Palatin Technologies, Inc. (PTN) Q2 2018 Earnings Call Transcript
Published at 2018-02-12 13:34:04
Carl Spana - President and Chief Executive Officer Steve Wills - Executive Vice President, Chief Financial Officer and Chief Operating Officer
John Newman - Canaccord Michael Higgins - Ladenburg Thalmann
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.
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?
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 the sole responsibility of Fosun. We hope to have the remaining rest of the world territories licensed by the end of calendar year 2018. We are working closely with AMAG Pharmaceuticals, our licensee for North America, on completing the activities necessary to file a new drug application with the FDA. NDA filing with the FDA by AMAG is targeted by the end of this quarter. With respect to our Melanocortin Receptor 1 Agonist program, which is under development for inflammatory bowel diseases, we received FDA clearance of an IND, investigation new drug application, for PL-8177 for Ulcerative Colitis and initiated subject dosing in a first and human clinical study earlier this month. Moving over to our financial results. Regarding the second quarter fiscal year 2018 financial results, Palatin reported net income of $3 million or $0.02 per basic and $0.01 per diluted share for the quarter ended December 31, 2017, compared to a net loss of $10 million or $0.06 per basic and diluted share for the same period in 2016. The difference in financial results between the three months ended December 31, 2017 and 2016 was primarily due to the recognition of 10.6 million in license and contract revenue during the 2017 period pursuant to our license agreement with AMAG, and a reduction of 2.1 million in research and development expenses. Regarding revenue, as I stated, we recognized 10.6 million in the license and contract revenue for the quarter ended December 31, 2017, which consisted entirely of license and contract revenue related to our license agreement with AMAG. There was no revenue recorded in the quarter ended December 31, 2016. Regarding operating expenses, total operating expenses for the quarter ended December 31, 2017 were 7.7 million, compared to $9.4 million for the comparable quarter of 2016. The decrease in operating expenses was mainly attributable to our program development cost for bremelanotide being lower as we advance towards the NDA filing stage by AMAG with the FDA. Regarding other income and expense, total other expense net was $300,000 for the quarter ended December 31, 2017, compared to 600,000 for the quarter ended December 31 of 2016. Total other expense, net of both periods consisted primarily of interest expense related to our venture debt. Finishing with our cash position and working capital Palatin's cash and cash equivalents were $35 million as of December 31, 2017, compared to cash, cash equivalents, and accounts receivables of $55.6 million at June 30, 2017, and $49.3 million at September 30, 2017. Current liabilities were 14.1 million, net of deferred revenue of 9.5 million as of December 31, 2017, compared to 19.9 million, net of deferred revenue of 35 million as of June 30, 2017 and 19.3 million, net of deferred revenue of 20 million at September 30, 2017. We believe that existing capital resources will be sufficient to fund our planned operations through at least the next 12 months. Carl?
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 quarter 2018, we began dosing PL-8177 and a combined single ascending and multiple ascending dose study. This study will evaluate the safety in pharmacokinetics of subcutaneous PL-8177 in healthy subjects. This study will enroll approximately 55 subjects and we expect to complete the study in the third quarter of 2018. In addition, we have developed an oral formulation of PL-8177 and plan to move this formulation into clinical trials later this calendar year. Our second melanocortin development candidate is PL-8331. It’s an agonist at the melanocortin 1 and 5 receptors, and we are currently evaluating PL-8331 in multiple pre-clinical disease models and drug safety studies. If the data supports continue development, we plan to start the activities required to file an IND. Our second area of focus is our naturally peptide program for cardiovascular and fibrosis diseases. Heart failure in fibrosis diseases remain major health problems in these new treatments. We have developed multiple compounds that regulate the naturally peptide systems that can address these potential indications. PL-3994 is selective agonist at the naturally peptide A receptor. And as previously disclosed, we will be evaluating the safety and efficacy of PL-3994 in a Phase 2a clinical study that is planned to start in calendar year 2018. This study will enroll heart failure patients with preserved ejection fraction. And we plan to provide further details on this clinical trial when patient enrolment begins. Our second naturally peptide compound is PL-5028. It’s an agonist of both the NPR C receptor and the NPR A receptor. We believe the dual agonist activity of PL-5028 should allow for superior efficacy in a much broader dosing window, compared to other naturally peptide approaches. PL-5028 has demonstrated excellent efficacy in preclinical models of heart failure. We are planning to begin pre-clinical activities to support first human clinical studies. We believe that the potential charge being naturally peptide and melanocortin peptide systems has potential beyond indications discussed above. We plan to allocate additional resources to activities that will expand the potential indications of our compounds and also strengthen our intellectual property. As you think about the future of Palatin, I am very excited by the potential of our development programs to lead to new treatments that could significantly impact the lives of patients. The success we have had in developing bremelanotide from concept through phase clinical trials and now multiple commercial partnerships not only provides resources realizing the value of bremelanotide, it has provided us with the resources to unlock the value in our pipeline programs without having to have access to the capital markets for funds. Looking forward, we aim to achieve the following objectives. We will be working diligently with AMAG Pharmaceuticals, our bremelanotide North American commercial partner to complete the new drug application and file with the FDA in the first quarter of 2018. This will put us on track or potential bremelanotide approval in 2019. In addition, we will be working with Fosun Pharma and Kwangdong Pharmaceutical to support their development in regulatory activities. And our business development activities will be primarily focused on bremelanotide partnerships with the EU, Latin America, and other territories. For our natriuretic peptide system program, we are looking to move PL-3994 into the Phase IIa clinical study in heart failure patients with preserved ejection fraction. And finally, for our melanocortin peptide programs the following objectives are to complete Phase 1 single ascending, multiple ascending dose study and initiate the clinical studies of our oral formulation and for PL-8331 to initiating and complete the required preclinical activities to begin first in human studies. As we end the call, the management and employees of Palatin will be focused on achieving our objectives and building value for our stakeholders. As we mind these and find more information on our website at www.palatin.com. Thank you. We will now open the call to questions.
Thank you. [Operator Instructions] We’ll go first to John Newman with Canaccord.
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?
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.
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?
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.
We will go next to Michael Higgins with Ladenburg Thalmann.
Thanks. Good morning guys, how are you?
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?
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.
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?
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.
Okay, that’s helpful. I’ll jump back in the queue. Thanks guys.
And at this time there are no further questions. I’ll turn the call back to Dr. Spana.
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.
This does conclude today's conference. We thank you for your participation.