Indivior Pharmaceuticals Inc (INDV) Q4 2022 Earnings Report, Transcript and Summary

Good day and thank you for standing by. Welcome to the Indivior Plc Full Year Results 2022 Conference Call. At this time, all participants are in a listen-only mode. After the speakers presentation, there will be a question-and-answer session. [Operator Instructions] Please be advised that today's conference is being recorded. I would now like to hand the conference over to your host today, Jason Thompson. Please go ahead.

Thanks, Sharon and good morning, 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. Actual results may differ materially and we will list these factors on Slide 2. We also may refer to non-GAAP measures, the reconciliations for which may be found in the appendix to this presentation posted on our website at indivior.com. I'll now turn the call over to our CEO, Mark Crossley.

Thank you, Jason. Good morning and good afternoon, everyone. Thanks for joining us. I'm Mark Crossley, CEO of Indivior. With me today to discuss our results and progress 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 our strategic progress, after which Christian will review our research and development priorities and then Ryan will conclude our formal remarks by detailing our financial performance and the full year 2023 guidance we published in our press release. We'll then move on to Q&A. Turning to Slide 5. Starting with our performance in 2022, I'm pleased to report that Indivior made excellent progress against our strategic priorities. At the heart of everything we do is our vision that millions of people across the globe suffering from substance use disorders and serious mental illness have access to evidence-based medical treatments to change their lives. Driven by this unwavering focus on patients, the team have delivered strong financial results. Our full year 2022 net revenue grew 14% to $901 million, powered by strong double-digit growth in our long-acting injectables, SUBLOCADE and PERSERIS. I'm particularly proud that SUBLOCADE our once-monthly buprenorphine for the treatment of moderate-to-severe opioid use disorder, became Indivior's largest selling medicine in 2022. This speaks to the transformational nature of this important medicine. And as you heard at our Capital Markets Day in December, we believe we're only just getting started in realizing its full potential. Staying with our financial results, we delivered adjusted operating income growth of 13% to $212 million. Given the step-up in growth and R&D investments in the year, this was solid performance and comfortably ahead of our expectations as we enter the year. Touching briefly on our fiscal year 2023 guidance, we expect to deliver another year of attractive profitable growth. Ryan will take you through the details in a few minutes but I would highlight that we do plan to deliver top line growth and positive operating leverage in 2023, consistent with the medium-term financial outlook we outlined at our Capital Markets Day. As we've previously signaled, our guidance does not include the impact of Opiant Pharmaceuticals acquisition as the transaction has not yet closed. However, I'm pleased to report that following recent regulatory approvals, we expect this deal to close in early March following anticipated approval by Opiant's shareholders. Maintaining a strong balance sheet continued to be a priority in 2022. Our capital allocation policy allowed us to fund the core business growth, pursue the Opiant acquisition, return cash to shareholders through our second $100 million share buyback program, as well as maintain financial flexibility to meet our existing obligations. Lastly, I'm pleased to report that the preparations for the listing of our shares in a U.S. exchange are on track and we anticipate the listing to become effective in the spring. We expect to begin trading under the symbol INDV on NASDAQ shortly thereafter. On Slide 6, I want to address the exceptional provision of $290 million we've recorded for the legacy civil antitrust litigation. We previously have disclosed a contingent liability and with the fiscal year-end results, we've updated to a provision and we've updated our footnote disclosures based on current information available. Due to the ongoing nature of the business, I'm unable to go into much detail beyond what we shared in the release. However, I would offer the following. We have participated in very early-stage mediation sessions with the claimants where offers were submitted by the parties. We have and will continue to evaluate the claims of the plaintiffs in light of our meritorious defenses. The group is determined that it's in the best interest of it's stakeholders to work towards settlement at the right value. We continue to caution that we cannot predict with any certainty whether we'll be able to reach an ultimate settlement and the provision we recorded is the best estimate at this time considering the current status of events but it could ultimately be higher or lower. Turning now to our regular scorecard, we've established a clear set of strategic priorities for value creation and delivered substantial progress against each in 2022. We know this is a busy slide but it captures the year's milestones and there were many. Most notably, we've raised our peak net revenue expectations for SUBLOCADE to greater than $1.5 billion from the previous $1 billion. This reflects our confidence in our ability to successfully execute our commercial strategies together with a substantial patient opportunity that we see in what remains a very undertreated disease space. In 2022, SUBLOCADE net revenue reached $408 million, representing an increase of 67%. The number of patients receiving SUBLOCADE in the U.S. for the year grew to approximately 82,500 from approximately 49,000 in 2021. To reach our peak net revenue target of greater than $1.5 billion, we are targeting an annual total of 270,000 patients on SUBLOCADE. The team is making great progress towards this and we expect to exit 2025 with a run rate in SUBLOCADE net revenue of over $1 billion. Looking to 2023, we're guiding for SUBLOCADE net revenue of $550 million to $600 million, representing another strong year-over-year increase of 41% at the midpoint. Our growth strategy for SUBLOCADE is primarily based on accelerating adoption in organized health systems in the U.S. and on expanding access to treatment in the U.S. justice system. Combined, these channels contain approximately 3 million patients. In case -- in each case, excuse me, we're relatively early on in the journey but we're making significant progress. In organized health systems, we achieved our goal of activating 500-plus priority accounts in 2022. And moving forward, our strategy is to deepen SUBLOCADE's availability in the 10,000-plus facilities contained within these parent organized health systems. As we set out at our Capital Markets Day, we have so far captured about a 4% share of organized health system patients and a 1/3 of the way towards the 12% patient share needed to hit our greater than $1.5 billion of peak net revenue. In the U.S. justice systems, the challenge is more complex due to the often transient nature of the individuals with opioid use disorder, particularly as they transition back into community care. However, it's a huge opportunity with around 1.2 million patients and importantly, one we feel SUBLOCADE's product profile is ideally suited to. Over the last 1.5 years, we've established a dedicated team that is targeting treatment access in 1,000 priority Justice facilities. In 2022, SUBLOCADE was used in approximately 200 of these facilities in the first year of this dedicated team. We're just scratching the surface, having achieved around a 1% share of patients to date in this hugely undertreated and complex channel, so there's significant room for future growth. While SUBLOCADE remains our number one priority, we're also working to diversify our revenue sources and help more patients across the continuum of care for multiple substance use disorders. With the planned addition of Opiant and its addiction-related assets, we aim to create a platform focused on treatment of substance use disorders across the continuum of care. For OUD patients, we're especially excited about the potential of bringing to market 003, on investigational nasally administered rescue medication designed to address the current wave of overdoses caused by fentanyl and other highly potent synthetic opioids. Addition of 003 allows Indivior to meet patients where they are in their recovery journey. This could require patient rescue with OPNT003 Opim003, or for those in treatment for moderate to severe opioid use disorder, the once monthly, long-acting injectable SUBLOCADE. This offering would be supported by proven complementary commercial capabilities from Indivior and Opiant that span across organized health systems, practicing health care professionals and public interest channels. While 003 remain subject to the FDA approval, the FDA recently set a PDUFA date of May 22nd this year, granting it a priority review designation because 003 has the potential to provide a significant improvement in the safety or effectiveness of the treatment, diagnosis or prevention of a serious disease. Assuming approval, we'd expect to launch the product later this year or in early 2024. We expect to share more details on our plans and on the financial impact post-closing, likely with our first quarter results in late April. In terms of diversification of revenues outside the U.S., we continue to roll out our new addiction treatments in new markets. Ex U.S., SUBLOCADE net revenue grew to $27 million, an increase of 69% and it is now the principal growth driver of our business outside the U.S. To date, we received regulatory approval for SUBLOCADE in 11 countries and launched in Canada, Australia, Israel, Finland and Sweden. In the first half of 2023, we're expecting to make SUBLOCADE available in Germany. When we also add in the growing net revenue contribution from SUBOXONE Film in the ex U.S. markets, where I remind you, this is a new product that's not subject to generic competition. We're confident we can return our ex U.S. business to sustained growth over the medium term. In addition to strengthening our position in global addiction, we made encouraging progress during 2022 with PERSERIS, our differentiated long-acting injectable risperidone for the treatment of schizophrenia. We successfully expanded our commercial force to achieve national coverage and are seeing improved market visibility and prescriber uptake. PERSERIS net revenue reached $28 million in 2022, an increase of 65% versus the prior year. Importantly, the number of patients receiving PERSERIS reached 5,400, representing solid progress towards our goal of 40,000 patients. Our net revenue expectations for PERSERIS in 2023 are $45 million to $55 million, representing an increase of 82% at the midpoint and we remain confident in achieving our peak net revenue expectations of $200 million to $300 million. We also saw significant progress in building and progressing our pipeline. As we discussed in December, under Christian's leadership, we continue to be at the forefront of addiction science and true pioneers in the space. In a moment, Christian will provide his fulsome update, so I'll only offer that we continue to be excited by our portfolio of novel investigational assets for cannabis use disorder, OUD and alcohol use disorder. Furthermore, as we're really looking forward to welcoming Opiant's R&D team and bringing on board their pipeline assets and scientific capabilities upon closure of the transaction. Lastly, on this slide, let me highlight some of our operating model milestones. During the year, we maintained our balanced approach to capital allocation, reinvesting in key growth drivers, strengthening the business through potential diversification opportunities, sustaining our ability to meet our obligations and returning capital to shareholders. As we look to 2023, we expect to bring on board a second contracting -- contract manufacturing facility for SUBLOCADE which will provide additional capacity and further derisk our SUBLOCADE and PERSERIS supply chains. We will also work to resolve outstanding legacy litigation at the right value, including the legacy civil antitrust matter I referenced earlier, so that we can focus single-mindedly on the tremendous prospects for growth and shareholder value creation that we see ahead of us. Lastly, I want to highlight that how we do business matters to us and we recently took a significant step in communicating our ESG journey aspirations with the publication of our inaugural sustainability report. My final slide repeats what I presented in December and looks out over a 5-year horizon. We are very confident in the prospects for SUBLOCADE and PERSERIS over the coming years and we expect our growth in net revenue to translate to compelling medium-term profitable growth and strong cash flow. The scalability of our business model means we expect to deliver significant margin expansion over the medium term, even though we plan to increase our R&D expense ratio towards industry benchmarks as we build a broader and deeper pipeline of innovation, next-generation medicines for substance use disorder and their adjacencies. Taken together, we expect the combination of attractive net revenue growth and operating leverage to drive strong cash flow which we will deploy according to our balanced capital allocation framework. In 2023, we look forward to making meaningful progress against this medium-term outlook as we seek to create value for all Indivior stakeholders. With that, let me hand over to Christian to talk about our R&D priorities.

Thank you, Mark and good morning, good afternoon, everyone. Our contribution to SUBLOCADE's success are focused and we'll continue to focus on breaking barriers to treatment access by creating a new evidence through 5 strategic pillars. First, we are pursuing long-term collaboration studies to understand the long-term outcomes of SUBLOCADE treatment, it's differentiation versus current standard of care and the journey towards recovery. Second, externally sponsored studies are supporting recent areas of interest, including high-risk opioid overdose, criminal justice system, rapid initiation in different treatment settings, comorbidities and the long-term efficacy and safety. Third, we have initiated a broad range of real-world evidence studies with the work streams along 3 themes as disparity, including social determinants of health, recovery and the harm reduction. Fourth, we initiated Phase IV studies, aiming at addressing knowledge gaps in the areas of SUBLOCADE rapid induction, patient subpopulations that may benefit from the 300-milligram maintenance dose, alternate injection sites, long-term recovery outcomes, treatment cessation guidance, impacts of SUBLOCADE treatment in the emergency department environment and comparative effectiveness with other medications for the treatment of opioid use disorder. We also launched a platform for data integration sharing with the scientific and medical community. Fifth, we continue to listen to patients' voice to identify and foster adoption of best addiction medicine practices in a range of clinical settings. On the next slide, you can see a few examples of peer-reviewed publications in the fourth quarter of 2022. This included a characterization of individual subgroups of recovery from opioid use disorder following treatment with SUBLOCADE and how these subgroups related to different recovery trajectories. The second example is a very complex concentration response analysis to confirm the buprenorphine plasma concentrations driving mu-opioid receptor occupancy in the brain that are necessary to maximize buprenorphine efficacy in patients. The third example is a retrospective analysis performed among Medicaid patients, clearly showing that utilization of medications for opioid use disorder significantly reduces health care resource utilization and, of course, medical costs for Medicaid patients with opioid use disorder. And the fourth example is an in-depth review of the history of the discovery and development of buprenorphine as a drug product as well as the U.S. regulatory approval of several buprenorphine-based medications for the treatment of opioid use disorder over the last 20 years. The next slide is an update on our activities to support SUBLOCADE and SUBOXONE Film outside of the U.S. as well as PERSERIS in the U.S. SUBLOCADE outside of the U.S. has now been approved in 11, most of the world countries as related by Mark a few minutes ago. Approval is pending in the United Kingdom and further geographical expansion includes planned submission in Middle Eastern countries. Regulatory approval of SUBOXONE Film has now been granted in more than 30 countries listed on the slide. And for PERSERIS, 2 main FDA approvals of prior approval supplements were achieved in 2022. First, the extension of shelf life and time out of the fridge. And second, alternative injection sites in the back of the arm. On the pipeline front, on the next slide, our strategic collaboration with Aelis Farma for the development of AEF0117 for cannabis use disorder is progressing as planned. Aelis Farma achieved the first subjects first visit with AEF0117 in the Phase IIb trial on the 23rd of May last year. The estimated last subject as visit and database lock is in the first part of 2024, with a final CSR clinical study report in the second part of 2024. Importantly, other CMC, nonclinical toxicology and clinical work streams are progressing as planned. The 2023 objectives with our selective OX1 receptor antagonist as a nonopioid medication for opioid use disorder are to complete the multiple ascending dose study as planned per protocol for delivery in the fourth quarter of this year, as well as other supportive clinical and nonclinical studies. We will also progress our tablet formulation development and manufacturing. Our GABA-B positive allosteric modulator program for alcohol use disorder has now led to the characterization of 2 lead molecules as well as 2 additional backup molecules and scale up and manufacture of 1 lead, primary and secondary in vivo profiling studies for the lead molecules are now being finalized and the decision for candidate selection of 1 lead molecule is on track for the end of the first quarter of this year. Thank you. And let me hand it over to Ryan for the financial update.

Thanks, Christian and good morning and good afternoon to everyone. Our financial performance for Q4 and full year 2022 was solid and our full year underlying results were within expectations. I will quickly touch on some highlights for Q4 and full year 2022 but will spend most of the time on our outlook for 2023 and our assumptions. Performance highlights for the full year include total net revenue growth of 14% to 209 -- excuse me, $901 million, driven by a 67% increase in SUBLOCADE net revenue to $408 million and adjusted operating income growth of 13% to $212 million. U.S. net revenue increased 21% to $731 million and represented 81% of the group's total net revenue in full year 2022. Our improvement in adjusted operating income included approximately $46 million of incremental growth investments reflected in the step-up in adjusted sales and marketing and R&D expenses from full year 2021 to full year 2022. We also exited the year with close to $1 billion in gross cash and investments. Looking at our financial performance in more detail, starting with the top line. Total SUBLOCADE reached net revenue of $118 million in Q4, increasing 57% versus the prior year and 9% versus the prior quarter. U.S. SUBLOCADE net revenue also grew 9% versus the prior quarter, while dispenses grew 11%. The difference between dispenses and net revenue reflects trade spend accrual updates related to a slightly higher-than-expected mix of Medicaid business. As I look forward, the leading indicators for SUBLOCADE in 2023 are off to a good start and align with the full year 2023 guidance I will share in a moment. Moving to PERSERIS. Full year 2022 and Q4 net revenue of 28 and $8 million, respectively, increased by 65% and 60% versus the comparable year ago periods. Growth was driven by the expansion of the PERSERIS sales team earlier this year to achieve full national coverage in the U.S. Turning to SUBOXONE Film. Average share in the fourth quarter was approximately 19%, essentially flat sequentially. Our share position exiting 2022 was also approximately 19%. In the quarter, we saw net revenue benefits from stocking activity in the high single-digit millions of dollars to finish the full year with net revenue ahead of our expectations. As a reminder, we do not promote SUBOXONE Film in the U.S. Net revenue outside the U.S. declined by 10% versus full year 2022 at actual FX rates, although it would have increased 1% at constant FX rates. We continue to see good year-over-year growth in SUBUTEX PR, the brand name for SUBLOCADE outside the U.S. which increased 69% in full year 2022 to $27 million, while SUBOXONE Film grew modestly year-over-year. These benefits, however, continue to be mostly offset in full year 2022 by pricing pressure in our legacy tablet business and by the sale of the TEMGESIC business. Moving down to P&L. Our full year 2022 adjusted gross margin was 82%, down from the prior year's adjusted gross margin of 84%. The decline reflects a higher mix of less profitable government channels for SUBOXONE Film in the U.S. and some cost impacts from inflation. Our adjusted overall operating expenses were $533 million in full year 2022, an increase of 12% versus full year 2021. The increase primarily reflected commercial growth investments behind SUBLOCADE and PERSERIS and an uptick in R&D to advance our ongoing SUBLOCADE studies, progress our early-stage pipeline assets and to expand our manufacturing capacity for SUBLOCADE and PERSERIS. Moving to adjusted operating profit. Full year 2022 adjusted operating profit of $212 million was up 13% versus full year 2021, reflecting top line growth, partially offset by the growth investments. Adjusted net income also improved in full year 2022 versus full year 2021, reflecting similar dynamics along with lower net finance expense. Quickly touching on the balance sheet and our capital position. As I mentioned, we ended the fourth quarter with gross cash and investments of $991 million before any payment obligations or other liabilities are included. As Mark touched on, our balance sheet allows us to maintain our balanced approach to capital allocation with investment against each of our strategic priorities, including our second share repurchase program and the proposed Opiant acquisition. Now turning to 2023. Over the last 2 years, we believe we have largely put in place the infrastructure needed to achieve our long-term net revenue goals for each of SUBLOCADE and PERSERIS. Incremental investments in 2023 will be geared towards accelerating our path to the delivery of our peak annual net revenue. As noted in the release, our guidance does not include any impact from the pending acquisition of Opiant Pharmaceuticals. We plan to update guidance at the appropriate time following the completion of this transaction, likely with our first quarter results in late April, as Mark noted. Considering the overall scalability in our business model that we have outlined previously, we expect adjusted operating income and operating margin to be higher versus last year based on the midpoints of our guidance elements and we expect this performance to translate into positive cash flow from operations. I'll now provide more detail on the assumptions behind our guidance, starting with net revenue. We expect to deliver total net revenue of $950 million to $1.020 billion. At the midpoint, this would represent growth of over 9% versus 2022. Our net revenue expectations for SUBLOCADE in full year 2023 are $550 million to $600 million. The midpoint of this range would suggest 41% year-over-year growth. As in 2022, SUBLOCADE's growth in the coming year is expected to be driven by deepening penetration in the OHS channel and significant ramp-up in the justice system. The guidance for 2023 also aligns with the SUBLOCADE trajectory to exit 2025 with an annualized net revenue run rate of $1 billion. For PERSERIS, our net revenue expectations are $45 million to $55 million which represents 82% growth at the midpoint. Our commercial team is now firmly in the field with full national coverage and continues to gain traction in the expanded account universe, driving new HCP conversion and strong retention of active HCPs. With regards to U.S. film which I remind you, we do not promote. We continue to take a prudent stance on guidance. As you are aware, a fourth generic has been approved since last summer and could enter the market at any time. We have no visibility on the timing and market impacts of these new entrants. Our guidance assumes this additional generic will enter the market in the second quarter and contribute to an accelerated film share loss compared with an underlying average annual loss of approximately 2 percentage points over the last 2 years. To round out the total, in Rest of World, we are anticipating broadly stable net revenue compared to full year 2022 with SUBUTEX PR and fill momentum being offset by continued legacy tablet competition and pricing actions. Longer-term, we remain confident we will return our Rest of the World business to growth on an annual basis based on the improving mix of our portfolio. Looking at gross margins, we are expecting to deliver in a low to mid 80%. This reflects the mix benefit from continued strong growth in SUBLOCADE, mostly offset by expected higher cost inflation, chiefly related to wages and benefits and third-party services. In the medium term, we remain confident that SUBOCADE will support higher gross margins overall. Turning to operating expenses. We continue to break out R&D and SG&A to provide greater transparency in our guidance. Our total operating expense for full year 2023 is expected to be in the range of $570 million to $590 million, up approximately $50 million or 9% at the midpoint from adjusted full year 2022. Breaking down the components of the total OpEx range, we expect SG&A to be $490 million to $500 million and R&D to be between $80 million to $90 million. Our SG&A range at the midpoint reflects a 7% increase versus adjusted 2022. This increase is largely driven by across-the-board inflation in wages and benefits, travel and entertainment and other third-party services. We are also further building out the Justice team to support this key growth channel and adding some key account leadership personnel as we penetrate deeper into OHS accounts. Turning to R&D. The midpoint of our guidance suggests an increase of 18% compared to full year 2022. This reflects our continuing investments to advance early-stage assets and funding to support important long-term studies for SUBLOCADE. Inflationary impact similar to the SG&A component are also contemplated in the 2023 guidance. In the medium term, we expect R&D to align more closely with industry benchmarks of low double digits as a percentage of net revenue. Factoring the above, as I mentioned, we expect adjusted operating income to be higher versus last year, with positive operating leverage at the midpoint of our guidance and positive cash flow from operations. Lastly, I would add that the exceptional provision of $290 million for the antitrust matter that we recorded in Q4 of 2022 will impact our expected tax rate for the year. As a result of the provision, our tax rate on an adjusted basis is now expected to be in the low to mid-20% range in 2023. In 2024, we expect it will begin to return to the historical range of mid- to high teens. Regarding our capital allocation framework, we expect to maintain our approach that I outlined in December that balances our financial flexibility, while meeting our obligations and derisking the business. Specifically, we will reinvest in the business where we can extend our leadership position and look at additive business development opportunities. Additionally, we will regularly evaluate our capital needs and we'll look to return value to shareholders if appropriate. I will now turn the call back over to Mark for some closing comments.

Thank you, Ryan. In summary, the team have delivered strong financial and operating results in fiscal year 2022 with significant progress against each of our strategic priorities. Our 2023 financial guidance indicates strong top line growth and positive operating leverage in 2023 despite expected revenue loss of our heritage film product due to a fourth generic and continued high inflationary pressures. We move towards potential close of the Opiant deal as well as a U.S. listing this spring to enhance Indivior's visibility to investors in its largest market. With that, I'll hand back to Sharon to open up for questions and answers.

Thank you. [Operator Instructions] And your first question comes from the line of Thibault Boutherin from Morgan Stanley. Please go ahead, your line open.

Yes, hello. Thank you for taking my questions. And I'm sorry but I will have to start with the antitrust litigation because, unfortunately, this is what investors have been focusing, I think, this morning. And I think they are seeking reassurance that this is a one-off that can depend behind and look forward on a clean basis. So I guess my first question is, can you confirm that the number of plaintiffs in the MDL has been locked up by now. So there is no chance of seeing additional plaintiffs joining the MDL. I think that's the case but if you can have a confirmation. Second question, you mentioned as well a separate distinct litigation in early stage that you [indiscernible]. The claims are similar to the MDL. And if I understand correctly, during your mediation for the MDL, you also talked with some plaintiffs that may be involved in the cost of case. So if you could elaborate a bit on the overlap between these 2 litigations and maybe the opportunity for a settlement that could address both? And then third question, still related to the litigation. Is the MDL results in the settlement? Kind of explain what is preventing additional groups of plaintiffs to engage in new litigations on similar claims? Thank you.

Thanks for those questions, Thibault. I really appreciate it. And I think in our disclosures, we've provided is detailed a possible disclosure as we can with regards to these legacy litigation issues. I think the recent activity that's occurred in these matters that are before the court. Our overriding goal is providing certainty for stakeholders at the right value and I think we have a strong track record with the management team. I think as you speak to the plaintiffs in the MDL, obviously, there are end payers, private payers and -- end payers, private payer and the state AGs. And there are a couple of carve-outs as you said, as you mentioned, that are outside of that group that are with related activities that would have to be contemplated but are at earlier stages. So, those are not included in the current mediation as of this time.

Thank you. And okay, that's clear. So just to come back on the settlement, if the supplement between now and the trial, then there is no mechanism that prevents additional plaintiffs from potentially trying to set up a notification on similar claims. Just trying to understand basically how we can get reassurance after a settlement that is behind us?

Yes. We don't have any visibility to -- to additional claims other than the ones that are in the disclosure, Thibault and those are the ones that we're actively trying to resolve and bring certainty to shareholders and clearly at the right value for shareholders for that certainty.

Okay, that's very clear. Thank you very much.

Thank you.

Thank you. We will now go to our next question. And your next question comes from the line of Jim Vane-Tempest from Jefferies. Please go ahead, your line is open.

Yes, hi. Thanks for taking my questions. A couple of financial ones, please. If you can just help us think through the phasing of R&D spending for this year, you obviously had sort of about 40% of your budget in Q4. Can we expect the same level of phasing in 2023? And my second question is just around cash flow. I noticed that there was quite a significant payables outflow. Just wondering if there's anything specific there you can help us understand in terms of those dynamics? And then, my third question is the Q4 gross margin was a little lower, I think some people were anticipating. Is there anything on rebates or mix or inflation we should be aware of there? And is that the kind of level we should expect for 2023? Thank you.

Thanks for the questions, James. I'm going to go ahead and hand over to Ryan and I think he can address all 3 of those from the phasing of the R&D to the cash flow and then the Q4 gross margin.

Good morning. So on the R&D phasing, I tend not to provide timing in regards to the spend quarter-by-quarter. But what I would tell you is it's more of the progression of those large studies that we put in place at the back half of 2022, that was just being referenced by Christian. So we have that rolling into next year. We have the continued pipeline work being done on the Phase 2 assets as well as the build-out of the second manufacturing site. So at this point, it's more of just continuous progress from 2022. In regards to the accounts payable unwind, if you recall at the beginning of 2022, unfortunately, some of our accounts payables did not get out in time at the end of 2021, so we had to carry over a large quantum of payables that got released immediately at the beginning of Q1. So that is a nonrecurring event. It was just due to the timing of some payments getting out at the end of 2021. And then, in regards to gross margin, I think that's just the reflection of films still having a substantial amount of the business in Q4. It did have a Medicaid mix true-up in there that doesn't help the margin at this point. And you're also seeing some inflation catch up in Q4 as well. But as you look forward, we did project that as SUBLOCADE continues to grow its presence in this portfolio, that our gross margins as well as our op margins that we do predict to become healthier.

Thank you. And just one follow-up, if I can. And that is, I guess, looking at what you delivered for SUBLOCADE in Q4 comparing to how the script growth looks, I think there was some in the market that thought, perhaps Q4 would have been more towards the upper end of your guidance. So is there any sort of dislocation between what the data is telling us and how the numbers are coming in? And any clarity on that would be helpful as well. Thanks.

Thanks, James. And on SUBLOCADE, listen, I think we're very proud of the execution of the results, $408 million, 67% growth year-over-year. Quarter-to-quarter, you sometimes can see some results that fluctuate based on one-off items. And Ryan, in his comments mentioned that there was a Medicaid mix catch-up due to accelerated growth in the government channel. And if you look at the underlying dispenses in Q4, those were still at 11% growth. So we take that results. And as we look to the 2023 guidance, it's another strong year of net revenue growth, puts us on track towards our peak net revenue goal. So I have all the confidence in the 2023 guidance.

Thank you. [Operator Instructions] We will now go to the next question. And your next question comes from the line of Christian Glennie from Stifel. Please go ahead, your line open.

Hi, good afternoon, guys. I hope you can hear me all right. First question, please. Just to come back on the provision, the $290 million. Release mentioned it could be higher or lower. Our understanding was that $290 million was pretty much the full claim or the entire claim. So just wondering what is the scenario in which you could actually be higher than the $290 million, please?

Thanks, Christian and then we could hear you loud and clear. Listen, we've updated our Q4 fiscal year-end with the current facts of the case based on where we are and that's resulted in a provision of $290 million. That provision is our best estimate. It's in line with IFRS and has been audited by our external auditors. But because it's in early stages, we have to say could be materially different. It could be lower, it could be higher just because we're in the early stages of those mediations. And again, we want to make certain we bring certainty at the right value for shareholders.

Sorry, just to pull off -- it's not as if there's -- the plaintiffs have actually requested more in compensation than the $290 million?

Christian, as you can imagine, this is ongoing mediation. It's before the court. I can't get into the details of the facts and the actual status of these things. This is the best estimate of management. And as I said, in line with IFRS and it's been before the auditors. So I can't -- I just can't get into more detail because it's ongoing before the court.

Thank you. I appreciate that. Sorry it's worth pushing but I understand the situation. Second question then relates to the new legislation signed in by Biden on the removal of the wave -- of the waivers and so forth and the extended ability for places to store product to 45 days from 15 days. Just wondering in terms of your guidance on things like SUBLOCADE for this year, how much of it is reflected on the current uptake in the market? Or could there be upside if you see any real kind of inflection from release of some of the prior restrictions around -- restrictions around prescriptions of buprenorphine? Thank you.

Yes. Thanks, Christian. And listen, in line with our statement that we made in December following the passage of the law, we're really supportive of the removal of Data 2000. I think it's a real step towards normalizing opioid use disorder treatment which is that it is highly stigmatized disease space and it also helps break down barriers to treatment. Now in the short term, we're not expecting an immediate or major impact in the market. If you recall, previously HCPs were allowed to prescribe buprenorphine for up to 30 patients without the waiver and the training and we didn't see a material uptick or change in habits. This said, we are actively assessing the opportunity of the law changes in normalizing the disease space by allowing use of things such as alternate sites of care and for administration of long-acting injectables -- for those of you who cover other disease spaces like schizophrenia, this is a common item where it enables a physician to prescribe the medication but have another DEA waivered physician to prescribe the medication. So for those smaller doctors’ offices and things of that. And so we'll be assessing that opportunity seeing where it's at. But obviously, there's an infrastructure build out on that, that limits the impact in the short term. So more to follow on that evolution.

Thank you. And then finally, if I can. I know the Opiantv deal hasn't gone through yet but any comment on a couple of things as it relates to 003, the likely move of Narcan to OTC, that the advisory committee overnight in favor of that shift, the potential impact of that as it relates to 003? And then just to clarify what you said on 003, assuming approval launch second half of the year or even into 2024, just to clarify what sort of -- what are the things you need to get in place in order to start rolling out that launch, why wouldn't be -- if it was '24, that would be a sort of 6-month preparation. Thank you.

Certainly. Certainly and listen. Applaud the expansion of all treatments to help patients that deal across the continuum of care. I mean, overdose is a horrible thing. And with naloxone and safety profile having that VOTC, we applaud that broad access to treatment. As it relates to OPNT003 which is nalmefene, we just don't see the real impact with regards to the launch on that. For us, this is a differentiated asset that has a quicker onset of action. We believe a quicker onset of action, a longer half-life, longer than fentanyl and a stronger sort of indication that we think is suited towards the synthetic opioids like fentanyl that are kind of ravaging the drug supply. And so we think in those first responders which is where the vast majority of the volume is flowing today, we think it is going to be a great opportunity for them to use that for treatment of those patients. So we just -- we don't see a major impact. As a result -- as it relates to the timing of the launch, listen, we'll get into this more once the acquisition is complete but we do anticipate a second half launch there in the majority of cases.

Okay, thank you. That's helpful.

Thanks, Christian.

Thank you. We'll now go to our next question. And the next question comes from the line of Thibault Boutherin from Morgan Stanley. Please go ahead, your line open.

Yes, thank you. Just a couple of follow-up questions on business. When we think about SUBLOCADE outside of the U.S., you have very understandably focused your investment until now in the U.S. So how should we think about the excess opportunity going forward? And how do you think about the balance of your commercial investments between U.S. and ex U.S. regions? That's my first question. And maybe second question, you mentioned additional contract manufacturing program for SUBLOCADE in the second half. How should we think in terms of the P&L impact for this? And I'll stop there.

So on the first one, Thibault, I think, with regards to the SUBLOCADE ex-U.S. and commercial investments, the go-to-market sort of channels in the rest of world are completely different than in the U.S. In the U.S., we've had to pivot, expand into our ecosystem model in these large organized health systems, whereas the embedded infrastructure and typically in the rest of world allows our current infrastructure to be scaled without tremendous incremental investment. So we don't see a ramp-up of investment as we go into those new countries. So from a contract manufacturing standpoint with regards to do we expect the P&L impact on a going basis, I think Ryan -- Ryan has built that in to both the guidance with regards to 2023 but also the medium-term sort of guidance that he's given on the gross margin where we expect that to continue to improve in the medium term.

Thank you.

You are welcome, Thibault. Thanks for the questions.

Thank you. I will now hand the call back to Mark Crossley.

Thanks, Sharon. And that officially closes our fiscal year 2022 results call. We appreciate the continued interest and support in Indivior and we look forward to seeing everyone in the near future. Thank you.

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