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Executives

Thornton Kuntz – VP, Human Resources and Administration

Pete Petit – Chairman and CEO

William Taylor – President and COO

Michael Senken – CFO

Analysts

Matthew Hewitt – Craig Hallum

Bruce Jackson – Lake Street Capital Markets

William Plovanic – Canaccord Genuity

Matthew Hewitt – Craig-Hallum

Jonathan Block – Stifel Nicolaus

Troy Welker - IPT

MiMedx Group, Inc. (MDXG) Q3 2013 Earnings Call October 30, 2013 10:30 AM ET

Operator

Good day, ladies and gentlemen and welcome to the MiMedx Group Inc. Third Quarter Earnings Release Conference Call. My name is Erica and I will 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].

I’d now like to turn the call over to Thornton Kuntz, VP of Human Resources and Administration. Please proceed.

Thornton Kuntz

Thank you, Erica and good morning everyone. This presentation contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These statements are based upon the current beliefs and expectations of our management and are subject to risks and uncertainties. Actual results may differ materially from those set forth in, contemplated by, or underlying forward-looking statements based on factors described in the conference call and in our reports filed with the Securities and Exchange Commission including our Form 10-K for the year-ended December 31, 2012 and our most recent 10-Q. We do not undertake to update or revise any forward-looking statements, except as may be required by the company’s disclosure obligations in filings it makes with the Securities and Exchange Commission under Federal Securities laws.

With that, I’ll turn the call over to Pete Petit, MiMedx’s Chairman and CEO.

Pete Petit

Thank you, Thorn. Welcome and thank you for joining us for our third quarter of 2013 conference call. I have with me today Bill Taylor, our President and Chief Operating Officer; and Mike Senken, our Senior Vice President and Chief Financial Officer. There are other corporate officers present. We’ve had another great productive and very active quarter filled with a number of issues. We exceeded the upper end of our revenue forecast, which put us at eighth consecutive quarters of meeting or exceeding our revenue guidance goals, and we’ve produced increased EBITDA as a result. One area that should be of interest is the fact that the centers for Medicare and Medicaid services or CMS announced in July of this year that they were proposing changes to the way skin substitutes are reimbursed. This is how EpiFix, our wound allograft is reimbursed.

At the 2014 hospital outpatient perspective payment system, which is called OPPS, proposed a rule which covers hospital outpatient ambulatory surgical center reimbursement, CMS recommended bundling or as they call it “packaging” the products used in advanced wound care into one reimbursement code. CMS noted that it was seeking to promote efficiency in delivery of healthcare services and long-term cost containment. This basically means that that one fee would include fees associated with doctor’s activities as well as cost of the graft. We’re in agreement philosophically with CMS making this change in reimbursement. There’s been so much waste associated with skin substitutes used of advanced wound care healing that we think CMS was compelled to recommend making these changes.

Our two major competitors, Apligraf which is manufactured of Organogenesis and Dermagraft which is manufactured by Shire Pharmaceuticals had major waste factors associated with use of the grafts. Each of these products is offered in only one size, 37.5 sq.cm for Dermagraft and 44 sq. cm for Apligraf. There are numerous medical publications that highlight the fact that diabetic foot ulcers have a medium size of approximately 1.3 sq. cm and venous leg ulcers have a medium 2.3 sq. cm. With their grafts that are 15 to 20 times larger than most wounds, the remainder of the graft is discarded since this is a single-use product only. Thus massive wastage that probably averages 80% of graft is discarded.

We’ve analyzed the substantial amount of CMS data, and we estimate that there is over $100 million of CMS reimbursed dollars per year for product being discarded from these two products alone, plus there is waste at the Veterans Administration in Medicaid and in private health plans. Therefore, reimbursement changes must occur. On the other hand, MiMedx has been extremely cost effective because our grafts come in size appropriate grafts. We have a number of grafts available and they range in size from 1.5 sq. cm on up. There is very little wastage associated with our grafts, and this is one of the primary reasons they have been so widely and quickly accepted. On the “packaging” proposal, physicians will be motivated to use most cost effective grafts, so we believe the proposed change will enable us to increase our market share.

In addition, our graphs have shown to be significantly more clinically effective than the Apligraf and Dermagraft products. Comparing publications associated with clinical results of those two products and publications on EpiFix, we’re showing healing rates of 40% to 60% higher than those products. Also, we’ve been quite busy in Washington meeting with Senators and Congressmen and encouraged them to support the CMS reimbursement change on skin substitutes. Of course, Shire and Organogenesis have been busy opposing the proposed change. We expect a decision from CMS on this matter by November 27.

Although, there are many possible outcomes to this initiative, we feel that two are the most likely. First, CMS could decide to postpone this imitative, but we sincerely believe because the massive wastage that has been occurring on certain of these tissue substitutes that they will eventually make these types of changes. If it is postponed, reimbursement will continue as it has been, and we will expect to continue to gain market share because of the cost effectiveness and clinical effectiveness of our allografts. A second possibility if CMS decides to make the change to either single or multiple bundles effective January 1, if this is the case this will significantly disadvantage Dermagraft and Organogenesis products due to their single large size.

Another topic of interest is our FDA meeting. I believe this meeting was enlightening to us as well as to the FDA staff. I believe the scientific information and the clinical information that we provided was enlightening because some members of the clinical staff stated that was the case. They stated that they’d take our new data into account and get back to us quickly with their comments. What we would like to make clear is that the company has numerous ways to resolve any FDA issues of this nature. We are very experienced and [competent] (ph) consultants as well as staff experience in this area which will allow us to make very quick decisions depending on FDA’s determination.

We think there are numerous precedents for our micronized products to remain on the market. There are certainly no safety issues associated with this product, since we shipped over 18,000 micronized units without any reported adverse reactions. We shipped over 170,000 of our allografts with the same results. We have one peer reviewed publication on our randomized controlled trial with EpiFix micronized being used for plantar fasciitis. Thus, we have a number of alternatives which allows us to continue with tough markets with these micronized products. Either way, we hope to resolve this matter quickly.

I’d like to mention one other successful project was completed in the third quarter. That was the distribution agreement that was signed with Medtronic. As you well know, Medtronic is the largest medical device manufacturer in the world. As such, they select their partners very carefully. We spent over a year working with Medtronic as they evaluated our allografts and our corporation. It’s very exciting to have Medtronic show their strong interest in our allografts. As you might know, Medtronic commands almost 40% of the spinal device market in the U.S., and our allografts will eventually be utilized in some of those procedures.

Also, Medtronic offers us potential international distribution, which is an area where we have very few initiatives. We are looking forward to our strong relationship with Medtronic on our new product additions in these new areas. It’s been an extremely busy period for executives as we dealt with numerous strategic matters. These involve including our relationship with the Veterans Administration, with CMS, and now with Food and Drug Administration. Even with all those strategic activities, our management brought our quarter in ahead of expectations. Surely congratulations for all of our staff and management.

Let me pass the meeting over to Bill Taylor now. Bill?

William Taylor

Thanks, Pete. From a sales and operational perspective, as Pete said, we consider this past quarter a very strong success. I would also like to thank and congratulate our entire organization for staying focused on our customers, and the patience that they have served considering all of the distractions. Our PURION process tissue is a remarkable product that helps people every day, and in many cases has changed lives. Even with the significant distractions related with the [untitled] (ph) letter, our organization was able to exceed the upper end of the guidance. Put that into perspective, our Q3 revenue was just a few hundred thousand dollars less than our first nine months of last year, so it’s a very strong performance. Mike Senken will discuss the revenue breakdown in more detail, but I want to highlight that a large percentage of our growth came in the commercial wound care side of the business as we expected.

Our reimbursement team is growing and has been very successful in obtaining more widespread coverage for our tissue. We have a long way to go, but are making progress every day. Also, you’ll note that our gross margins this past quarter came up a bit. We had several factors combined for that improvement including some favorable mix, but we expect that the next few quarters will likely be somewhere in between the second and third quarter actuals. Regarding our building move, the facility improvements are concluded and our clean room validations are essentially complete. We’ll migrate our processing in stages over the new building over time as we mentioned previously. As you can imagine, recent issues have understandably taken a good deal of management’s attention, and a move like this is a big endeavor, so we expect to finish this move over this coming quarter.

On the publication front, our success has continued with the acceptance of another two EpiFix publications, this time in JAPMA, which is the Journal of American Podiatric Medical Association by Dr. Alap Shah and another one in wound medicine. The second is a long-term follow-up study from our first EpiFix RCT and crossover study with principal investigator Dr. Charles Zelen. The bottom line is that nine to 12 months after the treatment with EpiFix, 94.4% of the wounds remained fully healed, basically only one out of 18 had recurred or 5.6%. This is significant because it had been published that typical rates at the one-year mark are upwards of 35% recurrence, and about 60% recurrence after three years. A recurrence rate of less than 6% in nine to 12 months is an excellent outcome. This paper was also subject to a poster presented at SAWC, The Symposium on Advanced Wound Care, and won best in show for its class.

Now turning over to our sales force. We continued to expand our sales force over this past quarter, and we increased from 56 executives at the end of Q2 up to 66, so from 56 to 66 at the end of Q3. We still expect to have between 70 and 80 people total at the end of this year and are targeting territories and candidates in new areas. We completed a mid-year sales meeting two weeks ago, and I continue to be impressed with the strength and professionalism of our sales executives. Entering this last quarter, we’ve repositioned and promoted several of our sales management team members to achieve better communication and efficiencies within the sales team. One notable change is that while we still have essentially two sales forces at the account executive level, one focusing on the Federal accounts and another on commercial wound care, we have combined the regional and national management teams. This has already led to streamlined communication and more efficient call patterns for the sales executives. We made this change on October 1. In this structure, we have a flexibility now to allow our federal team account executive to call on our few commercial accounts if it makes sense in a given territory and vice versa. So, over time, this group may merge into simply one overall sales force, but as of today, we still have two largely separate groups.

Pete described our activities with respect to the proposed CMS changes and our efforts to support the initiative. I’d like to highlight a few things about the chronic wound market, its size, and how our size appropriate grafts help reduce waste that has previously been associated with this category. First, let me walk you through how our size appropriate grafts are an advantage for us, and how that relates to the proposed CMS bundling change or packaging change. Since 50% of diabetic foot ulcers or DFUs are 1.35 cm or less as it was reported as the median in a recent publication, our small disc which is around $300 can be used with minimal of any waste. This was compared to the competitors who were up around $1,600 or $1,700, and waste the majority of their product for those 1.35 sq. cm or smaller wounds. The current proposed one tier bundling approach would pay around $874 per procedure, including the skin substitute. Clearly, this puts EpiFix in a favorable position for the 50% of smaller DFUs, especially when we take into consideration its healing rates. Also note that after analyzing the 2011 data, MiMedx has proposed for CMS to use instead of one bundling rate, four bundled payments based on wound size, so that the small percentage of very large wounds would be reimbursed with a higher bundled rate.

Now I’m sure many of you are wondering how this relates to our chronic wound market opportunity? First, I want to highlight how a very large amount of these wounds are treated with conventional therapy such as wound dressing that do not utilize advanced therapies, but they would, if they lower priced shelf stable product would be available like EpiFix. First of all, the chronic wound market in the U.S. is very large. It’s been reported that there are approximately 1 million patients suffering from DFUs, diabetic foot ulcers, in the United States annually, and just shy of 900,000 VLUs or venous leg ulcers in the U.S. annually. And accordingly also to a recent publication, the median wound size per DFUs as I mentioned is 1.35 sq. cm, and for VLUs it’s around 2.3 sq. cm. Now according to the same publication, 77% of all DFUs and 66% of all VLUs are less than 5 sq. cm. Now this means that when the two large skin substitute products Apligraf and Dermagraft are used, most of their product is thrown away in excess of 80% of it for those majority of wounds that are 5 sq.cm or less. That’s a major advantage for us.

Now there are several ways to model the EpiFix chronic wound market opportunity. I’ll take a very basic approach for DFUs first. If you look at the 1 million DFUs in the U.S. annually and then use the breakdown from the recent publication in the Journal of Wounds that came in July, according to that publication, 50% of these are 1.35 sq.cm or less, so they can be treated with our $300 disc. Assuming it takes 2.5 applications on average to close a wound, that would be 500,000 wounds times $300 per disc x2.5 applications which ends up being a $375 million addressable market. Then you take the next 27% of the wounds that are between 1.35 sq.cm and 5 sq.cm, and then you use our 2 x 3 graft or 6 sq. cm graft, assuming it needs three applications to close that wound, using on average 2 of the 2 x 3s and one disc, you will use the one disc on the third application because the wound gets smaller, that’s two EpiFix at $1,200 each and one at $300, x270,000 wounds which equates to about $730 million in market opportunity. Then next you take the 16% of the wounds that are between 5 sq. cm and 20 sq. cm.

Conservatively, assume that also it only takes three applications to close a wound, and it uses a combination of our 4 x 4s or 16 sq. cm grafts and our 2 x 3s over those three treatments. Those wounds will then drive another $1 billion in market opportunities, a little bit above that. So, that’s even without taking into consideration the wounds above 20 sq. cm. So the EpiFix specific opportunity in the DFU market alone is in excess of $2 billion, and knowing that the VLU prevalence rate is nearly as big as the DFU prevalence rate only with slightly larger wounds, then the combined total of the DFU and VLU market as expressed in terms of EpiFix, is in excess of $4 billion market opportunity. So, we only need to reach 2.5% of that total possible market of people with VLUs and DFUs, and we’ll hit our $100 million in revenue in EpiFix alone next year just by hitting that 2.5% of that addressable market. And I want to remind you that this does not even include other chronic wounds or any acute wounds, so this is a very, very large market.

Changing gears now, Pete already described our meeting with the FDA on Monday, and I want to add one little bit of color of my own. I would characterize the meeting as going essentially as expected, possibly little better considering that they seem open and receptive to the new information that we presented to them and indicated they would review it and determine if it affects their previous decision, so either it does or does not, if not, then we expect to proceed much like others have like Osiris and AxoGen among others.

Last, as Pete indicated, we’re very happy to have announced our new distribution agreement with Medtronic during the quarter. This agreement came after over a year’s worth of discussions, audits, and negotiations, and it was signed after the untitled letter was public. So to have the largest medical device company in the world to be interested in partnering with MiMedx is a true honor. The agreement is nonexclusive and focused on spinal applications. There will be a private label version of our AmnioFix numbering.

At this point, we expect to start shipments either late this quarter or early next quarter, and we don’t expect any impact on the rest of our distribution because this industry is very relationship focused, and generally speaking, our current distributors do not sell into physician relationships where Medtronic is strong. Also we expect Medtronic will conduct additional clinical and scientific studies, which will further describe the clinical and scientific benefits of our PURION Processed DHACM or Dehydrated Amnion/Chorion Membrane Tissue.

With that, I’ll turn it back over to Pete.

Pete Petit

Bill, thank you. Next Mike Senken, CFO. Mike?

Michael Senken

Thanks, Pete. The company reported revenues for the third quarter of approximately $16.1 million, an increase of 103% or $8.1 million over the prior year third quarter revenue of $8 million. Wound Care revenue represented 57%, surgical and sports medicine 38%, and other 5% of quarterly revenues. Sequential growth was driven primarily by wound care sales which were up 25%, while surgical and sports medicine revenue was up 10%. Commercial revenue grew to 42% of total revenue from 39% in the prior quarter due to the increase in number of direct sales resources targeting commercial accounts in territories where we have [MAC] (ph) coverage.

Revenue for the nine months ended September 30, 2013, increased 149% to approximately $41.2 million as compared to $16.5 million for the same period in 2012. Wound care revenue increased 258%, while surgical and sports medicine revenue increased 95% when compared to prior year. Sales to government accounts has increased almost 400% on a year-to-date basis, recognizing that we only began selling direct into government accounts in the third quarter of 2012. Sales to non-government accounts have increased over 40% on a year-to-date basis as well.

Gross margins for the quarter were 87% as compared to 82% in the third quarter of 2012. For the nine months ended September 30, 2013, gross margins were 85% compared to 79% for the nine months ended September 30, 2012. The improvement was driven by favorable product and customer mix. R&D expenses for the quarter were approximately $1.3 million or 8% of quarterly revenue, which represents an increase of 53% as compared to prior year.

On a year-to-date basis, R&D spending was approximately $3.5 million as compared to $1.8 million in 2012. The increase in R&D spending is driven primarily by increased investments in clinical trials. Selling, general, and administrative expense was approximately $12.7 million for the quarter and $31.9 million year-to-date. The increase in spending as compared to prior year is primarily due to the move to a direct sales force for the wound care market. As Bill mentioned earlier, the company added 10 new direct sales resources during the quarter.

The company reported positive adjusted EBITDA for the seventh consecutive quarter. Included in today’s press release is a supplemental disclosure that reconciles our reported net income to adjusted EBITDA. The company reported positive adjusted EBITDA of approximately $1.9 million for the quarter-ended September 30, 2013, which is a $1.1 million improvement as compared to an adjusted EBITDA of $726,000 in the third quarter of 2012. Year-to-date adjusted EBITDA more than doubled to approximately $4.1 million as compared to $2 million in 2012.

Year-over-year improvements in adjusted EBITDA is a result of higher sales volume and improved gross margins. The net loss for the quarter was approximately $307,000 as compared to the reported net loss of $4.2 million for the quarter-ended September 30, 2012. It should be noted that the 2012 quarterly net loss included $1.3 million in expense related to the Surgical Biologics acquisition earn out provision and also includes $1.8 million charge for the impairment of intangible assets. The net loss for the nine months ended September 30, 2013, was approximately $2.7 million or a loss of $0.03 per diluted common share as compared to a net loss of $6.1 million or $0.07 per diluted common share in 2012.

Turning now to the balance sheet. The company reported approximately $25.9 million in total current assets, an increase of approximately $7.8 million as compared to the $18.1 million as of December 31, 2012. The total asset amount includes approximately $6.1 million in cash which is an increase of approximately $1.9 million as compared to the June 30, 2013 balance of $4.2 million. The company reported $9.8 million in total liabilities, a decrease of $5.4 million as compared to the balance of the December 31, 2012 of $15.2 million. The reduction was primarily due to the payment of earn out and the conversion of the senior secured promissory notes earlier in the year offset by increases normal operating liabilities. Capital expenditures for the quarter were approximately $955,000, primarily related to the expansion of our production capacity, improvements to our IT infrastructure, and additional facility related costs.

Turning now to the statement of cash flow. For the first time in our history, the company reported positive cash flow from operating activities of approximately $1.7 million for the quarter. On a year-to-date basis, net cash used in operating activities was approximately $1.1 million, an improvement of $1.3 million as compared to the same period last year. Cash used in investing activities for the quarter included capital expenditures and patent application costs of approximately $1.1 million and on a year-to-date basis were $2.5 million. Cash flows from financing activities for the quarter were approximately $1.3 million, including almost $1 million from the exercise of stock options and $300,000 from the exercise of warrants. On a year-to-date basis, proceeds from the exercise of stock options and the exercise of warrants were approximately $865,000 and $5.9 million respectively. The company did not drop down on its working capital line of credit during the quarter.

Turning now to our cap table. There are approximately 97 million shares outstanding, 1.9 million warrants, and 15.1 million stock options outstanding as of September 30, 2013. And one final note, the company will be presenting at the Canaccord Genuity Medical Technologies and Diagnostics Forum Conference in New York City on Wednesday November the 13th. Please refer to the Investors’ section of our website to access the webcast of the conference.

With that, I will turn the call back over to Pete.

Pete Petit

Thank you, Mike. Well as you can tell, it’s been a very busy and productive quarter in spite of some distractions. In spite of our rapid growth, our management team is very effectively managing all of our new initiatives and process improvements. I’m very proud of this team and their results. They are quality professionals. With that, I’ll turn the call over to questions and answers.

Question-and-Answer Session

Operator

[Operator Instructions]. And your first question comes from the line of Matt Hewitt with Craig-Hallum Capital Group. Please proceed.

Matthew Hewitt – Craig Hallum

Congratulations gentlemen on a great quarter.

William Taylor

Thanks, Matt.

Pete Petit

Thank you, Matt.

Matthew Hewitt – Craig Hallum

Couple of questions. First, on the gross margin, 87% is remarkable. I’m curious how we should be thinking about that in Q4 and more specifically next year as you may see changes in the mix and as Medtronic comes on? I mean do you think that falls back closer to 80% or how should that shake out?

Pete Petit

Matt this is Pete. I’m going to let Mike address that, but just let me remind everybody that a year ago this quarter, we cautioned everybody about a rapid, rapid revenue growth, and we said that we are excited about what just happened, but it won’t continue to happen that way. Mike’s probably going to give you some of the same color on margins.

Michael Senken

Matt, I think on previous calls we said, we’re still putting our plans together for next year, but an assumption between 80% and 85% is a good assumption for 2014, and that’s really driven by product and customer mix keeping in mind that we haven’t started shipping on the Medtronic agreement. That is an OEM agreement, and obviously in an OEM agreement, the margins are slightly less than direct sales. So, I think 80% to 85% is a safe number.

Matthew Hewitt – Craig Hallum

All right. Thank you. Secondly, maybe an update on the reimbursement front you’re still at six out of the nine MACs. I’m curious how the dialog has been going with the remaining three, and then more importantly at least over the longer term, what are you hearing and how are you gaining reimbursement from the commercial providers? Any update there would be helpful.

Pete Petit

Okay, this is Pete. I spent a good bit of my time focused in this reimbursement area, mainly because I’ve lived with it for decades. We’re still having conversations with the three remaining MACs, some days I think we make progress, other days I think we don’t. We still have hopes of bringing some closer to some of those by the end of the year. However, keep in mind that right now we have 80% coverage across the country, so the three remaining MACs are not major deterrent to our -- beginning next year in a very positive way. Each of them is different, each of them has their own little issues that they want to discuss or hold out. There is a reason they haven’t given us coverage. They are some disruptions in terms of the MACs, there’s been some consolidations so there’s a lot of confusion out there. So, it is not the focus on that we’d like to see but we’re still working on it every day.

Generally speaking on health plans, I’ll say that as having been around as long as I have, this day’s environment reminds me a little better when managed care first started blossoming in the earlier 90s. There was a lot of confusion in the market, and health plans always take that opportunity not to throw switches or not to turn coverage on when they should. So we’re very busy, very focused within our people in this organization on being certain that we get our switches thrown in the health plans and our coverage is initiated in a reasonably good timeframe. We certainly have – we think all the clinical papers published that we should ordinarily need, and it’s just the case of working each health plan one by one each medical directive , and that’s all I think. As you know Mike – Donald Fetterolf our Chief Medical Officer has a lot of experience in this area, I do and a lot of our staff here that came from quality company does, and we’re very busy every day working on the what I call the reimbursement war. And it is a war, it’s skirmish here, it’s a battle there, but it’s a war that just gets fought tenaciously day by day and pretty soon those things are behind you.

William Taylor

Thank you and adding here too. Pete mentioned that there is a lot of changing with the different MACs, one case in point is that I think four, five days ago, one significant change happened where NHIC, which was kind of up in the Northeast got turned over and is part of one of the other one now, I’m just trying to remember which one it is part of – it’s WPS I think, that’s right, but they consolidate. So basically now there are eight MACs instead of nine now because of that consolidation. Excuse me, that moved to NGS, it is where it went to. So we still have, they will be the 80% covered lives, even though now it’s five out of eight instead of six out of nine, so there is really no change there, and we expect that there is going to be more and more changes as these systems continue to trade programs over time. In terms of the ones that we don’t have yet, we are making some progress with I think two out of the three, but this is very hard to project when we’ll be able to clear those as of now.

Matthew Hewitt – Craig Hallum

Okay. May be one more from me, and then I’ll jump back in the queue. As you look at your current -- look at the third quarter, what – I don’t know if there is a way for you to break out what percentage of those sales were coming from the DFU, VLU markets versus may be some of the newer markets whether it’d be the radical prostatectomies or the mole surgery? Is there a way to break out where you’re seeing a bulk of your business?

William Taylor

Well, I can tell you that in a lot of cases, we’ll have to rely on our tissue utilization records, which are the records that are submitted after implant to see what kind of procedure they are used on . Other than that, it’s tough for instance, if an EpiFix is out there and it is used either on a DFU or VLU or a mole surgery or a decubitus ulcer, really no way for us to know unless they report back on our [TUR] (ph) card. But we are trending that and hope to kind of factor that into some of our numbers going into next year, and maybe Mike can have another color on it too?

Michael Senken

Yeah, obviously Matt that was – those other procedures would be included in our surgical and sports medicine revenue that we gain some detail on here. But as Bill mentioned, we are finding and looking at the TUR cards, it’s actually a percentage of that surgical and sports medicine, which actually is accounted or should be accounted for in wound care, and we’re trying to figure out how to report on that on an ongoing basis, because we’re dealing with data that is after the fact, and we’re trying to relate it back. So, we’re still working on that.

Matthew Hewitt – Craig Hallum

All right. Fair enough. Thank you. I’ll jump back in the queue.

William Taylor

Thank you, Matt.

Operator

Your next question comes from the line of Bruce Jackson with Lake Street Capital. Please proceed.

Bruce Jackson – Lake Street Capital Markets

Hi Congratulations on a positive cash flow.

Pete Petit

We agree.

William Taylor

Thanks, Bruce.

Bruce Jackson – Lake Street Capital Markets

First on, to follow up on the sales force extension, were the 10 hires in the wound care commercial operations group?

William Taylor

Most of them were in that group, I think we had one or two that were in the Federal side, but the majority of them certainly were in the commercial side.

Bruce Jackson – Lake Street Capital Markets

And then going forward, will the next hires be distributed between the different groups or again focused primarily on the wound care side of it?

William Taylor

Certainly, the majority will we expect to be in the commercial wound care side, although there are a few pockets on the federal side that we still don’t have the coverage we’d like. So it will be a mix, but it will be heavily weighted on the commercial wound care side.

Bruce Jackson – Lake Street Capital Markets

Okay, great. And then with the Medtronic agreement, sometimes these OEM agreements can be somewhat lumpy in their ordering patterns, are there any like minimum sale agreements or anything in there or would the – should we fasten our seatbelts for a little bit of volatility on that particular revenue line item?

William Taylor

We were fortunate that we are able to kind of structure that in much the same way as our other distribution agreements. So, as you can imagine, any time we have a startup, there is generally going to be kind of a bolus order upfront, and then trail off and then start going up in a more linear fashion. So, I would expect for a situation like this for to be lumpy for a little while, but relative to any minimums or anything like that, I can’t really comment on those kind of details of the contract.

Bruce Jackson – Lake Street Capital Markets

Okay. Then, the last question with the inventory, I noticed it kind of ticked up a little bit, is that related to the move of the manufacturing facility? Did you just build up some safety stock or is it just an anticipation of greater sales?

William Taylor

It is really a mix of a couple things. We do expect that that’s going to be kind of the peak for the year and based on our planning now coming out of fourth quarter, we should have a nice trending down in terms of that, but we did have a fairly good build up in preparation for the move just to make sure there are no issues. Also, as you recall just going into the year, we knew we were going to growing wound care fast, but we didn’t exactly know how fast, so we wanted to make sure that we had sufficient inventory to cover that. So, I think going forward, you’ll see that number start to come down a little bit and be a little bit better in terms of our turns .

Bruce Jackson – Lake Street Capital Markets

Great. Thank you very much.

William Taylor

Thanks, Bruce.

Pete Petit

Thank you, Bruce.

Operator

Your next question comes from the line of Bill Plovanic with Canaccord. Please proceed.

William Plovanic – Canaccord Genuity

Great. Thank you. Good morning and congratulations on a good quarter.

William Taylor

Thanks, Bill.

William Plovanic – Canaccord Genuity

Just a couple of questions, first on as we look at guidance, I look at the range you’re providing for Q4 and I’m just trying to understand what would drive Q4 down sequentially from Q3?

Pete Petit

You stomped us.

William Taylor

Well, I guess if you’re saying if the lower end of our range is -- if we hit the lower end of our range which is 57.9, if I remember the numbers correctly, we commented 15.8 as opposed to 16.1, and that’s what you’re concerned about?

William Plovanic – Canaccord Genuity

That’s why I’m asking the question. What would drive towards the lower end rather than the higher end?

William Taylor

We just thought 57 million was a round number, we can round it up by 300,000 if you’d like Bill.

William Plovanic – Canaccord Genuity

Okay well I’m just asking, and then there was no comment regarding the 2014 guidance goals that have been out there earlier of 90 million to 110 million, I just want to see if there is anything you would like to provide there?

Pete Petit

Well, we still feel that the numbers that -- we will provide details on December after we have our December Board meeting when we always provide guidance for the next year, but management is still very comfortable with those set range and we haven’t changed it.

William Plovanic – Canaccord Genuity

Okay. And then you’ve had the meeting with the FDA, I think one of the comments was that -- and not to put words in your mouth, but that I think is both of you came away enlightened. And I guess my question for you is what was enlightening to you in that discussion?

Pete Petit

Well first of all, realize that was the first real communication that we’ve had with FDA staff other than one phone call and a fax and a couple of short phone calls in the meantime over the 60 days as we asked for additional information, which they decided they didn’t want to provide or didn’t need to provide, so the meeting itself was enlightening. We met some of the staff on the clinical side and some of the staff on the enforcement side, and we had I think shared a lot of information both ways, and particularly the clinicians seem to be – because they told us that the information we were providing was quite enlightening, and they would take that into account as they made deliberations as we asked them to do, to reconsider their letter. So, I think from our standpoint that was quite enlightening, and I think we understand I think the clinicians – the agency’s issues even if they haven’t really told us exactly what the specifics are.

We have some of the same concerns as they do in terms of the 361, can be loosely applied because it’s up to the corporation to make the determination and they have concerns about that as we do. We’ve seen some things happen with some of our competitors that were to us very blatant violations of 361, and we don’t want to see that happen, because we want to see -- as stewards of this technology, we want to see them marketing in an orderly way, so there is no question about the regulatory pathway and there is no questions about the way it’s being used and the claims being made about it. So, I think we’re very much aligned with the agency on matters of that nature, and we clearly conveyed that to them. We want to see this product, this whole area of amniotic tissue enter the market place and become a standard of care, and I think we’re well on our way, and we don’t want to see someone else cause issues that cause more regulatory issues or cause concern on anybody’s part whether it be physicians, patients, or regulatory agencies .

William Plovanic – Canaccord Genuity

Okay. And then is there a specific timeframe that FDA will get back to you post this meeting or will this be an ongoing, your discussion between FDA?

Pete Petit

Well, their commitment was to, the word was quickly and I can’t define that. I think it’s in their interest to get this moved along as it is in our interest, and if we have to work through some details we’ll do that from our part very quickly, so we are involved with this every day, and at this stage I think some of their staff is now. So, we had the meeting we needed to have and we exchanged information, and I think both staffs are very busy working on it.

William Plovanic – Canaccord Genuity

And last question is… I’m sorry.

Pete Petit

The only other thing I could add is I think Osiris, our competitors a week or so ago had a press release discussing their situation where they have had some issues brought to their attention where they were in violation of 361 and they apparently quickly resolved that. It’s our intention to do the same, so we’ve had different issues here of course, but we quickly want to get this resolved of course.

William Plovanic – Canaccord Genuity

And then if I may, just any color you can provide with the traction that you’re gaining at the MAC. So 2013, you got your code in place, you started getting on policy at some of these MACs and now you’ve populated the rep into there, and I am just -- any thoughts on kind of contribution or the time to contribution or any changes or thoughts you may have would be helpful? That’s all I have. Thank you.

Pete Petit

Okay, well first of all, remember what Bill said, we have 80% of company covered. So these last three MACs will be the last 20%. We want that done just because we’ve cleared it off our to-do list and move on. There are issues, different issues with all three of them, and some of them are beyond our control in terms of some of the internal issues going on within the MACs and consolidations and things of that nature, new personnel coming in and those kind of things, but it’s something that I am personally involved in all of our reimbursement activities in this company, and I deal with matters upon a day-to-day basis, so what that’s worth, we we’re very focused on it and we’re working on a daily basis. So we’ll bring it to conclusion, and the other reminder I can give you is there was I think four or five other companies that got Q codes at the same time we did and nobody has MAC approval, number one as far as we know. We’ve done an excellent job of getting where we are and these last three, we will work those.

William Taylor

I would like to point out too just as a frame of reference when ABH Shire was up at $200 million a year on revenue in diabetic foot ulcers alone, they had roughly 200 sales people. So with us being at 66 now in surgical sports medicine group, Federal team, and our commercial wound care team, we’ve got a long way to go even in just the states where we have covered that 80% before we get full penetration in those states, so we can continue to grow and drive our revenue and add sales people into that 80% even before -- well before we even get coverage in those other three areas, so we’ve got a lot of room to grow before we have that covered, so obviously we’d like to get that coverage as soon as possible, but if not slowing it down to the near term.

William Plovanic – Canaccord Genuity

My question, actually I was looking for a little more granularity on the actual contribution from the MAC in the quarter, right? Because last year you didn’t have anything from them, you just got them on board with the Q codes, you’re just populating them with reps and getting them policy. So to me, as I look at the story, the company for the next 12 to 24 months, the big piece of the revenue driver is revenues from the MAC. So, what I’m trying to kind of pull out of here really is if I look at this number, your wound care number was -- it’s called 9.2 million roughly, is 2 million of that coming out of the MACs versus nothing a year ago? Is 1 million, 3 million, how much of this growth is being driven by the MACs, that was the crux of my question?

Michael Senken

Bill, it’s Mike. We give the breakdown of revenue between our government and commercial, and the way that breaks out on a quarter-over-quarter basis, the commercial revenue grew by 29%. So it’s suffice to say that all of that is driven by penetration into the direct sales in the MACs.

William Taylor

Well, not only in the MACs but to the direct sales.

Michael Senken

The direct sales.

William Taylor

Yeah. So we will have to come back with you on a little bit more defined number on that Bill.

Michael Senken

Well, I think the majority of that is from MAC related revenue, I think that’s safe to say.

William Taylor

Probably, if I had to estimate, I’d estimate about three quarters of it, but we need to go back and take a look at the numbers.

William Plovanic – Canaccord Genuity

Okay, great. Thank you.

Operator

Your next question comes from the line of John Monaco with -- he’s a private investor. Please proceed.

Unidentified Analyst

Hey congratulations from me also and good quarter actually, good (inaudible) at the corporation.

Pete Petit

Thanks John.

Unidentified Analyst

I was just curious about this, can you comment on the impact of any of the apparent legal actions that we see being discussed either by others or SEC regarding MiMedx or yourself for that matter?

Pete Petit

Well, our general counsel is sitting in the room with me, and I’ll make, in spite of her try to give me, her hand is moving left and right, but anyway, let me give just a little color here. Having run publicly traded companies for 30-plus some years, over the decades, it helped and/or (inaudible), we had two of these situations develop. The firms that deal in this kind of activity are very much optimistic. Any time somebody has an issue, they’ll shoot first ask questions later. Today, the legal system has improved the way that they go about this and made it tougher on them to actually have good proof of what case they’re bringing. There is nothing here, I’ll simply say that and we’ll move on. These cases will generally speak and go to the point where the federal judge will look at and make a decision, and in our two previous cases, they were settled or thrown out. So we don’t have an issue here, it will work its way through. It will add some legal expenses, a bit of legal expenses to it over the next couple of quarters, and that’s it, it’s taking very little management time, we’re using the same law firm that we used here in Atlanta that helped us with the other two cases decades ago and it will -- (inaudible)/

Unidentified Analyst

That’s outstanding. Thank you very much for that input. That’s all I had.

Operator

Your next question comes from the line of Matt Hewitt with Craig-Hallum Capital Group. Please proceed.

Matthew Hewitt – Craig-Hallum

Thanks for taking the follow-up, just one for me. You talked in length, and we appreciate the color on the bundled reimbursement. And I’m curious how do you envision, and I know it’s tough to say because it’s your peers, but you’ve got these two competitors that are selling at an average price of well above even the bundled price. How do you think they respond if CMS goes ahead with those new hops rate?

Pete Petit

Well I think number one, the only place their grafts are going to be used is going to be on the very large wounds. And one of those, the Dermagraft product is used on diabetic foot ulcers which are generally smaller than the venous leg ulcers. So, it’s not going to be a good day for them, and that’s why they are busy in Washington trying to convince senators and Congressmen to campaign with them with CMS to not do this on the grounds that generally speaking it’s going thwart medical innovation, cost jobs etcetera, etcetera, so I think they are on the wrong side of this argument. This is going on much too long, and I’ve never seen anything in my business career that is this compelling as this case is, so I think it’s just a matter of time.

William Taylor

Now remember too this is just for hospital outpatient ambulatory surgery centers, so physician’s office remains unchanged, physician’s office will still be reimbursed at ASP plus 6%, so they will have an opportunity to play there, but obviously they’re going to have to have -- in the case of Dermagraft, they’re going to have to have a cryogenic freezer there to store it which not all the physician offices do, and they can still technically play in DRG cases for the very large wounds, but again they are not high percentage of the frequency of wounds.

Pete Petit

What I can tell you, the whole industry is now focused on this. CMS has brought the light, and the light has been shined on it, and everybody realizes it that, yes this is going on for a long time and we had to look the other way because there weren’t alternatives. There are alternatives now -- good alternatives, and it is MiMedx.

Matthew Hewitt – Craig-Hallum

And refresh my memory, but if they do decide that they want to stay in this market because they went through PMA process, they would likely need to get to amend those applications, which would take time correct?

Pete Petit

That’s correct.

Matthew Hewitt – Craig-Hallum

Okay great. Thank you.

William Taylor

Thanks, Matt.

Operator

Your next question comes from the line of Jon Block with Stifel. Please proceed.

Jonathan Block – Stifel Nicolaus

Yeah great. Thanks and good morning. Actually, I had a couple of questions, one was just answered in terms of how your competitors would respond if the reimbursement landscape changes. But I’m going to move to the second one, just in terms of the reimbursement more, Pete you referenced earlier I mean you also talked about a couple more papers that were recently published. What else do you think you need, is it just time or are the remaining MACs coming back to you and saying we want a couple more studies, we want a couple more economic studies? And if that is the case, is there anything in the pipeline from a publication standpoint that you see coming through that may help you tip I guess without the remaining two MACs? Thanks guys.

Pete Petit

Good questions and the answers are yes. We have continuous clinical studies underway, some of which will deal with cost effectiveness, some of which will deal with additional clinical effectiveness. But frankly, what we have today is more than sufficient, generally speaking if someone’s still pushing back, there are other issues there in terms of personalities. I’m here to change – I’m the new sheriff in town, and I’m changing everything, some of those kinds of things go on, and you just have to persevere and keep poking through it, but time will take care of all this, and I can’t tell you how focused we are, and how we will persevere, I mean that’s just the way you have to do it. There is no simple solution other than just perseverance every day making enquiries, getting other people to make enquiries even when necessary going to Congressman or Senators. So we’ll use all of those tools. We’ve used them before successfully, and we’re just clicking them off day by day.

Jonathan Block – Stifel Nicolaus

Okay. And maybe I’ll still try to go back and ask my first question in a different way on the OPPS landscape, I mean you mentioned you’re out there trying to eliminate ways to lobbying on one side your competitors because you’re a little bit pigeon holed on the other side of the argument. There is also the chance that this thing gets stable, sort of kick the can down the road, do you want to sort of say how you think this may play out or ascribe certain percentages to it? Do you think there is a very good chance we get a decision one way or the other this November or do you think there is a decent chance that they are going to sort of move to the side and say, you know what, we’ll table this and we’ll circle back in a later date? Thanks guys.

Pete Petit

Okay here’s what we’ll say, I think. Number one, CMS has been very, very distracted (inaudible) with some of the issues associated with the change in the healthcare process. Unfortunately, [indiscernible] has been involved with that and her staff have now also taken a vacation so to speak, been furloughed. They came out with a press release saying if they’ve not made this decision on November 1, they are going to make it by November 27. So, it looks like they’re still working on the matters, and so we’ll see what comes out of it. Other than that to me it’s a coin toss, it’s a lots of reasons to kick the can down the road. $100 plus million a year is a lot of money, and as I said (inaudible) Senators and Congressman in Atlanta, that’s a lot of money. In Washington, it is not necessarily a lot of money. So, it may get kicked down the road, again it may get kicked down the road or they may take action or they may take partial action, we don’t know, and we are just continuing to do the things we think are right, and we are at the right side of this argument regardless to CMS does. The skin substitute wound and advanced wound care side of this industry is now very focused on it and understands it as an issue, and you can’t waste this kind of material without affecting the way people think about things, everyone’s thinking about it.

Jonathan Block – Stifel Nicolaus

Great. Thanks for your time guys.

Operator

[Operator Instructions]. Your next question comes from the line of Troy Welker with IPT. Please proceed.

Troy Welker - IPT

I don’t have a question. I just want to say great job on everything you did. I couldn’t be happier with what you’ve done. I guess there is one small question when you talk about them having go back for a BLA, your competitors under the CMS issue, can they do something like what’s put out in the press release from Osiris the other day that they are going to continue to (inaudible) why they work through a BLA . In the event that they have to resize their grafts lengthily, would it take them very long at all to be able to resize their grafts, Dermagraft from Shire and the other company to be able to compete with this if this does affect, or they’re going to be froze out for at least a year they try to get their production facilities up and going forward?

Pete Petit

Okay let’s just straighten the record out here. Osiris has tissue allografts like ours. They’re totally different than the Apligraf and Dermagraft products. If Apligraf and Dermagraft wanted to serve this wound care market – advanced wound care market where the wounds are smaller, they have to have smaller grafts in order to do that, have they got to take the rather lengthy process back through a supplemental PMA. Frankly, if I’ve been involved, we’d have made those kinds of decisions years ago, but you can’t continue to do what they were doing and now provide smaller grafts. But they didn’t make those decisions where they are today, and they’ve got to make decisions if CMS reimbursement change takes place is to how to quickly as fast as they can bring smaller grafts to market, but this probably won’t take a year plus to do that. Organogenesis has a different set of issues. They are like us, they can generally make changes fairly easily in terms of size of their grafts.

Troy Welker - IPT

Thank you very much. And thank you so much for all the work you’re doing. I know you had a great quarter and you worked hard. Thank you so much.

William Taylor

Thanks Troy.

Operator

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

Pete Petit

Okay. Thank you, I might add one thing here in closing that our General Counsel suggested on Medtronic comment, and we think that the claims have been made by the strike firms are subject to dismissal, and we intend to move for dismissal at the appropriate time in front of the federal judge. That takes care of our comments. I appreciate your interest and being on the call. And if we didn’t get your questions answered, please feel free to pick a phone and call us and we’ll answer at that time. Thank you very much.

Operator

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

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