Thanks. Much better, so starting off, would you provide a background on yourselves?
Sure. Yeah, I'm the President, Chief Executive Officer, and Chair of the Board. I joined Organogenesis in 2001, actually, when the company was still public, and my role was to negotiate the rights of the product back from Novartis for the product Apligraf that we had, and build out the organization from a commercial perspective, build out operations, address product access issues, and build out the sales channels, and I've been doing that ever since.
David Francisco, CFO. I've been with the company for about three and a half years. Spent the prior 20 at a company called PerkinElmer, which was a life science tool company in, you know, that space, so.
Great. Gary, you wanna walk through the history of the company, how it's evolved over time?
Sure. So Organogenesis has really been the pioneer of the regenerative medicine field. It formed in 1985, based on technology out of MIT, Dr. Eugene Bell's lab, and did primary and translational research from '85 all the way to 1998, when the company launched its first product, Apligraf, which was the first product ever approved by the FDA that was manufactured living and shipped living. And today is the only product in the space that actually has an indication for diabetic foot ulcers and venous leg ulcers, and truly is the gold standard in wound care, even today. And the company, you know, was a one-product company until 2014. 2014, we acquired two products from Shire Pharmaceuticals, which was Dermagraft and TransCyte. Dermagraft is a PMA-approved product for DFUs, and TransCyte is a PMA-approved product for third-degree burns.
So though the company expanded its portfolio, we still were a below-the-knee company with a TAM of about $2 billion at that point in time, and we continued to expand, and we launched our PuraPly brand products and PuraPly Antimicrobial, which was one product unlike any other product, which is purified collagen and a broad-spectrum antimicrobial, still the only skin substitute that has those components, and really changed the company, and we now could treat wounds head to toe, increased our TAM in the wound care space to about $10 billion. And that really did change the company. It changed the procedures that we addressed. Again, we could address everything from head to toe and really changed the dynamic of the company.
And we continued to grow, and in 2017, we acquired a company called NuTech Medical, where we acquired our placental, pain, and ortho fusion technologies. And at that time, we increased the TAM of the company to about $25 billion, which is what it is today. We went public again in 2018, and today we have nine products commercially on the market. We have five robust products in the near-term pipeline, and we have four technology platforms that we use to drive future growth. So from a one-product company, from an idea in Dr. Eugene Bell's lab, to a $25 billion TAM and a significant commercial infrastructure and product pipeline.
Great. And then looking at those nine commercial products, maybe highlight two of the more, not necessarily important, but contributors to revenue, what the competitive landscape looks like there.
I'll start, and you can jump in, Dave.
Sure.
I mean, we sell on a portfolio approach, so our products cover the entire continuum of wound care, so the three phases of wound healing: the inflammatory phase, you know, the regenerative phase, the proliferative phase. So we sell based on that algorithm. So all of the products are important. PuraPly is the first line of defense because of its antimicrobial capabilities to get the wound out of the inflammatory stage by eliminating the reformation of biofilm, and getting it out of that inflammatory stage, you know, which it has to get out of before it's going to heal.
And then you move to our amniotic technologies, both our living and dehydrated, and when you have significant comorbidities with a patient, and they're really struggling to heal, that's when you use a bioengineered skin, like an Apligraf, or a Dermagraft when it was on the market.
Yeah, we haven't highlighted the exposure that we've got to the current LCDs yet. This is a proposed LCD as opposed to a final that we saw last year, so we put some guardrails around that last year. We haven't done that yet, and I think, you know, to Gary's point, we've got products across the spectrum of, you know, continuum of care, and we've got the capability to the extent that PuraPly is on the non-covered today, you kind of shift some of those products that are covered, you know, onto those kinds of wounds. So-
Okay.
A lot of switching internally.
Yep, so you alluded to the LCD. Maybe for those less familiar with some of the reimbursement dynamics, can you walk through the proposal, what it means for you guys and the market, and how you see it playing out?
Sure. So, the LCDs, all seven of the MACs in a coordinated fashion, put out a draft LCD. They were all very similar. It was coordinated, apparently even through CMS, because they issued the press release, so clearly it was a heavy focus on the market, as it should be. And we've been pushing for reform for a long time, so we think that long term, this is a good decision. It needs some adjustments and tweaking, for sure. But, what the LCDs did is they basically in the skin substitute market, approved fifteen products and non-approved over two hundred products, and that list of two hundred is growing every day as new products keep coming on with no evidence, and therefore, will be on the non-covered list.
That represents about 87% of the volume of product sold in the market today, so an enormous market opportunity. We feel extremely confident with the size of our sales force, the skill level, the clinical skill level of our sales force, our brand equity, that we will be able to convert our customers who are... We have some products on the non-covered list, to our covered products and, you know, take advantage of the market share in the short term and long term. So of the 15 products that are approved, we have three. Two are commercialized, Apligraf and Affinity. Six of the products on that list are really surgical products, so they don't compete in the wound care space, and six are basically competitors in the wound care space.
So we'll be competing with those six products with our two commercialized products, and when we bring Dermagraft back at some point, assuming it's still on the approved list, which we believe it would be, based on the data that it has, we'll be in a really strong position. We also have some additional clinical studies that we've submitted as part of the comment period for two additional products that we have that are not on the list, that we expect will be on the list, and a clinical strategy to get additional products on the approved list in the second half of next year.
Great. And then in terms of, once you have some of the trials done, what does the process look like for getting onto the list?
Yeah, from our perspective, our expectation is, at least in the PuraPly trial, which is the first one that we had initiated, we expect that trial to be completed by sometime in the second quarter. You know, we've got to go through the statistical analysis and such, and then, the expectation is it gets published maybe in late Q2, 2025, or early Q3 2025. There's probably a 45-90-day, you know, period in between, that and getting it back on the covered list, is our assumption. And so we'd expect to have that, you know, late Q3 or Q4 of next year.
Great. Switching gears, can you walk through your ReNu program?
Sure. So, really excited about ReNu. You know, if approved, for us, it certainly will be transformational. So we completed our first phase III trial, 515 patients, and successfully met the primary endpoint, which is a statistically significant reduction in pain, and the first secondary endpoint as well, which was a statistically significant maintenance of function. So both of those were met with a very strong p-value. In subgroup analysis that we've done, we uncovered that the most severe knee osteoarthritis patients, which are identified as KL4s, had similar pain reduction as the moderate to KL3 patients as well, which is a significant finding. There is no solution, there is no approved product for KL4s. That represents about 15% of the osteoarthritis knee market. So that is unique in the space.
If approved, and if we get an indication for that, that would significantly expand the TAM available for ReNu. So really excited. We completed enrollment in our second phase III trial. We had a Type B meeting with the FDA. They confirmed we needed to complete our second phase III, which we completed enrollment at the end of Q2. Last patient last visit will be Q2 of 2025, and we expect to be filing the BLA in Q4 of 2025, and hopefully approval in Q4 of 2026.
That's great. And maybe taking a step back, can we walk through the disease state of knee OA?
Mm-hmm.
You mentioned, you know, a couple different types of classes of patients.
Mm-hmm.
Just walk through what those look like.
Sure. So, you know, you have moderate, which are KL1's, and KL2's, and KL3's, and KL4's. That's the continuum. And, you know, at each step, the disease state usually more pain in KL2's, and in function in KL3 and KL4's. And the treatment algorithm is, you know, NSAIDs, as you're in, you know, moderate to KL2's. You start moving into physical therapy, then you move into HA. Excuse me, steroids, then HA, and then unfortunately, a total knee replacement, which is pretty invasive. Very effective, though, but extremely costly and invasive. So the treatment algorithms now are basically NSAIDs, physical therapy, steroid injections, and HA.
Got it, and then I think you guys have announced maybe a couple new products coming out, in the business?
Yeah, in the surgical space. You know, we're pretty excited about it. It's actually a line extension of our PuraPly AM product, and so that product was doing quite well in the surgical channel. Albeit starting from a small base, but it was really gaining traction. But what we realized in the OR, they needed larger sizes. So we've gone through a plan to introduce four new SKUs. Three of those are on the market today, and the fourth one will be coming in the fourth quarter.
Great. And then maybe just summarizing some of the financials. Recently, you had another strong Q2. Q1 was great as well.
Yeah, we did. We had a really strong second quarter. We were pleased to see the growth up 11%, you know, and that was in excess of what our expectations were. So we were pleased with that. As you said, Q1 was strong as well, so we really saw Q2 as a follow-on of that momentum that we saw in the first quarter. So we're pretty excited about that. Great first half. Obviously, you know, have some concerns that the LCD may have some impact in customer buying behaviors, as we've talked about on our earnings calls and such. But, and the primary areas where we saw that was really in our dehydrated products and then also in the office channel. So saw some good growth across those areas.
... Sure. And then in terms of your assumptions of when we should get past these reimbursement headwinds, any thoughts there?
Yeah, what we've indicated externally is our expectation, at least when we guided, was it would come into play in the 1st of January 2025, is when we would expect to get it implemented. There's a forty-five day window before it's, you know, when it's finalized and goes into effect, so that would have to be in mid-November. And as days go by here, it might, you know, push out a little bit. We're just not sure, so we're not getting a lot of visibility from any of the authorities at this point.
Makes sense. And then in terms of cash generation, how should we think about that over time?
Yeah, I mean, I think we did have a little bit of cash burn in the first half. I think that was primarily related to some AR buildup. So we had some investment in working capital based on the fact that we were returning to growth and had, you know, good solid growth, 57% in the first half. As far as liquidity is concerned, as you know, we've got $90 million of cash, $63 million of debt, so we're in net cash position. We also have 100 million of working capital and a $125 million undrawn revolver, so I feel like we're in pretty good-
Good spot
... from that standpoint. Yeah.
And maybe looking at 2025 as, I think 2024 is gonna unfortunately be around reimbursement, what are the top initiatives for next year?
Yeah, so 2025, it will, excuse me, will really depend on when the LCD is enacted, which products are on, which are not, you know. So, I mean, we have to gauge that as news comes to us. But, you know, clearly it'll depend on how much disruption is in 2025. But, you know, obviously, we'll continue to invest in the BLA and the long-term prospects of the organization. So-
Mm-hmm.
We're very interested in continuing to do that and, you know, hope that that disruption is as minimal as it can be.
Great. Any questions from our audience? All right, if not, I'll leave the floor with you guys for some closing remarks.
We appreciate the opportunity. It's really an interesting time in wound care. It's a bit disruptive, but we think based on where the regulators are moving and that the pace that regulation is moving, that the market is gonna stabilize. That's been our focus and our belief for the last four or five years as we continue to lobby for changes on the regulatory and reimbursement side. We think the LCDs will eventually settle in on the coverage side, appropriately, based on appropriate data. Then on the payment side, you know, CMS has indicated for the last three or four years, there is gonna be an adjustment on the payment side, such as bundling.
We think based on our interactions, and the fact that they haven't really created the same bundle in the office as they have in HOPD, that's not the model, 'cause that does not work, and certainly won't work in the office. So and I think they understand that, and they're looking for input. So we're feeling pretty good that long term, that's gonna be a stable, growing market for us. I mean, the secular tailwinds that drive our markets are strong. Aging demographics, obesity, diabetes, vascular disease, the markets, the broader market's growing 6%. The skin substitute subsegment is growing at 12%. So that side of the business, we think, settles down over time, and then our pain and surgical business with ReNu is pretty exciting, so we look forward to the future.
Yeah, as do we. Thank you for being here.
Thank you.
Thanks, Russell.