Indivior Pharmaceuticals, Inc.

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, and that actual results may differ materially. We list the factors that may cause our results to be materially different here on slide two. We also may refer to non-GAAP measures, the reconciliations for which may be found in the appendix to our presentation that is now posted on our website at endivere.com. I'll now turn the call over to Mark Crossley, our CEO.

Thank you, Jason, and good morning and good afternoon, everyone. Thanks for joining us to discuss Endivere's fourth quarter and full year results. I'll begin with some opening remarks and a review of our growth strategy. Christian will then provide an update on our R&D priorities, following which Ryan will detail our financial performance and our 2024 guidance. Lastly, I'll provide some preliminary thoughts on the process we're initiating to consult on a potential primary US listing in the summer of 2024. 2023 was another year of strong execution and performance by our team. Led by Sublocate, our total net revenue increased 21% to approximately $1.1 billion and adjusted operating profit increased 27% to $269 million. This was our third consecutive year of double-digit top-line performance, and even after absorbing the incremental costs of the opium business and strategic growth investments behind Sublocade, adjusted operating margins increased for the full year. We also made excellent progress against our strategic priorities to create a durable addiction-focused franchise capable of delivering consistent value creation for shareholders. I'll highlight the key milestones we achieved in 2023 in a moment. Looking ahead to 2024, we expect another year of strong net revenue growth led by Sublocade. Taking the midpoint of our guidance, $850 million of Sublocade net revenue implies 35% year-over-year growth, marking another major step towards our target of greater than $1.5 billion in peak net revenue. This in turn supports the group's expectations of fiscal year 2024 of delivering 18% overall net revenue growth and approximately 300 basis points of operating margin expansion. Again, both taken from the midpoints of our guidance range. Importantly, both our performance in 2023 and our outlook for 2024 are in line with the medium-term profitable growth framework that we committed to at our Capital Markets Day in December 2022. Lastly, I wanted to take a moment on the earnings call to provide my perspective on the apparent disconnect between the market data available via Acuvia and our results for Sublocade. This phenomena has occupied a significant amount of investor mind space and has been further reinforced with our fourth quarter and fiscal year results shared today. As I mentioned last year, and not dissimilar to some other specialty pharmacy products, it appears as though Acuvia data does not capture our justice systems business Products fulfilled via specialty distributor, via buy and bill, and based on our estimates, appears to capture about 25 to 30% of the OHS business, excluding justice systems. For that reason, and has been the case since launch, I can only endorse that you measure Sublocade's performance via results data that we provide at our quarterly earnings. Turning to slide six, expanding on our strategic priorities, we delivered on a number of important milestones in 2023. These included growing sublocate approximately 54% year-over-year to 630 million, with the total number of sublocate patients reaching nearly 137,000 on a 12-month rolling basis. This is an increase of 66% year-over-year. We diversified our revenue base and expanded treatment across the continuum of care through the acquisition of opiate pharmaceuticals and subsequently launched Opvi, our differentiated overdose rescue treatment, Our ex-US business continued to contribute to our growth through new products, including over a 50% increase in net revenue from Sublocade. We expanded our pipeline with two important opportunities targeting opioid use disorder. We took steps to secure our supply chain with the acquisition of a sterile manufacturing facility in the US to support Sublocade's greater than $1.5 billion net revenue goal. And also in terms of securing our future, we settled the antitrust multi-district litigation and continue to believe that the remaining legal matters are manageable. Our confidence in our future was reinforced by the initiation of a $100 million share repurchase program last November. And finally, today's announcement that following our successful listing on NASDAQ last June, we'll be formally exploring making the US the primary trading venue for Indivior shares while maintaining a standard listing in London. As we enter our 10th year as a public company, I want to briefly highlight the compelling fundamentals that support our business and how our team has successfully executed against this backdrop. First, the market in which we participate, broadly defined as substance use disorders, is a terrible global crisis that shows no signs of abating. Looking at our highest value at stake market, the U.S. continues to offer a substantial opportunity for growth and treatment penetration driven by increased funding and access. Drilling down to Indivior, our business is demonstrating attractive levels of growth and profitability. We've built a stronger addiction-focused franchise with tremendous growth potential. The Indivior of today is an attractive growth platform based on new and proprietary growth products with an expanded pipeline of exciting potential medicines. Consequently, we're confident in our ability to sustain and build on our position for the benefit of our patients and stakeholders over the long term. The tragic reality is that the needs of our patients have never been greater. Given the evolution of the opioid epidemic and the incidence of substance use disorders more generally, overdose deaths are continuing to reach new record levels. The U.S. is now in the middle of the deadliest phase of the epidemic, fueled by the rise to prominent powerful synthetic opioids such as fentanyl. The latest data from the CDC suggests the annual overdose deaths in the U.S. are now provisionally reaching over 112,000 lives, On a daily basis, this is equivalent to over 300 deaths a day. What's also important to recognize is there continues to be a significant treatment gap with only a minority of patients diagnosed with OUD receiving medically assisted treatment. As shown on this slide, the estimates for the number of those affected and treated vary by source, but our view is that the higher end of these estimates is more reflective of the terrible reality. In Divya's OUD and overdose statistics, Rescue Treatment, Sublocade, and now Opvi, place us uniquely at the forefront of this complex and evolving disease space. We think efficacy is the critical treatment attribute for patients, particularly given the high potency of synthetic opioids. And we strongly believe that the unique scientific evidence base for our products makes them true paradigm shifts in treatment. Turning to slide nine, to execute against this backdrop and reach more patients, we reconfigured our go-to-market strategy in 2020 to focus on organized health systems. This strategy has driven strong double-digit growth over the past three years, and the channel now accounts for 80% of sublocate volume. We continue to make excellent progress against our three-phase growth strategy for sublocate in this channel, comprised of facility activation, HCP adoption, and ultimately treatment of more patients. Furthermore, we're continuously refining and improving our ecosystem model to help prescribers and patients navigate the complexities and fragmented nature of the OUD treatment landscape. These efforts include building out our regional specialty pharmacy network in order to deliver better customer service to treatment providers, as well as deploying new tools for prescribers and patients. As a result, we expect the organized health system channel will continue to be Sublocade's primary growth driver. A second important refinement to our go-to-market strategy was to build out dedicated capabilities to target the OHS subchannel US justice systems. This is critical as it's estimated that over 60% of OUD patients pass through the justice system at some point in their journey. Furthermore, with the recognition that justice system patients are an underserved and high-risk patient group, the environment is improving with increasing access to treatment as well as increased funding availability. Following our investment since 2022, the justice system has become our fastest growing subchannel and now accounts for approximately 20% of Sublocade's net revenue. With over 600 activated facilities out of 8 to 12,000, we believe this channel will continue to grow in importance in fighting the opioid and substance use disorder epidemic well into the future. Taken together, we believe we've created an unrivaled continuum of care that will continue to meet and evolve with the needs of the majority of patients and treatment providers. As we look to 2024 and beyond, we've chosen to strategically resource sublocate in the U.S. With our third quarter results last year, we announced the decision to extend sublocate's reach into the retail channel, which represents an incremental revenue opportunity. This followed the removal of the data 2000 waiver in December 2022, which is an important step to open up the potential alternate sites of care. We successfully trialed this approach through our relationship with Albertsons, the second largest supermarket chain in North America. The pilot clearly indicated the value to smaller prescribers for alternate sites of care, and our network now operates approximately 1,160 locations across 20 states. We look forward to creating a nationwide network with additional partners in the future. We've also made the decision to invest further in justice system team, building up on a strong performance and access achieved to date. And lastly, we see a clear opportunity to provide additional medical and scientific inquiry support to help advance OUD disease state awareness and to engage key opinion leaders and clinicians with the differentiated science behind Sublocate. To do this, we increased the size of our medical science liaison team. I'm confident that these strategic growth investments are scalable and will help us accelerate our progress towards our peak net revenue aspiration of greater than $1.5 billion. Moving from Sublocade to our other proprietary growth opportunities, let me start with Opvi, where I'm pleased to say that our launch is fully on track. We continue to believe that this product has the ideal profile to address the epidemic of overdoses caused by both natural and synthetic opioids. We have a multifaceted commercial strategy, which includes an approved experience program for states that are allowed to trial OPVY within their populations. We're also leveraging our government affairs team to ensure that these state standing orders, grants, and emergency medical service protocols are updated to include OPVY as an overdose rescue treatment. And we were pleased to have secured a 10-year contract with BARDA that is potentially worth approximately $110 million, including funding for phase four clinical studies, a year one order of $8 million in revenue for 100,000 units, and options for similar orders over an additional nine years. Our 2024 guidance includes $20 million of net revenue from OPVY at the midpoint, reflecting the early establishment phase for this important life-saving medicine, and we continue to expect peak net revenue in the range of $150 to $250 million. Moving now to Braceras, it's fair to say that we did face some significant challenges in the last couple of quarters of 2023 as a result of competitive pressures from a well-funded new market entrance. We nevertheless continue to believe in the potential of the important medicine for schizophrenia based on its differentiated clinical profile and strong feedback we get from clinicians. Furthermore, since we expanded the field force nationally in 2022, we've seen increases in market coverage and penetration. we believe the team is regaining share of voice across targeted prescribers and volumes at the start of the year are building on the growth achieved in the fourth quarter. As a consequence, our guidance for 2024 is for strong double-digit net revenue growth as Ryan will detail later. On my final slide, I just wanted to remind you of the key elements of the medium-term profitable growth framework that we provided in December 2022. As you've seen today, We delivered against this in fiscal year 2023 with 21% net revenue growth and over 100 basis points of adjusted operating margin expansion. And as we achieve this operating leverage while also acquiring and integrating the opium acquisition, which is both strategically and financially attractive, albeit with dilution of 40 million in OPEX or 400 basis points in 2023. Our fiscal year 2024 guidance indicates another year of significant progress towards meeting these medium-term goals. With that, I'll hand over to Christian for his R&D review.

Thank you, Marc, and good morning, good afternoon, everyone. As you can see, over the last year, our pipeline has expanded with several projects expected to reach development milestones in 2024. You may also note that INDV 4002, The intranasal naltrexone product for alcohol use disorder that came with our acquisition of Opient Pharmaceuticals last year no longer appears in our pipeline. INDV 4002 failed to meet its primary endpoint in a clinical phase two study that had been initiated by Opient. We have therefore decided to discontinue its development and prioritize our most promising project. Let me start with an update on our activities in the opioid use disorder and opioid overdose rescue. Our support to sublocate is fourfold. First, label updates with a focus on rapid induction and alternate injection body sites. We are currently planning for preapproval submissions to the FDA in the third quarter of this year. with estimated approval in the first quarter of 2025 if priority review is granted, or third quarter 2025 under standard review. Second, evidence generation and peer-reviewed publications, including additional Phase IV studies, externally sponsored studies, and real-world evidence studies. Third, product optimization with the implementation of our oxygen absorber desiccant for room temperature and shelf life extension in the US, Australia, and Canada, as well as additional regulatory submissions. And fourth, access expansion in most of the world. Unfortunately, Fentanyl use continues to rise across the U.S. with now more than 90% of opioid overdose deaths involving fentanyl and other synthetic opioids. Synthetic opioids have a more rapid onset of action than, for example, morphine and heroin, and delayed intervention can produce diffuse brain damage and cardiac arrest. Therefore, the ability to rapidly restore normal breathing has become essential for a successful overdose reversal. We are currently supporting our intranasal namiphene rescue medication, OBVI, through a series of initiatives as follows. First, as we have previously disclosed, we have started our contract with the Biomedical Advanced Research and Development Authority, BARDA. The overall objective and scope of this contract is to further support the efficacy and safety of OBVI in real world and to expand access as a medical countermeasure in the event of a synthetic opioid mass casualty event. Second, we started post-marketing requirements studies, including pediatric studies, as well as studies further characterizing the safety profile of DDM, which is the nasal absorption enhancer in OBVI's formulation. Third, we are committed to conduct real-world evidence studies to help understand the clinical real-world utilization of OCD compared to naloxone. Fourth, we are conducting studies to see FDA approval of a shelf life extension from 28 to 36 months. Fifth, we have expanded our externally sponsored studies program and independent medical education grants to cover opioid overdose rescue As we believe, encouraging the scientific and clinical review and use of these medications will help with this crisis. And finally, we are preparing a series of peer-reviewed publications that are covering the pharmacokinetics and pharmacodynamics characteristics of OBVI. There are also two projects that are currently in clinical development for opioid use disorder. First is INDV2000, our selective orexin-1 receptor antagonist. On November 3rd last year, we had a successful end of phase one meeting with the FDA and agreed upon major aspects of clinical and non-clinical safety, enabling progression to a phase two clinical proof of concept. Therefore, our key objectives in 2024 are fourfold. First, release the final clinical study report for the multiple ascending dose study that we finished last year. Two, make sure the drug product is available to initiate the clinical phase two proof of concept study. Three, initiate drug substance manufacturing campaign to supply future clinical phase three studies. And four, select the contract development and manufacturing organization for manufacturing the commercial drug product. The second project, INDV 6001, is the outcome of our acquisition of the exclusive global rights to develop, manufacture, and commercialize ALR Pharmaceutical's portfolio of long-acting injectable formulations of buprenorphine, which includes its lead three-month injectable candidate ALA-1000, now INDV-6001. Our key objectives for 2024 are equally fourfold. First, complete the technical transfer from ALR to Indivir. Two, optimize the drug substance and drug product manufacturing to support future clinical history studies. Three, initiate multiple-dose pharmacokinetics study to support future clinical history studies. And four, initiate developmental and reproductive toxicology studies. Let me now talk briefly about our contribution to alcohol use disorder treatment. And as you can see, among the 137.4 million current alcohol users age 12 or older in the U.S., Almost 30 million people had a past year alcohol use disorder. And unfortunately, only 2.1%, or a little bit more than 600,000 people, received medication-assisted treatment in the past year. Although several medications have been approved for the treatment of alcohol use disorder, they have limitations in terms of efficacy and safety. Previous research, however, consistently indicated that GABA-B receptor agonists can significantly attenuate alcohol intake. Unfortunately, the use of full agonists is limited due to their pharmacokinetics profile and unfavorable safety. In contrast, positive allosteric modulators in the GABA-B receptor have the potential to achieve mechanistic and therapeutic effects similar to GABA-B receptor agonists while avoiding their tolerance and toxicity issues. To date, all preclinical behavioral results have invariably shown the efficacy of GABA-B positive allosteric modulators for alcohol use disorder treatment. Our collaboration with ADDx Therapeutics for the lead optimization of INDV1000 has now resulted in the selection of two lead compounds for comprehensive in vitro and in vivo characterization. Extensive formulation work has also been initiated to optimize drug formulation over the anticipated dose range. We are aiming at a clinical candidate selection in the third quarter of this year, and the selection will then be followed by starting investigation on new drug application enabling studies, as well as the manufacture of the drug substance for phase one studies currently planned in 2025. Let me conclude this presentation with an update on our activities to support cannabis use disorder. As you can see from the map, as of January 1st this year, about 38 states have legalized cannabis for either medical or recreational use. In the U.S., the latest data estimated that almost 62 million people age 12 or older were past year cannabis users, and 19 million were diagnosed with cannabis use disorder in the past year. And we now know that a quadruple confluence of factors is leading to cannabis use disorder. First, increasing prevalence of use. Two, increasing intensity of use in both frequency and quantity. Three, increasing THC content of cannabis products. And four, the age of cannabis use initiation. Our partnership with ALIS Pharma includes, as you know, an exclusive option and license agreement for the global rights to AEF0117, which is ALIS first-in-class synthetic signaling specific inhibitor engineered to modulate the cannabinoid 1 receptor. In clinical phase 1 and phase 2 studies, AEF0117 showed promising safety, tolerability, and efficacy signals in subjects with cannabis use disorder. These data were actually published in the journal Nature Medicine in June last year. Our objective this year is to continue to carry out major collaborative work with ALICE aimed at completing the Phase 2b trial and supporting additional clinical and non-clinical studies in preparation of late-stage clinical development. ALICE is expected to have the clinical Phase 2b last patient in the second quarter of this year, with an end of phase two meeting with the FDA that we are trying to plan for the fourth quarter this year. And finally, the development of INDV 5004, which is Drinabant, the cannabinoid 1 receptor antagonist for acute cannabinoid overdose, is being pursued and funded by the National Center for Advancing Translational Sciences, NCATS, which is one of the NIH institutes. to progress IND enabling studies, including the optimization of the drug product formulation and completion of toxicology and safety studies. Thank you, and let me hand it over to Ryan for the financials.