Well, good morning. Thanks so much for joining our 45th Annual Healthcare Conference. I'm Stacy Ku, part of the biotech team with my colleague Vishwesh Shah, and we're happy to be hosting Supernus today. We have Jack Khattar, CEO. Thank you so much for being here today. Thank you. Thanks for having me. So before we drill down into specific questions, do you want to just very briefly provide an overview of the recent earnings update for 2024 and maybe, again, very briefly, the view and outlook for 2025? Yeah, sure. Thanks, folks, for joining us. Just a quick reminder that I'll be making forward-looking statements, so please check our SEC filings for all the risk factors associated with the business, so we just announced the results very recently for 2024. It was a great year for Supernus, where our revenues were around $661 million. As a reminder for some of you who probably know us, we've been going through a transition because we had lost exclusivity on some of our legacy products, and our growth products, specifically and primarily Qelbree, have been pretty much taking over and more than just overcompensating for the loss of revenues, but continue to grow and had a great year in 2024 with huge momentum behind the product. At the same time, in 2024, we've been advancing our pipeline. We had a lot of data that came out of our pipeline. The company continues to generate very significant cash flows. We have a very clean balance sheet with about $454 million in the bank at the end of the year of 2024, and we have a lot of flexibility for doing M&A or any external growth opportunities. Okay. Well, wonderful. So just given the recent kind of pipeline news, I think we'll start there. Update on SPN-820, phase II-B study for TRD. So ahead of kind of the update, we had gotten a lot of inbound, and so our sense was that investors were really optimistic. Do you want to just talk about some of the kind of post-data analysis, what you've kind of looking at with Navitor and kind of steps from there? Yeah. Yeah. 820 is our mTORC1 modulator for depression. We had done a study last year that we announced the results on, which was an open-label study for MDD, and the dosing regimen on that study was a 2,400 milligram dose every three days. That study read in 2024, and the results were really extremely good, but it's open label, clearly. In parallel, we had a phase II-B study that was going on, a placebo-controlled study in TRD, and that's the most recent study on which we issued the data, and that study didn't separate from placebo. Looking at the data, looking at the comparisons between the two studies, we believe what could be the culprit here is because of the mechanism and the system we're working with here, which is the mTORC1 activation and the biology system, that an intermittent dosing is what really needs to be administered for the patients. This is a system that may need to reset. It's not a system where you have to hit it every single day. In the placebo-controlled study, we had 1,600 milligrams per day every single day versus in the open-label study, we had 2,400 milligrams every three days. There is a lot of science and data behind that hypothesis that that's perhaps what's going on because when we looked at all the sub-analyses in the placebo-controlled study across different patient populations, different diseases, different dose levels, and different sites, we couldn't really find anything that sticks out that could have resulted in the results that we published. The main difference continues to be mainly the dosing regimen between the two studies. At this point, what we're doing is we continue to look at the data, make sure if that is a question that definitely warrants to be answered, we will probably do something else that's yet to be determined. We will certainly communicate that to folks when we're ready. As far as whether we do another study with the single dose given intermittently every three days at 2,400 milligram, that's the natural probably next step, but we're not there yet. We'll communicate that when we have a final decision on it. Okay. And you talked about the different subset of patients. Specifically, you looked at kind of the MDD patients in the study and the TRD patients in the study and saw no. Yeah, we had actually a few patients in the TRD study that are more like MDD type of patients, and the data didn't really separate or wasn't that much different than the TRD patients. Also, there weren't any sites that stuck out where they messed up the data one way or the other. Actually, the study was very well run, very consistent, very clean, the data across the demographics, the baselines, everything looks pretty clean from that perspective. And that's why the dosing regimen is really the only thing that sticks out as a key difference between the studies. Okay. Timing of strategic conclusions, that can happen this year? I'm sorry, the? The timing of kind of strategic conclusions around 820? I mean, hopefully in the next few weeks, maybe a month or so. We'll see. Yeah. Okay. Understood. You've also, in the last year or so, released proof of concept results for SPN-817, so SPN-817 and treatment-resistant seizures. Just want to talk about your development plans there, recent kind of efficacy results we've seen, and obviously the opportunity in focal epilepsy. Yeah, SPN-817, which is a very potent acetylcholinesterase inhibitor. Last year, again, we issued the data on the open-label study, which showed significant seizure reduction, a pretty strong profile, specifically from the efficacy perspective. Given that class of drugs, acetylcholinesterase inhibitors, these are very well known for a lot of the cholinergic effects that tend to happen when they're administered, things like nausea, vomiting, GI side effects. So we had those. We those. We came across those same issues clearly, which were expected in the study. What we have done since then to address the tolerability or improve the tolerability is currently in the phase II-B placebo-controlled study that we just initiated at the end of 2024. We have a requirement for the use of antiemetic in the first five weeks of titration. In the next five weeks of titration, if the patient continues to be in the titration phase, it's as needed, and you give ondansetron for 30 minutes before the dose of 817. Then once they titrate to the three or four milligram, which is the target dose that we're looking at twice a day, they can enter the maintenance treatment. Because actually, in the open-label study last year, we noticed that once patients go through the maintenance period, they stay at the maintenance period, the tolerability is pretty good. They get to build the tolerance for these kind of side effects. The toughest period is the titration period that we want to make sure they can go through it. Now, in parallel, we're looking at other strategies to improve the tolerability, potentially different dosage forms, different delivery systems, and a couple of other strategies that we're looking at. We are testing those in parallel in a second portion of the open-label, so we kept the open-label study going, although it finished last year, but we kept one section of it going on where we're testing some of these strategies, so given that it is open-label, as we learn and get data from that study on these new strategies, we will incorporate that through protocol amendments in the phase II-B study, so that's really the strategy there, and as far as the phase II-B study, folks have been asking me when to expect the data and so forth. I mean, epilepsy studies are notorious for being slow. Now, given that we just started the study, give us at least a few months to see what the projection could look like from a recruitment perspective, and then we can update folks on when could be the target date for getting the data. Okay, and by the way, for the phase II-B, I do believe you said you've extended the titration period. Is that correct from your proof of concept to? Yeah. I mean, in the open-label, if I remember, it was, I think I might be wrong, but I think it was eight-week treatment, I mean, titration period. We have it here at 10-week titration period, and we split it up into two pieces in a way. The first five weeks, you have the obligatory requirement for the physician to give the antiemetic. In the open-label, we suggested it to them. We told them to use it, but they didn't use it in the open-label. They only used it on like 7% of the patients. I mean, it was really random use. And a lot of times when they did use it, they used it way too late. They waited for the nausea to happen, and then they used it, and that was, in a way, almost too late for that. So we think that will definitely help. Now, I want to put the whole issue in perspective. I mean, we're talking about in the maintenance period in the open-label, we had about 27% nausea. That is not really terrible in a way. If you put it in perspective and within the landscape of epilepsy drugs, I mean, unfortunately for patients, epilepsy drugs do have a lot of tolerability issues. A few examples we've been very familiar with: Topamax, oxcarbazepine, topiramate. All these drugs over the years have been very well known for significant side effects. And yet a lot of patients over time tend to develop the tolerability and the tolerance for these side effects, and eventually they get used to it, and the benefit, of course, way outweighs the risk of these side effects. So it's not like it's a horrible situation, but of course, we're doing everything we can to make it better if we can, absolutely, and improve the tolerability. Understood. And SK Bio obviously had success despite a tough titration period and kind of tolerability issues. That's correct. Last question on 817 then. Could we get an update, at least just on tolerability this year from the open-label extension trial? Any type of comments as we read through to the phase II-B? Yeah. I mean, if we see certain things that we're going to try to incorporate into the phase II-B study through protocol amendments, and we see some strategies that potentially are working well, we will communicate those to the street. Some of them also could generate additional IP, so we're just trying to be careful when we disclose what it is that we're exploring. So the timing of those things might be a little off because it's driven also through the IP strategy. Okay. You discussed that you exited Q4 with around $400 million, and you did kind of mention business development potential. How much time are you spending there these days? Maybe talk about what stage of development you might think about, how big you go, are you comfortable leveraging up? Yeah. I mean, BD is always a top priority for us, has been and continues to be. So regardless of what happens in the portfolio, we're always looking and we're always out there. And we have very specific criteria we're looking at all the time. So now that APO-go, our infusion device, has been approved, and we will be launching it in the quarter. Clearly, when you look at our pipeline, there is really nothing to be launched at this point from 2026 till 2030 or so. So that's a window where we would like to launch more products, clearly. That's an area we're focused on, either getting more commercial products already in the marketplace that will generate growth from revenue and profitability, as well as later stage assets that could be already in phase III or pre-phase III, where within a couple of years we might be able to finish the development and launch these products. That's how we prioritize these opportunities. We're fairly agnostic in CNS, whether it's psychiatry or neurology. But also, we've been mentioning it several times that we're not opposed to looking outside CNS, especially if it's a situation that could have multi-asset profile, meaning either a product commercially available in a pipeline or a couple of products in the pipeline that gives us some scale in that new therapeutic area if we were to enter a whole different therapeutic area. As far as the size of the transaction, I mean, clearly it depends on what the asset is that we're looking at. Clearly, we can easily do a one-product type of transaction, and the size could be from $500 million to $1 billion, $1.5 billion if it's a multi-asset situation, commercial products. Clearly, commercial products, if they have significant cash flows, they can help us fund that and finance those kind of transactions. Okay. Understood. You mentioned APO-go. Do you want to talk about launch timing? What else needs to be done to be ready and maybe the infrastructure that's required and what's already set up? Yeah. APO-go will be launched in the second quarter of this year. APO-go is a great, perfect fit within our infrastructure that already exists. We've been in Parkinson's now since 2020, so I have a major presence there with several products, not one product, with Gocovri, Apokyn, and Xadago. So we have a very substantial infrastructure that supports these products, and the infrastructure is not just the sales force. Clearly, we have a very focused sales force, about 50-plus reps in that space, but also we have a regional nurse network, 30-plus nurses that help the patients. So they call on patients, they train them on the products, they help them with compliance. So we have a very well-rounded support system around the patients and, of course, the hub services. So we have a significant hub services and infrastructure there to help patients adjudicate, go through the system, get their prescriptions. We also have field reimbursement specialists. So it's a very well-rounded system, and we're very much equipped, of course, to plug in APO-go in that same infrastructure. So, as I said, we'll be launching it in the second quarter. So we're very excited about it. Potentially, it could be a very significant opportunity for us. We're excited about the product. We know about the product extremely well because it's been used in Europe for 30-some years, interestingly. So there is a lot of history behind the product, a lot of learnings from our partner as to how is it used, all the dynamics around it, the kind of patients, and so forth. So there are a lot of learnings that we can work on here in the US. Okay. So what are maybe your expectations for this year for APO-go and then maybe remind us the peak sales opportunity year? Yeah. I mean, as we just mentioned recently on our earnings call, I mean, we said in our guidance, we have not too much on APO-go, probably a high single digit from a net sales perspective. As far as the product potential overall, we think that's going to be somewhere in the $200 million-$300 million peak sales. A lot of people have been telling me, "Well, Jack, you've been really conservative here," but I don't know. It remains to be seen. We're not willing to jump the gun here and say, "Well, it's going to be throw a billion numbers out there," but everything is possible, clearly. The potential is there, no question about it. The need is there, and AbbVie and us together, we're creating pretty much a new segment here in this market that hasn't existed in the U.S., infusion devices. These products will work and work pretty well. Apokyn has a great profile, and it could be used. The label, it says on advanced PD, Parkinson's disease patients. Now, the thing that really could change the forecast or the peak potential here is where it ends up being used. Physicians, the definition of advanced may change and may be different in different physicians in their mind. It's somebody who might say, "Well, I have a patient who has been diagnosed for 10 years. That's an advanced patient." Somebody else might say, "I have a patient who has been diagnosed only three years ago, but they are up against major challenges with the current oral drugs and adjunctive, and none of them are really keeping the off episodes away or they're hitting dyskinesia and then so forth. I would like to use the pump." So different KOLs, different physicians may look at the product differently. And we certainly see that in Europe, where over the years, a lot of the therapy has moved down the progression, so to speak, towards more moderate patients. And some people are using it earlier in the stage than later. Okay, but we'll have to think about pricing and payer reimbursement and kind of clinician need. Okay. Understood. Obviously, Qelbree is key to Supernus for the next few years. The pediatric launch continues to kind of chug along in our view. But how is the adult launch progressing for you all? What else needs to be done to increase adoption? Maybe remind us the recent study results for Qelbree and ADHD with depression comorbidities and the adult awareness campaign. Yeah. Qelbree has been a great, amazing product for us. It's been a great launch. I mean, we're now four years into it, and we continue to chug along very, very nicely with strong momentum. The product had an incredible year in 2024, growth through prescriptions 25%, 70% or 70%+ growth in net sales. So the product has really done extremely well. And at the end of the day, it all boils down to the product performance. I mean, it really does well from a clinical medical perspective. The feedback continues to be very positive, regardless of whether it's pediatric or adult in both patient populations. Finally, physicians are realizing there is a real option here. It doesn't always have to be stimulants that we throw at people all the time as a first-line treatment. There is a real option here that works within a week or even two weeks, and then we can always use stimulants if we want to. Why not give a child a non-stimulant, non-controlled substance and give it the chance? And the same thing with adults. Now, adults, there is a little different dynamic with adults. Some adults, or a lot of adults, actually, they love their immediate-release stimulants. It gives them a nice high, a nice buzz, whatever you want to call it. They like that, so they don't want to give it up that quickly. And actually, physicians don't want to take them off that medication pretty quickly. So what's happening in adults is they tend to add Qelbree to the stimulant use. And they titrate Qelbree very slowly until they hit a certain dose, while at the same time tapering off the dose of the stimulant. So they take the stimulant off the table very gradually instead of completely stopping it at the beginning. And that's why, actually, when you look at the mix from a prescription perspective, about 40% of the prescriptions in adults on Qelbree are actually combination therapy in addition to the stimulant. Not so much in pediatric. In pediatric, it's around 20% of the prescriptions are combination. So there is a slightly different dynamics between the two populations. We are pushing forward on both segments, continue to push because there is a lot of growth to be gotten from both segments. And the nice thing, it's a high-quality problem, I guess. We continue to push in adults, and people keep telling me, "Well, Jack, but the mix is not changing. You keep telling us it's 30% adults and 70% kids." Well, the good news is we keep growing in adults, but it also keeps growing in pediatrics. So we're not changing the mix much, but I'd rather have it this way than having pediatric not growing and changing the mix. So all in all, really great momentum behind the product. And to your point, we continue to invest in the product. I mean, since we launched it, we've generated data on a phase IV on combination use, the co-administration of Qelbree with stimulants. We've generated recently data we just talked about, which is Qelbree in patients who are ADHD, but they have comorbid conditions such as depression, anxiety, bipolar, whatever, because in those patients, actually, stimulants are contraindicated. And a lot of times, physicians continue to ask us, "Can I use Qelbree on these patients? Could you at least generate some data for us to look at?" It's not in the label, but at least physicians want to see what data could come out of any study. So that's why we did that phase IV study. And also, very recently, very important data on lactation for the female adult patient segment, which is also a fast-growing segment in the market. And of course, the mechanism of action of viloxazine or Qelbree. And that's a huge win for us because serotonin, and we've known all along that viloxazine does have a serotonin partial agonist activity, and that separates it truly from Strattera and atomoxetine. And that's not just important for physicians to know, even the payers, because everybody at the beginning when we launched the product, "Who cares? It's like Strattera. This is another Strattera," and so forth. Well, it's not. We've been saying that and finally generated the science clearly and the data behind it. We're very excited about all these things really coming together and continue to drive the momentum behind Qelbree. Okay. Understood. So it sounds like on the last earnings call, we talked about Qelbree consensus for $250 million or $280 million seems to be within a general range of something that you're comfortable with. I see you nodding. But let's look long-term. How big do you think it could become? Obviously, 100 million prescriptions, big, big market, non-stimulants, a much smaller piece of the pie. So how do you think about how Qelbree could grow? Yeah. I mean, it is a huge market. It actually hit $100 million way before we ever, when we did the initial forecast way back. So the market has been very healthy and continues to grow. Last year, it grew by 9%, just the market itself. So that's clearly great background behind and a great foundation for the growth of Qelbree. That probably will continue in a way at some point, but maybe in a more normalized at some point. The brand itself, Qelbree, we're only about maybe 1% market share penetration of the total market and about 10% for the non-stimulant segment of the market. So we have a long way to go here from a growth point of view. Again, I've been always, yes, I'm biased, of course, but I've been always of the opinion there is no need whatsoever for a physician to start with a stimulant. Every kid should be, if it's the right medication for them, they should try Qelbree first. I mean, there is no downside. Within a week, you will know whether it works or not. What's the downside, right? Or within two weeks, and you get a free sample on top of that to see for two weeks whether it works or not. Why try and put these children on controlled substances, and then for adults, not that different, actually. Why should you be on a controlled substance if you can have a non-controlled substance that really works, so Qelbree really pretty much sums it up. It is a non-stimulant that actually works. We haven't had that for a long time, for many, many years. Okay. In the last few moments, maybe remind us Qelbree durability, how are you guiding investors on exclusivity? Yeah. I mean, we just updated folks recently. We were able successfully to extend the term of one of the patents to 2035. So that's the longest we have. So we have three families of patents: API synthesis, the formulation, and the use. So we have different areas for protection on the product, and the farthest one is 2035. Okay. That's the question. I wanted to find out what's the payer dynamic? Are they asking people, doctors to go with stimulants first? How is that shaping the market? And also, your growth demand expectations directionally? Yeah. On the question about the payers, we have actually great coverage, one of the best coverages as far as brands. You look at the brands in the ADHD space. So we've been able to have very strong coverage across-the-board Medicaid, commercial, and so forth. And related to that, we're very happy to where we sit today in the gross-to-net area because we've been able to accomplish that coverage without just throwing exorbitant type of rebates to people. So our gross-to-net in 2024 for the full year was around 46%. For 2025, we think it will be more in the 50%-55% because if you remember, in 2024, we had more favorable adjustments to the gross-to-net that are more of a one-time type of adjustments related to a favorable return pattern or trend on the business. So it's more likely going to go back to the 50-55 range, which is a great range to be in. I mean, Trokendi XR, Oxtellar XR, we've had these products for 11 years, and they're in the 55% range. So that's really where we are in Qelbree. So we continue to be very disciplined on contracting on the payer side. We will not and will refuse to pay rebates that are just crazy because over time, it only goes up as time goes on. So if you start with 40%-50% rebates, that's not a recipe for success. Any other questions? Well, wonderful. Thank you so much for the time. All right. Thank you. Appreciate it.