Cytori Therapeutics Q3 2009 Earnings Call Transcript

Nov. 9.09 | About: Cytori Therapeutics (CYTX)

Cytori Therapeutics Inc. (NASDAQ:CYTX)

Q3 2009 Earnings Call

November 9, 2009 10:30 am ET

Executives

Christopher J. Calhoun - Chief Executive Officer, Director

Marc H. Hedrick M.D. - President, Director

Mark E. Saad - Chief Financial Officer

Analysts

Brian Gagnon - Gagnon Securities

Joe Feshbach - Joe Feshbach Partners

Ren Benjamin - Rodman & Renshaw

Erica Layon (ph) - Noble Financial

Jason Napodano – Zacks Investment Research

Stephen Brozak - Westfield, Bakerink, Brozak

Stephen Dunn - Jesup Lamont

Neil Gagnon - Gagnon Securities

Bart Blout - Sawtooth Capital

Presentation

Operator

Good day ladies and gentlemen. Thank you for standing by. Welcome to the third quarter financial result conference call. During today’s presentation all parties will be in a listen only mode. Following the presentation the conference will be open for questions. (Operator’s instructions) This conference is being recorded today, Monday, November 9, 2009. I would now like to turn the conference over to our host and CEO, Mr. Chris Calhoun. Please go ahead, sir.

Christopher J. Calhoun

Thanks Jeremy. Good morning. And welcome to Cytori Therapeutics third quarter 2009 conference call. Before we begin, we want to advise that over the course of our call and question and answer session, forward-looking statements will be made regarding events, trends and business prospects which may affect our future operating results and financial position. Some of these risks and uncertainties are described under the risk factor section in Cytori Security and Exchange Commission filings, which we advise you to review.

We assume no responsibility to update or advise any forward-looking statements to reflect events, trends or circumstances after the date they’re made.

Now let’s turn to the quarter. In the first nine months of 2009, we experienced very positive signs that we’re building a solid foundation for our business. Our technology continues to reach more physician practices and as a result we’re seeing related growth in consumable sales.

In Q3 specifically, we saw a marked reduction in inventory that key distributions and thus an increase in number of systems that have been installed and are now being operated.

This is being driven mostly by demand in Europe within the cosmetic surgery market where Celution customers are starting to aggressively market cell enriched cosmetic surgery to patients to differentiate their practice.

We’re also making progress in our clinical trials. For our breast reconstruction study, 69 out of 70 patients have been treated and completion of enrollment is eminent. This month the last patients will come in for their primary six month follow-up in both of our cardiac studies.

Also this month, we will be submitting our Celution 700 510(k) to the FDA for which a response from the FDA could result in an initial market clearance will allow us to further define a specific path.

Collectively, we view these events as setting us up for an exciting six months. And with that we’d like to open up the call for questions. Jeremy?

Question-and-Answer Session

Operator

Thank you, sir. We will now being the question and answer session. (Operator’s instructions) Our first question comes from the line of Brian Gagnon with Gagnon Securities. Please go ahead.

Brian Gagnon - Gagnon Securities

Can you talk a little bit about the investigator led studies? What’s going on with those? And where do you stand on some of the progress? And is it possible that any of these are going to lead into expanded trials and/or therapeutic programs for you in the future?

Christopher J. Calhoun

Brian, as you know, we’re pretty excited about a lot of these investor led studies because we’re focused on – our core areas of cosmetic and reconstructive surgery and our cardiac work. But the investigator led studies really allow us to expand the platform. And based on some of that data that’s been coming out as well as the revenue that we’re generating, we’ve seen an increase in both partner interest and more active conversations with partners. For example, recently we’ve signed a non binding letter of intent with the group for specific field in Japan based on one of these investigator led studies. It’s like a Q1 event. But it shows the model of the potential value of some of these translational activities.

Brian Gagnon - Gagnon Securities

Okay. A non binding letter of intent. What does that mean? Could this be something substantial for the company, as in potentially up front money and/or milestones in royalties? And could you maybe expand and give us a little idea how a structure of a transaction like that might look?

Christopher J. Calhoun

Yeah. I think you’re thinking about it in the right way. Obviously, there’s no guarantee this will get done. It’s a non binding letter of intent. But I think it shows the interest, the structure, again, because there’s confidentiality around some of these things. I can’t go into specific detail. But I think you’re thinking about it right. It would be a meaningful deal to us with significant up front in the milestones and then ultimately in commercialization model. So I think you’re looking at it exactly the right way. And I think it shows the model on how we can really leverage the value of a lot of this investigator led work.

Brian Gagnon - Gagnon Securities

Fantastic. Well, good luck on getting it down. Can you give us an idea on system sales. Is anything really happening in the US? And what types of markets are they looking at, at this point?

Christopher J. Calhoun

I’m going to hand over to Marc Hedrick for the sales.

Brian Gagnon - Gagnon Securities

Thank you.

Marc. H. Hedrick

Thanks for the question. The US is just really getting off the ground. We’re settling with our partner, GE in the US. Remember that we don’t have specific regulatory approval for the StemSource System. Which is the system that’s being sold in the US today. It’s being sold as laboratory equipment.

Really for clinical research doctors can acquire this system and use it. But it’s used through the practice of medicine. And it’s not a medical devise and we can’t make claims about that, and don’t. And neither does GE. However, having said that there is still over interest in the US based on the interest and demand that we’ve seen in Europe and also in Japan.

And we’re seeing more and more position, potential key option leaders, visiting Cytori, expressing interest at meetings in the US about the technology. And in fact giving presentations at major meetings, talking about the future of plastic and reconstructive surgery. And using our technology as part of their talk. So, we’re still early but we really are pleased with the level of excitement demanded that we think we’re seeing in the US.

Brian Gagnon - Gagnon Securities

Good. Thank you. I’ll get back in queue.

Operator

Thank you. Our next question comes from the line of Joe Feshbach with Joe Feshbach Partners. Please go ahead.

Joe Feshbach - Joe Feshbach Partners

Hi. Just can you provide a little more color on the thought behind reacquiring some of these distribution rights? What the impact will be, when we should – when it was done and when we should see that impact start to show up in the numbers? And sort of to that end what sort of momentum in terms of sell through do you have this quarter versus the quarter we just completed now that you’ve sort of reorganized this?

Marc. H. Hedrick

Thanks for the question. As I answer the question and think about the answer, I put it in context and say that while we’re seeing steady growth in terms of systems going out the door and systems getting to patients and to physicians the goal is to really drive to an inflection point in sales in continued acceleration of sales. And part of that is an ongoing relook at better tailoring our channel model. And as you know we have a direct sales force, let’s take Europe, for example, where we have a handful of individuals selling direct. We also have a significant partnership in 10 countries with GE Life sciences. And we also have distributors in areas like, Greece, Spain and Poland. So we’re working through these different models in each location.

But one of the things that we’ve noticed by virtue of our relationship with GE, for example, is that GE does a good job in terms of their communications, interactions with large institutions where they may have a breast center in sell, radiological equipment at that breast center. Whereas Cytori tends to have better relationships and greater reach into private practice and individual plastic and reconstructive surgeons. So a lot of this tailoring really is allowing GE to focus on where their strengths are. Letting Cytori focus on where our strengths are and then letting the margins reflect the amount of work that Cytori’s doing in building the market in those private practices.

With respect to NBA who’s our partner in Spain, Italy and Portugal. Similar thing there where Cytori, who has its European base of operations in Italy, we’re driving a lot of the business in Italy whereas, NBA is located in Spain, it just made sense that Cytori drive that business on a go-forward basis in Italy. So, over the next year that really lays the foundation for Cytori driving its own sales force, its channel and its own business to a greater degree than it has been over the last year.

So, when you think about growth, I think there’ll be some system sales in now Europe related to GE and these large institutions and they’ll drive those and Cytori will focus on the private practice cosmetic market. I think it’s a win-win all the way around.

Joe Feshbach - Joe Feshbach Partners

Got it. And do you guys have a good read on distribution inventories? You kind of eluted to the idea that they were pretty much emptied out, dried out, whatever, in your letter. So should we start to see – I would assume that because you’re going direct we’ll see higher margins, higher revenues and perhaps we’ve cleaned up the distribution inventories so we might see a little re-acceleration in system and instrument sales? Are those all fair assumptions?

Marc. H. Hedrick

Yeah, I think so. The way I would explain the inventory situation is that over the last two quarters or so we’ve been working with partners to – big partners like NBA and GE Life sciences to burn down their inventory. As we’ve gotten their sales force trained we’ve increased their ability to get systems installed and up and running and service customers.

That inventory’s been bled down. But at the same time there’s a competing factor which is we’re bringing on new distributors like GE in Thailand. Our Polish distributor, Middle East and others. And so that offsets and increases inventory until we get them trained and up and running, so they’re sell sufficient.

But the overall net trend is that inventory levels are going down. A lot of the systems (inaudible) inventory over the last year so have been burned down. And you’re getting systems in the doctor’s hands. You’re seeing doctors beginning to use the technology on patients that are now, six months and longer out.

They’re getting more comfortable with the technology and they’re doing more patients. They’re building their own internal marketing efforts and we’re working with those practices to do that. And their practices are growing and that’s reflected in the increasing consumable reorders. So those are the exact trends that you want to see in a growing business like this. And it’s exciting now to see the numbers coming through and really seeing the business built.

Joe Feshbach - Joe Feshbach Partners

Got it. And you just comment a little bit on how the quarter to date looks versus last quarter from a (inaudible) point of view? It is really the –

Marc. H. Hedrick

Well, I think if you could look backwards as an instructed point for looking forwards. And if you dial back for the last four quarters we’ve seen universal quarter-over-quarter growth and the number of systems in our revenue base from – it’s about 42 systems back in Q2 2008 to 85 today. If you look at the number of overall consumable shipped, in fact in Q4 2008 it was 179, and we’re up to 314, roughly doubling reorders reflect that same trend, roughly doubling over the last year.

And then you care to drive that into Q4 you see that continuing growth so far in Q4. So, our visibility is that those trends continue yet while that’s all well and good we’re trying to accelerate that growth and that’s why the focus on sales and marketing support for doctors, enhanced product features, better tailoring the channel model and getting US regulatory approval are all clearly critical in creating an inflection point for the technology globally.

Joe Feshbach - Joe Feshbach Partners

Great. All right. Well, that’s great. I will get back in the queue.

Operator

Thank you. Our next question comes from the line of Ren Benjamin with Rodman & Renshaw. Please go ahead.

Ren Benjamin - Rodman & Renshaw

I guess just a couple of number questions. You mentioned that there 314 consumables shipped this quarter. Clearly things are still growing but it seems to be growing a little bit slower from, I’ll say previous quarters. And so, can you give us a sense as to – you still have all of the marketing efforts that’s on going. You’re trying to, of course, tap the cosmetic market. I understand all that. But can you give us some sort of color as to how you see this growing substantially into the new year? And then maybe some color as to how many of these orders were – of the consumable ships were reorders versus new ones? And then I have a couple of other questions as well.

Marc. H. Hedrick

Thanks for the question. So, the way I look at the trends is consumable reorders and overall demand is growing. And it’s a little deceptive to look at that delta in 313-314 over Q2 to Q3. Remember laying on that is a relatively slow European season in August and September. We had clinical trials that are winding down or it’s wound down over the last couple of quarters. But competing with that are increasing realtors. So reorders were up from last quarter to this quarter. And it’s been up every quarter for the last year.

Overall consumable orders have been up every quarter, quarter-over-quarter last year. So you’ll see as we’ve said all along, you’re going to see some variability. But we’ve never had a quarter over the last year where consumables haven’t been up quarter-to-quarter. And we’re seeing that pull through demand in terms of number of cases. In October we had the most number of revenue base cases in a month than we’ve ever had in Europe. So we’re monitoring that as closely as we can and you’re seeing it at the end user level. You’re seeing at the doctor level and the patient level. And those are the exact trends that you want to see.

Ren Benjamin - Rodman & Renshaw

Okay. Are we going to see – I guess one question is what percentage of the 314 were reorders, if you could saw that out for us? And then the other is would you expect to see some sort of softness in, let’s say, the end of the fourth quarter as well? Just like you mentioned the August-September time frame, the November-December time frame going to kind to a softness in sales as well, just because of the holidays?

Marc. H. Hedrick

The percentage of the overall consumable shipped that are reorders is greater than 50% and it’s been greater than 50% basically ever quarter over the last year. So it’s kind of hanging in at, kind of 50%-60% range each quarter. Because as we bring on new distributors that means new stocking orders and also there are continuing base of reorders. You kind of see that reorder trend picking up a little bit slowly each quarter-to-quarter. But it’s still greater than 50%. With the clinical trials ending, that contribution to the overall consumable shipments is going down.

So the relative importance of the reorder is growing. And revenue related to that is another measure of growth is that. And that – for every quarter over the last year we’ve increased the amount of revenue attributable to consumables, both the total revenue and reorder revenue. So that’s growing quarter-to-quarter. And it’s grown roughly 100% year-over-year looking back through the entire four quarters of last year. So we see those trending continuing to grow. And with respect to fourth quarter, it’s hard to say.

But because we are much stronger positioned than we were, let’s say last year, and over two or three quarters, I think what we’re seeing now is indicative of those strength that we have in the market, of growing partnership with GE, we’re seeing our own sales force, making efforts. And the Christmas holiday is relatively short, for example, in Europe. But it’s not a six week holiday like you see in the September-August time frame. So it might be some, kind of, seasonable variability. We see that in numbers. But the overall growth trend is clear.

Ren Benjamin - Rodman & Renshaw

Okay. Of the 15 – this is just semantics here, but just to get some clarity, of the 15 new systems that were shipped, you mentioned that 12 were sold to physicians and distributors. Where are the other three? Where did the other three go?

Marc. H. Hedrick

Well, we’ve got some systems that are in a small loaner pool. So they’re a group of physicians that either are a direct customers or are customers or potential customers of our distributors who maybe aren’t quite ready to buy the technology but would like to try it out and do a few cases. And early on in developing a market that’s something that we’ve anticipated and we’re prepared for it.

And so every quarter a few systems might go out to physicians and they’ll use the technology and the goal is that we convert them to a sale after they get a little bit of clinical experience. So not every system that goes out in our revenue base is a sold unit, although the vast majority are and a few go into that loaner pool either directly or through out distributors.

Ren Benjamin - Rodman & Renshaw

And what’s the hit rate been with the loaner pool? So if you had a number, let’s just say 10, I mean, you probably have the actual number. What has been the hit rate or the ability to convert them into sold units then?

Marc. H. Hedrick

I would look at it this way, and that I can’t think of an instance where someone’s had a loaner unit and they’ve wanted to give it back.

Ren Benjamin - Rodman & Renshaw

Okay. Can you give us an update as to what’s happening with the stem celled banking component. What can you tell us about how things are going there?

Marc. H. Hedrick

Well, I think for those that aren’t that familiar with banking, I think our sense is that there is growing verbal commitment towards banking. And people are taking action. Business, investigations, discussions, reflecting their interest in banking. Banking, you could divide it up into those large institutions, particularly in Japan who are interesting in more of the broader appeal for their constituency for banking and treating the overall health of the patients. In other words, if you bank the cells when the patients are younger, when they get old they’ll have young cells and you can use it for heart attacks and other things.

And that’s going to be driven by these large institutions who have long buying cycles. And it’s a pretty big ticket item. And we and our partner, Green are working with those big institutions. And those are long sale cycles. But we think those will come eventually. Particularly are the overall breathe of the clinical applications grow.

Ren Benjamin - Rodman & Renshaw

And can you remind us just how many sales have already taken place?

Marc. H. Hedrick

So we’ve sold basically two system. One to a large institution as described at Kyoto Prefectural University in Japan. And that’s a big public institution, long buying cycle and that technology has been installed. And then also to a core blood banking company in Greece, which is a little bit flavor of that same model.

The immerging interest is really on private practices. And individual physicians who now have the Core Celution or StemSource technology in their practice. They’re doing patients. They like the results. Many cases they have extra fat tissue or stem cells they would like to store for the patient. A, because in an era of regenerative medicine it doesn’t make sense to throw cells away. Those cells are valuable. And patient has been treated once is likely to be treated again.

But the second thing is, if the physician banks those patients in a bank that they control they effectively have captured that patient on a go-forward basis. So if that patient wants to be retreated it will mean that that patient will call that physician back, have a revisit. And that could mean both treatments related to this cell therapy for that patient, but also potential other treatments. So it’s a way to enhance the life time value of that particular customer.

So we’re seeing more and more interest from private practices and smaller groups interested in getting a slim down version of the bank for their practice or group of practices. And stay tuned to see how that market develops. But in the end all of these banking models will be driven by clinical success, not vice versa.

Ren Benjamin - Rodman & Renshaw

Right. I guess one last question has more to do with guidance. I don’t remember, just looking at my model, but I have somewhere close to say $10 million in revenues for this year, which doesn’t seem like it’ll be achieved. And I don’t remember if that was guidance provided by you guys are not. Do you have any revised guidance? And then how should we be thinking about 2010?

Mark E. Saad

I think we certainly talked about the guidance last quarter on the call. We acknowledged it was going to be a challenge. In meeting that we’ve had, they’ve been webcast since then, we’ve re-acknowledged it’s going to be a challenge. So I don’t think there’s any great mystery to that. And at the same time, we also said that we see a building strong funnel of revenues both large practice, small practice, banks, etcetera, all building strong momentum in terms of what we think are the realistic revenues to get in the near term.

We continue to see that building. In no different than before the 2009 anticipated number is certainly a challenge. Internally we still are driving towards achieving those revenues. And if we do that we think we can grow very significantly in the near term and long term. And so I focus less on the $10 million number, consistent with what we said before, consistent what we’re seeing. But at the same time I think we’re driving to an inflection point that while we’re defining a new market here, there’s no path to follow.

We’re creating our own path. And in doing so a lot of good things are happening. A lot of things that show us that revenue well in excess of that number are possible and we’re driving to that. So without getting a specific number, because I think that’s proven to be difficult to project, I think you can see a lot of very tangible evidences of physician experienced, patient experienced, growing in solid base, striving to inflection point, that could make a good case for strong growth. And I think that’s where we’re going to focus.

Ren Benjamin - Rodman & Renshaw

This is a follow up to that. The inflection point that I think both Marks have mentioned, how do you characterize that? I mean I understand it’s easy to see as far as revenues going up. But what do you need to see prior to that being registered, let’s say, on a P&L statement?

Mark E. Saad

We can smell the inflection point. And the question is, by clinical background you have to make a diagnosis in the field what’s holding things back from the perspective of increasing adoption, on one hand, people buying the technology, putting in their practice. And on the other hand, driving through put the number of consumable sales. And I think the four things that we tried to outline in the letter that I kind of focus down on a little bit that will contribute to that inflection point. And with the (inaudible) we can’t predict when it’s going to happen. But we feel confident it will. And we just need to drive as hard as we can to that.

So, number one, is making our customer, physician, practices successful. So doctors aren’t used to selling cell therapy and stem cell related technology. So marketing and sales support. We’ve done some internal restructuring. We are working incredibly hard, devoting a lot of resources to putting tools into doctor’s practices to make it easy for them and their business. Folks within the practice to sell the technology.

We’ve added a new Vice President, David Oxley, to run our sales support group. Which is a way to say marketing. There’s a clear interest on the consumer side for the technology. So when we have any physician that’s particularly astute in marketing goes out and gives a presentation or gets some media attention, the number of calls that flood the practice almost closes down their phone lines. And so, you really see patients saying, yes I want stem cell treatment X or stem cell treatment Y. So we’re starting to see the beginning in Cytori as we develop this of a direct to consumer approach that will grow in scale with the business. And that includes increased media exposure, trying to leverage a focus on local markets and minimize costs initially, but growing that. So, there’s this whole marketing as sales support function that’s been increasing, growing and morphing over time.

The second part of that is improving the features and benefits of the technology. Perhaps you remember the press release of a few weeks ago where we put out a major new release of a software that’s really geared towards allowing the doctor to have more tissue volume available and cell volume to treat individual patients.

On a practical level that means in a lot of patients whereas before they could only do one cup size breast augmentation now they can do two cup sizes, for example. So not only providing - broadening the utility of the technology but decreasing the time so it works better in the patient/doctor workflow. And the doctor can basically boost his pay per hour during the day using the technology. So it improves the practice economics.

And then an ongoing basis to peer graft technology that’s coming out, Celution 1, the Olympus version that’s coming. And perhaps things in the future, are all geared towards enhancing the product of features and benefits and its use in the practice.

And two other things to highlight, one I highlighted previously which is better tailoring the channel model by letting GE do what GE does best, let Cytori do what Cytori does best. And the same with NBA and going direct in places where maybe we haven’t before and capturing that margin. They’re all important in tailoring that channel model to make it more successful.

And then finally, well we haven’t really touched on it, is our US regulatory strategy. We’re happy that we’re going to be a device. We hope we’re going to be a 510(k). And as soon as we get regulatory approval in the US, then we look forward to launching the Celution family of products in the US where we think demands are already there. So all those things together, I think, drives towards an inflection point. And having the number of people that we have in the field, interacting with the customer, having customers coming to San Diego and taking a tour and seeing the technology, hearing the presentation. All this lead us to the strong belief that inflection point is coming.

Ren Benjamin - Rodman & Renshaw

I guess just one last question. The US regulatory strategy. Can you just give us an update as to, sort of, what are your thoughts, what’s the timing, when might we be looking for an approval?

Mark E. Saad

So, remember, in the US granted for those that are not as familiar, the StemSource device sold through GE in the US is sold as laboratory equipment. It’s not a medical device. And there are limited things we can claim about that system. We do have some 510(k) approvals on components of the device in the US. And those are our predicates. We also have – there are products that are external to Cytori that are also predicates for the Celution System.

And so married with that we have feedback from the FDA that says that we will be regulated through the Center for Biologics as a device. And that a 510(k) is possible. And that feedback on that will come after we file it, which will be this month. And we expect over the course of two to three months we’ll get feedback from the agency. And in the best case scenario, relatively early in 2010 if it’s a 510(k) pack, which would be the best option in terms of speed to market, that we will have in a general claims, like we have in Europe, and allow us to get on the market in the US with a medical device under 510(k) clearance.

In terms of the slowest path would be if we had to do a PMA and the clinical trials related to that. And that would probably take more like late 2010, 2011, sort of time frame depending on the nature of those clinicals. And then also possible is something in between where we do really a heavyweight 510(k). So it’s a 510(k) but with some clinicals.

And part of what our clinical team is doing right now is contingency planning based on what we hear back from the agencies so that when we do hear back, or we begin to get correspondences back that lead us down one direction or the other that we’re ready to move with either commercialization or with a clinical strategy.

Ren Benjamin - Rodman & Renshaw

All right guys. Thank you very much and good luck.

Operator

Thank you. Our next question comes from the line of Erica Layon (ph) with Noble Financial. Please go ahead.

Erica Layon (ph) - Noble Financial

Good morning. It seems like a good number of questions have already been asked. It looks like you’ve done a very good job with this cost containment. I’m curious if this is now done and we’ll start growing from this level or if you can give us any guidance?

Marc. H. Hedrick

To your point, we did a lot of cost containment, specifically in R&D and within that a lot of the early science and product development that had to get us through the key milestones as well as on the G&A side. With that in place our hope is to hold the line. Probably grow marketing a little bit, where we’re starting to see some payoff for that. Within R&D we should be able to continue to keep the science and hopefully the product development low.

Clinical, there’s always the opportunity to grow that. I think we look at that pretty rigorously. We’ve completed enrollment of our heart studies. And as you heard we’re got it now a completion of enrollment is imminent for RESTORE-2. There will be ongoing follow up there with the clinical. So we expect that component of R&D to be reasonably stable considering those factors. So overall I’d saying trying to keep the overall operating costs stable. Some things hopefully coming down a little bit, some things growing a little bit, likely on the marketing side.

Erica Layon (ph) - Noble Financial

Okay. That's definitely helpful. And I know you’re looking at getting the RESTORE-2 data that you will out at San Antonia breast. Do you have any time frame for the cardiac results to be presented?

Marc. H. Hedrick

Right. We think both cardiac studies are going to be available, the data from those studies at the six month primary end point data will be available in the first half of 2010. And likely that APOLLO could be sooner, which is the heart attack study, on the earlier end of things maybe late Q1 if possible. Probably APOLLO first and then more likely in later end of the first half of PRECISE.

Erica Layon (ph) - Noble Financial

Okay.

Marc. H. Hedrick

As far as which meeting goes, I mean, there’s a number of different meetings that are, sort of, a noteworthy cardiac meetings. And that really drives a lot of the timing there. And so there’s a number of different meeting, as you can imagine, that are being looked at as date – when the data is available and what the right venue is. So I think that’s more likely to drive that.

Erica Layon (ph) - Noble Financial

Okay. That is definitely helpful. And then I guess as a last question. These placements that you’ve made in the US, are you including that in what would you call a stem search revenue or are you including them more into the basket along with Europe?

Mark E. Saad

Well, with the StemSource – when we say StemSource revenues, we don’t break it out between banking and system sales. We talked about that. Technically these are StemSource Systems that are available in the US. But we include them in the overall base of systems.

Erica Layon (ph) - Noble Financial

Okay. That’s definitely helpful. And I’m guessing you probably won’t let us know how many you’ve placed this quarter in the US?

Mark E. Saad

It would be hard to give a number. We do see some encouraging signs this quarter that Q4 got off to a faster start, for what it’s worth. We take every day as a new day. So it’s hard to – in a business where just a few quarters into commercialization to make any tangible sign of trends. But if the first few weeks of the quarter are indicative we feel like Q4 is off to a good start.

Erica Layon (ph) - Noble Financial

Okay. That’s very helpful. Thank you very much.

Operator

Thank you. Our next question comes from the line of Jason Napodano with Zacks Investment Research. Please go ahead.

Jason Napodano – Zacks Investment Research

Thanks for taking the question. Just looking for an update on your cash raising activities with Seaside that you’ve probably completed as of today, probably either 10 or 11 transactions. You’re coming up on that 13th transaction. And just wondering if you think that you’ll continue with the 14-26 or – when you look at your cast position now do you find it sufficient enough that you’ll eventually stop those offerings?

Marc. H. Hedrick

Seaside has been achieving everything that we had hoped they would do as a fund, in terms of their commitment and recently acknowledging their ownership position that they are a long term holder, versus just a financing vehicle. So I think they’ve delivered their part of demonstrating that they’re a fund. And it’s been a good program for us to really minimize the overall delusions staying away from warrants and other things like that, and knowing who our investor is. And those are very important for us as a company in the transition stage that we have strong confidence in who the fund is and why they’re investing.

So with that in mind, we have the agreement in place. We’ll look at the opportunities available to us at that time. And the only thing I would offer is that it’s been a productive and successful venture so far. And they’ve lived up to what we believed in them. And it’s been far more attractive than some of the hedge fund deals that are out there as well. And we have a number of different opportunities as we go forward. It was mentioned a little earlier that we signed a LOI, non binding with a group for commercial partnership. I mean there are other things that we think will drive significant capital into the company. And that this could be a good accelerator of those.

Jason Napodano – Zacks Investment Research

Okay. And as far as their ownership position, they’re above 5% now. Have they made any comments on where they’d like to get to?

Marc H. Hedrick

We believe they have an interest in building a long-term position in the 10% area. And as always, that's what's represented to us so that's all we can offer.

Jason Napodano – Zacks Investment Research

Right. Okay. Thanks a lot.

Operator

Thank you. Our next question comes from the line of Stephen Brozak with WBB.

Stephen Brozak - Westfield, Bakerink, Brozak

Hey. Good morning, gentlemen. It seems like quite a few folks have asked a lot of questions so I'm going to defer to a background question. There' something that struck me as interesting and I'd like you to elaborate on it. You did a deal with GE on Thailand — now, in putting two and two together, Thailand is considered, how should I put it, one of those places where people travel for the medical procedures and for travel health care. What kind of color can you give us on that because it's interesting when you have a place like that where the prices you get are so much different and they're more on the cutting edge — what can you tell us about that? And I'll have a followup question after that because that's the one country where it kind of took me a little bit in terms of asking some granularity?

Christopher J. Calhoun

Steve, Hi. It's Chris Calhoun. I think you're right. I think there is this significant growing market for what's being classified as "medical tourism." And there's some leading markets that are evolving in that space and Thailand is certainly one of them. I know that Dubai is looking at it. Singapore has been active in this area probably 15 years. There's some areas that are probably less advanced like Costa Rico, maybe Mexico, Israel to some extent. So this idea of medical tourism is really a very interesting area and it's a growing market for sure.

In Thailand we've been kind of going in and out of there for a number of years really looking for the academic centers and the real kind of long-term oriented groups versus an opportunistic approach which I think Thailand has seen some of. There's been an ability to go to Thailand for a number of years, pay a lot of money for early self-therapy applications. Recently the Thai government's cracked down on a lot of that. They just instituted a whole new regenerative medicine policy and so the government's kind of taken control of, particularly self therapies, and trying to really regulate that field.

And so we're fitting within the Thai government's new definition of self therapy and we've been in there working with a couple of the leading hospitals in Thailand, again, which GE as a partner has tremendous relationships into. So I don't know if this is going to be a massive new amount of business for us. I probably wouldn't look at it that way, yet it's another market opportunity that we're leveraging. And again, with GE in there, and their relationship even in the government and ministry, not just into the customer level — so on a lot of level we're leveraging our partnership relationships as well.

Stephen Brozak - Westfield, Bakerink, Brozak

Actually that prompts me to a followup question. You had mentioned a few other places like Mexico basically people are obviously unfairly or so derisive of it, but with places like Thailand you're talking about — you see a lot of advanced cardio procedures being done at a fraction of the cost or you see other elective procedures done. I would guess that would lend it — that the elective procedures certainly with breasts would lend itself very well to that kind of an approach. Would you concur? And at the same time, with the number of patients that are going over there for procedures on the cardiac side, that would be the next area to concur, is that something that makes sense?

Christopher J. Calhoun

Well, I mean to the first point I think yes and no. I think that in terms of the economics, I wouldn't say it's cheaper. I think people are paying richly for access to self therapy and this echoes what Marc said we're seeing in the market that there is, despite whatever kind of regulatory conservatism's out there or kind of early market, there is a significant and growing interest by individuals to have access to self therapy for their health care. And in markets where they don't have access to it, whether from a regulatory point of view or just from a clinical access point of view, they're going to where they can get it, particularly for things like cardiac.

Thailand's been an early mover in that area, certainly not cheap from what we understand and even in the places like India which you may not initially think of, but it's projected that within a year or two, India will be the largest cardiac market in the world. So I think there are these opportunities out there, and that's where our business model, I think, is really unique and well positioned that what we do is we provide access to sells in an affordable easy workflow way and without all of the potential complications and complexity of a cell manufacturer environment.

So that business model and the economics associated with that really make it affordable and appropriate to get into these maybe tertiary markets whether it's for medical tourism or just directly for the market itself. I think we're really well positioned in that regard.

Stephen Brozak - Westfield, Bakerink, Brozak

Okay. I'll switch to one last question because inflection points have been mentioned several times and I know that you look at competition, not necessarily obviously in the stem cell area, but competition in terms of devices. Have you noticed the bifurcation in terms of acquisitions of equipment? Because we've been monitoring that hospitals are not just stopping buying, they're basically cancelling orders that they've had in place.

Are you seeing a bifurcation where they're willing to talk to you where they're basically saying we're not going to buy anything new in any other product areas for the foreseeable future whereas you guys are differentiated obviously by the novelty of equipment and they're willing to talk to you guys based on that. Is there some granularity you can give on that and after that I'll hop back in the queue.

Christopher J. Calhoun

Steve, it's a complex question. I think that what we're seeing is that if you really look back 18 months, there was no self therapy market, at least from a device point of view. We've created this and so we're pioneering it and the early customers are really characterized as the early adopters and — well, I think that you're right in that these groups are probably reaching out to us and finding us and we're finding them without a lot of the other overhang of some of the other issues that are going on. I mean it certainly affects some accounts.

For example in Japan I know there was an institutional bank backed by a governmental grant. There was a recent election there that basically changed the whole probably 50-year history of how the government was being run in the party. And as part of that they've kind of put a whole on all funding and really reshuffled the deck for all the grants that were out there and they're relooking at that. So there is an impact in some ways on us by some of these things.

But I think in general to look at it, I don't think we're as affected as others because there is this new area, the guys looking at it are particularly on the early adopters side, the leading kind of innovative type of physicians and practices and institutions and we're finding demand there. Now how that compares with somebody buying a liposuction machines or GE selling a new MRI I don't really know, but our numbers and our experience is what it is and we're really finding growing demand.

Stephen Brozak - Westfield, Bakerink, Brozak

Great, thanks. And I look forward to seeing that inflection point real soon. Thank you.

Operator

Thank you. Our next question comes from the line of Stephen Dunn with Jesup Lamont.

Stephen Dunn - Jesup Lamont

Hi, guys. I'll make this quick. I kind of want to focus on the 510(k) versus PMA thing. Have you gotten any more color from the FDA on which way they're leaning? As everyone knows they're getting very tough on the 510(k)'s, so are you getting any color or changes instance since July?

Marc H. Hedrick

Hey. It's Mark Hedrick. So no, we really don't have any further color from the FDA beyond the formal decision that we'll be regulated as a device, but I think that the next 1-2 quarter event will have more granularity and be able to know. There are benefits and downsides to a 510(k) versus a PMA and so we want to work with the agency to find the best regulatory approach for our technology that protects our ability in the market going forward, but also speeds us to the market as quickly as we can. And right now we're in the mode of getting a 510(k) filed and contingency planning for whatever the agency comes back with.

Stephen Dunn - Jesup Lamont

I guess I didn't hear exactly what the predicate device would be for a 510(k), could you give us a little bit more?

Marc H. Hedrick

Sure So Cytori has three approvals — clearances, for 510(k)'s on the core system, on the canister, and on the enzyme so those represent three separate 510(k)'s cleared and that are performed by Cytori's regulatory group. In addition, there are other enzymes that are out there, for example, the digestion of the lining around the oocytes that are similar, where those cells are reimplanted or back into the same patient. And blood concentrators and other systems that concentrate cells that are approved through the 510(k) process.

So, part of the process is to marry what's outside the company with what's inside the company to produce a compelling argument to the Center for Biologics for 510(k) approval. We think we have a good shot and we're giving it everything we have, but recognizing that it's out of our control.

Stephen Dunn - Jesup Lamont

Okay. So you're saying you're drafting up that document now. If they come back and say look, we want you to file an IDE and go through the PMA process, how long would that take you to switch gears? Do you already have something in mind on what that PMA trial would look like?

Marc H. Hedrick

So yeah, I think to that point earlier, we're contingency planning through all that so that we have a clinical trial strategy that's ready to go with minimal downtime and so with respect to interactions with the agency it's not necessarily you wait for 90 days and then you get your answer, it's an interaction and so you can leverage the information that you get in ongoing basis with the agency to better tailor your ultimate approach were we to have to go down a clinical path either heavyweight 510(k) or a PMA.

But at the same time, just remember that we can be as successful company on what we're doing in Europe and in Japan and that a significant — we're an important part of the overall global company, but the lion's share of our sales and marketing efforts are focused outside the US. So with the US it's going to come and we're going to push it as quickly as w can, but we're also going to become a successful company based on what we're doing in Europe and in Asia.

Stephen Dunn - Jesup Lamont

All right. Last question, it doesn't necessarily pertain exactly, but the Isolagen which is now Fibrocell, they filed a VLA for autologous fibroblasts that went in front of the ACTG outside the CTGT committee. And what they found for wrinkles — they found safety issues or they were not convinced that there was not tumorigenicity issues closed. Have you had any feedback from the FDA since that's also through Seaber regarding that and what you're trying to put through with the Celution 700?

Marc H. Hedrick

Well, we're very familiar with Isolagen, its products, and the regulatory approach that was used in that case and recall that that's a cultured product and it's beyond minimal manipulation which is one of the key kick down factors in the FDA for whether it's regulated as a biologic or a device that was regulated as a biologic, not as a device.

And so it's really apples and oranges, and so having that feedback from the FDA that we had that said we're regulated as a device, as always thought, and as we're regulated in Europe as well as a device, not as a biologic or drug — makes us feel confident that not only do we have a good shot at a 510(k), but that we'll be seen completely differently from a regulatory and safety perspective even if we're regulated in the Center for Biologics because we have a completely different approach and a completely different technology.

Stephen Dunn - Jesup Lamont

That's (inaudible). Thanks, Mark.

Operator

Thank you. Our next question comes from the line of Neil Gagnon with Gagnon Securities.

Neil Gagnon - Gagnon Securities

Good morning, gentlemen. A couple of questions. You use the term — excuse me just one second, that you want to hit this inflection point, and I guess that's a code word for breakeven on ongoing revenue, is that correct?

Mark E. Saad

Hi, Neil. It's Mark Sad. I think our vision of what an inflection point is, is when the revenues related to the systems being in the field, both the system revenue, but also seeing that big pickup that we think will come from the consumable reorders where it can become more obvious to people outside the company that there is a strong and growing business here.

And we think that the fundamental pieces to that are getting these pieces into the customers' hands, getting them past that early experience timeframe where they're getting comfortable with what the technology does and the impact on the patients, and then getting more and more of them to where they're making a big part of their practice, and that will then, in turn, show itself in revenues where I think as one outside the company's able to see that revenue growth really step up and see that this is not a short term, but a very long-term trend that the inflection point will be when I think people realize it's a foregone conclusion we're going to get there.

Neil Gagnon - Gagnon Securities

Okay. So it's some combination of continued increase in the systems base plus increase consumables driving higher revenues and lower losses?

Mark E. Saad

Right. So if we look backwards in the last four quarters going from 42 revenue based systems to 85, well that implies 10 or 20 per quarter. What is it going to take to get that 10 steady growing number which in and of itself can drive good things and more and more of them become active systems? What changes that number to make it go from 10 to 20 to where really more and more of the funnel of interested customers have seen enough where they then come over and actually get the system in their offices.

And then similarly to what you said, of the small percentage users that you make it a very big part of your practice, what's the point of experience for these customers? Is a big swing of those install base going to make it a big percentage of the practice? I think those are the two key drivers.

Neil Gagnon - Gagnon Securities

Okay. And the term you're using in this release, revenue base, 85, those are actually production machines out in the field, not machines being used for experiments?

Marc H. Hedrick

Hey, Neil. It's Marc Hedrick. So, just to be clear, when we say revenue base, what we mean are those systems that have been sold to the distributors, directly to physician end users, or systems that are in the small loan approval, but they're not the pure clinical trial systems.

Neil Gagnon - Gagnon Securities

These either are or will be production machines not in the clinical trial?

Marc H. Hedrick

Right.

Neil Gagnon - Gagnon Securities

Okay, good. I just wanted to make sure of that. Back earlier you mentioned that you had a nonbinding letter of intent and possibly being a Q1 event. Can you size that for us in terms of what it might mean to you in money?

Christopher J. Calhoun

Hi, Neil. It's Chris. I really can't, but I would just again characterize it as a meaningful event. It's still not a done deal, but obviously we're still excited about the opportunity. It would be meaningful up front and then meaningful milestones with a very nice long-term commercialization structure, but I can't really give you more than that on this. I think this will be a very good deal for a specific market in a specific territory and then we can leverage on that to going to a lot of other places in the rest of the world where there's interests as well.

Neil Gagnon - Gagnon Securities

Okay. Would you give us just a little idea of what are the things you'd love to be done in getting this over the hurdle line?

Christopher J. Calhoun

Well, it's a process. There's a lot of due diligence that's behind us. There's still some yet to go. The group is obviously doing their internal work and contracts and so forth and there's no lack of landmines out there, but hopefully we've landed some reasonable partnerships in the past. We have experience with it. We feel confident that at least from our part we'll do what it takes to get this done and we hope that we can deliver that in Q1.

Neil Gagnon - Gagnon Securities

Good, thank you.

Operator

Thank you. Our next question comes from the line of Bart Blout with Sawtooth Capital.

Bart Blout - Sawtooth Capital

Thank you. What I wanted to know is anything that has followed the Dr. Todd Malan and heard what he has to say, et cetera, why they wouldn't already know, that follow your company, that this is already a foregone conclusion and that it's going to play a particular role in the stuff it is trying for?

And number two, I don't understand how many Todd Malan types there are out there or Todd Malan wannabes or followers that would also be candidates to followup on and why we haven't, or maybe we have, proceeded to attack those guys with full course right away so that we can get more stuff going on out there, the world of understanding our product?

Christopher J. Calhoun

Bart, thank you for the questions. With respect to the US market, it's still really early. There are, through GE, some institutions and physicians that are acquiring the stem-source laboratory equipment and they're contemplating how to use it clinically. It's still really early in the US, but as mentioned before, there are a lot of physicians that have come through the office here or through our booths in the US, that are clearly interested in bringing the core technology into their practice.

And I think from a US perspective, while it's nice to work with GE to sell the StemSource laboratory equipment systems, in the end, for us we want to have a regulatory approval through the FDA and sell the technology for clinical applications. And that's really our main focus in driving that to that point as quickly as we can.

Bart Blout - Sawtooth Capital

I understand, but there would seem like it would cause demand to go overseas to Europe or something.

Christopher J. Calhoun

Well, there is demand. For example, and we hesitate to use any physician names or practice names, but there are instances in the US where because the technology's not approved in the US that customers have gone overseas for their treatment to physicians that have the solution system in Asia or in Europe and have their treatments done there. And that trend has not gone unnoticed by physicians in the US.

Bart Blout - Sawtooth Capital

Oh well one last thing, if Todd Malan is on TV in Arizona on ABC, obviously somebody thinks it's okay for him to be doing what he's doing or he would be under some pressure to stop it.

Christopher J. Calhoun

Well, we can't — individual practice of medicine is what it is, Bart. And so all we can do is continue to work with GE, sell our laboratory equipment in the US, and get regulatory approval for the solution system. We do our best to work with individual physicians to let them know our view of what is the best way to implement the technology or how to best understand the technology in light of their practice and we'll continue to try to do a better and better job of that.

Bart Blout - Sawtooth Capital

I understand. I mean, you have a tough job there, but in conclusion then, do we have a way of offering the system at a price that is — I mean, what do you do to make them try it out? What do you charge? I mean, everything is a different arrangement.

Christopher J. Calhoun

Well, if you just take Europe for example, and our partnership with GE. So our goal always is to sell the technology, the system, for a retail price directly to end-user customers and work with them to maximize consumable utilization and make the patients and make their practice successful.

And so while we'd always like the economics to be absolutely the greatest for us right off the bat, we understand it's new technology and we, in some cases, have to roll up our sleeves. And with an individual doctor who wants to acquire the technology, use it in their practice, but may have economic limitations or practice limitations, it means that a leasing arrangement might work better or a loan to buy sort of strategy might work better.

And so a lot of what we've talked about this morning is really driving to an inflection which part of that is to provide the best possible marketing sales support tools for doctors to be successful and helping them acquire the technology in their practice when they may have a limitation on capital equipment, for example, is an important part of that and that's not unique to us. It's for every company that has a capital equipment component, but we want to make that a minimal barrier to entry for these physicians.

Bart Blout - Sawtooth Capital

Okay. Thank you.

Operator

Thank you. Mr. Calhoun, I show no further questions at this time. Please continue.

Christopher J. Calhoun

Great, thanks. Well, I think there's a couple of key takeaways today. One, we really have a real business here and it's growing. The second thing is, and we talked about it some, but just to re-highlight that, there's real near term value drivers, particularly in corporately sponsored clinical trials and we've got data coming out as early as next month from RESTORE-2, and then likely Q1 for APOLLO and then Q2 for PRECISE. So there's a rich pipeline of data coming out that we think are going to be key value drivers for the company.

I think that from what you're hearing, we're steadily building momentum. Many of the core elements are there to achieve global scale and together with our strategic partners and core solution of (inaudible) products, we strongly believe that Cytori is setting the standard for point-of-care regenerative medicine and looking forward, we'll continue to focus on expanding our installed base of systems, as well as increasing the rate of consumable usage per system.

I want to thank you for your interest in Cytori and we look forward to updating you on our growth and progress, building our brand, and restoring patient lives. Thank you.

Operator

Ladies and gentlemen, this concludes the third quarter financial results conference call. If you'd like to listen to a replay of today's conference please dial 1-800-406-7325 and for international participants 1-303-590-3030 and enter the access code 4178319 followed by the pound key. The replay will be available until November 16th, 2009. ACT would like to thank you for your participation. You may now disconnect.

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