Greetings, and welcome to Palatin's Fourth Quarter and Fiscal Year End 2023 Operating Results Conference Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference call is being recorded. Before we begin our remarks, I would like to remind you that statements made by Palatin are not historical facts and may be forward-looking statements. These statements are based on assumptions that may or may not prove to be accurate and that the actual results may differ materially from those anticipated due to the variety of risks and uncertainties discussed in the Company's most recent filings with the Securities and Exchange Commission. Please consider such risks and uncertainties carefully in evaluating these forward-looking statements by Palatin's prospects. Now I would like to turn the call over to our host, Dr. Carl Spana, President and Chief Executive Officer of Palatin. Please go ahead.

Thank you. Good morning, and welcome to the Palatin fourth quarter and fiscal year end 2023 call. I'm Dr. Carl Spana, CEO and President of Palatin. With me on the call today is Steve Wills, Palatin's Executive Vice President, Chief Financial Officer and Chief Operating Officer. I'll now turn the call over to Steve, and he will give financial and operating updates.

Thank you, Carl, and good morning and good afternoon, everyone. Starting with Vyleesi. As a reminder, Vyleesi is our FDA-approved commercial product for pre-menopausal women with hypoactive sexual desire disorder, or HSDD. The goal of the Vyleesi program is to demonstrate commercial product value in the marketplace. With six consecutive quarters of double-digit growth that we are going to talk about shortly, I think we are doing that. But the objective is to re-license the U.S. rights to a committed women's health care company, and that process is advancing. When I say nicely, we do expect that there will be a transaction that we will strongly consider later this year. More about that as we move forward. Specifically, for the fiscal fourth quarter ended June 30, 2023, Vyleesi gross product sales amounted to $4.1 million. This was an increase of 20% over the prior quarter and an increase of 78% over the comparable quarter last year. Net product revenue of $1.8 million, increased 47% over the prior quarter and increased 128% over the comparable quarter last year. Total prescriptions dispensed increased 16% over the prior quarter and increased 92% over the comparable quarter last year. All the value metrics are moving in a positive direction. Refill rates, commercial insurance reimbursement and net revenue per prescription dispensed continued with impactful results and trends versus the prior quarter and comparable quarter last year. Regarding Vyleesi licensees outside the U.S., Fosun Pharma, Palatin's license of Vyleesi in China, reported its first sale in the Hainan Province of China. Kwangdong Pharmaceuticals, Palatin's license of Vyleesi in South Korea, completed enrollment in its Phase III clinical trial, evaluating the efficacy and safety of Vyleesi in pre-menopausal women with HSDD. And data from this trial is currently anticipated by calendar year-end, with a potential regulatory submission in the first half of calendar year 2024. On an additional distribution front, Palatin entered into a strategic partnership with UpScriptHealth, a leading direct-to-consumer telemedicine company, providing telemedicine services to pharmaceutical and medical technology companies, and we anticipate the reach for Vyleesi from an awareness standpoint will be increasing over the coming quarters. Moving over to the financial update. For the fourth quarter – and I will also highlight certain fiscal year ended June 30, 2023 results. Regarding revenue, total revenue consists of gross product sales of Vyleesi, which is net of expenses, allowances and accruals and license and contract revenue. Vyleesi gross product sales to pharmacy distributors for the quarter ended June 30, 2023, as I mentioned, was $4.1 million, with net product revenue of $1.8 million, and this compared to gross product sales of $2.3 million and net product revenue of $0.8 million for the comparable quarter last year. Gross product sales increased 78% and net product revenue increased 128% over the comparable quarter last year. Moving to operating expenses. Total operating expenses were $12.6 million for the fourth quarter ended June 30, 2023, compared to $13.9 million for the comparable quarter last year. The decrease in operating expenses was mainly the result of the recognition of expenses during the fiscal year June 30, 2022, in connection with the sale and issuance of our Series B and Series C redeemable convertible preferred stock and secondarily, to lower spending on our marketing efforts of Vyleesi during fiscal 2023. I do want to expand a comment in that – regarding this $12.6 million, again, from the fourth quarter of June – fourth quarter ended June 30, 2023. This $12.6 million of operating expenses, this is actually greater than what we, if you will, had projected internally. And the reason being, we advance our programs, primarily our Phase III dry eye disease trial, which we did report on recently [hit full] enrollment, that full enrollment did trigger a milestone, which triggered an expense and a payment. But I do want to note that $12.6 million expenses – operating expenses for the June 30 quarter, going forward, over the next several quarters, that number, those operating expenses will be significantly less than $12.6 million. Again, we advance the programs, we hit some milestones, we're going to have some greater expenses. There's always going to be some timing issues in that regard. Let me move over to the cash flows. Palatin's net cash used in operations for the quarter ended June 30, 2023, was $9.6 million compared to net cash used in operations of $7.7 million for the same period in 2022. Again, same reason as I just addressed above, we had some greater expenses due to the advancement of the programs, which is a positive thing, hitting some milestones that hit in the June 30 quarter. Palatin's net cash used in operations for the fiscal year ended June 30 for the full fiscal year was $28.4 million compared to net cash used in operations of $29.9 million for the same period in 2022. The decrease in net cash used in operations, which is not a significant amount, was frankly due to a number of items, including different spending levels for Vyleesi, but also we did recognize some sales from net operating losses to the State of New Jersey that generated over $4 million of non-dilutive financing. Finishing up on the financials with the net loss and the cash position, Palatin's net loss for the quarter, fiscal year ended June 30, 2023, was $10.7 million, again that was for the quarter, and $27.7 million for the year, respectively, compared to a net loss of $12.8 million and $36.2 million, respectively, from the same periods in 2022. Regarding our cash position. As of June 30, 2023, Palatin's cash, cash equivalents and marketable securities were approximately $11 million, plus $2.9 million of accounts receivables. Those accounts receivables 100% good. All those funds have been received in the July, August time frame. And this compared to cash and cash equivalents of $19.6 million with $1.7 million of accounts receivables as of March 31, 2023. I'd say, hey, those accounts receivables went up a little bit. Well, we're selling more, all good. And based on our current operating plan, we believe that existing cash, cash equivalents and marketable securities and receivables will be sufficient to fund currently anticipated operating expenses through calendar year 2023. Of note, I do want to highlight that Palatin's audited financial statements for the year ended June 30, 2023, to be included in the annual report on Form 10-K does include an audit report from our independent registered public accounting firm, KPMG, that contains a going concern explanatory paragraph, which we have had for quite some time. With that said, I'm going to turn it back over to Carl to talk a bit more granular about our exciting development and commercial programs. Carl?

Thank you, Steve. Over the course of 2023, we have continued to successfully execute on our strategy to develop novel therapeutics based on activating the melanocortin system. As I stated previously, we are focused on establishing the melanocortin system as a target for safe and effective medicine to treat inflammatory and autoimmune diseases and to develop a pipeline of highly effective drugs with unparalleled safety. An important component of our strategy is to advance our understanding of the role of the melanocortin system in stress responses, inflammation and tissue repair. Our research efforts are being recognized with the numerous peer-reviewed and scientific presentations by our scientists and academic collaborators. Our research efforts have allowed us to identify opportunities for novel innovative therapeutics to design better clinical trials and are key support for our business development activities. We have three active clinical programs based on melanocortin agonist developed from our research efforts. We are very pleased, as Steve mentioned, to have completed patient enrollment in the PL9643 MELODY-1 Phase III study in dry eye disease and are working to deliver top line data before calendar year-end. Our Phase II study evaluating oral PL8177, a selective melanocortin-1 receptor agonist in ulcerative colitis patients is on track to complete patient enrollment by calendar year-end with the interim assessment data as early as calendar year-end. BREAKOUT, our Phase II open-label study in diabetic patients with kidney disease is also on track for top line data in the first quarter of 2024. Some of the additional highlights for the fourth quarter and fiscal year-end 2023 are as follows. On the commercial front, we are pleased with Vyleesi's quarter-over-quarter double-digit increases across all value metrics. Notably, net product revenue increased 47% and prescription dispensed increased 16% over the prior quarter. We are excited that Vyleesi quarterly net product revenue continues to exceed Vyleesi quarterly operating expenses, i.e., we make some money. As an extension of our commercial efforts in sexual dysfunction, we have developed a co-formulation of our melanocortin receptor-4 agonist bremelanotide with a phosphodiesterase-5 inhibitor as a treatment for men with erectile dysfunction that have failed current PDE-5 inhibitor therapy. To [set us in] aside, bremelanotide is the active ingredient in Vyleesi and phosphodiesterase-5 inhibitors, or PDE-5 inhibitors, are such drugs as Viagra, Cialis and these are the standard of care for men with erectile dysfunction. You may not be aware, but approximately 35% of men with erectile dysfunction fail or have an inadequate response to current treatments and represent a very large underserved market. The only treatment options for these patients are highly invasive, such as penile injections or penile implants. We have previously conducted clinical trials showing the synergistic effects of combining bremelanotide with the PDE-5 inhibitor as a treatment for erectile dysfunction. The large market opportunity and our clinical work support commercial development of this novel formulation, and we are planning to initiate clinical programs as early as the end of this year. Our ocular programs continue to make impressive advances as we stated, MELODY-1 is fully enrolled, and we expect data by year-end. We are very excited by the emerging product profile for PL9643, which is highly differentiated from current treatments for dry eye disease with excellent ocular tolerability, broad efficacy that we believe will make PL9643 the leading treatment for dry eye disease. We presented data from the analysis of the Lead-In population of MELODY-1 Phase III trial at the Annual Meeting of the Association for Research and Vision and Ophthalmology, also known as ARVO, where PL9643 demonstrated broad efficacy and statistical significance separation across multiple signs and symptoms of dry eye disease and excellent ocular tolerability and safety profile with no, I repeat, no ocular adverse events. This analysis was extremely important, allowing us to confidently set the primary sign and symptom endpoints, the analytical methods and sample size of secondary endpoints, the analytical methods and sample size for the double-blind segment of MELODY-1. We are very excited about the data coming out, and we believe we've done everything we can to reduce the risk of this trial and are anticipating a very positive outcome. We also presented data at ARVO on PL9588, our melanocortin-based treatment for glaucoma. And preclinical studies, PL9588 show competitive effects on reducing intraocular pressure with a single topical dose with the magnitude of effect similar to the positive controls of latanoprost and timolol, which are some of the current treatments that are used with effects lasting out to 24 hours. Importantly, we also have shown effects on optic nerve protection, which we think next-generation treatments for glaucoma are not a need. So not only do we lower intraocular pressure with this compound, we actually protect the optic nerve. As we are preparing to advance this important program, we have already initiated regulatory discussions with the FDA. Our research efforts also made significant advances with multiple presentations at scientific meetings, publications and peer-reviewed journals. And our expertise in melanocortin system and innovative clinic programs are supporting our business development activities. We have multiple ongoing discussions with potential partners for our programs, and we remain optimistic that we will enter into one or more partnerships to help advance some of these very exciting programs. As we look forward to fiscal 2024, we have significant opportunities to drive value. We have data coming from 3 clinical trials, initiation of 2 new clinical programs, continued Vyleesi growth and partnerships, advances of Vyleesi by our South Korean and Chinese partners. Steve and I would like to thank you for listening to the Palatin Fourth Quarter and Fiscal Year-end 2023 Conference Call. You can find additional information on our science and clinical programs on our website, www.palatin.com, and you can find additional information on Vyleesi at the vyleesi.com website. Thank you. We will now open the call to questions.

Thank you very much. At this time, we will be conducting a question-and-answer session. [Operator Instructions] Your first question is coming from Joe Pantginis from H.C. Wainwright. Joe, your line in live.

Hey, guys. Good morning. A couple of questions, if you don't mind. But first, best of luck with consummating a Vyleesi transaction. I know it's highly anticipated as you continue to show good traction by not doing that much on your end and having DTC actually show some good results. So best of luck with that. So first, on the 8177 program, I wanted to focus a little more on the upcoming data, which is, I think, anticipated around year-end or maybe going into the beginning of the year. What level of data or what do you think you're going to be able to show us for that interim in UC patients?

So that's the primary endpoint data. So we're – this is a eight-week treatment study, obviously, active versus placebo. And we're looking primarily at a colonoscopy score, so – an endoscopic score. So we're looking for grading. We're looking forward to see at those lesions – also kind of lesions to decrease and show clear evidence of healing based on the Mayo endoscopic sub-score.

Got it. And then, obviously, I mean, going back to Vyleesi a little bit, but more for the combination that you recently announced and gave more details today with the PDE-5 combination. Any more color regarding the design that you're looking at? And what kind of enrollment expectations you might have to be able to drive, say, rapid data?

Sure. A couple of things. So on – so in company. So in the study that we're anticipating in conducting the drugs will be given in – co-administered. So they won't be the co-formulation. What we're looking for in the study is to determine the right ratio of bremelanotide to the PDE-5 inhibitor for the failure patients. The co-formulation would be used in the second – in the follow-up study to that where we can limit the number of combinations that we have to look at. So the study – these studies enrolled very rapidly. We've got – we probably have two clinical sites, actually Philadelphia and New York. We're working with – one of the advantages we've had obviously, a very long history in working sexual dysfunction and ED as well. So as we reach back out to some of our key investigators, they were quite enthusiastic about conducting this study. As they pointed out to us, there hasn't been a new innovation in erectile dysfunction in 30 years, and these guys really don't have an alternative. So I would anticipate extremely rapid enrollment in the study.

Okay. Good. And then you know what, I will go back to Vyleesi by itself for a second. So look, I believe you guys have the wherewithal to be able to say consummate transactions because, obviously, you've had the ex U.S. deals as well already in with upcoming news, as you alluded to. I guess let me play the opposite the argument. Nothing in this world is guaranteed until things are signed. So on the other end of spectrum, if you do not say, license it in the U.S., what potential plans or scenarios would you entertain with regard to Vyleesi and what kind of potential investment you might or might not be considering?

Well, thanks for that question there, Joe. Internally, we couldn't be more pleased with the results, 6 consecutive quarters of double-digit growth. But more importantly, we're not losing any money. In fact, we're making money on Vyleesi. We have a very limited infrastructure. Our plan is the targeted profitable growth, and we're doing that. I mean we got $1.8 million of net sales. We anticipate that going up for the third quarter and the fourth quarter. And at some point, if we don't pull the trigger, and we have options. We 100% have options on pulling a trigger for a transaction for Vyleesi. It's always that balance of the value now versus potentially the evaluator. There's many things that we could do to – and we are considering, but we're trying to balance on it well, if you do it something here now, how does that affect the potential transaction if it's going to be a quarter or two later. 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.

Got it. Appreciate the color guys.

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

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?

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.

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?

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

I see right? I have those. I was thinking some additional work...

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.

Yes. And that looks great. So we'll refer to that again in our notes. But another exciting program coming up here might be in obesity considering its melanocortin target that you have for your pipeline? Any update or feedback for us on interest in the obesity space?

I'll just say – I'm going to say a few of these. Steve's kind of looking at me, he is giving me to glare. I want to say a few things there. Many of you, of course, know we've had a very strong interest in obesity because, in part, many of the people that may be listening to this are a little bit younger, not even around one as we have. The melanocortin-4 receptor was probably the first validated target for obesity treatment. And many of the – most of the larger companies did have programs looking for small molecules. And unfortunately, it's a very difficult target for small molecules, but a very good melanocortin peptides. I know, Michael, you're aware, you cover [setmelanotide] in the [indiscernible] product. We have published on two studies that we conducted with bremelanotide showing very nice weight loss using bremelanotide in obese patients. We also had a very nice collaboration with AstraZeneca for a number of years. So we have a tremendous experience in the role of the melanocortin system in regulating food and taking obesity with excellent compounds good insight on how to develop small molecules. So we're quite excited about the current growth in that marketplace. And there is a coming attraction. There's an obesity week coming up in a couple of weeks. I'm sure you're well aware of that. And so I would just say stay tuned.

Definitely. I'll be down there in Dallas for that. So look forward to that. Question for you, last one, and I can jump back in the queue or keep going, you let me know. But one last one here for now anyway is on Vyleesi. Listening to your comments on the program and your conversation tea with Joe about where to go with this. And occurs to me that with successful advancement in erectile dysfunction, you could market this as the only drug for sexual dysfunction in both men and women that will be unique, that would get a lot of attention. Any thoughts about hanging out of the program a bit longer, at least through some Phase II data with the combination study?

Well, since you brought the topic up about [erectile] dysfunction, there are also clinicians that are prescribing it for men that have other types of sexual dysfunction. Sexual dysfunctions due to SSRI use, low desire due to stress factors and other things. And it works very well in those, and there may be some upcoming data at a meeting about that in the near future. So I personally believe that this will be the more treatment for both male and female sexual dysfunction.

So let me just jump in also, Michael, in that, listen, we couldn't be any more excited with the results we've had and some of the things that we're not going to elaborate on today on where we think with the right investment, very significant normative value for both patients and different types of patients, albeit the pre the post and the male that you're referencing. So 100%, we're analyzing and assessing that. And we have to balance that with, okay, you have several potential transactions that you could maybe move forward with – and even if you feel that strongly, and we do, we think there is a lot of value. The longer we keep Vyleesi and we keep having these results, the more value you're going to get in the future. But we also have to balance it in being realistic. This is a tough landscape, right? We're a small biotech company, and we're getting into cash numbers where we may have to do something over the next several quarters. And the dilutive financing for some deals out there are not pretty. And we're not going to do some of those deals that are being done. I'm not trying to throw a dart or judge anybody else. There are different factors that they take into account. But we are not going to be doing some of those deals that are being done that I don't think a company can recover from. So with that, we have to balance, hey, I have a non-dilutive financing. And no matter what, it's going to be a good deal. But timing is a significant factor for us, and we do take into account the market landscape regarding raising funds. A quick pause on that after the Coke and a hot dog that's not the only potential collaboration that we have that could happen. And I'm not just moving away from Vyleesi, which we have a lot of confidence in. Dry eye disease, we have – obviously, the data is coming out we're hoping for that nice Christmas present in the holidays there. But our other programs have interest. And that's also something – a lot of times, the more – the further you take your program as long as everything is working well, safety, efficacy, tolerability, those types of things, more than likely the greater value you're going to get, but you have to balance where your company is and doing what's right for the shareholders regarding non-dilutive versus dilutive financing. But I want to be clear, we do have other interest. Carl and I try to talk to as many people as we can, where I think it was either you or Joe asked about the 8177 ulcerative colitis endpoints. Listen, these endpoints, this is based on a lot of conversation, not just for KOLs, but companies that would be interested, it's a nice way you start with, hey, if we get the first phase, do you care, right? And we've changed the protocol based on that type of feedback, and that was both with the dry eye disease and also with the ulcerative colitis. But to be clear, we have multiple shots on the goal for cash flow coming in 100% separate than a potential equity raise.

That's great feedback. If I may, speaking of the earlier pipeline programs and cash as well, you've talked about 9643 starting another indication, possibly by year-end. It doesn't sound like that's going to happen. I just want to bring that one up because it's that still...

Sure. So Michael, we look – in the ocular space, we are following up with a separate compound for glaucoma. That would be the next ocular program that pending resources, obviously, we would take forward. We've already started outreach to the FDA on what a trial design would look like with some of the preclinical things we would need and we'll have that feedback before year-end. So we would tend to go there, in part, because our goal at 9643 coming out of the MELODY-1 would really do look for a partnership. So obviously, in a partnership, we take all of the opportunity for PL9643 we will be taken up by that partnership. So that's why we've held back on some of the things we could do there. And really, we're focusing on glaucoma and also back of the eye with 9654, which we didn't talk about, but there's tremendous interest in our retinal programs. Even though they're preclinical, they do represent a novel mechanism, and many people don't – many investors don't follow the scientific literature of the posters and the things we've been presenting there. But the data is quite really quite exciting on how this melanocortin mechanism works to protect the back of the eye from damage. And that really feeds into both retinal and glaucoma. So that's why we're very excited. I mean there's not a product out there for glaucoma, for example, that can lower intraocular pressure and provide nerve protection, which is really what's needed. So when we think about how we choose these programs, we do want to make sure these products are well differentiated from what's out there in the marketplace and they have opportunities to become the leading products in their category.

Yes, I would very much agree. We get back to the eye programs. A question we had coming into this, I'll dovetail after that is 9588. I think you're looking to have by year-end, but you're also working with your subcu formulation. Any update for us on that? And maybe that's bumping into 9654.

So we go through – so 9588 for glaucoma is topical administration. Again, the progression of these types of programs are purely resource dependent, right? There's no – we have no impediment to moving that product forward. The data is sufficient. The activities that we need are beginning to occur. It's a matter of, as Steve was saying, in a tough landscape, we do have to balance out, we will balance out. But I think we'll be successful in what we're doing. So I think the cash will take care of itself.

Appreciate all the feedback guys. Thank you.

Thank you very much. We don't appear to have any further questions in the queue. I will now hand back over to Carl for any closing comments.

Yes. I'd like to thank all of you for participating in the Palatin fourth quarter and fiscal year end 2023. I think through our presentation and the – I think the – hopefully eliminating questions from the analyst, I think you've gotten a good flavor of the depth of what Palatin can deliver from a valuation standpoint. And I know there can always be frustration and disconnects between valuation and opportunity, particularly when we deal with microcap companies. But we certainly believe we're undervalued, and we certainly are going to be working hard to correct that. And we believe we have all the right things in place to do that. So thank you. We look forward to continuing to update you guys and have a great day, and thank you on behalf of Steve and myself and all the employees at Palatin.

Thank you very much. This does conclude today's conference call. You may disconnect your phone lines at this time, and have a wonderful day. Thank you for your participation.