had changed there in terms of bringing that back on to the market.

Okay. Thank you, Max. Yes, we are pleased with the compliance rates. When you look at the chart, you see that the fourth injection of 45%, it -- what’s not clear from the chart is that, actually, if you’ve had your fourth injection, you’ve probably been in treatment for 6 months. Because if you imagine the time frame when these patients were receiving their first injection, they were probably been on treatment with SUBOXONE Film for one or two months before they received their first injection. So when we think about the fourth injection here, we’re probably looking -- and we can’t be unequivocal about this, of course, but we’re probably looking at patients who have been really in treatment for five or six months rather than only four months. So it’s very difficult to make a direct comparison with SUBOXONE Film in absolute terms. But we should think that -- how long has this patient been on SUBLOCADE or injections? How long they’ve been in treatment? Probably six months. So the retention rates tend to correlate to that extra time frame. So I think this is a very encouraging statistic because what we’re starting to learn is that getting to six months is quite an important milestone in terms of duration in treatment for patients starting to sort of -- to be seem to be having a significant impact in progressing the management of their disease. So we are pleased with that. With respect to the EU filing of SUBLOCADE and film, Christian, would you like to comment on that?

Yes, absolutely. So SUBLOCADE in Europe, we are targeting the fourth quarter 2018 to make the filing according to a decentralized procedure because this will be an extension on Subutex. We are going to basically target EU whole, that is France, UK, Germany, Italy as well as the Nordic countries. That is Denmark, Norway, Sweden and Finland. With respect to the SUBOXONE Film, there has been, in fact, a lot of changes. As you may know, we have addressed several questions from the European regulatory agencies from the past. We are now in a position to really file the film dossier, following a very important meeting we had with BfArM, the German regulatory agency. That was the rapporteur of our filings. And we are currently targeting the first quarter of 2019 in order to make the appropriate filing according there to a centralized procedure.

We will now take our next question from Paul Cuddon from Numis. Your line is open. Please go ahead.

Just a question on the attrition rates between the prescription and dispensing, in light of the 82% payer coverage. Because I mean, for me, the number of prescriptions initiated is very encouraging. The number of physicians attempting treatment is also very encouraging. But it’s that conversion that that 35% from 29% doesn’t appear to be moving. So it’s the balance of where the 65% is falling away, if you could explain.

Yes. I mean, we were very quick to gain formulary access. And I think, as we’ve talked before, the sort of implementation of the medical benefit takes time. The more people we talk to, the industry experts are saying, "Well, you’re making very good progress against industry analogues about the time it takes from going on formulary to having medical benefits policies written, drafted, implemented and then systematized." So I think what we’re seeing is we are seeing improvements. We’re hearing it in from the field. The doctor’s offices are finding it easier to get patients through the system. Fewer percentages. We talked before. We had a lot of inconsistencies between plans and patients getting rejected from the same plan with different rules. That’s all kind of sort of working its way out now. So I think we are seeing, people say that normally takes six to nine months. So I think that’s pretty much on track and making good progress. Although we’re, by no means, happy with it, of course. But the issues that have held it back are working their way out. Admittedly, it’s not yet as visible in the performance indicators as we would like it to be, but we are confident we’re doing all the right things. Reimbursement team, strengthening their relationships with office practices. And that’s giving them greater access and better quality of trust and relationships with the practices so that they now embrace the education that they’re being given on how to do this. And so all these things are having a cumulative effect.

But you would say it is the medical benefits analysis that is the primary part of that 65% attrition?

That’s a major contributor. Another contributor is, obviously, we have had taken a long time for patients to wait to get their treatments. So some doctors and patients have given up. That’s improving all the time. So we would expect, subconsequently, that to improve the yield rates as well.

I think the thing to remember also, Paul, is you do have new physicians coming in, doing this for the first time. And so if you go back to the example Shaun used with whether it’s a passport or one of these things, they’re going through that learning cycle, potentially making errors in paperwork and things like that along the way, and that impacts this somewhat also. So you’ve got some that are starting to become functional with regards to this new go-to-market model, and then you’ve got new people coming that are still naïve and still learning. So it’s a combination of those things.

I think there’s also -- I was just saying, we’re also looking out for opportunities in selected plans where we might be able to move this from the medical benefit to the pharmacy benefit, which will also sort of systematize some of these out-of-the-manual process. But that’s not something that’s universally available, but we’re exploring opportunities there to make it. I think the benefits there are twofold. Not only is it about the time that it takes for this to work through the system and the inefficiencies within it, it’s also about how much work and effort is it for the doctor’s practice. So what you’re really seeing here, in terms of who are the early adopters, these are the doctors who are most patient-oriented. These are the patients that -- the doctors that really, really, really care about this particular patient population, and they’re willing to go the extra mile, right, for their patients. So if it has been a little bit of hard work in the 6 months, they don’t care because they really want to help their patients. Now of course, there’s a limit to how many patients they got time to do, so that’s not being helpful. But the doctors who just say, "I don’t really have the infrastructure to spend too much time on that." That will build as the simplicity and the ease and the time all comes down so that will help us improve our penetration. So all these things sort of work cumulatively, and we see good progress.

We will now take our next question from Nick Keher from RBC.

Just wanted to talk through the launch for PERSERIS. But also, you discussed the fact that you would think again, as the PI decision goes your way for Dr. Reddy’s. I’m just quite keen to understand what you’re thinking would you also be on an Alvogen risk launch beyond Dr. Reddy’s as well. And if you can just talk through the potential scenarios there.

Gladly. So the first thing we have to recognize is that Alvogen don’t have a product approved yet. But I think if we’re realistic, it probably will get a product approved at some point. But certainly, it’s not available yet. Now I am aware they talk a good story about looking up a launch, but their fate would be pretty much the same as Dr. Reddy’s . The minute we got word of an approval in any distribution, we’d be straight in through the courtroom door within -- literally within minutes and hours. And we would be issuing -- asking the court for a Temporary Restraining Order. And we would go after that with as much passion and enthusiasm as we did with Dr. Reddy’s, and then follow that through with the same level of ruthlessness and determination about getting a preliminary injunction on Alvogen. It would be going to the same judge. It’s unlikely that he would welcome all of this nonsense from Alvogen when it’s very clear what his ruling is on this subject that he’s already made very public with Dr. Reddy’s. So -- I mean, we would expect to follow the same path. While we’re talking Dr. Reddy’s, just to remind everybody, we had a ruling on the 4th of October. We are optimistic about the ruling there. But nevertheless, it wouldn’t be wise to make business decisions on the assumption of something that you feel good about until it’s actually happened. When it -- clearly, it would have so much impact on the business. So that’s why we need that confirmation before we can go ahead and activate the PERSERIS launch. So we have done good work on recruiting. And we’ve identified some good talent. So we’re ready to move very quickly and effectively once that ruling comes. Next question will probably be when will it come. The answer is we don’t know. We hope to have it sometime this month. But again, it’s up to the court and the judge when they issue their ruling. And it’s not good news or bad news if it comes quickly or takes longer or if they just take as long as they take to work these things through as we all know. What specifically would you like to know about the PERSERIS launch?

No, sorry. It’s really just in terms of -- you did answer the question. But the key thing I suppose probably from that is, would we be fair to say then if Alvogen did launch at risk, this wouldn’t impact your PERSERIS launch? You wouldn’t change your profile of that launch at all? Is what you said there, you’d be quite confident going the same way.

Assuming that the judge -- well, yes. I mean, we can’t guarantee anything that happens. And clearly, we have these binary risk events in our business, and we run our business on the expectation of a positive outcome. So our expectation would be, or I hope or however you would like to characterize it, that if Alvogen did launch, then there’s no reason to believe that we would not get a restraining order because we did with Dr. Reddy’s and the arguments are the same, very similar. The preliminary injunction, similarly. So we don’t really have any reason to change our position on that. Therefore, our position in court remains the same.

Okay. And then just referring back to one of the questions from earlier on Slide 7 of the presentation on the treatment adherence rates. Are there any other -- I mean, you talked about 6 months -- the fourth injection suggests that somebody’s been on treatment for 6 months. With that 45% rate, it all seems a little bit low against the analogue of the film, for instance, at 6-month treatment rates. A benefit, but not perhaps as much as what we had expected from prior presentations and results. Are there any other reasons why the injection rates are dropping off the way they are for the patient from what you’ve seen today?

Yes. I’m not sure which data you have in mind when you think these don’t have significant variation from the film. The data I think we’re most familiar with is that you tend to see about 50% drop off in the film in the first sort of couple of months of treatment, though if you could remind me of the data point you’re thinking.

It’s actually from your prospectus from the -- when you came to market the presentation at the time. So you put against the film against the tablet for 6 months. At six months, 33% on therapy on the film. I think you’re -- yes.

All right. Okay. So you’re comparing the 45% with the 33%. So yes, I mean, I think if you ask a lot of opinion leaders and experts, they would see -- if you -- that’s nearly a 50% improvement. They would see that as a significant benefit then there’s a significant improvement. I think they would try and think that’s very valuable and clinically relevant. If you think what’s likely to be happening for those patients if they’re not in treatment, potential for relapse, overdose and all the negative things and costs that the payer incurs when patients are not in treatment, those are quite significant. And we also have to recognize the sample size is relatively small. We’ve only had 2,500 sort of patients through this year. So it’s still early days to draw too many substantial conclusions.

We will now take our next question from Nick Nieland from Citi.

A couple of questions just on PERSERIS. The price looks to be in line with the lower end of competitors in that market. I wonder if you could just comment on whether that is the case. And about your pricing strategy.

Yes. I mean, the -- we tend to find that a lot of these products are all on a fairly similar sort of net price. And we certainly don’t have any intention to sort of disrupt the market at a pricing level. So we expect that we will be in the sort of normal range of most of the market.

And then secondly on PERSERIS. I seem to recall the price for the SUBLOCADE launch, you did the market evaluation and you increased your peak sales guidance based off the back of that. And I wonder if you’ll be doing the same for PERSERIS and whether the chance you might change your guide based on the market analysis prices to your first commercial launch next year.

Yes. I think that we don’t have any change basis at the moment to change our PERSERIS forecast. However, when we do recognize that this is a rapidly growing sector and the sort of the segment is growing quite healthily. But at the moment, based off our research, we don’t have a basis to make any changes.

Okay. And then lastly, just on SUBLOCADE. You’re putting aside all of the logistical issues that you’ve documented. Just talking about actual demand for the product from patients described it. I was just wondering how that compares to the expectations you had before you launched.

Yes. Well, I think -- I mean, one thing that is the big difference in terms of our sort of expectation on the demand front is that we clearly had anticipated we’d have a full promotional mix, and we would have the resources and the materials. And we’ve only really had those in full -- a full suite of those in September. So this is a very complex message. We’re trying to transform the treatment of addiction. We’ve got a lot of new science. It’s very technical, and it needs careful explanation. It’s not the sort of thing you can get done in three minutes in the product label. But the product label is all our field force have had for the first six months. So we don’t want to make excuses because we’re not -- we’re accountable for delivering what we said what we were going to do. But nevertheless, the fact is that we did have to wait an extra four months for those resources. So I think that we will be in a better place to judge how well physicians are really responding to the message when we’ve had three or four months with all the support materials that the physicians need. Because the physicians find themselves, "Well, I’d like to talk to my patients about this. What have you got to help me." Well, haven’t got anything. "Well, what can you give to me?" Well, I haven’t got anything. I’ve only got my label. Now we’ve got the patient labels. The physician can give something to the patient. The patient can read what they should expect on the treatment. And all the reassurance that’s required. Because that emotional level, when you’re asking people to do something different, they believe it, and they want to do it, and they follow you, and they’re ready to do it. But they often need a bit of reassurance and to make them just -- make that commitment. And that’s where it’s been difficult without those materials. So we are very pleased. We are seeing numerical things that we can look to, like 350,000 hits after the first month on the website. So people are hungry for this information. We know that patients are talking to other people about their experience on SUBLOCADE. And that’s encouraging other patients to come into the doctors and ask the doctors for SUBLOCADE by name. So I think those things have all -- we would wish that they had happened sooner. But nevertheless, they are happening. And we believe that, across the board, we’re doing the right things to continue to drive that demand in the right direction. We can’t underestimate the importance of some of these legislative changes as well. That allow psychiatrists to have non-waivered injectors, support them in the administration. The fact that doctors now feel more comfortable about this distribution system and storing in their practice because the distribution system is specifically written down in law that it’s lawful. It’s not that it wasn’t lawful before. It just wasn’t clarified anywhere that it specifically is. So now doctors can feel more comfortable with that. So I think it’s all good progress.

We will now take our next question from Harry Sephton from Jefferies.

Just had a quick question going back to the adherence rates. So looking at that fourth injection, does that count for any patients that might have missed like an injection cycle, as it were? And if not, do you have any indication as to how many patients who do potentially lapse an injection cycle might potentially come back further down the line?

Yes. I think it’s too early to have any real data on that. We haven’t picked that up as something that we have observed. But it’s an interesting question, and we’ll look for it moving forward.

So that fourth injection is someone who has had consistently those four injections over and not potentially missed the cycle?

Yes.

Yes. Okay. That’s clear.

Yes, that’s correct. Yes. That’s correct.

And then on conversion rate, how many of those -- I guess, the 65% which have been rejected is from prior authorizations? And it would just also be helpful to know why they’re getting rejected for those prior authorizations.

Yes. I mean, we don’t have specific data to share on the exact numbers. But what we do know with the prior authorization, a lot of it is being driven by a lot of the health plans haven’t had enough patients through yet while the policies have all been embedded in place. Where we are finding doctors who sent patients to the same health plan, they’re kind of getting systematized. They’re getting used to it and things let down. We’re seeing the inconsistencies starting to flush out of the system. And I think it’s the inconsistencies, the poor training, the inexperience of the people who are adjudicating the claims, that is an important issue here. And that’s what we are hearing predominantly. We’re not hearing generally that all the health plans are systematically rejecting this because they don’t want patients on it. The vast majority -- and this is a very important point, the vast majority of the prior authorizations only require that the patient is confirmed, has a diagnosis of opioid use dependence. So what does that mean? So well, it means, the payer -- you could argue the payer’s being responsible. There’s an opioid crisis. Everybody who is in the opioid business is being scrutinized rightly so by the government, and they need to demonstrate they’re doing the right thing. If you were an insurance company and you want to show you’re doing the right thing, you say, Well, we do double check. Anyone who gets this medication is actually appropriately treated and diagnosed as a non-label patient. That’s all they’re asking us to do. If they didn’t want to pay for it, they’d put multiple step edits and all sorts of other criteria in addition to that diagnosis. But they’re not doing that. They’ve also rapidly put this on the formulary, right? We’ve got 82% of the U.S. lives covered, which is an incredible achievement at this moment in time. There are lots of things that you can quite rightly say, "Well, we’re disappointed with this and disappointed with that." But we can’t possibly be disappointed with how payers have embraced this and put onto formulary. We also know -- the whole environment around the opioid crisis is positive. And nobody wants to be seen to be working against the opioid crisis. So we think these efficiencies will improve, that the environmental support and encouragement is there. The experience and the learning of the administrators and the engine room of these health plans is improving.

And just one final question. It’s clear there are actual growth and the number of prescription journeys has been positive. But it’d be useful to get an indication as to how many physicians your clinical liaisons have actually been directly in contact with in that time and what sort of percentage conversion that ‘18, ‘17 number is of the total number of physicians you’ve been in contact with?

We’re in contact, obviously, with most physicians. But I think the sort of priority focus has sort of been targeted on the top sort of 5,000 to 6,000 physicians in the first phase.

This concludes today’s question-and-answer session. Mr. Thaxter, I’d like to turn the conference back to you for any additional or closing remarks.