Good day, ladies and gentlemen, and welcome to the Palatin Technologies First Quarter Fiscal Year 2021 Operating Results Conference Call. As a reminder, this conference is being recorded. Before we begin our remarks, I'd like to remind you all that the 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 the 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'd like to turn today’s call over to our host, 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 first quarter fiscal year 2021 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. On today's call, we will provide financial and operating updates. We sincerely hope that you and your families are safe and healthy as you deal with life-altering changes brought about by the COVID-19 pandemic. Now, I’m going to turn the call over to Steve, and he will provide the financial update as well as an update on Vyleesi. Steve?

Thank you, Carl, and good morning everyone. Regarding the first quarter ended September 30, 2020, net loss for the quarter was $3.9 million or $0.02 per share compared to a net loss of $4.5 million or $0.02 per share for the comparable quarter of 2019. Vyleesi gross sales for the period July 25 to September 30 amounted to $809,100. We recognized negative $288,560 in Vyleesi net product revenue, and net being net of allowances and accruals. We recognized no contract and license revenue for the quarter compared to $97,379 for the comparable quarter of 2019. Total operating expenses for the quarter were $3.7 million, including a $1.6 million gain on the license termination agreement related to Vyleesi with AMAG. This compared to a $5 million -- compared to 5 million of operating expenses for the comparable quarter of 2019. As of September 30, 2020, the company had $86.6 million in cash and cash equivalents and $5 million in accounts receivable compared to $82.9 million in cash and cash equivalents and no accounts receivable as of June 30, 2020, and no outstanding debt. The amount of cash and cash equivalents of $86.6 million puts Palatin in a comfortable position to fund its anticipated operating results well through calendar year 2021. Regarding Vyleesi, in July 2020, Palatin announced the mutual termination of its license agreement with AMAG Pharmaceuticals for Vyleesi. Under the termination agreement, Palatin regained all North American development and commercialization rights for Vyleesi. AMAG made a $12 million payment to Palatin at closing and will make a 4.3 million payment to Palatin on March 31, 2021. Palatin assumed all Vyleesi manufacturing agreements and AMAG transferred information data, all the assets related exclusively to Vyleesi, including existing inventory. AMAG is providing certain transitional services to Palatin for a period to ensure continued patient access to Vyleesi and regulatory compliance during the transition back to Palatin. Palatin is reimbursing AMAG for the agreed upon costs of the transition services. The accounting treatment of this transaction resulted in a $1.6 million gain on the license termination. Regarding Vyleesi commercial activities, we've been pretty busy the last few months. To a certain extent, there was very limited support for Vyleesi during the first half of 2020 and prior to Palatin regaining the rights. Some of the items that we have made, what we believe are very positive steps are, we've solidified the distribution network and procedures. We've improved contact and prescribers with -- prescribers and healthcare providers through virtual meetings. We've increased insurance reimbursement coverage, and we just recently initiated a highly selective digital marketing and telemedicine campaign to rebuild awareness and demand among premenopausal women with an initial geo-targeting approach to top prescriber and digital locations. Carl will expand on some of these points related to Vyleesi and also give us a program update for Palatin’s other programs under development. Carl?

Okay, great. Thank you, Steve. As we continue to operate under the COVID-19 pandemic, a primary concern of ours has been the safety of our employees, our patients and our healthcare providers, and partners. As such, we've instituted a work from home policy in March. It continues to remain in effect for our office staff. However, our research laboratory is open and functioning. Fortunately for us, most of our key research and development partners continue to remain in operation and by using teleconferences and various online meeting platforms, we have been effective in continuing to advance our programs. However, we understand with resumption activities there can be further disruptions to business activity based on resurgence of the virus, which is currently happening across the country, and we will be prepared for this potential outcome. As Steve mentioned in July 2020, we re-acquired Vyleesi from AMAG Pharmaceuticals. Just as a reminder, AMAG’s divestiture of Vyleesi was based on strategic and operational changes at AMAG and not on the potential value of Vyleesi. Although Steve covered some of the details of the Vyleesi commercial plan, there are a number of accomplishments that I would like to emphasize. When we re-acquired in late July, there had been limited marketing efforts and nominal focus on the distribution and patient access to Vyleesi. This has led to a sub-optimal patient experience and very unfavorable economics. Under Steve’s directions, we have assembled an excellent and motivated commercial team that has rapidly addressed these issues. Over the last quarter, we have solidified the Vyleesi distribution network, improved the patient experience by retraining our specialty pharmacies, and we have expanded insurance coverage. In addition, we are engaging with healthcare providers through virtual office visits and virtual meetings. These activities are leading to a much better patient experience, improved…

Thank you. [Operator Instructions] And our first question will be from John Newman from Canaccord.

Hi, guys, good morning. Thank you for taking my question. First question is, just wondered how much longer AMAG will continue to provide transitional services, excuse me for Vyleesi and then also wondered if you could talk about potential licensing discussions for Vyleesi and what you'd be looking for here? Thanks.

Hey, John, thanks for the question, it’s Steve. I'll take this one and Carl will jump in with color. The – it's confidential on the period of time, but suffice to say it's going to be orderly. We negotiated with AMAG; you know what we think is a very reasonable amount of time regarding the transitional services, and that also carries over, I think you're probably aware AMAG is going to be acquired by Covis. I believe that transaction is targeted to close very shortly, if not this month. So, we don't see any issues in that regard. Regarding the re-licensing interface for the U.S. or the North America, you know, we are in multiple discussions where we're trying to go about it in a, what we call a very direct way, and that the first few months post the termination of the license and us regaining the rights. They were just as Carl did more than allude to on his presentation, on his prepared remarks. There was just a lot of work that had to be done before we could, you know, if you will have what we consider substantive discussions and move forward. So that is underway. You know, for the most part, it's pretty traditional. We're looking for someone that plays in the female healthcare space, that landscape has the infrastructure and is committed. We have a lot of flexibility at Palatin because we can be a very supportive partner. Depending on the company, the size, the focus, we can handle the CMC, anything in a nice way other than the commercial efforts even though we are handling that right now. So, I think that puts us in a position to be flexible. I think the work we've done in the past – it's been less than four months that we've gotten the product back. And to be clear, the suit wasn't completely tailored in that regard. So, we're, we do believe that we will be in a position at some point in the future to seriously consider a relicensing and make the best decision for the shareholders.

I think that John, I think – [indiscernible] margin, one of the things we’ve also accomplished is really, which will help in licensing is really stopping our dependency on AMAG. So, a lot of the things like manufacturing distributions, these agreements have already been transferred over to Palatin. So, a lot of things that you know, will need to be in place so that you can have a valuable license and a quick license turnover are really, you know, transitioning or have already transitioned from AMAG to Palatin, and as, you know, we've been saying, they needed attention, and they're now been cleaned up and they're functioning. So, we would like to be able to turn over to the partner, you know, like a well oiled machine that's functioning so that this can be just dropped into the bag and they could just focus on the commercial activities. And I think that's the way they will get, you know, maximum value for the product, and a lot of those things have been done already, and I think relatively shortly, we really won't be that dependent on AMAG for much of anything.

Great, thank you.

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

Hi guys. Thanks for taking the question. So, first, just based on your earlier comments about AMAG and the sale to Covis, I just wanted to dot the final I here. So, is there anything that we need to be aware of with regard to the change of control, number one? And then number two, when you look at the pipeline, you are seeking additional -- you're seeking funding, external funding for the COVID-19 program for 8177. So, I thought it might be a good opportunity to just give us a little bit of a reminder, and me a little bit of a reminder with regard to the preclinical data that you have in hand that gives you encouragement for the program. Thanks.

Right. Sure. Just dealing with the transition. We've already been in contact – Steve has really already been in contact with the Covis senior management, and they confirmed that they are, you know, will be in place and continue to, you know, support any other transitional services that we do need from them. So, I don't think –we just think there will be nominal with no impact of that transition, which will close shortly. Well, moving on with this, you highlighted for PL8177 potentially as a treatment for COVID patients, we'll take that in a couple of directions. So, from a pre-clinical standpoint, you know, clearly we know that PL8177 through a variety of models has shown a suppression of production of pro inflammatory cytokines. What was quite interesting to us and quite encouraging to us was really work that was done in a model of lung disease, which is for interstitial pulmonary fibrosis, which is done as what's called the bleomycin model, which is one of the standard models that really looks at the effect of a drug to impact a lung fibrosis, which is really a key detriment in these inpatients. And we saw really nice success in reducing the fibrosis that occurs in lungs in that model. So, there is a nice set of preclinical data from both the anti-inflammatory side and then from the anti-fibrotic side that really supports transitioning into clinical trials. And really, we've had review by both the BARDA program and the ACTIV program and the scientific reviews have been very positive. It’s just that, you know, with the wealth of compounds moving through, and, you know, and the desire to have late stage compounds, you know, we, wind up with great scientific reviews, but you know, come back when you’re ready for Phase 3 type of responses. So, what we're doing along those lines is, we've actually brought in a group that specializes in and helping to get funding for programs such as PL8177, and we're resubmitting grants and other applications to get more support. Unfortunately, because we've had a little bit of delay in the manufacturing, we will have the time to play these things out. Irrespective of the financing, if it comes in or not, we may choose not to go forward if we don't get financing in COVID patients, but we do believe in the value of PL8177 for treating acute lung diseases in general, and we would look at maybe moving in a different indication that may be easier for us to get at, you know, clinical trial sites and patients that would be harder to do with COVID patients right now without support. So, we do think that it will go forward in lung disease in one manner or another. It's just not clear until we really play out the granting process and the external funding process, which way we’d go.

Got it. Very helpful. Thanks, guys looking forward to a lot of important catalysts in the near future.

Thank you. Our next question will be from Michael Higgins from Ladenburg Thalmann.

Good morning. This is Edward on from Michael. I appreciate you guys taking our questions. Just starting with Vyleesi here, looks like the $1.1 million charge in the quarter that generated the negative net sales, just wondering if that's correct, and whether this is a recurring charge, and in terms of net margin, I'm just wondering what we should look for in the next few quarters.

Hey, it's Steve. Well, that number is not correct. I have to talk to our outside auditors. But it is correct. The strategy out of the gate by AMAG was about demand. They did not – if you will have certain procedures in place where you'd have the insurance reimbursement. That was just not the initial strategic strategy. They were going to evolve into, if you will, instituting those procedures where you get insurance reimbursement. They started the – procuring coverage, expanding the coverage, and then the divestiture process started. So, what you see is, if you understand how Vyleesi is being distributed and sold. The first script and the script being defined is for autoinjectors. Palatin subsidized and AMAG had done it prior, subsidizes 100% of that. So that means the patient has zero dollar co-pay. Zero out of pocket for the first – for the script, first script. All subsequent scripts, the refills, they're at a pocket cannot exceed $99. So, what you have is a little bit of a perfect storm right now as we got the product back and that we're expanding the coverage. And I think we're making some very significant increases in that regard. But we importantly, we adjusted to procedures with the specialty pharmacies, whereby we are seeking insurance reimbursement on all the doses. So, as of right now, you have a very substantial amount of, say offset, the rebates, the allowances from the say, the positive gross, the gross sales. That for this period resulted in net sales. As we go forward, that's going to be turned to positive sales, and ideally significant positive sales. A little bit further down in the statement, we also have the cost of goods sold, you can see that it's, we have a very good margin. Even once we get some things in place, and the insurance reimbursement and the demand is moving in the right direction, our gross profit margin will exceed 90%. So, the takeaway there, Edward is this is a timing difference. We've remediated certain procedures and processes. They're in place now. And it is increasing every week and every month.

All right, that sounds great. I appreciate that clarity. And just as a follow up on that point. Looks like you have you know, sales were about 800,000 you have a $5 million run rate for the year. And then are these initial revenues then based on demand or does it include some of the stocking and destocking from the AMAG transition?

You know what, we believe the – I wouldn't extrapolate from what we just did for July 25 to September 30, as Carl highlighted in his prepared remarks, and I commented there that there was work to be done before we could move forward with the attack and the awareness and the demand. The insurance coverage needed to be expanded, pre-certain procedures to allow for insurance reimbursement needed to be modified, corrected at the specialty pharmacy level. So, our position is that demand will increase, and ideally significantly as we go forward. We did also just recently start this geo-targeting digital marketing campaign. And you might say, well, yeah, recently within the last few weeks. And even though we've had the product for a little under four months, it would have made no sense to start that campaign prior; you don't want to increase the demand. And also, if you will have a negative impact on what type of revenue dollars and cash dollars, you were knowing as a manufacturer. So, we believe we're in a really good position with that too, as we're attacking the [indiscernible] going forward to have that upswing in the demand curve.

I'm going to just kind of maybe put it in, because I'm not an accountant. Unfortunately, according to Steve, I'm going to put it in more blunt terms, you know, what we inherited, was a product that was really just aborted. And it had a negative, you know, net sales. We couldn't tolerate that. We need to make money when we sell our fill of Vyleesi script. And we needed to put a lot of things in place to do that, and we've done that now. So, we're now in a position where we can work on increasing the demand, because instead of having said, increased demand costing us money, we're not going to make money. I don't know, maybe I'm a little silly, I think when you sell something you want to make money when you sell it. So, we needed to fix, put in place, the infrastructure that allowed us to do that. And that's now the case. And that's going to expand as Steve; again, they will be modest. We have good insurance coverage. And we're going to have even better as we get into the New Year. We've got a great team working with us. And we're expanding coverage, you know, almost every day. Any other questions?

Yeah, you sort of [granted] my next question there. You mentioned on the previous call about the digital marketing campaign and the coverage, you provided a few numbers around that. I was hoping you could talk a little bit about how much you're investing, what sites you're looking at for the digital marketing campaign, and then if you could provide any updates on the coverage, compared to the last quarter’s call?

Yeah, hey, it’s Steve. The coverage coming in and it was really advancing as we were taking the product back from AMAG was in that 50% range. We were able to get that into the mid-60 range, you know, the mid-60 range being defined as the covered lives out there, which is the acronym that people use, and we're aggressively moving forward. We have a third party expert consultant that's assisting us in this endeavor and our target is to [clear] 75%, if not 80% by the first quarter of next year. So that's about as much specificity I can give around the coverage and it's always confidential on the type of who's covering us, but it's you know, the general rule of thumb is there's five main covers, coverage groups that handle if you will 80% of the covered lives. So, we're in a pretty good position there. We're not seeing any pushback once we get – once we get the right person and the right attention. This is a product that's on demand. We don't have any safety issues. The, you know, the pricing and things of that nature are – there's no push back in that regard. So, it's just a matter of a timing difference again. So, our plan is to come, you by – during the first quarter that was north of 75% to 80% of covered lives.

Okay, excellent. That’s exactly…

Yeah, regarding the digital marketing it's, I mean we're not a full commercial activity. We don't have a salesforce and I believe and Carl believes and a lot of other people that probably be limited impact on the Salesforce during this stage of the pandemic. So, we're utilizing the digital marketing, the Facebook's, the Instagram’s, the telemedicine and the investment is what we think is reasonable. It's between $500,000 and maybe $750,000 for the first few months, you know, as you're laying layering the foundation in there. Thereafter, it probably will go down maybe 50%. And as I mentioned earlier, this is a geo-targeting. We're, you know, we view this as, you know, heightened proof of concept, right. We're not going out national. There are certain areas that we want to show that if you invest the dollars, you have the impact, you have the demand, you have the value proposition regarding the net sales, and that's going to put us in a – what we believe, you know, a much better position regarding the re-licensing.

Okay, makes sense. And then, just one final question on 9643, just about the Phase 3, going forward, I guess if you could provide, you’ve got a little bit of timeline for the outlook? If you could also touch a little bit on the cost and the likelihood of partnering or retaining this asset depending on the Phase 2 results going forward.

I mean, just in general terms, if we have positive outcome, and we're fortunate enough there, we're running a full Phase 3 program next year, you're going to be – it's going to be about $20 million to complete all of the activities for full Phase 3 program, meaning all the manufacturing additional tasks were validation work, all the clinical work, and being in a position to get those studies done, they would be done next year. The good thing about dry eye studies is they're very quick. So, if we start them in the first half of the year, they'll be done in the second half of the year, and you're in a position to file. So, it's a very rapid program. And it's not – for a Phase 3 program that would lead towards an NDA submission. It's not particularly expensive, but will be in the $20 million range to really conduct all the activities we would need to do, and then reposition to file an NDA late next year or early in 2022.

Okay. So, it sounds like you'll be doing this in-house then?

I mean, we – until we have the data and we see it. We certainly have had, Steve has done a lot of the business development activities. And we certainly have had preliminary discussions with potentially larger companies that would be interested in a dry eye product. But really, so you have the data and your regulatory path forward is fully clear. You know, you can't do much. You know, that was going to do a deal with us with data pending. So, when that data comes out, we certainly will look at business development options, if they're on the table and we'll go from there.

Okay, excellent. Thank you, guys. That's all for me. I appreciate all the details.

Thanks Ed.

Thank you.

Thank you. That concludes the question-and-answer session today. I'd like to turn the call back over to Carl Spana.

Great. Well, thank you. I thank everyone for participating on the call. Good questions there we received. Helped us clarify what's going on in the company. We look forward to continuing to update you as things occur. I'm sure I'd be surprised if we don't have another call based around the data coming out from the dry eye disease study in December. We look forward to that and we look forward to keeping everybody informed of the progress that we're making here. You know, team here is working quite hard and there'll be a lot of the [customers] that are coming and will continue to come. So thank you, be safe. Have a great day.

Thank you.

Thank you, ladies and gentlemen. This concludes today's teleconference. You may now disconnect.