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MiMedx Group Inc. (NASDAQ:MDXG)

Q2 2014 Earnings Conference Call

July 29, 2014 10:30 AM ET

Executives

Thornton Kuntz – SVP, Administration

Pete Petit – Chairman and CEO

Bill Taylor – President and COO

Mike Senken – CFO

Analysts

Matt Hewitt – Craig-Hallum Capital

William Plovanic – Canaccord Genuity

Bruce Jackson – Lake Street Capital Markets

Mike Matson – Needham and Company

Suraj Kalia – Northland Securities

James Terwilliger – Newport Coast Securities

Operator

Good day ladies and gentlemen and welcome to the MiMedx Group Inc. Quarterly Earnings Conference Call. At this time all participants are in a listen-only mode. Later we will conduct a question-and-answer session and instructions will be given at that time. [Operator Instructions] As a reminder today’s program is being recorded. I would now like to introduce your host for today’s program Thornton Kuntz, Senior Vice President, Administration. Please go ahead.

Thornton Kuntz

Thank you, operator. 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 the forward-looking statements based on factors described in this conference call and in our reports filed with the Securities and Exchange Commission including our Form 10-K for the year-ended December 31, 2013 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 MiMedx’s Chairman and CEO, Pete Petit.

Pete Petit

Thank you, Thornton and good morning. Thanks for joining us for our second quarter conference call. I have with me today Bill Taylor, our President and Chief Operating Officer; and Mike Senken, our Chief Financial Officer also they are the corporate executives present.

I assume you’ve seen our press release which came out right after closing bill yesterday. I hope you feel as strong as we do in turn of this being an excellent quarter for the Company. We started the quarter in attentive mode wait and see how our education activities related to the major reimbursement changes had taken place we’re going to through the system.

I think we can safely say that our process is to work well and this segment of healthcare as clearly informed on how to build with the new CMS changes for advanced skin substitutes and specifically for EpiFix allograft.

With that place of education behind us, I can certainly say that all investment we have made in our sales organization and related support group is paying off well and rapidly. As you are well aware we made major investments in our sales force today’s end of last year and earlier this year based on our prospects for growth specifically in the wound care area.

We continue to add qualified sales persons in this area and by the end of this year; we expect to have a sales organization of our direct personnel of over a 150 individuals by the end of 2015. We anticipate that number to be well over 200. As I initially stated we had an excellent quarter, we had successes in a number of areas, these included our quarter revenue increased 89% over the second quarter of 2013.

Our revenue increased 31% over the first quarter of this year. Wound care revenue increased a 181% over quarter two of 2013 and 40% sequentially over Q1 of 2014. Our adjusted EBITDA increased by 148% over the second quarter of 2013. Our free cash flow was positive for the quarter driven by increased EBITDA and bringing our accounts receivable base down considerably, very considerably.

This was our 11th straight quarter beating or exceeding our revenue guidance, also was our 10th consecutive quarter showing positive adjusted EBITDA. We came very, very close to an operating profit breakeven. Therefore please note that we expect operating profits to be positive this quarter, in other words the third quarter of this year. We are raising our guidance for the year to $110 million at the low end and a $115 million at the high-end.

We continue to make the progress we are currently seeing. We could very well show another year of almost a 100% revenue growth. Obviously we see numerous opportunities in advanced wound care for allografts. We have had this opportunity to build our reputation footprint across the country, we done so very prudently but rapidly. We expect advanced wound care to be a core strategic business unit for our company in the years ahead.

We have a hardly trained sales organization that knows etiology and physiology of wound exceptionally well, and we’ll continue to excel in the promotion of our allograft products. We’ll continue to exert our leadership in taking advanced wound care into an era of cost effectiveness and integrity with our allografts.

By the end of this year there shouldn’t be any questions in terms of who will be the long-term leader in advanced wound care in this country. Our allografts are both clinically effective, more cost effective and logistically much more efficient, because of the ease of preparation, ease of application and lack of cryogenic storage.

As you should know during the quarter, we filed our patent lawsuits against several organizations that we feel are fringing on our intellectual property. With the major investment in our intellectual property having been made over last six years, which is resulted in 15 issued patents about 35 U.S. patents some of which will begin to issue in the near-term and another 35 international patents we feel very strong about our position with the intellectual property.

I cannot provide any insight and the outcome of our first lawsuits, but I can tell you that we will be very aggressive in almost in a pursuit to protect our intellectual property. We had an normal publication and peer-reviewed journal occurred during the quarter. There were two clinical publications and one scientific publication, where there we have to close the quarter we have an excellent peer-reviewed article published in managed care journal. We have three other papers that we expect announce publication on very shortly. We will continue this rapid pace of scientific and clinical exploration, we will announce publications as they occur.

I would like to make some comments now about our revenue growth rate. The way 2014 is shaping up we can very well come close to another 100% revenue growth year. Our primary focus has been in establishing our presence in advanced would care market, because the opportunities that have been presented to us.

By the end of this year, we will certainly have a great strong national presence in every significant city with our own direct sales organization. That will take us into 2015 with a very professional well claimed sales organization, as well as the support groups that back them up.

Also I would like to discuss briefly our outlook for 2015, primarily because there is some concerns, because EpiFix will lose its pass through status for Medicare patients on January 1st. Therefore our wound care revenues are going to drop dramatically. Bill Taylor will give a bit more detail on this subject, but I want you to provide you with an overview.

Let’s start by stating why we have introduced our allografts in the market in terms of doing the right thing by sizing and appropriately to the wounds that are being used on. As a result we are broadening this market considerably. Prior to our entry into this market, the two major advanced wound care products had only gone less than 10% with the U.S. market. The reason for this is, because they are large size and costly grafts where the majority of these grafts on average were thrown away.

We’ve totally changed that philosophy so that physicians can use our smaller grafts on smaller wounds with little or no wastage and they are very economical. Therefore we think we have data that shows our small grafts that are being on wounds we were not pleased to give an advanced wound care, because of the extreme cost effectiveness and right sized approach. So the market is being broadened by our activity.

Now let me assure you that our management clearly understands all the issues associated with those pass through status change. This primarily will affect the economics associated with only a fraction of our large EpiFix grafts. We have known and analyze this situation for a extended period of time. There are number of things we can do to reduce the impact associated with change related to this portion of larger grafts.

However, approximately 80% of our volume is in our smaller grafts, as we expected after that our larger grafts are paid for in numerous ways other than through the Medicare outpatient system. Also with gross margins at our high levels, we certainly have the flexibility to reduce price on segments or on product lines. We also have the ability to quickly introduce new allograft sizes.

All those are factors which will greatly reduce any impact the pass through status has an EpiFix wound care product. Now up to this point, my discussion is focused only on our wound care business, but has been left out of these discussions is revenue from our surgical and sports medicine business. We expect to continue to see that part of the business grow rapidly beginning in 2015 and beyond.

You’re well aware of our distribution and private label agreement with Medtronic, they have 40% of the sponsor of the business in the U.S. and our AmnioFix allografts will be used in many of those surgeries. We have mentioned that we are considering some other [indiscernible] of that nature plus we have some very effective distributors and sales agents in certain surgical and sports medicine areas.

In addition we have some critical – clinical studies focused on use of our product and surgical procedures where we will probably feel the small sales organization to support those revenues. These are niche markets that could generate 25 plus million dollars in revenues annually for us as they mature.

Therefore I would recommend that you do not be too concerned about our revenue growth trading off dramatically in 2015. We will necessarily be conservative in December when we provide our 2015 revenue and profit guidance. But we do not expect sale revenue in wound care revenue to change very significantly.

By 2015 our direct sales force will be very well ingrained in local markets and it will be difficult for competition to make end road regardless to the effects of the pass through status on a portion of our very large EpiFix allografts.

I would like to being the reflect on MiMedx as regenerative medicine company with a broad product line that will find its way in the numerous healthcare procedures. Our primary focus is been on wound care and EpiFix allografts, because the opportunities we had to achieve, the unquestioned leadership role in this area. We have done that and are doing that. And that’s well on its way to being implemented. In the meantime, a significant amount of other resources have been focused in the surgical and sports medicine segments and in 2015 we expect those efforts should come more visible.

Let me address another question that’s beginning to receive, we are beginning to receive relative to the company producing operating profits. First let me assure you that Pete Petit, Bill Taylor and rest of us clearly understand the meaningful nature of operating profits. I have to keep in mind that MiMedx has been showing positive EBITDA for 10 straight quarters and the trend has been upward. In our case the EBITDA has recently close to cash flow.

Because of our financial leverage, once we cross breakeven our operating profits will increase and it will increase rapidly. However up to this point, we made significant investments in our infrastructure and our sales organization. We are particularly focused in developing a strong national presence in wound care, every dollar we’ve invested in these assets as given us huge returns. We’re always balancing those types of investments against the EBITDA growth and soon to be operating profits.

We’ve achieved an almost breakeven on operating profits this quarter; we came within a few hundred thousand dollars with that goal. You’ve seen our forecast for third quarter which involves a $5 million or $7 million jump in revenues over second quarter. With that kind of incremental revenue jump and our gross margin as been exceptional, operating profit should develop this quarter.

However, we’ll continue to build infrastructure and make those type of investment, because of the huge returns we are getting on that invested capital. There will be a point where, because of our operating leverage, operating profits will escalate rapidly. We are close to achieving that annual situation and it should itself this quarter.

And I’ll turn the comments over to Bill Taylor. Bill?

Bill Taylor

That’s Pete. As Pete said this is an incredible quarter for us and the quarter played out even better than we expected. The confusions surrounding the CMS reimbursement and the outpatient setting to settle down considerable, and enabled EpiFix to be used much more frequently. We added a few sales people in the quarter, but mainly focused on getting the nearly 15 new reps from the first quarter up to speed and productive.

We progressed our discussions with the FDA regarding our micronized product and submitted our first IND last week. We were able to resolve the Medicare coverage issue in Jurisdiction H in EpiFix and now eligible for coverage as we’ve expanded our reimbursement group and we’ve increased the number of pure view published articles to 18 including three in the second quarter and most recently a paper published last week in managed care.

I go into detail in several of these areas starting with sales. First I want to point out something about our $25.6 million in revenue. With an incremental $6 million in revenue over last quarter, just eight quarters ago we only had about $5 million in total revenue. So we had more than five times our quarterly revenue of just eight quarters ago. You can’t have this kind of growth without having a fantastic technology and a great team at every level of organization.

You also recall we had 76 new sales professional at the end of last year and a 122 at the end of March. This number includes only our field sales executives and field sales managements no other functions. Since the first quarter were up to a 128 field sales professionals. To put this in perspective, I just mentioned our revenue eight quarters ago, but we had zero direct sales people eight quarters ago and now we have almost a 130. So that helps put things into perspective.

You will note that our end of year target previously was a 130 to 150 sales personnel in the field. And based on our updated plans we’re on pace to finish this year with between a 150 to 160 field sales professionals. We have target list of our next way of professionals and expect a higher number of them this quarter.

Now I’m sure that some of you may be wondering about the productivity of our sales force. Recall that nearly 40% of the sales force was hired in Q1 of this year, with most being in February and March. We’ve indicated in the past that our target monthly sales per rep in their sixth full month after hiring is $85,000 per month. So after six months $85,000 per month which is about a $1 million run rate.

So as of June these new hirers on average still have not completed their ramp up to their targeted level of sales. So after removing our house account revenue from our ophthalmic, dental and OEM sales, the average revenue per person on a run rate basis at the end of the quarter was just shy of 800,000 hours per year, including these new reps.

Now our ten year people having more than 6 months in MiMedx average a run rate in the second quarter, at the end of the second quarter of just over a $1 million a year. So these new reps on average are on track to reach their $85,000 per month run rate late in this quarter. So our model is holding as expected and overtime we look to drive some additional efficiencies and increase the average revenue per month per rep over time.

Now let me address an issue where many of our small competitors are making a lot of noise. The products aren’t as clinical effective as ours and they don’t have reimbursement like we do. So they are doing the only thing they can do, and that’s go after the VA business. As you can see from our numbers, our federal sales are still going strong. Our sales this – in the second quarter were level at $9.1 million each quarter, so the same number of revenue in both first and second quarter.

Now we’ve been focused as you can imagine on our commercial accounts. And this month we’re stepping up our VA focus and already this quarter looks like we’re getting a nice uptick in our sales there. So we’re projecting in our revenue growth in this VA sector in the third quarter will be approximately 5% more or even higher than we were in the second quarter.

Additionally, we’ve recently picked up more than a dozen new facilities in the VA system, so stay tuned you’re going to see some nice growth in the sales force in the coming parts of the year. Of course we’ve heard some noise in competitors in a few of these VA’s that we’re in, we were not seeing really much of any traction in those VA’s where we have business.

Some of those competitors “maybe be” the VA’s with a few grafts or more likely with products other than skin substitutes, but other than the “noise” they are not having a noticeable effect on our federal revenue. So we expect this business to continue growing over the coming quarters.

On the IP front, four new patents were issued to us until last quarterly shareholder call which puts us to 15 issued patents on our amniotic tissue. We have about 70 additional U.S. and international patents that are pending and we’re evaluating additional IP concepts. Now relating to our patent and false advertising lawsuits we are into the discovery phase of that process and other than that there is really no further update.

As Pete mentioned, we will continue to protect our IP rights aggressively and we will also address any false and misleading advertisement claims. We’ve been very successful in the market, so of course there is going to be company that try to humiliate our success we welcome legitimate competitors who operate with integrity. It’s a very big market out there, so there is room for legitimate competition and it’s good for the industry.

And again it’s a very big market, multiple billions of dollars and opportunities in chronic and acute wound, spine, orthopedics, sports medicine, a lot of other areas. Now that said, we don’t have any tolerance for companies who operate without integrity, including those who claimed our product is “just like EpiFix” especially when the fact is that none of those products that are on the market are equivalent as its proven by scientific examination and the published literature.

Changing gears now to our IND with press release that we filed our IND for our first BLA last week and our team has done an incredible job working with the FDA and preparing this 1700 plus page IND submission. This submission included a significant amount of safety data including physician interviews and patients record reviews represents more than 3000 applications of our – applications or injections of our micronized amino.

We’ll take to the next steps; we will take the next steps in our discussion with the FDA once they’ve had a chance to review the data. We won’t go into much more detail on this just yet as we obviously still expect a certain amount of discussion with the FDA and we think it’s best to reframe from going into too much detail until we’re further into the process.

Moving on reimbursement, I’ll cover a few additional items. As you can see, we exceeded the high-end of our revenue range even though Medicare coverage and Jurisdiction H was rescinded for all the new skin substitutes on March 27th, the day the New York City was suppose to go live.

Our sales pool through was considerable stronger than anticipated in the rest of the country and as such made up for this issue and then some. Now with the July 10th revised LCD was published to include EpiFix, we expect a significant increase in sales from that region.

I will also note that no other products we added in this LCD revision none, we were the only one. So we were added because of our direct efforts with this MAC in the body of clinical and scientific evidence on EpiFix. I will again remind you that – there are the five or six products that received a Q code in January of 2013 at the same as us. We are the only one that is eligible for coverage in all eight MAC, the only one. As you probably are aware the draft 2015 CMS skin substitute perspective payment plan was issued in early July.

The physician office, this is the draft plan. The physician office is proposed to continue at ASP plus 6% basis, so there is no change from this year as proposed. And as expected for the hospital outpatient there was no major change to the skin substitute reimbursement landscape.

We believe there still could be some slight improvements on the perspective payment system and we will formulate and submit our comments to CMS by the due dates. But as composed the low and high package system will stay in place for 2015. Also as expected the pass through status for several products including EpiFix will expire next year.

Now many people have mistakenly assumed that this will affect the majority of our business, but they are incorrect. They do not understand the mix of our revenue or the entire reimbursement landscape. And I’ll go into more detail here. First of all as Pete mentioned MiMedx is a regenerative medicine company. We are not just a wound care company, not only a wound care company. Yes wound care is a big part of our business, but it is not all of our business.

There is a very diverse use of our wound care offerings which are not limited just the chronic wounds. Now that said, I’ll do my best to bring down our revenue here to illustrate how the loss of pass through status next year will only affect a small portion of our business.

First I’ll remind you the pass through payments are only in a hospital outpatient and ambulatory surgery centers and only apply to Medicare patients. Furthermore as it relates to MiMedx, it does not affect our ophthalmic, dental or a private label or our OEM business, neither does the pass through status affect our surgical, orthopedic or sports medicine, neither it doesn’t affect our small size of EpiFix as 80% of our units are below the package rate and still will be profitable even this package environment.

In fact because of the low price of our disk, pass through status is irrelevant for our disk, our smaller size which, on our small disk there is no pass through payment even this year. That’s 50% of our units going out the door even though our EpiFix product is eligible for pass through payment, because our disk is so low in price around $300. There is no pass through payments.

So loss of that next we will have no relevance to the small size. Also not affected our EpiFix that are used on non-Medicare patients which is a very large number of people in the commercial payer side. Also not affected our – any grafts that are placed in the physician office. Also not affected our sales into the VAs, also not affected our grafts used in other types of surgeries outside of DFUs and VLUs like the other nearly 40 types of wounds that EpiFix is used on. Also not affected our grafts using the hospital inpatient or DRG setting.

I know that’s kind of been a long and boring explanation of where the host pass through status will not affect our business next year, but it illustrates my point. The vast majority of our business is in areas where the loss of pass through status is irrelevant. The only place it is relevant is in about 8% of our projected revenue, 8%.

And this is for the small percentage of our larger sizes that are used in the hospital outpatient or ambulatory surgery setting from DFUs and VLUs. And is it that number was not small enough, we have to find in an updated sizing strategy and a large price structure that will further reduce this potential issue. As well as we have a few other initiatives that could help us well. We’ll announce those a little later in the year.

Plus as we mentioned on a previous conference call, even if a facility loses money on the first graft they will generally breakeven or make money on the full cost of closure of the wound. Remember 80% of our unit that we sell are smaller sizes, so as the wound progresses from a larger wound to a smaller wound they will actually start making more money in this packaged environment.

So again based on factors like a full year of MAC coverage, increased coverage for VLUs increased commercial coverage, deeper wound care penetration and surgical DRG cases, stronger physician office sales expanded surgical uses and a strong OEM business, this team is not worried about the loss pass through status.

So with that now, I’ll turn it back over to Pete.

Pete Petit

Thank you, Bill. I hope you picked up Bill’s point. Mike?

Mike Senken

Thanks Pete. The company reported revenues for the second quarter of approximately $25.6 million, an increase of 89% or $12.1 million over prior year’s second quarter revenue of $13.5 million. Wound care revenue represent a 81% of total revenue at $20.6 million with surgical, sports medicine and OEM revenue coming in at $5 million.

For the six months ended June 30th 2014 revenue increased 80% to $45.1 million as compared to $25.1 million in 2013. Wound care revenue represented 78% of total revenue at $35.3 million with surgical, sports medicine and OEM revenue coming in at $9.8 million. Wound care revenue growth was driven by increased penetration in commercial accounts due to the increase in hiring of direct sales associates that occurred during the first quarter of this year.

Gross margins for the quarter were 89% as compared to 84% in the second quarter of 2013. On a year-to-date basis gross margins were 87% as compared to 84% in the prior year. Improvements in gross margin were driven by both product and customer mix. R&D expenses for the quarter were approximately $1.8 million or 7% of quarterly revenue, which represents an increase of 95% as compared to prior year. On a year-to-date basis R&D expenses were approximately $3.2 million or 7% of revenue which represents an increase of 47% as compared to prior year.

The increase in R&D spending is driven primarily by increased investments in clinical trial. Selling, general and administrative expense was approximately $21.2 million for the quarter or 83% of total revenue as compared to $10.9 million in 2013. On a year-to-date basis SG&A expense was $37 million or 82% of revenue as compared to $19.2 million in 2013.

The increase in spending reflects the accelerated build out of our direct sales force primarily target in commercial accounts. In the second quarter, the company added five new direct sales associates bringing the total at the end of June to 127. As mentioned in the Q1 earnings call, the second quarter would be impacted by the aggressive hiring that took place primarily from the middle of February through the middle of March. With the rate of hiring slowing in the second quarter, we would expect the rate of spending as a percentage of revenue to just claim in subsequent quarters.

The company reported positive adjusted EBITDA of approximately $2.9 million for the quarter ended June 30th 2014 which is a $1.7 million improvement as compared to an adjusted EBITDA of $1.2 million in the second quarter of 2013. It is the 10th consecutive quarter of reporting positive adjusted EBITDA. Year-to-date adjusted EBITDA was $4.9 million which is an increase of 113% as compared to prior year.

Year-over-year improvement in adjusted EBITDA is a result of higher sales volumes and improved gross margins. Included in our press release is a reconciliation of adjusted EBITDA to reported net loss. The net loss for the second quarter was approximately $390,000 or $0.0 cents per diluted common share as compared to the reported net loss of $757,000 or $0.01 per diluted common share for the quarter ended June 30th 2013.

The net loss on a year-to-date basis was $1.3 million or $0.01 per diluted common share which is a reduction of $1.1 million or 45% as compared to prior years reported net loss of $2.4 million or $0.03 per diluted common share. Turning now to the balance sheet.

The Company reported approximately $66.3 million in total current assets, an increase of approximately $910,000 as compared to $65.4 million as of December 31, 2013. The increase includes $4.4 million in accounts receivable due to higher sales volume as well as an increase in prepaid expenses and other current assets related to tradeshow sales support and training activities somewhat offset by a decrease in cash of $4.8 million primarily due to our share repurchase program.

It should be noted that there was a significant improvement in accounts receivable collections in Q2 with day sales outstanding coming in at 72 days as compared to 87 days in Q1. Total assets were $86 million, an increase of $1.3 million as compared to December 31, 2013. The company reported $11.5 million in total liabilities with zero debt on the balance sheet, which is an increase of approximately $410,000 from year end. The current ratio of 6.7 as of June 30, 2014 is slightly lower than the reported current ratio of 6.8 as of December 31, 2013.

Total stockholders’ equity increased by $920,000 to $74.5 million as compared to 473.6 million as of December 31, 2013. There were approximately 105.3 million shares of common stock, 268, 000 warrants and 17 million stock options and 958,000 of restricted stock units outstanding as of June 30, 2014.

During the quarter, the Company repurchased 740,000 shares under the previously announced repurchase program bringing the total number of treasury shares to 834,200 as of June 30, 2014.

Turning now to the statement of cash flow. The Company reported positive cash flow from operating activities of approximately $1.2 million for the quarter as compared to a negative $755,000 for the quarter ended June 30, 2013. Positive cash flow from operating activities for the quarter was driven mainly by an increase in adjusted EBITDA somewhat offset by an increase in working capital.

Cash used in investing activities in the quarter, included capital expenditures and patented application cost of approximately $800,000. Capital expenditures included IT structure and production processing equipment in support of our continued growth. Cash flow from financing activities for the quarter were a negative $4.2 million including approximately $4.6 million in the share repurchases somewhat offset by $438,000 in stock option exercises.

During the quarter, the Company also decided not to renew our working capital line. Total headcount at the end of the quarter was 320 which represents an increase of 32 associates in the quarter and brings the total increase in the first half of this year to 98 associates. And finally please note that MiMedx will be presenting at the Canaccord Genuity 34th Annual Global Growth Conference at 2 PM on Thursday August the 14th at the InterContinental Hotel in Boston.

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

Pete Petit

Thank you, Mike. Let’s open the call now for questions.

Question-and-Answer Session

Operator

[Operator Instructions] Our first question comes from the line of Matt Hewitt from Craig-Hallum Capital. Your question please.

Matt Hewitt – Craig-Hallum Capital

Congratulations gentlemen an phenomenal quarter.

Bill Taylor

Thanks Matt.

Pete Petit

Thank you Matt.

Matt Hewitt – Craig-Hallum Capital

Couple of questions from me, I guess looking out a couple of years, so a little bit more mid-term type expectations. But number one operating margins obviously you’re going to flip to operating profits, in the third quarter. I think previously you discussed longer term this is a company that could get to 25% operating margins. Is that still kind of your mid-to-long-term goal?

Pete Petit

Well I certainly think a company that has the gross margins that we have and the other metrics in terms of our financial profit and loss statements et cetera, should be producing once we get up one step operating profits in that range. We’re very fortunate to have the financial metrics we have and the technology metrics we have. So this company should produce strong, strong operating profits.

Matt Hewitt – Craig-Hallum Capital

Okay fantastic. And then simply and I think you touched on this very briefly in your prepared remarks, but your competition previously done I don’t want to say a poor job, but they hadn’t penetrated the market to the extent that maybe you will be able to with the smaller sizes. How much of your growth this year and maybe even in the next year, can you correlate to market share gains versus the competition so essentially taking share from them versus expanding the market because of your smaller sizes and the storage capabilities?

Pete Petit

Matt, first of all we generally don’t like to speak until we know our metrics very exactly. We have a strong IT an informatics group here and we’re busy gathering those facts and we’ll discuss some as it get clear to us. But we know that’s happening, we’ve seen our preliminary data, but we want to get very specific with it. And if you just stop and think, over the decade of the two previous large competitors with $1800, $1700 grafts where we have a small graft $900 to $300 range, physicians just weren’t going to use those large grafts through over 80% or 90% of them on small wounds. They just let the wounds progress in some cases to become larger wounds.

But this market is going to get broadened, they had only less than 10% in that range penetration and this market will be, it has needs it will be fulfilled by cost effective grafts and I think we have those.

Bill Taylor

And if I could add to it Matt, we have access now to Medicare data where we’re coming through that we just bought commercial data and we’re going through that and I think as our informatics team gets a little more familiar with the data we’ll be able to give you the metrics as Pete indicated. So it’s just a little premature now, but getting into later this year, we’ll be able to give you more specifics there.

Matt Hewitt – Craig-Hallum Capital

Okay, but it’s safe to assume that the market is expanding not just through you taking share from your peers, but it is because, you are garnering a greater percentage of the wound care market, whatever their percentage its up from maybe what the advanced wound care market was a year ago?

Pete Petit

We think we can say that for certain, we just don’t have the specific metrics, we would like to provide.

Bill Taylor

Yeah so it’s a combination of both, and when you look at the units and the wounds treated we think that we are doing both.

Matt Hewitt – Craig-Hallum Capital

Okay great. And then maybe one last one from me, and I realize it’s still very early, but just looking for an update on Medtronic relationship there, their big annual sales kick off meeting, I think it was mid-June, I’m just curious if you had any initial feedback from, Medtronic directly or maybe even some other reps or doctors on that is progressing?

Bill Taylor

Probably the best way to answer that is they are a very large company and they don’t quite move as dynamically as we do. So I think this time next quarter, we’ll be able to give you much better read on that, but it’s still pretty early in their launch, early indications are positive, but it’s really beyond that it’s really hard to put anything behind it.

Matt Hewitt – Craig-Hallum Capital

Okay great. Thank you very much.

Bill Taylor

Thanks Matt.

Pete Petit

Thank you Matt.

Operator

Thank you. Our next question comes from the line of William Plovanic from Canaccord Genuity. Your question please.

William Plovanic – Canaccord Genuity

Great thank you, good morning.

Bill Taylor

Good morning Bill.

William Plovanic – Canaccord Genuity

Just a couple of questions first Pete I think you mentioned 200 reps by year end 2015 is that all wound care or there are other areas you expect to go direct in?

Pete Petit

I’ve said 200 plus and I expect the emphasis should be on plus, but no Bill we will be adding some other direct sales people mix where perhaps even this fall and beginning in the next year and some of these other niche areas we’re going to be stepping into. And there will be other reps added to support our initiatives with the surgical side and sports medicine side.

William Plovanic – Canaccord Genuity

And as wound care goes you think that of start leveling off over the next year or so?

Pete Petit

Well it certainly wouldn’t be as dynamic, it as has been this year. But at the same time the territories will become more efficient and sales people will become more effective in their territories. We should have by year end and that certainly a goal we’ve set all the large national health plans given us coverage, so there won’t be any territorial disparities and we can hold our sales force accountable on making equal basis across the country on in terms of performance. So we’ll get into the normal routine territory management issues that companies that are little more mature than we’ve been, haven’t and we’ll hopefully manage those effectively, so that each sales person will be more effective in their territory.

William Plovanic – Canaccord Genuity

Okay that’s a perfect segue into my next question, which is lot of commentary regarding the coverage of the large payers, at this point are there any major payers that don’t cover you for wound care and roughly how many lives you think you have covered in the U.S?

Pete Petit

Well if you look at the commercial sides and just health clients we probably have 40% of our last coverage and working on the big five or the big six and making some progress there they are, in today’s environment and I’ve dealt with health clients now for 35 more years, I know them very well, I know individuals and I know the way they do things. They are very tough today, and there is lot of reasons for that, but they are very tough and even allowing conversations to take place.

We have our work cut out force, but we’re busy doing it, and I think by the end of the year we’ll have made a lot of progress. But we – every week that goes by here we get additional coverage on health plans. Now remember in wound care the private size is only about 25% of the market, we have approximately half of that already, but at the same time we want all the large health plans to cover our allografts. They should, they are wasting money on once they do cover there been most of the grafts being thrown away, we are all aware of that getting through to them and help them become aware of that is the key.

William Plovanic – Canaccord Genuity

And then as we think about the, sales ramp and the leverage that you will have, as I think in back-half of 2014 and into 2015, I mean if the sales force is not going to expand as much, I guess, how do we think about the cost, the fixed cost versus the variable cost. I mean right now you have a distribution channel of roughly a 130 direct people, you’re running an SG&A line annualizing an 18 million which is I don’t know, 600,000 a person per rep or something like that. I mean how should we fundamentally think about kind of that cost, because obviously you’re absorbing some of the non-productivity of those reps?

Pete Petit

Well first of all you’re dealing with the subject that we have a lot of management discussion about and lot of discussion with our Board. Our sales expense as a percent of our revenue is high and it will be coming down like Mike talked about a little bit. But when you have the opportunity to do what we’ve done, seldom no situations like we’ve had and we’ve executed well on it. You make your commitments, because every dollar you put into investing in the sales organization and broaden your footprint is a huge return on your investment, huge. But there is a point where that begins to settle out and as I mentioned our territories have been, sales territories have been different, because there is different coverage issues and is we got all the MACs dealt with and all the national health plans dealt with there are going to be territorial differences.

The efficiencies would come as we begin to mature and begin to get into territory management, territory risk reduction things like that, then you see that the normal expenses on the sales basis are reflected as the percent of revenue come down and come down fairly dramatically.

So there is nothing here that concerns as there is a case of mature and a rapidly growing organization keeping your cost and line and starting to bring them down as you mature. So I think you will see sales expense and our G&A, I don’t think our G&A is out of line we’ve been putting a lot of investment into research and development, our clinical studies some of that would continue, but sales – the sales area has been high but there is reasons for it being high and it will start coming down.

Mike Senken

Yeah Bill if I can add one point there. In the second quarter obviously if was affected by the hiring in the first quarter and as Bill mentioned there is a six month ramp to get sales people up, we are very aggressively going out there and we pay very well and we want to be fair to the sales people, while their going through this ramp up stage, so there is a bit of guaranteed cost that are in those numbers. But as they ramp up, obviously that cost that commission cost as a percentage of revenue comes down, it comes down fairly significantly.

So otherwise, a pop in the second quarter I think we went from 81% to 83% on the SG&A line, but that can be specifically tied to a couple of different things that will normalize in third and fourth quarter.

William Plovanic – Canaccord Genuity

And should I think of it the way you’re paying these people if your grafts you have been paying them well, you’re almost paying them as if they generating in the lien year and sales?

Bill Taylor

On the first, I would say in the first three months or so, I would say yes, because lot of these people are coming from job where they are – they are making a pretty steady commission and when we’re putting him to a new territory where they have to develop it, we want to give them a little bit of a guarantee for the first few months to keep them fairly level and then after that they should be billing enough commission where they are paying for themselves. So I would take for the early on, I would model it that way.

Pete Petit

Plus and certainly with some these territories where it has been in terms of Medicare coverage and insurance coverage. So as those things go away, then you get into a more normal territorial management scenario.

William Plovanic – Canaccord Genuity

You know are they guaranteed for a year, six months, three months?

Pete Petit

No, no a short period of time.

Bill Taylor

So some – there is some of them are have no guarantees, some of them have up to three months guarantee, so you generally we don’t go beyond that unless it’s a very special circumstance.

William Plovanic – Canaccord Genuity

And I assume that it’s just like a high payout the first year something like that to help them transition?

Bill Taylor

We go on a standard commission after, from the beginning actually.

Pete Petit

It’s not the first year, to be honest its short period of time.

Mike Senken

Yeah.

William Plovanic – Canaccord Genuity

Perfect, thank you very much. I appreciate taking the questions.

Bill Taylor

Thanks Bill.

Pete Petit

Good questions.

Operator

Thank you. Our next question comes from the line of Bruce Jackson from Lake Street Capital Markets. Your question please.

Bruce Jackson – Lake Street Capital Markets

Hi good morning.

Bill Taylor

Good morning Bruce.

Pete Petit

Good morning Bruce.

Bruce Jackson – Lake Street Capital Markets

So is the IND that you filed with the FDA, can you just tell us sort of what the next steps are, what the discussions are like and when you might have a transition letter in hand?

Pete Petit

Well, Mike let’s see. Excuse Bruce, first of all there is a set period of time formality related to the IND process. So we’re going through that and you’re not going here by accent with specifics for at least a month or so. So we got that to deal with. The IND is a formal presentation of us moving down the pathway towards the BLA, but in the process there is a lot of data in that embedded in that 1700 pages that the FDA had to formally receive and take a look at understand the details of what our micronized product has done in the marketplace. So that’s an educational process.

Now, we’ve had discussions with the shareholders hoping that we would have clarification on the transition status of the transition agreement; frankly I hope to have that now. But we have moved on our part very, very rapidly to get this IND done completed and filed, because that’s part of the process. But I can’t speak for the AMC I think we’ve made great progress, we’ve been they helped us to great deal with a number of these issues and but they don’t necessarily move and shouldn’t necessarily move with the pace within that it actually moves out.

So we’re going to have to just be patient, I hope that during this quarter some time we will be able to give our shareholders some indication of where that’s going to end up. But I cannot and I’m learning, I just can’t make time commitments here, because things don’t move with the pace that we necessarily move it.

Bruce Jackson – Lake Street Capital Markets

Okay that’s perfectly understandable. And then with the, you mentioned during the prepared remarks that one of the areas you’re looking at for 2015 as the surgical and support area and one of the trials that you’ve got underway the use of AmnioFix with the da Vinci prostatectomy. When you think we might see some data from that trial and is this one of the markets that you intended to pursue in 2015?

Pete Petit

It is one of the markets that we’ll be pursuing in 2015, we have a publication has been worked on right now, we like to step into markets where we’ve gotten some clinical data and have gotten it through a publication peer-reviewed publication process then we feel comfortable with that, talking about the process and procedure and what we recommend the physicians to do about it. So that’s well underway and we’ll keep everybody informed as it plays out, but it’s an exciting opportunity for us. But we have more data to develop and get published.

Bruce Jackson – Lake Street Capital Markets

Okay great, thank you very much.

Pete Petit

Thank you Bruce.

Bill Taylor

Thanks Bruce.

Operator

Thank you. Our next question comes from the line of Mike Matson from Needham and Company. Your question please.

Mike Matson – Needham and Company

Hey thanks for taking my questions. I guess I was just wondering, I appreciate all the commentary on the loss of the pass through in 2015, but I had some and I guess more specific questions on that. So just I was wondering on the 2/3 size what sort of impact do you expect there given that, I know that they wouldn’t be unprofitable but the profit margin would be pretty slim for the wound care facilities that are – that would be using that product without pass through?

Bill Taylor

That’s a good question Mike. And Mike that goes back to the various sizes, I mentioned that we have actually a strategy for introducing some additional sizes into the market for instance, simply if we had a five square centimeter graft at roughly a $1000 and that would still capture according to data out there at 70% that one in the disk 70% of the wounds that are out there versus the 80% with – we have with our 2/3. So I think offering another size graft in between the two that would be much more profit for them as it going to be a big piece of that. We’ve also got a little bit more strategy relative to that, we won’t go into detail here, but suffice to say that we’re – we’ve got a number of sizes we’re going to be adding or make it better for these facilities and we have a few others things we’re doing to that will make it helpful.

Mike Matson – Needham and Company

Okay and then just one more on pass through, so in 2015 I guess you mentioned that there is other competitors that are losing the pass through, but how many competitors do you anticipate will continue to have a pass through payment 2015?

Bill Taylor

There are few that will have it, in terms of the ones that have it this year, there is not that many that have it this year. So, I’m sure there are going to be some of the new comers in the next year or two that we receive a pass through payment. But I just like to remind everybody to that just because you have a pass through payment doesn’t mean that it’s actually going to get paid. You need to have the MACs actually decide to have coverage for it. So and as we’ve shown it takes a long time to get coverage and if people miss time when they get their pass through status, by the time they actually get coverage their pass through status makes buyer. So people need to be very cautious on that, when they are looking for it. So and again just because you have pass through status doesn’t mean you’re going to actually get a payment. I think there is one other product out there today that there the smallest two sizes if I remember correctly don’t get a pass through payment at all, because their pricing is lower than the offset which you have to be above that offset pricing in order to get any incremental payment. So again just because you are have qualified for offset it doesn’t mean there is going to be incremental payment.

Mike Matson – Needham and Company

And then, the margins were outstanding at 89%, gross margins were outstanding at 89%, I didn’t hear any commentary about where we should expect this to go. I think you said in your last call, the 85% range but, given that you put up 89% the revenues per quarter only going up from here, is it realistic to assume something higher than 85%?

Pete Petit

Well, this is Pete let me first my opinion, first of all. Having done this for decades, I would say there is going to be more of a trend of our gross margin coming down somewhat rather than continuing to go up somewhat. There is all kind of issues of course blending of this product mix et cetera, et cetera. But 85% is certainly a number we – we’re very, very comfortable with, well we go above 89% we could, but over time as if you model in 2015 you would probably, would use something in the mid 80s. Our revenues next year will begin to on the surgical and sports medicine business there will be a lot of private label business there we think. But either way, there is a good problem to have in terms of trying to forecast gross margins when you’re trying to figure out was 85% or certainly 92%. So I think the trend will probably be down, Bill could argue with me on that, either way it’s for them to have.

Mike Matson – Needham and Company

Great. And then I guess just one final question on the surgical, sports medicine or OEM business, by my math it looks like the growth, I guess the client now there is about 10% on a year-over-year basis and it was flat roughly sequentially. So number one is that correct? And then number two, what – why was the growth weaker this quarter and what you’re going to – obviously you mentioned you’re going to hire some reps to focus on that area. But anything else you’re planning to do to try to get faster growth of that business?

Mike Senken

Mike maybe I can start this is Mike Senken. In terms of the comparison year-over-year it’s a little bit tricky, because in 2013 all of our micronized product was reported under surgical and sports medicine. And in starting 2014 we had developed specific SKUs for the injectable for wound care. And now that those numbers are reported in the wound care number. So there is some impact year-over-year in terms of just moving the micronized.

Bill Taylor

Yeah I’ll just add to that Mike, we’ve used our micronized, we have our AmnioFix injectable which was launched first, but we ended up having a lot of physicians wanting to use that in wound care both as a powder as well as injected. So then we later introduced our EpiFix micronized, but it was within the calendar of 2013, so we didn’t change the way we were reporting that within 2013. We just changed it effective January this year. So it’s a little misleading, the business is not really down the way it appears, because of that.

Mike Senken

Thanks Mike.

Pete Petit

Thank you Mike.

Mike Matson – Needham and Company

All right. That’s all I have, thanks a lot.

Operator

Thank you. [Operator Instructions] Our next question comes from the line of Suraj Kalia from Northland Securities. Your question please.

Suraj Kalia – Northland Securities

Gentlemen good morning, congratulations on a nice quarter.

Pete Petit

Good morning. Thank you.

Bill Taylor

Good morning. Thank you.

Suraj Kalia – Northland Securities

So Bill, Pete or Mike, I guess I just have one question, I would like to follow-up on Bill’s question earlier, to the extent that you can – can you walk us through the comp structure of the 10 year sales reps. And I’m curious to know how many of these new reps you all have hired are ex-shire reps and finally, SG&A was round if my math serves me right around 79% of sales last year. And Pete I think so you all gave pretty good color in terms of, you’ll expect synergies to come in, I’m curious how you’ll see synergies come in given everything going on in the industry. I know a long winded question, but hopefully you get the just of it? Thanks for taking my question.

Pete Petit

I would first of all, I got little uncomfortable with the fact that we’re given a lot of specifics here on our conversation and how we’re doing certain things and I’m not going to do that anymore, okay. I’ll just [indiscernible] Bill and Mike that’s our business, I know you analyst want to drop your models, but really how we hire people and how we compensate them and when we do this and when we do that, I think we’ll keep that to our sales in the future.

Now you are asking for a lot of specifics and I’m going to throw it back to you and say give me, I’m not going – we are not going to see any more questions about how we compensate sales organization, I think we’ve done enough of that. So come back to me with another question.

Suraj Kalia – Northland Securities

Pete that I’m just trying to get to understand the synergies, how our SG&A will come down, given everything going on in the marketplace, any color would be great?

Pete Petit

Okay, well first of all the discussion I had a minute ago on territory management, in a faster growing organization and understand we gone through this for decades. The faster growing organization were you would put in a new sales force on a – add on a national basis there is going to be disparities territory to territory you cannot hold sales people accountable for this ex-number of people live in territory, the number of diabetics in this territories is 3.6% therefore, therefore, therefore. There is too many disparities as we’ve developed, our sales organization from reimbursement coverage and so on. So you cannot have a territory model and drop a guy into it and say all right go to work. There is a lot of [indiscernible] circumstances.

Those things will begin to have dissipated by the end of this year. So we can get into it in 2015 a formal territory management model where we can hold our sales force accountable, the territories will be smaller, there is less time behind them, we will have a car driving distances, those kind of efficiencies will be in the work they way into the system. We’ve allowed our sales expenses as a percent of revenues to go beyond areas that frankly I was comfortable with or Bill is comfortable with. However, the invested dollars that we were getting from those investments and letting those cross escalate have been huge, couldn’t have gotten a better return on invested dollar.

Now some of that was because of our expertise, some of it because of our competitors just not doing some things they should have done. So we had a huge opportunity, we’ve taken advantage of it. Those cost now have come down now I fear alluding the fact that we’ve got some competitors out in the market now and therefore pricing is going to be an issue let me deal with that once again. As Bill said, you start back with the year and a half ago, about five or six of us got, our codes only one almost have ended up with all the MACs, a second company is ended up with the MACs we’ve almost given free coverage. The hard coverage comes when you have one or two or three published [indiscernible] trials and finally convince a number of medical directors each one of those MACs to sign off and give you coverage.

There is a several year of process here. And just because people show up and say I’m now in a market and we’ve got something it looks like the MiMedx product, we’re ready to go, we don’t worry about that. They’ve got a long hard role ahead of them. So if you’re worried about as you’ve generally have been about the competition is coming something is going to happen dramatically to our revenues, frankly we don’t worry like that, we’ve been around a long-term, we’ve done this before and we know the dynamics of the marketplace. I won’t allude to the fact that our sales people ought to be better trained and more effective, because number of them came from the Shire organization you asked about that a minute ago.

With the well trained people we’ve added additional training we’ll continue to do that, a competitor coming into this market today as a tough road ahead of them. And I’m, as not all to do with the fact that we’re pretty good in what we do. It is just some real constraints they have to work their sales through in order to get the Medicare coverage much less the other coverage. That’s why they are heading towards the – the VA market, and they are going to find same kind of issues there. You can’t just show up and say, hey I’m here model looks like theirs, where is the evidence of base medicine. Physicians generally have been raised in this era with evidence of base medicine prevails. So us clinical trial, show us scientific information, so those are things that Suraj we just don’t lose a lot of sleeper because this is the natural process. Is that help?

Suraj Kalia – Northland Securities

Thank you very much for taking my questions.

Pete Petit

Thank you. Our next question comes from the line of James Terwilliger from Newport Coast Securities. Your question please.

James Terwilliger – Newport Coast Securities

Yeah, hey guys can you hear me.

Pete Petit

We can.

Bill Taylor

We can. Good morning.

James Terwilliger – Newport Coast Securities

Good morning, congratulations on a great quarter. I’m new to the story and a lot of my questions have been answered, but I would like to talk about R&D a little bit. When I look at R&D year-over-year I think it’s almost doubled, I think it’s great that you are increasing your R&D expenses to future growth. So two macro questions on R&D, how is the headcount trending in terms of the number of people that you have in terms of your R&D workforce, I don’t care about compensation, I just want to see the growth in the headcount? And then the second question on R&D is since I’m new to the story what are the two or three things that you’re most excited about that you are comfortable talking about on this call that’s in your R&D pipeline?

Pete Petit

Well first of all, a lot of our R&D happens to through the expenses associated, happens to be expenses associated with our clinical trials. We necessarily had clinical trials to start with through focused on reimbursement. After we satisfied our sales of the efficacy of the product, our sales then we want to develop lot of clinical trials and we’re continuing to add clinical trials here on our quarter-by-quarter month-by-month basis. We have a lot of things going on there.

The things that we will be interested in talking to shareholders about have to be things that we’re not necessarily concerned about from a competitive standpoint. So there is going to be some things we just don’t talk about and I think the shareholders you have to understand that there are competitive issues here. We’ve already talked about the urology area, we’ve talked about some other areas I’m just know that Bill pick up here in timing, but the R&D function we’ve hired a number of new individuals in the areas another MD has joined our staff David Mason. David has a lot of experience with clinical trials and he has worked with some of the big pharma organizations. He is very experienced there, we’ve brought another PhD in who was with ABH or Shire, very experienced in this area.

So we’re continuing to add staff as necessary, but I’m going to let Bill kick around a couple of products with you. But, just to understand that it is not just product development here they are clinical trials embedded in that number.

Bill Taylor

And related to that just had a macro level give any actual numbers here, but at as a macro level as our R&D expenses went up as you mentioned about two times, you have not doubled the size of our staff over that time, but mostly the increase has been in the clinical trial areas Pete mentioned and a lot of those clinical trials have been specifically related to wound care, but other trials are also related to other surgical applications to help us do two things, number one help to drive some data for our sales group, but the second thing is to help drive some incremental reimbursement in these areas as well.

Wound care is challenging that’s been to get where we are right now is actually probably one of the easiest areas with respect to reimbursement, because it’s when you do a clinical trial there you can see the result in our case in six weeks, in some cases even less than that, whereas in the surgical cases it’s a lot harder to get the proof that we’re looking for on those, so the clinical trials necessarily take longer.

But talking about products we talked before about our AmnioFix being used in spine cases and also in cranial cases. So one of our clinical studies there is in craniotomy that’s probably now to talk about that before, and then we also have another spine setting in posterior spine, essentially in looking at the performance of our tissue as a barrier to reduce scar tissue that’s with both of those doing, we think both of those studies are going to help drive potential reimbursement down the road.

Turning to other areas, probably the largest area that we’ve been talking about is the [indiscernible] area, where we’ve also done some other animal studies in a few other areas that you’ve mentioned before, probably not going to go into a lot of detail now. So like in the coming quarters, in the next probably one or two quarters we’ll start getting a little bit more business there.

Pete Petit

Let me add one same to that, I think as some of the questions which you’ve asked are probably best dealt with in a management presentation. So MiMedx is planning the whole on Analyst Meeting in New Year City with dates going to firm up here with some calls with some analysts. But probably in the mid-to-late September range. And at that time I think we can commit to shareholders to be a little more specific about some of these other product areas and we will probably, we can explain it more clearly and maybe show some in terms of specifics related to it.

James Terwilliger – Newport Coast Securities

Okay, thanks for taking my questions and congratulations on a great quarter.

Pete Petit

Thank you.

Bill Taylor

Thank you very much.

Operator

Thank you. This does conclude the question-and-answer session of today’s program. I would like to hand the program back to Mr. Petit for any further comments.

Pete Petit

Well I thank you all for being on the call. And the interest and confidence you’ve expressed in our management team. Hopefully we’ll continue to do what we’ve done this quarter and so produced some certainly good to exceptional results and continue making the progress we’re making. We certainly as a management group feel that way and so does our Board of Directors. So thank you very much, I appreciate the questions. And we’ll keep you informed.

Operator

Thank you, ladies and gentlemen for your participation in today’s conference. This does conclude the program. You may now disconnect. Good day.

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