Hi, good morning, everybody. Welcome to the Virtual Jefferies Healthcare Conference. Very pleased to be hosting a fireside chat with the next company, Avadel. On behalf of the company, we have both Greg, the CEO, and of course, Richard Kim, I believe the new joiner, right? Thank you, Chris. Appreciate the opportunity to be here and spend some time together. Thank you. Absolutely. Hey. All right. Maybe let's just level set here. For those that are not totally familiar with the story, what is FT218, and what is the indication that you're trying to go after here? Yeah, thanks. FT218 is our once-nightly sodium oxybate treatment using our proprietary drug delivery technology, designed to treat and indicated for a rare orphan condition called narcolepsy, and specifically two cardinal symptoms related to narcolepsy, excessive daytime sleepiness and cataplexy. Currently on the market today, there's a couple of agents approved for both excessive daytime sleepiness and cataplexy. Sodium oxybate has been a standard of care molecule for quite a bit of time, for nearly two decades in the marketplace for these patients. We're seeking to get approval and bring to market what we believe is substantial improvement and innovation in our delivery of our once-nightly FT218. Okay. All right. I mean, that's pretty clear. There's an incumbent on the market that's twice nightly. A lot of people have used it, and you have a dosage form that I think a lot of people would say is better, including this guy. I guess, let's quit beating around the bush here. There's some controversy, let's say, out there, or discrepancy in terms of what people believe might be possible. I guess, where are you at with your NDA submission and then we can find out what the lawsuit with Jazz might mean about that. Yeah. Technically we're almost six months, a little over 5.5 Months since we've submitted. We're over 3.5 Months since the official acceptance from an NDA perspective. I would say generally, we're very pleased with where we are to date on the NDA, the progress we've made, the types of questions, both in terms of context and in quantity, or in that regard, the comments we've received to date from the agency. I think generally, there's not a lot we can share from a specifics perspective on the NDA. For those who aren't familiar with the story in great detail, FT218, we filed, was accepted as a 505(b)(2). There's been no Paragraph IV patent certification included, nor has one been requested of us at this stage of the game. I think we're really pleased with where the NDA stands at this point, knowing we've still got a little less than half of the review period left. Where we are, let's call it midway through the review cycle. We're very pleased and with both the way the review's gone and the fact that, again, there's been no P4 patent certification request. Yeah. I mean, maybe I'll just be slightly pedantic here. I guess, if there was a Paragraph IV certification, what would that mean? As a 505(b)(2), we certainly have to, you know, any relevant Orange Book listed patents we have to effectively navigate and deal with. What it would mean if we did have to certify was the references to drug holder could assert their rights under Hatch-Waxman and potentially, seek a 30-month stay of our approval, of our formal full approval, which could potentially create a delay in our launch. From our perspective, again, our NDA does not have a Paragraph IV certification as part of our submission strategy, and as we've gone through nearly halfway the review to date, we haven't had one asked of us by the FDA, and we're quite confident that the FDA has looked at all aspects of our NDA so far. Okay. All right. Very good. I guess basically, and that was put to bed pretty recently, right? Like we definitively knew that it was accepted and all that. Certainly from a public perspective, we've been able to track that to some degree. Okay. I guess, what is Jazz doing now with their lawsuit? What are they asserting that you guys are doing? Jazz or the reference listed drug holder recently filed a lawsuit for us and again, asserting one of their Orange Book listed patents and a handful of additional, what we'll just call extended release patents that don't apply to the current in-market products that they've asserted. I would say that there's little we can say specifically on our view, our strategy, or even their merits, given it's in the middle of the litigation. I think a couple of comments that are important for us to make. First, as it relates to this specific action that they've taken, I think it's important to note that we're not surprised by this lawsuit, nor are we surprised by any of the allegations that have been made. Right. We're quite confident in the fundamental differences between the technology behind our revolutionary once-nightly FT218 sodium oxybate product and the patents that are being asserted by the other company. I think it's also important to note that we've disclosed intentionally very little about certain aspects of our program, and it's important to note that the allegations that are in this suit are based on what's known as information and belief. Which means that the lawsuit is somewhat of an exploratory mission to determine if there's any basis to maintain the suit with respect to any of the patents that are being asserted from that standpoint. We've been long aware of all the intellectual property in the other company's portfolio, including some of the newer patents that have been asserted that aren't being practiced in the market today. We have been and will continue to be very well prepared to address all of these allegations, and we will vigorously defend them for sure. I think the last thing to just state, Chris, so I don't forget, is that it's important because we started this conversation off on the 30-month stay. Yeah. This lawsuit cannot trigger a potential 30-month stay on FDA approval of FT218. As we sit here today, we feel, again, very confident in our regulatory filing strategy, and we're prepared to vigorously defend our position in this lawsuit. Okay. Yeah. That's interesting. There's, I guess, a couple things that were interesting to me about that. One was the timing, I guess, of the lawsuit. It sounds like you guys weren't surprised at all, but I think I had this story in my mind that they would wait until after you were approved and then file a lawsuit and potentially try and throw some roadblocks with that methodology. I guess the interpretation of doing it now is what? That it's more exploratory in your view? Well, I think the question of timing and why now versus another time is probably a better question for the other party. Okay. Yeah. Fair. Yeah. I don't think we can really comment on their rationale for timing or whatnot. I think they've been fairly public that they intended to defend their intellectual property. We weren't surprised by it. I think when you believe that a lawsuit is coming, I think you're very confident in what you do know. You're a little uncertain about what you don't know. I think from our perspective, there's been nothing asserted in the case to date that we aren't very familiar with and weren't surprised by. Okay. You have a game plan for everything you've observed thus today? Absolutely. Okay. Fantastic. That's great news. I guess, remind us of when the potential approval or PDUFA date is, and I guess what's your commercial readiness upon that date? Yeah. Maybe I'll take the first part, and I'll turn it over to Richard from that standpoint. Yeah. Great. Our action date is October 15th, 2021. We're again four or five months away from that time period. Again everything, as far as we're concerned, all of our regulatory filing strategy remains on track, and feel good about where the NDA's review process sits today. Richard, maybe you can comment on commercial readiness. Sure. Thanks for having me, Chris. Chris, it's good to see you again. I think I spoke to you a couple weeks into starting with Avadel. Yep. It's been really awesome to be part of this team. We've been, first and foremost, exceptionally lucky to really attract just athlete top-tier talent at Avadel. Actually, in the last week alone, I think we've announced four new hires to join our team here in pivotal roles for our launch. If you think about what we've done, we've done a lot to really do a few things. One, learn about this marketplace and connect with physicians, connect with payers, and also connect with patients and advocacy groups as well. I've personally had the benefit of being involved in a couple advisory boards and actually now even meeting thought leaders face-to-face over the last couple weeks as well, both with physicians and also with several WebEx calls with patients as well. We've also been doing a lot to build our infrastructure to get ready. We've made decisions already on our REMS provider, on our hub services here, and in the process of doing that for specialty pharmacy distribution. A lot of the mechanics that we have to have ready to be ready for world-class launch, we have already set in motion for quite some time. Now we're really focusing on enhancing our customer engagement over the upcoming months as well. What I can say in short, it's been a lot of fun, a lot of long days. Yeah. Really been exciting to really hear directly from our customers who we are really looking to serve throughout this launch as well. Okay. What about supply? Is the drug product ready to go at this point? I assume just waiting for the final label. Yeah. From a supply perspective, we have a primary CMO. They've been making this product since really the beginning. That CMO, for instance, we've been making it for so long that we filed with three years of stability data. We'll tick over the four-year period during the review process. We'll have great stability data. From a supply perspective and timing of launch, which is I think one of the questions you're inherently asking is, there's some work we have to do post-approval when we have a final label, right? From that standpoint, by the time we get to an approval and are getting close to being ready to launch, we'll have all the bulk product really done, right? Yeah. What we'll have to do then is blend those and put those into our daily stick packs, and the rate limiter, if you will, on that is just getting that final packaging printed, which will require the final label. There's a little bit of time post-approval. Yeah before we'll come to the market, but there's always going to be. We knew there was always going to be some time because we have to finish building our REMS based upon our final label. We have to get physicians certified. I see. to be able to prescribe our drug. Yeah. There'll be some time post-approval pre-launch, but as Richard noted, we're well down the path on a number of those work streams making really, really good progress. Yeah. Okay. All right. Maybe before we go too far down the commercial road, there was a question that came through here that I think might be pertinent to ask here. Could you just remind us of when is the-- I assume we're going to have a Markman hearing at some point and then oral proceedings. What is the timeline of those, the court case? I think it's a little bit early to be able to really give specificity around. I see. Okay what's going to happen next, but I'll tell you what's going to happen next that we can give specificity to. Okay. You'll see our response filed this week. We have a deadline. Got it. to respond by a certain date. You'll see that going from us later this week. Our expectation is that, upon receipt of that and the judge reviewing all the relevant information, our expectation is that judge will require us to come together and lay out a schedule. Right? Okay. That's how we view what will likely happen next. What will happen next, I think is still TBD. Yeah. I think the next important milestone in the litigation is our response, which people should expect to see this week. Okay. All right. There is another outcome also, right? Instead of going right to scheduling, there could be a summary judgment for dismissal, right? That is another possible outcome. Yeah. Again, I think it's really too early to speak on specific outcomes or potential timings and any of those. Okay related matters at this point. Right. Yeah. There's a number of different ways it can go, for sure. I got you. I think we stand really firm in our belief of our position in this case, and we're prepared and have been for quite some time to defend our position. Okay, great. I guess just to put a bow on that, the follow-up question that I got here is that do you expect that to impact launch timing or anything like that? Is there any outcome that you can foresee that would impact your ability to launch as expected? As we sit here today, based on what we know today, and again, I think when you're in these matters, it's what you don't know that you get concerned about and debate. There hasn't been anything that has surprised us. Without a Paragraph IV certification in our NDA filing, this lawsuit won't trigger a 30-month stay. Yeah. We don't view this litigation, as we sit here today, as an impediment to our timing or anything else from that matter. We recognize we're going to have to navigate through this matter. From that standpoint, there is going to be some time to do that. Yeah. We don't think it impacts any of our current commercialization planning, both in terms of preparation work and how we do when we'll come to market. Okay. That's very clear, and that's fantastic. All right. Sorry about that, Richard. We got to basically finalize the label and the drug product packaging. That's fine. Simultaneously, it sounds like you're going to getting REMS certification of different physicians. How does that work, and what's the cadence that we might expect on stuff like that? Sure. Yeah, once again, to your point, Chris, we get our label from our label. We'll understand the final elements of the REMS requirements. It will be a unique REMS program for once -nightly FT218. That will take us some time to get up, but we would anticipate upon a successful approval on October 15th, that we would have our REMS program stood up within a few months of that. Okay. From that point forward, potentially likely in the early part of 2022, we could begin to actually have HCPs who are certified. Got it. Okay. What is the distribution strategy? Yeah, go ahead. What's the distribution strategy? Well, we haven't made all of our decisions, but obviously this is a controlled substance. Yeah A Schedule III product, we've got to have really tight logistics around this. The good news is there's already a good system out there that people are aware of. We're just going to be building upon what people are used to using, especially pharmacy distribution. We still have decisions that we have to make there. Our goal is really to provide just exceptional service through a patient services hub. We know that through the hub, that's really the lifeline with a lot of patients and offices as well. Yeah are well in play right now. We anticipate that we'll be really well set up and ready once we can actually get the product out to the patients as well. Okay. What can you tell us about the size and the shape of your sales force? Yeah, as far as the sales force is concerned, actually, even today, we just hired our new head of sales who's starting with the company. Nice today. What we know right now is this is a relatively concentrated marketplace. Sure. There are about 4,000, 4,500 prescribers of oxybate, about 1,600 prescribers who make up 80% of the oxybate total volume. The good news is it doesn't require a large group to cover them all. If we look at other analogs, companies could be using 50, 60 representatives. We're probably in that zone-ish to think about. Okay. We'll be doing a lot more of our diligence around our customer model, because beyond just sales representatives, we know that there's other important customer-facing roles that we create to really support not only the physicians, but their office in supporting those patients who are suffering with narcolepsy. Got it. Is the strategy to target current oxybate prescribers? Is that maybe one way that you're going to target physicians, or is there other ways that you're thinking about that? Well, the great news is, we know that with once-nightly FT218, there may be opportunities beyond where twice-nightly oxybate is being used today. We're going to be focused at launch. We know sort of where the right opportunities are, and a lot of those will likely exist within current oxybate users or patients who were maybe recently discontinued because of the twice-nightly formulation. Yeah. I think, we don't have to do everything in the first couple of weeks. We will stay focused at the beginning, assuming we do have successive approval and with the launch, that gives us an opportunity to continue to build our coverage going forward as well. Got it. Okay. All right. That's pretty clear on the REMS. I'll stay tuned to see what that looks like, when the time is right. You're going to implement that and kind of get providers signed up. What about discussions with payers? Yeah. We have begun those discussions with payers right now as well. The good news for us in some ways is they're very aware of Avadel and once-nightly FT218. Okay. That's great. As a category of narcolepsy, obviously, there's been new entrants in that marketplace. Yeah. For us, what's very important in our payer discussions is that we clearly make sure we convey that once-nightly FT218 is not a convenience play at all, this is really a clinical value proposition. I will say in all the research and now that I'm actually speaking to both patients and healthcare providers as well, narcolepsy is one of those things. I'm new to this category. It is really profound how much it can really impact the day-to-day activities of a patient. Sure. The simple notion, it seems like of a once-nightly, how much more profound that can be for them as well. We're really confident in our ability to speak to payers to convey that clinical proposition and make sure that they understand, as I said, that this goes well beyond a convenience play. We're in the early stages. Yeah We're really looking forward to an ongoing relationship that we build because, as I've known throughout my career, the last thing you want to do is surprise a payer. We're definitely not surprising them. We're going to be going in there as early as possible. Yeah Making sure that they understand exactly where we're going to be coming from. It sounded like at least some of the conversations you've had thus far, they already knew you. I mean, that's great. I wonder what that is. It must be Greg's notorious reputation. I'm just playing. Okay. What can you tell us about your pricing strategy? Yeah. Well, the good news today on June 1st is we haven't had to lock down every element of the pricing strategy. Sure. As what we said in the past is, we're not really looking at a premium price play here. I think we've been conveying more of a parity perspective according to other oxybates. At the end of the day, our most important goal for launching once FT218 is making sure patients can access it who really could benefit from it. As you know here, it goes well beyond just initial price. It goes also to the services that we provide along with that as well. What we need to do is really focus on really more of a parity sort of accessibility compared to the other oxybates. Yep. I think we have a strong position to be able to do that. Like I said, I think right now we're in the early stages with the payers, but it's been really interesting so far, and we really look forward to how we can work with them to make sure that the right patients can get access to FT218. Okay. All right. I guess, when you look at the treatment landscape here, I guess, what do you see as the opportunity here, Richard? What is the kind of addressable market and, I guess, how do you see this stacking up against the competition? I think most notably, we could say there's the low sodium XYWAV new product that's out there, obviously the incumbent Xyrem. You got Sunosi, which is an SNRI. You have WAKIX, which is a histaminergic agent. I think that's all the new stuff out there as of right now. I guess, where do you see this as fitting in? I think I have a follow-up for you, Greg, on this one that might be relevant. Sure. Well, I think first and foremost, what I've clearly learned is, today that oxybates are viewed as the most effective class of treatment for narcolepsy. Totally agree. Yeah. I've heard that so many times. Yeah. It allows us to sort of differentiate from some of the wake-promoting agents and other things that go on there. Clearly, when we look at sort of the difference with a twice-nightly regimen, we've done extensive market research here, and we know that when patients look at attributes, a once-nightly is right at the top of the list that would be transformative for their treatment when they've been exposed to twice-nightly oxybates. It's a bit of a no-brainer in some ways. Yeah. We also know that the sodium is clearly coming up with the launch of XYWAV as well. We supported an extensive literature search that was published last year in "Sleep," co-authored by two leading sleep experts that show that after almost 20 years of experience in the marketplace, that sodium hasn't really changed the cardiovascular outcomes of narcolepsy patients. That was really their outcome of their findings from their study. Good. We actually view the switch that some patients may be going for to XYWAV as positive because we also know that in general, this marketplace is quite unsatisfied. Yeah. The average narcolepsy patient goes from first-line to second-line treatment in about a month and a half, and from second to third line in about two weeks. Wow. Okay. Looking at new treatments. Yeah would actually bode well for us as we prepare to come to the marketplace. Okay. All right. Well, let's invite the last minute here, Greg. First of all, I think relevant to what you just said, Richard, is when are we going to get the switch data for FT218, and what are you saying about your current cash runway? Yeah. On our open label extension/switch study, which we call as RESTORE, we've got patients continuing to enroll. We continue to assimilate data. I think as we get a larger sample size, as we get towards either later this year or closer to an approval or launch, we'll likely begin to disseminate some of that information because we think it's very relevant clinically. Yeah for healthcare professionals, right? It's not necessary for our NDA. It has no bearing on our approval, it is, we think it's going to be important as we're coming to market to be in a position to share some of that data. Again, like we've said publicly, we're pretty pleased with how that has played out to date, right? Yeah. As it relates to kind of current cash runway, we just reported into Q1 over $205 million of cash on hand. In a really strong position financially. We're still collecting on the sale of our hospital business. We'll wrap up the last collection of that this month in June that we sold a year ago. Yeah. which streamlined the company. Again, we feel really good about the cash on hand to fund the investments we need to finish the NDA, to compile the additional supporting data, to prepare for launch and to lead us into the launch from that standpoint. Fantastic. All right. Well, I'm really excited. It's a great time for Avadel. Thanks again for joining us guys, and hope you all enjoy the rest of your day. Yeah, thanks, Chris. Thanks for the opportunity to be here. Yeah. Thanks, Chris. Bye.