Earnings Labs

Palatin Technologies, Inc. (PTN)

Q4 2014 Earnings Call· Tue, Sep 9, 2014

$21.21

-1.37%

Key Takeaways · AI generated
AI summary not yet generated for this transcript. Generation in progress for older transcripts; check back soon, or browse the full transcript below.

Same-Day

-3.06%

1 Week

-8.16%

1 Month

-16.33%

vs S&P

-13.03%

Transcript

Operator

Operator

Good morning, ladies and gentlemen, and welcome to the Palatin Technologies Fourth Quarter Fiscal Year End 2014 Conference Call. As a reminder, this conference is being recorded. Before we begin our remarks, I would like to remind you that 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 would like to introduce to you your host for today, Dr. Carl Spana, President and Chief Executive Officer of Palatin Technologies. Please go ahead, sir.

Carl Spana

Management

Thank you, and good morning, everyone. I am Carl Spana, President and Chief Executive Officer of Palatin Technologies. With me on the call today is Steve Wills, our Chief Financial and Operating Officer and Executive Vice President; and Dr. Jeffrey Edelson, our Chief Medical Officer. On today’s call we will cover the details of our recently announced bremelanotide license and co-development agreement with Gedeon Richter, updates on our development programs and our fiscal year end 2014 financial results. To begin, Steve will provide the financial updates.

Steve Wills

Management

Thank you Carl and good morning everyone. Regarding fiscal year June 30, 2014 and recent operational highlights, on August 29, 2014 we executed a licensed co-development and commercialization agreement with Gedeon Richter Plc a European based specialty pharmaceutical company with a strong focus in female healthcare to co-develop and commercialize bremelanotide for female sexual dysfunction indications in the European Union, other European countries and additional selected countries. On September 4th last week we’ve received €6.7 million approximately $8.8 million as part of the total upfront payment of €7.5 million approximately $9.8 million. €800,000, $1 million as an option fee was received prior. The total of approximately $9.8 million is being recorded as deferred revenue and will be amortized to income ratably over the anticipated European development period. A milestone payment of €2.5 million approximately $3.3 million is due upon the initiation of the Phase 3 clinical trial program in United States. We also have the potential to receive up to €80 million approximately $106 million in regulatory and sales related milestones. This $106 million consist of approximately $30 million in regulatory milestones and approximately $76 million in sales based milestones, plus low double-digit royalties on net sales in the licensed territory. All sales, marketing and commercial activities and associated costs in the licensed territory will be the sole responsibility of Gedeon Richter. We completed discussions and meetings with the FDA on Phase 3 protocols for our bremelanotide for female sexual dysfunction program in the United States. We received comprehensive guidance from the European Medicines Agency on Phase 3 protocols for bremelanotide for female sexual dysfunction in Europe. We advanced our lead natriuretic peptide compound, PL-3994, a receptor-A agonist for treatment of cardiovascular and pulmonary indications. A Phase 2A multiple dose clinical study in heart failure patients is targeted for the…

Jeffrey Edelson

Management

Thank you, Steve. Our fiscal year end 2014 operational and programs update will start with an overview of our Bremelanotide Phase 3 female sexual dysfunction program. Our activities are focused in two areas, operations required to start and conduct Bremelanotide North American Phase 3 pivotal registration studies and ongoing corporate partnering activities. We believe that there is a substantial global market for Bremelanotide with the United States being the large potential market followed by the European Union. We believe the most effective strategy is to have distinct partners each of the United States, European Union and other territories of the world. Carrying out this strategy we announced last week that we entered into a license and co-development agreement with Gedeon Richter, a European based specialty pharmaceutical company. Earlier in this teleconference Steve provided additional details on the agreement, I will now provide some details on what this agreement means to our Bremelanotide program. We believe Gedeon Richter will be excellent partner for Bremelanotide as they were a leader in the development and marketing female healthcare products. The female healthcare franchise at over $500 million in sales in 2013 and they have a strong ongoing presence in Europe and other regions. In addition Gedeon Richter brings relevant regulatory and clinical operations experience that will help to ensure the potential success of the Bremelanotide European Phase 3 development program. Prior to execution of the agreement Palatin and Gedeon Richter met with the European Medicine Agency and received written scientific and regulatory guidance for the Bremelanotide European Phase 3 program. Bremelanotide European development program will mainly consist of a single Phase 3 pivotal trial conducted in Europe. Gedeon Richter with support from Palatin will conduct European Phase 3 clinical trial. Currently we’re working with Gedeon Richter on the activities required to begin enrollment…

Operator

Operator

(Operator Instructions) And we will take our first question from Charles Duncan with Piper Jaffray.

Charles Duncan - Piper Jaffray

Analyst

I wanted to ask you a question regarding bremelanotide and the FSD programs. You spoke about giving some decent advice. I'm wondering if it might be useful to just remind us of some of the differences between the Phase 3 trial design as proposed in the United States and the Phase 2 data or a Phase 2 trial. And then perhaps even talk about maybe some of the differences between the U.S. and European strategy?

Carl Spana

Management

Sure, I will cover a couple and then Jeff may jump in. There weren’t a tremendous number of differences, the endpoints that will be -- we had a single primary endpoint in the Phase 2B program which was the change in satisfying sexual events, it will now be a co-primary endpoint of the change of satisfying sexual events and then the change in desire as measured using the female sexual function index desire sub-domain. And I know that’s a lot to say, but the FSFI desire domain is a validated instrument for measuring changes in desire. That was a secondary endpoint in the Phase 2B program, which is elevated to a co-primary. Other than that, really the changes, the trial design will be fairly similar. The duration of treatment was 12 weeks in the Phase 2B, it will be 24 weeks in the Phase 3 program. But beyond that I think they're fairly similar. I don't know Jeff if you have any additional?

Jeffrey Edelson

Management

Sure Charles, it is Jeff Edelson speaking. The other two major improvements really in the design are the removal of the fairly rigorous ambulatory blood pressure monitoring program that was part of the Phase 2. As you recall one of our goals there was to actually characterize the presence, magnitude and duration of any change in blood pressure, we did that and don’t feel that further characterization is required going forward. And there will be just one active dose of BMT in the pivotal, having shown that the 1.75 milligram dose is safe, effective and well tolerated. We feel this is an appropriate dose to progress in pivotal studies.

Charles Duncan - Piper Jaffray

Analyst

At latter point it seems to me -- is a big positive in terms of impacting potential placebo effect. Are there any differences in -- call it the level of superiority or the enrollment criteria that you would point out?

Carl Spana

Management

No these patients will be screened in a very similar way to the way they were done in the Phase 2B program. Placebo and probably realize this, but female sexual dysfunction is not characterized by severity of disease, you either have it or you don’t, it’s kind of, more of a biphasic diagnosis. So they're not stratified by severity of disease. We of course do secondary analysis based on scores, but none of that has been validated to show that there is any difference.

Jeffrey Edelson

Management

Yes Charles, I mean as Carl says it’s a binary diagnostic, but the issue for us is potential confounders of the diagnose so for example substance abuse, relationship dysfunction, concomitant depression will be things that could confound the diagnosis of FSD.

Charles Duncan - Piper Jaffray

Analyst

And you will be keeping track of all those things at screening, right?

Carl Spana

Management

: Correct, those are all things that we monitored during screening and quite frankly I think we did a very good job in the Phase 2B in getting a handle on to actually do a diagnosis of this across a broad number of size to make sure that we get a consistent patient population and a lot of those learnings of course are tracking into the Phase 3 program. So I think we have a good handle on making sure that we will get as uniform patient population for Phase 3 as we can.

Charles Duncan - Piper Jaffray

Analyst

And then the European advice, how could things will be different, is there going to be some kind of active control there?

Carl Spana

Management

: No, there is nothing approved in European Union, so we don’t have the issue of active control. Again it’s not that dissimilar compared to the U.S. there maybe two doses evaluated there, the 1.75 milligram and a lower dose is under consideration. The European Union, the women are a little bit lighter in weight so a lower dose maybe commercially reasonable to have. Addition to that the end points will be very similar patient selection criteria will be very similar.

Jeffrey Edelson

Management

: One of the differences was that the EMA advice thus not to conduct the placebo baseline period. We actually wanted to characterize the placebo response and then innumerate the drug effect on top of the placebo response as we did in Phase 2 that is our U.S. design. They did some sophisticated analysis and felt that we could just demonstrate the total drug effect, which obviously would include some element of placebo effect in European study and we find that doable.

Charles Duncan - Piper Jaffray

Analyst

Okay, good, and then the size of that trial roughly similar or I guess if you’re going to include possibly another lower dose it might be a little bit larger.

Carl Spana

Management

: Well, it get larger I mean I think we’re talking around 600 patients in each of the U.S. pivotal so about 300 patients per arm, the European pivotal program as it includes two active arms plus the placebo would be around that.

Jeffrey Edelson

Management

: Yes, we can innumerate the central tendency or the standard deviation if we will around the treatment effect including the placebo effect by back calculation from our Phase 2 data we have.

Charles Duncan - Piper Jaffray

Analyst

Okay. And then, I’m sorry to take more time, but I had a quick question, it wasn’t clear to me what you’re saying Carl regarding 3994, do you plan to conduct the Phase 2 yourselves or would the next be looking for possibly a collaboration to help fund that program for 3994 in heart failure?

Carl Spana

Management

I think we’re running potentially right both in parallel, so we have the resources internally to prepare to do the next study with 3994. We’ve actually got a fair amount of corporate interest in that program as well. We really don’t have to make that decision until the beginning of next year. So we are putting all the pieces in place and we’ll make a decision probably as we really get into the beginning of next year whether or not we'll run it. The next study is not a large study, it’s a multiple ascending dose study that would be conducted in the clinic, so it is something that -- not would be something within the realm of what we could conduct at Palatin. Will be the study after that which would be the one that'll be a larger and proof of concept where you're talking about larger number of patients going to be at home setting and that's something where we most slightly want to have a partnership on board with that.

Operator

Operator

And we’ll take our next question from Joe Pantginis from Roth Capital Partners.

Joe Pantginis - Roth Capital Partners

Analyst

Hi guys good morning, thanks for taking the question. Maybe just a little more feedback on the end points for the Phase 3 in the U.S. Obviously you have agreement with the FDA in terms if you will, I guess the question that I have is FFD seems to be a little bit in flux still with the physician community company is waiting to see if flibanserin is going to get approve I believe it's at the end of October I think the FDA is hosting a workshop regarding FFD and end points to look at parameters in the space. So I guess my question would be, is there the potential for any future changes still to your pivotal design study based on what happens with flibanserin or the potential outcomes from this FDA workshop?

Carl Spana

Management

: Joe, couple of things, one, flibanserin is a little bit an odd situation because the two pivotal trials there they use satisfying sexual events as one of the co-primaries, but they use the daily assessment of desire as the second co-primary end point and they fail to meet that. So what they’re actually are basing, potentially the FDA will be basing their approval on would be a number of larger trials that were not considered to be pivotal in which the satisfying sexual events and the change in desire as measured by the FSFI Desire sub-domain the 28 day recall was the second co-primary end point. So I think in line with that our end points are in line with where I think current FDA thinking is. You asked me with the exchange if things are in flux, one of the things that we’re doing is we have a fairly robust assortment of secondary end points and measures in the phase 3 pivotal program and I'll just give my opinion, Jeff can give his own, this is purely an opinion. If there is probably going to be a change in how the FDA potentially evaluates these products it would be more likely based off of the day that we generate than just an overall coming up with things but Jeff may have a different opinion.

Jeffrey Edelson

Management

Yes, I think that the way I see the trend, this is just my opinion, but I think it’s pretty clear that regulatory agencies including the FDA are increasingly comfortable with a combination of a behavioral measure like SSEs which is kind of the integrated sum of a lot of inputs and then something that more relates directly to the path of physiology of the disease which is the decrease in desire. So the FSFI desire domain has been well validated, we think the interrogation interval of a month is appropriate because there is pretty good data that women conceptualize their sexuality over a more longitudinal period and there is some data that daily assessment of desire they just find annoying and then kind of negative. So we think there is a sort of general themes emerging and we think we’re totally -- our program is can concurrent with those and in fact in these end points, these specific end points in the phase 2A program, the program was very successful. So, we think we’re well situated to evaluate the drug in its phase 3 program.

Joe Pantginis - Roth Capital Partners

Analyst

That’s helpful, thanks and anything any, just quick comments about the upcoming FDA workshop.

Steve Wills

Management

: This is I think -- I won’t say public relations, it may be not the right word but this is a process that the FDA is doing for a number of indications they’ve done it for restless leg syndrome, I think they've done it for fibromyalgia and this is one of the series of these public workshops that they’re doing where they’re trying to be seen as reaching out to the patient and advocacy groups to illicit their input into the FDA process.

Jeffrey Edelson

Management

: Yes, I mean this is part of the patient consultation program and as such we hope that it clearly captures both the both prevalence of this disease and the severity and impact it has on individual people.

Operator

Operator

And we’ll take our next question from Rahul Jasuja with Noble Capital Markets.

Rahul Jasuja - Noble Capital Markets

Analyst · Noble Capital Markets.

I missed almost the entire prepared statements, so if I’m being redundant excuse me. One clarification on the FSD program so it’s my understanding that there is two studies acquired in the U.S. 600 patients each and then there is one study in Europe and then the U.S. supporting data for a sufficient to submit with the EMA with just one study in Europe but given the fact that there is a small difference in the design given the measure that placebo response is that still true that it just needs one study in Europe and the supporting study will based on the U.S. study even though there is a small difference in the placebo design, placebo management rather?

Jeffrey Edelson

Management

Yes, Rahul this is Jeff Ed, that is correct. The clearest anticipated difference would be that if in the European study the primary analysis enumerates both the placebo effect and the drug effect one might anticipate there will be a larger magnitude of effect and the U.S. studies will be backing out the placebo effect at baseline and as we can model from our phase 2 data, the absolute magnitude maybe slighter but the clinical significance et cetera, responder analysis et cetera will be identical we think.

Carl Spana

Management

: Also this topic was actually discussed with the EMA scientific advice group and they’re well aware of the differences and they’re comfortable with the concept that Jeff just talked about. So we don’t see an issue with the U.S. studies being supportive or the European trial.

Rahul Jasuja - Noble Capital Markets

Analyst · Noble Capital Markets.

And then again I want to ask and again I apologize, I missed the prepared statements this maybe redundant, I want to talk about 3994 and especially in the context of -- the Novartis data was great, it has ramifications for in the value of 3994 but could you comment on the past experience with Natrecor which was again a different kind of drug different setting and then on the renewed interest with the natriuretic peptide system approach for heart failure there was past use of the NPS system, how is the current setting, the current data at Novartis change everything and this may be redundant because I missed the prepared statements but please --

Carl Spana

Management

: We didn’t address that topic. Natrecor is approved as a short acting IV infused product for acutely decompensated patients really for symptom relief and was predominantly given in hospital setting where these patients came in after having a decompensating event. The issues with Natrecor were really got into trouble when it was used off label as an intermittent treatment for heart failure patients and they were making plans that there may be real benefit there and it turned out in large studies there went, which is not surprising that we’re giving it our short acting drug once a week by the infusion and trying to see if they would have long-term effects. Our program 3994 was actually designed to actually in part to have a long acting natriuretic peptide upregulation, so that you could interrogate the value of upregulating natriuretic peptide system on a more chronic basis. Novartis took a very similar approach, in that they wanted to upregulate the system, they did it by blocking degradation. So what it tells you at least is that when you add-on natriuretic peptide upregulation, you get additional benefits that help in the management of heart failure patient -- the symptoms get better, the hospitalization rates get better, survival gets better. And that’s not surprising, the natriuretic peptide system essentially counteracts a lot of the negative effects of heart failure. Jeff you want to?

Jeff Edelson

Analyst · Noble Capital Markets.

Yes, I mean it’s an interesting question. I think the most obvious difference as Carl emphasized is the difference in PK and that’s a very short acting drug in terms of its plasma half-life, not clear how long the biological effects and potential benefit last but clearly it doesn’t appear to be a chronic therapy. The 696 program is interesting because just in terms of the natriuretic side of the equation, the neurolysin inhibitor is clearly much more long lasting in its pharmacodynamics and one would anticipate that the endogenous natriuretic peptides are -- the effect is sustained for a much longer period of time. So I think that’s probably one of the biggest differences. There is a lot of complexity in this pathway. Neurolysin actually -- there are other vasoactive peptides that also decay which could be inhibited by blocking neurolysins, that’s one hypothesis. Additional hypothesis is that we know that there is a functional defect in activation of some of the natriuretic peptides in a large percentage of the population as many as 15% of some sub-groups of people have a deficiency of corn which is the processing engine that activates some of the natriuretic peptides. And then finally what we don’t understand that the receptor pathway level is whether there is attenuation of the response with continued signaling. So, there is a lot of complexity to be sorted out, but bottom line is that the drug was beneficial with a significant mortality and morbidity benefit and we find this extraordinarily exciting.

Rahul Jasuja - Noble Capital Markets

Analyst · Noble Capital Markets.

Thanks. And then one more follow on that front quickly. This phase 1/2 data, this phase 1 data that was completed several years ago 3394 and the utility of the NPA system was I guess less rather than today. And if I remember correctly there was really encouraging cardiovascular metrics that panned out of the phase 1 study. So, one, are you going to build on that approach of course the same sort of clinical trials for the phase 1, 2 going forward? And isn’t there a subset of patients that have a mutation in the NPA system that can be targeted more as a mixed population?

Jeffrey Edelson

Management

: That’s great -- a really excellent question Rahul, yes, there are some population of people who one might anticipate to have greater benefit. My understanding of the PARADIGM-HF trial that was published two weeks ago was that there was no selection based on pharmacogenetic or genotype markers. We would attempt to characterize that during the phase 1b, phase 2 program with this drug. One question is do people respond differently to different doses of drug like is there a rationale for individual dose titration, one might anticipate people who have a corn deficiency to have a different optimal dose than people without such a deficiency for example. So these are things that need to be sorted out I think in the clinic. Clearly there are endpoints like cardiac ejection fraction, cardiac function imaging and response to exercise loading that can all be done in smaller, more carefully controlled trials. And then obviously if the drug looks promising there than a more larger phase 2a proof-of-concept study I think would be in order.

Operator

Operator

And we’ll take our next question from Charles Duncan from Piper Jaffray.

Charles Duncan - Piper Jaffray

Analyst

Thanks guys for taking the follow-up. I have a quick question on the obesity program, which I understand now a lot of folks are focused on but I did want to ask you, if you and your current partner AZ have a development candidate that is identified and ready to move through IND enabling studies yet?

Jeffrey Edelson

Management

: As I think I mentioned on the call while AstraZeneca was kind of going through their internal changes and so we’re almost kind of -- didn’t get as much attention as it probably deserved. We continued to do the work at Palatin on moving forward. So, we have a Palatin developed additional compound that we characterize and characterize as we compounds based on our internal characterizations. We’ve shown that data to AstraZeneca and we are in the process of working with them to determine if these compounds will be acceptable for them to go forward. But we believe that they are quite strong candidates and will be acceptable.

Charles Duncan - Piper Jaffray

Analyst

Let me ask you Carl if AstraZeneca doesn’t agree or perhaps a different way, does AZ have total ownership of this program or would you be able to seek alternative or additional partnerships perhaps for a different region and move this program forward?

Carl Spana

Management

The answer is yes. So the compounds that I am referencing were developed by Palatin and owned exclusively Palatin. If we decided not to go forward then we would have the ability to do -- to move them to either on our own or with other partners.

Operator

Operator

There are no further questions in the queue. At this time, I would like to turn the conference back over to Dr. Carl Spana for any closing remarks.

Carl Spana

Management

Well thank you all for participating on our fiscal year end 2014 conference call and obviously thanks for the excellent questions. I hope to certainly bring clarity to some of the things that we covered on the call. So we look forward to a very exciting 2015. We have a lot of exciting programs and projects running on and we are working very hard to get our bremelanotide Phase 3 program started. So with that being said, I am going to close the call, wish you all the very good day and certainly look forward to seeing as many of you as we go out and meet with investors over the next several months. So good bye and have a great day.