Black Titan Corporation (BTTC) Q1 2015 Earnings Report, Transcript and Summary

Thank you for holding, and welcome to the Titan Pharmaceuticals First Quarter 2015 Financial Results Conference Call. At this time, all participants are in a listen-only mode. There will be a question-and-answer session following today’s remarks. Please be advised that this call is being taped at the company’s request and will be archived on the company’s website starting later today. At this time, I would like to turn the call over to Sunil Bhonsle, President of Titan Pharmaceuticals. Please go ahead.

Thank you, Eric, and thank you all for joining us today. And welcome to the Titan Pharmaceuticals call to review financial and operational results for the first quarter of 2015. Before we begin, I wanted to inform you that on May 13 we filed our first quarter 2015 Form 10-Q with the SEC and the press release issued yesterday morning provides the summary of the results and can be found on our website at titanpharm.com. Joining me on the call today from Titan are Dr. Marc Rubin, our Executive Chairman; Dr. Kate Glassman Beebe, our Executive Vice President and Chief Development Officer; and Brian Crowley, Vice President of Finance. Before we get into the details of the financial results and provide an update on the company, I want to remind everyone that certain matters we will discuss today, other than historical information, consists of forward-looking statements relating to, among other things, our expectations concerning our financial results, available cash, development programs, partnering arrangements, regulatory strategies and business plans. The forward-looking statements are not guarantees of future performance and are subject to a variety of risks and uncertainties that could cause actual results to differ materially from the results contemplated by the forward-looking statements. These risks and uncertainties are described in our Annual Report on Form 10-K filed with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today. We undertake no obligation to update or revise the information provided in this call whether as a results of new information, future events, or circumstances or otherwise. So as always, let’s start with an overview from our Executive Chairman, Dr. Marc Rubin. Marc?

Thank you very much Sunil. Hello everybody, and as always thank you all for joining us today. We are very pleased to be here today to provide you with an overview of our activities in the first quarter and discuss the development of our pipeline of product candidates based on our ProNeura long-term delivery technology, including ProNeura for Parkinson’s disease and of course Probuphine. As its’ been only a few weeks since the last conference call, I will be brief with my comments today. Like all of you, we are eagerly awaiting the results of the ongoing Phase 3 study of Probuphine for the long-term treatment of opioid addiction. We have been very encouraged by the speed of which the trial has progressed and as we’ve mentioned previously, our development in commercialization partner Braeburn Pharmaceuticals completed enrollment in the study in November in a little over four months which was well ahead of schedule that was already set at an aggressive pace. With all activities we track, we look forward to recording results from the file sometime next month and hope to submit the NDA in the second half of this year. If approved, for the long term maintenance treatment of opioid dependence in adults, Probuphine would be the first commercialized treatment for opioid dependants to provide continuous around the clock levels of Buprenorphine for six months, following a single treatment. The demand for the daily dosed sub-lingual formulations of Buprenorphine has continued to grow, with annual sales of about $1.8 billion last year in the United States. And as a proprietary sub-journal in plants with patent coverage in the U.S. to at least 2024, we believe Buprenorphine has several advantages over the daily dosed formulations of Buprenorphine. It is clear that new treatments for opioid dependence that was safe and effective are critically needed for patients, for families and for healthcare providers. While we await the results for the Phase 3 study with Probuphine, Titan was continuing to advance other ProNeura technology based programs, most notably ProNeura for Parkinson’s disease. Dr. Glassman-Beebe will provide additional details on that program in just a moment. We continue to believe that the success of the development of Probuphine will provide an elevation of our proprietary ProNeura technology and we look forward to the developing platform, not just for Parkinson’s but for other select chronic diseases for which maintaining consistent levels of medication in the drug over long periods of time, may provide a health or a safety benefit for patients. And with that, I will pass the call back to Sunil to review financial results of the first quarter of 2015. Sunil?

Thanks, Marc. Next, I will provide you with our first quarter financial results and Dr. Glassman-Beebe will update you on the development activities during the quarter. Then to conclude, we will open up the call for your questions for the Titan management team. So for the financial results, total revenues in the first quarter of 2015 and 2014 were consistent at about $0.9 million. The first quarter revenues consistent entirely up license revenue and reflect the amortization of the upfront license fee received from development and commercialization partner Braeburn Pharmaceuticals in December 2012. Our total operating expenses for the quarter ended March 31, 2015 were approximately $2.5 million compared with about $1.8 million in the same quarter in 2014. These expenses consisted of research and development expenses of approximately $1.4 million compared with $1 million in the first quarter of 2014. The $0.4 million increase in R&D expenses was primarily due to external R&D expenses related to the support of the Probuphone and ProNeura product development programs, and a small increase in other R&D expenses. The general and administrative expenses for the first quarter of 2015 were about $1.1 million compared with about $0.9 million for the same period in 2014. The $0.2 million increase in G&A expenses during the first quarter, was a result of higher non-cash stock compensation and employee related costs of about $0.1 million and an increase in other increases of about $0.1 million. Net other expense for the quarter of 2015 was about $3.3 million, compared with about $0.9 million for the same period in 2014. The net other expense consisted primarily of non-cash losses on changes in the fair value of warrants. Net loss for the first quarter 2015 was about $4.9 million or about $0.04 per share compared with about $1.8 million or about $0.02 per share in the same quarter in 2014. At March 31 of this year Titan had about $13.4 million in cash which we believe is sufficient to fund planned operations into the fourth quarter of 2016 same as what we have indicated previously. These financial results were as expected and we will continue to support our partner Braeburn to advance Probuphine to the final steps prior to potential commercialization next year, while also advancing the ProNeura Parkinson’s program to enable a proof of concept clinical study in the second half of next year. We continue to look for product opportunities to expand the use of the ProNeura platform and we look forward to providing updates as we make progress. This is an exciting time for us and as Marc said, we are looking forward to reporting results of the Probuphine study next month. Now, to provide you an update of recent development activities, let me turn the call over to Dr. Glassman-Beebe. Kate?

Thank you, Sunil and hello everybody. I'm pleased to provide you with additional details on Probuphine and our work in developing ProNeura for Parkinson’s disease. During the quarter, we continued to support our partner Braeburn in the clinical and CMC regulator preparation activities of Probuphine programs including the manufacturing activities associated with the validation of the manufacturing process. As Marc also mentioned the trial is progressing its plant and we’re really looking forward to evaluating the data and sharing the top line results with you in the next several weeks. Now just to remind everybody that Probuphine study is a randomized double-blind, double-dummy designed that enrolled just a 180 patients into two parallel treatment arms across 20 clinical centers in the U.S. Study participants are clinically stable patients who are receiving maintenance treatment with an approved sublingual formulation containing Buprenorphine at a daily dose of 8 milligrams or less for at least three months prior to entering the study. Patients have been randomized to receive either four Probuphine implants or to continue their daily sublingual Buprenorphine therapy. The primary analysis will be a non-inferiority comparison of responders in the two treatment arms. Responder status is based on an FDA agreed upon clinical algorithm, based on urine testing for opioid use, together with patient self-reported opioid use. We believe this study design is robust and will provide a well-controlled evaluation of Probuphine compared with the current standard of care in these stable maintenance patients, and of course, all participants are receiving active treatment during the study. The U.S. market for addiction treatment has continued to grow with prescriptions for Buprenorphine products increasing by more than 12% just last year and there are now three proprietary daily dosed formulations on the market along with a few generic versions. Also off note, there are three injectable one month deeper formulations in early to mid-stage clinical development which further emphasizes the importance of long term treatment in this severe disorder. Probuphine with a six month treatment option has the potential of being the first such product on the market and if approved, we believe will become an important tool for combating the growing academic of opioid addiction. Now with regards to ex-U.S. opportunities as indicated on previous calls, we expect to initiate regulator discussions outside of the U.S., following release of Pro-814 results later this year. And now to provide you with an update on our ProNeura for Parkinson’s program, which we’re very excited about. Our goal is to complete all the non-clinical work required in support of an IND this year and early 2016 meet with the FDA for a pre-IND meeting possibly late this year. File the IND in the first half of 2016 and be prepared to initiate a clinical proof of concept study in late 2016. We remain on track to meet these goals. ProNeura for Parkinson’s is an important program and could provide a valuable treatment option for those suffering from this progressive disease. About one million people in the U.S. suffer from Parkinson’s disease and that number is expected to double by 2030 due to the aging population, according to the Parkinson’s disease foundation. Dopamine agonist therapy, which is a current standard of care, is designed to replace dopamine in the brain in early stage Parkinson’s patients, but typically stops working efficiently after several years and can trigger serious side effects. About a third of treated patients develop motor response fluctuations and/or drug-induced dyskinesias within three to five years of treatment. Clinical and nonclinical research now suggests that these motor side effects may rise from the pulsatile dopaminergic stimulation resulting from current oral treatment modalities. In clinical studies, dopaminergic stimulation by continuous infusion has been shown to palliate these motor complications and to also delay or prevent the onset of dyskinesias in Parkinson’s patients. The ProNeura drug delivery system can offer a simple way providing around the clock stable levels of an effective medication like [indiscernible] in an outpatient studying and we believe that this has the potential to elevate some of the motor complications and offer another treatment option for patients with Parkinson’s disease. I would really look forward to providing results for the Probuphine clinical study, our progress to the regulatory process and also updates on other ProNeura development program. Now I’ll turn the call back to Sunil. Sunil?

Thank you, Kate. This brings us to the end of our formal remarks. And now Eric, if we are ready to take questions from the call participants.

Thank you. [Operator Instructions] And we’ll take our first question from Jason Napodano, with Zacks Investment Research.

Hello there, this is actually Dr. Nisha Hirani calling in for Jason Napodano. Hope that you all are doing well.

Hi Nisha, how are you?

Hello, how are you guys doing? I just wanted to start-up by saying thank you for the company update and we look forward to seeing the data from the Phase 3 trial next month. My first question is regarding R&D expenses, I just wanted to clarify, are your full year R&D expenses for 2015 still expected to be similar to those in 2014? And are we correct with our understanding that R&D expenses will start ramping up in the middle part of the year?

Nisha, the R&D expenses overall will fluctuate quarter-to-quarter as we do similar with the non-clinical testing that we’ve planned. But the total amounts are as projected previously and we expect the cash that we have now will take us into the end of next year basically, but there will be some fluctuations from quarter-to-quarter, not [indiscernible].

Okay, great, thank you so much for that clarification. My second question is, we do understand that Titan is currently evaluating these to ProNeura long-term delivery for other chronic diseases. I was just curious if you would be able to share with us and you’d be told regarding some of the other drugs and disease settings that you’re currently exploring?

I can share with you only that we have actually looked at delivering [indiscernible], we’ve looked at small molecules, we’ve looked at a different types of things that can be delivered in the system successfully. So it’s a wide variety of compounds that we have tested and we are now starting to narrow down in areas where we feel a chronic treatment would make the most sense and I hope with some success with the large scale testing we’re doing, we will talk more openly about these specific areas. As you know, we have to be both confidential as well as make sure intellectual property things like that are protected until we get ready to talk about it.

Okay, sure I understand. Thank you so much for that information. And my last question is just the follow-up from one of my questions in the previous call, regarding your efforts to target global regions, I know you had mentioned in the past a fairly upfront some countries in Asia, Germany, UK and Italy, you’re looking at these countries following U.S. FDA approval of Probuphine. Are there any more regions around the globe that you’re currently targeting, are there anymore – any other progress that you could update us with?

Hi Nisha, this is Kate. We continue to look at those opportunities very seriously and we will be ready as soon as we have the results from the Pro-814 trial to request meetings and hope to have some meetings scheduled before the end of this year with at least two or three different local health authorities in Europe, and that’s really all the expanded update that I can give you right now.

Okay, thank you so much. I really appreciate it.

You’re welcome. Thank you for your questions.

Thanks, Nisha.

[Operator Instructions] And we’ll go next to Scott Henry with Roth Capital.

Thank you, and good afternoon. I really don’t have many questions given…

Hey Scott, how are you?

I’m doing pretty good, thank you.

[Indiscernible] which is even better.

It is definitely easier. But I guess just a standard question, have you had any interaction with the FDA since the last conference call, anything we would want to be aware of?

No. It’s certainly the interactions if any of that Braeburn has had been routine I think that – I know it shows significant.

Okay, and then thinking longer term, assumingly we get some good Probuphine data, any thoughts on the timeline when you may consider bringing new molecules into the clinic?

In terms of the clinic certainly our first focus is with the Parkinson’s, it’s [indiscernible] in plant. And our current goal is to certainly have that in the clinic in the latter half of next year, and Kate and our team are working very diligently and then certainly expect to get that clinical program started at that time. As you know, our goal is sort of getting Probuphine approved and the funding from the milestones allows us to continuing to be – clinical setting would be additional programs in Parkinson’s especially. With that, we expect to other areas, later this year I hope we can talk about at least one more product, an exciting product. And likely maybe two, three quarters behind [indiscernible] at the most get back into the clinic as well.

Okay, great that’s helpful. That’s should do it from me and good luck next month.

Thank you, Scott.

Thank you very much Scott.

Thank you.

It appears there are no further questions at this time. Mr. Bhonsle, I’d like to turn the conference back to you for any additional remarks.

Thanks, Eric. Thank you all for participating in this call. This an important and potentially transformative time for Titan. We are very excited about the prospects for Probuphine and believe that our ProNeura drug delivery platform holds great promise for Parkinson’s patients and others suffering from a number of chronic diseases. As always, we appreciate your ongoing support and talk to you soon next month.

This concludes today’s call. Thank you for your participation.