Good morning, ladies and gentlemen, and welcome to the Palatin Technologies Second Fiscal Quarter 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 could 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'd 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' second quarter fiscal year 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. Now, I'm going to turn the call over to Steve, who'll provide financial updates. Steve?

Thank you, Carl. And good morning, everyone. Regarding Palatin's quarter ended December 31, 2018, and recent operational and financial highlights, with respect to Vyleesi, which is under development for female hypoactive sexual desire disorder or HSDD, the FDA PDUFA date is June 23, 2019. Of note, if approved Palatin is due to receive a $60 million milestone from AMAG Pharmaceuticals, our North American licensee. On the Vyleesi business development front, Palatin is in discussions with potential collaboration partners for certain regions outside the licensed territories of North America, China and South Korea. Carl will expand on the Vyleesi program during his portion of the presentation as well as our other programs under development. Regarding the quarter ended December 31, 2018 financial results, Palatin reported a net loss of $5 million or $0.02 per basic and diluted share for the quarter ended December 31, 2018 compared to net income of $3 million or $0.02 per basic and diluted share for the same period in 2017. The difference in financial results between the three months ended December 31, 2018 and 2017 was mainly due to the recognition of $10.6 million in license and contract revenue during the 2017 period pursuant to our license agreement with AMAG. Regarding revenue, there were no revenues recorded in the three months ended December 31, 2018. For the three months ended December 31, 2017, 100% of the revenue Palatin recognized was related to our license agreement with AMAG. Regarding operating expenses, total operating expenses for the quarter ended December 31, 2018, were $5.1 million compared to $7.7 million for the comparable quarter in 2017. The decrease in operating expenses reflects the completion of the Vyleesi Phase 3 clinical trial program and related ancillary studies necessary to file the NDA in 2018. Regarding our cash position and working capital, Palatin's cash and cash equivalents were 24.7 million at December 31, 2018 compared to $32.6 million at September 30, 2018 and $38 million at June 30, 2018 are natural fiscal year. Current liabilities were $4.5 million at December 31, 2018, compared to $8.5 million of September 30, 2018. Palatin has also decreased its debt and related liabilities from $7.2 million at June 30, 2018 to $5.3 million at September 30, 2018 to $2.8 million at December 31, 2018. We believe that existing capital resources will be sufficient to fund our planned operations through at least March 31, 2020. Carl?

Thank you, Steve. I'll start operational update with Vyleesi, our lead clinical product. Vyleesi is a first in class melanocortin agonist which is the only on-demand drug to complete Phase 3 clinical trial for hypoactive sexual desire disorder. Product's format is a simple single-use subcutaneous autoinjector self-administered by the patient approximately one hour prior to sexual activity. We've been working with AMAG Pharmaceuticals, our North American licensee partner for Vyleesi to support the Vyleesi new drug application, which AMAG submitted to the FDA in March 2018. The NDA was accepted for review by the FDA in June 2018 and the PDUFA date for Vyleesi NDA is June 23, 2019. In November 2018, as part of our discussions with the FDA regarding its review of the new drug application submitted for Vyleesi, the FDA requested additional data assessing 24-hour ambulatory blood pressure with short term daily use of Vyleesi. Palatin and AMAG are currently conducting the study and will have the data submitted to the FDA in advance of the Vyleesi June 23, 2019 PDUFA date. In the two large North American Phase 3 Vyleesi studies subject to Vyleesi approximately three or four times per month or about once per week. However, there was a small subset of subjects that use Vyleesi more frequently. The requested study is designed to provide data on the short term daily dosing of Vyleesi or informed labeling purposes. Outside of North America, we are working with our Chinese licensee, Fosun Pharma and our South Korean licensee partner Kwangdong Pharmaceuticals to advance Vyleesi development in those territories towards regulatory filings. In addition, the Committee for Medicinal Products for human use of European Medicines Agency has provided advice on the European Union Vyleesi Development Program indicating that only a single Phase 3 study in the European Union…

[Operator Instructions] Our first question will come from John Newman, Canaccord

Hi there. Good morning. And thanks for the update. Thanks also for taking my question. So Carl, you give us an update on the clinical data that the FDA have asked you for and just curious if you could talk to us about why you think the agency is asking for this study at this particular time point? And also just remind us the blood pressure monitoring that was done in clinical studies, I know that you had previous alluded that.

Sure. I think as I noted in the presentation or the discussion, for the most part, the Vyleesi is used about once a week. That's probably going to be the average use pattern for the product. However, we turned out that there was a small set of patients that clustered their dosing. So they may have taken the drug for four five days in a row versus say once a week. In our Phase 3 program or in our overall program, we extensively evaluated the effects of Vyleesi on blood pressure using ambulatory blood pressure measurements in a once a week format and I think the agency was very pleased with that data. They accepted it and realized that there was a small 2 to 4 millimeter transient change in blood pressure. However, we didn’t have the data or we didn’t have comprehensive data on what happened if patients took it every day or say four or five days and naturally what the study is doing. It's really just evaluating the use of Vyleesi over eight consecutive days and measuring and characterizing the blood pressure effect. I don't anticipate that we were going to see anything different than we saw in the once a week, but I think the agency is doing its job and being careful. There is a non-life-threatening indication and I think that they're dotting the I's and crossing the T's and making sure that they can provide a label to patients and prescribing physicians that really characterize the effects of the drug. I determined if there are any subsets of patients that you might not want to take the drug or if you have some precaution when taking it. So that's really the nature of this. I don't think this is not an issue, I don't anticipate that we were going to see anything that we haven't already seen or don't really understand but it will be a formal study that will characterize the effect over short term daily use, which will allow the agency to feel comfortable in putting the appropriate label on the product.

Great. Thank you.

Thank you. Our next question will come from Joe Pantginis, H.C. Wainwright.

Carl, since you just mentioned the label curious, if the data come out clean from this blood pressure study, could this lead to a potentially better label for the drug?

Certainly, compared to not having it yes, in the absence of the data, the agency would have had to put a very cautionary label on because it didn't exist or they weren’t comfortable with the data over there or the extent of it. So I think that we will wind up with a label that is appropriate for the product that that highlights or has all the pertinent information allows the safe use of the product.

And just had a curiosity, did the filing, the NDA filing with the Phase 3 data, did that have the level of granularity for patients enrolled in the reconnect studies that had sort of as you describe it the clustering use and impacts on blood pressure that would sort of act as a supplement to this study.

So in the Phase 3 program, that's a more general study. So blood pressure there was characterize through blood pressure cuff measurement. We certainly have patient, different types of patient there and pre-menopause, women are relative healthy, premenopausal women that were your control [indiscernible] were in that study. In general go over up to almost 18 or 24 months of use, there were no signal, there's no change in blood pressure over time with it, but that's not the type of study one that you would use to characterize the potential effect. We did have other Phase 1 data over short term daily use, but not using as extensive ambulatory blood pressure over 24 hours. We use them over the duration of dosing for example 12 hours. We did have 24 hours. So there was enough data in there to one, indicate that there is not a high probability that there is going to be an effect here, but we didn’t -- we have always characterized the drug as a pure end drug with the subset that this will be taken once or twice per week and I think we came out and when they got to the point of looking at the labeling and looking at the dosing density, there were a subset of patients they did use a daily basis and this is just really a study that is better characterize the blood pressure in those patients. As I said, I don't anticipate based on what we know, based on previous Phase 1 studies that there is going to be any cumulative effect. We know that there does appear to be at all. It's just that this is really a formal study that poses that question and answers it using up-to-date methodology that wasn't necessarily using the earlier programs, earlier studies.

And then my last question is, I don't know if you can answer this, based on either direct feedback from the regulatory agents or from the FDA in this case or from even body language regards to the need or the desire for them to conduct an adcom at this point assuming the data are clean?

What I can tell you is there was an Adcom scheduled for January 15 that obviously did not occur and I think based on -- I think if we get a study done in a timely fashion, which we will and submit it to the agency with sufficient time for review, I think if there's no -- if it's a clean study, which I anticipate it will be. I don't think that there will be -- I don't personally think there will be need for an Adcom and they certainly would not be time from when we would submit it to the June 23 date. So I'll leave it at that.

The next question will come from Michael Higgins, Ladenburg Thalmann.

Thanks for taking the questions. Couple on Vyleesi if I could and then on the pipeline. The plan outside you also believe they started to bridge in the first half of '19, if that's still the case and also noted in your PR and your Q, I think all your discussions with partners outside you currently partnered Vyleesi, can you give us some feedback on the timing of those discussions? Great to have those, I am little surprised what's happening there? Are your partners involved with your discussions with European authorities and when you look for next year as it relates to potential [ph].

Sure, I'll start and then I'll pass over to Steve, what we did, one thing that we wanted to accomplish prior to really finalizing any business development activities with the -- around the year right to [indiscernible] and European market in particular, was really to understand and get feedback from the EMA, the regulatory authorities for the territory as to what would be required for the development of bremelanotide or Vyleesi in that territory. We had some earlier discussions with them and we wanted to confirm your structure of the trial, what it would look like. We obviously want to conduct the trial that is very similar almost identical to what we did in North America marketplace and we wanted to confirm that a single study would be sufficient in conjunction with the North American studies for a licensing application. We have just towards the end of last year, got our feedback. We were pleased with the feedback. I think we were able to conduct a trial using endpoints that were identical to what we used in the US and that a single Phase 3 trial would be a sufficient filing. So that now really opens up the door for us to accelerate or reinstituting the discussion that we were having and I'll turn that over to Steve, since he is leading that activity.

As Carl mentioned, the AI that we needed was, we needed more specificity, granularity around the specific protocol for approval in Europe. We have that now and as Carl mentioned, we were pleased with the response and the dialogue from IMA/CHMP. So that activity has definitely increased, not just us calling, but also inbound calls. We're actively and aggressively in discussions with all the regions outside of the already licensed territories of North America with AMAG, China with Fosun and South Korea with Kwangdong Pharmaceuticals. So we and as we get closer to the PDUFA date and the approval I'm very comfortable that these discussions will even advance greater. We're also working closely with our existing rest of the world partners i.e. Fosun, Pharma and Kwangdong. They are in active discussions with the related regulatory FDI in China and the same equivalent in South Korea on planning their specific regulatory path. So we're very excited and enthusiastic with the activity and the interest and with the assumption and caveat that were approved in June. We would anticipate that frankly all the regions outside the existing territories would be licensed before the end of calendar 2019.

Okay. Congrats. That's great, that's critical, identical to what you've done in the U.S. Last week in the conference call management suggested that the common signal at the experts on the blood pressure signal, is that view as well that without the Adcom agencies more bullish on the NDA and early May your time in which we would expect to hear whether or not there be an Adcom ahead of the PDUFA?

Sure, so just (inaudible) I think that each product is evaluated by our own merits, risk reward profile. Vyleesi is a PRN medication, the vast majority of patients who are going to have exposures of three to four times per month, there will be a very limited subset of patients that may have a few more times in that. Keep in mind our dosing limitations that we only would anticipate approximately six to eight doses being available per month on a prescription basis. So I think that Vyleesi falls into a category where you're characterizing the blood pressure effect. The clinical risk is low and probably I don't the agency would necessarily have to go out and seek advice from an AdCom. I think that the personnel that we've been working with the agency that are coming from the cardiorenal group are quite conversant with – meet the type of study designs we're using and the potential risk of intermittent changes, of small changes in blood pressure. So I think that we're okay there. However, with that being said, we will be submitting the data back. The agency has the right to take -- to have additional time to review that data should they choose to do so. I don't think at the moment based on our discussions with them, that they will do that, but we always have to plan for that, that they could.

Okay. And then just on the timing, it's early May, there is no AdCom requested, is that a reasonable timeframe to look for that will signal that wouldn’t need an AdCom or think you’ll have discussion with the FDA, you can pass that on.

Sure, I am not getting into the exact timeline that we're going to be submitting. We’ll be submitting sufficiently in advance of the PDUFA date. The agency will make a decision relatively quickly I am sure on whether or not they will be in a major submission and request additional time or not. So I think what I would say is I would anticipate there would be an announcement that we file the data back and then you if you don't hear anything within one to two weeks, you can anticipate that they're moving towards a decision on the June PDUFA date and they won't wait long. The data is pretty simple, it's pretty straightforward, it's going to be a few grasp. They will make a decision relatively quickly I would think on whether or not they want to maintain the current timeline or they want additional time. And obviously if there is any change in that, we would communicate that.

Just as a follow-up to that, any plans in the press release about pressure results from this study?

That is not, the study is in conjunction with AMAG and the NDA is filed in AMAG's name. So although we are heavily involved in the conduct of the study, AMAG will be submitting the data. So that will be up to them as to what they do. I would guess that they will have some statement of concerning the data when they submit it, but I can't speak for them and we have to be guided by them of when they want to disclose.

Couple of questions on the play time if I could 8177, when do you expect to start grower report the sub-queue formulations?

We're targeting probably second quarter start and the study design that we're anticipating are relatively quick. So I would expect if we start in the second quarter, we will get preliminary data late fourth quarter, early first quarter from those studies. They're not designed to be long-term studies. They're designed to have 28 day treatment periods, So they go quickly.

Okay. And based on the point that's really light, next there I think maybe Phase 1 results if you can on that, it will be great.

I missed, you broke up on

Sure 9610, the

So 9610 right now, sure 9610 is in scale at manufacturing for drug product -- for the active pharmaceutical ingredient that will be done probably second quarter and then we'll institute the formal phase preclinical studies. So I expect you really talking about first half 2019 first in human studies, that compound. You will see that we will put out some data on the compound. We have been put this date out on some of the preclinical model and we've done. So we will probably second quarter, we will begin to put out some of that data at some point.

Just quick correction, Carl said first half of 2019, he meant 2020, sorry for that initiation study.

Got you. Sounds good and then one final one here on 8331 dry eye, we plan on Phase 2 back half of '19, is that the oral or is that due?

So that's for 8331 for dry eye is -- they are eye drops and that is progressing and we would expect to start in the second half of this calendar year, we have that already scaled. We are actually working with Ora Pharmaceuticals out of Boston area and this is all they do. So they’ll be helping us lead that charge and we feel comfortable with the timelines they put forward.

Good. You get a lot of pipeline news coming up over the next year or so, so look forward to that. Appreciate the time. Thanks guys.

Thank you. Our next question will come from Joe Pantginis, H.C. Wainwright.

Hey guys. Thanks for taking the follow-up, just had a curiosity and you could say Joe it's too early to ask these questions, but if we get the good news that we're all expecting in June and the drug is approved, maybe this is a question even more for AMAG, but you know what do you think the potential launch timing or turnaround could be number one? And then number two, can you give some comments about the supply chain of the finished device your support there?

Just quickly in their public disclosures, they're anticipating a second half calendar 2019 launch. Steve has been working with them very closely on the supply side. So probably I'll turn it to him.

As Carl stated, AMAG has publicly disclosed that assuming we have that June PDUFA date and approval that they will be launching commercially in the third quarter of calendar 2019. Everything is moving towards that, planning towards success albeit whether it's the education on all the various fronts, AMAG is an excellent partner. Really fits the profile. We're extremely pleased with the relationship and when I say planning for that launch, that does include obviously commercial inventory.

Thanks a lot guys.

Thank you. At this time, we have no further questions in the queue. So I would like to turn the conference back over to Dr. Spana.

Well I would like to thank all of you for participating in the Palatin Technologies second fiscal quarter 2019 call. We look forward to updating you next quarter. It's exciting time for the company. We have a lot of great things going on and we're quite excited about the prospects for the company. So have a great day and we'll talk to you soon, bye, bye.

Thank you very much. Ladies and gentlemen, at this time, this now concludes this morning's conference. You may disconnect your phone lines and have a great rest of the week. Thank you.