Vanda Pharmaceuticals Inc. 12th Annual Cantor Fitzgerald Global Healthcare Conference

Yep. Thanks, Olivia. Appreciate you guys having me.

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 3 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 9 months now and in the coming months are that we had 2 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. 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.

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% to 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.