Palatin Technologies, Inc. (AMEX:PTN) Q4 2023 Earnings Call Transcript

And a lot of that is around distribution expansion. We are not considering adding a sales force or feet on the ground. But there’s many more outlets out there, especially around the telehealth – telemedicine, i.e., with UpScript that would like to distribute Vyleesi. So we are advancing those types of discussions. Those are things that we, frankly, once we do the deal, we’re transferring the product over to them for a certain price and they’re selling it there. It doesn’t – it’s not going to disrupt what we’re doing. Right now, a lot of those outlets utilize cash-only basis, but it’s really a market and a patient group that we are currently not able to serve because of the way we’re set up for the infrastructure and the spend. So to come back around, we have very significant – we have multiple options that could generate significant value and increase revenue, but not one of them is going to result in us spending money where we’re not making money with Vyleesi.

We’ve been making money on Vyleesi over the last several quarters. And anything we do, we’ll continue with that type of strategy.

Joseph Pantginis: Got it. Appreciate the color guys.

Operator: Thank you very much. Your next question is coming from Michael Higgins of Ladenburg Thalmann. Michael, your line is live.

Michael Higgins: Congrats, guys. Thanks for taking the question. [Indiscernible] and continued progress with Vyleesi and the rest of the pipeline. Just a follow-up if I could on the erectile dysfunction program. Joe was asking some smart questions about the trial. I just want to ask one more, if I could, on design, size, that type of thing, what you’re already able to share at this time? Or do you plan to wait until you start that program?

Carl Spana: No, I mean these are very straightforward studies. These are – as I said, these are dosing studies that are designed to find the appropriate ratio in patients that have failed PDE-5 inhibitor therapy. So you’ll be looking at static dose of the PDE-5 inhibitor with increasing doses of bremelanotide on top of that in patients that have failed PDE-5 inhibitor therapy. So no real – there’s no trick to these studies. They’re pretty straightforward. The way we do the – metrics that we use to measure efficacy are well established. So these studies, as I said, they enrolled very quickly. And there are lots of patients out there. Keep in mind, we’ve also had some discussions with potential third parties around this, and there’s a high interest here.

There are a lot of companies, as you are aware, that are distributing PDE-5 inhibitors on a cash basis. Many of those companies have now added reimbursement – insurance reimbursement, and they’re looking for new products in the ED space. So this is one where I would expect that we would be able to transact relatively early in its development process.

Michael Higgins: That’s fair. We’ll take a look at the other Phase II that have been done many, many years, but will give us some sense for it. It sounds like you’ve got some bremelanotide and PDE-5 inhibitor combination data. If so, what are your plans to share that?

Carl Spana: Well, those are published. That data is published. It’s out in the public domain. You can easily find it.

Michael Higgins: I see right? I have those. I was thinking some additional work…

Carl Spana: There are additional publications by third-party groups, not Palatin, that have looked at monotherapy, for example, of bremelanotide in PDE-5 inhibitor failure showing that significant percentage of 1/3 of the patients that failed PDE-5 inhibitor therapy can be rescued on monotherapy alone. So there’s a very strong precedent here. And I think this is a program that, in our mind, represents – has a very low clinical risk. You have FDA-approved agents that are – with, obviously, PDE-5 inhibitors work. Obviously, we know they work in men and we’ve shown – we’ve treated almost 2,500 men with erectile dysfunction with bremelanotide. So I think there’s very strong clinical precedent here. And more importantly, there’s a very high medical need here. I mean a lot of these – a lot of men out there that just don’t have other options. So we like it from the standpoint, I think both the commercial side and the development side are relatively low risk.