Palatin Technologies, Inc. (PTN) Q1 2014 Earnings Call Transcript
Published at 2013-11-14 17:23:01
Carl Spana - President and CEO Steve Wills - CFO and COO Jeffrey Edelson - CMO
Roy Buchanan - Piper Jaffray Joe Pantginis - Roth Capital Partners
Good morning, ladies and gentlemen, and welcome to the Palatin Technologies First Quarter Fiscal Year 2014 Conference Call. 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 you to 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 and our fiscal year 2014 financial results. To begin, Steve Wills will provide the update.
Thank you, Carl, and good morning, everyone. Regarding financial highlights during the quarter ended September 30, 2013, we received a $1 million non-refundable option fee relating to negotiation of a potential future license of Bremelanotide in a defined territory primarily Europe for the treatment of female sexual dysfunction. Subject to certain contingencies (Ph) if not exercised the option expires at the end of the first quarter of calendar 2014. This payment, which is credible against any upfront or initial license fee in the event of negotiation of definitive license agreement, which recorded as unearned revenue on the balance sheet, as of September 30, 2013. Regarding the first quarter fiscal 2014 financial results, Palatin reported a net loss of $4.5 million or $0.04 per basic and diluted share for the quarter ended September 30, 2013 compared to a net loss of $10.5 million or $0.15 per basic and diluted share for the same period in 2012. The decrease and the loss for the quarter ended September 30, 2013 compared to the same period last fiscal year was mainly attributable to a non-cash non-operating expense of $7.1 million recognized in the quarter ended September 30, 2012, which represented the increase in the fair value of warrants related to our July 2012 private placement offering. Regarding revenue there were no revenues recorded in the quarter ended September 30, 2013 compared to 4,000 for the same period in 2012. Revenue consisted entirely of reimbursement of development cost and per employee compensation earned at the contractual rate pursuant to our agreement with AstraZeneca. Regarding cost and expenses total operating expenses for the quarter ended September 30, 2013 were $4.5 million compared to $3.4 million for the comparable quarter of 2012. The increase in operating expenses for the quarter ended September 30, 2013 was result of an increasing cost primarily related to our Bremelanotide for treatment of FSD program. Regarding Palatin’s cash position our cash, cash equivalents and short-term investments were $22.3 million as of September 30, 2013 compared to $24.4 million at June 30, 2013. Current liabilities were $4.2 million as of September 30, 2013 and included unearned revenue of $1 million previously mentioned related to the option agreement compared to $2.1 million as of June 30, 2013. We believe that existing capital resources will be adequate to fund our currently planned operations including submitting complete protocols to the FDA for our Phase 3 studies but not initiating patient enrolment through at least calendar 2014. We do not intent to initiate patient enrolment in the Phase 3 program unless we have adequate funds or commitments for adequate funds to complete the Phase 3 program. Carl?
Thank you, Steve. Our first quarter fiscal year 2014 operational update will focus on our Bremelanotide Phase 3 Female Sexual Dysfunction program. Since our last teleconference which was about a month ago we have made good progress in advancing Bremelanotide. Our activities are focused in two areas, development operations required to start and conduct Bremelanotide Phase 3 pivotal registration studies and business development activities. On the operating front we recently reported top line results in the clinical trials comparing Bremelanotide dose using single-dose disposable autoinjector with dosing using a pre-filled syringe as we anticipated Bremelanotide delivered with the autoinjector demonstrated by availability in formal cosmetic parameters almost identical to pre-filled syringe and that the [indiscernible] delivered with the instrument (Ph) autoinjector is ready to move into Phase 3 trials. As a final point Phase 3 Bremelanotide clinical trial supplies have been manufactured. As we have previously disclosed in the second quarter calendar 2013, we had ended Phase 2 meetings with the FDA we represented and discussed the Phase 2 be safety efficacy data, our plans Bremelanotide Phase 3 Female Sexual Dysfunction pivotal registration program and our preclinical toxicology manufacturing data. We have lease agreement with the FDA on key aspects of the Phase 3 program including patient population, primary end key secondary end points, study design and safety monitoring. Currently, we are actively engaged in the activities required to start and run immediate Phase 3 programs. These include finalizing Phase 3 protocols, identifying, screening and hiring multiple contract research organizations and related vendors identification in screening and clinical trial sides. As previously stated, we should be in position to begin patients screening late this calendar year. However, the final decision when we start patient involvement in Phase 3 Female Sexual Dysfunction clinical trials is dependent on a number of factors including status of our corporate partnering discussion and financial resources. I would now like to switch gears and give a brief update on the status of our corporate partnering activities. Currently the Company believes two large potential markets for Bremelanotide on Untied States and European union with United States being large in potential market. Based on a number of factors including differences in patient population, regulatory requirements, marketing and reimbursement practices it may be most effective to have distinct partners for each of the United States and European Union. As part of our licensing activities in European union, we have entered into a short term option agreement with the pharmaceutical company with research and development, sales and marketing, manufacturing regulatory activities at the European union. Also received $1 million nonrefundable option fee relating to the negotiation of a future license of Bremelanotide for European countries including the European Union, this option expires in the first quarter of calendar 2014 if not exercised. As part of the option agreement, the potential licensee who has extensive clinical and regulatory experience in the region is collaborating with Palatin regarding a regulatory meeting with the European Medicines Agency. The objective of this meeting is to receive scientific advice on the Bremelanotide Phase 3 registration program for the European Union. In addition to the option agreement in nonbinding terms it has also been negotiated which will form the basis of final terms and agreements. We believe these nonbinding terms are reflected by Bremelanotide’s potential value in the territory. We believe the potential licensee will be a strong partner for Bremelanotide in the European Union having substantial sales and marketing activities numerous health areas. Let me stress that the option agreement does not impact our ability to license Bremelanotide in the United States in more local basis or our ability to undertake other strategic activities. Now moving on to licensing activities in the United States right for Bremelanotide for Female Sexual Dysfunction. We are currently involved in competitive licensing process with multiple and I do mean more than two potential partners under CDA and an active discussion and due diligence. In some cases preliminary, nonbinding terms has been negotiated. We will continue to progress these activities and we anticipate being in position by the end of this year to select a potential partners or partners and to move to final agreement in 2014. Now we'll move on to our obesity and diabetes program which is under the direction of our partner AstraZeneca. After running into an issue with the personal candidate in subcutaneous injected peptide AZD2820. AstraZeneca has been focused on preclinical research to identify potential new melanocortin-4 receptor clinical lead compounds. 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 intended pathways in the regulation of food intake and weight. Our results from earlier clinical trials of these patients with compounds that target the melanocortin-4 receptor showed significant reductions in food intake and weight loss. This program has significant commercial potential and we believe that our partner AstraZeneca has the resources to realize this potential. Pursuant to the terms of the research collaboration and licensing agreements with AstraZeneca, Palatin is eligible for milestone payments upon achieving development and regulatory milestones as further payments on achievement our sales targets in addition to royalties on sales of approved products. AstraZeneca has the responsibility for product commercialization, discovery and development cost. Moving on to our PL-3994 natriuretic peptide receptor agonist program, a key objective for fiscal this year was to conduct a variety of preclinical activities to better define the role of natriuretic pathways in pulmonary and cardiovascular diseases. This being done to support our objective of finding a potential licensing partner for one or more of these programs. We believe that the preclinical data we have generated along with our earlier clinical work now puts us in a stronger position to move the development of PL-3994 forward, as well as track potential licensing partners. Our final update on this call is on melanocortin-1 receptor based therapeutic program. We believe that melanocortin receptor 1 based therapeutic will have the potential to treat a variety of inflammatory immunological indications such as inflammatory bowel disease, kidney disease and uveitis. And currently we have designated compound to move into clinical development. This past fiscal year, we've focused on evaluating MCR receptor 1 targeted compounds in a variety of preclinical animal models. Positive and exciting data from these studies has allowed us to designate a lead clinical compound and the pre-clinical activities which if successful will lead to first studies in 2014. Before we open the call to questions, I'd like to make a few concluding remarks. We are extremely pleased with our opportunities to move Bremelanotide forward into Phase 3 pivotal registration study for Female Sexual Dysfunction. This is supported by the strength of our Bremelanotide Phase 2B efficacy and safety data and the regulatory guidance received from FDA. We have designed a comprehensive Phase 3 program that if successful will provide the safety and efficacy data to support regulatory submission 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. We have an active program to continue to present data from the Bremelanotide Phase 2B study at additional medical meetings and to prepare and submit reports of the Phase 2B data for publication in peer-reviewed journals. As we just reported we're making substantial progress on establishing one or more corporate collaborations to facilitate the advancements of our Bremelanotide Phase 3 Female Sexual Dysfunction program. For PL-3994 we have generated substantial package of preclinical data to support our corporate licensing efforts. And finally regarding our melanocortin receptor 1 program we have selected the first lead clinical candidate and are conducting pre-clinical activities we acquired to begin human clinical trials. We also continued to make progress in identifying potential corporate partners. I'd like to thank you for participating in Palatin's first quarter 2014 conference call. And we will now open the call up for questions.
(Operator Instructions). And we will take our first question from Charles Duncan with Piper Jaffray. Roy Buchanan - Piper Jaffray: Hi guys. Thanks for taking the question; this is Roy in for Charles. I had a couple of questions on the ex-North America option. Did you guys have any prior discussions with European regulators and what were the outcomes of those discussions?
This will be our first interaction with the EMA. Roy Buchanan - Piper Jaffray: And do you have dates for the meeting?
We have submitted a briefing document, we’ll leave at that. Roy Buchanan - Piper Jaffray: And can you provide anymore I guess color on the individual countries that might be under the option agreement?
I mean that’s we put in the press release it’s for the most part the European Union, the company that we’ve entered into this option agreement is very well entrenched in this region and from capability standpoint really covers A to Z from potential manufacturing of the API to manufacturing of the drug product and most importantly the actual sales and marketing infrastructure in the targeted markets. Roy Buchanan - Piper Jaffray: Okay, so is it fair to assume the major markets like Germany et cetera are covered?
Absolutely, yes. Roy Buchanan - Piper Jaffray: Great, thanks. And then just a question on the kind of [indiscernible] question on the RNA discussions for the U.S. is that in any way depending on the Soman and Sarin (Ph) NDA?
No, not at all I mean look I can’t discuss the Soman, Sarin (Ph) NDA it’s not our product but what I can tell you is the partners that we’re talking to I think have already reviewed that program and I think are in discussions with us because they would prefer Bremelanotide. Roy Buchanan - Piper Jaffray: Okay, great. Thanks guys.
And we’ll take our next question from Joe Pantginis with Roth Capital Partners. Joe Pantginis - Roth Capital Partners: Good morning. Thanks for taking the question, wanted to focus also on your option agreement as well it’s nice to see that you’re making incremental progress on the BD front, so I guess there’d be two arms to my question here. First, can you add any more color regarding the capabilities of this potential partner? And then second I would have to imagine since you’ve had real extensive discussions with the FDA about the clinical design of the Phase 3 study in the U.S. I would find it somewhat hard to believe that the design would be much different but I don’t know if there is any geographical issues that might come up that might lead to different type of designs?
Sure, I’ll answer both parts of the question and then these guys can add color. Dr. Edelson can add some color on that. With regards to the potential partner in Europe they’re really a strong player in European Union and a number of indications in particular they rank very high in sales in women’s health and that’s a key area for us. They clearly see a very strategic fit with this into their portfolio and we have been working it very collaborative fashion with them to get ready for this meeting as well as to talk about the design of potential Phase 3 program in Europe as well. With regards to differences, clearly the basis of discussions will be the work that we’ve done in United States. It is likely that there will be some slight differences, the patient populations are indeed different, there are cultural differences, each regulatory agency may have certain particular potentially populations that they feel may use Bremelanotide or be it close to Bremelanotide that they may want us to do additional work in. So there will be slight differences in the programs between the U.S. and the EU but the basis of the patient population, the types of endpoints that we use duration of treatment and so and so forth will be very similar. Joe Pantginis - Roth Capital Partners: Okay, and sort of using that as a launching pad for the next question. So you mentioned that this was more in the spec pharma space. Can you discuss with regard your U.S. efforts, are you -- what kind of interest are you getting? Is it more in the spec pharma space as well or what kind of companies are showing interest?
It’s across the board. Some multinational and then U.S. spec farm the large biotech is across the board. Joe Pantginis - Roth Capital Partners: Okay, great thanks a lot guys.
And we’ll take our next question from Rahul Jasuja with Noble Financial.
Hi, good morning. This is actually [indiscernible] for Rahul and thank you for taking our questions. Sorry, if I may have missed this, regarding Phase 3 FDA protocols how similar is Phase 3 compared to the Phase 2 design and if you can walk us through the timelines?
Sure, I mean, Phase 3 in general fairly similar to the Phase 2 in the scope of the patients that are being treated, types of instruments that are used to measure efficacy overall clinical trial design and the Phase 2 obviously as a basis for are -- we look forward to discussion with the FDA moving in the Phase 3. As we’ve stated we’re pretty comfortable with that we will have really almost all the operational activities required to begin patient screening by the end of the year. So we’re working very hard to make sure that all pieces will in place before that and I think they’re coming together quite nicely and of course now that puts us in a position to be dependent on getting the resources to run the program.
Regarding the timeline, this is Steve. From the U.S. perspective, we are in a good position to start Phase 3. We anticipate finalizing everything regarding protocols with the FDA, this quarter. And we have already manufactured the doses so we can turn that switch on reasonably quickly to actually start dosage screening and dosing patients in the first quarter of calendar 2014. If everything went along as projected, we would be able to submit the NDA in the second half of 2015 with feedback from the FDA in the second half of the 2016. From a European standpoint, we’re a few quarters behind of the timeline. If things progress as planned, we would anticipate being able to start clinical trials in the European Union, if necessary in the second half of calendar 2014.
Okay, great thank and regarding the MCR1 program, could you expand on the targeting patients and the specific next step, will you pursue a partnership at this stage?
Sure, as we stated in the presentation, there were number of inflammatory or immune indications where we think MCR1 agonist will play a key role and areas where we have been running preclinical programs in the areas of inflammatory bowel disease, uveitis, nephrotic syndrome and these all areas where we have been running preclinical programs and generating data. So, we think it will be potentially fairly broadly applicable; and with regards to potential partners, we want that in parallel. We will move -- as we designated the compound, we will move that compound through the preclinical process and in parallel we will be out talking to potential partners as well.
And that does conclude our question-and-answer session. At this time, I would like to turn the call back to Dr. Spana for any additional closing remarks.
Thank you everyone for participating on our 2014 first quarter conference call. We are extremely excited with the progress we’re making here. We have a very good product, the Bremelanotide, we’re getting great interest in it, and although maybe not as highlighted as much, we really are quite enthusiastic about the building pipeline that we have, and we think that’s going to be a major driver for us this year as well. So look forward to meeting people as they get out on the road and do some one-on-one and certainly look forward to updating you guys on our progress. You have a great day. Good bye.
And again that does conclude today's conference. We do thank you for your participation.