Indivior PLC

LSE:INDV

Earnings Call Transcript 2022-Q3

[Operator]

Good day, and thank you for standing by, welcome to Indivior's Q3 Results Conference Call. [Operator Instructions] Please be advised that today's conference is being recorded.

I would now like to hand the conference over to your first speaker today, Mark Crossley, Chief Executive Officer. Please go ahead.

[Mark Crossley, executive]

Thank you, Sarah. Good morning and good afternoon, everyone, and thanks for joining us. With me today to discuss our Third quarter results are Ryan Preblick, our Chief Financial Officer and Dr. Christian Heidbreder, our Chief Scientific Officer. For today's call, I'll provide an overview of the strategic progress, after which Ryan will detail our financial performance and our 2022 guidance, and then we'll move on to Q&A. Turning to Slide 3, I'm going to assume that everyone has read the forward-looking statements.

Turning to Slide 4 in the Third quarter, we continue to see strong year-over-year and sequential growth in SUBLOCADE. This important treatment reached a new milestone in the quarter, crossing the $100 million mark for the first time in the third quarter to deliver $108 million in net revenue. SUBLOCADE's strong performance was the main driver of our top and bottom line growth in the period. As in the past several quarters, this performance was driven by the growing presence in the organized health systems channel.

We're very pleased with the progress of PERSERIS in the quarter, with net revenue up 14% sequentially and 60% versus last year. Importantly, we saw an encouraging uptake in unit volume and net revenue contribution from the new sales territories where we've expanded our presence. Based on our performance year-to-date, together with the progress we're making against our strategic priorities, we're confident we will deliver a strong finish to the year.

We've now narrowed our fiscal year 2022 guidance for SUBLOCADE to the higher end of our previously communicated range, and we've increased our expectations for total net revenue and adjusted operating profit for the group. Ryan will provide a little more detail in a moment. Clearly, the macro environment remains challenging with the geopolitical climate as well as decelerating economic growth and inflation across our markets. In this regard, our strong financial position with over $1 billion in cash and investments continues to provide us flexibility.

Finally, on this slide, we're pleased to have received overwhelming shareholder support for the additional listing on a major U.S. exchange. We believe this important initiative will be beneficial in raising the group's profile in its highest value market and potentially attracting a broader group of Biopharma focused investors and analysts. In preparation, we executed a 5-for-1 share consolidation earlier in the month, and we're working at pace to affect the additional listing spring of 2023.

Turning to our strategic priorities report card on Slide 5. Our go-to-market strategy has now driven 9 consecutive quarters of double-digit increases in SUBLOCADE net revenue and patient dispenses. The organized health system channel continues to be the predominant driver for SUBLOCADE, generating approximately 75% of the growth. As we highlighted on our last quarterly call, we've reached our goal of activating the top 500 key organized health system accounts earlier this year, and the primary focus of our strategy now is to increase prescribing depth within our activated organized health systems.

Where we have clear line of sight, we're tracking our progress against a number of metrics, including the number of new prescribing physicians and those prescribing more than 5 patients, which in our experience signals treatment adoption. I'm pleased to report that both KPIs grew solidly versus the prior quarter, indicating we're making real inroads into prescribing depth. As you're aware, we've carefully targeted investment where we see the biggest opportunities to extend SUBLOCADE's leadership position as a long-acting injectable for treating opioid use disorder.

For example, we formed a dedicated team to access the criminal justice system. We bolstered our medical science team to educate physicians on the science of medically assisted treatment broadly and SUBLOCADE science more specifically. And we remain on schedule for a second manufacturing site to increase capacity for SUBLOCADE and PERSERIS.

If I turn to revenue diversification, I'm pleased to report continued progress for SUBLOCADE and SUBOXONE Film outside the U.S. Net revenues for SUBLOCADE in international markets was $7 million in the quarter, and we're pleased with the initial SUBLOCADE SUBOXONE Film net revenue in Europe. The combined impact of these launches is helping us to largely offset the declines we see in the legacy tablet business. Over time, we continue to expect this dynamic to return us to net revenue growth outside of the U.S.

For PERSERIS, as I alluded to earlier, we're seeing sequential pickup in performance driven by our investment in national sales coverage and strong quarter-over-quarter and year-over-year growth. We did see a short-term disruption in sample supply, leading to allocation of samples in the Third quarter, which will be alleviated in November. However, based on the significant patient need, the differentiated product profile that PERSERIS offers, we remain convinced of its net revenue potential of $200 million to $300 million.

Regarding the pipeline, here, our focus is on strengthening the evidence base for SUBLOCADE and progressing our innovative early-stage approaches to a range of substance use disorders. On the latter, we continue to be very excited by the potential of AEF-0117 to transform the lives of people with cannabis use disorder. As you're aware, the Phase IIb clinical trial of this important asset is now underway, and we are very much looking forward to the full result readout in 2024. Finally, on our operating model, we've maintained our focus on prudent cash management and asset optimization so that we're able to both fully invest in our #1 strategic priority, SUBLOCADE as well as continue to execute on our second 100 million share buyback, which is about 2/3 of the way complete.

On that, during the quarter, we bought back over 10.2 million shares on a pre-consolidation basis as part of our second $100 million share repurchase program. This brings the total on the second buyback program to $66 million at the end of September. Even after this outflow, we ended the quarter with a healthy gross cash and investment position of over $1 billion and net cash and investments of close to 800 million.

To summarize, this was another strong quarter of execution and delivery against our strategic priorities. As we look to the remainder of 2022 and beyond, we're confident we have the right strategy, the right products and the right team to deliver on our mission and our long-term growth objectives. We look forward to sharing more detail on our long-term shareholder value creation plans as part of our upcoming Investor Day on December 7 in New York City.

With that, I'd like to hand over to Ryan to take you through the financials for the quarter in more detail.

[Ryan Preblick, executive]

Thanks, Mark, and good morning and good afternoon to everyone. I'm pleased to report another good quarter of financial execution and business momentum. We delivered excellent top line growth driven by the strong performance of SUBLOCADE.

Our adjusted operating profit also increased versus the prior year, reflecting results from the growth investments we made to support the success of SUBLOCADE and PERSERIS. We also maintained our disciplined approach to capital allocation, balancing reinvestment in the business with shareholder returns as we progress with the share buyback program we announced in April.

We once again exited the quarter with over $1 billion in gross cash and investments, providing us tremendous flexibility. I'll now provide some more detail on the performance drivers in the quarter and discuss our outlook for the remainder of the year. Starting with top line. Total net revenue growth was up 24% versus the year ago quarter and by 27% at constant exchange rates.

For year-to-date results, total net revenue grew 16% versus the same period last year and by 18% at constant exchange rate. The increase in total net revenues throughout 2022 was mainly a function of strong SUBLOCADE growth in the U.S., but we also continue to see growing contributions from PERSERIS and from SUBLOCADE in markets outside the U.S. By geography, total U.S. net revenue grew by 32% versus the prior year quarter.

Net revenue for the rest of the world returned to growth this quarter and was up 9% year-over-year, excluding unfavorable FX impact. SUBLOCADE net revenue outside of the U.S. grew 75% year-over-year to $7 million, continuing to help offset the ongoing pressure from generic competition in the legacy tablet business. While the rest of the world net revenue result continues to be impacted by the strong U.S. dollar relative to other currencies. The overall bottom line income impact is mostly mitigated by corresponding expenses, which carry a similar negative FX adjustment.

Total SUBLOCADE net revenue of $108 million and $290 million for the Third quarter and year-to-date Q3 2022, respectively, puts us on track to be at the upper half of our previously revised guidance of $405 million to $420 million, as we noted in our press release. Sequential net revenue growth for SUBLOCADE was 10% and generally aligned with dispenses when you exclude the impact of FX.

Moving to PERSERIS, net revenue of $8 million was up 60% versus Q3 of last year, largely driven by the rollout of our new national sales team earlier this year. Sequential net revenue was up 14% and was impacted by some sample limitations Mark had mentioned earlier. We recognize that PERSERIS net revenue continues to be off a small base, but nonetheless, are encouraged by the growth in PERSERIS on a number of internal demand metrics and positive prescriber feedback.

Turning to SUBOXONE Film. The average share of approximately 19% in the third quarter was essentially flat from the prior quarter's average share of 19. As a reminder, we do not promote SUBOXONE Film in the U.S. I will discuss Film share guidance for the remainder of the year in a moment. Moving down to P&L. Our Third quarter adjusted gross margin was 83%, flat from the prior quarter and down from 86% in Q3 of last year, reflecting a higher mix of less profitable government channels for SUBOXONE Film in the U.S. and some cost impacts from inflation. Like other companies in this environment, we have seen elevated costs for labor, logistics and services in our COGS as well as our OpEx. However, the overall impact for us has been manageable this year and has not required a change in guidance in these impacted areas. We are, however, closely monitoring these inflationary impacts and are actively making offsets where possible without disrupting the business.

Our adjusted overall operating expenses were $133 million in the quarter, an increase of 8% versus Q3 of last year, reflecting the growth investments behind the LAIs and the phasing of our R&D initiatives to the back half of the year. As you all have noted, Q3 R&D increased 42% versus Q2 as expected. Moving to adjusted operating profit.

We saw solid results versus the prior year, with operating profit of $58 million in the Third quarter, up 53% versus Q3 of last year. For year-to-date through Q3 2022 adjusted operating profit of $172 million was up 11% versus the same period in the prior year.

Lastly, on the P&L, our adjusted net income of $43 million increased 59% in the Third quarter versus Q3 of last year. For year-to-date through Q3 2022, our adjusted net income of $130 million increased 14% versus last year, reflecting the dynamics I just highlighted. Quickly touching on the balance sheet and our capital position. As I mentioned, we ended the Third quarter with gross cash and investments of $1.035 billion. Included in that balance is $64 million of collateral returned to us from the settlement we reached with Dr. Reddy's last quarter. Year-to-date cash generation from operations, excluding the $64 million in return of collateral in Q3 and the $108 million in litigation settlement payments in first half was at $107 million. I will now discuss the adjustments we are making to guidance for full year 2022.

For SUBLOCADE, we are narrowing the net revenue range to $405 million to $420 million. This represents the upper half of our previous net revenue range of $390 million to $420 million and is based on the strong year-to-date momentum and our continued strong progress in the OHS channel expected in the fourth quarter.

On SUBOXONE Film, as you are aware, the FDA approved a fourth generic film competitor in June, which increased the level of uncertainty in what has been a relatively stable market over the last 18 to 24 months. At this point in the quarter, a fourth generic has not launched. As a consequence, we now assume that any potential launch impact is considered in our upwardly revised total net revenue guidance for the current year. We will continue to assess the competitive environment, and we'll update the market accordingly.

Turning to the total operating expenses. We are maintaining our guidance of $520 million to $540 million. We have, however, chosen to reallocate some new anticipated under spend in R&D towards incremental marketing behind SUBLOCADE. As a result, we are raising our SG&A guidance range by $5 million to $445 million to $460 million. These incremental commercial efforts will continue to support and expand SUBLOCADE's leadership and position us for further growth as we move into 2023. Our revised R&D guidance range of $75 million to $80 million still anticipates a sequential uplift in expense in fourth quarter for SUBLOCADE, post-market requirement and life cycle management studies, SUBLOCADE manufacturing capacity expansion and early-stage asset advancement. However, some components of these important studies will now phase into 2023.

Taking these factors together and considering continued FX pressure, we are narrowing and increasing our overall net revenue guidance range to $890 million to $915 million. We also now expect adjusted operating profit to be modestly higher than our prior guidance given the resultant impacts on our P&L.

Let me close by saying we are pleased with our execution and our financial results for the quarter. We believe our year-to-date performance puts us solidly on track to deliver strong full year 2022 results. We are confident that we can deliver our full year revised guidance and look forward to seeing investors at our Capital Markets Day on December 7 in New York City.

I will now turn the call back over to Mark for some closing comments.

[Mark Crossley, executive]

Thank you, Ryan. Once again, I'm extremely pleased with the team's execution against our strategic priorities. Our go-to market strategy on SUBLOCADE is working, and 75% of our growth is coming from that channel and our current midpoint of fiscal year guidance is marking just over 40% progress towards the $1 billion in sales. We continue towards adding an additional U.S. listing next year and are extremely excited for our Capital Markets Day in New York in December, where we'll provide more detail on our road map to delivering sustainable shareholder value.

With that, I'll turn the call over to Sarah to manage questions and answers.

[Operator]

[Operator Instructions]. We'll now take our first question. This is from the line of Thibault Boutherin from Morgan Stanley.

[Thibault Boutherin, analyst]

I have a couple of SUBLOCADE. First question, could you give us a rough idea of the market share of SUBLOCADE right now in terms of patients within the BMAT category. And second question, when you think of a different component of growth for SUBLOCADE going forward from a top-down perspective, there is an unfortunate increase in the pool of patients due to the acceleration of the pandemic. There is potentially the increase in the proportion of patients treated and then the market share of SUBLOCADE.

So just if you when you talk about the mid- to high single-digit growth in the BMAT market, could you just help us understand how much is just patient growth and how much is potential increase in the treatment penetration, thank you.

[Mark Crossley, executive]

Thibault, thanks for that. I think on SUBLOCADE, you know, there's such a tremendous unmet need here and I think it really combines kind of both of your questions. The first is the market share now, we're still in such an early days of the launch of our organized health system strategy. Remember, we just pivoted to that 2 years ago with a reorganization to the ecosystem model.

We've seen tremendous growth with double-digit quarter-over-quarter growth over the last 9 quarters. And despite that, we still only have about a 3% patient share of the market. So it's early days. There's tremendous opportunity for this asset to continue to help patients in their journey towards recovery. The market side of this disease space is hugely unfortunate and really represents how the opioid epidemic has just continued to propagate here in the U.S.

If you think about it, there are over 10 million people that have used opioids here in the U.S., over 3 million have been diagnosed with opioid use disorder and less than 20% of people are in treatment. So I think as you think about the growth of SUBLOCADE, the market will continue to grow. And there's a huge ability for that to grow from more patients entering in treatment even if the disease doesn't grow specifically because of that low treatment penetration of less than 20%. And then I think when you think about the market share of SUBLOCADE, absolutely, as we continue to bring this paradigm-shifting treatment into the market, build more awareness, we expect growth to come through more patients utilizing it on their recovery journey. So we expect kind of growth on both sides of the market as well as SUBLOCADE awareness and penetration.

[Operator]

We'll now take our next question. This is from the line of James Vane-Tempest from Jefferies.

[James Vane-Tempest, analyst]

Two, if I can, please. Firstly, just looking at the trend quarter-on-quarter growth for SUBLOCADE and looking to what, I guess, is the upper end of your guidance, and that implies a pretty big step-up in Q4. So I'm just kind of wondering if the business has historically done plus or minus $10 million sequentially a quarter. What gives you the confidence potentially looking at full year, we could maybe double that on a year on a Q4 basis to roughly $20 million. My second question is, again, just around market dynamics.

I appreciate we've got to wait until probably next year to get guidance for 2023. But when you look at sort of the momentum of growth that you're seeing, are there any sort of low-hanging fruit, which you've kind of been able to get this year where we should expect slower growth next year or given the market dynamics you've kind of laid out is the level of growth you're seeing potentially sustainable as we get into next year.

[Mark Crossley, executive]

Thanks for that, James. And listen, I think we are extremely pleased with regards to the continued strong quarter-over-quarter growth. I have a lot of confidence in the guidance range that we've given for the full year and carrying that momentum into Q4. So we expect to deliver on that guidance. When I start to think about the market dynamics, while we'll guide on 2023 in February.

We will talk about at a Capital Markets Day, a little bit more in depth with regards to SUBLOCADE the go-to-market model, the bipartisan nature of this disease space which we expect all of those things coming together to continue to drive that growth moving forward. So it's those dynamics all combined that just continue to give us conviction behind $1 billion plus of peak net revenue guidance we have for SUBLOCADE.

[James Vane-Tempest, analyst]

If I can just give ask a follow-up just on the first point, I completely understand the sort of confidence in meeting guidance, but is there anything which would suggest there could be a potential inflection in Q4 or kind of higher sequential growth in Q4? Just wondering if there's any potential new contracts coming up or anything like that, which could suggest a larger sort of sequential Q4 improvement specifically?

[Mark Crossley, executive]

James, I think it's just continued delivery on the operating model, and there's normally some Q4 dynamics ahead of the year-end and ahead of price increases that sometimes has modest impacts on stocking. But we have confidence in, again, in delivery on the yearly numbers that we've given.

[Operator]

We'll now take our next question. This is from the line of Max Herrmann from Stifel.

[Max Herrmann, analyst]

Congratulations on another strong quarter. A number of questions, if I may. Firstly, just trying to understand a little bit on the gross margin. I appreciate that SUBLOCADE in the Medicare Medicaid channel is low gross margin. But I was expecting given the strength of SUBLOCADE and the high gross margin nature of that product that you might have seen a bit of improvement. So just trying to understand that. I'll leave that as the first question and follow up with the others.

[Mark Crossley, executive]

Okay. I'm going to go ahead and ask Ryan to take you through kind of the gross margin expectations.

[Ryan Preblick, executive]

Yes. So no, that's a fair question. And we were in line with where we expected the gross margin to play out for the quarter. We certainly do expect as SUBLOCADE becomes a larger contributor of the business for the margins to expand. It's just right now, you're still seeing the impact of the large contribution coming from the less profitable film. And on the back end of that, we are seeing some cost pressures as well due to inflation. But net-net, we're right in a position where we thought we'd be at this point.

[Max Herrmann, analyst]

Great. And then just a couple of more finance questions and then focusing on SUBLOCADE. So just I wonder in terms of the tax situation for 2023, if you've got an idea there. And I know you don't want to give guidance for the full year, but I just wondered on the tax situation that seems to be ticking up in the group and what the likely potential benefits are from the patent box on SUBLOCADE on the tax side. And then just on SUBLOCADE itself, a couple of questions. One is kind of a bit more color on your OHS experience.

So obviously, I appreciate the dispensing benefits within the large hospital, which may be the center of that OHS, but I wonder how they trickle down into the clinics that operate within the OHSs, how you found your experience with SUBLOCADE in those networks. And finally, just on SUBLOCADE ex-U.S. Could you update us on the launches? I know you obviously launched in Canada, Australia and Israel. I know you were planning to launch over the coming months in the European territories now. I wonder whether you had an update on that.

[Mark Crossley, executive]

Okay. So Max, I think I'll start with the SUBLOCADE and then hand over to Ryan to give a little bit of color on tax without guiding in 2023, which, of course, as you mentioned, we'll do in February. The color on the organized health system, I think remains as we've been talking. We've gotten access at the parent level. And now it's about depth.

It's about opening up these children accounts within the parents now that the parents have authorized this controlled substance specialty pharmacy sort of product in. And that sell-in cycle, that acquisition sort of model is not as long as the parents that we talked about, which was 9 to 15 months, but it's actually probably more sort of quarters and not months. So that takes time but what that does is it starts to open up more doctors and more patients. And as we've talked about before, the majority of doctors and patients that treat opioid use disorder are in these organized health systems. So we're getting deeper access.

And as I mentioned in my script, what we're seeing as we follow cohorts is we're getting deeper adoption through time with people that have started to prescribe the medication. So a very positive experience, but it certainly isn't a faucet that when something is open, you get to max prescription. There is an acquisition process on those children organized health systems. Outside the U.S., we are in Canada, Australia and Israel, as you mentioned. We continue to work at a country level with regards to reimbursement and launch plans, still expecting here in the balance of the year to go to launch in the Nordics and looking towards Germany and other markets in Europe in 2023, and we'll be able to provide a lot more color on that in February. Ryan would you like to handle tax question?

[Ryan Preblick, executive]

Yes, so on the tax situation, certainly, the first point I would highlight is it's been relatively stable over the last 2 or 3 years. Our tax rate is mainly dependent on the mix of business or tax local in regards to where we're generating the net revenue. But that's something that we certainly monitor closely and plan accordingly. And the patent box benefit that you did mention certainly factors into our strategy as we go into every year. And one of the things we pride ourselves on is definitely keeping a loop in regards to what's going on with the tax changes, both here in the U.S. and the U.K. So those are all the factors that we will build into our tax plan as we get into next year.

[Max Herrmann, analyst]

If you don't mind a follow-up question just to trying to understand how you adjusted systems are working within the clinics. I understand that, obviously, when you first launched, there were some challenges with getting opioid use disorder positions to hold inventory and/or to prescribe, given they may have been in sort of like general psychiatry clinics. When you go to the hospital, you obviously have the pharmacy unit there and that makes life easier for dispensing with us through a specialty. I wonder when you get into the clinics within those OHSs, is that still the case or are they then starting to come across that more challenging dispensing issue that you had early on in the launch.

[Mark Crossley, executive]

No, it's a great clarification question, Max. And I think you're right, at the big regional sort of parent centers, they obviously have pharmacies on site. They've got all the things to manage. And when you go out to the more satellite sort of children campuses, you still have the back office that helps with billings, they help with scheduling, they help with all these things. And then it can vary a bit within the various units.

Some of them have pharmacies on site. Some of them are smaller and maybe don't. And so it can vary children to children with regards to those. Now what we know is the experience from the network of specialty pharmacies and specialty distributors that we put together is extremely strong. The days to getting medication, the prior art and the yield that comes through that, we've built a network that is extremely efficient. But there will always be for smaller clinics that don't have pharmacies on site, there will always be a bit of friction, just associated with a specialty product, and that's just a nature of this sort of drug.

But when you're in the organized health system, predominantly, a lot of the friction points are removed and what we see are people adopt sooner and adopt deeper with more patients per HCP than you see in other areas. So we're excited. It is still very early days in these organized health systems. Again, we're only 2 years into this. And we've only got a 3% patient share. And so we look forward to continuing to partner with those organized health systems moving forward.

[Operator]

[Operator Instructions] We'll now take our next question. This is from the line of Paul Cuddon from Numis.

[Paul Cuddon, analyst]

I have 3 questions, please. Just focusing on the depth of prescribing I mean do you think sustaining double-digit sequential growth that is possible into kind of 2023 quarter-on-quarter? Secondly, I mean, any stocking issues for the rest of the world business or do we think that's started to turn? And then sort of just a final question on sort of cash and the prevailing interest rate environment.

[Mark Crossley, executive]

Certainly, Paul. I'll handle the first 2, if that's okay. I think you're talking about depth of HCPs prescribing. And listen, I can tell you, I continue to expect there to be both additional new prescribers and additional depth. How that translates into the guidance for 2023 I think that's a great question when we get together in February with the fiscal year-end results and give our formal guidance for next year. But you can tell we have very strong momentum with regards to how we're moving forward. I think as you look to the rest of world, and I think what you're getting to is, obviously, the underlying non-FX sort of growth this quarter is quite strong is there some one-off sort of items.

I think there's always a little bit of fluctuation quarter-to-quarter. And I think here, we have to look towards our medium-term sort of guidance where we expect this to return to growth. There are heavy generic presence in the heritage business significant austerity measures that many governments imply on this in these markets and what we look to is in the medium term to return this business to growth. So I think quarter-to-quarter, there will be some fluctuations. Maybe what I'll do is hand over to Ryan to answer the questions you had with regards to cash and prevailing interest rates.

[Ryan Preblick, executive]

Yes. So again, quite happy with the cash position we have. What it does is it gives us a lot of flexibility and optionality to make quick business decisions as we move forward. Cash at this point, as the environment is quite dynamic in the markets, it's something that gives us some protection that we feel good about. And in regards to the debt facility, again, that's just another way for us to keep the optionality open, provide maximum capacity. So we feel good where we are between our cash position and our debt facility going through these uncertain times.

[Paul Cuddon, analyst]

Okay. With regards to the success that you're having with kind of PERSERIS now with the national field force. I mean do you think that you'll always be committed to substance use to sort or do you see potential to deploy some of that capital into kind of more adjacent clinical indications?

[Mark Crossley, executive]

Yes, it's a good question, Paul. And I think one with regards to capital allocation that we continue to get. And I think we just remain incredibly consistent on how we think about capital allocation for Indivior. And the first priority is to reinvest in SUBLOCADE to achieve the billion dollars plus and then after that, the Board and management sit back and think about how do we create value for shareholders. And in the short term, you've seen we've done a couple of returns of capital via buybacks. We're in the midst of our second $100 million buyback. And then we think about business development. Obviously, items in addiction are the highest priority, but we continue to look with regards to those opportunities on a value sort of basis for shareholders.

[Operator]

I'd now like to hand back to the speakers for closing remarks.

[Mark Crossley, executive]

Thank you, Sarah, and my thanks to everyone for their time today and continued support of the Indivior team. I look forward to seeing everyone in New York City on December 7. Thank you.

[Operator]

Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect.