I think we have some slides to go up as well. There we go. Great. Thanks everyone for being here. It is a pleasure to be here with Vanda Pharmaceuticals. We have Kevin Moran, the CFO, who is going to do a quick presentation and then we will jump into Q and A. Thanks for being here Thanks for h aving us, and thanks to the Stifel team for having us here this week. I'll give a brief overview of Vanda and our products before we jump into some Q and A, but Vanda is a leading global biopharmaceutical company dedicated to innovating in the service of people's pursuit of happiness. We have three commercialized products. We have Fanapt, which is approved for bipolar disorder and schizophrenia in the U.S. We have Hetlioz, which is in both the capsule formulation and the liquid LQ formulation that's approved here in the U.S. for non-24-hour sleep-wake disorder in adults, as well as nighttime sleep disturbances in patients with Smith-Magenis Syndrome, both in adults and the pediatric patient population. Hetlioz is also approved in Europe for non-24-hour sleep-wake disorder in adults. Our third product is Ponvory, which is approved in multiple sclerosis and was acquired from Johnson & Johnson at the end of 2023. In addition to those commercialized products, we have a robust pipeline with a number of recent and upcoming regulatory submissions and we are in a very strong financial position with approximately $294 million in cash and no debt as of the third quarter of 2025. In a bit more detail on our commercial products, as I mentioned, Fanapt is approved in the U.S. for bipolar disorder and schizophrenia. In addition to that product and those indications, we are pursuing FDA approval for Basanti, which is the active metabolite of Fanapt for the treatment of adults with bipolar disorder and schizophrenia. Our NDA has been accepted by the FDA. We have a PDUFA target action date in February of next year, February 2026. In addition to that, we have a phase three program underway for major depressive disorder where we expect results in 2026. Finally, on the Fanapt side, we have a phase three program underway for the long-acting injectable formulation of Fanapt, where we're currently enrolling patients. On the Hetlioz side, as I mentioned, Hetlioz is approved in the U.S. and in Europe for non-24-hour sleep-wake disorder and approved in the U.S. for nighttime sleep disturbances in Smith-Magenis syndrome. We continue to pursue FDA approval for Hetlioz in other indications, the most proximal of which is we have a re-review of the jet lag SNDA with an FDA decision date expected by January 7, 2026. On the Ponvory side, as I mentioned, it's approved for multiple sclerosis. In addition to that, we are pursuing other indications of psoriasis and ulcerative colitis. On our strategic focus, we remain focused on growing our revenue both organically through existing products, but also potentially through business development opportunities where those could be synergistic and potentially accretive. We remain focused on advancing our pipeline, both as I mentioned, with the upcoming clinical and regulatory milestones that we have as well as our early stage programs. We always remain focused on our consumer and that is increasing access and affordability for patients and engaging directly with consumers wherever possible. Upcoming commercial priorities and milestones, we remain focused on the commercial launch of Fanapt in bipolar I disorder. The reminder there is that that was approved in April of 2024 and at the time of approval we had a sales force of approximately 50 sales reps. We increased that to approximately 150 sales reps by the end of 2024 and around the middle of this year, at the end of the second quarter, beginning of third quarter, we increased that further to approximately 300 representatives detailing Fanapt in the U.S. We remain continued to focus on the market for schizophrenia where, sorry, Fanapt has been approved for some time and then we continue to move forward with Basanti where we're expecting our PDUFA decision, you know, February 21 and then would move towards a commercial launch sometime thereafter. On Hetlioz, where generics have now been in the market for a little less than three years. We remain focused on retaining our market share despite this competition through a focus on patient loyalty. We continue to focus on growing Hetlioz in the SMS market in the U.S. where the generics do not have that indication on their label. As I mentioned, we continue to pursue other indications for Hetlioz, the most proximal of which is the jet lag indication where there is a re-review date by the FDA of January 7. On Ponvory, our commercial launch of Ponvory in multiple sclerosis is proceeding well. We most recently commented on the Q3 earnings call that we have seen increased underlying patient demand between both the first and second quarter of 2025 as well as the second and third quarter of 2025, and then in addition, tradipitant where we have our upcoming PDUFA date on motion sickness of December 30. We are highly focused on as well as continuing to pursue FDA approval for tradipitant in patients with gastroparesis as well as our upcoming phase 2 results on tradipitant in nausea in patients taking a GLP-1 on our upcoming milestones. As I mentioned, we have a clinical study of tradipitant in the prevention of vomiting induced by a GLP-1 analog. The study is complete as of the end of our third quarter earnings results and we expect results in the fourth quarter of 2025. Our NDA for motion sickness is under review and we have a PDUFA target action date of December 30th of this year. Our Imsidolumab Biologics License Application or BLA in Generalized Pustular Psoriasis or GPP is expected to be submitted to the FDA by the end of the year and we would expect to receive a priority review which would likely give us a PDUFA date sometime around the middle of next year. The FDA is currently conducting a re-review of our Supplemental New Drug Application or SNDA for Hetlioz in jet lag disorder and we expect them to complete that re-review by January 7th of 2026. On Basanti, our NDA for bipolar and schizophrenia is under review and we have our PDUFA action date of February 21st. Finally, on upcoming milestones, our Basanti phase 3 clinical study for major depressive disorder is enrolling patients right now and is expected to have results in 2026. Maybe finally before doing some Q and A, this is an overview of our late stage clinical development program. In addition to the commercial indications that I already mentioned, Fanapt, we have our long-acting injectable formulation that's currently in a phase three trial where we're actively enrolling patients. Again, our Basanti application has bipolar I disorder and schizophrenia under review with the PDUFA target action date in February, and in addition, our phase three program underway for MDD, a number of indications that we're continuing to pursue, but again the most proximal of which is the jet lag disorder FDA re-review that we expect to be completed in January. On Ponvory, we're continuing to move forward with our phase three programs in psoriasis and ulcerative colitis and then on tradipitant we have our upcoming motion sickness PDUFA date of December 30 as well as our phase 2 readout expected in the fourth quarter on the vomiting induced by a GLP-1. Finally, on Imsidolumab, we've got our upcoming BLA that we expect to be in by the end of this year. Maybe with that I can actually—maybe one last thing before jumping. I'll go to the financial results real quick and then we can do Q and A on the financial results. Our 2025 guidance is total revenues of $210 million-$230 million. Our guidance also includes ending the year end 2025 with cash of $260 million-$290 million. Our Q3 2025 revenue was $56.3 million. consisted of $31.2 million of revenue from Fanapt, $18 million of revenue from Hetlioz, and $7 million of revenue from Ponvory. Maybe with that we can do. Some Q and A. Yeah, awesome. Thanks for that, Kevin. Yeah, so maybe we can start on Basanti in, you know, Fanapt. And so I guess we're like with Basanti first on the PDUFA, you know, obviously, you know, I think there's an interesting sort of question or dynamic where the data you've generated is like bioequivalence data and it's. But it's going through the FDA as kind of like a full, you know, NDA, not a 505B2 pathway. Right, correct. Maybe just kind of like talk a little bit about that, kind of why that's the path that the FDA kind of like wants you to go through and just your overall confidence and kind of approval there's. Yeah, absolutely. Maybe for a bit of the background here on kind of how the dynamic has developed over the last 18 months or so. Last year we disclosed that we had discovered that Basanti, the active metabolite of Fanapt, was bioequivalent to Fanapt. With that discovery in hand, we went to the FDA for a pre-NDA meeting and said, hey, we think we have the data necessary to submit an NDA and got their feedback. As part of that, we then submitted our NDA, which we disclosed earlier this year was accepted by the FDA for review and they gave us a PDUFA date of February 21, 2026. As part of that disclosure, we noted that there had not been any review issues identified by the FDA as part of that acceptance. Typically what we've seen in other applications that we've submitted is that there generally are review issues that are identified as part of the acceptance both for applications that were ultimately approved and for applications that were ultimately not approved. The fact that there were no review issues identified at the time of filing was obviously an encouraging development for us that we disclose as part of the disclosure of the acceptance. From there, as we've kind of moved through the year and provided additional updates, we've said that the review, you know, is proceeding as we would have expected. You know, at this point we know we're past the mid cycle review and again, it's proceeding as we would have expected. In terms of the comment or the question around the pathway being 505,1 or 505. When we went to the FDA for the pre-NDA meeting as part of that discussion, we sought their input on whether we should file under 505(b)(1) or 505(b)(2), and they requested that we file under 505(b)(2). Obviously, given the preferences between a 505(b)(1) or a 505(b)(2), we took their advice and filed as a 505(b)(2). The expectation there would be that if we received approval in February, that would come with the five years of exclusivity at a minimum, and then we'd have other patents that go up beyond that that would be subject to future decisions about how those are ultimately protected. Yep, yep. Okay, makes sense. Yeah, I guess kind of like on that point, how much do you think Basanti extends sort of this franchise? Like, what's sort of the expectations on the IP front? Yeah, absolutely. As it is right now, the reminder there is that Fanapt has exclusivity likely through about the end of 2027. With Basanti potentially receiving an approval early next year, that could, with the five years at a minimum, take us through the end of the decade. We have patents that go out into the 2040s. We have been very consistent in our assertion of our patents both on all of our previous products, including Fanapt, where the NCE on Fanapt went through 2016. We have extended that, you know, that IP through the end of 2027, as I mentioned, in terms of our confidence level in the FDA's upcoming PDUFA date. You know, I think we're very optimistic based on what we've seen to date in terms of no issues identified and where we've been able to proceed through the various kind of checkpoints along the way. Obviously that remains subject to the FDA decision in February. In terms of the extension of the franchise, again, we'll see where we fall between kind of the five years exclusivity at a minimum, and other patents that go up far beyond that. As we look at the opportunity, we do think of these as kind of a portfolio of psychiatry assets. That includes both the Fanapt oral, the Basanti oral, and then the Fanapt long-acting injectable formulation. We think of those collectively as kind of our psychiatry portfolio. Obviously with Fanapt, you know, coming up on an exclusivity date and the expectation that would be that Basanti carries us beyond 2027, we with hopefully the Fanapt LAI coming online somewhere near after that. The way that I'm kind of chronologically thinking about the franchise is continue to grow Fanapt, get Basanti approved, grow Basanti and Fanapt collectively while they're on the market. We've talked about this a bit, but there's also some significant price advantages to Basanti relative to Fanapt. That's due to the fact that Basanti would be a new drug application that would be entitled to a reset on Medicaid pricing. Where our Fanapt gross to net has historically been about 50% is what we've disclosed. We'd expect the Basanti gross to net to be more like 30-35% just given that reset on Medicaid. For the same volume, we could see a significantly higher net revenue. As we move into 2027 and beyond, hopefully we've got positive results in MDD in 2026, get a filing in in 2027 or so, and hopefully get that on the label soon thereafter. Finally, on the portfolio side, the Fanapt LAI phase 3 program, which we're very excited about, is underway. We're enrolling patients. We haven't provided specific guidance on the timing of results there, but generally those programs take a couple of years to run from when they are initiated. Again, hopefully, that's kind of the next leg on the stool for the psychiatry portfolio as we kind of exit those years. Yeah. Yep, that makes sense. Yeah. I guess, like, in terms of, you know, having both on the market, like, how long or, you know, what do you think the dynamics are going to shake out in terms of patients switching over to Basanti? Like, are there any sort of, like, hoops to jump through with payers or doctors? Like, what is that kind of dynamic going to look like and how long will it take to kind of play out? Yeah, I think we a lot remains to be kind of seen of how that dynamic plays out. I think that as Fanapt, you know, continues towards its exclusivity date and Basanti is introduced. One of the things that's most important about drugs in this class is sampling in the spaces for patients to get kind of a fast start on treatments when they present in doctor's offices is critical. How you navigate sampling and both Basanti or maybe at some point Fanapt as it heads towards its end, obviously it doesn't make sense to do some of these things beyond the exclusivity date. Basanti is the one where there's primary attention on that and primary detailing attention to doctors, you know, kind of a migration in the P1, P2 and you know, kind of emphasis and other programs like commercial co pay, you know, support programs. You know, that's how we see that dynamic kind of shifting as we, you know, head towards the exit on the payer side. You know, Basanti is going to be a new drug application. It's a new, even though it's the active metabolite and it's bioequivalent, it's going to be a new drug application. Currently what we've discussed is, you know, historically there's not been a lot of contracting done on Fanapt. We've basically had our statutory agreements with the states for Medicaid and have not been overly active outside of that. While that could change in the future on both Fanapt and Basanti, as a base case, my expectation would be that Basanti has pretty similar coverage to Fanapt. Just given, you know, the level of commitments that we've had in that space previously. Yep, yep, that makes sense. I guess how is this whole antipsychotic market, you know, now we have Kobenphy and other muscarinics are kind of coming behind it, like how is sort of the treatment landscape evolving and how you know, Fanapt and eventually Basanti kind of fit within that evolution. Yeah. We are very excited to see Cobenphy and other products come to the market because obviously there remains a high unmet need in the space and we want patients to have, you know, as many treatment options as possible so they can find a medication that works for them. What you see in the class, you know, very generally is that it is a very promotionally sensitive class. Products that are out there being detailed and are front of mind for prescribers and patients tend to be used more extensively than products that are not. That is not necessarily unique to, you know, some classes. You do not see the same level of promotional sensitivity. You may not be able to have as big an influence by being out there and talking to prescribers. That's one, and then two is given the nature of the products in the space. You know, unfortunately there's no silver bullet in the class. They, you know, all the drugs are good and have some level of efficacy and some level of side effect profile that may be unique to them and slightly better than some other products, but also slightly worse on a different side effect profile. It is a very high switch class. You see patients cycling through medications on a somewhat regular basis until hopefully they find a medication or a combination of medications that works for them. You know, that landscape, although, you know, again, different products are being introduced, we haven't seen a dramatic change really in how doctors are, you know, treating patients and working through these different, you know, options and trying to find the right thing for their patients. Yep, yep. No, that makes sense. Yeah, and one of the things you mentioned, obviously Psych in general is very promotionally sensitive and you guys have invested a lot more and you can see that sort of like return in terms of growth and kind of revenue. You know, as you look at your kind of balance sheet today, how much more can you invest? Like what is sort of the kind of runway to kind of further pushing investment and promotions, etc. that your balance sheet kind of allows you to do. Yeah, and maybe just first on the growth side since you mentioned it. You know, I do not know that I mentioned this, but third quarter to third quarter on Fanapt we saw 31% revenue growth, 35% underlying TRX growth. On a kind of continuous basis we have seen, you know, new highs in NBRXS and a number of other metrics. We are very encouraged by the traction that we are seeing in the, in the Fanapt space. The investments that we have made to date have been very significant. We have reached a point where, you know, those were essentially the current investments were baked into the third quarter financials in terms of our run rate. Although, you know, that is a constant evaluation that could change over time. That is, at least for the moment, a good kind of baseline of where we think about things. As we, you know, as revenue is growing on Fanapt and as we're, you know, from a cash perspective, this year, we started the year at about $375 million. The midpoint of our guidance is $275 million, so imply about $100 million burn for the year. That included a $15 million, you know, cash out the door for the in-licensing. You know, that obviously isn't a recurring expense. As we think about it, as we head forward, you know, revenue is growing, we are making significant investments that we'll have to figure out how we can, you know, right size as we head forward. We've, you know, I think we think of 2026 as another investment year. Given the number of variables that are in play, especially over the coming months with, you know, FDA decisions on tradipitant for motion sickness, FDA decision for Hetlioz on jet lag, Basanti for bipolar and schizophrenia, and then potentially not thereafter, Imsidolimab for GPP, you know, there remains a lot of uncertainty in terms of where we're going to be making investments, hopefully on all those things, obviously. You know, we'll see how the cards kind of turn over and then we'll have to evaluate things. We want to make sure that we're doing these launches well and making the proper investments in those. We feel very well positioned with the cash balance that we have now of $260 million-$290 million. Obviously it's a continuous evaluation based on your commercial performance and your commercial opportunities, which some are about to be unveiled as to are we able to take them to market or not? Yeah, yeah, no, that makes sense. Maybe one more on Basanti. Obviously, you mentioned the MDD data are coming next year. Maybe just kind of help frame up that sort of like, you know, how important that is to kind of the overall Basanti kind of growth franchise and just your overall confidence in that study. Like, is there any prior proof of concept data that you have, etc. Just kind of curious, your perspective. Yeah, yeah. When we look at the kind of the, the total, the TAM for these markets, right. And there's a number, you know, everybody's got their own kind of estimate of these. But, you know, I think universally, you know, schizophrenia is kind of the smallest, you know, maybe 3 million people in the U.S. you know, again, very. Estimates may vary. Bipolar, you know, maybe twice as large or, you know, a little larger than that and then MDD, you know, maybe 20 million. Right. You have kind of between, you know, bipolar and schizophrenia, maybe 10 million people in the U.S. and then MDD, you know, maybe 20 million people. And that's also kind of a spectrum of receptivity to marketing efforts in terms of from schizophrenia to bipolar to MDD. You know, MDD patients are generally the most receptive to, you know, marketing efforts that companies are doing. It is very important. Obviously it presents, you know, the biggest revenue opportunity within those three categories. We are very, you know, have a keen eye towards getting that trial run as quickly as possible and getting a readout. I think, you know, we are hopeful that that will be positive, we will have that in the market. Fanapt in bipolar and schizophrenia, though, represents a very significant opportunity as it exists today. We are focused on maximizing that in the meantime. In terms of the confidence level on the trial, you know, MDD in this space, you know, there are a number of other products that have run a very similar trial and had success. Right. For us, we don't have any MDD data on Fanapt or Basanti. That is kind of our, you know, you know, gives us conviction in taking it to the phase three. It's more the overall class data and the fact that others have been able to successfully run programs in the space. To that end, you know, where there's a well established program that others have run and the FDA has already opined on, you know, we're not looking to necessarily reinvent the wheel and we're running a program that I think is in line with, you know, what others have done and what the FDA would expect to see with results. Yeah, yeah, makes sense. Yeah, we saw that Capillida was successful there. Okay, great. Maybe kind of beyond Basanti, maybe we can talk about some of these other upcoming PDUFAs later this year, like, you know, motion sickness, jet lag, maybe help kind of frame up sort of the size of these opportunities. And you know, I think the, like, the question I have is these are kind of like over-the-counter markets sometimes. Like, how do you think about where these drugs kind of fit in? Yep, and so that's exactly right. Even between the two of them, there's some differences obviously between them. When we think about Trudipitant, you know, obviously there's going to be, if it's approved for motion sickness, the underlying demand for motion sickness treatments in the U.S. is actually very high. It's estimated that between 30% and 40% of the U.S. population suffers from motion sickness. That doesn't mean to the level that they seek treatment, but that they suffer from motion sickness. In terms of the number of people seeking treatment, you know, there's 2-3 million units of Dramamine sold in the U.S. each month. Right. It's an incredible amount of, you know, demand for the product Dramamine over the counter, different pricing point, all those elements, but to just show there's just a strong underlying demand for, for a treatment option. And Dramamine comes with its, you know, side effect profile of, you know, in terms of drowsiness and other elements that tradipitant may not, you know, have as side effects. Generally, I think when people are taking a treatment for motion sickness, it's not because they want to go to sleep, you know, they're actually trying to do something. The fact that tradipitant could be a treatment option for those folks where they still maintain, you know, kind of a higher functioning could be significant in terms of the, ultimately the distribution and kind of, you know, who's paying for it. I think that's likely to have a, you know, both an insurance element to it, but also potentially an out of pocket element to it as well. As you mentioned, maybe be a more consumer based product. Right. When we look at jet lag, we're also thinking of that the same way that that's likely going to be more driven by consumers than by insurance coverage. Right. When we look at the jet lag market, you know, in a bit of an oversimplification, you have kind of luxury travel, business travel and leisure travel. Right. When you look at kind of the leisure travel, there may be people who are not as willing to pay for, you know, out of pocket for a treatment option. Maybe as folks who are traveling for business or, you know, kind of in the luxury realm. On the business side, you know, obviously if you're traveling somewhere for two days and you're getting off a plane after a red eye and you have meetings that day, you know, having a treatment option like Hetlioz for jet lag could be critical for, you know, making those meetings as productive as possible in what's already an expensive business trip, you know, actually having them be worthwhile. Similarly, if you're thinking about people who are doing luxury travel where they're flying on private jets, you know, for international travel, you know, a Hetlioz treatment option, you know, is probably not a significant expenditure for them with what they're already spending on a trip. Those markets are very interestingly different from our existing products. Again, I think tradipitant has both an insurance and a consumer element. Hetlioz may as well, but likely a bit of a tilt more towards the consumer. Yep, yep, makes sense. Yeah, maybe just on the context for this, this jet lag kind of like re-evaluation, like some of the history there, and again, your kind of confidence in it ultimately being approved. Yeah. And for a bit of background there, we received a CRL on Hetlioz for jet lag previously and then we've had several pieces of litigation with the FDA over the years related to both our Hetlioz programs and our Trudipitant programs. Somewhat recently there was a ruling in the federal appeals court in our favor on our Hetlioz jet lag application and the requirement for the FDA to hold a hearing on our application for the approvability of it. As part of that or subsequent to that, we reached a collaborative agreement with the FDA to seek to settle our disputes, you know, across this kind of the broader landscape. As one of the pieces of that, that agreement was that the FDA would conduct a re-review of our Hetlioz SNDA by January 7. They would consider both the broad jet lag indication, which we feel very confident in, but they also potentially would consider a more narrow indication, you know, something to the effect of sleep and jet lag. You know, we're obviously very hopeful that we felt our data was very compelling and that, you know, that obviously we think it should be approved given the data package that we were able to develop. We're hopeful that the FDA will, you know, as part of the re-review, agree with us and that we could see an approval as early as January. Okay, that makes sense. Yeah. And then maybe on tradipitant, this GLP-1 study, maybe just talk about kind of the design of it and like what a win looks like in this kind of initial study. Yep. As part of that, as I mentioned, we're running a phase two program with patients having nausea while taking, you know, a GLP-1, in this case Wegovy, and we've got a drug arm and a placebo arm. On the drug arm is going to be patients taking Wegovy and tradipitant, and the placebo arm obviously is going to be folks taking Wegovy and a placebo, and we're going to measure the difference in nausea and a number of other measures in patients in those two arms. As you may be aware, in these GLP-1s, generally, nausea is the most prominent side effect of these medications. In some cases, 40-50% of patients have that experience, that is a side effect. It's a significant issue for these treatments and it leads to a fair amount of discontinuations of patients not being able to cope with the nausea and discontinuing after a few weeks instead of not being able to get past that. We're going to be looking at the separation obviously between tradipitant and placebo in terms of the effect on nausea in patients taking these GLP-1s and very exciting to see what that looks like. The trial itself was run fairly quickly. I think we announced that we were running the trial either at the end of last year or very beginning of this year and obviously already having results in the same year. If we have positive results, the ability to move that program forward quickly is very realistic. In the context of a potential tradipitant and PDUFA approval in motion sickness, it could be very interesting if it's a product on the market where we're moving it forward into phase three. It could be a significant differentiator for GLP-1s that having nausea versus not having nausea. Yep, yep. Okay. And then yeah, maybe just in the last minute here also on tradipitant, you know, what's the kind of like the latest on gastroparesis? Is there sort of any path forward there? Like what's kind of your guys' latest messaging there? Yeah, so, you know, nothing specific, I would say, but as part of this broader collaborative framework that we've established with the FDA, we're obviously looking forward to engaging with them on the path forward for tradipitant for gastroparesis. The reminder there is that we had very positive phase two data. On the phase three, we missed on the primary endpoint due to a number of confounders. When we looked at a pooled study between the phase two and the phase three, felt the data is very compelling. No approved treatments in over 40 years. Only approved treatment in the market is metoclopramide. Comes with a black box warning for tardive dyskinesia and does about 300,000 prescriptions on a monthly basis. Right. Very significant unmet need. Almost no treatment options, obviously none approved in the last 40 years. We feel our data is very compelling and looking forward to engaging with the FDA hopefully on a path forward as part of this collaborative agreement. Yep. Great. Perfect timing. We're up on time, so thanks, Kevin, for coming. We appreciate it. Thanks, everyone, for listening. Thanks, James. Great question. Thank you. Yeah, that was good.