Earnings Labs

Plus Therapeutics, Inc. (PSTV)

Q1 2015 Earnings Call· Tue, May 12, 2015

$5.83

-2.67%

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Transcript

Operator

Operator

Good evening, ladies and gentlemen. Welcome to Cytori Therapeutics First Quarter 2015 Earnings Release Call. At this time, all participants have been placed in a listen-only mode, and the floor will be open for your questions following the presentation. Before we begin, we want to advise you that over the course of the call and question-and-answer session, forward-looking statements will be made regarding events, trends, business prospects and financial performance, which may affect Cytori's future operating results and financial position. All such statements are subject to risks and uncertainties, including the risks and uncertainties described under the Risk Factors section included in Cytori's Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission from time to time. Cytori advises you to review these risk factors in considering such statements. Cytori assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made. It is now my pleasure to turn the floor over to Dr. Marc Hedrick, Cytori's President and Chief Executive Officer. Sir, you may begin. Marc H. Hedrick - President, Chief Executive Officer & Director: Thank you, Susan, and good afternoon, everyone. Welcome to our first quarter 2015 conference call. As Susan said, my name is Marc Hedrick, President and CEO. And joining me this afternoon is our Chief Financial Officer, Tiago Girão; and our Chief Medical Officer, Dr. Steven Kesten. Just for your information, our press release was issued today and has been posted on our website. And also, a copy of this transcript can be found there as well once it's posted. On today's call, I'd like to discuss, first of all in detail, our financial situation has changed over the quarter, then update you on our clinical and…

Operator

Operator

The floor is now open for questions. Your first question comes from the line of Jason McCarthy with Maxim.

Jason Wesly McCarthy - Maxim Group LLC

Analyst

Marc. Hi, Tiago. It sounds like everything is going really well with the corporate restructuring. And thank you for taking the question. And I wanted to go back to the thermal and radiation burns and the BARDA contract. I know you presented your compelling data in the preclinical models, and my understanding from the literature is that kind of like antibiotics, what you see in animal model is usually very telling of what you might see in a human. So I was wondering how quickly you can get to the pilot study and kind of accelerate development in thermal burns. Marc H. Hedrick - President, Chief Executive Officer & Director: Hi Jason, it's Marc. You're right. So in translating promising data from a preclinical model such as a pig model and going into the clinic, and particularly in this case in patients who might be very sick of other comorbidities and have lesions that are of varying degrees of severity, it creates challenges on the clinical trial side. And so, I think the right answer to that question is that the things that we're doing on the preclinical side right now are – while they're taking a little bit longer maybe than we would like, they are quite detailed and should provide the best foundation upon which to go in the clinic, with the maximal chance of being successful in a Phase II study. So, taking a little bit more time upfront to try to be successful in a pilot clinical study in the U.S. So, I don't know that there's anything specifically that we can do today to accelerate that. We'll be ready on the device side when the rest of the preclinical data is ready. That's going to be sometime in 2016 that we'll file that IDE. We have and we'll continue to spend a lot of time with the FDA just to make sure that that situation goes smoothly. And then, at the same time, with respect to BARDA, where we do have some opportunity to accelerate things or expand things is we're really scratching the surface of the opportunity with the late stage burns. And I think there's some other opportunities to expand our relationship and the infrastructure we've built with BARDA. We'll be increasingly looking at ways to do that going forward.

Operator

Operator

Your next question comes from the line of Ken Arnold with Everglades Parkland.

Ken Arnold - Everglades Parkland Advisors LLC

Analyst · Everglades Parkland.

Good afternoon, gentlemen. I'd like to ask if you could take a little deeper dive and expand on the latest secondary. It had a discount to the last sales price with a large warrant coverage. Can you explain – it looks like the ATM was pretty effective. Why that – was chosen to do then? Was it the Olympus liability or just the loan covenants? Can you go into a deeper dive on last week's secondary please? Marc H. Hedrick - President, Chief Executive Officer & Director: Hi, Kenny. Yeah. I think the answer to that is very clear to us, and hopefully I can convey the thinking behind that clearly to you. For the last six to eight months, Tiago and I've spent a tremendous amount of time on the road talking to a variety of investors from hedge funds to mutual funds and trying to figure out what people want to see in terms of our data, our financial picture, our trials, that are really going to drive institutional ownership and shareholder value. I think one of the things that was sort of the flashing red light for us is that, given the debt load, the Illumina Olympus (31:48) liability and the fact that we didn't have enough data to get to – enough cash to get the data, it really made it a tough investment thesis for the kinds of funds that we felt like we needed to attract. So, while there's never a good time, I think we two laid out a plan where we could maximize the use of the ATM, the warrant exercise and then add a capital raise to that, if needed. The problem with using – with capitalizing the company on the heels of the warrants or the ATM is that it's…

Ken Arnold - Everglades Parkland Advisors LLC

Analyst · Everglades Parkland.

It just seems that the placement agent, the terms seem a little tough with the coverage, considering the milestones the company has achieved over the last few months. Like I said, just what the book showed. Marc H. Hedrick - President, Chief Executive Officer & Director: Yeah. So I understand why one would think that and – we don't like the terms either, right. So, the challenge is trying to raise money when some of that's going to debt repayment and debt restructuring and to pay off an Olympus liability such as that. So, that created, in our view, more of a challenge in terms of optimizing the terms. To your question about the ATM, the terms are much better when you use the ATM given the degree of discount fee to the banker and no warrant coverage. That clearly is the lowest cost of capital. But in the situation we found ourselves in, we had – now was the time to make that decision, not bear anymore market downturn risk, get the best possible situation, raise the least amount of capital to be able to address those three issues that we had. And I think – I understand where you're coming from but – I get that, but this was in our view the right thing for the company at this time.

Ken Arnold - Everglades Parkland Advisors LLC

Analyst · Everglades Parkland.

All right, thank you for the clarification. Appreciate it. Marc H. Hedrick - President, Chief Executive Officer & Director: Thanks Kenny.

Operator

Operator

Your next question comes from the line of Steve Brozak with WBB.

Steve G. Brozak - WBB Securities LLC

Analyst · WBB.

Hey, good afternoon, gents. You've done a really good detailed job on the finances obviously, but I do have a question. And Marc, this is specifically for you. Between scleroderma and burns working in conjunction with BARDA, you've got two different types of companies in a way. You got one which is an orphan or even ultra-orphan company and you've got another one which is more designed, let's say, for general applications. How do you position your company or how should we expect for you to position the company going into the future? And what models do you like best about both? And what should we expect as – or as how you decide to run the company? And I'll jump back in the queue. Thank you. Marc H. Hedrick - President, Chief Executive Officer & Director: Steve, it's a good question. And I look at it two different ways. One is what's the path to create in the fastest possible way the most shareholder value, and there's one way to address that question and then there's another way to address that question, which is based on how do we preserve the cash that we just mentioned could be painful to raise and not incur substantial cost in terms of development in that regard. So, kind of let me look at it two different ways. First of all, on the growth side, I think it's pretty clear to us that these niche indications can represent very substantial markets and could be relatively quick half the market. And I've alluded to the fact that the paradigm that that we used to bring scleroderma to a Phase III in the U.S. was based on an investigator initiated study, a little cash investment that we're able to fortunately saw good data and we're…

Steve G. Brozak - WBB Securities LLC

Analyst · WBB.

Got it. So you've got the hybrid large-scale economics with the specific focus on quicker outcomes. That encapsulates it? Marc H. Hedrick - President, Chief Executive Officer & Director: Yes, absolutely, Steve.

Steve G. Brozak - WBB Securities LLC

Analyst · WBB.

Great. Thank you, gentlemen. Marc H. Hedrick - President, Chief Executive Officer & Director: Thanks.

Operator

Operator

We do have a question from the line of Pooya Hemami with Edison Group.

Pooya Hemami - Edison Investment Research, Inc.

Analyst

Good afternoon. Thank you for taking my question. I just wanted to know with regards to the scleroderma program, if you had any discussions with insurers about potential reimbursement there. It might be early in the process, but just what are your strategies in case it does get approval on getting reimbursement? Marc H. Hedrick - President, Chief Executive Officer & Director: Steven – our Chief Medical Officer, Dr. Kesten, who is very involved in developing the longer term commercial approach and reimbursement modeling with respect to scleroderma principally in the U.S., but also to some degree in Europe. Steven Kesten - Chief Medical Officer & Executive Vice President: Yeah, thank you for the question. It obviously is a critical component of the success of the company. We've been focusing on the development pathway and looking to various data to get us to an approval, and we've had some early look. But now, we are engaging specific specialty assistants who understand the reimbursement issues that exist in U.S. and elsewhere. So, I can't give a specific answer now. I can tell you that we are engaging the right people to allow us to move forward and get those answers.

Pooya Hemami - Edison Investment Research, Inc.

Analyst

Okay, thank you.

Operator

Operator

And we have reached our allotted time for questions. I would now like to turn the floor back over to Dr. Hedrick for any closing or additional remarks. Marc H. Hedrick - President, Chief Executive Officer & Director: Thank you, Susan. From my vantage point today here in first half of May 2015, I believe the company is in a fundamentally different position than it was about a year ago. If you look at our cash, that's substantially up. Our expenses remain down. Our debt and liability picture are improving and will continue to improve. We've substantially increased the financial support from BARDA from $5 million to $14 million plus another $8 million that's possible. And I think most importantly, we fundamentally repositioned the clinical program to focus only on later stage principally U.S. opportunities that we think we can bring to market quickly and that should expand our partnering and commercial opportunities over time for this company. At the same time, we're making great strides in bringing our next-generation platform to the development process. I can tell you that that product is performing at or better than expectations currently where we are. I have a good feeling that that's going to significantly change the economic proposition of bringing adipose-based cellular therapies to market. It's going to enhance the customer experience based on the amount of engineering fire power that's gone into this thing, and then it's going to expand the business model. We've talked about not only device-based model, but potentially selling the therapeutic as well. And this system is going to address all of those issues. And then finally on a practical level, the implementation problems that we've seen using the current technology in terms of the time it takes to process, the costs and so forth should be solved substantially in this forthcoming generation of technology. So, we're excited about where we are. We're in a fundamentally different place than we were a year ago. We're going to protect the capital and the progress that we've made over the next few quarters. We're going to be thoughtful and we're going to question everything, but we are very excited as a management team about where this company is today. And we're in a great position and we're going to do our best to create value for our shareholders. As always, we appreciate the thoughtful questions, the e-mails that we've gotten, a considerable number in fact over the last couple of weeks, and we appreciate the continued interest for those of you who have followed us over the years. So we'll do our best to keep you updated, to be transparent, and thanks again for your interest and support. Please have a good evening. Susan, thank you.

Operator

Operator

Thank you. This does conclude today's conference call. Please disconnect your lines at this time and have a wonderful day.