Hello everybody. Welcome. Joining us right now, I'm a little winded. I was running here. My name's Jan Zies. I'm an Equity Research Associate on Ram Selvaraju's team. Thank you for coming. It's my pleasure to introduce Kevin from Vanda Pharmaceuticals. Could you give us a brief introduction going into, for those who are still trying to get familiar with Vanda, could you give a simple snapshot of the company today and how the portfolio has broadened overall? Yeah, perfect. First off, I'd like to say thank you to Jan and the HCW team for having us here. Thank you very much, Jan. To table set for folks, as we entered 2026, we had three products on the market, three commercial products. We had Fanapt, which is an atypical antipsychotic approved for bipolar and schizophrenia, doing a little more than $100 million of revenue per year. We had HETLIOZ, which is an orphan product approved for two sleep indications, Non-24-Hour Sleep-Wake Disorder and nighttime sleep disturbances in Smith-Magenis syndrome. Then we had a third product, PONVORY, which is an S1P approved for multiple sclerosis. As we entered 2026, we had two new products approved, one just before the end of the year and one at the beginning of the year. The first one of those was NEREUS for motion sickness, and then BYSANTI, also an atypical antipsychotic approved for bipolar and schizophrenia. As we are here today, we have five approved products in the U.S. market, four of which have been launched, and BYSANTI, which is expected to be launched by the end of the year. In addition to those five products, we have a potential sixth product approval later this year, which is imsidolimab, which we licensed from AnaptysBio in 2025, and have a PDUFA date for generalized pustular psoriasis, GPP, by the end of the year. In addition to those six potentially approved products by the end of the year, we have a number of upcoming exciting clinical readouts within the next few quarters. Prior to the end of this year, so by the end of 2026, we have phase III readouts for HETLIOZ in delayed sleep phase disorder, another product called VQW-765 in social performance anxiety, and then NEREUS in vomiting and nausea induced by a GLP-1. Those are all expected to read out prior to the end of this year. Then we have for BYSANTI, a phase III program underway for MDD, which is expected to read out in the first half of next year. As we stand here today, a very diversified commercial portfolio, and it is growing in the years to come, hopefully, with a number of exciting clinical readouts, which hopefully will lead to either additional new product approvals or label expansions into large and exciting markets. That is really exciting. You seem like you guys are really busy. We are. I would like to touch on all of those going forward, but briefly before we do so, looking past the heavier investment years, how should people start thinking about 2027 at a higher level? Yeah. If you look at this year, we began the year with cash of about $260 million. We ended the second quarter with about $170 million. Just to give you some sense of what the burn trajectory had been to date. What we talked about on the Q2 call is that we're at a somewhat high watermark, I would say, on the operating expense perspective, given the four phase III programs that we have reading out fairly soon, the commercial inventory production that's necessary for these two and maybe three commercial launches, as well as the build-out of commercial infrastructure to support those launches. What we expect to see as the year progresses and into 2027 is that as those activities begin to complete, we'll see expenses begin to moderate, likely not in Q3. I think Q3 will look pretty similar to Q2. As early as Q4 and into next year. At this point, as we've completed a number of those investments that we've been working hard on for several years to get to these milestone moments, the outcome of those will have a significant impact on what 2027 looks like and where we're making our next investments. But the vision that we have for next year is that we've got a growing psychiatry portfolio with a launch of BYSANTI, a switch strategy as Fanapt reaches its end of exclusivity and BYSANTI comes into the market. Then that hopefully developing into a potential label expansion with, if we see good MDD data next year and move towards an sNDA. Then additional products that round out this diversified revenue opportunity. Again, some of the outcomes of those clinical readouts will also determine what the next clinical catalysts might be for the company, depending on those outcomes. Great. I think that's the perfect segue, actually, into the next part of your pipeline, your psychiatry franchise. I'm wondering, could you walk us through how you think about Fanapt and BYSANTI, and the part they play in the greater franchise you have? Yep, absolutely. The reminder for folks is Fanapt has been on the market for now over 15 years. It was originally approved in acute schizophrenia. Subsequent to that had maintenance added to the label, and then in 2024, had the bipolar indication added. The product is expected to lose exclusivity towards the end of next year. It has done very well in recent years as we have put additional commercial resources behind it with the bipolar expansion. We have seen 30% revenue and script growth year-over-year last year, and our guidance this year would tell a similar story. As we head into 2027, though, with the BYSANTI product coming to market, BYSANTI is bioequivalent to Fanapt. The BYSANTI launch has, at a minimum, two elements to it. Switching existing patients of Fanapt to BYSANTI, and then switching patients that are on other medications to BYSANTI. Growth through additional volume growth from patients that are not currently on Fanapt. As we look at the opportunity there, the other thing that is important to highlight is that on gross to net, Fanapt has a gross net that is in the neighborhood of about 50%, is what we have said. The largest driver of that is the Medicaid URA. Given that Fanapt has been on the market for as long as it has, the Medicaid URA is essentially 100% of the Medicaid business. We essentially generate no revenue from our Medicaid business line on Fanapt. With BYSANTI coming to market, you actually get a reset on pricing there, and so the discount or the gross to net adjustment on Medicaid will be 23.1% at launch. Because of that, the gross to net on BYSANTI is expected to be in the mid-30s, as compared to the 50% that we currently see on Fanapt. That provides a significant revenue growth opportunity outside of volume, just on the ability to have the Medicaid price reset. So that is how we are seeing things play through on the switch. The next leg to the stool or next leg to the story is that as we head towards this phase III readout on MDD, depending on what that data shows, hopefully we are moving towards an sNDA next year and then a label expansion as early as 2028. So in our minds, 2027, launch and switch, and then 2028 label expansion and additional inflection point opportunity for growth, just given the size of the MDD market relative to the size of the bipolar and schizophrenia markets. Got it. So you are talking about MDD as being the next development step. What would you say is the most attractive, or why do you find that indication really attractive? Yeah. For a couple of different reasons. First and foremost, when we are looking in potential indications, we are looking for unmet need where patients are either underserved or could be better served by having another option available. Unfortunately, the atypical space is that scenario where there is a number of treatment options available, but there are no silver bullets. Providing additional alternatives to patients and providers will meaningfully benefit those folks. That is always first and foremost as we are evaluating programs. Because of that in the space, we think there is certainly an opportunity for BYSANTI to be a meaningful treatment option for patients on MDD. Additionally, as we evaluate market opportunities, you are always considering what the dynamics of a market could be and whether obviously there is going to be a positive ROI on pursuing that type of market. When we look at the patients in the schizophrenia patient population, varying estimates, but in the neighborhood of, let us say, 3 million patients in the U.S. Bipolar two maybe three times larger than that. From a patient population, bipolar patients tend to be more accessible than schizophrenia patients do commercial efforts. MDD is even further on that spectrum with a patient population estimates in the 20 million neighborhood. Again, an accessible patient population for commercialization efforts. It is both larger and more accessible, and therefore provides, we think, a great opportunity to provide patients with an additional treatment option, and also a very potentially lucrative option for the company from an ROI perspective. Got it. Taking your psychiatry franchise as a whole, how do you think about the scale of that business over the next several years or so? Yeah. As we look towards the next couple of years, first just from where we sit now. When we received the bipolar approval for Fanapt back in 224, we had a sales force in place at that time of about 50 sales reps, so relatively small. That was given the nature of the Fanapt product and the indication at the time, that was sufficient to support that need. Once we received that bipolar indication, we expanded the sales force to 150 in 2024. Again in 2025, we doubled it to about 300. Just to give you some size, and that is where we stand right now. Across the space, that is, I would say, in the competitive size, but you do see many of our competitors with larger, some much larger, sales forces. We think that that sales force gets us a good reach and frequency with the providers that we are targeting. If we see MDD data that is positive and move towards hopefully an approval in that indication, we may need a larger sales force to support what is a larger prescriber base and target universe. We feel like we are very well-positioned to support our existing business in both Fanapt and BYSANTI. That is both from a sales perspective and then all the other aspects of commercial infrastructure. Again, with good news could come the need for additional investment to make sure we are maximizing the opportunity and our ability to get in front of the appropriate providers. Absolutely. Moving away from your psychiatry franchise now towards NEREUS, specifically now with motion sickness. I find this to be a really interesting opportunity given that the market is not really well established here. How are you framing the opportunity overall? Yeah. When we look at the market opportunity for NEREUS, we also find it very interesting. There is a very large potential market. There are about 70 million people in the U.S. impacted by motion sickness. There are actually more than 10 million people seeking treatment on an annual basis. So a very large market and a very large market where people are seeking treatment. In addition to that, though, there is a potentially kind of not well-quantified potential large market of people that are impacted but not seeking treatment. That is because they just do not participate in the activities that are causing motion sickness. If I get on a boat and I am terribly impacted by motion sickness and either I do not want to take Dramamine because of whatever the side effect profile is, I just choose not to go on boats, right? Right. There is an additional population that is again, a little bit more difficult to quantify. That is people that do not seek treatment because they do not experience symptoms, because they do not participate in those activities. So a very large market. That being said, it is a very broad market, so it is not necessarily a market where you can go after a very specific segment. It is a very broad, general market. We think it is a very large opportunity. We think there are a number of patients that are underserved by existing options and would find this as a useful and meaningful treatment. We think, though, that it is going to take some time, given the breadth, the broadness of the market, to raise the awareness level. Because that is to the point of it is hard to target a subset of the market and run very directed commercial efforts. It's a pretty broad market, in terms of you have to kind of do broad reach to access those. We think it'll take some time to establish the large market, but we think the potential market size over time is tremendous, and we're excited with that front. From a commercial plan perspective, what we communicated earlier this year was that the product became available in May, and we launched our direct-to-consumer website where you can purchase the product, cash pay. That's a very novel approach in this space. It's also available, obviously, through insurance channels, and we'll be actively pursuing that as well. But that was kind of the initial launch with some deliberate DTC and commercial efforts supporting it. On the Q2 call, what we additionally commented on is that our psychiatry sales force and our neurology sales force would begin detailing NEREUS to their target universe in the later part of this year, as we think there's significant overlap with those targets and providers that may be seeing patients with motion sickness. Very early in the launch of those activities, but we'll be looking forward to sharing updates on those in coming quarters about the receptivity in the market to NEREUS by providers. Hopefully script volume growth through that channel as well as the direct-to-consumer channel. That's great. Those all sound like very encouraging early signals. Is there anything other than what you just listed that you'd also consider to be these positive early signs leading up to the launch? I think from a much more qualitative perspective, a significant amount of interest in the market about the product. I think that the early response that we've seen from, again, from a qualitative perspective, from the advertising and from our interactions with prescribers is positive. Now whether that translates to scripts and revenue and over what period of time remains to be seen. But from a qualitative perspective, very encouraging kind of feedback that we continue to hear. Got it. Moving from motion sickness now to GLP-1 nausea. There has been a lot of interest in the GLP-1 nausea idea overall, and I am curious what made the opportunity worth pursuing. Yeah. In the GLP-1 space, obviously a rapidly growing market for the products that are already approved and in market and the number of products that are in development. As you look across those products, almost universally they all have significant nausea and vomiting side effect profiles, which is the reason why they all have significant titration schedules. Folks take many months to get to the actual therapeutic levels because they have to mitigate that side effect profile. So the reported incidence of nausea and vomiting in the GLP-1 scene vary widely, but in many cases are cited as being over 50% of patients, right? Right. Another figure that you see is there is a significant amount of discontinuations in the GLP-1 space, also of about 50% within the first year or so, many of those due to the side effect profile. So there is a significant issue here in the market in terms of patients being unable to reap the benefit of these medications over long periods of time due to the side effect profile of the medications. So a very significant opportunity there. The interesting part about it, which is not always the case in any business or drug development scenario, is this is largely a win-win-win scenario. Payers win in the sense that they would get these patients to be able to stay on the therapy, get the benefit, and therefore hopefully have lower long-term healthcare cost issues. Patients and providers benefit, obviously, because they are staying on the medication that the patient and provider want them to be on. Then we would benefit obviously, because we would be selling the product and generate revenue. So we think it is a tremendous opportunity. As we look across the landscape, we think we are one of the leaders out in front in terms of developing something in this indication. Our phase II data was very positive. If you remember, we had a placebo arm and drug arm where patients were taking one milligram of Wegovy with either drug or placebo. Reminder, their one milligram is about the third month in the titration schedule for Wegovy. You start with 0.25, then go to 0.5, then go to one. What we saw on the trial was that about 60% of the patients in the placebo arm experienced vomiting, some of them multiple or many vomiting incidents in the days that we're talking about. In the drug arm, we saw the vomiting incidents at about 30%. So a very significant effect size and very encouraging. Subsequent to that, by the way, NEREUS was approved in motion sickness. At the time we had the phase II data, NEREUS was not yet approved in any indication. We had the positive phase II data, had NEREUS approved in motion sickness, and then initiated our phase III program. The phase III program, as a reminder, is expected to read out by the end of this year. The trial design is very similar to the phase II trial design that we ran. We're obviously very optimistic about those results and what the path forward could be there. We think it could be a very significant opportunity for all the reasons that I highlighted, but maybe just one more to flag is, it's not necessarily something where you can readily identify who is going to have the debilitating nausea and vomiting when you're prescribing a GLP-1. It's not necessarily something that is limited to a subset of folks that are experiencing symptoms. It may be something that's used in more of a preventative measure, right? Sure. As we're looking at that. Very exciting, very large market in terms of the GLP-1 market, and we think as an adjunct to that, this could be a very large market opportunity. We felt the phase II data was very compelling. It subsequently has been approved in a different indication, and the phase III trial, again, is similar in design, and so we're excited to get to those results. Excited to see those results as well. Just in the interest of time, I'd like to quickly ask you a little bit about Qulmilza, and then in closing, what you could see for the upcoming for Vanda. You have a December PDUFA for Qulmilza in GPP. Can you frame the opportunity for us? Yeah. As we look across the potential GPP space, orphan indication, varying estimates in the 5,000 to 30,000, depending on where you look in terms of what the potential population is. But these folks that are experiencing this, need treatment. The folks that are actually experiencing these flares need treatment. There is an existing product approved, which is SPEVIGO, which has done very well in the space in being the first approved for GPP. We think that there are certain items about Qulmilza that could make it a very interesting medication for prescribers and patients, and have a very significant role in the space for GPP. Coupled with some of the time we are looking at commercial opportunities, you may be saying, "Hey, we are going to need to have a significant amount of DTC to support this opportunity." Qulmilza is not really that type of opportunity. It is much more akin to a traditional orphan opportunity where we think we can do it in a very efficient commercial model as well, which also makes it very appealing as we think of substantial revenue opportunity, that can also be commercialized in a very efficient fashion. Great. You have given us a lot of good stuff to digest. In closing, when you look at Vanda as it stands today, which area do you think has the best chance of becoming much larger than the market currently assumes? Yeah. Good and bad, I think there are a number of different ones, so it is hard to pick one to focus on, but maybe just given the proximity of them, I would say, the Fanapt opportunity, both in the existing market that it is approved in, but also in potentially the MDD expansion in the near future. It provides for a very large opportunity. The GLP-1 for NEREUS is just such a large market with such an unmet need, that that also could be very exciting, and we have got data right in front of us. Again, we love all of our children. But I think in terms of proximity-wise, those are the ones that we are most excited about as near-term inflection. Great. Kevin, thank you so much again for coming and doing this Fireside Chat with us, and to all the investors for coming and attending.