Palatin Technologies, Inc. (NYSEMKT:PTN) Q4 2019 Earnings Conference Call September 12, 2019 11:00 AM ET
Dr. Carl Spana – President and CEO
Steve Wills – EVP, CFO and COO
Conference Call Participants
Justin Zelin – Canaccord Genuity
Joe Pantginis – H.C. Wainwright
Good morning, ladies and gentlemen, and welcome to the Palatin Technologies Fourth Quarter and Fiscal Year-End 2019 Operating Results Conference Call. As a reminder, this conference is being recorded. Before we begin our remarks, I would like to remind you that the 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 may 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.
Dr. Carl Spana
Thank you. Good morning and welcome to the Palatin Technologies fourth quarter and fiscal year-end 2019 call. I am 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.
I’m going to turn the call over to Steve, who’ll provide financial and certain operational highlights. Steve?
Thank you, Carl. Good morning, everyone. Regarding Palatin’s quarter and year ended June 30, 2019, certain operational and financial highlights include, with respect to Vyleesi, which is approved for female hypoactive sexual desire disorder. In June 2019, the FDA granted marketing approval of AMAG Pharmaceuticals NDA for Vyleesi, a melanocortin receptor agonist developed by Palatin, and indicated for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder referred to as HSDD.
The FDA’s approval of the NDA triggered a $60 million milestone payment to Palatin under our North American license agreement with AMAG. This $60 million was received in July 2019. Additionally, Palatin is entitled to receive tiered royalties on net sales ranging from high single-digit to low double-digit percentages, and sales milestones based on escalating annual net sales thresholds, the first of which is 25 million, triggered at annual net sales of 250 million.
Vyleesi is the first as needed treatment for premenopausal women with acquired generalized HSDD. It is currently available through specialty pharmacies, Avella and BioPlus, and AMAG will launch Vyleesi nationally with its full sales force mid-September. We remain focused on advancing discussions on Vyleesi collaborations for territories outside the currently licensed territories of North America, China and Korea. And we have excellent interest from multiple parties from multiple regions.
With respect to corporate, cash and cash receivable balances at June 30, 2019 of $102 million is sufficient to cover planned operations through at least calendar 2021. Included in the accounts receivable balance is a $60 million milestone payment due from AMAG for the Vyleesi FDA approval, again, which was received in July 2019. Debt related liabilities decreased from $7.2 million at June 30, 2018 to approximately $800,000 at June 30, 2019. The final payment of $800,000 was made in July 2019, and we now have no debt.
With respect to financial results, Palatin reported net income of $52.2 million, or $0.25 per basic and $0.23 per diluted share for the fourth quarter ended June 30, 2019, compared to net income of $11.8 million or $0.06 per basic and diluted share for the same period in 2018. The difference between the three months ended June 30, 2019 and 2018 was attributable to the recognition of license and contract revenue pursuant to our license agreement with AMAG of $60.3 million for the quarter ended June 30, 2019 compared to $20.6 million for the same period in 2018.
For the year ended June 30, 2019, Palatin reported net income of $35.8 million, or $0.17 per basic and $0.16 per diluted share, compared to net income of $24.7 million, or $0.12 per basic and diluted share for the year ended June 30, 2018. The difference in net income for the years ended June 30, 2019 and 2018 was primarily the result of a $16.6 million decrease in operating expenses to $24.6 million for the year ended June 30, 2019, compared to $41.2 million for the year ended June 30, 2018. This was, of course, partially offset by the recognition of our license and contract revenue of $60.3 million for the year ended June 30, 2019, compared to $67.1 million of the license and contract revenue for the year ended June 30, 2018.
Regarding the revenue, for the quarter and year ended June 30, 2019, Palatin recognized $60.3 million in license and contract revenue, all related to our license agreement with AMAG. Regarding the operating expense, total operating expenses for the quarter ended June 30, 2019 were $8.1 million, compared to $8.3 million for the comparable quarter in 2018. And for the year ended June 30, 2019, Palatin incurred $24.6 million of operating expenses, compared to $41.2 million for the period of June 2018.
The decrease in operating expenses reflects the completion of the Vyleesi development program and the related ancillary studies necessary to file the NDA with the FDA. Regarding cash position and working capital, Palatin’s cash and cash equivalents were $43.5 million at June 30, 2019, compared to $38 million at June 30, 2018. Accounts receivable were $60.3 million at June 30, 2019 and this included the $60 million milestone payment due from AMAG, which, yes, again, was received in July 2019. There were no accounts receivable at 6/30/2018.
Current liabilities 4.2 million at June 30, 2019, was significantly less than $10.8 million of liabilities at June 30, 2018. And again, cash and accounts receivable balances at June 30, 2019, of 102 million is sufficient to cover planned operations through at least calendar year 2021.
Now, I’ll turn it call back over to Dr. Carl Spana.
Dr. Carl Spana
Thank you, Steve. I’ll start the operational update with Vyleesi. On June 21st, the FDA approved Vyleesi as a treatment for premenopausal women with acquired generalized, hypoactive sexual desire disorder. The Vyleesi approval is a major achievement for us and we are excited that premenopausal women with HSDD now have a safe and effective as needed treatment options. Vyleesi is a first-in-class melanocortin agonist and the only as needed product approved by the FDA to treat HSDD. Vyleesi is self-administrated by the patient approximately 45 minutes prior to sexual activity.
Commercial sales of Vyleesi in the U.S. are the responsibility of our Vyleesi North American partner AMAG Pharmaceuticals. In late August, AMAG made Vyleesi available on a limited basis to patients and the national launch of Vyleesi is scheduled for mid-September. We believe that Vyleesi has significant potential and AMAG with a strong commercial presence of female health is well positioned to drive sales of Vyleesi.
Outside of North America, we are working with our Chinese partner, Fosun Pharma; and our South Korean partner, Kwangdong Pharmaceuticals, to advance Vyleesi development in those territories towards regulatory filings. The recent FDA approval of Vyleesi has accelerated global interest in Vyleesi and we are focusing our licensing efforts on finding commercial partners for territories outside North America. And we believe that we will enter into one or more Vyleesi licensing agreements by the end of calendar 2019. Our goal is to have Vyleesi partnerships for all major global territories. We believe our Vyleesi licensing strategy will maximize return on our investment and allow us to focus our resources on our pipeline programs.
In the past year, we have also significantly advanced our earlier stage programs. Palatin’s melanocortin program has two primary therapeutic areas of interest, autoimmune and inflammatory diseases and rare genetic forms of obesity. We have developed new families of highly selective melanocortin receptor agonist with potentially broad applications in the treatment of a variety of inflammatory and autoimmune diseases, including inflammatory bowel disease, dry eye, uveitis and other retinal diseases.
Our clinical development candidate PL-8177 is a highly selective and potent melanocortin-1 receptor agonist, which we believe will have broad applicability as a treatment for inflammatory and autoimmune diseases. In the past year, we have completed two Phase 1 PL-8177 clinical trials. The first was a single and multiple ascending dose study with PL-8177 subcutaneously administered to healthy volunteers. PL-8177 at all administered doses was well tolerated and no potential safety concerns were noted.
The second clinical study was a pharmacokinetic study of an oral dosing formulation of PL-8177 as a potential treatment for inflammatory bowel diseases. The data from this study indicates that the oral formulation can deliver PL-8177 to the colon without systemic exposure. In addition, the FDA granted orphan drug status to PL-8177 as a treatment for non-infectious uveitis.
Our current, clinical development plan for PL-8177 includes conducting two proof-of-principal clinical studies in two indications, non-infectious uveitis, which will begin patient enrollment in the fourth quarter of 2019 and ulcerative colitis, which will begin enrolling patients in the first half of 2020.
We’re also developing melanocortin-based compounds for other ocular and autoimmune diseases. Our new compound PL-9643 has demonstrated excellent activity in animal models of dry eye disease and retinal inflammation. PL-9643 replaces our older compound PL-8331 providing for substantially longer patent term and potentially better efficacy.
We have developed an eye drop formulation of PL-9643 as a potential treatment for dry eye disease, and we are currently completing required preclinical activities to file an IND, or new investigational new drug application and start clinical studies. Our plan is to begin patient enrollment in PL-9643 Phase 2 clinical study and the first half of 2020 with top line data reading out by the end of the year.
We have two programs that are supported by our research on the natriuretic peptide system. PL-3994, a selective natriuretic peptide receptor A agonist is scheduled to start in Phase 2 trial sponsored by the American Heart Association, which is being done in conjunction with two major research centers. The trial has received the required regulatory approvals and we anticipate patient enrollment beginning by year end 2019.
Although still preclinical, we are very excited by our compound PL-5028, a dual natriuretic peptide A and C receptor agonist for potentially treating cardiovascular and fibrotic diseases. In preclinical studies of liver fibrosis and pulmonary fibrosis completed in the last year, PL-5028 has produced encouraging results.
Our development plan for 5028 is to complete additional preclinical efficacy studies in models of fibrotic diseases and if these are positive to begin the preclinical activities required to file investigation new drug application and beginning clinical studies. You can find additional information on our programs on our website www.palatin.com.
In closing, the significant accomplishments of the past year have put us in an excellent position to grow our company and increase shareholder value. The approval of Vyleesi is a major milestone for us and results of multiple years of hard work and dedication by the employees of Palatin with the support of our investors.
Vyleesi is a significant addition to the treatment of premenopausal women dealing with the physical and emotional impacts of HSDD. In addition, it provides validation of the melanocortin system as a target for drug development.
In the background of supporting the Vyleesi New Drug Application review and approval by the FDA, we were able to advance two new compounds into clinical development. Our development efforts will be focused on ocular and inflammatory disease programs. We’re excited by the potential of PL-8177 and PL-9643 to positively impact the treatment of a variety of ocular diseases and look forward to the clinical trial data that will begin to read out in the second half of 2020.
Finally, the milestone payments from Vyleesi licenses, the revenue that we will receive from new Vyleesi licenses and royalties and our financing efforts have given us a strong balance sheet and will allow us to maintain — continue to maintain a strong balance sheet and to support the advancement of our exciting pipeline programs.
Thank you. We will now open the call for questions.
Thank you. [Operator Instructions] We’ll take our first question from John Newman with Canaccord Genuity.
Hi, good morning, guys. This is Justin Zelin on for John Newman. I just had a question, I was wondering, if you could give us an update just on the potential timing for additional business development deals around the world outside the current available geographies? And I was just curious on both your interest and your partner’s interest in potentially additional partnerships?
Dr. Carl Spana
Sure. Steve can take that question.
Thanks for the question. We’re actually quite pleased with the activity and the interest, and that activity and interest definitely increased post the approval of Vyleesi on, that we announced on with AMAG on June 24, 2019. We fully expect to get as Carl mentioned, at least one, if not multiple collaborations executed before year-end. And our target is to basically have all the regions that are not currently licensed and just to remind everyone the current licensed regions are, North America with AMAG Pharmaceuticals; China with Fosun Pharmaceuticals; and South Korea with Kwangdong Pharmaceuticals.
So, we’re working hard, a lot of interest and looking forward over the next several quarters to executing collaborations in all the available regions throughout the globe. And one thing that we’re doing with the multiple interest is making sure we have the right partner. We want to fit their profile and vice-versa regarding our Vyleesi drug. And when I say, their side that they’re either already in the female healthcare franchise, have some infrastructure distribution in place, or they have some very specific granular plan strategically and synergistically to go into those areas.
Great. Thank you and just quick follow-up. Is there any additional trials that are needed for regulatory approval in China and South Korea? I was just curious, if you give an update there?
Sure. Both of those territories require a minimum of pharmacokinetic studies, and we are in the process of working with both of them to finalize those protocols and provide drug supply. Anticipate that they will start most likely late this year, but more likely the first quarter of 2020. And since they’re relatively short-term studies, they will be conducted relatively quickly. So, we would anticipate that really as we — either as early as late 2020, if not the first half of 2021 that we would see approval and commercial introduction of Vyleesi in both of those territories.
And we’ll take our next question from Joe Pantginis with H.C. Wainwright.
Hey, guys good morning, thanks for taking the question. With regard to the Vyleesi launch, besides the blocking and tackling of the sales force, I mean, just getting the drug out there and the message out there. What do you identify as the key factors that AMAG needs to address? Whether it’d be just educating physicians about the market or what have you? What do you think the key factors are?
Dr. Carl Spana
This is Carl. Well, thanks for the question. And someday one of the operators is going to get your last name right. But, I think the key issue here, this is the new indication, Vyleesi is only the second drug approved for the indication; and as you can see even in their presentation, I think the two things are really driving patient awareness and physician education. I think those are the two things that really — will be required and will take some time to do.
I mean AMAG has been out there doing that already. They’ve had, I think 25 plus sales medical reps out since the approval, sitting down with doctors, providing them with the materials required to diagnose and appropriately get patients on to Vyleesi. They’ve had multiple websites out both prior and then now, after approval for disease awareness and patient education.
Tremendous pick up, I mean, hundreds of thousands of patients coming off of those websites, since they’ve gone on. And I think that those continued efforts will continue to drive the awareness in both the patient population as well as the clinicians that will be treating these patients or treating these women. So, those are really two key issues that I can see.
Joe, I would just add, we’re extremely comfortable with AMAG Pharmaceuticals. As I mentioned, for on the earlier response, you look for the right partner and you fit each other’s profiles there. They are very motivated. This is the space they play in. They can talk much better than we can, if you will, but from what we know and what we’ve been informed about, they’re taking all the right steps, and we are very confident that this launch is going to do very well. They’re doing everything they need to do. And again, they are very motivated and very aligned with our interest; and frankly, the interest to get a new treatment available to the premenopausal women out there.
Certainly, that’s good to hear. And then my next question is and I don’t know how much you want to or able to address this. But with regard to the, with the way the shares have been trading, obviously you have a new drug approved, there was like transient uptick in the shares. I personally don’t believe as part of our work that you’re getting value right now from your pipeline assets. So do you think right now that, is there anything beyond the typical, I guess, perceived launch execution risk that might be impacting the shares at this point?
Dr. Carl Spana
I’ll pass over to Steve to answer that.
I mean, the short answer is, we don’t believe so. Nostradamus doesn’t call me back, but it’s — there’s a number of different factors out there. We do have a bit of a significant short position for our type of company, based on what we’re, from a profile standpoint. We trade on June 24, we traded 50 million shares of which 20 — a little over 20 million were short positions. We do have some warrants outstanding that from an overhang standpoint, we believe it’s not unreasonable to certain shareholders. We’d use those warrants as hedging strategies.
That said, we couldn’t be more enthusiastic and excited about where we’re going with Palatin. We’ve never had, I’m not going to call it a war chest, but for Palatin, it’s a very significant sum. Once the $60 million came in, in July, we have over $100 million of cash. And we’re going to be very prudent and very informed of how we — and we don’t like to use the word spend, it’s more like how we’re going to invest those funds and invest in the Palatin pipeline.
As you can see, we’re a small company, but we have a lot going on, the Vyleesi approval, AMAG handling the launch. We’re very confident that they’re going to do an excellent job with that. Our support to AMAG in North America is now somewhat limited, but we’re of course moving very aggressively for the rest of the world collaboration. Even though, we’re very excited with Vyleesi, and no question, the milestone achievement is absolutely a landmark for us.
We couldn’t be any more excited for the programs that we’re now able to advance and advance because we now have the cash and the infrastructure in place. So, we’re very much looking forward to reporting, to starting, if you will these three trials within the next few quarters and reporting some of the data before the end of calendar 2020.
And that concludes the question-and-answer session. I would like to turn the call back over to Dr. Carl Spana for any additional or closing remarks.
Dr. Carl Spana
Sure. Well, I’d like to thank everyone for participation in our fourth quarter and fiscal year-end 2019 conference call. I think Steve has made more than crystal clear. We are quite excited about the prospects of Palatin and achievements that we have and we continue to look forward to advancing our programs and continuing to have positive progress as these things go forward.
As always, we look forward to seeing some of the institutional investors that are on the call, as we go out and meet you. And unfortunately, we don’t have ways to see the retail investors, but we do hear your questions when they come in. And many times you can find the answers to those questions in our filings. And I hope we’ve addressed many of them on this conference call. Thank you. Have a great day.
Thank you. And that does conclude today’s presentation. Thank you for your participation. You may now disconnect.