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Palatin Technologies Inc (NYSEMKT:PTN)

F4Q2011 Earnings Call

September 22, 2011 11:00 am ET

Executives

Carl Spana – President and CEO

Steve Wills – EVP, CFO and COO

Jeffrey Edelson – Chief Medical Officer

Analysts

Leland Gershell – Madison Williams & Company

David Moskowitz – Roth Capital

Rahul Jasuja – Noble Financial

Operator

Good morning ladies and gentlemen and welcome to the Palatin Technology’s 2011 fiscal year end conference call. As a reminder today’s conference is being recorded.

Before we begin our remarks, I would like to remind you that statements made by Palatin 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 your host for today's call, Dr. Carl Spana, President and Chief Executive Officer of Palatin Technologies. Please go ahead sir.

Carl Spana

Thank you. Good morning I’m Carl Spana, President and CEO of Palatin Technologies. With me on the phone 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 and financial results. To begin Steve Wills will provide an update on our fiscal yearend financial results. Steve?

Steve Wills

Thank you, Carl. Good morning everyone. Regarding the financial update Palatin’s net loss for the quarter ended June 30, 2011 was $3.3 million or $0.09 per basic and diluted share compared to a net loss of $4.2 million or $0.40 per basic and diluted share for the same period in 2010. The change in net loss for the quarter ended June 30, 2011 compared to the net loss for the quarter ended June 30, 2010 was primarily attributable to $1.3 million of non-cash non-operating income, which represents the decrease in estimated fair value of the warrant liability from March 31, 2011 through May 11, 2011, which is the date the warrant seized to be classified as a liability on stock holder approval of the increase in authorized common stock.

For the year ended June 30, 2011 we reported a net loss of $12.8 million or $0.64 per basic and diluted share, compared to a net loss of $1.8 million or $0.18 per basic and diluted share for the year ended June 30, 2010. The change in net loss for the year ended June 30, 2011 compared to the net loss for the year ended June 30, 2010 was primarily attributable to a decrease in revenue recognized under Palatin’s research, license and clinical trial collaboration agreements with AstraZeneca as a result of the successful completion of the research collaboration portion of the agreements.

Regarding revenue, total revenues for the quarter as of June 30, 2011 were $0.2 million mainly consisting of grant revenue pursuing to the Patient Protection and Affordable Care Act of 2010 commonly referred to as Section 48D, compared to $0.7 million for the same period in 2010 consisting entirely of amounts recognized under our license and collaboration agreements with AstraZeneca.

Total revenues for the year ended June 30, 2011 were $1.5 million consisting of $1 million of grant revenue pursuant to Section 48D and remainder from our collaboration with AstraZeneca. For the year ended June 30, 2010 total revenues were $14.2 million consisting entirely of amounts recognized from our collaboration with AstraZeneca.

Regarding cost and expenses for the quarter ended June 30, 2011 total operating expenses were $4.7 million versus $4.9 million for the comparable quarter 2010. For the year ended June 30, 2011 total operating expenses were $15.1 million compared to $17.2 million for the year ended June 30, 2010. The decreases in operating expenses for the respective periods is a result of reducing staffing levels pursuant to Palatin’s strategic decision to concentrate on our clinical programs announced in September of 2010.

Regarding our cash position, our cash and cash equivalents were $18.9 million as of June 30, 2011 compared to cash, cash equivalents and investments of $8.9 million at June 30, 2010 with current liabilities of $2.8 million as of June 30, 2011, compared to $2.4 million as June 30, 2010. In March 2011, Palatin closed on a $23 million firm commitment public offering consisting of 23 million units at a price to the public $1. Net proceeds to us after deducting underwriting discounts and other offering expenses were $21 million.

We believe based on our current operating plan that our cash, cash equivalents will be sufficient to fund our operations through at least calendar year 2012.

Carl Spana

Thank you, Steve. Now we will update on our programs. First I will cover our obesity and diabetes melanocortin receptor 4 program which is partner with AstraZeneca. Over the past year this program has made excellent progress. Earlier this year under the direction of AstraZeneca with assistance by the team at Palatin our melanocortin receptor 4 obesity program took a major step forward when AstraZeneca initiated Phase I clinical studies with a compound they call AZD2820. AZD2820 is a clinical candidate selected by AstraZeneca from its collaborative research program with Palatin.

The decision to move this program to clinical development was in part based on exciting clinical data generated by Palatin as part of our collaboration with AstraZeneca. Results from (Inaudible) clinical trials of these patients with non-commercial compounds had target melanocortin 4 receptor showed significant reduction in food intake and weight loss. We believe this clinical data along with earlier work animal [ph] models of obesity demonstrates the significant role that the melanocortin pathway placed in regulating food intake and weight and validates that melanocortin receptor as a major target for obesity therapeutics.

AstraZeneca continues to move this program forward and we expect initial clinical data in this program later this calendar year. We believe that therapeutics that target melanocortin 4 receptor has a potential to demonstrate safety and efficacy required for approval and to dramatically impact the treatment of obesity.

As you can imagine this program has huge commercial potential and we believe our partner AstraZeneca has the resources and commitment to realize this potential. We are eligible for milestone payments totaling up to $145 million up to $85 million contingent up on development and regulatory milestones and the balance on treatment of sales. Plus mid to high single digit royalties on sales of approved products. AstraZeneca has responsibilities for product commercialization, product discovery and all associated costs.

Next program I would like to talk about is our PL3994 our natriuretic peptide receptor agonist in development as a treatment for acute exastribations [ph] of asthma, which is defined as an ongoing asthma episode in which asthma symptoms do not adequately respond to initial bronchodilator or (Inaudible) steroid therapy.

This fiscal year our PL3994 program has achieved several key development milestones. PL3994 asthma program includes both subcutaneous formulations and inhalation formulations. This year we opened up a new IND with the update to envision the pulmonary products to begin clinical studies in asthma patients. Protocol for PL3994 subcutaneous group of principle asthma clinical trial was probably designed to that asthma clinical trial and the trail a formulation work and design a frequently toxicality studies to support the use of inhaled PL3994.

A key near term objective for our PL3994 program is to identify development and marketing partner and once we do that to initiate clinical studies. We are in discussions with multiple potential partners that we believe has a developmental, regulatory and commercial resources to assist us in advancing our PL3994 program forward.

Finally let’s say a little bit about bremelanotide, which is our melanocortin 4 receptor agonist in development as a treatment for female sexual dysfunction and is our lead clinical development program. Over the past fiscal year this program has made tremendous strides forward. We completed the second of two Phase I pharmacokinetic and safety studies with the subcutaneous bremelanotide formulation demonstrating that our subcutaneous bremelanotide formulation provides consistent and reproducible exposure to bremelanotide.

We also concluded meetings and discussions with the FDAs division of reproductive and neurological products and reached agreement on a Phase II B protocol. We initiated a major Phase II B clinical trial in premenopausal women with female sexual dysfunction results to the study if positive will support transition of this program into Phase III clinical trials. We also made substantial progress in the number of non-clinical product development activities that required sports based studies and commercial development of bremelanotide.

And I will provide a brief overview of the bremelanotide Phase II B female sexual dysfunction study. The main objective of this trial are to generate the safety and efficacy data to support the transition of this program into Phase III registration trials. The trial was designed as a foreseeable controlled double blind study but you will have four parallel arms one placebo and three bremelanotide doses you are talking to involve 100 premenopausal, female sexual dysfunction patients per arm for a total of 400 patients.

The primary efficacy measure for the study will be the improvement in the number of satisfying sexual events. This will be measured using a validated event log or diary. Additional efficacy evaluations will include changes in arousal, desire and dysfunction associated distressed as measured using validated patient self assessment questioners. We will also evaluate the (Inaudible) bremelanotide in this target population.

Bremelanotide Phase II B study and female sexual dysfunctions initiated patient recruitment in June of this calendar year. I’m very pleased to report that enrollment is proceeding on schedule. Enrollment is targeted for a completion by the end of this calendar year and we anticipate delivering the result to this study early in the second half of 2012.

We have designed a comprehensive program to evaluate safety and efficacy of bremelanotide and the results of this study are positive they will support the transition into Phase III registration trials. We believe that bremelanotide female sexual dysfunction program has tremendous potential. There are no FDA approved treatments for female sexual dysfunction and these patients have limited treatment options. We believe that female sexual dysfunction represent a significant area of medical need and a substantial commercial opportunity.

Just a little bit more before we open up to questions. Over the past fiscal year we have made significant progress in positioning Palatin into advancing number of exciting programs and to build value for our shareholders. On the corporate front, we completed the reorganization started last year in which we significantly reduced our basic research activities. We now have an organization and resources focused on supporting and driving our clinical development programs forward.

In addition, we also conducted an underwritten public offering to obtain the funding required to take us through significant program data points. We have sufficient cash on hand today to fund our planned operations to at least calendar year 2012. Our bremelanotide female sexual dysfunction program is enrolling patients in a major Phase II B clinical trial designed to provide the safety and efficacy data to move into Phase III registration trials. This program is on schedule to deliver data in the second half of 2012.

Our PL3994 program for severe asthma is ready to begin approved principle clinical trial and we are in discussions with potential partners. And finally our melanocortin 4 receptor obesity program, which is partner with AstraZeneca is enrolling patients into Phase I study and it’s on track to deliver data later this calendar year. We believe that these accomplishments have put the company in a strong position to generate substantial value for shareholders.

I would like to thank you for participating in the Palatin 2011 fiscal year end conference call. And we will now open the call for questions. Thank you.

Question-and-Answer Session

Operator

Thank you very much. (Operator Instructions) We will take our first question from Leland Gershell with Madison Williams & Company.

Leland Gershell – Madison Williams & Company

Hey, thanks for taking my question. Question Carl I know you discussed partnering opportunities for PL3994 just thinking about strategic future for bremelanotide as you are getting going into the Phase II B and looking to next year how you see that asset playing out in terms of future development going forward thanks.

Carl Spana

Sure, you are certainly well there are couple of points to that. One, as we stayed on the call they are in just a number of activities that we are doing to be prepared for transition into Phase III and so what we like to do is have a program as that data from the Phase II B study comes out in the second half of next year we want to be in position for a end of Phase II meeting with the FDA and have it really a turnkey program that we could partner with a potential partner for the program.

So one that we will be looking for as we get a little bit more enrollment under our belt is really starting to corporate development process there, process for bremelanotide. Certainly, we want to be positioned to make sure that that program does go forward but we think that, that indication probably one where a minimally someone who can help us with the marketing as required.

Leland Gershell – Madison Williams & Company

Okay, great and then I guess in the same topic PL3994 any further clarity you can give us in terms of where those discussions may stand potential timing of an announcement of a deal and what you might be looking for in terms of.

Carl Spana

I’m sorry like I say is that you know we’re having conversations with you know the company’s that we believe have the regulatory and financial resources and also the devices that we needed to really move this from sub queue and nebulizer to either a small inhaler technology and then moving forward. And we are hopeful that we will be able to get something done but from a timing standpoint we generally don’t comment on when we would have the deal done.

Leland Gershell – Madison Williams & Company

Alright, great thanks. I will jump back in the queue.

Carl Spana

Great.

Operator

And we will take our next question from David Moskowitz with Roth Capital.

David Moskowitz – Roth Capital

Yes, thanks. Good morning guys.

Carl Spana

Good morning David.

Steve Wills

Good morning.

David Moskowitz – Roth Capital

Thanks. Since noticing the expenses that we saw in the fiscal fourth quarter were a little bit higher than I was expecting. And I’m wondering if you guys have comment on why we are seeing the higher level particularly in the R&D line.

Steve Wills

Well the, this is Steve Wills I will respond to that David. We are as Carl mentioned we are on target for enrollment we are also on target for the budget. So if we spent more which we did based on our projection in the quarter ended June 30, 2011 and we are on budget for the entire program that just means we are going to be spending our lives in some of the subsequent quarters. So the with development in this particular case of Palatin spending a bit more on the program which you are being on budget frankly just maybe we advanced a little quicker than I might have initially projected.

David Moskowitz – Roth Capital

Interesting so you are saying that trial is a little bit ahead of plan at this point when, what would that mean in terms of overall crowd progress and involvement in those sorts of metrics?

Carl Spana

Dave, we have out there with our public disclosures we are trying to complete enrollment at the end of the year and have data you know as we get into this into the begin the second half of next year. And as I said we are on track with that (Inaudible) are on track with that and as Steve stated you know the expenses we are on budget and if we spend a little bit more now that just means that we will spend a little bit less in subsequent quarters. That’s all.

David Moskowitz – Roth Capital

Just seeing into just a little further. Is there anything going on in particular that is enabling you guys to spend more and move quicker along the time line.

Steve Wills

Well this is Steve from the dollar standpoint one of the reasons the cost look greater in the June 30, we got a number of that sites up and running a little quicker than I’d initially projected and nice way always going to look a bit conservative with those projections. So the we have more sides up and running than we thought would be in the June 30 quarter, which is good because the program is advancing quicker than we targeted.

David Moskowitz – Roth Capital

Okay. And just sticking with the financials for one more question. Can you tie in the $19 million that you had in cash at the end of the fiscal year in your burn rate can you just refreshes again with those metrics and how long the chances are expected to last.

Steve Wills

I mean we publicly stated that we based on our current operating plan we had sufficient cash to fund those operations through at least calendar year 2012. So to qualify and quantify that a bit for you we are primarily spending the money on the outside standpoint with (Inaudible) bremelanotide for the FSD clinical trials.

We budgeted when I say budgeted approve contracts and we are now well into the trial so we are pretty comfortable with the projected spend for the FSD bremelanotide program. And we are targeting that to $7.5 million range through June 30, we’ve already spent $2 million of that so the remainder is going to be approximately $5.5 million we will probably spend another $500,000 on some you know ancillary related R&D for some of the other programs we have under development. Say for a total of $6 million over the six quarters, I’m going to try and tell you into calendar year 2012.

So if we started with $19 million at the end of June 30, 2011 and we are going to spend approximately $6 million $5.5 million another $500,000 on BMT FSD and some other R&D the six left to 19 leads you 11 the inside burn and the inside burn being we find us anything other than our outside third party cost over the next six quarters should be approximately $9 million. The $9 million is made up of approximately $1.3million for quarter for the inside burn and some working capital changes you know we will come up, you know just say the $1.3 million totaled in the $8 million range we will probably have approximately $1 million of the working capital changes to get it to the $9 million. So the 9 inside burn which includes working capital changes over the next six quarters $5.5 for the FSD another $500,000 for other R&D items nine plus to six is 15 less than $19 million at 6:30 we are targeting to have approximately $4 million at 12/31/2012.

David Moskowitz – Roth Capital

(Inaudible) thank you for that. In terms of any interim results we could get having the trial do you guys have any plans for any interim works or in terms of the clinical trial progress how will you be updating us on that.

Carl Spana

We don’t have any interim analysis planned these studies are only run total of 16 weeks with a patients so they go very quickly so there is really no reason why we do (Inaudible) for then and we will update as enrollment progresses we generally will update you as enrollment is completed as left patient is out if the database is locked and then as the data comes out. So the normal steps as we go through we certainly will be informing how the investor’s that the that’s progress has been track that delivered the data. So what I’m hearing is potential enrollment completion best deals. The progress has been made in those boxes have been checked and never on track to deliver the data where we said we are.

David Moskowitz – Roth Capital

So what I’m hearing is potential enrollment completion by year end perhaps January and four months to that for the last patient to be dosed. And then by April just start being locking.

Carl Spana

If you a little bit longer if you would be June you cannot date a lot in probably the June time frame and have to be QCD and I was QCD and then we are out after that. But we will keep you informed as that we will be keeping you guys informed as those events occur. But those are generally, those are the marks to be looking for completion of enrollment last patient out data lock and then release of data.

David Moskowitz – Roth Capital

Okay, one last question I have for you guys. So there is going to be some visibility in the female sexual dysfunction rate everybody is looking at the (Inaudible) so I would like to just post you a question on those potential results. You know what if the data are good you know that mean we have our treatment for female sexual dysfunction in Phase III data. And then again for us the data are bad how do we look at the space at that point.

Carl Spana

I think you look at them in both the same way (Inaudible) is being targeted for postmenopausal women that have been recognized in our hormone replacement therapy. That’s a very different population and we also have (Inaudible) sexual desire or low desire. So that’s really the population that you targeted for. Bremelanotide is targeting a different patient population first of all we look towards the premenopausal women that have not only they have hyperactive sexual dysfunction they may also have FF 80 for intersexual (Inaudible). So we have a broader patient population and we are talking a younger patient population so the patient population are different and then hope it goes forward because I help that to re-impact it does have to be goes forward to us. Is that a does how to set the paradigm to satisfy test for a do I think that is which we hope it does get accrued. That product has good data it get’s approved I think it was a totally different patient population. I think that we are in a very strong position with our products moving forward and we certainly (Inaudible) in that product investment and hope it goes forward because it helps it the impact that it does has for us is that it does help to set the paradigm for satisfying sexual events as a measure of efficacy in these types of studies. So overall the positive or negative it works or doesn’t work I don’t think it it’s nice to have it out there but I don’t think it backs us.

David Moskowitz – Roth Capital

Got it. Okay, thanks for taking my questions.

Operator

We will go next with Rahul Jasuja with Noble Financial.

Rahul Jasuja – Noble Financial

Hey good morning folks. Those are all very informative questions. I’m going to take my question to a different direction maybe redundant for many of you guys but to a fresher. You know given the fact that there is plenty of data with the previous experience with bremelanotide and then the upcoming package the end of Phase II package that you provide a thing now. Carl is what is with from these studies that we can correct from the past given the fact that of course this is now subcutaneous delivery how would these studies collect the safety and tolerability that were the issue. Efficacy was fine some of us thought safety was fine how can we correct this going forward?

Carl Spana

Sure, I will make some comments and then if Dr. Edelson wants to jump in he can as well. You know the key issue that we faced with the inter-nasal formulation was the variability in patient exposure to the drug. So we have some, we had a absolute availability of only got 15% and some patients absorbed the whole 100% of the dose so you had almost up to seven times more drug being observed by some patients. And in real side that’s outside of work here little drug.

So from a safety standpoint there were two types of issues there were GI side effects (Inaudible) and those are very tightly correlated with exposure to the drug and as we transition this subcutaneous exposure we know that we can actually put these patients in a very tight exposure range to (Inaudible) and when we look at the deck for the safety deck for so if you study there is any (Inaudible) very little, very moderate to very little nausea. So it appears that the GI issues should be well resolved with regards to the transition which enables the queue.

With regards to blood pressure that was slightly less it’s highly correlated with exposure levels but still was and we have generated a very extensive safety or blood pressure monitoring jack with the subcutaneous Phase I studies premenopausal population and it appear to be us that these larger changes that we saw in blood pressure do not tend to occur at the levels that we are talking and this patient populations and therefore we should have a pretty clean safety profile for both the GI and the blood pressure as well.

So with that also being said, we also expect that now instead of having a subset of patients in the therapeutics on for the drug. We should have all patients in therapeutic zone. So I think we should be able to maintain efficacy if not even do a little bit better than we’ve seen in the past because those subset of patients that 15, 20 set of patients (Inaudible) any drug and have any potential benefit they won’t exist they will all be in the therapeutic range. So this is a much needed profile with this particular drug this is the right format to go forward and then now Jeff if you want to say a few more words about it or not.

Jeffrey Edelson

Just a supplement Carl thanks. This is Jeff speaking. In addition to this to the items that Carl mentioned the current trial actually much more rigorously define the patient populations at entry in terms of their baseline characteristics and in fact the two subpopulations of HSDD, FSAD and patients remain how both conditions came commonly. There is a much more rigorous (Inaudible) of the human dynamic profile I’m after the supervised clinic doses can in fact a much more rigorous definition of outcome in terms of SSCs but also a number of other end points including the subscales of the FSFI instrument. So this is a much more rigorous trial but I think we will really give us a good information and allow us to proceed into late phase of studies.

Rahul Jasuja – Noble Financial

And then you know given the fact that there has been past discussions with the FDA and you’ve got now and instead of you know I guess a developing Phase II trial what this Phase II study design as a sufficient based on the preponderance of cash data or this you think just standing a little given the fact that the proposed data was inhaled. But you’ve also got some other data using IV our (Inaudible) DMT [ph].

Carl Spana

I mean whenever you sit down with the agency and discuss the president or the previous data base from a safety sense why I’m particular is certainly relevant to go forward. The whole package the your previous days information it ends up cute and we are done in the target population overall safety, inter-nasal sub queue into some of our previous studies that we’re done we all considered as part of our decision making process to go forward. An agency so this is not, this is a bill and you know this study will certainly form the bulk of the decision to transition into Phase III but it certainly won’t be just alone.

Rahul Jasuja – Noble Financial

Okay, thanks and one final question quickly did you (Inaudible) FSD present to gynecologist, psychologist or private care all three of them.

Jeffery Edelson

I think it’s a bit of a mix in terms of who they are, where their initial point of contact and who sub possible subsequent referral mainly of his patients would likely present to a family position many wafers into a primary care gone to colleges gynecologist many actually may come in through mental health or counseling services. So I think you are right it is a sort of a diverse set of entry points.

Rahul Jasuja – Noble Financial

Great thanks.

Operator

And with no further questions in the queue I would like to turn the call back to Carl Spana for any additional or closing remarks.

Carl Spana

Thank you. I would like to thank everyone for participating on our call. We are very excited about what we are doing here. I think we have a lot of great exciting programs going forward. We are well capitalized and we have a lot that we intend to deliver over next year. So I hope you guys pay attention to the story and keep involved and I look forward to updating you and (Inaudible) updating you guys as we continue to progress. Thanks, have a great day. Bye.

Operator

And this does conclude today’s conference. We thank you for your participation.

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