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Palatin Technologies, Inc. (PTN)

Q2 2009 Earnings Call· Mon, Mar 2, 2009

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Transcript

Operator

Operator

Good morning, ladies and gentlemen and welcome to the Palatin Technologies’ second quarter fiscal year 2009 conference call. At this time, all participants are in a listen-only mode. Later we will conduct a question-and-answer session and instructions for the question-and-answer session will be given at the end of the Company's remarks. As a reminder, this conference call 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 your host for today’s call, Dr. Carl Spana, President and Chief Executive Officer of Palatin Technologies.

Carl Spana

President

Thank you. Good morning, ladies and gentlemen and welcome to the Palatine conference call. I am Carl Spana, President and CEO of Palatin Technologies. With me, Steve Wills, Palatin's Execuvie Vice President of Operations and Chief Financial Officer and Dr. Trevor Hallam, Palatin's Executive Vice President of Research and Development. To start our conference call today. Mr. Wills will provide the financial update.

Stephen T. Wills

Management

Thank you Carl and good morning everyone. For the quarter ended December 31, 2008, which is the second quarter of our fiscal year, Palatin reported a net loss of $4 million, or $0.00 per share, compared to a net loss of $3.8 million, or $0.04 per share for the same period in 2007. The decrease in the net loss for the quarter ended December 31, 2008 versus the quarter ended December 31, 2007 was primarily attributable to a decrease in both research, development and general and administrative operating expenses. At December 31, 2008, Palatin's cash, cash equivalent and available for sale investments totaled $6.3 million compared to $12.8 million at June 30, 2008 and $22.8 million at the period December 31, 2007. Regarding revenue and other income for the quarter ended December 31, 2008, Palatin recognized $1.2 million of contract revenue under its collaboration agreement with AstraZeneca versus $0.7 million in the comparable quarter of 2007. Other income for the quarter ended December 31, 2008 consisted mainly of proceeds of $0.5 million from the sale of equipment and supplies previously expensed on our books. There was no such activity for the quarter ended December 31, 2007. Regarding cost and expenses, total operating expenses for the quarter ended December 31, 2008 were $4 million versus $6.1 million for the comparable quarter of 2007. The decrease in operating expenses was primarily due to the strategic restructuring and refocusing of our clinical stage product portfolio development programs. Additionally, there was $1.2 million decrease in administrative expenses primarily attributable to the reductions and work force initiated in September 2007 and May 2008. Regarding our cash position in addition to our $6.3 million of cash and cash equivalent and available for sale investment at December 31, 2008, we have $4.9 million of accounts receivables that…

Carl Spana

President

Thank you, Steve. Dr. Hallam and I will now give an update and overview on the Company’s research and development programs. We have focused on three exciting programs that we believe can drive significant shareholder value. These are PL-3994 for the treatment of heart failure, our MCR4 obesity program which is partnered with AstraZeneca and PL-6983 on melanocortin receptor compound for treating both male and female sexual dysfunction. All our programs target patient populations in which the medical need is high and with tremendous commercial potential. With that being said in the current economic environment, how we advance and drive value from these programs vary. Over the past year, the research teams of Palatin and AstraZeneca have made significant progress in our MCR4 obesity and diabetes program resulting in the expansion of our joint research development collaboration. Obesity and diabetes are two diseases in which there remained a strongly need for pharmacological interventions. The human and medical cost associated with treating these patients is enormous. We, along with our partner AstraZeneca believe that pharmaceutical agents targeting MCR4 have tremendous potential in treating obesity and diabetes. As Steve previously mentioned, license and extension in clinical trial agreements point to the progress Palatin and AstraZeneca have made with the collaborative melanocortin receptor obesity program. In addition to reimbursement of Palatin's activities at an agreed upon full-time equivalent rate, it totaled $6.6 million in milestone payments as recently have been received from AstraZeneca. Additionally with working closely with our partner, we initiated a proof of concept trial in humans or MCR4 obesity program in January of this year. Regarding our PL-3994 and PL-6983 programs, over the next year, our primary focus will be on establishing collaborations with large pharmaceutical or especially pharmaceutical companies to advance these programs forward. Our PL-3994 clinical results and commercial potential have generated a significant interest in both the medical community and from potential pharmaceutical partners. I am now going to turn the call over to Dr. Hallam who will provide you additional details on our programs.

Trevor Hallam

Management

Thanks Carl and good morning. I will start with an update on our melanocortin-4 receptor programs. Our collaborative research and development program with AstraZeneca for the discovery and developments of anti-obesity agents continues to show a great progress. Accumulating data from genetic pharmacological and physiological studies continue to identify with central melanocortin system as an important regulator of energy homeostatis and potentially a key pharmacologically amenable mechanism for treatments obesity. Palatin's melanocortin receptor obesity program combines our core technologies for lead-generation chemistry with our preclinical and clinical experience with the melanocortin system to develop novel therapeutics for treating obesity and related diseases. The collaborative R&D teams have further developed the small molecule and peptide compounds series that modulates the function of the melanocortin-4 receptor. The activity profile indicates that we have potential as treatments for obesity and associated diseases. In studies using animal models of obesity, selected compounds reduced food intake and body mass as well as decreasing plasma glucose and insulin levels. As Steve mentioned based on the successful progress, the research agreement was recently extended and expanded and a separate clinical study agreement was also reached specifically to take a proof-of-principle melanocortin agonist to the clinic. Dosing of subjects in the clinical proof-of-principle study began early this year. The study is on track to complete by midyear and certain parameters will be evaluated that will guide the selection of further commercially viable clinical candidates for development. Now to sexual dysfunction. We continue to evaluate the opportunity for melanocortin-4 receptor agonist in both the male erectile dysfunction field and in female sexual dysfunction. As you will be aware, Palatine has performed a program of Phase I and II clinical studies of the first generation cyclic peptide melanocortin-4 receptor agonist, Bremelanotide for both male and for female sexual dysfunction. Promising…

Carl Spana

Operator

Thank you, Trevor. In closing, in the past quarter we have been successful in reducing our expenses and increasing our projected cash flow by expanding our research and development collaboration, affiliates consolidation and sale of noncore assets. With cash on hand and projected revenue, we are confident we can move Palatin forward and secure significant value for our programs. In the near term, we will continue moving our MCR4 program for obesity and diabetes with our partner, AstraZeneca, and look forward to initial clinical results later this year. Our ongoing efforts with PL-3994 and PL-6983 have strengthened their scientific, intellectual property and commercial value which supports our activities on generating additional corporate and research development collaborations for these programs. In these difficult times, we continue to remain positive about the Company's opportunities and are working on a variety of avenues to strengthen our financial resources. Now, I would like to open the call to questions.

Operator

Operator

(Operator Instructions) Your first question comes from the line of Amy Wang - MDB Capital Group, LLC.

Amy Wang - MDB Capital Group LLC

Analyst · Amy Wang - MDB Capital Group, LLC

My first question, can you remind us, I know you talked about your continued partnership discussions for your clinical and preclinical program. For the 3994 program, is that your top priority in terms of looking for partnership or are you sort of looking at all the different strategies at the same time?

Carl Spana

Operator

Well, with regard to potential corporate partnerships, the two programs that are furthest advanced and most likely candidates would be PL-3994 in this heart failure program as well as the sexual dysfunction program which would be, the lead candidate would be PL-6983. So both of those are moving forward and there are discussions on both of those programs.

Amy Wang - MDB Capital Group LLC

Analyst · Amy Wang - MDB Capital Group, LLC

For the 3994 clinical trials that are planned for later this year, the multi-dose and the long-term study, will you be going forward with those regardless of whether a partnership is finalized or will you..?

Carl Spana

Operator

Amy, as you might imagine we are very reluctant to spend corporate assets that cannot easily be replaced. So we would really elected to take a strong shot at trying the corporate partner route before we move forward those clinical trial programs on our own.

Amy Wang - MDB Capital Group LLC

Analyst · Amy Wang - MDB Capital Group, LLC

Okay and one last question about 6983 for sexual dysfunction, you talked about a plan Phase I study so that will be in the male, looking just the male population first, right?

Carl Spana

Operator

Correct. If we go forward with that program or as we go forward with it, we would look at the male population first for a couple of reasons, the predominant one being that we can look at both efficacy as well as safety in a single population because we can monitor erectile activity in the males. So in a single study, we will get a chance to look at where we see the erectogenic effect and then if we see a cardiovascular effect where we see that and our hope would be based on animal data that we would see either, dramatically reduced cardiovascular signal or not at all and if we do see one, that would be a nice separation between the efficacy signal and the potential safety signal. So that is why we will do that in man first.

Operator

Operator

Your next question comes from the line of Rahul Jasuja - MDB Capital Group LLC.

Rahul Jasuja - MDB Capital Group LLC

Analyst · Rahul Jasuja - MDB Capital Group LLC

Just a couple of clarifications on the sexual dysfunction program. So, 6983 is the new version that lacks the high increase in blood pressure but what about plans to look at the original Bremelanotide as a second line therapy? Could you elaborate on intent and prospective plans for Palatine working a second line therapy irrespective of the 6983 which is the new version?

Carl Spana

Operator

I think if these presentations are posted, as you probably recall Dr. Hallam mentioned in his part of the presentation that we were looking at different aspects of Bremelanotide either from the formulation standpoint with delivery as well as patient positioning and certainly we do believe that there can be an opportunity for Bremelanotide to go forward in the sexual dysfunction space particularly erectile dysfunction as a second line treatment for men that have failed in [21.49] therapy, that is certainly something I do not want to elaborate on much more right now but it is certainly something that is a part of discussions with corporate partners as well as internally.

Operator

Operator

That concludes the question-and-answer session today. I would like to turn the call back over to you for any additional or closing remarks.

Carl Spana

Operator

Well, thank you everyone for participating in our quarterly conference call. We look forward to updating you next quarter and with that, have a good day and we will see you next quarter. Thanks, bye bye!

Operator

Operator

This concludes today's presentation. We thank you for your participation. You may now disconnect.