I'm James Vane-Tempest, Jefferies European specialty pharma analyst. I'm delighted to welcome you to day one of our Global Healthcare Conference in New York today. We've got Mark Crossley here, CEO of Indivior, leading specialty pharma company focused on opioid addiction. With that, I'll hand it over to Mark, and I think there will be some Q&A in the room afterwards, if people do have so. Over to you. Thank you, James. Appreciate that, and appreciate the interest in Indivior. I'll take the forward-looking statements as read. Let me just start out with why Indivior? We're a global leader in addiction treatment, and our platform, because of the huge unmet need in addiction, has a tremendous upside to help these patients that have such an unmet need. We've got a strong record of execution. We've been in this space for over 20 years, and we're entering our 10th year as a publicly traded company. Our strategy is very clear on how we're going to create shareholder value and help more patients, and we'll share that with you today. But we have a very scalable model, you know, that as we grow, we're going to be able to increase our operating income and our cash flow generation for shareholders. So, a very, very clear thesis on how we're creating value moving forward in an unmet need area. For those that don't know Indivior, we've got about 1,100 people helping people suffering from opioid use disorder in 37 countries. You can see predominantly, our revenue generates in the U.S., where the opioid epidemic has disproportionately been impacted. And on the right side, you can see kind of on the product side, our leading paradigm-shifting treatment, a once-monthly long-acting called Sublocade, is 60% of our revenue. We have a heritage business with sublingual assets, you know, that are the blue, and then we have a long-acting in schizophrenia that's about 4% of our revenue. So starting a diversification journey here at Indivior. It is a huge unmet need in substance use disorder. There aren't very many medications that help with treatment. You see the typical addictions on the left and the right, opioids and stimulants. I think we can all agree that those are addictive. We have commercial products in opioids. And then in the middle are your normalized addictions, where they're legal, you know, they're markets that are established, when used in excess, create addiction, and they're the largest sort of base of users. Alcohol, with over 100 million people diagnosed with alcohol use disorder. Cannabis, with users skyrocketing across the globe. All you have to do is step out on the streets of New York to know it's happening here in the U.S., too. I said we had a clear strategy. It is these four prongs. Right front and center is growing Sublocade to greater than $1.5 billion. It's a once-monthly long-acting. In 2023, we grew 54% year-over-year to $620 million. We helped just over 135,000 patients, which is about halfway to our target to get to the $1.5 billion. We made some incremental investments to expand our patient or our prescriber base from 8,000 to 12,000 prescribers. We're also looking to diversify our revenue. We do that by taking technologies that are in the U.S. to new countries. That's Sublocade, that's our Suboxone film into Europe and Australia, but also through some inorganic growth. We acquired Opiant last year, and with that, a product called OPVEE, which we think is the next paradigm of treatment for opioid overdose rescue, and I'll talk more about that in a bit. We're creating a very robust pipeline for substance use disorders. We know we've got two assets in phase 2 for opioid use disorder and one at 2b that we'll read out this year, potentially entering phase 3 in 2025, and I'll talk about those in a little bit. Then really at the heart of what we do, we also try to operate very efficiently and operate, optimize our operating model from capital allocation on the balance sheet, the P&L management, but also our operating model go-to-market. We're constantly making certain that that is in line with our strategy, as well as our listing status, where we just have received a vote of 97% support to go to a primary listing in the U.S. while maintaining our U.K. listing, going from a premium down to a standard. That strategy all kind of culminates into what we shared with a medium-term operating framework over a five-year period in December 2022. The keys to this is transformational technologies that deliver great double-digit growth in the medium term, a leverageable cost base and an operating platform that delivers significant OpEx or margin expansion, as well as gross margin expansion with the growth of Sublocade, which has a better gross margin than our heritage products. So all that generates significant operating margin and cash flow generation. Year one of that journey, we had 22% top-line growth, 100 basis points of margin expansion, despite acquiring, you know, 400 basis points of incremental costs associated with the Opiant. So very good first-year execution. So Sublocade, our top priority, you know, our bellwether product and a paradigm-shifting treatment for opioid use disorder. This is just a slide to reemphasize what you're probably reading in the press every day. Opioid overdoses are very high. All opioid overdoses are over 80,000. 90% of those are due to high-powered synthetic opioids, such as fentanyl, with 75,000. It's the leading cause of death in people 18 to 45, and when you look at treatment rates, you know, in the U.S., they're abysmal, and we'll talk about that in a second. When you look at the current waves of this epidemic, it started with pain pills, moved to heroin, now is on synthetic opioids and is now transitioning to poly substance use, both synthetic opioids and stimulants together. So people are starting to use those together. So it continues to... The drug cartels, they start to adjust to the model as we adjust our treatment. Here's the stats on this. You know, we've got about 9 million people that are self-reported that are abusing opioids. Only 3.1 million diagnosed with opioid use disorder, and over a 12-month period, 1.8 million in treatment, any point in time, about 1.2. So you get a very low treatment rate that we think is going to drive significant market growth and opportunity in the medium to long term, you know, mid-single digits. So why Sublocade? Sublocade is, you know, the first monthly long-acting, and shifting from 365 choices a year to stay in treatment to a highly addictive opioid is breakthrough. But it's the paradigm of treatment that we've put in place with Sublocade that is transformative also versus other long-actings. You know, the beauty of Sublocade is once it's injected, within 4-8 hours, you're up to therapeutic levels, and the therapeutic levels are maintained the entire 28 days. Again, very unique with long-actings that you're able to maintain those there. The therapeutic levels we've chosen provide blockade of the Mu receptor. You know, anything above 2 nanograms per milliliter in the bloodstream blocks that Mu receptor and makes it so that the opioids can't get to the receptor, should have someone have a moment of weakness and use their opioids. So they're blocked from the, euphoric effects. As Fentanyl has become part of the illicit drug stream, what you're also doing is protecting people's lives. And what we're seeing, as you've moved from heroin to synthetic fentanyls, the level of, of, buprenorphine in the bloodstream that people need to prevent the breakthrough is starting to increase. We have over 40% of our patients that are staying on our 300 milligram dose, which delivers 6 nanograms per mil in the bloodstream. So with the change in the illicit drug supply, you know, I think Sublocade is there to address that epidemic. There's really good tailwinds with regards to the market to also help its growth. We're starting with the both sides of the aisle normalize the treatment space. They've removed DATA 2000, which required specific waiver patient limits, and separate education for treatment of Opioid Use Disorder. So now any prescriber can prescribe. We still see a concentration in the short term with addictionologists. But another thing that happened in DATA 2000 is it opened up the ability to have alternate sites of care for injectable long-acting. So no longer does the doctor that's prescribing have to have it injected in his office. It can now be done similar to Schizophrenia, where there's injection sites across the U.S. And we're setting up that framework, and I'll talk about that a little bit more. In addition, you're starting to see states, federal, prisons, all starting to take treatment and try to stop the revolving door of these patients who, due to the nature of their disease, 60% come in contact with the justice system. Telehealth has been put in place during COVID and been extended so that patients don't have to go to a physician to start treatment, and they can continue to use that telehealth to do their prescriptions, which is very helpful. And then in addition, we've got record funding at a federal level, and we've got the opioid abatement funds that are starting to work their way through the system. So funding for treatment, funding for recovery, as well as prevention and enforcement, you know, are at all-time highs. Our focus over the last four years has been on organized health system. These are large regional health centers that have the majority of patients, the majority of doctors, as well as criminal justice systems, where these patients are floating through. We think it's a great place to initiate treatment and get them into recovery, so when they leave the jail, they're able to stay in that journey. We've increased our sales force last year by 50%, increasing the number of doctors we're able to call on from 8,000 to 12,000, to continue our growth journey and also to address the independent physicians who historically, before the removal of DATA 2000, weren't willing to prescribe long-acting injectables because of the administrative burden they have. Now that they can send these patients to these alternate sites of care, Sublocade is now back in their options. They can prescribe it and send the patients to a different space. They don't have to store a controlled-substance specialty pharmacy product on-site. So for them, it relieves a material burden, and Sublocade is now an option again for all those physicians. The results speak for themselves. You know, you can see the number of patients and revenue since launch. The strategy and the go-to-market model that we're using is working and driving significant growth, where at the end of last year, we were over 136,000 patients treated with Sublocade, halfway to our $1.5 billion waypoint, 'cause it's greater than $1.5 billion. That's our target. So great momentum with Sublocade. We've tried for shareholders to try and give them kind of a point in time of what it takes to get there. It is 270,000 patients that are required to get to the $1.5 billion. That's a very low penetration when you look at the dynamics of the disease, how many are abusing, how many have been diagnosed. It's really about a 10% market share of people treated with buprenorphine, so a very low market share to get there. Our research indicates that physicians think about 30% of their patients will end up on long-actings. So that's why we think of it as greater than $1.5 billion as we move forward. And you can see from the comments there, we have a proven model. It's working, it's driving growth, and we continue to expect to, to drive that moving forward. So very strong platform for growth with Sublocade. Staying on the fentanyl theme and where we are in the trends, we last year bought Opiant and brought in a product called OPVEE. OPVEE is quite a change versus the standard of care, which has been naloxone. It's a nalmefene molecule. It's the first time that's been brought to rescue medications. And the beauty of nalmefene is it's incredibly fast-acting and very potent on the mu receptor. So it gets to the mu receptors fast, and it knocks the, drugs of abuse that are reducing people's ability to breathe or stopping them from breathing, off the receptors and gets them back to breathing fast. You know, we think with these highly potent synthetic opioids, where the standard of care is taking 3-5 doses, you know, to be able to revive people, or in some cases, you know, not revive people, we think OPVEE can be transformational in this space. You know, we're in the midst of a launch that really is multi-pronged. It starts with having to change the laws across the US to have not just naloxone, but to have any FDA-approved rescue medication. We're in a good spot on that. We said it would take about 15-18 months to do that, and we've got 31 states that have changed their standing orders to allow any FDA-approved medication. We've gotten funding so that it's earmarked for any FDA-approved indication. Big source of the funding for these rescue medications is via SAMHSA's SOR grants, and they've altered their language to include, you know, any FDA-approved. So we're well on our way here in the launch. You can see the primary sort of providers of this medication are quite different than our call platform for moderate to severe opioid use disorder that we have with Sublocade. So it's a different sort of sales force that's calling on buyers for first responders, for patient advocacy groups that are taking these grants, buying product, and putting these in the market. So it's quite a different, it's a much more focused, small team that's on this, but they know where to go. This is the team that initially launched Narcan, that's come over and is launching OPVEE here at Indivior. The key part of our launch is an experience program. And we've had some early adopters that have had the product. It's proving out. The science is proving out, and working exactly as we thought. And what we've seen is as we've shifted to this and opened up this experience program to first responders at a local level, within three weeks, we've had 180 municipalities reach out to try and get this product. They want something that is targeted towards synthetic opioids. OPVEE is the only rescue medication that's specifically designated for synthetic opioids. So very exciting early stages of launch. With that, we've guided to $150-$250 million, you know, which we think is very achievable given the differentiation of the product, the experienced commercial team, you know, and the experience in the early adoption that we're having. So excited about the future of that for that launch. So on our pipeline, listen, I think our most advanced asset here is our cannabis use disorder asset, AEF0117, which is in phase IIb. It reads out in the third quarter. We have an FDA meeting on those readouts of those results in Q4, and we'll then make a decision on if we exercise our option and enter a phase III study. I don't have to speak to cannabis, what it is. I mean, the THC levels on average are well over 20%, and then you've got some high-potent sort of vapes, gummies, oils, tinctures that are over 70%. And the use on this, when it gets beyond recreational and becomes part of everyday life, has significant sort of, sort of negative effects, from psychosis to even to schizophrenia with heavy use, as well as, you know, quality of life issues, you know, motivation and things like that. And there is no medication out there for this, and we would be first to market, so very exciting. On the opioid use disorder side, we have a potential three-monthly injectable that we brought in last year, a partnership with Alar Pharmaceuticals. That's in phase II, working on duration and dosing. And then we would look to go into phase III with that. And then we have an oral medication on the Orexin-1 receptor that would be a non-opioid opioid use disorder medication. So starting to normalize treatment with a non-opioid, 'cause many of these people don't want to have an opioid to treat them because of their long-standing relationship with opioids. And that is entered phase II, so we're very excited about that. And then we've got an early-stage alcohol use disorder, where we'll do a lead candidate on the GABA-B, and we inherited a cannabinoid overdose medication that's been funded via grants when we bought Opiant, that we'll have a readout and see where we go with that asset moving forward. So a very exciting addiction-based pipeline. On the operational excellence, I think you can see, you know, since 2020, we've had significant margin expansion. I highlighted in 2023 that while we only had 100 basis points of margin expansion that year, it did include $40 million of incremental operating costs associated with Opiant, so it would have been over 400 basis points of margin expansion as our top line is growing much faster, you know, than our operating expenses. We have a very leverageable platform in addiction medicine. We've got positive mix associated with Sublocade, and we're making good choices with regards to which assets and how we invest them in them in R&D, as well as our supply platform, where we've brought in a sterile manufacturing platform to leverage with Sublocade. And by bringing a portion of that manufacturing in-house, we think we can save $20 million on a run rate once it's up and running in 2027. So very exciting with regards to the margin opportunities. And we've had a very, very consistent capital allocation framework over the last four years. You know, we're funding our strategy that we've detailed out. Sublocade is the number one priority. And then as we get to have excess cash flow at the end, we look at business development opportunities. Those could be early-stage addiction assets that we bring in, or it could be larger items, such as the Opiant acquisition or the plant we brought in. And then we look at shareholder returns, and we're on our third $100 million buyback at this time. I covered a bit the U.S. listing. We've with the 97% shareholder vote, we're looking to make that shift as of, June twenty-seventh, where we would flip over to be primary listed in the Nasdaq. We will have a bit of a orphan status, where we won't be indexed for a period of time, where we come off the FTSE premium listing, and then go through the process on indexation in the U.S. We really think this is in the best interest of shareholders. You know, our growth and value opportunities are here in the U.S. We think we can increase exposure to the company, to the therapy area, and have access to U.S. capital markets, you know, moving forward, which I think is, could be a big benefit, as well as from a passive sort of, volume standpoint. The FTSE is about 5%-6% of our volume. When you get to the U.S., you could have 30% of your volume, you know, that could be via indexation through time. So we think this is the right step moving forward. So to close, listen, we're the leaders in addiction treatment with a huge opportunity to help patients in a tremendous unmet need. We have a breakthrough paradigm shift in treatment on Sublocade that's driving tremendous growth and operating margin expansion, and there's further diversification opportunities with our pipeline, and business development opportunities like OPVEE, that are driving, you know, sustainable long-term sort of revenue. And operational excellence is providing us with great margin expansion. So with that, I'll close and open up to any questions from the audience or from James. Thank you very much. Any questions from the audience? Please. Thanks for coming. Just a quick question on litigation, if you can give any kind of updates on pending patent litigation or what kind of is still the overhang after the settlements? Yeah, I think there's three litigations which are ongoing. The dental is one of those in which the primary statute of limitation for the majority of the cases is the end of June. There's a few states that go to three or four years, and it has become an MDL in Q4, and the judge is working towards having the class bring all of their cases in by the end of June. So we'll have a feel for where those cases are, you know, at the end of June. It's still very early stages. We've had a couple of procedural sort of discussions with the judge. We do have insurance, you know, product liability insurance. We've notified our carrier. They've agreed that they will cover our, our expenses for defense, and they've done a very typical notice of reservation with regards to insurability until they get the, the details of, of claims. We also have some carve-outs of our antitrust MDL that we settled the vast majority of that. The end payers had a 20% of, of the lives carved out. We have a trial set for the middle of July, in that case. We have a strategy of certainty at the right value, if we can get it, but we will defend our case. We have meritorious defenses on both liability and damages, and if we have to go to court on behalf of shareholders, you know, we will. And the last one that we're in is the... The last one that most shareholders ask about is the opioid MDL. During the time that people were being brought into that, there were a lot of folks that looked at the DEA opioid manufacturer listing. We're on that because we are an opioid. We have different pharmacokinetics and dynamics, and we're very safe. We have a ceiling on euphoric effect, very safe on respiratory, but we're on that list, and we got put on just over 400 of the over 3,800 cases. So, you know, we're waiting to. We're part of a bellwether group now that's open for mediation, and we're waiting to engage with the Plaintiffs' Executive Committee with regards to, you know, that case. Thank you. Any, any more from the room? Thank you. As it relates to business development, what qualities do you tend to look for in a target? Yeah, for us, we think about items in addiction, you know, where we have probably the largest commercial model of anyone that's operational. And so we look at those and basically look for breakthrough science or areas of huge unmet need that we can then address. And if you look at things like what we do is we do a connect and develop model, right? So we don't do drug discovery. We watch about 70 different assets with a top priority mechanisms of action that we think can disproportionately help. We wait till they get to a stage where they're de-risked, usually phase 2, and look to do a licensing deal with the partners and bring those in. So then we can de-risk those through the balance of the pipeline, optimize the development for the commercialization, and bring those to market. So right at the heart, it's addiction and helping with the unmet needs. And I think we saw that with the cannabis use disorder asset. We see huge unmet needs on duration of treatment and opioid use disorder, so we brought in the potential three monthly. And then this unmet need of having an oral that's a non-opioid, where we think if it can act like buprenorphine, which is the hypothesis, you know, it could be a major differentiator. So that's what we look for. Any final questions, or I'll close the session? Going once. Okay, with that, I'll close the session. Thank you very much. Thank you.
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