Good morning, ladies and gentlemen, and welcome to the Palatin Technologies Fourth Quarter and Fiscal Year-End 2019 Operating Results Conference Call. As a reminder, this conference is being recorded. Before we begin our remarks, I would like to remind you that the statements made by Palatin that are not historical facts may be forward-looking statements. These statements are based on assumptions that may or may not prove to be accurate and actual results may differ materially from those anticipated due to a 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 and Palatin’s prospects. Now, I would like to introduce you to your host for today, Dr. Carl Spana, President and Chief Executive Officer of Palatin Technologies. Please go ahead, sir.

Thank you. Good morning and welcome to the Palatin Technologies fourth quarter and fiscal year-end 2019 call. I am 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. On today’s call, we will provide financial and operating updates. I’m going to turn the call over to Steve, who’ll provide financial and certain operational highlights. Steve?

Thank you, Carl. Good morning, everyone. Regarding Palatin’s quarter and year ended June 30, 2019, certain operational and financial highlights include, with respect to Vyleesi, which is approved for female hypoactive sexual desire disorder. In June 2019, the FDA granted marketing approval of AMAG Pharmaceuticals NDA for Vyleesi, a melanocortin receptor agonist developed by Palatin, and indicated for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder referred to as HSDD. The FDA's approval of the NDA triggered a $60 million milestone payment to Palatin under our North American license agreement with AMAG. This $60 million was received in July 2019. Additionally, Palatin is entitled to receive tiered royalties on net sales ranging from high single-digit to low double-digit percentages, and sales milestones based on escalating annual net sales thresholds, the first of which is 25 million, triggered at annual net sales of 250 million. Vyleesi is the first as needed treatment for premenopausal women with acquired generalized HSDD. It is currently available through specialty pharmacies, Avella and BioPlus, and AMAG will launch Vyleesi nationally with its full sales force mid-September. We remain focused on advancing discussions on Vyleesi collaborations for territories outside the currently licensed territories of North America, China and Korea. And we have excellent interest from multiple parties from multiple regions. With respect to corporate, cash and cash receivable balances at June 30, 2019 of $102 million is sufficient to cover planned operations through at least calendar 2021. Included in the accounts receivable balance is a $60 million milestone payment due from AMAG for the Vyleesi FDA approval, again, which was received in July 2019. Debt related liabilities decreased from $7.2 million at June 30, 2018 to approximately $800,000 at June 30, 2019. The final payment of $800,000 was made in July 2019, and…

Thank you, Steve. I'll start the operational update with Vyleesi. On June 21st, the FDA approved Vyleesi as a treatment for premenopausal women with acquired generalized, hypoactive sexual desire disorder. The Vyleesi approval is a major achievement for us and we are excited that premenopausal women with HSDD now have a safe and effective as needed treatment options. Vyleesi is a first-in-class melanocortin agonist and the only as needed product approved by the FDA to treat HSDD. Vyleesi is self-administrated by the patient approximately 45 minutes prior to sexual activity. Commercial sales of Vyleesi in the U.S. are the responsibility of our Vyleesi North American partner AMAG Pharmaceuticals. In late August, AMAG made Vyleesi available on a limited basis to patients and the national launch of Vyleesi is scheduled for mid-September. We believe that Vyleesi has significant potential and AMAG with a strong commercial presence of female health is well positioned to drive sales of Vyleesi. Outside of North America, we are working with our Chinese partner, Fosun Pharma; and our South Korean partner, Kwangdong Pharmaceuticals, to advance Vyleesi development in those territories towards regulatory filings. The recent FDA approval of Vyleesi has accelerated global interest in Vyleesi and we are focusing our licensing efforts on finding commercial partners for territories outside North America. And we believe that we will enter into one or more Vyleesi licensing agreements by the end of calendar 2019. Our goal is to have Vyleesi partnerships for all major global territories. We believe our Vyleesi licensing strategy will maximize return on our investment and allow us to focus our resources on our pipeline programs. In the past year, we have also significantly advanced our earlier stage programs. Palatin's melanocortin program has two primary therapeutic areas of interest, autoimmune and inflammatory diseases and rare genetic forms…

Thank you. [Operator Instructions] We'll take our first question from John Newman with Canaccord Genuity.

Hi, good morning, guys. This is Justin Zelin on for John Newman. I just had a question, I was wondering, if you could give us an update just on the potential timing for additional business development deals around the world outside the current available geographies? And I was just curious on both your interest and your partner's interest in potentially additional partnerships?

Sure. Steve can take that question.

Thanks for the question. We're actually quite pleased with the activity and the interest, and that activity and interest definitely increased post the approval of Vyleesi on, that we announced on with AMAG on June 24, 2019. We fully expect to get as Carl mentioned, at least one, if not multiple collaborations executed before year-end. And our target is to basically have all the regions that are not currently licensed and just to remind everyone the current licensed regions are, North America with AMAG Pharmaceuticals; China with Fosun Pharmaceuticals; and South Korea with Kwangdong Pharmaceuticals. So, we're working hard, a lot of interest and looking forward over the next several quarters to executing collaborations in all the available regions throughout the globe. And one thing that we're doing with the multiple interest is making sure we have the right partner. We want to fit their profile and vice-versa regarding our Vyleesi drug. And when I say, their side that they're either already in the female healthcare franchise, have some infrastructure distribution in place, or they have some very specific granular plan strategically and synergistically to go into those areas.

Great. Thank you and just quick follow-up. Is there any additional trials that are needed for regulatory approval in China and South Korea? I was just curious, if you give an update there?

Sure. Both of those territories require a minimum of pharmacokinetic studies, and we are in the process of working with both of them to finalize those protocols and provide drug supply. Anticipate that they will start most likely late this year, but more likely the first quarter of 2020. And since they're relatively short-term studies, they will be conducted relatively quickly. So, we would anticipate that really as we -- either as early as late 2020, if not the first half of 2021 that we would see approval and commercial introduction of Vyleesi in both of those territories.

And we'll take our next question from Joe Pantginis with H.C. Wainwright.

Hey, guys good morning, thanks for taking the question. With regard to the Vyleesi launch, besides the blocking and tackling of the sales force, I mean, just getting the drug out there and the message out there. What do you identify as the key factors that AMAG needs to address? Whether it'd be just educating physicians about the market or what have you? What do you think the key factors are?

This is Carl. Well, thanks for the question. And someday one of the operators is going to get your last name right. But, I think the key issue here, this is the new indication, Vyleesi is only the second drug approved for the indication; and as you can see even in their presentation, I think the two things are really driving patient awareness and physician education. I think those are the two things that really -- will be required and will take some time to do. I mean AMAG has been out there doing that already. They've had, I think 25 plus sales medical reps out since the approval, sitting down with doctors, providing them with the materials required to diagnose and appropriately get patients on to Vyleesi. They've had multiple websites out both prior and then now, after approval for disease awareness and patient education. Tremendous pick up, I mean, hundreds of thousands of patients coming off of those websites, since they've gone on. And I think that those continued efforts will continue to drive the awareness in both the patient population as well as the clinicians that will be treating these patients or treating these women. So, those are really two key issues that I can see.

Joe, I would just add, we're extremely comfortable with AMAG Pharmaceuticals. As I mentioned, for on the earlier response, you look for the right partner and you fit each other's profiles there. They are very motivated. This is the space they play in. They can talk much better than we can, if you will, but from what we know and what we've been informed about, they're taking all the right steps, and we are very confident that this launch is going to do very well. They're doing everything they need to do. And again, they are very motivated and very aligned with our interest; and frankly, the interest to get a new treatment available to the premenopausal women out there.

Certainly, that's good to hear. And then my next question is and I don't know how much you want to or able to address this. But with regard to the, with the way the shares have been trading, obviously you have a new drug approved, there was like transient uptick in the shares. I personally don't believe as part of our work that you're getting value right now from your pipeline assets. So do you think right now that, is there anything beyond the typical, I guess, perceived launch execution risk that might be impacting the shares at this point?

I'll pass over to Steve to answer that.

I mean, the short answer is, we don't believe so. Nostradamus doesn't call me back, but it's -- there's a number of different factors out there. We do have a bit of a significant short position for our type of company, based on what we're, from a profile standpoint. We trade on June 24, we traded 50 million shares of which 20 -- a little over 20 million were short positions. We do have some warrants outstanding that from an overhang standpoint, we believe it's not unreasonable to certain shareholders. We'd use those warrants as hedging strategies. That said, we couldn't be more enthusiastic and excited about where we're going with Palatin. We've never had, I'm not going to call it a war chest, but for Palatin, it's a very significant sum. Once the $60 million came in, in July, we have over $100 million of cash. And we're going to be very prudent and very informed of how we -- and we don't like to use the word spend, it's more like how we're going to invest those funds and invest in the Palatin pipeline. As you can see, we're a small company, but we have a lot going on, the Vyleesi approval, AMAG handling the launch. We're very confident that they're going to do an excellent job with that. Our support to AMAG in North America is now somewhat limited, but we're of course moving very aggressively for the rest of the world collaboration. Even though, we're very excited with Vyleesi, and no question, the milestone achievement is absolutely a landmark for us. We couldn't be any more excited for the programs that we're now able to advance and advance because we now have the cash and the infrastructure in place. So, we're very much looking forward to reporting, to starting, if you will these three trials within the next few quarters and reporting some of the data before the end of calendar 2020.

And that concludes the question-and-answer session. I would like to turn the call back over to Dr. Carl Spana for any additional or closing remarks.

Sure. Well, I'd like to thank everyone for participation in our fourth quarter and fiscal year-end 2019 conference call. I think Steve has made more than crystal clear. We are quite excited about the prospects of Palatin and achievements that we have and we continue to look forward to advancing our programs and continuing to have positive progress as these things go forward. As always, we look forward to seeing some of the institutional investors that are on the call, as we go out and meet you. And unfortunately, we don't have ways to see the retail investors, but we do hear your questions when they come in. And many times you can find the answers to those questions in our filings. And I hope we've addressed many of them on this conference call. Thank you. Have a great day.

Thank you. And that does conclude today's presentation. Thank you for your participation. You may now disconnect.