Indivior Pharmaceuticals, Inc.

Good day, 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 two of our presentation. We also may refer to non-GAAP measures, the reconciliations for which may be found in the appendix of this presentation and also at the back of our published press release. These items are 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, and thanks for joining to discuss our half-year results. I'll start with some opening remarks, review our progress against our strategic priorities. Christian will then provide a scientific update, and then Ryan will wrap it up with details on our financial performance and our updated guidance before heading on to Q&A session. Turning to the key messages, it was another strong quarter of execution by the entire Indivior team, which keeps us on track to deliver the attractive medium-term growth profile we set out at our Capital Markets Day last December. Recall, this framework contemplates double-digit net revenue CAGR and positive operating leverage. Looking first at the financials, our second quarter results were above our expectations, powered by another very good performance by Sublocade. Total second quarter net revenue of $276 million and adjusted operating profit of $71 million grew by 25% and 18% respectively versus the same period last year. On a half-year basis, we were able to maintain our adjusted operating margin despite the incremental operating expenses from the Opium acquisition. What stood out most to me about our performance was the solid contribution from all of the growth levers of our business. Sublocade year-over-year growth of 58% in the quarter is certainly the headliner, but we also saw an encouraging acceleration in net revenue from Preceris. And on a constant currency basis, we delivered a fourth consecutive quarter of year-over-year growth in the rest of the world, driven by new products, including Sublocate, which is now delivering double-digit quarterly net revenue outside the United States. Our strong half-year performance, along with the outlook of the remainder of 2023, now lead us to raise our full-year guidance for Sublocate and total company net revenue, as well as our adjusted operating profit. On top of our strong business performance, we achieved key strategic milestones in the quarter, which we expect will help secure our future growth potential. These included the successful integration of Opium and the approval of its key asset, Opvi, which we're projecting to launch in the fourth quarter of this year. We also have integrated Opium's pipeline of assets for substance use disorders, which you'll hear a little more about from Christian during his scientific update. We also took a step forward in clearing the backlog of legacy litigation through partial settlement of the antitrust MDL litigation, something I will come back to in just a moment. And then lastly, we successfully affected the additional U.S. listing of our shares in the NASDAQ Global Select market. Turning to our report card and looking at our performance in a bit more detail, Sublocade had a strong quarter with net revenue of $155 million. This represented growth of 58% year over year and 17% versus the prior quarter. Given this sustained strong performance through the first half of the year, we now expect sublocate to deliver net revenue in the range of 590 to 630 million. At the midpoint, this 30 million increase would represent growth of 50% versus fiscal year 2022. This performance continues to be driven by the success of our strategy to focus on and invest behind our organized health systems. In the quarter, we saw increased breadth and depth of prescribing in each of our targeted organized health system subsegments, including large private health systems, federal health care systems, and the U.S. justice system. Focusing for a moment on the U.S. justice system, it's still early days for us in this important subcategory. To date, we've accessed approximately 275 of the top 1,000 priority justice facilities we've targeted in the U.S. However, the justice system is our fastest growing subsegment and now represents 10% of total sublocated net revenue. Encouragingly, we're seeing growth across all three major justice system customer groups, federal, state, and local systems. The success of our OHS strategy has taken the number of sublocated patients above the 100,000 milestone for the first time. This is an important milestone, but still only represents about 3.5% of the 3.1 million people diagnosed with opioid use disorder in the US, showing just how much more work there is still to be done. Finally, The elimination of data 2000 waiver as part of the mainstreaming addiction treatment act now offers the potential to administer sublocate at alternate sites of care. In other words, outside the prescriber's office at qualified off-site locations. In response, we're working with Albertson's companies, one of the largest food and drug retailers in the U.S. with over 1,700 in-store U.S. pharmacies. 700 of which are now involved in this program across 15 states. If this proves beneficial for patients and healthcare providers alike, we would assess targeted incremental investment to accelerated growth, as this initiative should make prescribing Sublocade an option for offices that are smaller or have less resources. It's just another step in allowing for treatment choice based solely on scientific merits. To conclude on sublocate, our strong second quarter performance speaks to the continued successful execution against our strategy with this groundbreaking treatment for patients with moderate to severe opioid use disorder. When we then layer on top the favorable funding and legislative backdrop, this supports our expectation of delivering a $1 billion net revenue run rate for sublocate as we exit 2025 and ultimately our $1.5 billion plus net revenue goal. Turning to diversification and starting with Braceras, we're seeing benefits from our expanded national field force in terms of increasing awareness of Braceras among behavioral health treatment providers. Second quarter net revenue growth was strong year over year, but importantly, and as expected, we saw healthy, renewed sequential growth in the quarter after some destocking in the first quarter. Looking at the rest of world business, it's encouraging to report another quarter of growth, We continue to face challenges in Europe to our legacy tablet business, but this has been more than offset by the introduction of our new differentiated products, Sublocade and Suboxone film. Most recently, we've launched Sublocade in Germany, and we're pleased to gain UK approval earlier this month. We expect these contrasting overall dynamics to continue, and as a reminder, our expected double-digit growth kegger for the medium term includes modest growth in the rest of the world. Of course, the new news in the quarter, in terms of diversification, was the approval of Opvi, our new opioid overdose rescue medication. We're pleased with the FDA-approved label, given it specifically mentions synthetic opioids, which, as you know, are now the main cause of opioid-related overdoses. Our launch plans are underway. The Opvi.com splash page is live. Our digital marketing strategy has kicked off, and we're making outreach across public and private entities to help ensure maximum access, all in anticipation of going into the market with product in the fourth quarter. We've not yet announced pricing yet, but we recognize the innovation OPV brings to the market while also considering the broad access that we will seek for this important new product. We continue to expect modest net revenue in 2023, given the Q4 launch timing, with peak net revenue of $150 to $250 million. Looking at the pipeline, Christian will provide a more fulsome update at the conclusion of my remarks. That said, I must say I'm pleased to report that the timelines for our key assets and post-marketing studies are all on track. Finally, turning to our fourth strategic pillar, optimizing our operating model, we achieved important milestones in the quarter that we expect will enhance both value and create greater certainty for shareholders. First, we successfully delivered the additional listing of our shares on NASDAQ. We expect the listing to generate significant benefits for Indivior, including increased awareness among US investors and securities analysts, and most importantly, increasing awareness of OUD treatment overall. Second, We remain on track for final validation and commencement of commercial supply at our second long-acting injectable manufacturing site in the second half of 2023. Before turning over to Christian, I want to update you on the status of our antitrust multi-district litigation, where we've been actively pursuing our strategy of seeking resolution at the right value through mediation. As you know, we were able to reach settlement agreement with the states and the District of Columbia, and we've paid the $102.5 million settlement amount last month, which is in line with the existing provision. To date, we've been unable to reach settlement agreements with the remaining two classes of plaintiffs, but we remain open to settlement at the right value, and the trial has now been scheduled to start in late October. We've updated our disclosures to reflect this progress as well as the proximity of the trial. Our adjusted provision of $187.5 million continues to be our best estimate for settlement purposes with the remaining claimants. As a reminder, our overriding goal is to continue to create greater certainty for Indivia's stakeholders. While clear progress has been made, these matters are ongoing and we cannot predict with any certainty whether we'll be able to reach settlement with the remaining classes, and continue to caution that the final aggregate costs could be materially different. Before handing over to Christian, let me close out this section by saying the team continues to execute well and deliver strong financial results, and we're making good progress in advancing each of our strategic priorities. With that as an opening, I'll turn over to Christian for his scientific update.

Thank you, Mark, and good morning, good afternoon, everyone. Our contribution to sublocate success has focused and will continue to focus on breaking barriers to treatment access by creating new evidence through four strategic pillars. First, we have initiated five phase four studies aiming at addressing knowledge gaps in the area of sublocate rapid induction, patient subpopulations that may benefit from the 300 milligram maintenance dose, alternate injection sites, long-term recovery outcomes, treatment cessation guidance, and comparative effectiveness with other medications for the treatment of opioid use disorder. We also launched a platform called ROAD for data integration and sharing with the scientific and medical communities. Second, we are pursuing four long-term collaboration studies to understand the long-term outcomes of sublocated treatment its differentiation versus current standard of care, and the journey towards recovery. Third, we have launched a broad range of real-world evidence studies with 21 work streams along three themes, health disparity, recovery, and harm reduction. Fourth, nine externally sponsored studies are supporting research areas of interest, including high-risk opioid overdose patients, patients in the criminal justice system, rapid initiation in different treatment settings, comorbidities, and the long-term efficacy and safety. Our intranasal nalmophene product, OBVI, as you know, was approved by the FDA on May 22nd this year for the emergency treatment of known or suspected overdose induced by natural or synthetic opioids in adults and pediatric patients aged 12 years and older. We are currently planning the implementation of post-marketing studies, including pediatric studies, as well as development reproductive toxicity studies on DDM, the nasal absorption enhancer in the formulation. An enhanced pharmacovigilance request is also being implemented. On the next slide, you can see that we are making significant progress with our pipeline in opioid use disorder, alcohol use disorder, cannabis use disorder, and acute cannabinoid overdose. First, our selective orexin-1 receptor antagonist for the treatment of opioid use disorder, INDV2000, is on track to complete the multiple ascending dose study with the last subject, the last visit at the end of the third quarter of this year. and the preparation of an end of phase one meeting with the FDA in the fourth quarter this year. Supportive clinical and non-clinical studies as well as stablet formulation development and manufacturing are currently ongoing. In the alcohol use disorder space, we are expecting preliminary data from a phase two trial on our intranasal naltrexone INDV4002 towards the end of the third quarter this year. Our GABA-B positive allosteric modulator program, INDV1000, has led to the characterization of two new lead molecules. A decision for lead selection is on track for the end of the third quarter this year. In the cannabis use disorder space, our strategic collaboration with ALICE Pharma for the development of AEF0117 is progressing as planned. The estimated last subject last visit for the face-to-be trial is in the first quarter of next year, with a final clinical study report in the third quarter of next year. In the meantime, other CMC, chemistry manufacturing controls, non-clinical toxicology, and clinical work streams are progressing as planned. Finally, the development of Drenabant for the treatment of acute cannabinoid overdose is on track towards IND enabling activities. with a support from a grant from NIH NCATS. On the last slide, I would like to draw your attention to a seminal paper that was published by Ailis Pharma in the journal Nature Medicine, which summarizes the entire development of AEF0117 from its inception all the way to the data generated in clinical phase one and phase two trials. Thank you, and let me hand it over to Ryan for the financials update.