Okay. Hi, everyone, I'm Manjot Singh, Senior Biotech Analyst here at Jefferies, and next up, we have Supernus. To the left of me is Jack Khattar, President and CEO. Welcome, Jack. Thank you. Thanks for having me. So, for those in the audience who are less familiar with the Supernus story, maybe give a background about the company and any opening remarks that you'd like to make. Yeah, sure. Before I start, I just wanna remind everyone about the SEC filings and the risks associated with our business, so please make sure you check those. For those of you who are not too familiar with us, Supernus is in the CNS space, so we're a biopharma in CNS. We have several products that are on the market. Revenue guidance, which we updated last week, $590 million-$610 million. Our key growth drivers are Qelbree, which is a novel, new non-stimulant product for ADHD, and then Gocovri, which is a fairly new product, also about four or five years on the market, for the treatment in Parkinson's disease. It's a very unique product indicated for OFF episodes and dyskinesia. And we're also very excited about hopefully next year, you know, before we know it, it will be 2024 to launch another product in Parkinson's, which is the infusion device, apomorphine product. That should also expand our leadership position, in Parkinson's. We have several legacy products that are maturing, and this year, actually, we just saw the first transition for ourselves, which is losing Trokendi XR, the loss of exclusivity on that product. However, despite that, we were able to grow the business in the 24%-25%, excluding Trokendi XR, so we continue to emphasize growth as we move forward. And added to that, clearly, is our pipeline. We have a very exciting pipeline. We talked about it about a couple weeks ago. We had a full R&D Day where we went through the details of a lot of our programs, and perhaps we'll touch on some of that, today. Sounds good. Thanks. So maybe today we'll touch on the existing products, some of them, and then we'll move on to the pipeline. So actually, before we begin, high level is, you know, your, your revenue... As we think about your revenue cadence year over year, how should we think next year to compare relative to this year? Should we expect growth directionally? Because, like you said, some products are maturing. And I think I heard you earlier say growth, so. Yeah, I mean, we are a growth company. Clearly, like every other company in the pharma industry, you go through the ups and downs and the cycles of products losing exclusivity. So we've been very focused on growing our growth products, which I mentioned, you know, Qelbree and Gocovri, and this year, we managed to do 24%-25% growth, excluding Trokendi XR, which lost exclusivity. So excluding the mature products, the legacy products that are losing or have lost exclusivity, we continue to grow at a very, you know, solid, robust growth rate, 24%-25%, and certainly, that will be our intent for next year. We will give guidance in February. That's when we give the full guidance for the company, at that time, so stay tuned. Okay, and just to be clear, typically, there's a big sell-side conference in January. You don't plan to pre-announce? You know, we'll have to wait until- Yeah, normally we don't pre-announce at J.P. Morgan. Okay. Yeah. Very good. And speaking of guidance, how should we expect you around that and to guide around the total revenues, obviously? But this year you have guided individually on one of your products, Trokendi. Next year, could we expect continued individual product guidance, including perhaps for Qelbree, your ADHD drug? Yeah, I mean, our philosophy is trying not to do it product by product. We only like to give guidance for the total portfolio in totality. This year, you're right, we did it just because Trokendi XR was the first-year loss of exclusivity, to try to help investors, you know, see our growth outside Trokendi XR. So we'll see whether we do the same thing, you know, for next year, because also next year, we'll see a partial loss on Oxtellar XR, you know, at the tail end of the year. So we'll see if we can frame it in a way to be helpful. We wanna just be helpful to investors, actually, and not confuse them. You know, sometimes you do things to be helpful, and it backfires on you, so we'll try to be as helpful as possible, so we can isolate the growth products and really show how we're generating growth- Mm. -at Supernus. Very helpful. Okay, so we'll move on to Qelbree. One of the key questions is, how big can Qelbree be at the end of the day? You're, you're in the market, I think two, three years now. How are scripts tracking relative to other ADHD drug launches? Yeah, compared to the other ADHD drugs that have been launched in the last 10 years or so... Actually, we have a slide on our website on, and the investor presentation. It really shows Qelbree compared to all the other products that were launched, and Qelbree is the top leading launch over that period. And what the chart actually doesn't say is Qelbree is the only non-stimulant. All these other products are stimulants, and stimulants are very well known that they take up, the uptake is very quick. Typically, 90% of the market is stimulants, so obviously it's a fertile ground for new stimulants to come in and take quickly a market share in the market. The other thing is, the chart doesn't actually show is that Qelbree was launched during COVID, and we had major issues as far as reach, access to physicians, and despite all that, Qelbree is the fastest and best launch in the industry so far. It continues to perform extremely well because it is a non-stimulant that actually works. That's something we haven't had for decades in the industry, and we've known the ADHD space now for 30+ years, when we used to be all the way back to Shire days. We actually developed four ADHD products, unlike any other company in the industry, so we know the space extremely well. This is something we've been waiting for for a long time. A non-stimulant that works, works fast. There are non-stimulants, the leading one, Strattera, we all know about. It takes 4, 5, even 6 weeks for it to work. A parent may wait 4, 5, 6 weeks, and still doesn't work. Not everybody's guaranteed that it will work for them. And, you know, for me, as a parent, that's eternity, and I'm already halfway through school, and I still don't know whether the product is gonna work for my child, right? So clearly, this is a major differentiation for Qelbree, and it's really proven in the marketplace to perform exactly as the phase III indicated. Work as early as week one for some children and for adults, because you have to titrate another week or so within two weeks. So within two weeks, you know whether this medication is gonna work for your child or for yourself. On top of it, of course, we give a free sample, a two-week sample, so in a way, it's a trial free. The risk is not much there, and you can always add a stimulant if you need to. Mm-hmm. So that's why the product continues, you know, to perform very well. As time goes on, we continue to add more data on how the product is being used in the marketplace. One thing I'll point out is the new study, which was done independently of Supernus. Supernus had nothing to do with that study by two doctors in the US, Doctor Price. Actually, they put patients on atomoxetine for four weeks, which is Strattera, because that was dictated by insurance. After the four weeks, they could, if they choose to, switch the patients to Qelbree. Actually, they measured the ADHD score baseline before atomoxetine, four weeks later, and then four weeks afterwards on Qelbree. Ninety-six percent of the patients preferred Qelbree versus atomoxetine. Also, on the ADHD scale, Qelbree performed with statistical significance versus after treatment on atomoxetine, improving ADHD symptoms with statistical significance. So Qelbree is a very different product than atomoxetine, which everybody at the initial days of launch said: Well, it's gonna be like atomoxetine, a similar, you know, mechanism of action and so forth. Clearly, we've proven that the product is a much different product, and as I mentioned, works really well. Very helpful. And so Q3 sales, I think, were 37 million scripts, were up 12% quarter-over-quarter. How is Q4 looking in your view? Should we expect some type of quarterly acceleration versus the 12% growth that you saw? I mean, it's a little bit hard to predict quarter-to-quarter growth. Certainly, Q3, Q4 are typically the strongest quarters in the ADHD market because of the obvious seasonality with children. As we just said last week on our earnings call, the seasonality this year was a little bit softer. The back-to-school season was softer than previous years. And what we're actually seeing is probably normalization in the ADHD market. Because the last three, four years saw pretty much an explosion in demand for ADHD drugs behind the COVID mental health awareness, you know, telehealth practices and so forth. And what we think is happening right now, the market taking a little breather, so to speak, kind of normalizing, because there is really nothing changed in the market that is structural, that, you know, should tell us that the market should decline or increase one way or the other. The growth rates will normalize. My expectation will be something in the 3%-5%, you know, on an ongoing basis into the future. So depending on how the market continues to perform in the fourth quarter, back to your, you know, question, we sure hope we can do better than the third quarter. Obviously, that's always what we're aiming for, and we'll see what the data shows. Right. I mean, you raised a good point. The overall ADHD drug market did grow by, like, 10% year-over-year for the past two, three years. So arguably an anomaly or- Yeah, and, and this year it declined by 3%. Now, the market declined 3%, but Qelbree grew by 16.6%. Right. I mean, we way outperformed the market. Yeah, it's important to know Qelbree is growing consistently quarter-over-quarter. Yeah. Okay. So then, how should we think about net price? Starting with gross to net, I think most recently you're at 58.7% gross to net, and you have suggested 50%-55% by year-end. So, are we there? And realistically, can you get to 50% from 58, or is it fair to assume you're gonna get closer to 55% at this point? Yeah. We have two things that are working in our favor. You know, the natural progression, improvement, and gross to net, that always happens across all categories, not just Supernus products. You know, Q1 is always your worst, Q2 improves a little bit, Q3 improves a little bit more, and Q4 a little bit more. So certainly, just through the natural progression improvement of gross to net, we sure hope that we'll do a little bit better than Q3. In addition to that, you know, we added a major contract this year from the PBM perspective, so that's now starting to take full impact on the gross to net. So certainly, that's helping. And we've also made some changes in the co-pay program, which will help us as well towards gross to net. So our goal continues to be in the 50-55. Maybe in the fourth quarter, it will be closer to the 55, clearly. But our ongoing goal will continue to be in that range, and it will fluctuate. Mm-hmm. You know, quarter to quarter, you'll always have these swings. Is that the end goal or for you to reach 50 or 55? It- Or could it be lower than that? It is the end goal, but if we can do better, absolutely, you bet we'll be, you know, trying to do that as well. Got it. And how about average dose per script? Is that going to be increasing? I mean, one could argue back to school is more children, so less average dose per script. So how should we think about that for Q4? ... That should continue to grow, absolutely right. I mean, in the third quarter, actually, by design, we pushed more pediatric, even prioritize the sales force, effort and so forth towards more pediatric naturally, so we can piggyback on the back-to-school season and the strength of that. In the fourth quarter, we will reprioritize typically a little bit more on the, the adult. Now, it's not that quick that you will see because of that change in emphasis, you're gonna see the average daily dose all of a sudden in the fourth quarter, like increase dramatically versus the third quarter. This is something that will happen, but will happen gradually over time. Makes sense. Okay, so maybe last question on Qelbree is, you know, where are we in terms of innings? We still pretty early or middle? We're still way early in the... I mean, we're only in the third year after launch. The market is about 92 million prescriptions a year. We haven't really even scratched the surface. As I always said, you know, at peak, Qelbree could easily be in the multiple, multiple 100 million dollar products. It's very simple. 6, 7, and 8 years from now, the market will be 100 million prescriptions. If we get 4%, you know, we're not asking for more than that, 5%, 6%, you know, you can do the sensitivity. That'll be 4-6 million prescriptions, and we just mentioned last quarter, our net price per prescription is $227. So even if we don't take any price increase whatsoever over the next eight years, you know, this certainly can be a very big product. Makes sense. Okay, and so let's move on to some other products in your pipeline, not pipeline, but existing business. So one by one is Trokendi, like you said, it lost exclusivity earlier this year, although it does seem resilient versus a few generics. So how should we expect Trokendi to precisely trend, in your view, as we think about 2024? Yeah, I mean, again, in February, hopefully, we'll be a little bit more specific when we give the full guidance, but I mean, naturally, a product in its second year being, you know, with generics, you naturally are gonna see some more erosion. I mean, that, that's obvious. The key question, the big question is: to what extent, right? And how much do we retain out of the whole business eventually on the long-term basis? So that remains to be seen. Hopefully, in February, we'll be a little bit... You know, give you guys more clarity on it. And the same thing with Oxtellar XR. I already got the question today, you know, what do we expect, you know, to happen next year? Again, given that it's a partial year at the tail end of the year, obviously, the impact is not gonna be as severe as it was for Trokendi XR this year. So we'll see if we can quantify that and help folks, you know, put their arms around it. Very helpful. Then Gocovri, your Parkinson's asset, how should the cadence be going forward, and what's the ultimate market opportunity or peak sales potential? I mean, we see Gocovri as a very steady product in Parkinson's. It has a very unique positioning. No other products have the double indication, which is treating OFF episodes in Parkinson's, that pretty much every product has. But Gocovri has also treatment of dyskinesia. So, it's the only product that has these two indications, and that makes a big difference for a lot of physicians, and it takes a while for physicians to change the way they treat Parkinson's, because for so many years, they've been trained. You start with levodopa-carbidopa over the years, you keep increasing the dose, and then as you start hitting dyskinesia, you taper off the levodopa-carbidopa dose. Well, with Gocovri, you don't have to do that. You don't have to have that trade-off. You don't have to sacrifice on the levodopa-carbidopa. You can keep the dose as is and treat dyskinesia with Gocovri. And Gocovri also gives you that extra efficacy on the OFF episodes as well. So it takes a paradigm shift here for a lot of folks to really, you know, change their behavior and how they treat, especially on the neurology side, not as much with the movement disorder specialists who are pretty much on board, you know, with that type of thinking and treating approach. Okay. You know, part of my view on Supernus is for your multiple to expand, you know, we wanna see Qelbree growth, sales beats, but in addition to that, I feel like there are two other levers. So one is BD, the other one is pipeline. So before we go to the pipeline, BD front, you do have cash. You're managing your business well. You're a $600 million per year revenue company. What's the latest on BD? Is there any sense of urgency, and what type of deals are you looking for? BD is always urgent. I mean, you always have to be out there with BD. It's not like a switch, you switch it on and off. Clearly, you always have to be there looking for opportunities because you never know when things are available or a seller is willing to transact, so you always have to be looking for these. Our priorities are fairly straightforward. We continue to prioritize commercial assets if we can find, you know, those assets that increase our diversification from a revenue perspective, continue to increase and grow our cash flow. And the second priority would be later-stage pipeline asset, because if you look at our pipeline, it's phase II or earlier, aside than the pump, of course, that we hopefully launch next year. Everything is phase II or earlier, so we're very focused on finding something that could be phase II and but, and after. So, we're fairly agnostic on, as far as is it neurology or psychiatry, I mean, we have presence in both areas. We try to be also open-minded and looking outside CNS, if we can find opportunities outside CNS, but it has to be with depth, not just like one product, and then we're struggling to be efficient in the operation. So if it's a platform that has a product, a pipeline with it, then we're clearly very open to expand our, you know, verticals and get into another therapeutic area. Would you be willing to use debt or raise stock? Yeah, I mean, all these, you know, financing options are available because our balance sheet is fairly clean. So we don't have any debt at this point, so leverage is something clearly we can use. Now, for those of you who know us, we tend to be very fundamental in how we run the business and conservative, so we're not gonna over-leverage and do crazy things we're not supposed to do. For the right transaction, if it's really transformational and will get us to the next level or several steps above where we are today, certainly equity is something, you know, we'll be happy to use as well. Makes sense. Okay, and so maybe the last seven minutes, talk a little bit more about your pipeline. So first is the apomorphine pump that you have resubmitted. So the question is, this pump has gotten a couple of CRLs now, so what drives your confidence in an approval this time? Yeah. Yeah, we got the CRL, and before that, we got the refusal.. acceptance. So clearly, I mean, at this stage, we think the FDA has raised all the questions they wanna raise by now. We did have a meeting with them April this year before we resubmitted the file to make sure we have clarity on all the issues. So we are really confident about the file, the quality of the submission, and we're really looking forward toward the PDUFA, which is April 5 next year, and therefore, we're thinking about a launch, perhaps early second half. Early second ... of 2024. I see. And just to be clear, So sorry, RTF, then CRL. For the CRL, it wasn't due to any clinical data that FDA wanted additional. It was more so what- That's right ... specifically? That's right. There was no need for additional efficacy or safety data. That's a lot of it is related to the device CMC issues, things like that. Okay. Let's say it was approved, you do have a Parkinson's sales force with Gocovri. So can you leverage scale- Mm-hmm ... that way? Yeah, absolutely. I mean, that's the beauty of this product. We do have a fairly well-developed infrastructure in the Parkinson's for not just the sales force, also the hub services, nurse network that supports Gocovri and Apokyn, as well as reimbursement field specialists. So we have the full infrastructure to support the product. We might expand the sales force maybe by, I don't know, 5-10 reps at most. You know, you know, we... You only have a very restricted physician audience in movement disorder, so it's not like you expand the sales force by a few hundred, you know, reps, it doesn't help you much. So it's more about very smart targeting, reach, and the frequency that you have to get with these physicians. Understood. Okay. And so, it's also just interesting because AbbVie has their own pump, and they've guided to $1 billion peak sales. So, I mean, do you share the same view, or are you more conservative in your thinking? Well, when we purchased the asset way back in 2020, you know, we said it's somewhere in the $125 million-$175 million. I think that's probably underestimated the opportunity. We are in the middle of redoing the quantitative study and so forth, so when we get a better handle on it, we probably, because I don't like to just throw numbers out there, and we're not able to meet them clearly. I sure hope it is $1 billion, and AbbVie is right, and, you know, it's a big market clearly. It is a whole new segment, just to be clear. I mean, today, there is no such treatment approach in Parkinson's disease to have an infusion pump, so it's a completely new segment, but that's not the case in Europe. It's been around for many, many years. And from a volume perspective, unit perspective, in Europe, it actually does pretty well and has been doing pretty well. So we sure, you know, think that it's a good opportunity, very solid opportunity for us, and the market is ripe. It all depends on the label and what patient type this product will end up being suited for. Okay. Initially, it will start probably with very severe patients who are well progressed into the disease, so they really need some option before they resort to deep brain stimulation or invasive surgery. Then the pump will be a great option for them. But as time goes on, it might end up migrating into more moderate patients. I see. Interesting. Okay, so last couple minutes, like you said earlier, you had an R&D Day. So I wanted to touch on two assets really quickly. The first one, SPN-817, for your epilepsy asset, which has phase II open label data, first half 2024. So, what is good data or strong data to you? Acknowledging this is an open-label study. Yeah, I mean, as we highlighted in the R&D Day, I mean, what we've seen so far is really early, but clearly extremely encouraging. I mean, we've been in epilepsy for a long time, and there are so many agents out there, and the average seizure reduction is 35%-55% seizure reduction. And we're seeing numbers in the 60%-90%. I mean, it's really amazing. It's very small numbers. Again, I caution number of patients, but very consistent from the preclinical models all the way to all the early data that we've seen. The seizure freedom, you know, percentages are also very strong. So if that continues, if that profile continues, that will be a very well-differentiated product in this space, clearly. Also, the molecule itself, it's a very potent, very highly selective acetylcholinesterase inhibitor, which has potential use in other CNS indications, and those type of products are typically known for their cognitive improvement, memory, you know, and, and so forth. So there might be some interesting profile here that emerges even in the epilepsy space, because a lot of epileptic patients do suffer from cognition, that sometimes these cognitive deficits are caused either by medications or the disease itself. Okay, and then the very last question, you know, SPN-820, your mTORC1 for depression, actually treatment-resistant depression, so there's technically only two drugs, or three, or two approved. So I think we have a good handle on what strong efficacy is. It is a placebo-controlled. So, I guess the question is, you have data 2025, at R&D Day, you shared your enrollment numbers. So the question is, how confident are you that you can get the number of patients that you need to unblind the data and read? Yeah, initially, it was very slow by design. The protocol was very restrictive because it is such a unique molecule. There is nobody in front of us who's done mTORC1 activation or mediated synaptic function in, for depression. So we wanted to be extra careful as far as concomitant medication that patients can take. As time went on through the study, we relaxed some of these inclusion/exclusion criteria, so we are admitting more patients in, but with confidence that we're not gonna create any safety or tolerability issues. And, recruitment has improved. We are now in the 65, you know, patients randomized so far, but we have still a long way to go because we're shooting for 268 or 270 patients in total, so we still have a long way to go. Also, the study started at the tail end of COVID, so we had a lot of issues with clinical sites and so forth, like everybody else, unfortunately. But those have now, you know, subsided, and we should be able to pick up the speed. Okay, so lots going on, but regardless, thanks for joining me, and we'll chat again soon. Okay. Thanks, everyone, for listening. Thank you.