Indivior Pharmaceuticals Inc (INDV) Q3 2019 Earnings Report, Transcript and Summary

Good morning and good afternoon. Thank you for joining us to discuss our 2019 Third Quarter Results and Year-to-Date Results. I'm Shaun Thaxter, CEO of Indivior. And I'm joined by Mark Crossley, our CFO; Christian Heidbreder, our Chief Scientific Officer; and Javier Rodriguez, our Chief Legal Officer. We will have about 10 to 15 minutes of commentary. First, I'll provide a brief overview of our results and update you on the progress with our key growth drivers, SUBLOCADE and PERSERIS. Then Mark will take you through the financials and we will close with your questions. And I'm going to take us read the forward-looking statements. As you've already seen from the results, performance in the third quarter reflects a continuation of the trends we have seen all year. Just as we reported in the previous quarter, we delivered a solid level of operating profit and modest net income growth on a year-to-date basis, despite the expected decline in net revenue. The main drivers of our performance have been the better-than-expected share performance of SUBOXONE Film, together with our strict cost discipline and focus on cash management. As a consequence, earlier this month, we raised our net revenue and net income expectations for the year and reported an improvement in our cash balance to over $1 billion. Mark will take you through the detailed assumptions underlying our full-year guidance. But as we have cautioned throughout the year, we have yet to see a sustainable rationale for SUBOXONE Film's over-delivery. As such, we continue to conservatively expect that the erosion of branded film share will trend towards historic analogs. You will also have noted the most recent developments in our U.S. film business that is our decision to end the authorized generic film program as a result of new legislation. Under this legislation, which became effective on October 1, changes in best price methodology have resulted in an unsustainable situation whereby we would continue to lose money on a gross profit basis on every unit of SUBOXONE Film we sell in most government channels. In the light of the impact of this legislation, we took an immediate action to protect our business and cash position. We did not take this decision lightly and an important consideration for us was patient choice and availability. However, we ultimately concluded that with three other generic film products in the market along with SUBOXONE Film, our decision to continue the authorized generic would not adversely impact patient choice. You'll see that our net revenue from SUBLOCADE was $48 million, which puts us on track to deliver our narrowed full-year guidance of $60 million to $70 million. I'll return to SUBLOCADE's progress in a minute, but first wanted to share a brief word on the DOJ matter. We know this is an overriding issue for our stakeholders. But as you probably come to expect, I'm unable to go beyond the update in today's press release and the various public statements that we have issued. As you are aware from previous communications, a trial date has been set for May 2020 and that we are diligently preparing our case. Looking more closely at SUBLOCADE and the continued progress we are making, the key message is that over the last 18 months, we have remedied the major logistical aspects of the patient journey and greatly improved the quality of access to SUBLOCADE. While the specialty pharmacy journey will always be more work for the healthcare providers and their office teams, our progress brings us well within the benchmark of specialty pharmacy products. Not only have we reached excellent levels of payer coverage at 88%, but more than 220 million lives are now benefiting from simpler and less complex coverage. The prescription journey time, a major issue to begin with for patients and their physicians, has been optimized and maintained between 12 and 17 days. The dispense rate or yield is now consistently above 60% and has for the first time entered into the target range of mid 60%, which is comparable with SUBOXONE Film. So these KPIs are no longer a drag on our SUBLOCADE performance. And although we will continue to optimize, these problems are now solved and behind us. In conjunction with our project, our progress, the entire commercial organization has evolved to handle logistical and reimbursement complexities of this specialty medicine. As such, the overall reliability and trust in the ordering and delivery of SUBLOCADE is being rapidly reestablished among the treatment community. In terms of prescription initiations and administrations, we saw a continued growth as you would expect. And the sequential rate of improvement, however, was modestly lower, but within the established band of growth we observed since launching SUBLOCADE. While this great growth rate puts us comfortably within our net revenue range for SUBLOCADE in 2019, we are not satisfied with this growth rate. We've increased our focus in this area and will help bring this KPI up to the same level of performance as the other KPIs we have focused on today. We are deploying some of the over-delivery on SUBOXONE Film to support new initiatives to improve the demand trajectory and to accelerate net revenue growth thereafter. We are moving forward across multiple media channels to increase healthcare professional and patient awareness. So to conclude on SUBLOCADE, as we close 2019 and look into 2020, we remain confident in the future trajectory of SUBLOCADE and continue to work towards our $1 billion net revenue target. Now, I'll turn to PERSERIS. It's still relatively early days in the launch, which you will recall began in earnest in late March. However, we continue to be encouraged by the positive anecdotal feedback from our carefully targeted prescriber audience, from our success in achieving strong payer coverage of over 90%, and from the relative ease of distribution we have encountered. Our job now is to translate this level of HCP trial into greater depth with more prescriptions per physician. If we are successful in doing this and we believe that we have the right capabilities in place, PERSERIS will continue to become a meaningful diversification play for Indivior in the future. So I'll now turn over the call to Mark for a more detailed rundown of our financial performance.

Thank you, Shaun, and good morning and good afternoon, everyone. Overall, we saw another quarter of solid financial performance, as you can see in the supplement. Our top and bottom line results were again ahead of our expectations, and our financial position remains strong. As Shaun noted, earlier this month, we raised our outlook for fiscal year 2019 net revenue and net income, which I'll detail in a moment. Taking a closer look at the third quarter, starting with net revenue, overall we saw a 19% decline versus the prior year at actual currency. While overall net revenue has continued to outperform our expectations from the resilience in SUBOXONE Film, it declined versus the prior year due to generic film entry in February. This decline was partially offset by net revenue growth from SUBLOCADE and from the authorized generic film. Focusing on the U.S. market dynamics for a moment, SUBOXONE Film share averaged 26% in the quarter, only a point lower than the second quarter exit share of 27%, but down from 53% year ago. While we don't have quantitative data on why the film is outperforming analogs, we believe the resilience we are seeing is a combination of the current relative pricing environment, as well as patient success on film. While we've been pleased with the additional net revenue and cash flow the share outperformance has provided, we continue to believe the dynamic is unlikely to be sustainable and that branded SUBOXONE Film will in due course arrive at the share position suggested by industry analogs. In particular, as we move into 2020, we believe there'll be greater level of formulary scrutiny by the payers, which in turn likely to accelerate erosion of our branded share. Turning to the performance of the authorized generic film, Sandoz executed well and maintained their leadership position, with an approximate 50% share of the generic film market in the third quarter. However, as Shaun discussed, we've been forced by new legislation to terminate this program as we would have been in the unsustainable position of selling SUBOXONE Film at a loss through most government channels, which now account for over half of SUBOXONE Film sales. We do not expect to incur any material costs relating to the ending of the authorized generic program. Now turning to Most of World, we saw an 11% increase in net revenue in the third quarter. The primary driver of growth was one-time in nature benefits, principally from an out-of-stock situation in Canada with a generic provider, which resulted in greater SUBOXONE tablet volume there, as well as phasing of net revenue in distributor markets, mainly the Middle East. All of this versus a relatively depressed base period. The growth we saw in the Rest of World in the quarter improves the year-to-date net revenue decline to 10% on an actual basis. We are only minus 4% on a constant currency basis, which is in line with our expectations. We continue to expect a modest decline on the full-year. Low single-digit market volume growth in the EU and modest growth in Australia is expected to continue to be more than offset by pricing from austerity measures and competitive pressure in Europe. Moving to gross margin, we saw a decline in the quarter to 83%, which is within the range we indicated. This decline was primarily due to product mix associated with the authorized generic and lower branded SUBOXONE Film net revenue. Looking at operating income, on an adjusted basis this decreased in the quarter to $57 million, with a relatively solid margin at 29% of net revenue. On a year-to-date basis, operating profit was $248 million, a modest $6 million decline, although operating margin increased by about 500 basis points due to significant savings realized with focused SG&A and R&D investment. Overall, OpEx in the quarter was lower by $30 million year-over-year, which is 22% decrease. On a year-to-date basis, OpEx was lower by almost 30% or $100 million, again reflecting benefits from the streamlining actions we took as part of our contingency planning measures. In this regard, as Shaun alluded, we are deploying a portion of our over delivery on the top line to increase sales and marketing for SUBLOCADE. In fact, you'll notice the OpEx ticked up $8 million versus the second quarter from an increase in SG&A. The investment to increase SUBLOCADE awareness among healthcare providers and patients is absorbed in our maintained fiscal year 2019 OpEx guidance and includes increased outreach as well as modest personnel. Turning to third quarter net income on an adjusted basis, that was $48 million, down 17% year-on-year. On a year-to-date basis, net income increased modestly. Both periods include the benefit from lower overall finance expense and interest income on our increased cash balance. The year-to-date improvement in net income helped drive our cash balance higher to $1.023 billion at the end of September, giving us net cash of $783 million. This substantial cash buffer remains an important buttress for the company as we navigate through the transition period to renewed growth from our depot technologies and as we confront the legal uncertainties. When modeling our cash flow, I repeat my previous comments that an acceleration in the pace of erosion of branded SUBOXONE Film will likely result in a material use of cash associated with the group's negative net working capital position. Payables, again, were a drag on operating cash flow in the quarter. Turning lastly to guidance. As we announced on October 15, we expect fiscal year 2019 net revenue to be in the range of $750 million to $790 million. This uplift from our previous guidance of around $70 million to $80 million results primarily from a stronger than expected market share performance year-to-date from SUBOXONE Film. The guidance incorporates the adverse impacts from the new H.R.4378 legislation that Shaun spoke to earlier. As you can gauge from our guidance compared to our year-to-date and Q3 trends, we estimate the negative impact to be in the $40 million to $50 million range on the fourth quarter performance. As discussed, we've taken the decision to discontinue the authorized generic in order that we did not incur losses on SUBOXONE Film revenues through government channels in the coming year. With regards to the Rest of World business, we do not expect the one-time net revenue benefits we saw in Q3 to continue. Consequently, there is no change to our assumption of a modest year-over-year decline. On the new depot technologies, as you've already seen, our expectations for SUBLOCADE net revenues have been narrowed to $60 million to 70 million reflecting year-to-date net revenue of $48 million, and we expect only modest net revenue from PERSERIS. Finally with regards to OpEx, we continue to expect this to land in the range of $440 million to $460 million, although it is more likely to be towards the upper end due to incremental cost of stepped up marketing for SUBLOCADE we are undertaking. With that, I'll turn the call back over to Shaun.

Okay. Thanks Mark. So in summary, we are making great systematic progress with SUBLOCADE and the next focus is to drive physician trial with new patients. We continue to benefit from the overperformance of SUBOXONE Film in the near-term, but without a strong basis to believe that it will continue. Our promotional activity in the U.S. is exclusively focused on SUBLOCADE and PERSERIS. And as always, we continue to review our compliance programs to ensure that they meet the needs of the evolving business. I commend the resilience of our employees who remain dedicated to our vision and committed to helping the millions of patients who need treatment for opioid dependence. So with that, I will hand back to the operator, Brian, to take us to the question-and-answer session.

Thank you, sir. Ladies and gentlemen, we will now being the question-and-answer session. [Operator Instructions] And your first question comes from the line of Max Herrmann from Stifel. Your line is open. You may ask your question.

Thanks for taking my questions. Three, if I may. Firstly, just in terms of the SUBLOCADE and you've talked in the past about a potential inflection point. How relevant do you think is the increased marketing focus you're expecting to place on SUBLOCADE now at achieving that inflection point? That’s first question. Then secondly, just in terms of clinical data from the RECOVER study, I wonder whether we are looking to expect any new health economical other data from that study? And then finally just on Alvogen supply, it seems like they are no longer able to supply in the market. Have you seen any impact on that with SUBOXONE Film? Because it seems to have gained some share lately post the stock outage from Alvogen. Thank you.

Okay, thank you, Max. I will take the first question. Christian will speak to the clinical data. Mark will speak to the generic topic with Alvogen. So, yes, I mean what we're proud off with SUBLOCADE is clearly what we're focused on as our number one priority. We have delivered on across the last year in terms of systematically working through these KPIs. So now that we have the yield up into the mid 60%. We think now the time is right to put all that focused and more investment into driving awareness with patients and healthcare professionals. Whenever you're driving a marketing, you've always got the level of waste and inefficiency, and you don't want to compound that by having low yield rate. So we think that this is going to be an important time as we step up our spend and our efforts and our attention. And this will move us towards our inflection point. So that's where we're at with SUBLOCADE. Christian, would you like to speak to the clinical data in the RECOVER study?

Yes, absolutely. So for the RECOVER study, as you know, we presented the 12-month RECOVER data at the American Society of Addiction Medicine and the CPDD meeting here. We submitted a manuscript to a peer review journal. This is currently under review. So I'm expecting the paper to be published in the first or second quarter of 2020. As we said before, we are completely on-track for the final report of the 24 months data point of the RECOVER study. And again, that will be translating into several presentations at conferences in 2020 as well as a peer review manuscript later in 2020.

Max, on your third question with regards to the Alvogen supply dynamics, we noted their release and have seen the dynamics in the market. Most of that share has been redistributed amongst the other generic providers with both Dr. Reddy, Sandoz and Mylan picking up share with a small amount that a film picked up on share, but really within the normal fluctuations we've seen since the loss of generics, relatively modest and tenths of a point of share. So that's kind of what the market dynamic spend as Alvogen has lost its share.

Great, thank you. Just a quick follow-up on the RECOVER publication. Is that in what you'd call a high impact journal or are you able to say who – where you expect to publish that?

Yes, I'm not going to elaborate on the specific journal, but we only target high impact journal in addiction medicine.

Okay. Thank you.

Thank you. And our next question comes from the line of Mr. Nick Nieland from Citi. Your line is open. You may ask your question.

Thanks for taking the question. So can you talk about the potential impact on your business of the recent Teva settlement and the potential provision of free generic buprenorphine/naloxone tablets? And the second question is do you still stand by your long-term guidance for SUBLOCADE of greater than $1 billion, because I didn't see that in the release. Thank you.

Okay, certainly. So, I mean Teva statement is highly speculative and there's been a lot of commentary and counter commentary about this topic and whether what they've suggested as an idea is even remotely achievable. So I can't comment on that specifically because there isn't really anything tangible to get hold of. Certainly, they've said it. They've put it out there and it's just speculation at this point. So I'm not sure how helpful that would be. With respect to the long-term opportunity certainly, I mean structurally this problem continues to get worse. But environmentally and socially that there is maintaining a very high level of focus and attention in this area. And clearly up until now, the focus has been on how many people are dying, companies in the news with opioid manufacturers. But as the conversation starts to move towards what have we got for patients and we continue to see the new scientific data published, and then perhaps more importantly, the impact as that the scientific data gets processed and digested and incorporated into the transformation of this disease space, has certainly maintained my confidence and the Company's confidence in the $1 billion plus net revenue forecast. The fact that it – we've had issues to sort out over the last year does not in any way dampen our enthusiasm, our belief and our commitment to deliver on that promise.

Okay. Thank you.

Thank you. And your next question comes from the line of Mr. Paul Cuddon from Numis. Your line is open. You may ask your question.

Three questions, please. Firstly, on the Sandoz settlement – sorry, the authorized generic, were there any financial penalties associated with capital net agreement? International SUBLOCADE launches, when we might expect some developments there? I mean then finally, just generally, what would be your base case expectation for Braeburn?

So I will talk to the second two questions and Mark can talk about the authorized generic. In terms of international SUBLOCADE launches, we've already got approval in Australia and in Canada. As you know, outside the U.S., the next phase is to work through the pricing. So we're well into that. We can't be absolutely sure when the pricing authorities come back to us. But clearly we're at the tail end of having what we need to be able to go to market. In terms of our other markets, we have delivered on our commitment to file SUBLOCADE applications across a number of other countries, including in Europe. It's possible that we might get one or two approvals through 2020. But again, it's not possible at this point to really give specific dates as to when we will hear back from the regulatory authorities. The system is a little bit different than in the U.S. You don't get a specific PDUFA date, but those submissions roll in. We've had questions from the authorities. We're in the normal dialogue of going back and forth. So feel comfortable with where we're at, at the moment. In terms of giving any expectation for Braeburn, obviously we don't know yet when they're likely to launch. Have to assume its November next year, unless we hear otherwise. But we haven't really given a guidance or indication of what their revenues are likely to be because we don't really know much about their launch at all. Mark, would you like to speak to the authorized generic contract?

Of course, Shaun. Hi, Paul. On the Sandoz, obviously we've given notice on this. We don't expect any material one-offs associated with it. Those discussions are obviously still ongoing and we'll update on the full-year results if there's any change.

Okay. Thank you.

[Operator Instructions] And your next question comes from the line of Mr. Jason Gerberry from Bank of America. Your line is open. You may ask your question.

Hey, thanks for taking my question. Just wanted to come back to the commentary, just on the Teva settlement, I understand highly speculative. But just wanted to come back to the comments about the $1 billion sales forecast. I guess that would presume formulary choice remains available over the long haul, but the Teva deal construct. I think for it to make any sense economically presupposes that generic SUBOXONE tablet supplies the entire market. So can you just talk about what you see as sort of the biggest hurdles to that sort of settlement construct supply in the entire market and thus enabling open access from a formulary perspective for SUBLOCADE? Thanks.

Yes. I mean, I can't really speak to the very many hurdles that Teva will have to overcome in terms of sort of progressing that forward. I mean, it's something you'd have to ask them about. What I can speak to of course, is the sort of formulary access for SUBLOCADE. We've achieved 88% formulary coverage. We have managed very successfully to work with payers to reduce the onerous step-headed some prior authorizations and unnecessary complexities that existed for patients. So as I mentioned earlier, there's over 220 million patients now that have what we would consider to be relatively straightforward access to this medication. And I don't think, really, anyone is going to be judging SUBLOCADE by what Teva is doing. People are going to be judging SUBLOCADE by their own experiences that they see from the clinical outcomes that they get and when they treat patients. And they're going to hear back from treated patients on what their experiences are. And all of that is going to be set in this very, very compelling wraparound context of all the new science that is being published on SUBLOCADE through the work that the sort of health economics team is doing. I think it's very significant that as the leader in addiction medicine, as the company that is pioneering the future way forwards on how we should think about treating patients, look at the investment we're making. We're putting our technology on the line and we are doing the studies that people always want to see to say: well, what outcomes are we going to get, what are we spending on the medication? What is the return on our investment as we treat patients here? And this is the data that's coming out as we continue to publish and shine our light. I think over time, there's going to be – the gravitational pull is going to be towards the concept of monthly injectables and certainly SUBLOCADE because of the outstanding signs that underpins the two nanograms per ml with very consistent level of receptor occupancy, which is responsible for the clinical outcomes and all the positive things that we are seeing. So I think the uncertainties and ambiguities and the risk that come with daily administration and take-home medications are really going to come under close scrutiny as the evidence base and experience base builds for SUBLOCADE. So when you read that report, it doesn't make you feel good and you start to imagine: well, if they're giving stuff away for free, what happens here, there and everywhere else? But the real issue here is people need to get better. Patients need recovery. And patients need a technology that together with psychosocial support and counseling is going to help them move back towards living a more productive, more rewarding lifestyle, that is going to move them from a consumer of tax dollars and a burden to society, to contributing tax dollars and being a positive contribution to society. So I think the quality of that conversation far overshadows a number of these other matters and clearly underpins our confidence in our $1 billion peak, that revenue forecast, because we're clearly positioned better than anyone else to understand the arguments because we created them, and to lead the sort of the whole evolution of this disease space towards the future.

Just to expand one more piece on that, Shaun, I think all of that and the fact that we have the access we have and with the generics having 40% of the market at commodity MAC pricing. So the pricing is already at huge discount versus the WAC pricing that's out there. So the people have already realized the value that Shaun's spoken to in the pricing dynamic that's out there today.

If I can just squeeze in a follow-on question, were there tangible examples of where payers just could not force a switch from tablet to – from film or manage more forcefully with the closed formulary because of the data generated around accidental ingestion in the younger population, just sort of wondering about the sensitivities around that as a potential issue here?

Yes, we don't break that by payer.

Yes, and they're very specific questions. And on a payer-by-payer basis, we wouldn't be sharing that information. But I think as Mark said very clearly, payers have looked to this technology very clearly. They have evaluated the evidence base. And we've achieved the payer coverage and the quality of coverage has improved greatly over the year. So we're – I think there's everything to feel confident about in the results sort of being delivered so far.

Okay. Thank you.

Thank you. And there are no further questions at this time. You may continue, Mr. Thaxter.

Okay. Well, if there are no further questions, I'd just like to thank everybody for joining us on the call today. And we look forward to seeing you in the future in our one-to-one meetings and at the conference. It's in all the usual places. So thank you very much.