Vanda Pharmaceuticals Inc. H.C. Wainwright 28th Annual Global Investment Conference

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.

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.

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.