Palatin Technologies' (PTN) CEO Carl Spana on Q3 2019 Results - Earnings Call Transcript

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About: Palatin Technologies, Inc. (PTN)
by: SA Transcripts
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Earning Call Audio

Palatin Technologies, Inc. (NYSEMKT:PTN) Q3 2019 Earnings Conference Call May 9, 2019 11:00 AM ET

Company Participants

Carl Spana – President and Chief Executive Officer

Steve Wills – Executive Vice President, Chief Financial Officer and Chief Operating Officer

Conference Call Participants

John Newman – Canaccord

Joe Pantginis – H.C. Wainwright

Michael Higgins – Ladenburg Thalmann

Operator

Good morning, ladies and gentlemen, and welcome to the Palatin Technologies Third 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 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 introduce you to your host for today, Dr. Carl Spana, President and Chief Executive Officer of Palatin Technologies. Please go ahead, sir.

Carl Spana

Thank you. Good morning, and welcome to the Palatin Technologies third quarter fiscal year 2019 call. I am Dr. Carl Spana, CEO and President of Palatin Technologies. 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 updates. Steve?

Steve Wills

Thank you, Carl. Good morning, everyone. Regarding Palatin’s quarter ended March 31, 2019, operational and financial highlights, with respect to Vyleesi, which is the trade name for bremelanotide is under development for female hypoactive sexual desire disorder or HSDD. And FDA requested frequent dosing study with premenopausal volunteers assessing short-term daily use of Vyleesi has been completed by Palatin and our exclusive licensee for North America, AMAG Pharmaceuticals. Data from that study has been submitted to the FDA.

On the Vyleesi business development front, Palatin is in advancing discussions with potential collaboration partners for certain regions outside the licensed territories of North America, China and South Korea.

With respect to our anti-inflammatory and autoimmune programs, we announced positive topline results of an oral clinical study of PL-8177 for ulcerative colitis and other inflammatory bowel diseases. We are advancing activities to commence Phase 2 proof-of-concept clinical studies in ulcerative colitis and non-infectious uveitis. With respect to future milestones, the FDA PDUFA date is June 23, 2019. And if approved Palatin is due to receive a $60 million milestone from AMAG.

Phase 2 proof-of-concept clinical study with the oral formulation of PL-8177 in ulcerative colitis patients is anticipated to commence in the fourth quarter of calendar year 2019. Phase 2 proof-of-concept clinical study with a systemic formulation of PL-8177 in non-infectious uveitis patients is anticipated to commence in the fourth quarter of calendar year 2019 also. Carl will expand on these program during his portion of the presentation.

Regarding financial results for the quarter ended March 31, 2019, Palatin reported a net loss of $5.7 million or $0.03 per basic and diluted share for the quarter ended March 31, 2019, compared to net loss of $0.7 million or zero per basic and diluted share for the same period in 2018. The difference in financial results between the three months ended March 31, 2019 and 2018 was mainly due to the recognition of $9 million in license and contract revenue during the 2018 period pursuant to our license agreement with AMAG.

Regarding revenue, there were no revenues recorded in the three months ended March 31, 2019. For the three months ended March 31, 2018, the $9 million of revenue recognized was related to our license agreement with AMAG. Regarding operating expenses, total operating expenses for the quarter ended March 31, 2019, were $5.8 million, compared to $9.5 million for the comparable quarter in 2018. The decrease in operating expenses reflects the completion of the Vyleesi Phase 3 clinical trial program and ancillary studies necessary to file the NDA with the FDA in March of 2018.

Regarding cash position and working capital, Palatin’s cash and cash equivalents were $19.8 million at March 31, 2019, compared to $38 million at June 30, 2018. Current liabilities were $4.9 million at March 31, 2019, compared to $10.8 million at June 30, 2018. Palatin decreased its debt related liabilities from $7.2 million at June 30, 2018 to $1.8 million at March 31, 2019. By July of 2019, all of that debt at $1.8 million, which is our venture debt will be paid off. We believe that existing capital resources will be sufficient to fund our planned operations through at least the second quarter of calendar 2020. Carl?

Carl Spana

Thank you, Steve. I’ll start the operational update with Vyleesi, our lead clinical product. Vyleesi is a first in class melanocortin agonist, which is the only on-demand drug to successfully complete Phase 3 clinical trials for hypoactive sexual desire disorder. Vyleesi is a simple single-use autoinjector self-administered by the patient approximately one hour prior to sexual activity.

We have been working with AMAG Pharmaceuticals, our Vyleesi North American partner 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, the FDA requested additional data in a clinical study assessing 24-hour ambulatory blood pressure with short term daily use of Vyleesi. The requested study has been completed. The data and final study report haven’t submitted to the FDA for review and we are currently in labeling discussions with the FDA. We believe that we in our partner AMAG could provided the FDA with all the information requested for the completion of the Vyleesi new drug application review and decision by the June 23 PDUFA date.

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 the 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 is needed to support a licensing application.

Now moving on to Palatin’s melanocortin and natriuretic peptide receptor agonist drug development programs. Palatin’s melanocortin program has two therapeutic areas of interest, auto immune and inflammatory diseases and rare genetic forms of obesity. We have developed new families of highly selective melanocortin receptor agonist with potentially broad applications in the treatment of a variety of inflammatory in autoimmune diseases, including inflammatory bowel disease, dry eye, uveitis and other retinal diseases.

Our lead clinical development candidate PL-8177 is a highly selective and potent melanocortin one receptor agonist. In a Phase 1 single and multiple ascending dose study completed at the end of 2018, PL-8177 subcutaneously administered to healthy volunteers was well tolerated and no potential safety concerns were noted.

In the first quarter of 2019, we completed Phase 1 pharmacokinetic study of an oral dosing formulation of PL-8177, as a potential treatment for inflammatory bowel disease. The data from this study indicates that the oral formulation can deliver PL-8177 to the colon without detectable systemic exposure. We believe that PL-8177 will have broad applicability as a treatment for inflammatory and autoimmune diseases. We are currently developing PL-8177 for autoimmune diseases that affect the gastrointestinal system and the eye with two clinical studies targeted to start enrollment later this year.

We are preparing to conduct a Phase 2 proof of principle study in ulcerative colitis patients, which is targeted to start in the fourth quarter of 2019. In addition, we are also preparing to conduct a Phase 2 proof of principle study, non-infectious uveitis patients, which also targeted to start in fourth quarter of this year. PL-9643 is our melanocortin agonists for ocular autoimmune diseases. PL-9643 replaces our compound PL-8331 providing for substantially longer patent term and potentially better efficacy.

PL-9643 has demonstrated excellent activity in animal models of dry eye and diseases of retinal inflammation. We have developed an eye drop formulation of PL-9643 as a potential treatment for dry eye and clinical studies in dry eye are anticipated to start in the first half of calendar 2020.

Regarding our natural lead development candidates, PL-3994 is scheduled to start at Phase 2 trial sponsored by the American Heart Association in conjunction with major research centers in the first half of 2019. We believe that PL-3994 has a potential as a treatment for heart failure with patients with preserved ejection fraction.

And PL-5028, a dual naturally peptide A and C receptor agonist for use in cardiovascular and fibrotic diseases; including reduction of cardiac fibrosis. PL-5028 is in preclinical evaluation as a potential treatment for fibrotic diseases.

We’re looking forward to the FDA decision on the Vyleesi NDA and advancing our product pipeline. We are now positioned to advance multiple compounds into clinical studies for a variety of diseases with high unmet medical needs. We are preparing to initiate clinical studies for multiple ocular inflammatory diseases including dry eye, uveitis our oral formulation of PL-8177 is advancing into initial Phase 2 studies in ulcerative colitis patients.

And for PL-3994, we will begin enrollment in American Heart Association sponsored study early in the second half of 2019. We have a potential clinical candidate in PIPELINE-5208 for possible treatment of fibrotic diseases. We believe that we have a very exciting product pipeline that is positioned to drive long-term growth and shareholder value. You can find additional information on our programs on our website www.palatin.com.

At this point, I’m going to stop and open the call for questions. Thank you.

Question-and-Answer Session

Operator

Thank you, sir. [Operator Instructions] Our first question will come from John Newman with Canaccord.

John Newman

Hey guys, thanks for the question. It seems like the study of the FDA requested has been completed. Just wondering if you could comment as to whether the agency has requested any additional data or you think at this point you’re in good shape there. Thanks.

Carl Spana

Sure. Thanks for the question, John. At this point, there are no additional information requests that we’re working off from the agency. So we think that we’ve given them everything that they need. And as we stated, we’ve moved on and we’re in labeling discussion. So we’re now less than 60 days from the PDUFA date. So we’re very excited to hear what the FDA has to say.

John Newman

Okay, great, great. And in terms of the work that’s going on outside of the United States for Vyleesi, how should we be thinking about additional partnerships in territories that are not currently license? Does that something that you think would be more of a new term event or probably something that take a bit more time.

Steve Wills

Hey John, it’s Steve. We’re in advancing discussions right now with multiple parties. Nothing is going to happen before the FDA PDUFA date. But we’re – we’ve been socializing now for a few quarters, because it takes time to get people acclimated to where you’ve been, where you’re going. So where I’m going to go a little aggressive with this position, but we expect that we will have multiple rest of the world in the non-licensed territories executed before the end of calendar 2019.

The – as soon as that PDUFA date hits, we get what we expect and hope is the approval. We’ll have the traditional Coke and hot dog and then get right back on the phones and get the meetings to try and finalize these territories, these licenses. We have good interest. And as you can expect once, there’s only so much you can advance the discussions prior to the approval, but post that approval, we believe that the people that we’re talking to will – that activity will increase. And frankly some of the people that we’re not talking to, we anticipate knocking on the door.

John Newman

Okay, great. Thank you.

Operator

Thank you. Our next question comes from Joe Pantginis with H.C. Wainwright.

Joe Pantginis

Hey guys, thanks for taking the question. Just do a little follow-up if you don’t mind. With regard to the ambulatory blood pressure study that was submitted, does it appear like they were any hitches? You said FDA hasn’t requested any additional info, so thanks for that. Can you provide any info regarding that actual data that was generated from the study?

Carl Spana

Hey Joe, I knew someone’s going to ask that question. The study is in AMAG study in AMAG as you know has not disclosed the data. What I can say is the study was really designed to help inform the label, how the product would be labeled for patient or in case patients took multiple daily doses of the drug. And I think that since we’re now moving on to labeling discussions. We’ll leave at that. First of all, I’ve been pretty comfortable at the data will allow the agency to label the product appropriately for safe use.

Joe Pantginis

Understood, understood. And if I could just switch to a little bit of financial standpoint, obviously you have the potential for a real nice cash infusion with the $60 million milestone. So I was curious from a P&L standpoint is this – are you going to recognize this as revenue or deferred revenue, and then considering future milestones as well. Can you remind us what the potential milestone payments are from Fosun and Kwangdong.

Steve Wills

Sure. Thanks, Joe. If everything goes as planned, the $60 million, it would actually be recognize in the second quarter, say the PDUFA date of June 23. The actual cash will receive some time in July. The – that recognition is 100% revenue. There’s no deferred recognition for this type of payment at this stage.

Regarding the other, the two license deals that we have and the next regulatory or the next milestone rather. Fosun for China, the next milestone is regulatory approval in China and that is $7.5 million. And if things go as planned, the – it could come in as early as the end of 2020. But we’re internally our expectation is the first quarter of 2021.

Switching over to Kwangdong for South Korea, that milestone is a little less, that’s $3 million. It’s the same type of trigger event, which is regulatory approval. And the timing is actually the same as the focus on with the China. A little bit aggressive, but there is a chance for the end of 2020 – calendar 2020. But just like with the Fosun 1, our internal estimates are the first quarter of 2021.

Joe Pantginis

Great. Thanks a lot guys.

Operator

Thank you. Our next question comes from Michael Higgins with Ladenburg Thalmann.

Michael Higgins

Thank you, operator. Good morning, guys. It’s a follow-up on the ambulatory blood pressure monitoring that we understand from AMAG’s comment earlier this week. We were in discussions with the FDA and the label, has the agency given them or you any feedback whatsoever on the blood pressure monitoring study results?

Carl Spana

No, they have not given any feedback on it. I wouldn’t expect that they would. I would expect –most I would have expected would have been, when information request for some additional analyses, but they haven’t – that has not occurred.

Michael Higgins

Okay, great to hear. And then looking to Europe, you had some comments earlier about that. Just looking for some clarity as to the structure of these, are you talking with partner such that you would have a country by country partner in Europe, ours more likely that you’ve got partnerships across the entire European region? And then that structure of the deals look more for front end versus backend loaded deals. And I assume don’t take some time following the June 23 PDUFA. Should we look for anything and in the summer or would it be more so in the fall?

Steve Wills

Hey, Michael, this is Steve. We don’t anticipate – based on the discussions and our strategy, we don’t anticipate a very decentralized European partnership. We believe it’ll be all of Europe and frankly, some of the parties we’re talking to can – could take multiple territories. So we look as Europe as one territory. The Asia Pacific, Latin America being separate territories a lot of times, some of these companies they have a presence in New Zealand and Australia, that could be a territory. India appears based on some of our initial discussions would be a separate territory, but definitely not country by country licensing for Europe.

Regarding timing, it’s definitely going to be, I mean, the summer is starts when the PDUFA date. So that would be real ambitious and aggressive. So we’re really targeting the fourth quarter. So the fall going into the winter, but we do believe we will have multiple regions license by the end of calendar 2019.

Michael Higgins

Okay. That’s helpful. Also did you look for a start of the pivotal before year end your lead time then start, if you may, before you can start the pivotal in Europe? Thanks.

Carl Spana

We’re actually doing a lot of the work now. So we took the lead and making sure that we’ve got the correct regulatory feedback, which we’ve have, and we’re now putting the protocol together, you’ll find a protocol together identifying potential sites. So we will be make this as easy as possible for licensee coming in that they can essentially have a turnkey operation to pick up and start to run. It would be our preference that we would not be the lead on running a trial in Europe at the partner would do that and obviously, they respond that. But just to make sure that we maximize the downtime before that starts. We’re doing a lot of the work getting it ready.

Steve Wills

Hey Michael, let me just jump in Carl pointed out that I didn’t answer one part of your question. Thanks for that Carl. Regarding structure, it’s going to be a similar structure to say the Fosun and the South Korea deals, which is something upfront, something on approval. And then as you go forward, some sales milestones and royalties there. I can’t go overly specific on, is it going to be a larger up front versus the approval. It really depends on the region. Our main thrust is we want to advance the program, whether I mean Europe or the other regions. So we have some flexibility there. We look for partnerships and variable relationships good for us, good for them and more variable when milestones happened. I think the better both parties feel with sharing those types of proceeds. So hopefully that was helpful.

Michael Higgins

Yes, definitely. Thanks. Appreciate that. If I can turn our attention to your pipeline, specifically in PL-8177. You can give us some help on the timing and the size of those studies on the subcu looks like you’re getting them going before year end. But any trial design health would be helpful. Thanks.

Carl Spana

Sure. Ulcerative colitis is an oral formulation to be pretty traditional trial, there’ll be a controlled study, a randomized controlled trial with these two doses of the PL-8177. Since this is a proof of concept study, treatment duration here will be about eight weeks. We will be looking at additional outcomes that you would look for an ulcerative colitis trial, which are clinical outcomes, reduction and bloody stools, pain so on and so forth. But we also will be doing a lot of extensive colonoscopy examination as well, since this is really a proof of principle and a mechanism study. So there’ll be a combination of both clinical outcomes, as well as colonoscopy and biopsy and biomarkers as well. And then on the uveitis, again, that’s a systemic study, so the drug will be administered through a intimate and subcutaneous dosing.

And there are really no shorter terms, you’ll be doing a lot of ocular – looking at the retina, looking at improvement in the inflammation in the eye. But the overall outcome is maintenance to our improvement in vision for those types of studies. Size of these, they’re not going to be huge studies, the ulcerative colitis study will be probably around 100 patients over the three arms of the study. And then ulcerative colitis will be around the same size. So again, these are very classical first look at efficacy studies to get a sense of how to dose would take types of patients are going to show efficacy, what housing mechanism performing.

Michael Higgins

Okay. And then one of the big drivers for some time has been three, nine, four. Any comments there on the timing of that? I think you’re still looking for that to start at 2019, is it a backhand for the year is I want to hear it.

Carl Spana

Well, we’re optimistic we’ve had – which is we’re not running the study. It’s really – it’s funded by the American Heart Association and it’s – and the leads are the two academic institutions that are running it. We’ve provided the regulatory support, drug supply, so on and so forth. But we do have IRB approvals now. We will be delivering drug in late June. So we’re optimistic that, as soon as we delivered drugs to the site that they’ll start. So it should start really early in the second half. It’s taken a while to get that study going, but I think it’ll be a good study and it does appear as if these slides are now ready to go with all the appropriate approvals from their institutional review board. And we will have drug, as I said in your hands, late first half, early second half of this year. So it should start in the summertime.

Michael Higgins

Okay. Appreciate the feedback. I’ll jump back in the queue. Thanks, guys.

Operator

Thank you. At this time, I’m showing no further questions in the queue. I would now like to turn it back over to management for closing remarks.

Carl Spana

Thank you all for participating on the call and the good questions that we had. Obviously, this is going to be – the end of this quarter is going to be a very exciting time for us. Next time we speak will be after the PDUFA date. And we are optimistic that we will have a positive outcome and a lot to discuss with you. So with that being said, have a great day. Thanks for participating on the call and we’ll speak to you next quarter.

Operator

Thank you. Ladies and gentlemen, this concludes today’s teleconference. You may now disconnect.