All right. Hi, good morning, everyone. Welcome to day three and our final day of our healthcare conference here at Cantor. My name's Olivia Brayer. I'm one of the Senior Biotech Analysts at Cantor, and very excited about this morning's discussion. We have Kevin Moran, who is SVP and CFO of Vanda Pharmaceuticals. Kevin, thank you for being here with us. Yep. Thanks, Olivia. Appreciate you guys having me. Busy year for Vanda and for your team. I think maybe just for the investors in the room that are a bit newer to the story, can you just maybe start with a quick overview of where Vanda is today, some of the progress that you guys have made over the last six months, and maybe just set the stage for what's to come as we think about 2027. Thanks, Olivia, and thanks again to the Cantor team for having us here this week. Again, very much appreciated and very excited to be here. Maybe just to kind of set the stage for folks. As we exited 2025, we had three commercial products on the market. We had Fanapt, HETLIOZ, and PONVORY, which had all been on the market for some time and were kind of well-established products. The kind of exciting developments over the last nine months now and in the coming months are that we had two new drug approvals towards the end of 2025, beginning of 2026. The first of which was NEREUS for motion sickness. And then in February, we had BYSANTI, which is a novel atypical antipsychotic approved for bipolar and schizophrenia. NEREUS has since launched over the summer, and BYSANTI, we are expecting to launch sometime between now and the end of the year. Obviously, those are very significant developments, and it will kind of set the stage for future periods. But we also have a number of important catalysts coming up in the next six to nine months, both on the clinical regulatory side as well as the commercial side. Maybe starting with the commercial side, again, the BYSANTI launch later this year. Then what we see from new patient starts, both from new to BYSANTI, but also from patient switches from Fanapt, is going to be an important catalyst and an important kind of revenue trajectory item for the company. On the regulatory side, we have an upcoming PDUFA date for a potential sixth commercial product, which is imsidolimab, and that is in the indication of generalized pustular psoriasis. Finally, on the clinical side, we have got four phase III programs that are expected to produce results in the coming months and quarters here. Prior to the end of the year, we have got HETLIOZ in phase III for DSPD. We have NEREUS in phase III for nausea and vomiting and GLP-1, which might be kind of the most exciting of the opportunities, just given the potential size. We have VQW-765 in social performance anxiety. Finally, in the first half of next year, we have got BYSANTI in MDD. Kind of a number of exciting catalysts right in front of us, and I think for us, the focus as we turn into 2027 is obviously revenue growth for those five products that we mentioned, with probably a heightened focus on BYSANTI, just given the opportunity size, and the switch of our existing Fanapt revenue, hopefully to BYSANTI. Then these readouts on both the regulatory and clinical side and what they might kind of set the stage for from a commercial opportunity perspective in 2027 and 2028. Yeah. Kevin, obviously a lot of investment has been made over 2025 and this year to get to this place. As you think about driving revenue growth versus reinvesting and kind of adding on and layering on more programs, maybe just talk about the strategy there, right? A lot of moving parts in your pipeline, a lot of moving parts in your commercial portfolio. So when you think about putting together all the pieces, what is the overall strategy for the company from here? Maybe just kind of walk us through the biggest growth drivers, right? Again, there is a lot of moving parts. So how should investors really be thinking about the story with all these different assets and product launches and a lot of different indications as well? Yeah. Yep, certainly. I think for us, we've always kind of had this as a principle, but it's definitely certainly been something that you've seen kind of play out more extensively over the last few years, which is diversification, right? Although there's a lot to be said for singular focus on a product or indication, that also comes with obviously inherent risks of if something doesn't work out, that's kind of where all the eggs were, and that could be its own problem. We are a firm believer in having diversification of our products across various portfolios and various indications and therapeutic areas. That's been very important for us. I think as we kind of turn to what are going to be the most important drivers for us is, on the BYSANTI switch strategy, that's going to be clearly, I would say, kind of the continuation of the most significant portion of our kind of foundational revenue. But also with a very significant potential upside. We've talked about this, that there's definitely going to be some pricing favorability on BYSANTI relative to Fanapt, at a minimum with the gross to net dynamics on Medicaid. The Fanapt gross to net is in the neighborhood of about 50%, whereas on BYSANTI, we're expecting that to be more in the mid-30s, and that's just completely attributable to the Medicaid reset. Whereas Fanapt has been on the market for a number of years and has a URA that exceeds the WAC list price of the drug. BYSANTI will have a restart, and that means it'll be 23.1% discount there. So there'll be significant pricing benefits on BYSANTI. Also, we're still evaluating our final price, but it's likely that although our WAC price may be consistent between the two products, Fanapt and BYSANTI, the weighted average WAC may be favorable on BYSANTI, which that could be kind of additive to the gross to net benefit. I think that's going to be the kind of core revenue growth and the most important single contributor to the revenue story in the years to come. But then there's all these other indications that are possible, I would say, significant upside, right? The GPP indication, we think that imsidolimab will have a significant advantage over products in the market, and that could be a very nice contributor, with more limited, I would say, commercial effort. Typical kind of orphan support kind of approach. NEREUS and GLP-1, if we see positive data in the phase III. When we first had the phase II data, NEREUS was not yet approved. Now, if we're able to replicate the phase II data in phase III, NEREUS is approved. We think we can move quickly towards an sNDA. I would say that would be the very significant potential revenue opportunity a few years out from now once we're able to hopefully get that on the label, again, if we have good data and then have good outcome with FDA. Right. So maybe let's unpack BYSANTI first. You do have Fanapt that's already on the market as you think about where your psych franchise is today. How do you think about the opportunity set that you have between the two of them? Is it about leveraging the experience with Fanapt so that you can have a more successful BYSANTI? You mentioned switch. How do those two coexist together as you do roll out BYSANTI commercially? Yeah. So, for some context here, in the atypical space, the branded market is less than 10% of the overall market, and Fanapt is less than 2% of that branded market. So just for context, it's a relatively very small piece of the larger kind of ecosystem. What that means, though, in a market that is actually growing, so the broader market is growing, if we're able to grow Fanapt from what its current branded penetration rate of less than 2%- 3% or 4%, obviously, that's a very significant revenue growth without necessarily being a very significant market penetration rate. So that just kind of shows you that there's still a tremendous opportunity for growth there with the existing trajectory that we're doing. Right? I would say kind of element one of the BYSANTI story is if we're able to continue growing patients as we have been with Fanapt to about 30% year- over- year, we think that's sustainable for hopefully some years to come, just again, given how relatively small the penetration rate currently is. The second part of that strategy is there's about 10,000 patients or so on Fanapt currently. Fanapt has its LOE towards the end of 2027, and so we've got about a year where we'll be increasing our focus on BYSANTI and, as you would expect, as a product approaches its LOE, potentially decreasing our focus on Fanapt. Although the products are bioequivalent, so they're the same. We think that the area is very promotionally sensitive, and as we continue to detail BYSANTI, we think patients and providers will begin to choose that as their go-forward option. Then again, hopefully, we have MDD data that is positive and can hopefully be kind of another leg to the story in 2028 and beyond. Is there payer risk around BYSANTI, just given that you are getting close to that Fanapt LOE window? Is that not the right way to think about it? No, certainly the right way to think about it, because anytime you're talking about another drug being its bioequivalent, it certainly begs the question, are the payers going to then therefore try to put in place certain mechanisms to motivate patients and prescribers towards that product? Our expectation is that given the protected class status that on Medicaid and Medicare, we would anticipate coverage being similar. For context, by the way, we've talked about this a bit on gross to net, we don't have any substantial contracting currently on Fanapt, so it's not like we've got tremendous contracting in place right now that's securing access. We have good access, but very limited kind of contracting approach. On the commercial side, the same story. We don't have extensive contracting there. So our expectation is that payer coverage should be consistent between Fanapt and BYSANTI. Now, that being said, payers can certainly take more active actions to try to, again, motivate patients and prescribers towards a particular product. If those arise, we'll have to certainly navigate those if they come up. But our base assumption here is that we're going to have similar access. Okay. Switching will obviously be an important dynamic initially, but can you talk about maybe which patients you're hoping to reach with BYSANTI that you weren't able to access with Fanapt or maybe haven't yet been able to access with Fanapt? Yeah. I think that when we're looking at this, it's going to be more of a continuation of the same patients that we are accessing now and where we're seeing our growth come from. BYSANTI is going to be indicated for bipolar and schizophrenia just as Fanapt is, so it'll be the same patient profile. I think maybe the way that we're looking at it is, we grew 30% or so year-over-year last year. We've seen kind of consistent trends in that direction so far through 2026. We think there's just more patients to be reached in the bipolar and schizophrenia space from the broader patient population that we haven't yet been able to get to. I wouldn't say it's necessarily a different patient profile or patients that we haven't been able to reach because we haven't been trying to. It's more of a continued effort and continued success, hopefully making headway into the market where we already are. Okay. Understood. You are studying BYSANTI in MDD as well. Obviously, a potentially much bigger opportunity, but also somewhat competitive of an opportunity as well. Yeah. When you think about BYSANTI, maybe remind us when will we get the next update? How is that trial progressing on MDD? Ultimately, what do you think you need to show from that data set to feel like you have a real competitive drug in the MDD space? Yeah. First, the reminder there is that we launched our phase III program for BYSANTI in MDD last year. We originally had guidance out there of results by the end of this year, but that was fairly early on in the actual recruitment of the trial. As we've progressed through this year and we've gotten much better real-world data, actual data on recruitment projections and trajectory, we refined that to the first half of next year, which is based on, at this point, a substantial amount of recruitment data. That's what's driving the timeline refinement throughout the course of 2026. Again, we haven't run a program or a trial in either Fanapt or BYSANTI in MDD, but obviously there's been a number of products in the class who've been successful in that indication, so we're optimistic that we'll see good data given the profile of Fanapt or BYSANTI rather, compared to some of the other products in the class. We're optimistic we'll see, hopefully, a similar outcome as some of those programs have seen. From a market perspective, and this is the unfortunate truth about the space, there's a number of options. None of them are silver bullets and prescribers and patients need options because some medications work better for certain patients and some medications work out better for others. Although it's a very competitive space, we certainly think that BYSANTI would be a welcome addition to the class in giving patients and providers another option to try if for whatever reason certain medications have not been effective, or the side effect profile of those medications have been more difficult for them to manage than BYSANTI's potential side effect profile. Again, we think it will just be another good option for patients to have. Yeah. The only other thing I would point out there is Fanapt and BYSANTI both are approved BID. The BYSANTI MDD trial is being run as a once-a-day trial, so that would be a potential differentiator between Fanapt and BYSANTI is the fact that BYSANTI would potentially, if we get good data and good regulatory outcome, be indicated for MDD, but it also would be indicated with a once-a-day dosing. once a day Versus the BID. Right. Okay. Looking forward to seeing those data. Then you are also working on a long-acting injectable. How big of a strategic priority is that at this point, and how does that fit into the portfolio? Yeah. Moving forward with our long-acting injectable, what we have talked about there, is that it is the Fanapt long-acting injectable. There is the possibility that we could, at some point, explore a BYSANTI long-acting injectable as well. That molecule, similar to Fanapt, lends itself to being developed as an LAI. We have been pursuing a phase III program for schizophrenia, as well as looking at a program for hypertension. We have not communicated timelines on those programs. I think the LAI is an area where the market is continuing to migrate to and expanding upon. I think early on, the way that I would've thought about it is for those patients that had difficulty with compliance, obviously, the LAI would be a good solution for them and their providers and caregivers to make sure that they're receiving the medication they need without necessarily having to worry about them taking it every day. Also, I think in recent years with the significant expansion in GLP-1s, I think that the receptivity to injectables has obviously significantly increased, where people five years ago may have heard injectable and thought, I don't need an injectable. That's a very serious step. Now it's a much more commonplace that people are taking them in whatever form, whether it's in-office or subcutaneous. We think that the acceptability of that in the broader treatment space will only continue to increase. It's a very important part of our long-term strategy in the psychiatry space. Back to something we touched on earlier, with what's our broader strategic vision, obviously our biggest product portfolio is the psychiatry space, and so this would be the possibility of another leg to the stool of that longer-term story where we continue to make investments both from a R&D perspective and then obviously from a commercial perspective. Well, to that point, when you do put it all together, how big do you think your psychiatry franchise realistically could be? What we've communicated here is that we're targeting by 2030 total revenue from the psychiatry portfolio of $750 million. I think that that's a realistic target if we have a number of things. There's obviously some qualifiers to that happening. First is, was the BYSANTI approval. We've now been able to check that off the list. Then it'll be the success of our BYSANTI switch strategy, the MDD potential label expansion, and then LAI subsequently coming to market. With those, we certainly think that that's very reasonable, especially also layering in the potential BYSANTI price advantage over Fanapt, which could provide a step change in our existing revenue and the potential revenue trajectory in the years to come. Okay. Well, why don't we talk a little bit about one of your newer launches. You have NEREUS in motion sickness. A little bit of a different launch just because you guys are somewhat building out a market. So maybe just talk about the opportunity set that you do have in motion sickness. Who is the ideal patient profile that you are targeting with this drug? Yeah. So, for the background here, NEREUS was approved for motion sickness at the end of the year. We launched it in the May timeframe, first with a direct-to-consumer portal where you can go in and sign up and bring your prescription, and pay cash for the product. The WAC price on NEREUS is $255 a pill. Through the cash pay portal, it's available at $85 a pill, so a significant discount there, if you want to go the cash route, although it's certainly available to go through insurance, where folks can get it covered. That was kind of our initial launch and supported by some direct but limited DTC efforts. What we provided an update on in the Q2 call was that with our near 300-person psychiatry sales force and our near 50-person neurology sales force, that we were going to begin promoting the product through our sales team's activities this fall. We have since commenced that, and it's very early days both on the consumer approach, but also on the sales approach. But we're hopeful that we're going to see good receptivity there out in the market. That'll be part of the strategy going forward. One other thing that now is kind of many years ago, but just to kind of remind folks of, when HETLIOZ was originally approved, our approach of running Non-24 awareness campaigns, first that were targeted to the blind patient population, was certainly a novel approach there, too. Ultimately, it took some time for us to fine-tune and figure out the right path, but was ultimately very successful in driving HETLIOZ revenue prior to the generic entries into the market a couple of years ago. There's some similarities from that experience that we draw on as we look to bring NEREUS to the market. We're, again, in the early days of learning, but we're optimistic that this approach will ultimately result in significant revenue possibilities in the quarters and years to come. Yeah. You bring up your advertising campaigns. I have to ask because it is a question I get asked all the time from investors, what is the strategy behind some of the advertisements that you guys have at- Yeah at ballparks and during NHL playoffs and things like that, because I do think it catches people's attention and sometimes catches people by surprise seeing that. Yeah. I would say a number of different elements to it, but maybe just two that I would highlight. Clearly, you are a big sports fan. Well, I was actually going to say that I am, but that's kind of unrelated to why the focus is there. When we ran a lot of advertising campaigns for HETLIOZ, but also for other programs, including clinical trial programs, we ran them across an array of different programming. A lot of them were direct response campaigns. We were asking people to call in and either say, Hey, I'm interested in learning more about Non-24, or, I'm interested in learning more about a motion sickness clinical trial or a gastroparesis clinical trial. The response rates on sports programming were dramatically better than anywhere else. I think the audience for watching live sports is very engaged. Although I'm sure all the third-party measurement data on impressions is accurate, it certainly felt like you were getting a significantly higher return on sports advertising than you might see on other programming. It was significant enough that we leaned significantly into sports programming, be where we tend to play because we think it's a much better measure of the audience. They're much more actively engaged, and when you're asking them to take an action, they're much more likely to respond. That's, I think, the core element of it. The other approach that we've taken that probably catches people's attention is we do a lot of the advertising you mentioned is branded. It might be for NEREUS or other products, but a lot of it is also corporate branding. For us, the reason is that we're making a connection with our corporate branding and then our product launches. NEREUS, as an example, was available on Vanda Rx. We think patients, prescribers in the general population will begin to make the connection between our corporate branding of Vanda and our products that we're selling, especially directly with NEREUS. The sports part, again, yes, huge sports fan. When we ran a lot of this advertising in the past few years, the response rates were so dramatically better in sports that we've just feel like where we've got obviously a limited budget. We don't have an endless budget to be able to spend on DTC, that the ROI on sports is significantly higher. Sure. It's fun to see. Is there a point at which you're hoping to see a payoff, or maybe are you already starting to see that payoff? Yeah, I think it will be two-pronged on that again. I think that a lot of this has been kind of laying the foundation for programs to become. When we first started doing it, NEREUS was not yet approved, or BYSANTI. Some of this was to create awareness in advance of these product launches. I think that the hope is that we will see that payoff in the years to come. This is certainly not a short horizon approach in terms of how we are going about this. Yeah. Speaking of NEREUS, you alluded to it earlier, but you do have that GLP-1 related nausea vomiting study that is ongoing. Can you just maybe talk about the receptivity that you have gotten to that initial phase II data set that you have had? As we think about gearing up for that phase III readout, maybe just remind us what is the internal bar for success to move that program forward from a commercial perspective? Yep. From a receptivity perspective and from a general interest, it has been very high. When we look at the GLP-1 space, in general, the products that are available have a significant GI side effect profile, the nausea, vomiting being a significant part of that. Again, most, if not all, of the programs that are in development seem to have a similar profile. There does not seem to be a clear medication that is either available or likely to be available very near that is going to eliminate that issue. Surprisingly, the non-compliance rates and discontinuation rates on the GLP-1s are meaningfully high, and one of the most significant contributors to those are nausea and vomiting or other GI side effect profiles. There are patients that need to get the benefit of these GLP-1s and are likely discontinuing because they cannot sustain the treatment given the GI side effect profile. We think there is a very significant need and opportunity, and that that opportunity actually would kind of benefit everybody because payers, the idea is they are going to have lower long-term healthcare costs because the patients are healthier. Patients obviously are going to get the benefit of the treatment. Vanda would get the benefit of, we would make money, obviously, because we would be selling our treatment. In this case, whereas a lot of the time interests do not always align between all the parties, in this case, I think they do, that everybody would be better served by being able to stay on their GLP-1 treatment longer. As we see it, although this is obviously subject to the clinical trial results and discussions with the FDA and future potential labeling if we ever get to that point. But at a minimum, you're taking NEREUS along with your initial doses, so both your initiation and your dose escalation would be when the GI side effect profiles are perceived to be the highest, and so where this would be the significant benefit would be provided in kind of getting through that boldness of the side effect profile. We think it's a tremendous opportunity. When we look across the landscape, there's no other product available with this indication. Although there's some other products in development, we seem to be kind of first mover. We seem to be the furthest out in front. I think folks were always aware that this was an issue with the GLP-1s, but because there's no differentiation really between them, and because there's nobody that's got something very far along in development, it's not something that's actively promoted because there's no solution to the problem. Right. We think there's a huge unmet need there. As far as what we're looking at for the data, our phase II results that we produced last year, which again, were prior to NEREUS's approval in motion sickness, we ran it a placebo arm and a drug arm, where the 1 mg of Wegovy was what was being treated in both arms, and then you either were on placebo or on NEREUS. In patients that were taking placebo, the vomiting rate was over 60%, and in the NEREUS arm, they were approximately 30%. Obviously a very significant statistical benefit there. For the phase III program, it's very similar in its construct to the phase II program. For what we would be looking for is a very similar result, right? If we do, obviously we'll need to have discussions with the FDA about how to proceed, but we're hopeful and optimistic that that might be sufficient to support an sNDA filing which could be in the not too distant future if the plan is to have those results, obviously by the end of this year. Right. From an FDA perspective and regulatory lens, there have been a lot of conversations around chronic dosing, right? Of your drug, and I know it's been an ongoing saga, to say the least, with the FDA. As you think about approaching the FDA with a phase III data set in hand next year, what is the pitch, right, in terms of where this actually fits into the treatment landscape? You want to keep patients on dose longer, but it sounds like maybe it's just an upfront initial, I don't know necessarily how long you guys are hoping that a patient's journey would be. Yeah. I think exactly right around the chronic versus non-chronic. The reminder for the audience here is on NEREUS in gastroparesis which would have potentially been a chronic indication, one of the items that as part of the FDA's review that was cited was the fact that we didn't do a nine-month dog toxicity study, and we had provided an alternative data set from a long-term safety perspective. Putting that aside, then when we looked at the motion sickness submission, that was not a chronic indication, and so our safety data set was obviously sufficient for approval, hence the FDA providing the approval. When we look at the potential treatment paradigm for NEREUS in GLP-1 patients, the way that we've set up the trial is that they would take it for a week prior to initiation of treatment and then a week after. Potentially what it would be seen as is that would be when you would be treated and then when you're escalating doses. In Wegovy's instance, you start on 0.25 mg. A month later, you move up to 0.5 mg. A month later, you move up to 1 mg, and so on. You would take it bracketed around those dose escalations. Then when you reach therapeutic dose, you likely wouldn't keep taking it, right? Because you would be there, and you would have navigated the GI side effect profile kind of peak and be past it. So that's the way that we set up the clinical program and how we would envision it potentially being used, but obviously that's subject to the discussions with the FDA once we hopefully have good data. Okay, great. In the last minute here, you do have a number of new products that have come online. You have another number of products that could come online in the next 12 or so months. How should investors think about the contribution from new products going forward, especially as we think about revenue growth into 2027 and beyond? Yeah. I think that as we're kind of setting the stage for the years to come, Fanapt right now is our largest contributor of revenue, and certainly the transition to BYSANTI is, I think of the heightened near-term focus. That's going to be kind of continuation of that revenue stream is the most important near term kind of revenue catalyst or kind of milestone. As we look beyond that, obviously very significant potential revenue opportunities for many products. I think NEREUS in motion sickness, it's early on, and I think that'll take some time to see play through. Then the possibility in GLP-1 in the not too distant future is, I would say kind of like the significant upside. So BYSANTI kind of significant growth with continuation of our base foundation, then NEREUS potential significant upside on top of that foundation. Right. Okay, great. Kevin, thank you so much. Thanks, Olivia. Always great chatting with you. Yep, you as well. Thanks, Olivia.