Bill Taylor
Analyst · Craig-Hallum Capital
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.