Palatin Technologies, Inc.
Q4 2015 Earnings Call Transcript

Published: 21 Sep 2015

[Operator:]

Good morning ladies and gentlemen, and welcome to the Palatin Technologies, Fourth Quarter and Fiscal Year 2015 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 our host for today, Dr. Carl Spana, President and Chief Executive Officer of Palatin Technologies. Please go ahead, sir.

[Carl Spana:]

Thank you and good morning everyone. I’m 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. On today's call, we will provide updates on our development programs and our fiscal year end 2015 financial results. To begin, Steve will provide the financial update.

[Steve Wills:]

Thank you Carl and good morning everyone. Regarding recent operational highlights related to bremelanotide for female sexual dysfunction, we initiated Protocols 301 and 302 of our Phase 3 reconnect study with bremelanotide in the United States and Canada for the treatment of female sexual dysfunction in December 2014 and January 2015 respectively. These protocols and trials are progressing as planned and meeting target objectives. We are currently greater than 50% enrolled with complete enrolment expected by calendar year end. In August 2014, we entered into a license agreement with Gedeon Richter to co-develop and commercialize bremelanotide for female sexual dysfunction in the European Union, other European countries, and additional selected countries. We received approximately $10 million in total upfront payments and a milestone payment of approximately $3 million upon the initiation of our Phase 3 reconnect study in the United States. In September 2015, we entered into a termination agreement pursuant to which Palatin and Gedeon Richter agreed to mutually and amicably terminate the license agreement. In connection with this termination, all rights and licenses to co-develop and commercialize bremelanotide for female sexual dysfunction indications held by Gedeon Richter terminated and reverted to Palatin. Neither we nor Gedeon Richter have any future material obligations under the license agreement. There are no payment or reimbursement obligations as a result of the license agreement termination. We now have the global rights to bremelanotide for FSD, providing Palatin and our business development efforts with additional options and flexibility. We are actively engaged in licensing and collaboration discussions with multiple companies for both global and regional commercial rights to bremelanotide. Our research collaboration and license agreement relating to our MC4r Agonist Program for Obesity in Diabetes with AstraZeneca has expired because AstraZeneca seized developing a compound covered by this agreement. All rights and licenses that we granted AstraZeneca will return to Palatin. We are currently reviewing collaboration data as we assess the possibility of progressing any collaboration compounds. Moving now to financial highlights, in July 2015 we closed on $30 million of debt and equity financing, consisting of a $10 million venture loan with includes an interest only payment period for the first 18 months of a four year secured term loan, and $20 million private placement of Series E warrants to purchase approximately 21.9 million shares of common stock and Series F warrants to purchase approximately 2.2 million shares of common stock. The equity deal is considered a market transaction. Regarding specific financial operating results, we reported a net loss of $12.1 million or $0.09 per basic and diluted share for the quarter ended June 30, 2015, compared to a net loss of $4.3 million or $0.04 per basic and diluted share for the same period in 2014. The increase in net loss for the quarter ended June 30, 2015 compared to the net loss for the quarter ended June 30, 2014 was the result of an increase in operating expenses primarily related to our Phase 3 reconnect study with bremelanotide for female sexual dysfunction. For the year ended June 30, 2015, we reported a net loss of $17.7 million or $0.15 per basic and diluted share compared to a net loss of $13.9 million or $0.13 per basic and diluted share for the year ended June 30, 2014. The increase in net loss for the year ended June 30, 2015 compared to the net loss for the year ended June 30, 2014 was mainly attributable to the development costs for the initiation and progression of the Phase 3 reconenct study with bremelanotide for female sexual dysfunction. Regarding revenue, there were no revenues recognized in the quarters ended June 30, 2015 and 2014. For the year ended June 30, 2015, we recognized $12.9 million of licensing contract revenue under our agreement with Gedeon Richter. Regarding operating expenses, operating expenses for the quarter ended June 30, 2015 were $11.8 million compared to $4.3 million for the comparable quarter of 2014. For the year ended June 30, 2015, we incurred $30.2 million of operating expenses compared to $15.8 million for the year ended June 30, 2014. The significant increase in operating expenses for the year and quarter ended June 30, 2015 was primarily the result of higher period costs related to our Phase 3 reconnect study with bremelanotide for female sexual dysfunction. Regarding Palatin’s cash position, our cash and cash equivalents were $27.3 million as of June 30, 2015 compared to cash and cash equivalents of $12.2 million at June 30, 2014. Current liabilities were $7.4 million as of June 30, 2015, compared to $1.8 million, net of a $1 million differed income as of June 30, 2014. We believe our existing capital resources, together with the approximately $30 million received related to our July 2015 financings will be adequate to fund planned operations through the quarter ending September 30, 2016. Assuming our Phase 3 reconnect study with bremeloanotide for female sexual dysfunction is successful, as to which there can be no assurance, we will need additional funding to complete submission of required regulatory applications to the FDA for bremelanotide for female sexual dysfunction. Carl?

[Carl Spana:]

Thank you, Steve. Our fiscal year end 2015 operational update will focus on our bremeloanotide or BMT Phase 3 female sexual dysfunction program. The last four quarters have seen substantial positive progress in the female sexual dysfunction field and bremeloanotide FSD program as well. Historically, we are currently enrolling patients in the North American BMT reconnect study Phase 3 pivotal registration program, protocols 301 and 302, our multicenter, randomized, placebo-controlled parallel group clinical studies with a six-month randomized treatment phase and an open label extension phase. The clinical trials are designed to randomize approximately 1,100 women which is approximately 500 in each trail, to evaluate the efficacy and safety of subcutaneous bremelanotide in premenopausal women with hypoactive sexual desire disorder as an on-demand, as-needed treatment. The BMT reconnect studies are on schedule. Enrolment in the two Phase 3 studies is greater than 50% and is on target to complete in the fourth quarter of this calendar year. This puts us on track to have top line data by the third quarter of calendar 2016. The FSD feels major positive changes this past quarter. On June 4, 2014 the FDA Advisory Panel Reviewing the NDA for flibanserin voted 18

[Operator:]

Thank you. [Operator Instructions] We’ll go first to Charles Duncan at Piper Jaffray.

[Charles Duncan:]

Hi guys, thanks for taking my question and congratulations on a good quarter and progress. So my first question is regarding the North American program for bremelanotide in FSD. I’m wondering in terms of enrollment, first of all it’s nice to hear that you’re about 50% or more enrolled. Any surprises thus far regarding the protocol implementation or the enrollment of patients. Can you give us even a blinded read on the characteristics of those patients?

[Carl Spana:]

Sure. Yes, we can. Enrollment has been going nicely. We are on track and it’s very nice to see the end of that process coming by the end of the year and that really sets our date obviously for data. We are paying very close attention to evaluating the types of patients that are coming in, making sure that they actually have HSDD which is the indication. We’re also looking to make sure that we don’t see anything new coming in as far as adverse events that weren’t expected or anything else and quite frankly everything appears to be going well. I mean, everything is as anticipated, nothing new. No requirement to change a protocol or amend a protocol to expand enrollment or anything, so as it should be and hopefully should be, it should be boring and simple and we should get it done and get the right patients in and that is what it looks like we’re doing.

[Charles Duncan:]

Okay, so it appears to be executing well and I guess I’m wondering if you’ve heard anything from investigators regarding their interest in potentially a safety study or some kind of long term follow up that might indicate their interests or the patient’s interest in continuing to use the drug.

[Carl Spana:]

I mean patients in the overall program design, the two U.S. pivotal studies 301 and 302 feed into an open label study. So we now have patients obviously cycling off of treatment. They have completed the randomized part and they are in the open label safety part, so again there we don’t see any – everything appears to be going as planned. Patients are coming off the two trials as they should and most of them are moving right into the open label part of the program. So, right now everything looks to be on track operationally, moving well and we really at the moment don’t see anything cropping up that would keep us from meeting any of our scheduled objectives such as data in the third quarter of next year and that followed by a filing shortly thereafter.

[Charles Duncan:]

And Carl, regarding your use of the word most, you said that your greater than 50% or somewhere north of that that are choosing to enroll in that safety’s follow on study?

[Steve Wills:]

It’s sort of a target based on other trials of this type. This is Steve speaking. We would expect to get no less than 50%, but it could be a range of 50% to 70%; we’re fine with it either way.

[Carl Spana:]

We don’t -- at the moment we don’t see any – we’re in our, well within our anticipated range for patients rolling into the open label.

[Charles Duncan:]

Okay, and then regarding European plans, first of all congrats for getting the entire rights back on the asset. I’m wondering what the next steps could be or when you can kind of outline those and would this be post to partnering a process or are you able to launch a study in Europe in advance of that?

[Carl Spana:]

Well, we have a couple of parts and then I’ll give you some answers and maybe Steve will jump in as well. From an operating standpoint, we have the protocol feedback from protocols developed. We know what we want to do, so I think it would be straight forward for us to step in and move that program forward. That of course will always be dependent on finances and what have you and that’s something that we’re evaluating now. There’s just a lot of moving parts going on with the current discussions that we have and what we want to do, so you may want to add a few more things in.

[Steve Wills:]

I mean the one thing not withstanding that we are $13 million ahead since that’s what we’ve received to date from the Gedeon Richter development, licensing collaboration, we have not expanded any cash or expenses towards that development other than our internal personnel resources, but we also have a very, both specific and comprehensive roadmap related to the development program. The meetings with the MA/CHMP had already taken place, protocols were drafted. So we’re in a very good position from a flexible standpoint if we decide that it makes sense for us to move it forward, Palatin alone or frankly with either a new regional partner or possibly a global partner. As Carl mentioned, we do have enhanced discussions post the approval of Addyi where you now have that real specific regulatory path. So as of right now, over the next 60 to 90 days, we’re going to be assessing our options, continuing the discussions, and then decide what makes sense for us to progress. But the take away is we’re in a position where that very comprehensive roadmap, not just from a development, also from a marketing standpoint, Gedeon Richter did some very significant market assessments for this program. And just to make sure everybody’s trying to be transparent, the relationship with Gedeon Richter was very professional and collegial. There are some indigenous factors with any company assessing certain decisions, but we had no issue with our collaboration with Gedeon Richter and whatever those indigenous factors are, they were not related to the bremelanotide compound or the potential size and motivation of the potential female sexual dysfunctional marketplace in Europe.

[Charles Duncan:]

Okay, that’s helpful. Thanks for the added color Steve and Carl.

[Operator:]

We’ll go next to Joe Pantginis at ROTH Capital Partners.

[Joe Pantginis:]

Hey guys, thanks for taking the question. So you both said now that it appears that the – or not appears that the activity around partnering discussions has increased following the value and buyout of Sprout. I guess when you look at the amount of time until data, do you think you might deliver something ahead of data or even want to deliver a partnership ahead of data, because obviously you’re looking at two different potential pricing points. And then the second part of that question is, as these discussions are occurring, how much of these discussions revolve around the fact that BMT is an injectable versus say flibanserin being a small molecule.

[Carl Spana:]

Sure. Thanks for the questions Joe. Certainly we have the flexibility. We’re capitalized and the reason why we took money, additional money in July was really to be capitalized to maximize the opportunity and to really get to the data point, if that’s what is required. I can’t answer what’s the right place to do it. It’s going to be dependent on if we get any offer, what the offer is and how high it is and what we believe the risk would be doing something now versus with data in hand. Certainly, logically one would assume that with the data in hand and what clarity has to how differentiated the labels would be, you would think that the valuation point would be higher. But also keep in mind you know there probably was more than one person interested in adding compounds from Sprout and there may be certain companies that have a more emergency to get something done now and maybe willing to put a very comprehensive deal on the table, that’s what we’re working through, but we don’t have to do something now moving forward. Yes, we don’t have to do it now and it’s nice to have that flexibility, just have the flexibility.

[Steve Wills:]

We’re data driven and we’re in the good position where we have the flexibility that we don’t have to raise money to get the data and we don’t have to take money via partnership. So we’re going to be data driven. As Carl stated, if the opportunity is presented that makes sense from an anxiety standpoint with the shareholders, then we will strongly consider a partnership prior to data. We don’t believe we’re getting if you will, the proper value, then we’ll wait until the data comes out. So we’re going to be data driven in that regard.

[Carl Spana:]

There’s any other questions on that?

[Joe Pantginis:]

The objectable.

[Carl Spana:]

Sure. I think that the good news, they are assuming bremelanotide is successful and gets approved there really will be two players in this marketplace. One is a chronic medication you take every day and then the other is an injectable and we know from our work and this is being confirmed from the potential partners, because we’ve been having discussions on and off with the same group of success people for the last 18 months. The urgency obviously is much higher now with the approval and the clarity of the regulatory pathway that essentially patients probably prefer an on-demand treatment for this indication versus a chronic. We believe that many patients will prefer that and that’s been confirmed. So yearly, there’s not a formula you know that talks and says, well we love those attributes that you have with the pill. Certainly that’s the case, that’s to our society, but we don’t see that the injectable nature is going to keep someone from doing a comprehensive and valuable deal with us. It’s going to be really driven by the continuing differentiation of the two products, the fact that we’re on demand, we should not assuming we replicate our Phase 2 data into Phase 3 from the safety standpoint and from an efficacy standpoint there’s really no reason why we should have some of the restrictions that are seen on the Addyi label or that type of risk mitigation program requiring certifications and counseling; that’s just not something that should be seen with this drug. So we should be in a very good position to play against them and to market against them and I think that’s what we want recognized in any deal that we do, whether that’s done now or it’s done with the data.

[Joe Pantginis:]

That’s helpful, thank you, and if I could just ask one question on 3994. Obviously it appears, at least to me that there’s been a renewed focused obviously with Entresto’s approval with Novartis and then natriuretic peptide pathway; 3994 definitely hits this. So I guess, I would anticipate your answer would be similar with regard to your – the answers for BMT. But with your Phase 2 plans and funding capabilities, do you prefer or what would you like to see. Would you go like to go into the Phase 2 yourself to generate more date to potentially drive more value or do you think you’d like to look to deliver a partner ahead of getting into a larger Phase 2.

[Carl Spana:]

That’s a little bit – well, we had a very nice early around of interest in 3994. We learned a lot of what we need to have in place to get a comprehensive deal. That’s starting to take place now. I didn’t highlight a lot of the call. I probably will on the next one. We have a number of things that are going on that will come out over the next several weeks plus. So I think we are really, we are getting to a point to reengage at a more substantial level with potential partners to fill in some of the gaps that we needed to with that program. So for us, listen heart failure is a very, long term space. The expenses that we are spending on bremelanotide for Phase 3 will be worked by Phase 3 program in heart failure. So I think if we could find the right partner now that understands and is willing to make the commitment to drive the value, we probably would do a deal earlier with that program than we might say for example with bremelanotide. I think coming in at this stage, partners will have to understand where we are and what we are doing, and as I said, we had some very comprehensive meetings and we understand now some of the things that we did when we first started those and we filled a lot of the gaps in. So I think we are setting up nicely for some success on the business development front there over the next couple of quarters.

[Joe Pantginis:]

Okay, great. Thank you.

[Operator:]

And we will take our next question from John Newman at Canaccord.

[John Newman:]

Hi guys. I just had another question on PL-3994. You mentioned that you are planning on initiating a Phase 2 study in the first half of 2016. I wonder if you could talk a little bit about what the design might look like and also if you would prefer to run that study on your own or if you prefer to work with a partner on that?

[Carl Spana:]

Yes, the next study for us is a really an early Phase 2. It’s a multiple ascending dose study in heart failure patients, where we are really going to be looking at the dosing range over which we can give 3994 and I won’t get into, if you ask I won’t give you any details how we want to dose the drug to where we believe we’ll get maximal effect. So that study is not a hard study for Palatin to do and its one that we have money to do. So I don’t think that either us or any potential partners that we will be talking to are really looking at that study per say other than as the step to the real Phase 2 at home study, which would be more towards the end of next year, which is we first look at real at home efficacy dosing study. So for us we are moving the bull forward or to say our long term top studies are now progressing nicely. So really as we get to this time next year we’ll have clinical data talk dates really going to what I would call a true proof of concept study in a heart failure population. So for us its – I don’t think either us or potential partners coming in are really looking at the next two or three quarters worth of work. It’s really the stuff that starts after that and goes forward and that’s what we do, you want to have them partnering by then.

[John Newman:]

Right. And then on bremelanotide, I’m just curious if you have seen any uptick in enrolment given the recent FDA approval for the Sprout compound. I’m just wondering if that might be contributing to the enthusiasm for the space.

[Carl Spana:]

We saw a very nice uptick as to the panel meeting and the stuff around the panel meeting in June that’s kind of flattened out. July and August are routinely for these types of products, not the highest enrolling months that you have and our anticipation is and we were seeing now as of course everyone’s back in, kids are back in school and you will see uptick gain. I expect that we’ll see another big bonus occur when the product with Addyi is launched probably in mid-October. Irrespective of that, our current enrolment rates are actually five at the end of the year. Whether we get an uptick, we can make it happen couple of weeks earlier, that’s all. So there is really no – that doesn’t matter. But we did see one off of the original FDA meetings.

[John Newman:]

Great. Thank you.

[Operator:]

We’ll take our next question from Rahul Jasuja at Noble Life Science Partners.

[Rahul Jasuja:]

Hey, good morning guys; a few remaining questions that I still have. So let’s start with the BMT program in Europe. There were differences in terms of I guess the regulators and maybe even the dosing for Phase 3 study in Europe. Now from the discussion that we just had, I guess you may still want to pursue discussions with the regulators in Europe, even though they are out beating Richter and then can you just sort of briefly comment on what potential differences would they be. There was some discussion in the past about the body weight of U.S. versus the European women. So would there be drastic clinical trial changes and how far can you take this without a partner in Europe.

[Carl Spana:]

Sure, a couple of these. We’d have a lower dose in Europe than we do in the U.S. So U.S. is a single dose, 1.75 milligrams. In Europe we have a lower dose, either 1 or 1.25 milligrams there going forward as well and in large part that is driven by the weight differences that we see between the two geographic areas. From a process standing, we would right now, we would complete a protocol which is almost done and we would just submit it to the EMA as they have a certain period of time to review it, make any comments and then we are ready to go forward. The trail designs overall are very similar; the same type of running period, same type of endpoints, identical endpoints, identical patient population. So other than the addition of the lower dose, the trials are almost identical and it was designed to be – the program in Europe was designed to piggyback off the US data, so there would only be a single phase 3 clinical trial in Europe and if that was positive it is the data from the U.S. as support for your second trail. So overall we set up nicely there. Can we go forward? We are evaluating that right now. I mean we have certain money that we could use to continue that plan and go as normal. We just have to determine if that’s the right thing to do or should those money be used to be other trials, maybe in the U.S. that might add value by expanding its patient population so on and so forth and that’s what we are reviewing right now. But for me, incentive standpoint, the activities that would allow us to go forward such as manufacturing drug product, protocol, so on and so forth probably identification of Syros [ph], those are the types of things that will be ongoing, those won’t stop. So we’ll make a decision later this year or early next year and we will be able to role straight ahead and either start to study in Europe or do something different if that’s what we decide has got the best value.

[Rahul Jasuja:]

Okay, great and then my next question is also on the BMT program, but maybe a little redundant than the previous questions, but I want to ask it anyway. So post the approval of Flibanserin and the Addyi’s acquisition, I guess in the past there was a hesitancy by big pharma given the FSD space and then the discussion not just on the size of the market, but there was discussion on the end points. Now given the new world in FSD, qualitatively I guess our discussions with big pharma are far more robust, because you are not discussion risk of regulatory endpoint now, you are discussion other aspects. So could you just comment on how the world has changed in terms of your BD activity for bremelanotide for FSD?

[Carl Spana:]

I’ll give you my opening and ask Steve if can jump in with his. Certainly we heard – we’ve had on and off discussion with multiple parties in the last 18 months. Every six months these companies are back in and really what was going on is there’s strong – a number of companies want – they view this as an attractive space and have viewed it for a long term. One of the big issues really was would the FDA approve something or not and that’s gone now, that issue has centrally is gone and I think the parties that we are talking to recognize that. So now things are switched from okay, we want something, now the question is timing, timing when do we want to do it, you want to wait for your data, or do you want to something now and so on and so forth and Steve you may want to jump in and give more clarity.

[Steve Wills:]

I mean, I think we’ve really covered it. There is no question there was maybe some more people calling us post the approval. The lineup includes all the various types of parties from the big pharma to the specialty pharma, to the global versus the regional. So we are actually feeling pretty comfortable with the interest level and over the 60 to 90 days we’ll continue those discussions and try and gather enough data to make a decision on if it makes sense to do something, if something is offered versus wait unit the data. But as we mentioned before, we do not have to do anything. So it’s going to be data driven and assessing the opportunities of value.

[Rahul Jasuja:]

Great and then I have a question of PL-3994. So clearly there is a mechanistic difference in the way that 994 modulates the NPR system versus Entresto. You don’t have to go through the whole mechanism here, but in looking at the differences, number one, are there pros or cons for 3994 and two, does it make sense to look at genetic populations for the markets and the mutations and the NPR intercept curve and maybe targeting those sub-population or would you want to follow the path that Novartis did. Any thoughts there?

[Carl Spana:]

Sure, I won’t, because we were long on the call, so I won’t get into too much mechanistic stuff other than to say that one thing that we have done is really both with internally and then with external help was really take a very strong hard look at the commercial opportunity for a product like 3994 in light of Entresto and there are some very nice areas in the heart failure space where we think 3994 can play quite nicely. On some we did highlight. There are patients that have mutations that they don’t make enough Natriuretic Peptide and they are a very logical place to go with a hormone that would essentially – more as a hormone replacement. One of the things that you will also with Entresto is that the patients were generally NYHA II. So that’s great for the internist and the basic cardiologist who maybe writing some scripts, but for the part of the specialists, they are really seeing the more difficult patients, progressing patients, patients with NYHA III, IV, patients that have renal insufficiency and these all represent very nice populations where your direct acting agonist probably has a better role and can drive more efficacy than Entresto could. So we think there is a very nice setup for us commercially and as things will allow, we’ve not give you a lot of detail on the program. There’s a lot of these going on that we haven’t, but that is our intention to fill in some of those details. Some of that’s done for IP reasons, we are following some new IP there and so I don’t want to get into that, but I think our understanding of how to go forward though NI-4 [ph], how to do things has taken a really big leap forward and hopefully we’ll be able to convey that to you and get that across over the next quarter or so.

[Rahul Jasuja:]

Okay, very good and just in conclusion I sort of ratify and agree with others who have said that, this is – this turns out well for Palatin, the determination of the rest of the deal. I guess there is something that’s looking out that’s good for Americans. Thank you.

[Carl Spana:]

Okay, thank you.

[Operator:]

And that does conclude today’s question-and-answer session. At this time I’ll turn it back over to management for any closing remarks.

[Carl Spana:]

We want to thank you all for participating on the call. It’s been a good year for us, tremendous progress on BMT. We are quite excited where all is towards the end now and that really sets up for the data and we are really looking forward to that process and continuing to work to move all of our assets forward. So we are very pleased with the quarter. Everyone thank you for participating on the call. As always as we go out and we do our meetings throughout the quarter, we look forward to seeing some of you in meetings, and take care for the rest of the year. Thanks.

[Operator:]

And that does conclude today’s conference. Again, thank you for your participation.