Earnings Labs

Palatin Technologies, Inc. (PTN)

Q2 2014 Earnings Call· Tue, Feb 18, 2014

$21.21

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Transcript

Operator

Operator

Good morning, ladies and gentlemen, and welcome to the Palatin Technologies Second Quarter Fiscal Year 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 you to 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 be providing updates on our product programs under development and our second quarter fiscal year 2014 financial results. To begin, Steve Wills will provide the update.

Steve Wills

Management

Thank you, Carl, and good morning, everyone. Regarding operational highlights pivotal Phase 3 clinical trials of Bremelanotide for the treatment of female sexual dysfunction are anticipated to start in the first half of calendar year 2014. Carl will provide detail around the program during his presentation. In January 2014, we received $1.85 million in net proceeds from the sale of New Jersey State net operating loss carry forwards, which will result in the recognition of $1.85 million in tax benefits for the three months ending March 31, 2014 financial statements. Palatin obtained two patents during the quarter ended December 31, 2013, the first one tilted Amide Linkage Cyclic Natriuretic Peptide Constructs was issued November 12, 2013 and the composition of matter claims to a novel series of mimetics of atrial natriuretic peptide. The second patent titled Cyclic Natriuretic Peptide Constructs was also issued November 12, 2013, and it has composition of matter claims relating to our PL-3994 natriuretic peptide receptor A agonist for the treatment of cardiovascular and pulmonary indications. Regarding financial highlights; for the quarter ended December 31, 2013 Palatin reported a net loss of $3.6 million or $0.03 per basic and diluted share compared to a net loss of $1.7 million or $0.02 per basic and diluted share for the same period in 2012. The increase in net loss for the quarter ended December 31, 2013 compared to the same period last fiscal year was mainly attributable to the recognition of $1.8 million in tax benefits received in December 2012 pursuant to the sale of New Jersey State net operating losses. Regarding revenue, there were no revenues recorded and the quarter ended December 31, 2013 compared to 6,600 for the same period in 2012. Revenue in the 2012 period consisted entirely of reimbursement of development costs and for…

Carl Spana

Management

Thank you, Steve. Our second quarter fiscal year 2014 operational and programs update will start with our Bremelanotide Phase 3 female sexual dysfunction program. Our activities are focused in two areas; operations required to start and conduct Bremelanotide Phase 3 pivotal registration studies and business development activities. On the operating front, Phase 3 Bremelanotide clinical trial supplies have been manufactured, the contract research organization and related vendors that will assist us, potential future partners to conduct the Phase 3 program have been selected and also engaged. We continue to identify and stream potential clinical trial sites and we have been and we’ll continue to present and publish the extensive data from our Phase 2B female sexual dysfunction clinical program. On the regulatory front, we believe the recent outcome of the appeal of the FDAs non-approval of the flibanserin new drug application is positive for the development of pharmaceutical treatments for female sexual dysfunction. Our analysis based on review of publically available information is that the FDA appears willing to approve a product for female sexual dysfunction given an appropriate risk benefit profile and if there is additional clarity on the measurement of benefit in female sexual dysfunction clinical trials. We will incorporate this new information as we finalize the protocols for our Bremelanotide pivotal Phase 3 clinical trials with the FDA. As we have previously reported, we believe that we have reached agreement with the FDA on the main aspects of the Phase 3 program, including potential patient population, primary key, secondary end points, study designs and safety monitoring. We are now actively engaged in finalizing our Phase 3 pivotal trial protocols; expect to be in position to begin the trials later in the first half of this calendar year. As stated prior, the start of the Bremelanotide Phase 3…

Operator

Operator

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

Charles Duncan

Analyst

Thanks guys for taking the question and congratulations on a good year of progress, looking forward to more this year. So, Carl, you mentioned that the recent competitor regulatory dispute resolution is positive and I understand that generally. But I am wondering if you could touch on what the key point of debate was there and why resolution of that favors progress within your own phase III program?

Carl Spana

Management

Sure, I will give a viewpoint and certainly Dr. Edelson who is here can chime in to share some additional aspects to that. On your first, let me just you predicate any statements I make that our opinion and view on this is certainly based on publicly available information on not on any direct discussions with the other sponsor or any access to any type of confidential information. With that being said the flibanserin NDA resubmission was on the dispute and it is our understanding that the senior members of the FDA have reviewed the dispute and have, company has probably reported with regards to their pathway forward, they are only left having to do a number of small phase I safety directed studies. This would indicate that the FDA was comfortable with flibanserin’s measurement or benefit demonstrated in their clinical trials. And what’s important about that is if you think about two aspects of the phase III clinical program one is to measure benefit in the intended patient population and the other is to measure risk. And it would appear based on the public statement that the FDA is comfortable with the benefit aspect of flibanserin. They have a few remaining questions on risk and in order to come to a final risk benefit decision, will need that information. And why that’s positive is, if that product has measurement of benefit then the types of endpoints you use to measure that benefit certainly must be valid and acceptable from the FDA perspective. So, the positives here are, one, it does appear to the FDA is in line to approve a product again given at appropriate risk benefit and two, that the measurement of benefit is something that the FDA appears to be able to get their head around and can ascribe benefit to a product and that you carry it with all the other sponsors in the space. It’s okay to say that I did a perfect job.

Charles Duncan

Analyst

And some of the endpoints that you are using are the same as were used or evaluated flibanserin program?

Carl Spana

Management

Sure, Dr. Edelson will answer that.

Jeffrey Edelson

Analyst

Yeah, sure. The file structure of the flibanserin program was outlined in the briefing materials for the previous advisory committee meeting and that program was well constructed and extensive and generally consistent with the prior FDA’s guidance on evaluation of efficacy for this population. And those materials and then the subsequent finding that they had demonstrated benefit, we find very encouraging to the present program.

Carl Spana

Management

And the endpoints are similar that we will use and they really revolve around a behavioral measure of sexual activity such as satisfying sexual events and for those who have been following our progress we report quite frequently on the number of satisfying sexual events with Bremelanotide. And the other is a measure of a more longitudinal nature of the concept of desire because patient population, we are studying is the patient population has low desire and that’s generally done using a validated instrument such as the female sexual function index. And so these types of endpoints will be similar between the two programs.

Charles Duncan

Analyst

Okay. Now hopping over to the advice you have gotten from the European regulatory authorities. You mentioned that there is a path forward, would you see that as relatively capital efficient path forward and is a consistent with some of the same issues in terms of not only evaluating benefit in a way that you have done in the past that perhaps would have predicted value for phase III success as well as evaluating risk?

Carl Spana

Management

Charles I will say, the feedback we received is very consistent with our concept of the measurement of benefit and risk in this indication using Bremelanotide. We reached consensus on a variety of issues, patient population, duration of study, endpoints used, dosing. So, we’re very pleased it’s a very, I think they gave us relatively clear guidance and we should really have no problem designing and putting in protocols to support registration studies in European Union and then at the successful submission to the agency. Jeff if you have any other?

Jeffrey Edelson

Analyst

A lot of our discussion that was very helpful and as Carl said quite positive varied on some of the statistical approaches in terms of trial design which I won’t go into right at this moment and then some of the safety monitoring features which were not unanticipated given the non-pharmacology of the drug.

Charles Duncan

Analyst

Okay. And last question on Bremelanotide, you mentioned possible additional data presentations, could you point to certain meetings, I don’t know if you have actually submitted abstracts, but what are you targeting this year?

Carl Spana

Management

Sure, big one coming up at the end of this week which will be the [indiscernible] meeting which is in San Diego and we have a number of presentations going on there. And we will inform the community a little bit later in the week as to exactly what those presentations are. We’ve ACOG coming up in May, day after that as well. There are additional meeting, psychiatric base meetings as well as additional female health focus meetings that will really go throughout the rest of the year. And in addition to that we have submitted publications; I think fairly extensive set of publications that are in the process of being written right now. And we expect that those will start to hit as we get to end of this year and throughout next year.

Charles Duncan

Analyst

Carl, a last question, hop in over to the obesity collaboration. And I’m sorry for dominating, lots of questions here. Please see that that is being picked up again. Would you anticipate milestone payments either this year or in the next 12 to 18 months from that program in terms of achieving certain development goals with that program?

Carl Spana

Management

Steve you want to answer.

Steve Wills

Management

This is Steve. It’s a little bit of a moving target. There’s a number of things being discussed in terms of [indiscernible] and also with Palatin. And I believe there is a lot more clarity on that in the next 60 to 90 days. There is an outside chance that depending on certain circumstances we could receive a milestone and count it to 2014, our internal estimates -- projections are more in the conservative in the 2015 calendar year.

Operator

Operator

And we will now go to Rahul Jasuja with Noble Capital.

Rahul Jasuja

Analyst

Most of my questions on FSD have been answered but let me just broach the subject one more time. Now looking at the European and the US approaches here, now that you got an option agreement that could be executed this quarter, what are the differences between the European FSD approaches or the other guidance you’re getting versus the US. And how does that affect any phase 3 study design that you will like to conduct and maybe sort of leverage in one continent versus the other. Can you add some color on any differences there?

Carl Spana

Management

I will give a brief little bit and then Jeff can jump in. Certainly there is always when you do this types of regional programs, there’s always slight differences in regulatory requirements. In general the concept of benefit being a component of your behavioral measures such as SSCs and more longitudinal measure of something like desire and distress. It’s similar between the two regulatory regions. The overall patient population is very similar. There are small differences in the duration of trials and desire for duration of trials and safety monitoring. Jeff I’ll allow you to have any other.

Jeffrey Edelson

Analyst

The differences are really unique aspects of individual trial design perhaps statistical approach, this type of thing. In general I will say based on the current discussions that we have had et cetera, it’s pretty clear that the two regional programs will be mutually support of and really add to a very robust, we hope, body of evidence as it crosses the definitions of clinical benefit are very similar, the safety monitoring program, the profiles, the risks, or the equation are also very similar. And as I actually think one of the biggest differences I call out is the language and cultural differences perhaps unique to some of the individual valued of tools that we will be using. But then that is countered by the fact that this condition obviously is recognized and significant in multiple cultures that just validates the importance of this therapeutic area for drug development.

Rahul Jasuja

Analyst

Okay, that’s helpful. And then one more question on the FSD space and maybe I’m not going to get an answer, that’s a [indiscernible] let me try. In looking at licensing or partnering with a big pharma, how would you want us to view the fact that you got an option agreement in Europe and then you could progress that direction very soon beginning phase 3 studies. But then you’re looking for a US partner and the US partner may be conflicted with just getting US of wanting sort of a larger worldwide territory. How does that all play out as you look at sort of partnering worldwide?

Carl Spana

Management

Certainly, we’ve gone through a very intense process, in talking to multiple essential partners and as we reported I think last time at call, we think it is probably at the best interest of the this program to have them split at the current time. Even large pharma that we were talking to and have been talking to and continue talk to which would have an international view on really was focused on the U.S. market as being the larger potential opportunity in one that we drive the evaluation and the one they were interested in. So we felt that in order to secure additional benefit that we would bring in potential part of the European and that’s the process that we’re following. I don’t think at the end of the day and see may comment on this, it came down to the fact that we have to have - we were going to conclude with some multinational that wanted the rights, I think we would be able to accommodate them. We have flexibility there and as Carl mentioned based on the decisions thus far, we have in anyway biased or prejudiced our position by doing the option agreement with the company, European based company We don’t feel we’ve restricted our ability in any matter, right.

Rahul Jasuja

Analyst

Okay, good. And then finally the MCL one program and this is really to me is an under-evaluated and underappreciated program, could you tell us where you’re going with this year and sort of events and milestones coming up?

Carl Spana

Management

Sure, as I have reported, we’re really getting into the seek of the preclinical toxicology program for this because we’re moving towards first in men studies probably late this year so the activities are clearly actively underway. This particularly receptor is highly up regulated in variety of immune conditions in the local tissues that are undergoing formation. And they were number of preclinical stages that we’ve been doing and things such as IBD and kidney disease and the uveitis where we’ve been seeing some very nice results. Mechanistically, it appears that therefore effecting down regulating TNF-alpha signaling pathways, so that opens a whole variety of indications for us. What we’re doing in parallel now is really, I think, we’re going to have to at some point as we get to the end of second quarter really now we’re now in begin to select the final indication for the program and that’s going to be a mixture of both business development final clinical review and potentially regulatory feedback. So the lead indications for this really there’re three IBD, nephritis and uveitis which is ocular inflation. So you really just wind the business models right now clinical models right now to determine which is the best one, I think we’re going to be able to go all three at some point.

Operator

Operator

I would now like to turn the conference back to over Carl Spana for any additional or closing remarks.

Carl Spana

Management

Thank you. It’s very exciting time at Palatin. We have a very busy time coming up with regards to Bremelanotide and we’re pleased that we’re making tremendous progress on our other programs and as some of the questions that pointed out, you know, we don’t talk much about them but they’re going to add tremendous value to this company as we go forward along with Bremelanotide. So we’re excited by what we’re doing here and I’d like thank all of you for participating on the call and certainly all the people at Palatin that are working hard to make these things happen as well Jeff and Steve for their participation and contribution as well. So thank you all. We look forward to updating you next quarter and continue to make excellent progress here at Palatin. Thank you.

Operator

Operator

Ladies and gentlemen, this concludes today’s conference. We thank you for your participation.