Bill Taylor
Analyst · Needham and Company. Your line is open, please go ahead
Thanks, Pete. Good morning everyone. First quarter played out differentially [ph] as we anticipated and we’re very well positioned to meet or exceed our increased full year projection. We anticipate our quarter reported growth will replicate the primary [ph] established last year. The seasonality of the first quarter is well established and the rest of the year will show accelerated growth. Our team did a great job in strategic and tactical planning last year in preparing for this year and the evolving market dynamics. The planning it takes to successfully manage these market variables is extremely complex. Frankly it’s so complex that many of our competitors refused to give any revenue guidance. Fortunately our team is very seasoned and understands those variables and what we can do to strategically to affect them in a positive way and for three and a half years we’ve shown that we can accurately project our performance quite well. As you can see from our press release, we increased our guidance $180 million to $ 190 million for the year, which is a sign that we feel very good about our opportunities this year. Of course it helps that our business is very diverse and although our platform technology comes from one source, the placenta, it certainly has a multitude of applications where it can be used and that diversifies our customer base and therefore gives us many opportunities to grow even when the market dynamics in certain sectors in a given quarter. People often ask me how we can be so accurate of our projections overtime, particularly with the companies growing at more than a 100% per year over three plus years. Really comes down to the multitude of opportunities that are provided by our Purion Process tissues. Remember we’re regenerative medicine company, not just wound care. So when you have so many opportunities for growth and you plan well on multiple fronts, but still if something negative happens on one or two fronts, you still have enough other opportunities to meet your numbers. And then if things go the right way and you did a very good job planning and those negative things don’t happen, then you exceed your guidance. It’s really just as simple. So a good example of this happened in the first quarter. We did a very good job planning and executing and we planned for typical amount of inclement weather, by the end of February we were right on target with our planning. Then early March, one more big winter storm came through that made the winter a bit more harsh than we planned for, shutting down wound clinics and physician offices from the Mid-West all the way through the North East. Several offices were shut down for a few days. We just missed the upper end of our guidance by $200,000. So if you do the math, you’ll notice that our first quarter revenue averaged just over $600,000 per business there. Now, remember the spread between our low and high guidance was $1 million for the first quarter, so our margin for error from top to bottom was just over one day’s sales, so think about that. As the weather been average, we would have exceeded our guidance by a very nice margin. Now, let me talk about a couple of the key factors from the first quarter, the factors that I think we frankly managed very well. First, as everyone knows, the biggest change for us in the quarter was the expiration of the pass through status for EpiFix. I’ll remind you that some people mistakenly thought this reflected the majority of MiMedx’s revenue. As we’ve stated in the past, it’s only related to large EpiFix sizes used in hospital outpatient or ASC settings with Medicare patients. It does not relate to any of our sales to federal facilities nor does it relate to grafts sold to physician offices or grafts used in DRG cases nor does it reflect on graft sheets in patients with commercial insurance in hospital outpatient centers. It does not also apply to surgical or it’s surgical or sports medicine business. Also, I’ll remind you that an estimated 50% EpiFix grafts used in hospital outpatient settings last year were not eligible for the pass through payment because they were less expensive than the price threshold to qualify for that added payment. To mid last year we indicated the applicable portion of our business that could be negatively affected estimating around 8% or 9%. When the business is growing at a 100% plus a year, such an effect is certainly quite smaller relative to our full year revenue growth. Now that said, we still want to ensure that patients in need of our innovative technology have access to the best product in the market. We developed a strategy during the year, whereby we offered additional sizes of bundle [ph] or we developed a mesh version of EpiFix. Our regular grafts up to 7 centimeters are under the bundle, which represents some 80% or so of the DFUs and VLUs. Then with our meshed configuration, we can cover wounds up to almost 20 square centimeters. According to our data from last year, this should get us coverage around 96% or 97% of the wound in these outpatient clinics. One thing to remember is that effectively this meshed EpiFix is a lower dose being applied to a wound as compared to our regular sheet EpiFix. So it may take an extra application to fully close the wound, which will partially offset the lower price in many cases. By the way our mesh is the same as our regular sheet EpiFix, but with punched holes. It is not like a skin autograft that is penistrating and stretched, it’s simply punched holes. By way of example, our large mesh can cover that wound that I mentioned up to about 28 square centimeters, but it only uses 12 square centimeters of material. So the sales price of the material is less than a non mesh sheet of the same size due to it having less material. Our portfolio of EpiFix products is by far the widest selection in this industry and we expect it to enable us to grow significantly in this coming year. Another item consider that gives you an indication of the expected growth this quarter is that our mesh was only available for part of the quarter. We launched it our national sales meeting in early February. As you can imagine, a lot goes into a new product launch such as GPO and IDN contracts that need to be updated, submission to value analysis committees, training of our sales representatives et cetera. We made significant progress during the quarter and expect a very nice upswing in mesh sales this quarter and beyond. Now, briefly let me mention our GPO and IDN contracts. You’ve seen some information related to these over the last few months. I’m not sure the full expect [ph] of what we’ve done here is really understood by shareholder, but I can tell you that our smaller competitors are definitely feeling the effects. Over the last eighteen months or so we’ve been quietly working diligently with these various GPOs and IDNS in securing contracts and now they get us on contracted thousands of hospitals, but based on a clinical and scientific body of work as well as our cost effectiveness, it puts us in a advantageous position relative to our competition. Many of our contracts are set up facilities that opt in to a specific GPO contract must either use a MiMedx product at an 80% or higher committed level or in some cases that the exclusive amniotic tissue in their hospital. Additionally a few of our competitors that recently issued press release is indicating that they signed a specific GPO contract, but they left of those particular press releases with the fact that we have the same contract, but with the exception that if a hospital opts into it they’re committing to an 80% MiMedx usage. So just because you’re in, doesn’t really mean you’re in. Within the last year we were roughly in 50% of the wound care centers across the country. These GPO and IDN contracts will really help strengthen the position in the accounts and help and grow into the balance of those centers throughout the rest of this year. One are we had already spoken about much, we’re gaining some tractions, our product lines that are used in surgical cases for large wounds such as burns, surgical dehiscence. Many of these can be classified as wounds, we consider them as part of our surgical DRG business and as such are not reported our wound care numbers. You can see from our press release that our surgical business grew this quarter pretty significantly and a size of a portion of that revenue is more grafts used in this area. We are also rolling out this year our burn graft called EPIBURN. It’s specifically conducive of burns and we’ve had some very nice success early on and we expect to continue to significantly to grow this business. This product line consists of larger grafts that are used in various burns of the face, neck, ears and around joints where contraction can be a factor of the healing process. Truly, for those special areas at this stage rather than the very large torso or leg burns. We’re very excited about this new focus as well as other surgical wound grafts. Also our AmnioFix group of products grew this past quarter as well, going on with our focus on internal surgical applications. We attended several trade shows in the quarter and had great physician interaction and interests in orthopedics and urology. Our focus on building our urology business is going very well with numerous top robotic surgeons trialing the product and we’re kicking off our prospective RTT [indiscernible] technique to compliment our first published study that should we’re turning sexual function about half the time it took, without the use of the product. Regarding our federal business, you probably noticed that it grew in the first quarter. I still believe that there’s a substantial amount of business that we can target in these accounts that we’ve not yet touched. Some of you may have seen the $6.5 million BPA or Blanket Purchase Agreement for federal accounts that we recently signed. We purchased paid [ph] another few of these overtime, but this is a big one and I expected to sign several more of similar or larger dollar volume over the course of this year. Also, I’m sure many of you may be wondering about the status of our agreement with our federal distribution partner AdCare [ph]. The original three year contract was set to conclude this month. We’ve been very pleased with our partnership over the past three years, as they’re a well established company with years of experience with the federal government and are also a Service Disabled Veteran-Owned Small Business or SDVOSB. We extended our contract with them and we also have our own contract now with the federal government. We decided that we should begin the process ourselves and early this year we were awarded our own FSS contract. We can sell into the market through our own contract or through our distributor. A contract extension with our distributor enables us to transition the business over to our contract through mid next year, but also enables facilities that desire to order a product from an SDVOSB to continue during that period of time. We’re very satisfied with our relationship and we could not have entered the federal market as quickly or as deeply on our own as we did by partnering with them over these past few years, thankful for that relationship. With the growth we’ve experienced in the past three years, we’re now in a position now to have our own contract and fulfillment commitments on our own. So we’re going to use our new agreement to expand our federal business and in upcoming calls, I expect to just update you on some of these initiatives that should continue to drive incremental revenue for us. As we do so, we may have some quarter-to-quarter variability’s, since some of these orders can be stocking orders rather consignments, I expect to see a very strong trend overtime growing the business significantly. Now, relating to our field sales force. We continue our expansion activities and have brought in some additional strong sales executives and management. I think we had roughly a 140 or so field sales personnel in the third quarter last year. We added about 28 or 30 more by the end of the year to get up to about 168 or 170 field sales personnel into 2014. In the first quarter of this year we added about another 25 sales professionals to bring our total to 193 at the end of the quarter, we should hit 200 any day now. That means we have at least 25 people that have been here for three months or less and above 50 that have been here less than six months. As you know in the past it’s taken our reps on average our about six months to get to the million dollar pre-year run rate. This stage we might be a little longer maybe seven or eight months based on our hiring profile, but doing the simple magic and see that we expect a strong second quarter and rest of the year in terms of sales growth. If we can hire another 40 or so sales professionals per year [ph] through our current plan by the end of the year, we’ll be in a strong position ending this year and going into next year. Now, talking about our clinical studies, as you know we submitted our first IND for [indiscernible] last year, we intend to begin Phase IIB trial in the first quarter. I’m very pleased to announce that we have four sites enrolling patients and a total of 11 sites that are in process. This year [ph] we’ve already enrolled and randomized a number of patients out of our total of a 146. Our projections are that we may be able to complete enrollment of this study during this calendar year and we’re pushing hard to do so. And for a second IND, we’ve been assembling additional clinical data from the field to improve our position for [indiscernible] injectable study. And once that data is summarized, we’ll submit our second IND. Our sheet products, we have an EpiFix study that will hive over a 100 patients in all surely and then we expect to close it out and complete the study later this quarter or early third. That will continue to add to our body of evidence demonstrating that EpiFix is truly the best in class in chronic would healer. We have another five RCTs in process and another half dozen in the preparatory stages. Our commitment to leading the industry in scientific and clinical research definitely continues. Now, I’ll talk briefly about product development. Normally we don’t talk a lot about these evolving projects, but we are excited as Pete mentioned about expanding our focus on CollaFix. Our main focus over the past several years has been on our amniotic technology, although we’ve quietly been moving CollaFix along. We talked in the past about finding uses for the placenta material that we’re currently through our way, happy to announce that we’re elevating the priority of CollaFix and now are in the process of converting collagen source to be human placental tissue rather than bovine collagen. I’m sure that’s striking a chord with the long time MiMedx shareholders and we’ll have a number of them very excited. Those of you don’t know what CollaFix is, I’ll explain it a little bit deeper than what Pete did. This is one of the two original technologies on which MiMedx was founded and basically its proprietary technology that purifies collagen to about 99.9% pure collagen then it process it into a continuous fiber about the size of a human hair, then it’s cross linked to make it stronger. It can then be made into various woven of rated constructs that can be used in tendon and ligament repair, but as well in injuries such as specially sutures or meshes. The fiber is about twice as strong as the human tendon with about the same stiffness, which allows various contracts to mimic native tissue bio mechanics. We’re very excited about this renewed focus on CollaFix and in how it will be a fantastic addition to our surgical and sports medicine line of products. A little later this year, we’re going to talk more about our first few products that are in the timelines associated them, but I’ll give you a hint. Several are expected to be five, ten Ks, so the timelines of the launch will be reasonably short. So again we’ll give you more to come in future calls. And one last thing, you may remember on the last call I mentioned, we negotiated at least on a new 25,000 square foot office building in our current business park. It is signed and the construction has begun and the target completion date is early June. So we’ll move several of our groups in that building in the summer and create a bit more space for us here to expand. We’re very excited about this growth and look forward to the next phase in growing to $200 million and beyond. With that I’ll turn it over to Mike.