Okay, good afternoon, everyone, and welcome to day two of the 36th Annual Piper Sandler Healthcare Conference. This is David Amsellem from the Biopharma team. We're delighted to have Supernus with us and Jack Khattar, CEO. Thanks so much for joining us and lots to talk about. I'm actually going to lead off the discussion with the pipeline because there's quite a lot of news flow in the not too distant future and just a lot going on in terms of your R&D activities. Maybe as a starting point, there's SPN-830. You have FDA action coming up in Parkinson's. So just give us a quick refresher on the regulatory journey here and what was in this latest NDA resubmission. Yeah, sure. Good afternoon and thanks for having me, and just to remind everyone, I'll be making forward-looking statements, so please check our SEC filings for all the risk factors associated with the business, so regarding the infusion device, which is SPN-830, we had a CRL, the last CRL we had. It was down to a couple, really a couple of areas. One regarding the product quality on which we had given the FDA some data that they hadn't had time to review it by the time the PDUFA was due. And then the second issue was more related to the Master File, which is more a device-related issue, so we think we have a very good handle on it because since then we've addressed these issues. We had a meeting with the FDA actually to make sure we have addressed everything they're looking for, and that's why we did the resubmission. So we feel very confident today, a little bit more confidence than last time, and hopefully this will be it for us and we'll get the approval on February 1, is the PDUFA date. We are gearing up for launch in the first half of 2025. So this is a product which we believe will be a tremendous product for us in our portfolio. Peak sales $200 million-$300 million, maybe a little bit on the conservative side, but we think this will be a very great asset for us. Fits very well with the portfolio clearly because of our leading presence in the Parkinson's space. So we're very optimistic. Can't be 100% sure, of course, until you get that letter in hand that says approval, but everything points in the right direction at this point. So AbbVie got the approval of their device. It's the continuously infused levodopa-carbidopa prodrug called Vyalev. I'm not sure how you pronounce the trade name. But can you talk to how that might read through to your filing on 830, particularly in terms of the device component? Because that was also a multi-cycle review. Yeah, I mean, every case is obviously different and has its own circumstances and so forth. I mean, the division interestingly went through a period of time issuing CRLs to everybody, not just us and AbbVie, even Mitsubishi and Amneal and so forth. Now they're issuing approvals and hopefully they're on a streak with approvals and so forth. Now, as far as the products are concerned, I mean, the AbbVie pump is slightly different, of course, from a design usage. The drug itself is obviously a different drug. Ours is apomorphine, theirs is levodopa-carbidopa derivative and so forth. So we believe there is enough room for both products, no question about it. As far as the efficacy is concerned, they're pretty close. You're really very close as far as the efficacy. There are some differences on the tolerability side, some differences in the usage, ease of use. So we'll see how things pan out as time goes on. You do have KOLs who believe they might want to continue with levodopa carbidopa and therefore use a pump like the AbbVie pump, or some KOLs might say, "Well, my patient has been on levodopa carbidopa for so many years, maybe it's time to add something different like apomorphine, which is a very efficacious drug." But overall, we will be building together, I mean, a new segment in the marketplace that doesn't exist today. And two players is better than one with market education, educating KOLs on the type of patient who would be a good candidate for this product and so forth. Is there going to be significant need for incremental commercial infrastructure or do you have existing resources that you can allocate to 830? This will be a complete plug-in. Already, the infrastructure we have, the sales force will take priority. It will be for the pump. It will be our top priority. Gocovri will be the second priority. Those will be the Gocovri team. With that sales force. And the hub services, the nurse services, all that is in place. So yeah. Okay. Now you do have Apokyn, and so one question, I remember when you made the acquisition, I mean, this was a WorldMeds, this was sort of a question that a lot of people had, but I'm kind of revisit it, is what's the extent to which the availability of SPN-830 could cannibalize Apokyn to some degree? Yeah, I mean, depending on the label for the pump and the kind of patient eventually that KOLs will end up using the pump for. Now, initially, and this is based on the experience we've seen in Europe because the pump has been available for years, initially it will probably be for more severe patients that the pump will be used for. Apokyn today is used more on the moderate side, maybe some even mild, but mainly moderate patients that use Apokyn. Now, if you have a patient that takes, let's say, four or up to five injections a day, that could be a patient that might consider the pump instead of doing four or five injections a day of Apokyn. So the short answer, we've always talked about maybe 10%-15% cannibalization of the Apokyn business might end up shifting to the pump because of the patient type. Okay. Let's switch gears to 817 so you recently had more data in adults with focal onset seizures that you discussed on your call. I'm particularly interested in tolerability here and how you're approaching minimizing nausea and vomiting in the next stage of the phase IIa study. Yeah, in the open label, we did recommend to physicians to use an antiemetic because, knowing obviously potent acetylcholinesterase inhibitors, that's a very expected AE. So we knew we're going to be up against nausea and vomiting and so forth. Unfortunately, not too many physicians used it as was instructed, and if they did use it, they use it way late in the game, meaning the nausea already has come up. Some patients already discontinued, so it was too late for them to use the antiemetic. So one of the first strategies we're using is with the phase IIb, which we are about to initiate before year end, we're going to be requiring the use of antiemetic from the beginning and the titration. So we minimize discontinuation during the titration period. Secondly, we're looking at potential different formulations that could also help with the side effects. Obviously, as you probably know, we've done this for many years now on the drug delivery side, reducing side effects through PK, different formulations. So we're exploring that as well. And we are employing a third strategy that we're not ready to talk about yet that could also help with the nausea side of it. We're exploring these things in the current phase IIa study. We have extended it, and we call it a Stage B or Cohort B. So as we start the phase IIb in parallel, we're exploring these strategies. These strategies are in an open label setting. So as we learn from that, we can amend the protocol for the phase IIb as time goes on. So instead of losing time, we're going to initiate the phase IIb as is with the antiemetic. Looking at the other strategies, we'll incorporate any learnings from the open-label into the phase IIb as time goes on. How are you incorporating antiemetic usage into the phase IIb? I mean, is that a use as a rescue? Is it used as dosed at least for a certain defined period? Help us better understand how that's? It's really co-administration from the beginning. If you wait for a rescue, you're too late. Yeah, yeah, yeah. People are going to quit before you get the chance to keep them. And we've learned from the open label that if people go through the titration, they actually stick with the drug through maintenance because discontinuation in the maintenance period was only 7%-7.5%, which was very reasonable for an epilepsy. I mean, unfortunately for patients, a lot of these epilepsy drugs already on the market and have been on the market have very nasty side effects. So even putting it in perspective, I mean, our side effects are not amazingly great, but in the perspective of epilepsy drugs and so forth, they're not really terrible either, right? So we can manage through them, and we think given the potency and the efficacy of 817, that is something that we can manage very well eventually. Do patients need to be on an antiemetic through maintenance, or does the nausea and vomiting just tend to attenuate and it's really just to get them through the titration period? Our belief at this point is just to get them through the titration. Now, we did have some patients who got it through the maintenance. So maybe after the titration, they can use it as needed or as they feel it's coming up. So it might be, but it will taper off. The need for an antiemetic should taper off over time as they get and build tolerance for the drug. So walk us through the dosing of active drug in the phase IIb for 817. And then secondly, how should we think about the timeline to get the study enrolled and basically timeline from initiation to top line results? Yeah, from the open label, we learned that the three milligram or four milligram twice daily is the dose that we need to hit to give us the really strong efficacy we got from the study. So these are the two doses we're testing and we'll be testing in the phase IIb. So that's the target dose at this point. And as far as enrollment, I mean, epilepsy studies are not like your fastest enrolling studies typically. So I mean, we don't have a timeline yet until we start seeing recruitment and rate of recruitment and so forth. But I mean, this is not a study that's going to read in nine months or 12 months. It might take a little bit longer. It will be multi-site. It will be multi-country. Most likely that's where we are at this point, and we're about to initiate it. So remains to be seen clearly from that perspective, but that will take some time. Okay. And can you give us color on the number of sites that you're planning to activate and also the mix between U.S. and ex-U.S. sites? I mean, the sites are going to be probably 30 plus sites as far as the number of sites. Clearly, that changes over time. We may have less or we may need more as we monitor recruitment and the speed of the recruitment, and we'll try to balance it between North America and Europe. Typically, FDA would like to see a good portion of patients in North America versus other countries, so we'll do that in conjunction with that. Okay. So let's move on to SPN-820 in treatment-resistant depression and also major depressive disorder. So we have seen some open label data in MDD. We're going to see randomized treatment-resistant depression data next year. I guess one question I have is on the dosing. How is the dosing in the treatment-resistant study different from what you're evaluating in the open label MDD study? Yeah. The way this product has been developed and the progress of the development ended up where we ended up with the open label different dosing than the TRD that's going on right now. Initially, the innovator, Navitor Pharmaceuticals, tested the single dose over 72 hours. And that was very similar design to the open label that we just issued the data on, which was 2400 milligram day one, and then you dose day four, and then you dose day seven, and so forth. And so we duplicated that experiment, so to speak, and we got very good data, again, very consistent with what happened in the phase Ib. In the meantime, we had designed the phase IIb study in TRD with daily doses. So this is now daily of 1600 milligram, potentially to 800 milligram if you need to titrate down. Okay. We based these doses on the SAD and MAD studies that we have done post the phase Ib study. We didn't see the need to even go to 2400 on a daily basis, right? When we started the phase IIb, which was initiated way before the phase IIa study, we said, "You know what? The IIb is enrolling slow at the beginning, if you remember, was enrolling much slower than we expected. We really would like to get data as soon as possible on this molecule to see whether this mechanism even works in depression. Therefore, let's do this. Let's try the once a day, once per day dose every three days, and let's do it in MDD. Like this, we can learn even more in another indication, not just TRD. So that's how the thinking progressed over time as far as the development. That's why we did the open label. Sure enough, we were able to get data ahead of the phase IIb and learn even more about the drug. At the end of the day, we're going to look at collective data, both IIa and the IIb studies, and then we'll determine should the phase IIIb lead indication be MDD or TRD? What is the best dosing regimen? I mean, they're consistent in a way because if you think about it, 2,400 milligram single dose every three days is the same as 800 every day, right? In a way, right? So they're not widely different, but they are different. We'll determine all that once we have the collective data moving forward. I mean, I guess the question with you have a phase IIb, it's randomized. So if you do see separation, I mean, theoretically, the next step would be to go into a pivotal. Would that make the most sense? No, I mean, ultimately, I mean, that's clearly the next step. So we will be working very quickly towards an end of phase II meeting with the FDA, share the plan with them, and get into phase III as soon as possible. And eventually, I mean, the drug, we foresee it to be developed for both MDD, TRD, and even maybe other indications. Okay. What other indications? I mean, do you look at, say, bipolar depression, for instance? Do you look at even outside of the. The usual suspects. Usual suspects. That's right. Okay. So wanted to switch gears now and ask you about capital deployment. You get this question all the time, but I got to ask it anyway. So you've got the neuropsychiatry infrastructure, commercial infrastructure that you can leverage, and then there's pipeline. You have a clean balance sheet. So I guess all that in mind, how are you thinking about M&A or I guess what kind of assets would make the most sense? Either commercial stage or development stage or a mix of both? Yeah, I mean, the next immediate product launch we have is hopefully the infusion device, which is 2025. Sure. After that, I really don't have anything in my pipeline that could be launched in like, say, 2026 to 2028 or 2029, depending on how quickly we can finish 820 or 817, right? So ideally, we would like to acquire some asset that could be launched in that timeframe, the 2026, 2028 timeframe, which I don't have today in my pipeline. So that would be one of the things we're looking at. In addition to the fact that if we find something already commercial, we will always prioritize that to further diversify our revenue base and bring in more cash flow. So I mean, we are sitting in a very nice position right now, clean balance sheet. We continue to add to our cash position, which is $400 million plus at this point. So we have a lot of flexibility. But we also continue to be disciplined and selective in what assets we bring into the portfolio. Yeah. So if I'm hearing you correctly, it sounds like something that's a late-stage asset or market-ready would make more sense. That would sort of fill in any potential gaps in. Or anything in phase III or about to finish a phase III somewhere in that range. Okay. Is there sort of a net leverage, pro forma net leverage number beyond which you would not go in the transaction? I mean, ideally, I wouldn't like to go above 2.5, a multiple of EBITDA. I mean, that's, but it all depends on the assets we're acquiring. I mean, if the assets we're acquiring have very strong cash flows that could support such a leverage, then absolutely, we don't want to dismiss something like this. But theoretically, fundamentally, we like to stay financially a very sound company and don't take undue risks from a financial perspective. Does it have to be a neuropsychiatry asset or becoming therapeutic? No, it doesn't. I mean, actually, we have made bids on other assets outside CNS over the last couple of years. So we are open to other areas where we can be very effective and efficient in running the business, other specialty therapeutic areas. But in those situations, ideally, it's not one asset. It's a multi-asset situation because if you're going to build presence in, I'm just going to throw out examples, dermatology, ophthalmology, urology, whatever it is, you need more depth than just one product, clearly. But it sounds like you could leverage the patient hub, the hub that you have in place for Gocovri that you're going to use for 830. That's something you could leverage for another, say, rare disease asset. Absolutely. I mean, rare disease is also in the mix of all that. Absolutely. Okay. Let's talk about Qelbree. And I guess this is something that's timely because we're sort of at the end of the back-to-school season. So what are you seeing here in terms of the back-to-school period? And just talk to overall demand trends outside of pediatrics in the adult setting. Yeah. I mean, Qelbree's had a great year so far. I mean, the first nine months, prescriptions grew by 25%. And actually, the back-to-school season has been a very strong season. Just give you an example. I mean, in the May, June, summertime, we were looking at weeklies of 13,000 prescriptions, give or take. In the September, August, we were even up to 16,000, and the most recent was 17,200. So we're really happy with the back-to-school season, the growth. It's been one of the strongest. And the momentum hopefully will continue into the fourth quarter and then into next year. I mean, the product is still, we're only scratching the surface as far as the potential growth of this product. The market is about 100 million prescriptions, will be 100 million very soon, and we're not even scratching the surface as far as penetration. We're very happy with the momentum behind Qelbree. In addition to that, on the gross-to-net, we've really made significant progress on that end. And our payer strategy has really paid off pretty well in our discipline as far as to how we contract with PBMs and so forth. So we're pretty pleased with that and the success of the product. And we continue to grow in both segments, pediatric and adult. Actually, pediatric continues to grow very robustly. Despite our efforts in growing adult, the mix hasn't changed as much. But that's a good problem to have because we're growing the adult in a very healthy, robust way, but pediatric continues similarly to grow, and therefore the mix is not changing yet. What is the mix between adult and peds right now? Well, right now, the mix is 32% adult and around 68% pediatric adolescent. And the market is actually reverse of that. But we don't expect Qelbree to mirror the market because the market, 90% of it is stimulant. We have non-stimulants. So naturally, we're not going to be the same makeup. But adult is a very important segment for us to continue to push through it. We're finding, of course, the female segment is a very important segment as well within the adult. And we do a lot of DTC and through social media, digital channels, direct-to-consumer efforts in growing that. To be clear, you're seeing growth in both peds and adolescents and adults. That's right. Okay. Going back to your comments on the gross-to-net, I mean, I know it's narrowed considerably, but how should we think about the gross-to-net in 2025? Yeah. I mean, for this year, we adjusted our target to be in the 45%-50%. Now, as time goes on, we all know gross-to-net always gets worse, inches up over time because of the increased rebates that are always being requested by PBMs. So therefore, we would expect that to continue, and maybe we'll get closer to the 50% as time goes on. We'll see where the fourth quarter is, and then we'll give an update in February when we give guidance for 2025. But it's more likely going to be more towards the 50% range. Got it. In terms of competition, we're going to see data for Axsome, Solriamfetol, and then I think in the first quarter in adult patients, and I guess maybe more broadly, how are you thinking about the entry of another brand, non-stimulant, whether it's Solriamfetol, whether it's another agent, how that could impact Qelbree over time? I mean, the segment itself, non-stimulant, is still the smallest segment, 10%-12%, give or take. So there is still a lot of room for us, meaning all of us, whoever comes into the space, to grow the non-stimulant market. So I always look at competition in both ways. Yes, it may hurt you a little bit initially, but it may also help you in a lot of ways. So two or more players talking and pushing non-stimulants, and there is no need, and it's not necessary to put every kid on a controlled substance. I mean, that's not a bad thing, clearly, and we all know not every kid needs and should use a stimulant in general. So there is a lot of positives that could come in. At the end of the day, it's really their data versus our data and how the two products will end up comparing. Looking at the sales organization for Qelbree, I mean, you've had some expansion. Can you just talk about what the size is right now, the headcount? And then are you planning any more expansion down the road? Yeah. Right now, we're, give or take, depending on the quarter, around 240 reps. We're pretty comfortable with the footprint right now, so we don't have immediate plans to further expand. We just expanded about, I don't know, 12 months ago or something like this. So we like to see the return, see how that goes as far as the expansion before we make another decision to further expand. So for now, we're pretty happy with where we are as far as the footprint. And just in less than a minute we have left, just any update on early stage pipeline and what milestones or events we might see on some of the early stage stuff over the next 12 months? Yeah. I I mean, real early stage, SPN- 443, if you remember, we had highlighted it a little bit at R&D day. We just finished the first-in-human study, actually, which is a great milestone for us. That's a molecule completely from our discovery program. That molecule, we will announce the lead indication probably at some point next year, but it could be ADHD, potentially other CNS indications. So we haven't decided on that yet. So we're very excited about it. The first-in-human study went really well. The dosing has completed. And we have other things that we're actually creating a lot of different new chemical series, different products in the pipeline. Okay. Looks like we're out of time. I'll leave it there. Thank you, Jack. Thank you, everyone in the audience.