Palatin Technologies, Inc. (PTN) Q3 2014 Earnings Call Transcript
Published at 2014-05-13 15:24:05
Carl Spana - President and CEO Steve Wills - CFO, COO and EVP Dr. Jeffrey Edelson - CMO
Charles Duncan - Piper Jaffray Joseph Pantginis - Roth Capital Partners, LLC Rahul Jasuja - Noble Financial Capital Markets
Good morning, ladies and gentlemen, and welcome to the Palatin Technologies Third Quarter Fiscal Year 2014 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 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.
Thank you, and good morning, everyone. I am 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; and Dr. Jeffrey Edelson, our Chief Medical Officer. On today’s call we will be providing updates on our product programs under development and our third quarter fiscal year 2014 financial results. To begin, Steve Wills will provide the update.
Thank you, Carl, and good morning, everyone. Regarding Palatin’s operational highlights for the quarter ended March 31, 2014, and the month of April Palatin’s pivotal Phase 3 clinical trials of Bremelanotide for the treatment of female sexual dysfunction are anticipated to start as early as the second half of calendar year 2014. Carl will provide detail around the program during his presentation. In January 2014, we received $1.85 million in net proceeds from the sale of New Jersey State net operating loss carry forward, which resulted in the recognition of $1.85 million in tax benefits for the three months ended March 31, 2014. On April 30, 2014 a potential commercial partner exercised its option granting it an exclusive time-limited right to negotiate in good faith the terms of different license to Bremelanotide for the treatment of female sexual dysfunction in the European Union and other European countries. The primary financial terms had been negotiated and include an upfront licensing payment, the development regulatory milestones, royalties and annual sales related milestones. The $1 million option fee which was received in August 2013 and is creditable against any upfront or initial license fee in the event we entered into a definitive license agreement which recorded its unearned revenue as of March 31, 2014. Regarding financial highlights; for the quarter ended March 31, 2014 Palatin reported a net loss of $1.5 million or $0.01 per basic and diluted share compared to a net loss of $4 million or $0.04 per basic and diluted share for the same period in 2013. The decrease in net loss for the quarter ended March 31, 2014 compared to the same period last fiscal year was mainly attributable to the recognition of $1.85 million in tax benefits pursuant to the sale of the New Jersey State net operating losses. Regarding revenue, there were no revenues recorded in the quarters ended March 31, 2014 and 2013. Regarding cost and expenses, total operating expenses for the quarter ended March 31, 2014 were $3.4 million compared to $4 million for the comparable quarter of 2013. The decrease in operating expenses for the quarter ended March 31, 2014 was primarily the result of lower period cost related to our Bremelanotide program for the treatment of female sexual dysfunction. Regarding Palatin’s cash position, our cash, cash equivalents were $16.7 million as of March 31, 2014 compared to cash and cash equivalents and short-term investments of $24.4 million at June 30, 2013. As stated previously, Palatin did receive $1.85 million in net proceeds in January 2014 related to the sale of New Jersey net operating losses. Current liabilities were $3.4 million as of March 31, 2014 compared to $2.1 million as of June 30, 2013. The current liabilities as of March 31, 2014 includes the $1 million of unearned revenue which is, I mentioned previously is related to the non-refundable option fee granting an exclusive time-limited, right to negotiate in good faith, the terms of definitive license to Bremelanotide for the treatment of female sexual dysfunction in the European Union and other European countries. This payment we just received in August 2013 is credible against any upfront or initial license fee in the event we enter into a definitive license agreement. We believe that existing capital resources will be adequate to fund our currently planned operations including submitting and finalizing complete Phase 3 protocols with the FDA, for our Bremelanotide program for the treatment of female sexual dysfunction, but not initiating patient enrollment to at least June 30, 2015. We do not intend to initiate Phase 3 patient enrollment in our Bremelanotide program for the treatment of female sexual dysfunction, unless we have adequate funds or commitments or adequate funds to complete the Phase 3 program. Carl?
Thank you, Steve. Our third quarter fiscal year 2014 operational and programs update will start with an overview of Bremelanotide or BMT Phase 3 female sexual dysfunction program. Our activities are focused in two areas; operations required to start and conduct Bremelanotide Phase 3 pivotal registration studies and ongoing corporate partnering activities. On the operating front, we recently received additional FDA feedback clarifying the use of satisfying sexual events and the female sexual dysfunction index is our sub domain for the 28 day repo period as the co-primary endpoints for the Bremelanotide Phase 3 pivotal registration trials in the United States. We believe, this recent FDA guidance provide additional clarity on the BMT development path that is important for the advancement of BMT in potential licensing of Bremelanotide for the North American territory. We are now fully engaged in all the activities required to initiate patient enrolment in the North American Bremelanotide female sexual dysfunction Phase 3 pivotal registration trials. As you can imagine this is an extensive undertaking and we’re anticipating patient enrolment beginning in the second half of calendar 2014. As stated previously, the start of the Bremelanotide Phase 3 pivotal programs in North America is dependent on a number of factors including the status of our corporate partnering discussions and financial resources. I will now give an update on the status of our corporate partnering activities. We believe that there is a substantial global market for Bremelanotide, with United States being the large potential market followed by the European Union. However, we do believe there is also substantial opportunity for treating female sexual dysfunction with Bremelanotide in the rest of the world. We believe the most effective strategy is to have distinct partners for each of the United States, European Union and other territories of the world. We previously reported that as part of our corporate partnering activities in the European Union we entered into a short-term option agreement with a pharmaceutical company with research and development, sales and marketing, manufacturing and regulatory expertise activities in the European Union. We are very pleased that at the end of April this year our Bremelanotide European Union option to exercise their right to negotiate a license to Bremelanotide for the treatment of female sexual dysfunction in European countries including European Union. The next step is the execution of a definitive licensing agreement. We believe this will go quickly as financial terms and agreement has already been agreed to and we believe they reflect the market opportunity for Bremelanotide in the licensed territory. In addition, Palatin and the potential partner are working together putting in place the operating plan for the European Union Phase 3 program. We believe the potential licensee will be a strong partner for Bremelanotide in Europe in union and the currently has substantial sales and marketing activities specifically in women’s health area. As part of a license they will be committing substantial financial, product development and sales and marketing resources to Bremelanotide European female sexual dysfunction program. These commitments speak to the potential value of Bremelanotide in the licensed territory. Now let’s move to licensing activities for North American license for Bremelanotide for female sexual dysfunction. We are currently involved in active discussions and due diligence with multiple parties under CDA. In some cases preliminary non-binding terms have been negotiated. Resolution of the Flibanserin non-approval appeal and are recent FDA feedback to provide additional clarity on the development of treatments for female sexual dysfunction in the United States, further strengthening our corporate partnering activities. We continue to make progress with these activities and we anticipate being positioned to select a potential partner or partners and commence a definitive license agreement in the next few months. Now move on to our melanocortin-4 receptor obesity program which is under the direction of our collaboration partner AstraZeneca. After the period of corporate restructuring, AstraZeneca has assigned a new project development team to our joint melanocortin-4 receptor obesity program. We recently met with the new senior director of the program to discuss how best to jointly move this program forward. We expect that timeline to potential clinical trials will be clarified as we work with AstraZeneca over the next several quarters. Melanocortin-4 receptor is a well validated target for obesity therapeutics; human, genetic and preclinical experimental evidence indicates a key role for this receptor and associated signaling pathways in the regulation of food intake and weight. Our results from pre-clinical studies and clinical trials in obese patients with compounds that target the melanocortin-4 receptor to significant reductions in food intake and weight loss. We believe this program has significant commercial potential. Now we will move on to our PL-3994 natriuretic peptide receptor agonist program, we have been continuing to conduct a variety of non-clinical activities to better define the role of natriuretic pathways in cardiovascular diseases. This work is being done to support our efforts in finding a potential licensing partner. We believe that our ongoing preclinical work along with our earlier clinical results puts us in a strong position to move forward with the clinical development of PL-3994 as well as to attract potential licensing partners. Our final update on this call is a melanocortin receptor 1 based therapeutics program. We are very excited by the potential of our melanocortin receptor 1 therapeutic for the treatment of a variety of inflammatory and immunological indications such as inflammatory bowel disease, kidney disease and uveitis. A re-compound PL-8177 is progressing nicely through the preclinical activities, require to begin new pre-clinical trials and we’re on target for first in human studies by the end of calendar year 2014. In parallel with these development activities, we have begun discussions with potential corporate licensing partners. Before we open the call to questions, I like to make a few concluding remarks. We are extremely pleased with our opportunities regarding Bremelanotide for the treatment of Female Sexual Dysfunction and its essential commercial potentially of our product pipeline. Our excitement of Bremelanotide is supported by the strength of our Phase 2B efficacy and safety data, the regulatory guidance in both the U.S. and the European Union and the significant interest from potential collaboration partners. We have designed a comprehensive Phase 3 program that is successful to provide safety and efficacy data to support regulatory submissions for approval of Bremelanotide as a treatment for premenopausal women with Female Sexual Dysfunction. We are actively engaged in the activities required to begin patient enrollment in the Bremelanotide Phase 3 pivotal registration studies which are on track to begin in the second half of 2014. We’re making substantial progress on licensing of Bremelanotide as a treatment for female sexual dysfunction. Our potential European Union partner exercised their option to negotiate a license. The Bremelanotide for European Union, we’re excited about our potential partnership in Europe and are working with our potential partner to execute the definitive license agreement and on the operating plans for the European Union Phase 3 registration trials. The continued progress of our Bremelanotide Phase 3 development activities, recent FDA feedback and our pending European Union partnership which have occurred over the past quarter further strengthening our ability to enter into a partnership to North America for Bremelanotide. We have an active program to continue to present data from our Bremelanotide Phase 2b studies and you can find these presentations on our corporate website. In addition, we’re preparing multiple reports on the Phase 2b data for publications and peer-review journals. Regarding PL-3994, we have generated substantial package of preclinical data to support our corporate licensing efforts. And finally regarding our melanocortin 1 program PL-8177 our lead candidate is progressing through the pre-clinical activities required to begin in human clinical trials, and we’re on track to begin those trials later this year. We’ve also continued to make great progress identifying potential corporate partners. I would like to thank everyone for participating on our 2014 third quarter conference call and I’ll turn it back to the operator so they can open up the call for questions.
Thank you sir. (Operator Instructions). We’ll take our first quarter from Charles Duncan with Piper Jaffray. Charles Duncan - Piper Jaffray: Thanks for taking my question and congratulations on the recent progress with the EU partner. Carl what I wanted to ask you about is regarding the FDA guidance specifically on the end points in design. Wondering if you could help us understand some of the difference between the Phase 3 proposed protocol in the Phase 2 studies that you ran?
Sure, in Phase 2 study it was a smaller study and a single endpoint of satisfying sexual events as the only primary and the measurement of desire and the decrease in the stress were secondary endpoints. In the Phase 3 program, we will elevate the measurement of desire or changes in desire to a co-primary end point. So we’ll two primary endpoints the satisfying sexual events and then the improvement in desire is measured by the female sexual function index. So that’s really one of the key changes. Those studies, Phase 2 studies ran for 12 weeks ht pivotal trials run for four, 24 weeks, little bit more as well. Charles Duncan - Piper Jaffray: Okay. And once you are able to start enrollment, how much time do you think it will take and what’s your rough quarter magnitude of the costs of the Phase 3 study in the United States.
I’ll let Steve Wills take that.
This is Steve, Charles. We anticipate starting the U.S. Phase 3 trials in the second half of this calendar year. If that takes place based on our projections, we would anticipate following the NDA the new drug application with the FDA in the first half of 2016 and that would hopefully yield an approval from the FDA in the first half of 2017. From a cost standpoint as of right now we’re doing what we believe is a reasonable comprehensive Phase 3 program, obviously including the two pivotal trials the long-term safety study and approximately eight or nine ancillary drug-drug interaction studies. And we’re targeting that cost to be approximately $75 million going from this period forward. Charles Duncan - Piper Jaffray: And I believe in your prepared remarks you said that you would not start the Phase 3 unless you knew that you have enough money or commitment to have enough funds to complete that Phase 3? Is that correct?
That is correct. We don’t take any events to start the trials and not be able to finish it. Charles Duncan - Piper Jaffray: That makes a lot of sense to me as well. So your suggestion that you’re able to or prepared to start in the second half of 2014. Does that suggest that either U.S. partnership or even the European partnership will provide the majority of funding for the Phase 3 program?
The short answer is yes, the European partnership based on the financial terms we negotiated would not get us all the way home. As Carl mentioned we’re in advance discussions with a number of, with multiple potential collaboration partners. So our scenario is that we ink a U.S./North American deal, sometime as soon as possible to fully fund those trials. We’re in a position from an operational standpoint to pull the trigger very shortly; we could have the trials up and running within say eight to 10 weeks as we speak. All the contracts are if you will in the final stages with the third party vendors most notably the CRO. So we’re anxiously moving forward now that we’ve received the I’ve got the final guidance and handshake with the FDA on the Phase 3 protocols. Charles Duncan - Piper Jaffray: Okay. And then finally with regard to non-European and non-U.S. markets for FSD are there other partnering activities say for example either Asian markets or South America markets?
Yeah, I mean we’ve had some discussions with Latin American market partners we haven’t yet engaged with agent but as the -- really as we progress really our focus is North America right now as that gets concluded and we get the trials up and running we’ll focus on bringing in potential partners throughout the rest of the world. And in part we don’t want to rush on those others because North American partner may want to take some of those territories so they’d be part of a larger agreement. So although we have interest we have good interest we want to wait a little bit play out North America before we take it in there.
And we’ll take our next question from Joseph Pantginis with Roth Capital Partners. Joseph Pantginis - Roth Capital Partners, LLC: The question the simplistic question I have first is what’s going to get the new potential partnership over the finish line and then just looking toward some of the new ones there you did mentioned that this is a time limited negotiation and you do have primary terms so what’s still outstanding there?
Well, I mean we’re really working on taking of any now and putting into a license agreement. As I said the financial terms we’re agreed to so those are will be moved into the agreement the rest of it is really but the standard stuff dispute resolution how we operate, how we work together. I think that those will go quite easily from the standpoint of we have been working with this potential partner for a while we have as you remember from previous calls we actually jointly went to meet with the EMA to get the regulatory guidance. We’ve also been supporting a lot of their efforts to find the market in Europe so the operating relationship for two companies is quite good. And so I think that we should be able to write that down and get that into an agreement pretty quickly. We’re not going to put time lines on it we’re not going to do business development in the public format but sufficed to say both parties are very eager and working aggressively to get this done as quickly as we can. I think they committed to going forward and once they have made that commitment in their mind they can get to us as they want the license agreement in place and however they want the operating activities running they want to get moving and get this product into trials in Europe and approve as quickly as they can. Joseph Pantginis - Roth Capital Partners, LLC: That’s very helpful. Thanks. And then if you look at the discussion that you guys been having another way that you’ve also taking part that you disclosed was I know part of the negotiation periods was for that company to conduct a marketing research study that you guys assisted with. Would you be able to share any of the outcomes of that study with regard to the procedure market size or the potential market size in Europe and then what would this from a geographical standpoint what would this collaboration or partnership cover with regard to numbers of countries?
Well, I’ll do a little bit and then I’ll turn over to Steve. Obviously that I don’t think they would have exercised the option to go forward to license it was an substantial opportunity in Europe. We’re not at liberty to disclose the absolute market size yet we’ll let that occur as the definitive license is signed and we can do that on a joint basis with them. With that being said we have our own internal projections and Steve may want to talk about that these are separate from not based on that marketing work they’re based on [Indiscernible]?
Yes I agree with what Carl stated, we publicly stated that our -- we engaged a third party to do a comprehensive market assessment and they came back with a few well three scenarios on a low based and a high case and the parameters of that were 600 million annual U.S. sales on the low case, 900 million on the high case. The traditionally I think it also covers with this particular type of treatment Europe is going to be last we’re not at liberty to disclose the proprietary market assessment that our potential European partner prepared but it’s what we believe is a reasonable substance of market less than the 600 to 900 million range but still a very substantial market and we’ve also done some work with the rest of the globe separate them if you will the U.S. and the Europe and we think that market in the aggregate is about the size of the European EU and the European country market. I apologize for the background noise I am down and the landscapers are doing some work at our facility exactly the timing of our conference call. Joseph Pantginis - Roth Capital Partners, LLC: That’s helpful. Thanks.
We do have another question comes from Rahul Jasuja with Noble Capital Markets. Rahul Jasuja - Noble Financial Capital Markets: Good morning Steve and Carl, just a few more questions. The first one relates to the clinical trials in Europe versus U.S. under the Phase 3 trials. So my question really stand from the fact that the U.S. has you have a template with the sprout ongoing for FSD trials and endpoints are now sort of pumped up, but the European body doesn’t have that template. So should we be thinking that the European body is in agreement with what the U.S. is looking at the endpoints, so we’ll that Phase 3 in Europe be very-very similar in terms of endpoints in patient population and so on as the FDA discussions have gone?
Sure. The short answer is yes. The programs are designed to be mutually supportive. So the endpoints will be very similar, or identical, I mean obviously we have near over 100% sampled in Europe but they will be most likely very similar. They will probably include satisfying sexual events as well as a measurement of a proven in desire using this female sexual function index, and then in addition we want to show a decrease in the sexual dysfunction associated distress. So these will be quiet similar patient populations we will walk to make sure they match as closely as possible as well the premenopausal women, you know the co-medications co-morbidities and having all will be very similar. As I said you know we have had discussions with both the regulatory as well as the potential partner over making sure that these are going to be mutually supportive program. Rahul Jasuja - Noble Financial Capital Markets: Okay, and then of course we talked about the U.S. Phase 3 being about 600 patients and two trials. And that would again be similar case in Europe, I guess, just to confirm?
Yes. The short answer to that is yes. Again, we may, we have two doses in the U.S. We may choose to evaluate a third dose in Europe. Again those are things that were discussing with potential partner, but to answer your question, generally depending on the number of arms you have in the study of the number of doses you’re talking about 300 patients per arm. So you have probably 2 doses. That will be 600. Rahul Jasuja - Noble Financial Capital Markets: So, yes, I have in my notes, one dose, but because it’s a 1.75 make. So Europe now planning to doses. I would –
It’s under discussion in the U.S.; there are weight differences between U.S. and Europe. So you may want to evaluate a lower dose in Europe because they just, you know the body-mass index is, in a number of those women is lower than it will be in the United States. Rahul Jasuja - Noble Financial Capital Markets: Okay, that’s fair. The other question that I have is -- trying to understand the U.S. partnership here. Should we be thinking that there is a potential that you would have something again to maybe co-development, 50-50 kind of structure, or should we be thinking a complete set of out licensing.
It runs a gamut depending on the company that we’re talking to, so some of the best reform may be more joints on the larger guys, well what, more of a traditional straight license. It really just depends on the company and the partner we’re working through now with these various entities as to, what makes the most sense for us, what’s the best value that we can extract. And also who is the right partner, and most importantly who is the right partner to eventually hand this off to, although we may be involved very intricately in the development of the program through Phase 3 at some point because the personal license of North America will be taking this over, and will be responsible for generating the sales marketing and all of the other ancillary things, that go on, so we want to make sure we do have the right partner. So the terms will vary depending on the size of the company, and what’s most important to them, and what Palatin, would be as most important for Palatin. Rahul Jasuja - Noble Financial Capital Markets: Okay and then one question regarding the Phase 3 studies and the opportunity that is outside of premenopausal woman. Steve mentioned those numbers; those apply to the premenopausal FSD population. Is there any discussion of having postmenopausal track in the Phase 3 or just set of a supplemental population that needs to be looked at, or is that not even in discussion?
We will certainly -- we will take that in two front. From a safety standpoint, in both the EU and the U.S., we would like to have safety evaluations done because it is not unreasonable that although we don’t try both labeled use, you know the drug could be prescribed to women who are menopausal. So we just certainly want the safety data. We believe and we had discussions with various partners, I think some of them feels the same way, that there’s probably hope for substantial market in the postmenopausal arena and depending on the partners, how rigorously that would be studied during the Phase 3 program. It depends on the partner that comes on-board. But mostly we are talking to, we believe that is a substantial market opportunity and how we get at it whether it’s done simultaneously with the premenopausal or it’s done in a more staggered fashion, we just depend. But certainly the safety data will be collected. Rahul Jasuja - Noble Financial Capital Markets: Okay, and then you mentioned that moving onto MCR 1; you mentioned that potentially is to be in clinic towards the end of this year. When can we see animal data on the MCR 1 program?
Were pulling together a lot of that and we’re trying to decide what’s the best format. We do have some upcoming scientific presentations. So we’ll be announcing those as a curve and we would be putting out some of the data there. But at some point we probably will, either a conference call or more formally in an analyst day, I’ll provide a lot of the data, and present a lot of the data. We think it’s quite exciting and is also in a number of indications as we’ve mentioned on the call. And so you should expect that probably in the third quarter lot of data will start to become public.
And we do have a follow up question from Charles Duncan with Piper Jaffray. Charles Duncan - Piper Jaffray: Thanks for taking the follow up. There have been at least one IPO filing that I know of that focuses on genetically defined obesity. And so I guess I am interested in learning more about MC-4 obesity program. First of all, partner with AstraZeneca has that partnership fundamentally shifted, you did make some prepared comments but with the potential acquisition of Astra, is there any change there?
Not that they have notified us but obviously that potential collaboration or acquisition by Pfizer hasn’t been concluded. So I mean it’s reasonable to expect that if they get acquired by Pfizer that all programs will be booked some will review. So I mean that’s just reasonable but we have nothing [indiscernible] to us. Charles Duncan - Piper Jaffray: And you don’t have any kind of change of control provision or anything that atomically results in that one coming back to you Carl?
We essentially to be honest with you we don’t, we can go forward without to make a decision to do that. Charles Duncan - Piper Jaffray: And with regard to that program, do you have a lead compound moving through pre-clinical development that is kind of IND enable?
We believe that we have identified more than one we compound to have not yet transitioned into clinical development. So we believe that we multiple lead compounds that are indentified, we just have to make a final selection. Charles Duncan - Piper Jaffray: And in discussing potential fast forward with the partner that you have is the focus on general obesity or is it more narrowly defined or genetically defined obesity? For example for mutants in the MC-4 receptor?
Sure, I mean I think the ultimate goal is to have to intentionally treat the broadest patient population. We have had number of discussions as to what’s the best way to get there. Obviously the environment for treating general obesity there are two products approved and the third was a PDUFA date in early June. So that, I don’t it see it poses difficulties certainly that means that your target claim that there is no unmet, purely unmet, they have made the additional need or work that well and you may bring something that works better. But I think there are number of potential indications not necessarily genetic or purely genetic that you can study that provide a high unmet medical need and a very nice pathway forward to highlight the attributes of MC-4 based treatment then to be generalized to a broader population as the product gets approved and spreads out. And so those are types of things that perhaps the discussion we’ve been having. Charles Duncan - Piper Jaffray: Over the course of next year or say by mid 2015, could you see any milestones being met which would result in a payment to you from that program?
Yes, calendar 2015 actually the second half of calendar 2015 as things progress we would do a milestone. And if I can just back up on an earlier comment or question where you mentioned we do have rights not on change of control with the current AstraZeneca collaboration program, but if they did decide to not go forward in that area with that type of the MCR-4 agonist program, we do have a lot of rights regarding that program.
And ladies and gentlemen that does conclude our question-and-answer session today. Dr. Spana I’d like to turn the call back over to you for any closing remarks.
Want to thank everyone for participating in our third quarter 2014 update. We’re quite excited of what’s going on here at Palatin, I think we put a very nice company together, Bremelanotide is moving towards it’s Phase 3 trials part, but nicely as you can see we’ve been able to attract corporate interest and we will continue to do that. And as both Charles, alluded to the earlier program is also coming along quite nicely. So we think we’ve built very comprehensive pipeline that’s stretching really from Phase 3 back to late preclinical. And by the company and we look forward to updating you next quarter and as we do other presentations throughout the quarter as well. So with that have a great day and thank you for participating on our call.