INDV - NASDAQ

Good morning, good afternoon, everyone. Before we begin, I need to remind everyone that on today's call, we may make forward-looking statements that are subject to risks and uncertainties, and that actual results may differ materially. We list the factors that may cause our results to be materially different on Slide 2. We also may refer to non-GAAP measures, the reconciliations for which may be found in the appendix to the presentation that is now posted on our website at indivior.com. I will now turn the call over to Mark Crossley, our Chief Executive Officer.

Thank you, Jason, and good morning, good afternoon, everyone. Thanks for joining our first quarter results call. Here with me today are Ryan Preblick, our Chief Financial Officer; and Christian Heidbreder, our Chief Scientific Officer. I will start the call with an overview of the results for Q1 and a progress report against our strategic priorities. Ryan will then provide more detail on the first quarter results and updated fiscal year 2023 guidance. And then following that, we'll move to Q&A. Turning to the key messages, we delivered an excellent start to 2023 driven by strong execution against our profitable growth strategy, which is primarily focused on increasing SUBLOCADE's prescriber depth within our organized health systems. Our first quarter total net revenue grew 22% led by SUBLOCADE. The strength of our top line allowed us to absorb incremental growth investments behind SUBLOCADE in the U.S. Justice System channel while still delivering operating leverage. As a result, our adjusted operating profit grew 31% in the quarter. We also successfully completed the acquisition of Opiant at the beginning of March. This important strategic step strengthens our addiction portfolio with the addition of OPNT003, which we expect to become the next generation agent for opioid overdose reversal subject, of course, to regulatory approval by the FDA. I'm also pleased to report that we fully integrated the Opiant commercial and R&D teams. And with our combined experiences, capabilities and footprint, our teams have hit the ground running as we prepare for potential FDA approval and then launch. You'll also know that we've updated our fiscal year 2023 guidance for the Opiant acquisition as well as our updated share assumptions for film. As a result, we've increased our fiscal year 2023 net revenue expectations. Ryan will share more detail on these and other fiscal year 2023 guidance items in a moment. Finally, a quick note on the legacy litigation, which I know is top of mind among our stakeholders. While I'm constrained in what I can say due to the ongoing nature of these matters before the court, I can confirm that discussions continue with the parties as we actively try to bring greater certainty for our shareholders at an appropriate value. Doing so will allow us to focus all of our efforts on meeting the important needs of patients suffering from substance use disorders and serious mental illness. Moving next to our report card for the first quarter, we continue to make excellent progress against our strategic priorities. First, SUBLOCADE net revenue of $132 million grew 12% versus the previous quarter and 55% versus Q1 last year. Sequential dispense growth was 16%. This strong double-digit performance was driven by our ongoing strategy to increase prescribing depth in the 500-plus organized health systems that we've accessed. Organized health systems now account for approximately 80% of SUBLOCADE's growth. Additionally, we saw an increased contribution to SUBLOCADE net revenue from the U.S. justice system channel as more facilities were activated. You'll also note that SUBLOCADE patients at the end of the first quarter were approximately 95,000. This is just over one-third of the way toward the estimated 270,000 patients we are targeting to achieve our $1.5 billion plus net revenue goal for this important treatment. While we are pleased with our progress, it still only represents 3% of the 3.1 million people diagnosed with opioid use disorder. Moving next to diversification and starting with PERSERIS, we continue to see unit growth in volume and the number of new HCPs prescribing across our territories. Net revenue of $8 million reflects growth of 60% versus Q1 2022, but was negatively impacted by wholesaler destocking when looking at the quarter sequential comparison. Overall, we are pleased with the KPIs which remain strongly positive, including underlying dispense growth and sample demand across inpatient acute care psychiatric facilities and outpatient clinics. Taken together, we remain confident in our full year net revenue outlook for PERSERIS. Turning to ex-U.S. net revenue, strong growth from new products, which include both SUBLOCADE and SUBOXONE Film, drove the 5% increase in overall Rest of World net revenue. SUBLOCADE continued to make solid progress while net revenue contribute -- with net revenue contribution of $9 million. We continue to see strength in our ex-U.S. markets, including the Nordics launch, where we launched the SUBLOCADE in late 2022. We look forward to launching SUBLOCADE in Germany in May and remain focused on returning our Rest of World business to sustainable growth with SUBLOCADE and SUBOXONE Film. Lastly, on diversification. As I mentioned before, we successfully closed and integrated the Opiant transaction. And in a moment, I'll provide a bit more detail on our plan for OPNT003. Turning to our pipeline. We are pleased to have brought on board Opiant's asset portfolio and team, which gives us significant addiction medicine development experience and expertise across a broad array of delivery platforms, including depot, oral and now nasal delivery technologies. Under Christian's leadership, the R&D teams have come together nicely and are moving at pace to advance our key programs. By combining our portfolios, Indivior now has more robust pipeline to address patients' most urgent needs across the continuum of care for substance use disorders. Our fourth strategic pillar is optimizing our operating model and capital allocation. Here, our financial position remains strong despite cash outflows associated with the Opiant acquisition and completion of our second share buyback program. Finally, with regards to the additional U.S. listing of our shares, we look forward to completing the necessary regulatory requirements and expect to affect NASDAQ listing in June. Before concluding my remarks, let me provide a brief status update on Opiant. We closed the acquisition on March 2 and moved quickly to embrace Opiant's teams. It's now nearly 2 months into our combination and I'm very pleased with how we've come together as one company focused on patient needs. Clearly, our most immediate and compelling opportunity is OPNT003, which has a PDUFA action date of May 22. At this point, I have to make the standard cautionary comment that this is entirely subject to FDA approval. Nevertheless, assuming this proceeds as we anticipate, we are in full planning mode for a Q4 launch. As such, our updated fiscal year 2023 guidance does reflect incremental investment for launching OPNT003 later this year. Given the recent interest, I'd like to just take a moment to address the recent OTC approvals for naloxone. We certainly applaud efforts to increase access for all FDA approved medications. To be clear, OPNT003 will not be an OTC product, if approved, and therefore, our primary launch efforts will be squarely focused on the public interest markets. This includes law enforcement, first responders, departments of health, schools and corrections and so on. This approach reflects the unique profile of OPNT003, which was developed specifically to address the epidemic of overdose deaths arising from misuse of fentanyl and other synthetic opioids. Importantly, we believe we can cover all these key national public interest call points with a relatively small, focused and efficient field force. Next, to preempt your questions on pricing, we are still in the process of finalizing our strategy, but we will certainly look to price responsibly while considering the innovative nature of the product. Lastly, while our fiscal year 2023 guidance does not assume material net revenue contribution from OPNT003, given the anticipated launch timing late in the year, we continue to be confident in 003's peak net revenue potential of $150 million to $250 million and continue to expect it to be accretive to earnings after the second full year of launch. To conclude my formal remarks, the team has delivered an excellent start to the year with strong top line growth on SUBLOCADE and PERSERIS and continued return to growth in our ex-U.S. markets. We are looking forward to the launch of OPNT003, subject to approval and have raised our fiscal year 2023 net revenue guidance. And last but not least, we are working diligently to remove uncertainty for stakeholders as we seek to resolve legacy legal items so that we can exclusively focus on achieving our business goals. With that introduction, I will turn it over to Ryan.

Thanks, Mark, and good morning and good afternoon to everyone. We had a very good start to full year 2023 and are pleased with our continued execution. During the quarter, overall double-digit top line growth was once again driven by the strong performance of SUBLOCADE. Our reported and adjusted operating profit also increased versus the prior year, reflecting our increased net revenue from the investments in sales and marketing we have made over the last year to accelerate the growth of our long-acting injectables. We also maintained our financial flexibility with approximately $803 million in cash and investments at the end of the quarter. Before discussing the financial results for Q1, I do want to spend a moment discussing the accounting of the Opiant transaction now that the deal has closed. The final purchase price was $146 million, plus approximately $12 million in exceptional deal and transaction costs. Substantially, all of the purchase price is reflected in intangibles on the balance sheet and we expect to amortize this through COGS over the current 15-year patent life expectation of 003. The amortization expense will be treated as exceptional and is noncash and nontaxable. The possible liability for the contingent value rights, CVRs will be assessed quarterly and will be amortized in the same manner. I will now provide some more detail on the drivers of our performance in the quarter and discuss our revised guidance. Starting with the top line. Total net revenue grew 22% versus the year ago quarter and by 24%, excluding the impact of FX. The increase was primarily due to SUBLOCADE, which grew 55% versus Q1 2022 to $132 million. By geography, total U.S. net revenue grew by 27% and currently represents 83% of total company net revenue. Net revenue in the Rest of the World was up 5% year-over-year at actual FX rates and 13% if you exclude FX. As Mark mentioned, growth of SUBLOCADE net revenue outside of the U.S. was strong, up 50% versus the year ago quarter to $9 million. Our progress with SUBLOCADE and SUBOXONE Film outside the U.S. continues to offset the decline in the legacy tablet business. Total SUBLOCADE net revenue for the first quarter of $132 million was up 12% sequentially, reflecting stocking in Q4 that did not reoccur this quarter. Dispenses were up 16% sequentially, showing strong underlying growth. This performance is consistent with our full year guidance of $550 million to $600 million. Moving to PERSERIS. Net revenue of $8 million was up 60% versus the first quarter of last year and was within our expectations. As Mark noted, there was some destocking dynamics in the quarter, which impacted the sequential comparison. Underlying prescription growth and other supporting KPIs continue to be strong and underpin our net revenue guidance for the year. Turning to SUBOXONE Film. Average share in the first quarter was approximately 19%, which is essentially flat sequentially. We continue to expect an accelerated rate of SUBOXONE Film market share decline in full year 2023, reflecting underlying erosion at a similar rate to the last 2 years, approximately 2 share points, together with the assumed impact from an approved fourth generic entering the U.S. market in the second half of 2023. As a reminder, we do not promote SUBOXONE Film in the U.S. Moving down to P&L. Our first quarter adjusted gross margin was 85%, up from 82% in the prior quarter and prior year. This was driven by favorable manufacturing variances such as FX and a higher mix of SUBLOCADE net revenue. We continue to expect gross margins to be in the low to mid 80%s range for the full year. Adjusted SG&A expenses were $117 million in the quarter, up 7% versus Q1 last year, primarily reflecting the overall cost inflation and commercial investments to accelerate SUBLOCADE access in the U.S. Justice System. R&D expenses were $27 million in the quarter, reflecting phasing of SUBLOCADE studies, manufacturing capacity expansion and other pipeline activities. In a moment, I will discuss our revised view of expenses for the year considering the addition of the Opiant business. Our adjusted operating profit of $71 million in Q1 was up 31% versus the prior year, primarily based on higher net revenue, partially offset by the higher operating expenses I discussed before. Turning to our balance sheet and capital position. We maintained our solid liquidity position and ended the quarter with gross cash and investments of $803 million, down from $991 million at year-end. The reduction in cash and investments primarily reflects the net purchase price of $124 million for Opiant Pharmaceuticals, including the transferred cash balance and $74 million primarily in annual scheduled payments for the DOJ, RB and DRL settlements. Cash generated from operations, excluding these settlement items was $58 million. Turning to guidance for full year 2023. As we noted in our release, we have updated our full year 2023 guidance to reflect the increased expenses resulting from the acquisition of Opiant as well as increased net revenue expectations primarily due to the continued delay of the expected U.S. launch of the fourth film generic. We now assume the latter will occur at some point from mid 2023 onwards. But as we have said previously, we do not have any visibility or market intelligence on timing. Guidance was SUBLOCADE and PERSERIS net revenue is unchanged as is the case for gross margin and our underlying OpEx expectations prior to adding Opiant. Our revised guidance for OpEx assumes regulatory approval of 003 by the FDA on or before the PDUFA date of May 22 and a launch in the fourth quarter of this year. Given the expected late 2023 launch date for 003, we assume the impact to net revenue will not be material for full year 2023. Taking these elements together, we are raising our overall net revenue range to $970 million to $1.040 billion from $950 million to $1.020 billion. The new point of our guidance now suggests net revenue growth of 12% versus last year. Moving to our revised OpEx guidance. We now expect SG&A to be in the range of $530 million to $540 million -- excuse me, from $490 million to $500 million. The increase primarily reflects the addition of Opiant's commercial teams, including sales, access and medical affairs person well as well as the planned launch and marketing expenses for 003 in Q4 2023. For R&D, we now expect a range of $90 million to $100 million from $80 million to $90 million, reflecting the addition of Opiant's R&D personnel and assumption of their pipeline activities. Lastly, on adjusted operating profit, we now expect this to be slightly below full year 2022's adjusted operating profit of $212 million as a result of the additional operating expenses associated with the Opiant acquisition, partially offset by the increased net revenue expectations. In closing, we are pleased with our execution and our financial results for the quarter. We believe our Q1 performance puts us solidly on track to deliver our revised full year 2023 guidance and look forward to updating the market as the year progresses. I will now turn the call back over to Mark.

Thank you, Ryan. So in summary, a strong start to fiscal year 2023 by the entire Indivior team delivering against our strategic priorities, continued momentum behind SUBLOCADE, a raise in net revenue guidance based on the film resilience and integration of Opiant and preparation for launch of 003, if approved, as well as planning for the U.S. listing on the NASDAQ in June. With that, I'll open up to the questions-and-answer period.

[Operator Instructions] We will now take your first question. And your first question comes from the line of Paul Cuddon from Numis. Please go ahead. Your line is open.

Thank you very much. I have two questions, please. Firstly, on the incremental quarter-on-quarter growth for SUBLOCADE into Q1 at sort of plus 12%. I just wonder if there's anything that you sort of want to flag for Q2? I mean could it be double-digit again in Q2? Or should we anticipate that Q1 had a bit of stocking? And then secondly, just on the gross margin, 84.5 was a bit better than we were expecting. I'm just wondering, is that sort of possible that that could continue kind of as the year kind of progresses? Thank you.

Thanks for the question, Paul. I'll handle the first one, and then I'll ask Ryan to comment with regards to the gross margin profile in Q1. Listen, we are extremely pleased with the progress in the delivery in the first quarter, really demonstrates that our organization health system strategy and our go-to-market structure that we pivoted to in fall of 2020 is working and working well. With over 90,000 patients using SUBLOCADE over the last 12 months, it just gives us continued confidence behind our peak net revenue goal of greater than $1.5 billion. It also with the way we started the first quarter gives us strong confidence in the range that we've given for the year and achieving that. We don't break down kind of the quarter-to-quarter sort of guidance on that, Paul. So I'll have to ask for a little bit of relief on that question. But again, we do have a lot of conviction behind the full year numbers.

Thank you.

And then on the gross margin question, yes, there's no doubt that we did have a good gross margin percentage quarter and we look forward to the margins continue to expand as SUBLOCADE becomes the larger contributor to our profile. But I would caution that there was some FX benefit and some favorable production variances such as lower write-offs versus prior year in the quarter and those may or may not repeat in the balance to go, hence, the reason why we are still confident in our guidance range of low to mid 80%s for the year.

Thank you, Paul.

Thank you very much and congratulations.

Thank you.

Thank you. We will now go to our next question. One moment please. And your next question comes from the line of Thibault Boutherin from Morgan Stanley. Please go ahead. Your line is open.

Thank you for taking my questions. Three, please. The first one on litigation. The press release mentioned that new offers and demands have been exchanged with the state in the context of the MDL litigation. So just curious to know why the states have been singled out here? What about the other classes of [indiscernible] purchasers and payers, which are also involved in the MDL? Is there any reason why they have been excluded from these additional exchanges? So that's the first question. Second one, on the ex-U.S. sales for films and tablets. It looks like the numbers have been stabilizing for a few quarters now. Could we start to see some growth here? Could you just give some color on the drivers behind the potential growth and how much we could expect? And then last question on your plans for the launch of OPNT003, Hikma tried to launch a high dose version of naloxone, 8 milligrams, branded product called KLOXXADO. I think that strategy was similar to the one you -- I think you are thinking about for your own product. It seems that the uptake so far for them has been relatively modest and clearly, very far away from the ambitions you have for OPNT003. So if you could just give us some details on the differentiation that you have either in terms of go-to-market model or in terms of product differentiation that could be key to drive an update in this market? Thank you.

Thibault, thanks for the question. I think, I'll start with the litigation and a little bit of commentary on 003 and then I'll hand to Ryan to talk about the trends that we are seeing in the film and tablet market between both the U.S. and Rest of World. On the litigation side, I think the key message here is that mediation with stakeholders continues to proceed with engagement from the court and we continue to aspire to bring certainty for all stakeholders at the appropriate value. If you look at the provision for the quarter, which we reassess every quarter across management with the Board and with the auditors, the provision with our best estimate has not changed. So we'll continue to progress moving forward. We expect further mediation sessions moving ahead. And that's about all I can say on this matter due to the ongoing nature of this matter before the court. So on the litigation, that's where we are. With regards to 003 and the naloxone market, I think what we're trying to do here with the launch of 003 is the team has created what we believe to be a transformational product in this space, utilizing a totally different active in the space with a very, very different product profile. Nalmefene, if you look at nalmefene versus naloxone, it has a higher affinity to the receptors, it tends to act quicker to get to peak values and its half life is much longer, more in line and just beyond the typical sort of synthetic opioids that you're seeing. So the product is completely different, and we believe it will be the next paradigm of treatment for these synthetic opioids, which as you follow the market and you look at the over 200 deaths a day that are occurring, 90% of those are coming from fentanyl. So we think this is the product moving forward that if my daughter was out there, I'd want her to have it in her pocket book. So with that as kind of the 003, I'll hand over to Ryan to talk through the films and tablets.

Thanks, Mark. So in regards to the film business here in the U.S., we are still certainly surprised that the fourth generic hasn't launched at this point. We will certainly take the cash that's being generated from the film's resilience. But we do caution that we do plan, as we said in our guidance, that our assumption is that they will launch now at some time in the second half, and we are planning for further share erosion at that point. There's no fundamental reason why they shouldn't launch. And our objective is to keep a pulse on the marketplace and update you accordingly. In regards to the Rest of the World, really proud of the work that the Rest of the World team is doing, where they're stemming the losses that we've seen over the last couple of years where we've introduced film and SUBLOCADE into certain markets and you're starting to see, as we mentioned today, almost 12% or 13% year-over-year growth primarily tied to film and SUBLOCADE. So I think you're seeing some stronger tab business resilience, especially in large markets such as France. And then you're also seeing some of the nice performance on the new launches on film. And so when you combine all those, that's why we feel comfortable bringing up our total net revenue on the top line due to film and tablet.

Thank you.

Thanks, Thibault. Thank you, Thibault. Appreciate it.

Thank you. [Operator Instructions] We will now go to the next question. And your next question comes from the line of Max Herrmann from Stifel. Please go ahead. Your line is open.

Great. Thanks very much for taking my questions and congratulations on a strong start to the year. Three questions, if I may. Firstly, on SUBLOCADE and moving on to the OPNT003 launch. And then finally, just in terms of the -- again, a follow-up on SUBLOCADE. In terms of the SUBLOCADE sales, how are you seeing the mix between doctors who are currently prescribing it and maybe then increasing the share of patients that they are prescribing it to and actually adding new doctors to the roster? So that's kind of first question. So just trying to understand where the real driver is new doctor adds? Or is it just broadening or how is the balance between the two?

Yes, it's a great question, Max. And really, I think the whole focus on SUBLOCADE, now that we've been on this journey for organized health systems for a couple of years, it's focused on depth. These large organized health systems have multiple sort of subsidiaries out there and we are at the very early stages of driving depth of activation of those subsidiary accounts of driving more depth with current active providers as well as bringing, as you said ever so eloquently, new HCPs to the roster. And so the growth you're seeing is coming across all of those vectors, which gives us the confidence in the continued journey, both the confidence of our guidance for this year, but the confidence of being greater than $1.5 billion for peak net revenue guidance. So it's pretty good growth across all the vectors.

Okay. Are there sort of lessons you can learn from sort of certain doctors and how they're prescribing to their patients and that you can then kind of replicate in other maybe sales regions that you can use best practice from one region to another? And I'm just trying to understand the lessons that you may be learning there between the different areas. Just to try and see what the lead areas may be achieving.

Yes. Absolutely, Max. I think in any point in time where you're in the launch and trying to change the true paradigm of treatment, we are still in the early days with about a 3% share of the market and we see huge potential for the asset. So every -- continuously through the year, the team is taking learnings. They're having calls across the different areas, sharing best practices. We are continuing to modify the detailed aids to talk about this paradigm shift based on those learnings, both from where we have significant depth in prescribing, but where we see earlier prescribing and taking all of those lessons and building into our approach as we continue to drive penetration in the market, so.

And so the second question on SUBLOCADE is about the sort of relaxation of legislation, which will, I believe, allow you to use or dispense from a different location to the prescribing location and that will potentially enable you to have injection clinics or clinics that allow patients to be administered away from the prescribing position. Has that legislation now been implemented? And where is it in terms of you being able to actually leverage that? I think that was one of the key issues that you had with the initial launch in the prescription journey.

No. It's absolutely front of mind. And recall that the law changed in December, and it basically removes Data 2000, which has this requirement that's unique to the prescribing of buprenorphine that had it so that the prescribing physician had to actually administer the injectables. And I think it was a law that was put in place back when injectables weren't contemplated. So it was to deal more with the orals and trying to prevent potential diversion associated with those. But with the long-actings, the removal of the law we believe further normalizes the disease space similar to schizophrenia where patients can get a prescription from a psychiatrist who may not want to do the injection and they can go to an alternate site to have the injection done, we can now effectuate that for the treatment of opioid use disorder with SUBLOCADE. Now with that change in law comes a build out of infrastructure and the ability to get there. So it's not something that's going to happen overnight. It will take time, but we see it as certainly as a tailwind for future growth and normalization of the disease space, Max.

Okay, great. And then maybe just on the OPNT003 launch, how do you obviously approval potentially in May? What are the steps that you need to do to start to really get traction with these first responders? Is it going to be quite a long sales cycle? Does it take like you found with the criminal justice system, it can take quite a long time to negotiate those contracts? Can you start that process immediately on approval before the launch?

Yes. I think you're bringing some clarity to the process, which is quite different than on the treatment side where, first, you have to get access and then you can pull through by calling on physicians and talking about the merits of the asset. On this side, you tend to be dealing more with buyers with contracting and talking them through and talking to the various first responders through the benefits of the potential benefits of this asset. And of course, we'll have -- if it's approved, we'll have a final label and be able to articulate those more fully. And so that cycle is based on their contracting cycles and their buyer cycles and those can be a little bit more even through time. And so this is -- this will be a build through time. We haven't given year-to-year guidance. We have said this year, we think it will be relatively de minimis amount of revenue. But we still do have confidence in the peak revenue of $150 million to $250 million based on what we are hearing out there.

Great. Thanks very much.

Thank you for the question, Max.

Thank you. We will now go to our next question. One moment please. And your next question comes from the line of [indiscernible] from Bank of America. Please go ahead. Your line is open.

Hello. I'm sorry if it has been already touched upon, but I just wanted to ask a little bit about the listing of the company on NASDAQ. Is there any long-term view in terms of the listing in U.K.? Is there a plan to move primarily listing to U.S. at some point? Or is it just going to be an additional listing?

Thanks for the question, [indiscernible]. And listen, this is an additional listing. We will still have our primary listing in the U.K. And just to remind the broader audience that the sole purpose of this is to bring additional exposure to both the company as well as the disease space in its largest opportunity market of the United States. So this is about that visibility for the company. And we are excited to be able to go live with that at some point in June. So thanks for the question.

Thank you. There are currently no further questions. I will hand the call back to Mark.