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Palatin Technologies, Inc. (PTN)

Q4 2016 Earnings Call· Tue, Sep 20, 2016

$21.21

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Transcript

Operator

Operator

Good morning, ladies and gentlemen and welcome to the Palatin Technologies’ Fourth Quarter and Fiscal Year 2016 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 maybe 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. I am Carl Spana, the President and Chief Executive Officer of Palatin Technologies. With me on the call today is Steve Wills, our Chief Financial Officer and Operating Officer and Executive Vice President. On today’s call, we will provide updates on our development programs and our fourth quarter and fiscal year end 2016 financial results. To begin, Steve will provide the financial updates. Steve?

Steve Wills

Management

Thank you, Carl. Good morning, everyone. I will start with the fourth quarter and fiscal year ended June 30, 2016 significant and recent highlights. Regarding our bremelanotide development program for hypoactive sexual desire disorder, or HSDD, last patient visits for the efficacy portion of our Phase 3 clinical trials were completed in the third quarter of calendar year 2016 and top line results are expected to be released early fourth quarter calendar year 2016. Carl will give you more detail on our female sexual dysfunction program during his part of the presentation. Regarding the strengthening of our intellectual property portfolio, the United States Patent and Trademark Office issued a key patent from methods of treating female sexual dysfunction using the formulation and dose utilized in our Phase 3 reconnect study with bremelanotide for HSDD. This is the same formulation and dose we will use for commercialization upon FDA approval. The patent expires no earlier than November 2033. The United States Patent and Trademark Office issued a Notice of Allowance on a patent with composition of matter claims for a broad group of melanocortin peptides. The United States Patent and Trademark Office also issued a patent with composition of matter claims for a broad family of melanocortin receptor 1 peptides with potential application and inflammatory disease related and autoimmune indications. On the equity front – on the equity raising front, in August 2016, we closed on an underwritten offering of units for gross proceeds of $9.25 million with net proceeds after deducting offering expenses of approximately $8.5 million. We issued 11 million – approximately 11.5 million shares of common stock and 10-year pre-funded Series I warrants to purchase approximately 2.2 million shares of common stock at an exercise price of $0.01 and Series H warrants to purchase approximately 10.3 million shares…

Carl Spana

Management

Thank you, Steve. Our fourth quarter and fiscal year end 2016 operational update will focus primarily on our bremelanotide Phase 3 female sexual dysfunction program. Bremelanotide Phase 3 reconnect clinical protocols 301 and 302 are multi-centered, double-blind, randomized, placebo-controlled clinical studies with 6 months of randomized treatment followed by an open-label safety extension trial. Clinical trials 301 and 302 randomized 1,250 women with approximately 625 in each of the trials. The objectives of the trials are to evaluate the efficacy and safety of subcutaneous bremelanotide in pre-menopausal women with hypoactive sexual desire disorder as an on-demand, as needed treatment. Clinical trials 301 and 302 have been completed with the last patient completing treatment in Study 302 in August of 2016 and the open-label safety extension is now fully enrolled with 675 patients. In the last quarter, we also submitted the statistical analysis plan for the bremelanotide reconnect clinical program to the FDA’s division of bone, reproductive and neurological products. And now they are meeting with the division to discuss the statistical analysis plans and their comments. The meeting was collaborative and productive and we reached agreement on the analyses and methodologies that will be in the final statistical analysis plan. As we look forward to top line data, we are working with our various contract research organizations to complete data collection and entry and to finalize all the activities required to lock the trial databases and begin data analysis. These activities should be completed shortly with database lock anticipated at the end of the third quarter of 2016 and top line data ready for release in the early fourth quarter of 2016. Over the past year, the female sexual dysfunction fields has had major positive changes, with the approval and launch of Addyi, the first FDA approved treatment for women…

Operator

Operator

[Operator Instructions] And we will go first to Joe Pantginis with ROTH Capital Partners.

Joe Pantginis

Analyst

Hi Steve and Carl. Good morning. Thanks for taking the question. There are just two real questions I want to ask regarding BMT if you don’t mind and thank you for the update. So, you met with the FDA recently on the SAP, could you provide a little more color on any modifications, were there anything major with regard to the SAP and is that the reason for the few weeks delay for the release of the top line data?

Carl Spana

Management

Look, I mean, am not going to discuss any details of the SAP on the call, but certainly really, the goal there was to make sure we got appropriate feedback from the FDA before we finalize the system analysis plan, which really is to make sure that the methodologies used for analyses around potential clinical benefit were correct and in line with the FDA, it was looking for. And we were able to get that clarified and really reach a really good position with them. And we are very pleased with the outcome of the meeting. It was very collaborative and productive. And I think both the FDA and Palatin are on the same page as to how the data should be handled and analyzed and methodologies that should be used. Of course at this stage, any even minor change to the SAP would require reprogramming and it does add some time to it. But the other thing, just in regards to the data and when it’s coming out is we spent 20 months and an awful lot of money as you heard from Steve’s part of the presentation on this program. And we really want to make sure that everything is buttoned down, tight, solid, correct, FDA signed also that way, we go to top line data with confidence that we are delivering the data in a way that it should be delivered. So we will have it out quickly. We will get data as quickly as we can, but we do want to make sure it is correct based on all the time we spent for getting here.

Joe Pantginis

Analyst

I understand. Thank you. That’s helpful. One quick side question, once the data are available, are you planning to have a conference call around the data or just the press release?

Carl Spana

Management

Both, we would have a press release and then a follow-up conference call.

Joe Pantginis

Analyst

Okay, great. Thanks. And then the second part of my question was regarding the partnering landscape, obviously you said there are significant partners – partnering interest right now, if you can maybe comment about the tenor of those discussions and do you think, it’s possible that partnership might be signed ahead of the data, even though that were disclosed, but the primary focus of my question is obviously, there has been some trepidation in the market right now with regard to the weak or failed launch, depending on how you view it for Addyi and how that might be impacting your partnering discussions?

Carl Spana

Management

I will let Steve tackle that.

Steve Wills

Management

The – I would say the only – just say, I will characterize it as an A item, the only A item that we have seen in the last say, 12 months regarding potential partners has been around the launch of Addyi by Valeant. And specifically regarding the market, in a nice way, how well received will a female sexual dysfunction treatment be by this patient population. And in the absence of what we believe are significant differentiating factors of our bremelanotide versus the Addyi, Carl has covered them, we have covered them on past calls, whether it’s the REMS, certain issues around alcohol, which is you shouldn’t be taking any alcohol during treatment. But because of these significant differentiating factors of bremelanotide over Addyi, the potential collaboration partners are actually quite enthused about our treatment. Our expectation is that we will be doing collaboration some time after the release of the top line data. In a nice way, as long as what we call a thoughtful evaluation. And in that regard, our expectation is that we will have something between the top line data release and the filing of the NDA with the FDA, which is targeted for mid-calendar year 2017. There is significant interest. There is – yes, Addyi is ahead of us and approved, but obviously there are some questions and some challenges around the product. And frankly, there is – we don’t really see anyone, from a competitive landscape, that close behind us. There is no one through Phase 2. So again, we are comfortable that there is a lot of attention right now and that there will be more attention once we are able to release what we are hoping is the positive Phase 3 trial results.

Joe Pantginis

Analyst

Thanks, guys.

Operator

Operator

And we will go next to John Newman with Canaccord.

John Newman

Analyst

Hi, guys. Thanks for taking the question. Just one real question on the statistical analysis plan in terms of the discussion you had with the agency. I don’t know if you would characterize the outcome as clarification on the statistical analysis plan that you already had in your mind or if you would characterize it as some minor changes that were made to the analysis. Just trying to get a sense as to whether the FDA confirmed sort of the plan that you had in place or if there are some things that you learned coming out of the meeting that may result in some tweaks? Thanks.

Carl Spana

Management

Sure. It’s kind of a mixture of both, John. Really, a lot of it was just around statistical methodologies on how one would determine that the results assuming they are positive were clinically meaningful just what statistical methodologies would you use and making sure that we will clarify exactly what the FDA would want. There are number of ways that you can – there are number of analyses that you can do. We propose some, the agency had some comments on those and we sat down and said listen, there are couple of different ways you can do this. We are really agnostic as to what – all of them are correct. Just we are really agnostic as to what we use. We just want to make sure we get the ones that you want. And we were able to get clarified. They just clarified what they wanted. It’s also whenever you come to these meetings, you certainly are looking for – I am always looking for what’s the tenor in the room, how are the people in the room? Is it a meeting that is flowing nicely and collaborative or is it one where it’s more [indiscernible]? And then I would have to say in this particular case, this meeting was one and where I felt that the FDA was really there to help clarify our questions and make sure that we had a statistical analysis plan that meets their objectives. And as I said, it was one more positive collaborative meetings we have had with this division. So, it was quite refreshing from that standpoint.

John Newman

Analyst

Okay, great. Thank you.

Operator

Operator

That concludes our question-and-answer session for today. I would like to turn the conference back to our moderators for any additional or closing remarks.

Carl Spana

Management

Sure. Well, I would like to thank everyone for participating on the Palatin Technologies’ fourth quarter and fiscal year end 2016 conference call. Look, it’s a lot of excitement here. We have worked – the team here has worked long and hard and they continue to work hard to make sure that we get this data wrapped up and ready to be analyzed. It will happen soon. So, we are looking forward to it and we are looking forward to reporting the results out to everybody. I know many of you have followed this for a while. And this is a major event for us. And we are really looking forward and hopeful for a positive outcome. So, I would like to thank you all. Have a great day. And certainly, we will be in touch with many of you as the next quarter rolls on and the data comes out. Thank you.

Operator

Operator

This does conclude today’s conference. We thank you for your participation. You may now disconnect.