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Palatin Technologies, Inc. (PTN)

Q2 2018 Earnings Call· Mon, Feb 12, 2018

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Transcript

Operator

Operator

Good morning, ladies and gentlemen, and welcome to the Palatin Technologies Second Quarter Fiscal Year 2018 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’d 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

Good morning, and welcome to the Palatin Technologies second quarter fiscal year 2018 call. I’m Dr. Carl Spana, CEO and President of Palatin; with me on the call today is Steve Wills, Palatin’s Executive Vice President, Chief Financial Officer and Chief Operating Officer. On today’s call, we will provide financial and operating updates. Now, I’m going to turn the call over to Steve, who’ll provide the financial updates. Steve?

Steve Wills

Management

Thank you, Carl. Good morning, everyone. Starting with the second quarter ended December 31, 2017, significant and recent operational financial highlights include: with respect to Bremelanotide, which is under development for female Hypoactive Sexual Desire Disorder of HSDD. In November 2017, we announced the signing of a license agreement with Kwangdong Pharmaceutical for exclusive rights to develop and commercialize bremelanotide in the Republic of Korea. Under the terms of the agreement, we received 417,000 in December consisting of an upfront payment of 500,000 less 82,000 which was withheld in accordance with tax withholding requirements in the South Korea. Kwangdong is also required to pay us a 3 million milestone based on the first commercial sale in South Korea, up to 37.5 million in sales-related milestones, and Kwangdong is also obligated to pay us tiered royalties on annual net sales, ranging from high-single digit to low-double digit royalties. All development, regulatory, sales, marketing and commercial activities and associated cost in the license territory will be the sole responsibility of Kwangdong. In September 2017, we entered into a license agreement with Shanghai Fosun Pharmaceutical for exclusive rights to develop and commercialize bremelanotide in the territories of mainland China, Taiwan, Hong Kong, and Macau. Under the terms of the agreement, we received 4.5 million in October 2017 consisting of an upfront payment of $5 million, less 500,000, which was withheld in accordance with tax withholding requirements in China. Fosun is also required to pay us a 7.5 million milestone based on regulatory approvals in China, up to 92.5 million in sales-related milestones and Fosun is also obligated to pay us tiered royalties on annual net sales ranging from high single digit to low double digit royalties, all development, regulatory sales marketing and commercial activities at associated costs in the licensed territory will be…

Carl Spana

Management

Thank you, Steve. I’ll start our second quarter fiscal year 2018 operational update with bremelanotide. As Steve said, we're now working with AMAG pharmaceuticals our North American licensing partner to complete the new drug application to bremelanotide and we anticipate filing a new drug application in the first quarter of calendar 2018 putting bremelanotide on track for a potential approval in 2019. Our development of bremelanotide outside of North American market will only be done in the context of partnerships. Last quarter, we closed our second excellent American licensing deal with Kwangdong Pharmaceuticals granting them exclusive right to bremelanotide in South Korea. We are actively working with Fosun Pharmaceuticals, our Chinese partner and Kwangdong Pharmaceuticals to support their bremelanotide development in regulatory activities. We have ongoing discussions with multiple potential partners with different territories and anticipate closing additional bremelanotide licensing transactions in calendar year 2018. Palatin's other drug development efforts are primarily focused on our Melanocortin program or autoimmune and anti-inflammatory diseases and our naturally peptide program for cardiovascular and fibrotic diseases. Regarding our melanocortin obesity and diabetes program, we are reviewing of our development and business development strategy, including assessing the pursuit of treatments for rare genetic deficiencies resulting in life-threatening metabolic disorders in orphan drug designations. Our website www.palatin.com has detailed descriptions of our development programs, including methods of faction supporting science and commercial potential. So, on today's call, I will provide only a brief update. Our content PL-8177 is for selective agonist at the melanocortin 1 receptor, that has demonstrated efficacy in multiple models of inflammatory diseases, including inflammatory bowel disease and uveitis, and we are excited to be moving the compound into clinical development. In the fourth quarter 2017, our investigation of a new drug application for PL-8177 was accepted by the FDA. In the first…

Operator

Operator

Thank you. [Operator Instructions] We’ll go first to John Newman with Canaccord.

John Newman

Analyst

Hi guys, good morning. Just had a question on PL-3994, just curious on that particular compound, if you think it might be eligible for fast-track designation?

Carl Spana

Management

I don't know if it would be eligible for fast track designation, John. That compound is one of our older compounds and it’s the study that is, I discussed on the call is actually funded by third-party and being conducted by academic sensors. There may be some rare disease designations or often designations that we might follow with that compound, but it has a rather short intellectual property life. The compound that I think is really the winner in the naturally peptide space is really 5028. I think it is a much better profile with regards - particularly to potential close hypertension and some of the other side effects associated with natriuretic peptide. That's the one that we're really focused on. But we certainly - because of the clinical background we have with PL-3994 we certainly are looking to see if there are some other smaller indications as I said, may be some orphan ones that may we may be able to repurpose that for.

John Newman

Analyst

Okay. On bremelanotide, at this point in time, do you expect to have an FDA panel I know you have a profile, but just curious as to how you're thinking there?

Carl Spana

Management

Sure. We will be - it is a first-in-class compound in our discussions with the agency and the pre-NDA process they did, tell us that they were planning to have an advisory planning meeting for the NDA.

John Newman

Analyst

Okay, great. Thanks.

Carl Spana

Management

Thanks, John.

Operator

Operator

We will go next to Michael Higgins with Ladenburg Thalmann.

Michael Higgins

Analyst

Thanks. Good morning guys, how are you?

Carl Spana

Management

Good morning, Mike.

Michael Higgins

Analyst

Couple of partnering questions if I could, please go right on the next three years and your relatively holding stage pipeline you’ll have a lot in the pipeline, what is your outlook on signing for a partnership with the pipeline, is everything post Phase II? Would some of those be partnered sooner maybe your thought?

Carl Spana

Management

Mike, I think the strategy is going to emerge over the next several quarters as to the personal compound going into the 8177, that is targeted for ulcerative colitis. We’re doing the first systemic talks, we’re now, that will be followed up with an oral formulation for that compound and that approach. Certainly, we have had a few preliminary discussions with the potential partners, but based on the cash position that we currently have anticipating cash flow from licensing transactions and continued success of bremelanotide we’re not in a hurry to close any additional licenses on the pipeline right now. I think we can drive a little more value, substantially more value can be built in those programs before we bring at a partnership. I think what you will see us attempt to do over the next two to four quarters is really begin to focus the pipeline on indications where we can potentially take it through Phase 3 on our own. And those may be being such some of the - we haven't talked much about there may be some orphan designations that we haven't yet disclosed or something like dry eye or some of the ocular indications where the development pathway is a little bit cleaner, little bit more straight-forward doesn’t require quite as many patients. So, you will see certain mix of projects, really the following ones that we take forward on our own and some where we will look partnering a little bit earlier, but right now the main focus of the business development efforts will be on concluding the rest of the world partnerships with bremelanotide while we built some additional value in the pipeline.

Michael Higgins

Analyst

Thanks. That’s helpful. I just want to dovetail on your last comments on partners for bremelanotide. Any other areas that you haven't partnered up yet, what are your updated thoughts, what you're hearing from your discussion?

Steve Wills

Management

Hi Michael, it’s Steve. We’re pretty comfortable with the statement I made that we anticipate having the rest of the world territories that are not currently licensed by the end of the year. We have some excellent interest basically in all the territories i.e., the remaining larger territories i.e. EMA, Asia-Pacific, Japan, Latin America. So, as we - again we are advancing those discussions right now, and I would anticipate that they would even accelerate post the NDA filing by AMAG later this quarter.

Michael Higgins

Analyst

Okay, that’s helpful. I’ll jump back in the queue. Thanks guys.

Operator

Operator

And at this time there are no further questions. I’ll turn the call back to Dr. Spana.

Carl Spana

Management

Great. Thank you everyone for participating on our second quarter call. We look forward to getting out and meeting throughout the quarter and updating you at the end of next quarter. So, have a great day and thank you.

Operator

Operator

This does conclude today's conference. We thank you for your participation.