Cytomedix's CEO Discusses Q1 2013 Results - Earnings Call Transcript

| About: Nuo Therapeutics, (NUOTQ)

Cytomedix, Inc. (CMXI.OB) Q1 2013 Earnings Call May 10, 2013 8:00 AM ET


Michael Wood – IR

Marty Rosendale – CEO

Steve Shallcross – CFO


Jason Napodano – Zacks Investment Research

Ren Benjamin – Burrill & Company

Scott Pittman – Dalton


Good day, ladies and gentlemen and welcome to the First Quarter Cytomedix Earnings Conference Call. My name is Erica and I’ll be your operator for today. At this time all participants are in a listen-only mode. We will conduct a question and answer session towards the end of this conference. (OPERATOR INSTRUCTIONS) As a reminder this conference is being recorded for replay purposes. I would now like to turn the call over to Michael Wood. Please proceed.

Michael Wood

Good morning and thank you for joining us today for the Cytomedix first quarter 2013 financial results conference call. After the market close yesterday, Cytomedix issued a press release announcing financial results for the first quarter of 2013. If you not, yet received the news release or if you’d like to be added to the company’s distribution list. Please call Paul Arnd at LifeSci Advisors in New York at 646-597-6992.

I’m Michael Wood of LifeSci Advisors and before we begin, I’d like to caution that comments made during this conference call will contain forward-looking statements that involve risks and uncertainties regarding the operations and future results of Cytomedix. Actual results could differ materially from those projected. We encourage you to review the company’s filings with the Securities and Exchange Commission including, without limitation, the company’s forms 10-K and 10-Q as amended to date, which specify specific factors that may cause actual results or events to differ materially from those described in the forward-looking statements.

Additionally, the contents of this conference call contains time sensitive information that is accurate only as far as the date of this live broadcast, Friday May 10, 2013. Cytomedix undertakes no obligation to revise or update any statements to reflect events or circumstances after the date of this conference call.

Now I’d like to introduce Marty Rosendale, CEO of Cytomedix. Mary, please go ahead.

Marty Rosendale

Thank you Michael. Good morning everyone and thank you for joining us today. With me today is Steven Shallcross, our new Chief Financial Officer. As most of you already know, Steve was announced CFO of Cytomedix beginning of April and his appointment becomes effective today. For that reason, we felt it was important that he’d be on the call this morning, but because it is his first official day. I plan to discuss the company’s financial results during this call. Steve?

Steve Shallcross

Thanks, Marty. I’d just like to say that I’m fortunate to have joined Cytomedix in a time when there are so many exciting commercial and clinical opportunities. By positioning itself with two product platforms, that offer clinical solutions for difficult to treat wounds and a therapeutic platform from the ADLH Bright Cell technology that has the potential to become a leading treatment for skin, stroke and other cardiovascular diseases.

The company is ideally situated to take advantage of the (inaudible) potential near and long-term value creating opportunities. I look forward to working with Marty and his impressive team to help unlock stakeholder value and to address these large existing market opportunities with clearing unmet medical needs. Marty?

Marty Rosendale

Welcome aboard Steve. We’re glad to have you part of the team. Turning back to our update. I’m pleased to report to-date Cytomedix’s made significant progress into its commercial operations and corporate programs. And we continue to see positive advances in our research and development projects during the first quarter. Specifically, product revenues continue their steady growth with total sales of $2.3 million during the first quarter of 2013.

We were especially pleased to report a 40% year-over-year growth in Angel sales. The growth has been driven by the unique ability of the Angel system to adapt to clinical requirements and product an appropriate therapeutic. There is no other device that can boast the same degree of flexibility or clinical convenience to support the requirements of our physician customers and their patients.

Both Angel and AutoloGel achieved double-digit sequential quarter-to-quarter growth with Angel up 11% and AutoloGel up 14% compared to the prior quarter. Sales of Angel in international markets have been particularly meaningful to the products overall revenues. And this past February, we launched Angel in Australia, where there is significant growth opportunity for PRP.

We are fortunate to have Medtel, a leading supplier of medical equipment and devices as our partner in Australia. In addition, we are continuing to ramp up our sales infrastructure, to that end. We have hired Dr. Richard Kowalski to lead our medicine information group supporting our customers. I’ve known Rich, since working with him 13 years ago, when we launched a new immune system diagnostic product together.

He’s an excellent addition to our team. We currently have 10 full-time sales managers up from eight last quarter, and we are committed to driving sales and increasing shareholder value. We have now placed more than 500 Angel systems worldwide, and over 40,000 patients are currently being treated annually. The ability of Angel to process topology of the bone marrow, given the 510K clearance we received last November, has attracted a number of potential strategic partners interested in supply and distribution agreement for the orthopedic applications of the technology.

We are encouraged by the ongoing interest and enthusiasm of these potential partners and we remain optimistic that we will reach an agreement that will drive significant additional value for the technology. During the quarter, we also continue to see significant progress and our efforts to facilitate the reimbursement of AutoloGel.

As most of you know by now, the Center for Medicare and Medicaid Services agreed last year to provide coverage to patients under their Coverage with Evidence Development or CED program. CED is a determination made by CMS that their medical product is reasonable and necessary based on the best available clinical data, but CMS wants to be able to monitor ongoing evidence of effectiveness of the therapy.

In March, CMS issued reimbursement coding and claims guidance to its regional contractors for the use of AutoloGel in chronic non-healing wounds. This was an important milestone. The assignment of a healthcare common procedure coding system code, establishes the reimbursement mechanism for physicians and other providers submit claims for services provided to Medicare beneficiaries.

Receipt of the HCPCS code along with the protocol approval, we received under the Coverage with Evidence Development program brings up closer to the realization of the commercial reimbursement for AutoloGel. The new HCPCS code G-0460 is a temporary code that will be used to process claims for reimbursement of the products and service provided. In addition to the code, Medicare claims related to AutoloGel will include an identification number specific to AutoloGel and the appropriate protocol.

Under the reimbursement coding and claims payments instructions. Medicare contractors will pay claims for services provided in the number of settings including hospital outpatient department, skilled nursing facilities, rural health clinics, comprehensive outpatient rehabilitation facilities, federally qualified health centers and critical access hospitals.

We expect to begin treating Medicare beneficiaries with AutoloGel shortly and we will begin recording revenues concurrence with the July 1st, implementation date for the coverage. We are of course, pleased with these developments and our productive interactions with CMS will continue to engage in ongoing discussions with CMS regarding CED and the related guidance they publish and we will provide you with updates as appropriate.

Our conversations with potential partners for AutoloGel continue. Those conversations are moving forward and while we have nothing definitive to announce at this time. We can tell you that, the potential partners we have been talking with over the past months remain interested and enthusiastic. Based on their continued interest and our discussions, we are very optimistic about the possibility of a partnership that builds value for shareholders.

Now before I get into our pipeline and other projects, we have going on. I’d like to provide you with some more detail regarding our financial results for the quarter. As I mentioned earlier, total revenues were $2.3 million in the three month ended March 31st, 2013. The majority of this was comprised of Angel and AutoloGel sales. There was a decrease of approximately $700,000 compared to the same period last year.

I would stress that this decrease was entirely due to license fee revenue of $1.3 million recognized in 2012, with respect to an option agreement with a top 20 global pharmaceutical company that we were in discussions with at that time. Product sales increased by 34% compared with the $1.7 million reported in the same period last year. Gross margins on product sales was 44%. This compares with 50% reported in the same period last year.

Sales on lower margin products, specifically Angel machines sold to international distributors, made up a more significant portion of the product mix. This is now surprising, given the need to establish a strong core and base of business in the international markets. This along with the medical device excise tax, which took effect in 2013 as a result of the Affordable Care Act, resulted in the decrease in gross margin on product sales.

Overall gross margin decreased to 45% from 72%. The $1.3 million license fee recorded in the first quarter of 2012 had no associated cost of revenue and was the primary reason for the higher gross margin in 2012. First quarter cash margins on product sales were 52%. Cash margins on disposable products in the quarter were 56%. Cash margin is a non-GAAP financial measure, most directly comparable to gross margin, but should not be considered as an alternative to the GAAP accounting measure.

Cytomedix defines cash margin as gross margin exclusive of patent amortization and depreciation expense, and it is a significant performance metric used by management to indicate cash profitability on product sales. Research & development expenses were $900,000, an increase of $544,000 or 152% year-over-year. This increase was primarily due to research and development cost related to the ALD-401 Phase II clinical trial.

Selling, general and administrative expenses were $5.1 million during the quarter, an increase of 14% over the $4.5 million reported in the same quarter in 2012. It is worth noting, that there was a one-time $1 million non-cash charge included in this quarter’s SG&A expenses. Due to the modifications in terms of the contingent Aldagen acquisition consideration. After this charge, year-over-year, SG&A expenses were lower.

In total, operating expenses in the quarter were $6 million, an increase of $1.2 million or 24% compared to the same period in 2012. Net other expenses in the quarter decreased by $1.7 million or 83% to $330,000 compared to the first quarter last year. The decrease was primarily due to approximately $1.5 million recorded in 2012 related to a non-cash inducement expenses associated with common stock issued to Series D preferred stockholders as well as a $413,000 positive non-cash change in the fair value of the derivative liabilities.

The company recorded net loss of $5.3 million or $0.05 per share in the three month period ended March 31, 2013. Compared to a net loss of $4.7 million or $0.07 per share in the comparable period in 2012. At March 31, 2013 we had approximately $7.2 million. In February, we strengthened our balance sheet by entering into several financing transactions providing up to an aggregate of $27.5 million in capital.

These included at equity raise, a tranched senior secured term loan facility and a committed equity facility. We received approximately $9.5 million in gross proceeds with commitments for up to an additional $18 million. This capital effusion provides us with a necessary capital to fund our priority activities in 2013, which includes the launch of AutoloGel under CED, sales expansion for the Angel cPRP system. RECOVER-Stroke Trial, clinical trial activities as well as business developments and partnering activities.

Now I’d like to take a minute, to address the recently issued special shareholders meeting proxy statement. The company with (inaudible) from our board financial advisors, has decided to ask our shareholders to authorize a reverse stock split that can only be executed in connection with an uplifting to a major trading exchange such as NASDAQ.

Cytomedix currently meet all of the requirement for such an uplifting with the exception of our stock price. The purpose of the proposal (inaudible) will be to raise the per share trading price of Cytomedix’s common stock, to meet the requirement for listing on the NASDAQ capital market exchange. We feel strongly that increasing our price per share, decrease in the number of common shares outstanding and uplifting to a major exchange will likely make the company more attractive to potential new investors and strategic partners.

In fact, we have received direct feedback from a number of key institutional investors, who have expressed interest in becoming shareholder, who are currently unable to invest in CMXI because we trade and over-the-counter basis. And uplifting to NASDAQ will eliminate that barrier. While this spilt, is over to curve would not change the underlying value of Cytomedix. It would permit us additional flexibility in seeking funding and as I just mentioned, would allow some key investors in the by-side to consider adding CMXI to their holdings.

Ultimately, management and the board are dedicated to growing shareholder value, and their proposed reverse split is one of the options that we are considering to achieve that goal. This action requires a shareholder vote. We look forward addressing it in annual shareholder meeting at the end of this month. Now turning to our pipeline, our bright cell technology pipeline continues to make progress.

We have two phase, two studies ongoing. The first is the RECOVER-Stroke Trial designed to treat ischemic stroke. It is a 100 patient double-blind sham control study. We are now in the open enrollment period and have randomized the first 30 patients. We expect to have to top-line data released in the first half of 2014. 10 clinical sites are now up and running and the queue up sites working to get into the study is active.

We expect 15 or more sites to be enrolling patients before long, but the first 30 patients randomized. We are preparing documentation for the scheduled DSMB review and expect the results shortly. The PACE study is an 80 patient double-blind placebo control clinical trial designed to look at the safety and efficacy of ALD-301 in peripheral arterial disease. Specifically patients diagnosed with intermittent claudication.

This is the first ever randomized clinical trial look at the benefit of autologous stem cell therapy in this indication. The clinical study has received investigational new drug approval from the FDA and is expected to begin enrollment this quarter, upon the investigational review broad approvals from the participating centers. The study is fully funded by NIH and will be conducted by the Cardiovascular Cell Therapy Research Network, the CCTRN.

So there will be very little out-of-pocket cost for Cytomedix aside from what we will incur in manufacturing the therapy. Duke University and Medical Center is also conducting a Phase I clinical study with ALD-451 and patients that have been treated for Glioblastoma, brain cancer. This open label study will enroll up to 12 patients and is intended to demonstrate the feasibility and safety of ALD-451 when administered intravenously and patients with grade IV Malignant glioma following surgery, radiation therapy and chemotherapy.

One patient has been enrolled to-date in this study. In closing, the first quarter of 2013 was a period of strong growth and exciting milestones. Our products continued to well received and our pipeline is on track. With the recent financing transactions, we are confident that the company has sufficient cash with the near term and we remain excited and optimistic about the future.

Before we take questions, I’d like to take just a minute to address some of the questions that I have been getting from investors that have been calling lately. First of all, with respect to the reverse split. We understand clearly, the concerns about our reverse split. We’ve seen the data that demonstrates when a reverse split is done defensively, it can lead to lower value in the company that evaluation loss can be 25% even 30%, but again that’s when it’s done from a position of weakness and done defensively such as to maintain a listing on a major exchange.

If you look at the data that demonstrates, what happens when a company does a reverse split strategically? For instance to gain an uplifting, most often and most company who gain value, anywhere from 5% to 10%. Our plan is to facilitate a reverse split, only in the context of doing, of completing an uplifting to NASDAQ. We meet all other requirements for that uplifting, in every way except the share price.

In addition, we expect to have additional milestones that we’ll meet this yet, that will also support our valuation and continue to increase shareholder value. Now I’d like to point out that we requested from our shareholders last year, the same authority to do a reverse split under specific strategic conditions. Now those conditions were not met last year and being responsible in very strategic and the way we make these decisions, we chose not to implement that reverse split.

This year, we are asking for the same authorization from our shareholders to conduct a reverse split, only in the context that they said of an uplifting NASDAQ. This is a strategic move and based on the data that we reviewed, this is a move that should increase value for the company, by allowing additional shareholders to invest, increasing our liquidity and driving that value.

The other question that I’ve been getting frequently has to do with the partnership discussions that we have going on. And that question is, are we talking to the same potential partners today that we were talking with at the end of last year. Certainly the concern there is, that the partners have been coming and going and we are talking to an entirely different group today. That is absolutely not the case, these discussions take time. The companies have to get comfortable with one another, the potential partner has to get comfortable with our systems, our quality systems, the quality of our product, our ability to scale and so forth.

The potential partner, that we are talking with today, are the same partners that we’ve been talking with, they continue to be enthusiastic and excited about the opportunity. So I just wanted to make sure, that was clear. With that operator, we are ready to take questions.

Question-and-Answer Session


(OPERATOR INSTRUCTIONS) Your first question comes from the line of Jason Napodano with Zacks. Please proceed.

Jason Napodano – Zacks Investment Research

Hi, guys.

Marty Rosendale

Good morning.

Jason Napodano – Zacks Investment Research

Just housekeeping question, real quick. I’m going over the queue right now and I’m looking for the breakout in sales between Angel and AutoloGel, can you provide that?

Marty Rosendale

Well Angel, I don’t have the precise numbers in front of me Jason. So I’ll be general and we can be more explicit later when we follow-up, but Angel continues to be our number one revenue driving product, right. So Angel sales are for the quarter represents somewhere on the order of 90% of our overall sales.

Jason Napodano – Zacks Investment Research

Okay, I want to talk a little bit about RECOVER-Stroke. You’re at 30 patients now and I think that’s an improvements from I think, you were in the mid 20s last call. So I want to talk about the two things, with respect RECOVER. The timing of the dose and the method of administration. You guys are out there 13 to 19 days or so after the events. So we’re beyond that sub-acute phase where other companies like let’s say Athersys or NeoStem are targeting patients.

Going after, things like immunomodulation and neuroregeneration, where you guys are more focusing at that post sub-acute phase. So I’m wondering, can you talk a little bit about the mechanism of action for ALDH Bright Cells and why it makes sense for dosing something like those cells, after the sub-acute phase has passed and you’re kind of in that next phase of recovery?

Marty Rosendale

Sure. Jason, there’s a couple of reasons for the reason that we do that. First of all, when a patient suffer an ischemic stroke, there is a period of inflammation in nearly following the stroke that tend lead to further damage of the neural tissue. One of our objectives is to, dose a patient with bright cells after that period of inflammation has subsided. We want the patient to be stable, also what happens early in the stages post-stroke.

The patient’s condition is very dynamic, some patients get better, some patients get worse, but the condition is very dynamic. So from a clinical perspective, we want to dose the patient after the period of inflammation because we want that additional damage if you will to have subsided. We don’t want the inflammation to be ongoing because it could damage the cell that we are dosing the patient with as well.

And then also because of that dynamic change in conditions in the first few days, that can be found the results of our clinical trial. So that’s the – additional I would characterize non-clinical reason for dosing any patients two weeks, post-stroke. The mechanism of action of any cellular product is complex. There are multiple mechanisms of actions. We’ve demonstrated in our preclinical, animal studies that these cells are capable of angiogenesis, the production of new blood vessels that these cells release signal molecules, other proteins that can mobilize additional cells to the side of injury.

They can facilitate neurogenesis, there’s a number of things that these cells are doing, once they get to the side of the injury. So our objective here is to, basically repair the patients cognitive disorder if you will, allow the patient to regain enough neuro function to care for themselves following stroke. So it’s not our objective to prevent further damage by relieving the inflammatory condition post-stroke, but it is our belief that with these cells, we can improve the patient’s neuro condition because of the multiple mechanisms actions or the paracrine effect of these cells on application.

Jason Napodano – Zacks Investment Research

With respect to that, I don’t know how it’s going to play out in the market, but would it be possible for a patient to have two different cell therapies for stroke, they come into the hospital with a stroke, maybe they tPA, a day or two later, maybe they get something like Athersys, MultiStem and then week or two later, they get something like ALD-401, is that possible or is there kind of contract indications that would prohibit something like that?

Marty Rosendale

Well, I’m not familiar with any contraindications that would prohibit it. If its shown that, in fact the Athersys product is effective in those first few days, post-stroke at least in preventing further damage. And then Bright Cells can further facilitate repair then that scenario of receiving two different cell therapies at different time points is certainly possible and potentially practical, but that’s conjecture, right? There’s been no attempt to do that and that would take some research to demonstrate.

Jason Napodano – Zacks Investment Research

Okay and with respect to the preclinical data, the animal data that you guys have in STROKE. It’s impressive the data, but I wonder animals don’t have to consign consent forms. And so I wonder, if doing the bone marrow aspiration on a patient that just had a stroke two weeks ago, and then doing the intra-carotidal infusion is maybe limiting enrollment in the trial because patients just don’t want to either go through that kind of procedures or physicians feel like it’s too risky to put a patient that just had a stroke through those two procedures, the bone marrow aspiration and then the intra-carotidal infusion.

Marty Rosendale

Sure. So a couple of things Jason. First of all you can imagine, we are paying a lot of attention to the enrollment of this study because it has been going slower than we originally anticipated. A number of things that we believe have said into that, first of all. You’re aware from previous conference calls that we have made some protocol amendments to that, are having in effect and now all been rolled out.

In addition, we have seen because of the complexity that you describe. The requirement for bone marrow aspiration the fact that it needs to be couriered back to our facility process and sent back to the patient and as well as complexities and making sure that the sham process is appropriately controlled. There is been some, call it trepidation on the part of sites. What we find is, that once a site treats the patient or enroll the patient, that they become much more comfortable with the overall process.

And that initial concern about some of that complexities in the nature of the study. So once a site has treated a patient, they become much more comfortable with it realizes that it’s not as complicated as it might seen and then we begin to see better screening, more screening and more patients being enrolled. We now have, all of the 10 sites that we have up and running. We have now screen and enrolled patients, so that’s one of the things that gives us confidence that the screening and the enrollment will continue to increase.

And just looking forward, based on the screening logs and the feedback from the sites. It looks like we may enroll many as three patients just next week. So that the continued enthusiasm from the sites, the queue up sites waiting to get in, give us confidence that we will get the study enrolled completely in a reasonable amount of time.

Jason Napodano – Zacks Investment Research

Okay, let me just move to AutoloGel, real quick. You talked about the new, the t- codes, the temporary codes that have been issued by CMS and will go effective either in June or July. Are you seeing any increase from the private insurance companies, the private payers? I mean, one of things here that we talked about previous calls was that CMS was gatekeeper for some private insurances and that they were going to follow CMS’s lead in terms of improving in coverage.

So I’m wondering, I guess two things. Awareness by private insurance companies for the CMS decision and then whether or not private insurance companies are now starting to increase coverage for AutoloGel based on that CMS decision.

Marty Rosendale

So again a couple of things in my response here. First of all, this is a very public process, all of the guidance and guidelines that CMS puts out are very public and I can assure you that, private insurers monitor those public communications very closely. So there is awareness with the private insurers. Our focus has to been to make sure that, CED gets to kicked off and is established and working properly before we go to those private payers.

Again 67% of these patients are Medicare beneficiaries, so they represent the line share of the market, and that is our current focus. Now we will be going out and meeting with those private payers as soon as we’ve established contact with the regional MACs, the Medicare Administrative Contractors and ensure that all of that system is up running properly and moving forward smoothly.

Just kind of on a side note by the way, this is a great interest for CMS that this work well and worked properly and to that end. We’ve got another meeting schedule with CMS just to get some clarifications and clarity on the guidelines that have gone out, to ensure that the coding is going to work properly, that all the systems are in place. And CMS has been welcoming these meetings.

This is not been difficult to get the meetings in fact, in fact CMS the Coverage and Analysis Group had access to make this contact to reach out and to facilitate this meeting. So I feel very good about our relationship with CMS and this process going forward. It is the U.S. Government, there are a lot of distractions with the government these days given fiscal issues that we have, but they’re staying very focused on this particular project in this topic. So well, it takes a bit of time to make sure that everything is properly in place and running smoothly. We will have that done before the July 1st, implementation date.

I do expect to be treating patients before that implementation date, Medicare patient that is of course, we are already treating patients, but Medicare patients that is in June, before the July 1st implementation date. We will then have claims going in for processing as soon as the first day, July 1st and then would expect to see results of those claims a month or so afterwards.

Jason Napodano – Zacks Investment Research

Okay, last questions guys. In terms of the discussions you’re having with Angel in Greece, in orthopedics are you talking specifically for international distribution or these discussions for U.S. distribution?

Marty Rosendale

Worldwide, in most cases. Remember we got our BMA processing indications in November that gives us access to the surgical suite essentially with the Angel system. Our presence is in the clinic, in the doctor’s office, sports medicine and so forth. That’s where we’ve seen the most growth with blood processing in the use of concentrated PRP. So BMA indication, gives us that additional access, the companies that we’re talking to have a very strong presence in those surgical market places and so what we are talking with them about is orthopedics specifically.

And with one company would be a worldwide situation with a couple of others that we are talking with would be a domestic U.S. agreement.

Jason Napodano – Zacks Investment Research

Thanks for the answering questions, guys.

Marty Rosendale

Great, thank you.


(OPERATOR INSTRUCTIONS) Your next question comes from the line of Ren Benjamin with Burrill & Company. Please proceed.

Marty Rosendale

Good morning Ren.

Ren Benjamin – Burrill & Company

Good morning, thanks for taking the questions.

Marty Rosendale


Ren Benjamin – Burrill & Company

Just I guess a couple, could you give us a little bit of breakdown Marty on international versus domestic sales. You’d mention that international sales are increasing quite nicely, can you give us any sort of sense there?

Marty Rosendale

Sure, when we first acquired Angel in 2010 and the product was doing about $4.4 million in sales, about 10% of that was international. Today of the $8 million or so, our run rate in sales actually approaching $9 million now for Angel. I would estimate that about 17% is international, giving you sense for how quick the international business has been growing and one of the things that’s different about the international business, by the way which is why you hear me refer to the effect on our margins, on these calls is that.

We sell the devices to distributors and the margins on those sales because our profitability, our profit is in the disposables, the margin on those device sale is lower than our other margins, but it’s important for us to establish that base, to get those devices in the market place and then build on that with disposable sales.

Ren Benjamin – Burrill & Company

Okay, so thanks for that clarity because that brings me to another question regarding the margins. How should we be thinking about it, going forward and I guess what I’m trying to get at is, maybe a sense as to when that inflection point might occur when you feel like you’ve satisfied and gotten enough of a base and disposables will start taking over and contributing to gross margin number?

Marty Rosendale

Good question, I anticipate that throughout the remainder of this year, we focus on continuing to grow that dates internationally and so, where you see a positive impact on margins. You’ll see a bit of that because as the devices get placed for once we’ve placed already has become established and those customers begin growing their business essentially. We will see the increase in disposals and increase in margins as a result build slowly across this year as well, but probably there’ll be 2014 before we see the inflection point that you’re referring to, I believe.

Ren Benjamin – Burrill & Company

Okay, any sort of guidance you could prepare or provide us for 2013, especially given that I guess in the second-half is really where the reimbursement I guess will tick-in and start taking place?

Marty Rosendale

Right, so you’re right. We expect AutoloGel to be playing a much more meaningful role in our top-line sales towards the second-half of this year. The guidance that I provided is not specific financial guidance, but what I have said is last year, we treated approximately 300 patients with AutoloGel. This year, I anticipate that we will treat about a 1,000 patients with AutoloGel. And again as you pointed out, the majority of that will be in the back half of the year, once the coverage and payment has been established.

Ren Benjamin – Burrill & Company

Okay, just switching gears real quick to the partnership talks. Can you give us, you probably don’t want to give us a sense as to timing, whether this could happen, whether a partnership to be signed this year. Although, I’d assume that this year is probably still in the still your goal, but could you give us any sort of color as to where you might be in the strategic discussions, have terms sheets been discussed, have or is it still pretty early and CDA’s have been signed and due diligence are still being conducted.

Marty Rosendale

Sure, I can give you some clarity on that as you could imagine given the last time, we were in significant discussions and because we received a large fee for auction agreement had to go public with more details, the impact with that around on raising our share price and our share price falling, afterward been very sensitive to this, but I can tell you that the discussions.

We have a number of discussions ongoing and they’re at different stages. In some, we are pushing term sheets back and forth. And others were still in the early diligence process, so we are at different stages. As far as we’re likely to get something done this year, that’s certainly my expectation.

Ren Benjamin – Burrill & Company

Okay and I guess is following up on Jason’s question. You’re at these various stages, but what would be ideal deal be for you, is it more –you’d like to offload the entire asset and have worldwide sales conducted by the partner or would you prefer to have more strategic sales being conducted by partners in various geographies?

Marty Rosendale

While keeping in mind, that we have two commercial products, right. And we are relatively small company. What ideally, what I’d like to see is a, how do I want to describe it? A deal with one of the products, where the partners does most of the heavy lifting, right? And then what I’d like to see, with the other technology, with the other product is a partnership which would be some form of a co-marketing or co-distribution arrangement. Well, we’ve got some help, some resources helping us push it forward, but we are the strategy and promotion drivers in that arrangement.

Ren Benjamin – Burrill & Company

Got it. Okay, thank you for that color. Just switching real quick to the pipeline, when we talk about recovering in PACE. Can you just remind me, if they’re interim analysis or some sort of stopping rules that are set for both trials, so that a significant expenditure of resources are not committed, until the very end of the trial or is it something you’re fully committed to get till the end and un-blind and see, what happens?

Marty Rosendale

So there are no interim analyses planned except for safety. We’ve with the RECOVER Trial we have the safety review with the DSMB, we’ve 30 patients and that 60 patients. So there’s no futility analysis or interim analysis that has planned for either study. Now keeping mind the PACE study is being funded by the NIH. So there’s very little out-of-pocket expense for us on that one. And the RECOVER-Stroke Trial would expect to take it to its fruition.

Ren Benjamin – Burrill & Company

Got it. I guess one final question regarding the rationale for glioblastoma. Can you just remind us, why would you even be evaluating these types of cells and that cancer indication?

Marty Rosendale

Sure, it’s not really the cancer indication that the cells are being evaluated for, these patients have undergone, they’ve already undergone their therapy. They’ve already undergone brain surgery to remove the tumor. They’ve undergone the radiation therapy and chemotherapy to kill any remaining cancerous cells and prevent the reoccurrence, but because the cancer itself and the treatments results in brain damage, neural damage and cognitive disorders.

Based on the same preclinical work that we’ve done, demonstrating the potential for this technology in Stroke. We are looking to improve those cognitive disorders in these patients after treatment.

Ren Benjamin – Burrill & Company

Got it, terrific. Thank you very much and good luck.

Marty Rosendale

Thank you Ren.


Your next question comes from the line of Scott Pittman [ph] with Dalton [ph]. Please proceed.

Marty Rosendale

Good morning Scott.

Scott Pittman – Dalton

Good morning Marty. I’ll weighted slopes throughout the 1% shareholder. One of the things that I continue to monitor if your competitors and more specifically not any competitor in particular, although there is, my interest lies in the fact that the PRP, the AutoloGel product emerges on the market as a replaced technology, that wanted to improve wound care and particularly (inaudible) against holographs and the vacuum-assisted devices.

Now we see emerging on the market, it’s clearly. There seems to be a superior replacement to the Dermagraft and Apligraf products for the holographs.

Marty Rosendale


Scott Pittman – Dalton

And that’s the amniotic membrane Purefix [ph] and Epafix [ph] and I’m wondering, to what extent have you guys done an analysis of these replaced products as a threat to displacing your product AutoloGel, does that make sense?

Marty Rosendale

It does make sense Scott. So of course, we monitor competition and potential competition all the time, right so. We are all even analyzing new things. Couple of interesting points. Even with the sudden growth of the amniotic membrane products. If you look at the decline particularly in Dermagraft. What you’re going to see is that, there’s been no growth in the overall size of the skin substitute market.

It’s just been shift of market share between products, but I think it is an interesting phenomenon. With respect to AutoloGel and a number of things here. First of all, the skin substitute marketplace which includes the newer products the amniotic membrane, is a more mature product membrane [ph] reimbursement is better established and that’s what proven some of that growth in the past and it’s part of what’s driving the shift between Dermagraft to the amniotic membrane products.

Interestingly, we’ve looked for good clinical data support in the use of amniotic membrane’s and we don’t find, we can’t find it. So it’s a very difficult for us to compare clinical effectiveness between the products because that evidence isn’t there. We simply can’t find good published evidence for that product. We expect – I expect the AutoloGel system, now that we’ve got reimbursement. We are going to be in much more meaningful player in that marketplace.

And interestingly enough, we have data that demonstrates superior performance when you add AutoloGel to some of these skin substitutes. So we think, there’s an opportunity to work with some of those products as well.

Scott Pittman – Dalton

Very good, thank you for your answer.

Marty Rosendale

My pleasure Scott. Thank you.


We have no further questions at this time. I will now turn the call over to Marty Rosendale for any closing remarks.

Marty Rosendale

Thank you, operator. And thank you everyone as always I appreciate your interest and your support and I look forward to speaking to you again, next quarter.


Thank you for your participation in today’s conference. This concludes the presentation, everyone may now disconnect and have a great day.

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