Okay, we're going to get started. I'm Andrew Tsai, Senior Biotech Analyst at Jefferies. Thanks for joining me today. It's my pleasure to have Supernus next CEO, Jack Khattar, beside me today. Welcome, Jack. Thanks. Thanks, Andrew. Good afternoon, and thanks for coming today to listen to our story. Just a quick start for those of you who may not be familiar with our story. Just a quick reminder, I will be making forward-looking statements, so please check our SEC filings for all the risk factors associated with our business. Very quick overview. Supernus is in the CNS space. We've been operating since we founded the company in 2005. We were a spinoff of Shire Pharmaceuticals. We have 30+ years' experience in CNS and also, even more specifically, in the ADHD space. Today, we have several products on the market with revenue. Our guidance for this year, the last time we talked about it, was $580 million-$620 million and adjusted EBITDA $80 million-$110 million. We are going and have been going through a transition because our lead products, which we introduced way back in 2013, Trokendi XR, Oxtellar XR, are going through loss of exclusivity. But our priorities are our growth products, Qelbree in ADHD, which is a novel non-stimulant, and GOCOVRI in the Parkinson's space. We're also extremely excited about our pipeline and the new data that we've been sharing and is emerging on our two most important molecules. Both of them are first-in-class in their own therapeutic area. The first one is SPN-817 for the treatment of epilepsy, and the second one is SPN-820 for the treatment of depression. So very exciting time for us. A lot of catalysts coming up in the next 9-12 months. Stay tuned regarding the pipeline, as well as we have an infusion device, which we're also excited about potentially launching in the near term as well. Okay, very good. Thanks, Jack. Maybe just an overall business high-level question is you're expected to do, like you said, $580 million-$620 million in total revenues this year. It seems flattish year over year. Should we expect overall revenues to grow next year, in your view? Yeah, I mean, as far as next year, you have different dynamics. But excluding Oxtellar XR and Trokendi XR, we continue to expect that we will continue to grow the business, no question about that, because next year will be a full-year hit on Oxtellar XR as far as generic erosion, because our first generic entry is this coming September. So clearly, we'll have a full impact, more of a full impact next year. Right. Okay. And so maybe we'll talk about Qelbree and then move on to the pipeline today. One question, high-level, again, is how big can Qelbree be at the end of the day? It's been three years into the launch, I think, doing about $180 million run rate now. So how are scripts tracking relative to other products? And again, how big can it be? Yeah, I mean, the market is huge. It's in the 93 million last year of prescriptions a year. By the time Qelbree peaks, we think it will be north of 100 million. But if we just assume 100 million prescriptions per year on the ADHD side, even if we penetrate the market by 3%, 5%, you can model it pretty quickly. And the net price today, not at peak, is $255, is the last net price that was in the last quarter. I mean, that quickly adds up pretty much to several hundred million dollars in peak for this product, even if we achieve a very, very modest market share penetration. Q1 sales were $45 million when scripts were up 3% quarter-over-quarter. We're midway through Q2 now. How are scripts tracking relative to your expectations? Q2 over Q1, you're looking at sequential growth. It bounces around, obviously, every week, but you're looking at somewhere in the 6%-8%. So it's better than Q1, obviously. Of course, Q1 always has the other dynamics that play out in our industry in general. We're very pleased with Qelbree this year. So far, we've had this really strong first quarter. We couldn't ask for better from the brand itself. It's off to a great start. And Q2 seems to continue with that momentum as well. Okay. Sticking with the volume, optics, remind us when back-to-school season generally starts and ends. Are you going to put as much effort as you did last year, this year? Yeah, I mean, typically, across the U.S., of course, it varies by states, by districts, whatever. But most schools are out by mid-June, most of them, or first week of June. And then pretty much everybody is back by first week of September. It trickles in in August. Some states start a little bit earlier. So between mid-June, let's say, till mid-August, more or less, you're going to have a period which is slow because of the seasonality on the pediatric side, not much so on the adult side, clearly. And then it kicks in in high gear, of course, August, September, October, even November and December. There is a carryover effect from the back-to-school season as well. I see. And so because this is also approved in adults, the mix isn't necessarily just pediatric. So pediatrics can drive growth, but the question is, do you expect the acceleration in Q3 to be stronger than you saw last year? On one hand, last year was a weird dynamic. But on the other hand, there is a good chunk of adults here. Yeah, I mean, adult indication was approved about a year later than the pediatric. So we've been in the adult market about a year and a half to two years, actually. And you're right. Our mix of the business is actually reverse of what the market is. So only 30% of our business is in the adult. And we're making a big push in that segment for several reasons. It is the largest segment of the market, clearly. And also, it's a very important patient population for us. It also tends to be more on the higher as far as total daily dose. So from a growth perspective for the total brand, it's important. So from an emphasis priority point of view, we always work with the seasonality, so to speak. So in other words, now we're making a big push in adult. We'll continue to do that. And then appropriately, as the back-to-school season or a little bit before the back-to-school season kicks in, we start emphasizing the pediatric. That doesn't mean we neglect the other patient population when we do that, but it's more a degree of emphasis, basically. Right. Strategic. Yeah. Okay. And then going to price, the pricing side, gross to net in Q1, 50%-55% range. Are you seeing that improving in Q2, or do you expect that to improve in Q2 as well as Q3 to Q4? Typically, that's what you should expect. I mean, that's typically the trend in our industry and what we've seen over the last 10-12 years in the commercial side. Q1 is typically your worst. We started, as I said, in a good place with Qelbree. We were happy with that. It should improve unless something happens quarter to quarter. Sometimes you have certain fluctuations. Let's say you get hit by a big return or something really unusual that could change or make or cause certain fluctuations. Certainly, we will expect it to continue to improve. Hopefully, we'll end the year more on the lower end of that range of the 50%-55%. I mean, that's our goal. On an ongoing basis, you always have pressures of the gross to net getting worse. I mean, that's natural as time goes on with the contracting. PBMs are always asking for more money. Medicaid becomes a bigger portion from a rebate perspective and so forth. So you have opposing factors, so to speak, or dynamics. I see. Just to put it in perspective, Oxtellar XR, Trokendi XR are on the market for 10, 11 years. They're in the 55%-57%, 56%. Got it. Got it. Okay. And earlier in the year, you suggested for 2024, sales of Qelbree maybe could be $200-$220. It's not official guidance, but maybe it could be within that range. Are you still comfortable with that "soft" commentary? Yeah, I mean, given the strength of the Q1, what we saw in the first quarter and what we're seeing so far in the second quarter, we're still comfortable to be within that range somewhere. Yeah. Great. Then, okay, so sales just should continue to grow this year. Ultimately, several hundred million dollar opportunity for Qelbree. Shifting gears to GOCOVRI, which is another growth driver. Q1 was a little lower than expectations. How confident are you that it will return to growth in Q2? And what's also the peak sales opportunity for this drug? Yeah, this year, we saw a couple of dynamics at play in the first quarter. The typical one you always see, which is the Medicare, the pressure on patients and the out-of-pocket expenses. But another factor, which was interesting this year, is that many of the patient assistance funds have closed or dried up. And therefore, patients who used to resort to these funds for the extra help in order to counter some of the out-of-pocket expenses didn't have that avenue. And therefore, interestingly, coincidentally, at the same time, we saw a significant spike in sampling by physicians, about a 42% increase in sampling in the first quarter, which really tells us, basically, physicians were using the samples to bridge these patients so that they can go over the hump and get to the point where they can get the coverage later on. Actually, early in the second quarter, we started seeing a bounce back in the refills and the prescriptions. So we're very optimistic, hopefully, that we get the full recovery in the second quarter, but that remains to be seen. But it looks like this is a dynamic that may end up repeating itself from a Q1 phenomena perspective. I see. And then overall market opportunity? I mean, overall, GOCOVRI is a very solid brand. Its positioning in the market is very unique. No other product is indicated for dyskinesia and OFF episodes. So we continue to execute as far as its positioning. And the message continues to resonate with a lot of the physicians out there. So there is no reason for us not to see the growth or expect the growth to continue. Great. All right. So maybe we'll move on to your pipeline. Recently, SPN-817 for epilepsy. You reported some phase II initial data set. Do you want to walk through what you saw, how many patients, study design, anything you want to emphasize that gives you the confidence you have something here? Yeah, sure. What we're referring to here is an open-label exploratory study. So just to make sure upfront, we explain that and give the framework. It's about 40 patients, 41 patients that got enrolled. We reported interim results very recently. Overall, very briefly, I mean, this drug seems to be so exciting from an efficacy point of view, showing at 3 mg-4 mg b.i.d. seizure reduction in the 70%-80%. It's really incredible. In addition to that, the responder rate analysis that we have so far, I mean, we've been in epilepsy for 30-some years. I've never seen those kind of numbers where 80%-100% of patients, depending which way you cut the data, are seeing a response of 30% or more. Still in the 60%-80%, seeing a 50% response or more. And in the 19%-27%, seeing a 75% reduction or more. I mean, these are really high numbers. Early on, clearly, that is very encouraging to us. In addition to that, as a reminder, 817 is an acetylcholinesterase inhibitor. So this is the first time anybody develops this mechanism of action for epilepsy. We are focusing on treatment-resistant seizures. And clearly, when you have people who are resistant to treatment, you don't want to give them the same mechanism as the stuff they've been taking. So you want a unique mechanism of action. And it looks like this mechanism is truly adding some huge incremental value above what they're taking. And finally, given that it is an acetylcholinesterase inhibitor, the pro-cognitive effects that we were able to see, although in a very small study so far, are very encouraging. We used a specific tool that actually has been designed and validated to track the cognitive decline or cognitive side effects specifically of epilepsy drugs. We were measuring the other side of it, which is improvement. We saw that 80% of our patients from whom we had data at that time either unchanged or improved. Let me highlight the fact that here, unchanged is actually a big deal in this patient population because these patients, unfortunately, over time, always witness cognition, decline in cognition. Even unchanged is actually a progress. Very, very encouraged about that because at the end of the day, the profile, if that's what continues to be the profile for this drug, this is a very highly differentiated drug. As far as tolerability, we did encounter the nausea, the vomiting at very high levels, especially in the titration phase, which we would expect. We did have an antiemetic use that we encouraged physicians to do it, but they really didn't do it as well and as they should. They basically told their patients, "If you get nausea, take it." Well, it's too late at that time. You really have to take it at the beginning, beginning of the titration. So we're putting new measures into the phase II study as well as the phase II-B to incorporate the use of antiemetics. As well, we have a couple of other strategies. We're not able at this time to disclose what they are to really counter these GI side effects. And to keep it in perspective, when you look at the epilepsy landscape, I don't think there are too many drugs that are very clean in this space, unfortunately. And they all do have some side effects. I mean, we know for sure, for example, on oxcarbazepine, which we have Oxtellar XR. You look at Trileptal, the immediate-release product, has 40% diplopia and blurred vision, 50% dizziness at the high doses. I mean, patients, unfortunately, go through a lot of these side effects. And typically, especially with the cholinergic side effects like 817, what we see is that patients, as they go through the titration, they go over that hump, they tend to end up developing tolerance for the drug, and these side effects will go away over time. So our challenge, our opportunity here is clearly to get as many people through the titration phase, get them to the 3 mg-4 mg b.i.d. And once we get them there, the data actually is very strong on tolerability, only 2.4% discontinuation because of AEs. So we just need to get them through the titration phase. We'll use these several strategies, mechanisms. We feel very comfortable. We can get to a very good place. Are we going to get it to zero? Of course not. I mean, there is no such thing. But certainly, by reducing it from the 40%-48% that we saw in titration to a much more reasonable level, I mean, we have a drug that we believe is a game changer in the space. Yeah. And just to be clear, I mean, patients who ended up with the lower dose, it was still pretty good seizure reductions. Is that right? Oh, absolutely. I mean, if you look at the totality of the data across all doses, we still had in the 54%-58% in the maintenance period seizure reduction. I mean, by any definition, that's a very competitive profile on its own. You're absolutely right. Right. And you mentioned how all epilepsy drugs are dirty. And when I think drugs like Aptiom, Vimpat, they're still doing hundreds of millions in sales. Oh, yeah. No, I mean, Trileptal, the product I mentioned, was in the $500 million-$700 million. That's 15 years ago or 20 years ago in those dollars back then. Okay. So we have this data set on hand. You haven't shared all 40 yet. When exactly are you going to share the next data set? Yeah. So we still have a few patients that are still going through the maintenance period, finishing up. And we're collecting all that data. So it's going to be in the second half. I'm hoping, I'm hoping, not promising, that we could give it in August maybe, but that might be a stretch. So if we don't, nothing wrong. It's just we couldn't get it or the patient didn't finish by then in time for us. So in the second half, we'll report on the full set of data. Now, in the meantime, we did say that we are extending the open label extension. We're extending it further to add more or extra patients so we can study the couple of strategies that we are exploring to minimize nausea, vomiting, and so forth. That we won't have data to share and we won't share. That will purely be to explore it and to improve the design of the phase II-B study, which we will be starting before year end. I see. And so again, the initial data set, I believe, was around 20 patients. The next data set might include up to 40, or it should. But do you have any idea how many of those remaining 20 will have completed the maintenance phase? When we reported the results, I forgot the date, in May, we had, I think, somewhere between nine and 12 patients left that are still in the study at different stages in the study. So that's what was left from the total 41 that got enrolled. Got it. Got it. And eventually, do you think you can share the seizure freedom rates in this blinded? Oh, absolutely. I mean, the seizure freedom, and thanks for bringing that up, actually. I mean, you need more time, obviously. As time goes on, you'll have much more solid data on the seizure freedom. A lot of it happens over time, not necessarily from day one. We were very encouraged what we reported on two patients who were in the OLE, in the open label portion of the study. One of them was at 91% seizure reduction and became completely seizure-free. To clarify, and I know companies use different definitions of seizure-free, our definition is zero, not maybe one in six months or maybe one in three months. I mean, we take the most conservative definition. That patient became completely seizure-free and has been for the last seven weeks. So it's really lasting. The second patient is at 86% seizure reduction and hasn't finished that portion of the study yet. So two out of eight or two out of 16 who were in the maintenance. So it's really somewhere between 12.5%-25%, basically. But again, small numbers at this point. Hopefully, as time goes on, we can add more and more disclosure around that. Right. Maybe we can put this into perspective. The data you have shown, again, 3 mg-4 mg doses in a 70%-80% range. I mean, ultimately, once you start up the phase II-B placebo-controlled study, I mean, what do other drugs show on seizure reductions? I mean, typically, over the years, we've seen somewhere in the as low as 8%, 7%, whatever%, all the way up to maybe 15%. Some of the highest Oxtellar had 11%. Oh, it is seizure freedom. Seizure freedom, that's right. Seizure freedom, yeah. Seizure reduction, however. Oh, seizure reduction, I mean, if we continue to be in the 70%-80%, that is just incredible. But again, even the 55% or 58% or whatever the number ends up, that's a very competitive profile. You have products on the market that were a billion-dollar or even more with seizure reduction of 35%-45%, just to put it in perspective. Yeah. Is this phase II-B going to be designed as a supporting pivotal study if it was positive? We would like to be able to do that. So we'll see where we land on it at the end of the day. But that would be the idea behind it. But we may end up having to do two phase III studies anyway because we needed a full package of about 1,200 patients for the NDA. So we'll see where we end up as far as the number of patients in the development program. We'll move on to SPN-820 really quickly. It does have phase II-B data in treatment-resistant depression. Was it, remind me, first half 2025? Yeah. For 820, we have the phase II-B study in TRD. And that data, we're looking at first half of 2025, which is, my goodness, we're already halfway through 2024. So that's not too far out. Very exciting program, novel mechanism. And we do have as well going on right now, as we speak, an open-label phase II-A study on that molecule in MDD. So there is a potential. I'm not going to promise that, but there is a potential. We might see data before year end. Depending on how quickly it recruits, we're looking at 40-50 patients in total. So it's not a huge study. And it's looking at a single dose, 2,400 mg with intermittent flexible dosing. So we're giving one single dose every three days at the high level, which is 2,400 mg. The rationale behind that was basically what we saw back then in the phase I-B study, where the product had an effect, sustainable effect size through 72 hours with one single dose when that was studied back then. It's a different design, but it's also in a different area, which is MDD, because eventually, we want to maximize the potential, of course, of this drug as we develop it over time. I see. And as for the TRD, I think you said, what was it? You're over 50% enrolled. So I think by my calculations, like 134 patients left, something like that. How confident are you we will get the data in first half 2025? I mean, we have a really good chance to finish enrollment this year. The key is now we're focused on completers, number of completers. So yes, 268 or 267 was the total target randomized number of patients. But we had made assumptions of discontinuations and dropouts. And so far in the study, we've seen much lower rates than our initial assumption on the dropouts. So we may have more completers at this stage than we expected. And therefore, we might reach the 200 completers much quicker. So that remains to be seen. But so far, it looks encouraging from that point of view. I see. Okay. And then maybe a last question or two is you also have this program, The Apomorphine Pump, which unfortunately received a CRL recently. So I think you wanted to meet with the FDA in May. Did you meet with the FDA? And what did you learn? How do we get this resubmitted? Yeah. We just had very recently the meeting with the FDA. We're very excited. We're going to file it as soon as possible. We did ask the question, which is, is it going to be Class I or Class II resubmission? FDA basically told us, we don't know. We'll let you know after you submit. They wouldn't commit one way or the other. I think they want to see the package and how long it's going to take them to review it. Now, given the scope of the CRL, which was much smaller, obviously, than the previous CRL that we got, we hope they can do it in two months. That remains to be seen. At this point, we don't know. Any idea when you want to resubmit? As soon as possible. Okay. All right. I think that's all the questions or all the time we had. So thank you, Jack, for sharing these.