Vanda Pharmaceuticals Inc. (NASDAQ:VNDA) Q4 2023 Earnings Call Transcript

Page 3 of 3

And beyond that, as we have learned, this type of mechanism of action can be useful in an array of autoimmune disorders in front of us, of course, are the examples of the effect in ulcerative colitis. And the BMS compound has been successfully addressing that as well as Pfizer’s compound interestingly, not approved for multiple sclerosis do not pursue it, but actually directly being approved now for ulcerative colitis. And we think our drug, PONVORY is well-positioned from the mechanism of vaccine with very key similarities to the receptor binding effects that both the BMS compound and the Pfizer compound we have, both of them successful in ulcerative colitis to give us reasons to believe that could be successful in that indication. In addition, Actelion, a J&J company, had conducted a Phase 2 large study in psoriasis, which was successful.

And we are evaluating now a path to continue the development in that indication as well. And as I said, the opportunities around the once-day oral sphingosine-1-phosphate analog like PONVORY are just beginning to be realized and likely there will be wide. We are developing our plans now. We’re in the midst of the transition period, and we’ll be able to talk more about these plans in the future.

Andrew Tsai: Thanks. That’s very helpful. Thank you for the color. And then shifting gears to the HETLIOZ for insomnia news. What would be the realistic scenario here? Do you start hiring the sales force? Or do you wait until approval? How does this all work out? Thank you.

Mihael Polymeropoulos: Andrew, let me clarify. Are you asking about the insomnia in HETLIOZ or the bipolar in Fanapt

Andrew Tsai: HETLIOZ for insomnia.

Mihael Polymeropoulos: Yes. For HETLIOZ in insomnia, of course, we think given the negative letter by the FDA of deficiencies, although not named, preclude label negotiations. We think the most historical likely outcome is that will be followed by a complete response letter. We cannot imagine what the deficiencies are for this melatonin agonist now marketed for 10 years in dissolved indications and with the file that clearly and ambiguously supports the effect of the drug in sleep onset insomnia. We are not expanding the HETLIOZ sales force and we’re not planning any immediate marketing plans there.

Andrew Tsai: Got it. And then maybe just speaking of the Fanapt for bipolar then or as well as tradipitant for gastroparesis, my final question is, is your confidence in those applications the same despite the insomnia development and second to that is, are you hiring ahead of the potential PDUFA decision. Thank you.

Mihael Polymeropoulos: Yes. So just to talk about confidence. Of course, we’re optimistic because we believe in science and the robustness of our packages that we have already communicated with you all. But of course, we’re – the experience with the agencies that we are prepared for unpredictable results. And having said that, we’re cautiously working towards being ready to expand the already existing Fanapt salesforce. And I will let Kevin give you a little more color of how we think about cadence of operational expenses there. And the same thing holds through for tradipitant in gastroparesis. We have done work prelaunch to understand the market and develop a commercial plan. But of course, we’re quite a few months away from an agency action in September of 2018. And yet again there, we are proceeding very cautiously with the expenditures ahead of that decision. But I will let Kevin give you more color.

Kevin Moran: Yes. And thanks, Andrew. On the Fanapt side, specifically, as Mihael mentioned, we have a very well-established commercial infrastructure given Fanapt’s history on the market and as well as HETLIOZ’s history on the market in the supporting activities and infrastructure associated with those. That being said, we’ve certainly taken actions to be prepared to expand quickly on positive news. So, I’d expect from a cadence perspective that there will be some preparation costs that we’ve began to execute against the first quarter, but more so, it would be upon a positive development that we would see a kind of cadence change.

Andrew Tsai: Very good. Thank you. Thank you all for the developments.

Mihael Polymeropoulos: Thank you very much Andrew. thank you.

Operator: There are no further questions at this time. I will now turn the call back over to Vanda management for closing remarks.

Mihael Polymeropoulos: Thank you very much all for joining us on this call. Thank you.

Operator: This concludes today’s call. You may now disconnect.

Follow Vanda Pharmaceuticals Inc. (NASDAQ:VNDA)

Page 3 of 3